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Fast and predictable market access p. 11

Outcome of advanced oncological treatments to change significantly p. 13

Better understanding of regulatory affairs p. 15

Life Science

Creative activities are clearly health-promoting p. 27

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Suppliment to Affärstidningen Näringsliv, autumn 2020

West Sweden – Epicenter for Medical Technology and Biomaterials p. 2–13

p. 18 Volvo Cars meets Life Science in Sector Convergence

Strength, expertise, and drive to take lead in medical development p. 4

Meet the specialists in Osseointegration p. 7

p. 23 Emerging companies welcome at the AstraZeneca BioVentureHub


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West Sweden The West Sweden region has traditionally been a hotbed for people looking for a better life for themselves and their families. For centuries, people have travelled here and begun to build their future.

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y own great-grandfather came to Gothenburg with his brother from the border area Denmark and Germany sometime in the middle of the 19th century. They were entrepreneurs and started factories and businesses here. Herring was harvested and there was a need for conservation and a factory in Gårda was established. Per-Ingvar Brånemark, a more well-known immigrant from Skåne, came to Gothenburg about a century later and then helped in building the University of Gothenburg’s Medical Faculty’s reputation in medicine on the international stage. Through his creativity and entrepreneurship, people around him have continued to create ideas, research groups, companies and treatments for various diseases.

What were the results of Professor Brånemark’s research and development efforts? From a corporate perspective, Nobel Biocare and Entific were formed, both pioneers in the development of treatments for edentulousness as well as bone-anchored hearing aids. Nobel Biocare is still active, now headquartered in Switzerland and a world leader in its field. Entific was acquired by Cochlear, an Australian company, with its research unit still operating from Mölnlycke, Gothenburg. Just like Nobel Biocare, Cochlear is a world leader in its field. Strong global competition in the field of hearing disorders is now provided by Oticon Medical, another major medical device company with R&D center in Gothenburg and headquarters in Copenhagen.

Relationship between technology and medicine There has always been a close connection between technical research and education and medical practice. Chalmers University of Technology and the Sahlgrenska Academy (the very heart of medical research at the University of Gothenburg) and the Sahlgrenska University Hospital are all located in the vicinity of each other.

mers and the University of Gothenburg. These have been relatively successful. Examples are the joint research programs within Transport and Materials, respectively, which were granted within the framework of the Swedish Governmental research strategic initiatives. Within Chalmers and the University of Gothenburg’s Area of Advance Materials Science, Materials for Medicine is an important profile. In this program, basic studies are focused on, among other things, future sensors, new materials designed at the nano-level and advanced experiments with a focus on new, bacteria-repellent materials. A large number of graduate engineers will be attractive employees in the region’s medical technology companies. Today, research and development projects are run in teamwork where different fields of science interact. However, the need for specialist functions is and will always be important. The discussion can also be reversed: do doctors not have a need to gain a certain deeper insight into the technical solutions that are continuously introduced in healthcare? The frightening absence of such insight has been demonstrated in cases known from television. A physician usually has limited knowledge of concepts such as material biocompatibility, prosthetic materials and stem cells, especially when materials, cells and drugs are combined as part of advanced treatment. On the educational side, there is a lack of a comprehensive so-called Biomedical Engineering education in Gothenburg. By introducing an undergraduate program in Medical Technology in Civil Engineering for the first time this year, Chalmers has taken an important step in stimulating students in technology to increase understanding of medical issues, methodology and clinical areas. Another example is the initiative taken by Sahlgrenska University Hospital in which up to ten doctors in specialist training are offered a joint contact area for technology and engineering (Läkartidningen. 2019; 116: FMZU; Läkartidningen. 2019; 116: FXUL). The program runs for two years and accounts for 20 percent of working hours. The training program includes, among other things, making your own innovation project, from needs analysis to finished concept. Participants will also get to try out innovation environments outside the hospital.

How is West Sweden Medical Technology doing and what does the future hold? Sahlgrenska University Hospital (SU) and Sahlgrenska Academy (Medicinareberget).

For several decades, collaborations have generally been conducted at individual or research group level. An important breakthrough for longer-term collaborations has been recent joint strategic applications for major research programs from Chal-

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The short answer is; Excellent! And the reasons are as follows:

1. Creativity en masse Creativity a crucial factor Creativity is a crucial factor in research, and of course also in development projects in the medi-

cal technology industry. Problem solving requires people who dare to challenge current ideas. A consideration of research and industrial development in the field, with a focus on creativity and problem solving where real needs (patient needs) exist, provide many examples, some of which are mentioned here. When Brånemark and co-workers challenged common beliefs by showing that anchoring of teeth could take place via implants, the dental profession was challenged. After a long time, and with a lot of setbacks, the breakthrough came with this treatment. The concept of titanium osseointegration revolutionised dentistry globally.

obvious that Swedish dental biomaterial research has had the ability to regenerate even after the Brånemark era. Another valuable example is the Chalmers chemist Tomas Fabo’s invention of what became Safetac, a soft silicone-based wound treatment dressing, with great patient benefit and which has since become a big seller for the Gothenburg company Mölnlycke Health Care. In 2011, Fabo received the Stora Teknikpriset, established by Ny Teknik and Vinnova, for his efforts.

2. Major unresolved global challenges in focus Medical device-related infections Prevention and treatment of infections is one of the most important global health goals. It is also one of the strategic global goals that the University of Gothenburg addresses. The creation of the Center for Antibiotic Resistance Research (CARe) is an excellent initiative and a good example of how the academy can act with the times.

Schematic image of controlled tissue healing with membranes that separate soft tissue (top) from bone and bone defect (bottom).

When Dahlin, Linde and Nyman and others challenged their colleagues in the dental profession a number of decades later, the idea was to facilitate the regeneration of bone by shielding damage and holes in bone from competing cells from soft tissue. Membranes made of millimetre-thin plastic materials, with varying degrees of porosity and permeability, to gases and proteins but not soft-tissue cells, such as fibroblasts, were used. From the beginning, the treatment was only twostep-based with insertion of membranes, waiting for new bone formation and in a second session removal of membranes. Today, twenty years later, there are also degradable and malleable materials and the recent years’ continued research in Gothenburg has mapped some of the biological mechanisms for this so-called controlled tissue healing. This has created good conditions for new treatment concepts with membranes, largely run industrially through the international company Neoss, with its R&D center localized on Medicinareberget. Does the membrane treatment have anything to do with dental implants? Interestingly, it has been shown that controlled tissue treatment with membranes is used in connection with no less than about 40 per cent of the treatments with dental implants. From a Swedish odontologic perspective, both of these creative efforts play a major role: the treatments benefit patients and create growth and jobs. From an academic point of view, it is

Is it particularly important to prevent the onset of infection and improve the treatment of patients with implants or prosthetic treatment? Figures show that infected implants and prostheses account for about half of hospital-acquired infections. They are extremely difficult to treat. The basic hypothesis is that a so-called biofilm of bacteria can develop on surfaces. This biofilm develops into its own ecosystem where even super-high doses of antibiotics are barely enough to kill the bacteria.

Bacterial biofilm (Staphylococcus aureus) on a bone surface (Courtesy: Annika Juhlin and Furqan A. Shah)

A very important research and development work is to optimise not only properties of materials (for example to prevent or minimise bacteria settling on the prosthesis surface) but also medical preparations (patient, surgical technique, early detection and diagnosis of implant-associated infection, biofilm eradicating antibiotic dose and so on). The area has an obvious significance and many Swedish and West Sweden-based organisations and companies have this field on their agenda. For several years, the West Sweden wound care companies have developed in-depth knowledge. Essity, Abigo and Mölnlycke Health Care all have a track record of products for the treatment of advanced wounds. University of Gothenburg and


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Epicenter for Medical Technology and Biomaterials Chalmers, the research institute RISE and relevant clinical specialties (dermatology, orthopedics, et cetera) are also linked in this. It is likely that the central or regional funding organisations will find a need for larger, long-term investments in the area. West Sweden has a competitive advantage through the good collaborative climate between academia, clinic and medical technology companies.

Sustainability, simplification, fidelity to nature Synthesis of new materials with sought-after properties, processing and post-processing, cleaning, sterilisation and packaging are important parts in the development cycle of medical devices. For many products, traditional subtractive processing is a key step, but for many researchers and engineers, the dream is to be able to build a prosthesis or organ from scratch, without taking away any parts, with durability or elasticity, with living cells and stimulating factors and a frame that enables adequate cell function for a specific period of time.

part of tissue engineering is now spread around the world. Despite the great potential, however, the clinical use of all or part of organs created in test tubes is still in its infancy. Swedish organisations have initiated scattered, half-hearted direct tissue engineering investments during the past 25-year period, and the academic and industrial scope and development in this area in Sweden can currently be considered relatively small. The time span from idea to realisation is probably large and long-term (risk) capital may have been lacking. A Swedish exception is the international company CELLINK’s success with, among other things, the development of a so-called bio-ink for a broad use in tissue engineering. This entrepreneurially led company is located in Gothenburg and has established prestigious collaborations with international research groups and at the same time attracted long-term investors.

prostheses) can be manufactured using additive manufacturing and integrated into living tissue.

A second Gothenburg / Mölndal example of research, development and industrial development in additive manufacturing is the success story Arcam.

West Sweden is an important node

Arcam, partly based on Chalmers research, early developed a technology that enables the manufacture of complex parts, such as aircraft turbines and joint prostheses by, with the help of a three-dimensional electronic drawing, directing an electron beam at metal powder in a machine with a vacuum. The technology is called Electron Beam Melting (EBM) for additive manufacturing or freeform manufacturing. By building layer by layer, a product is created which requires cleaning and, as a rule, some surface treatment.

The most important components of tissue engineering, de Peppo G.M., Omar O., Thomsen P. (2019) Biomaterials for Cranio-Maxillofacial Bone Engineering. In: Seppänen-Kaijansinkko R. (eds) Tissue Engineering in Oral and Maxillofacial Surgery. Springer, Cham. https:// doi.org/10.1007/978-3-030-24517-7_2

Hip joint prosthesis, with the bowl-shaped so-called acetabular component made layer by layer with EBM technology.

The ingredients may seem obvious but not entirely obvious. The production can be called 3D printing or additive manufacturing. In the mid1990s, American researchers promised to develop “a beating heart” within a five-year period through so-called “tissue engineering”. The initial initiative, through the Whitaker Foundation, has been followed by US Government and other initiatives to varying degrees and the laboratory

Early on, Arcam targeted implant manufacturers in orthopaedics, as well as aircraft manufacturers and their subcontractors. In comparison with other competing technologies, EBM-manufactured prostheses showed very good material properties, minimal material waste and short lead times.In collaboration with the Sahlgrenska Academy, it has been shown that both titanium and cobalt-chromium implants (common materials for

Life Science G O T H E N B U R G

InfoTeam P.O. Box 2079 SE-433 02 Sävedalen +46 31-340 98 00 www.naringsliv.se Publisher Peter Fridén

Common to 3D printing / additive manufacturing is that there is a great element of freedom to construct both form and details. The white canvas can be filled with personal dimensions. Through medical imaging and three-dimensional electronic drawings, e.g. a patient- and injury-specific local tissue defect can obtain an individualised prosthesis with virtually perfect fit. The industrial story of Arcam’s talented staff and management is not over. The company was sold to General Electric in 2017, remains in West Sweden and is from an economic point of view one of the longterm owner Industrifonden’s three best investments ever.

Another major advantage for the region is the emergence of smaller, creative start-ups and spinouts that have taken place during the last 10-year period. In business hubs with a focus on Life Science, there are the meeting places that were previously missing. In these contexts, it is important to point out that a number of specialist functions are required. Going from idea to market is a diligent, systematic work where skilled experts in, for example, clinical studies and regulatory processes are indispensable. In academic contexts and in the general public, it is sometimes difficult to understand the time it takes to safely and effectively introduce a new diagnostic method or treatment. This group of experts, such as CROs and specialised subcontractors, will most likely have a lot more to do in the future.

How will the collaboration take place in the future?

3. Critical mass

The West Sweden region has historically been based on outside influences, trade and innovative individuals. West Sweden is an important node for future pharmaceutical and medical technology development in Sweden. Over decades, research groups and companies have developed, often in close collaboration with each other. Entrepreneurs have, for various reasons, changed workplaces, moved from one company to another, or been involved in creating a new one. There are at least two examples of how West Swedish medical technology companies have emerged in this way and grown to be among the top on the world market. In both of these cases, foreign principal owners have eventually taken over, but the research departments remain in West Sweden. In industry, employees form a major resource, probably the most important resource in each company. Through their competence and experience, product ideas are driven, contact routes and networks are developed. Leadership in the industry has been significant, many of the companies’ management teams own or co-own the companies. Ideally you stay and develop the companies here in West Sweden, not to primarily sell here, you do that internationally. The medical technology companies in the region are generally of a good size, they are successful but perhaps not yet so large that there is a need for external development nodes.

The goals should be high. Within academia, there is complete freedom to formulate one’s hypotheses and to choose approaches. Limiting factors are usually brains and resources. The academy with its research and education is a necessary prerequisite for the companies’ supply of skills. It is therefore a pity that it has been difficult to create an international medical technology top education between the two higher education institutions and Sahlgrenska University Hospital, where all medical technology companies are an important ingredient. The conditions are there. Interdisciplinarity and cross-border cooperation are part of the key words, another is language comprehension. A researcher in technology or an engineer does not need to become a doctor but needs an understanding of the complex biology in which technology is applied. A biomedical researcher or doctor needs a fundamental dose of physics, chemistry and materials science to not be afraid when the formulas spray over the whiteboard.

Peter Thomsen

Professor, MD, PhD Sahlgrenska Academy

Fellow of the Royal Swedish Academy of Engineering Sciences

Editor in chief Maria Lind

Art Direction www.madsen.ch

Editor / project manager Håkan Oltander

Print V-TAB Göteborg 2020 ISSN: 0281-6989

Editorial assistant Carina Olofsson co@naringsliv.se

Note The editors are not responsible for unordered material. Reproduction prohibited.

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The strength, the expertise, and the drive to take lead in medical development The Swedish pharmaceutical and medical technology company ABIGO Medical adopts a novel approach in many respects. Not only in terms of products, but also in terms of how the company is built up. All activities, from research and development to prototyping and full-scale manufacturing, are managed from Sweden.

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arlier this year, 75 per cent of ABIGO Medical was acquired by Essity. The remaining 25 per cent remain with founderJan G. Smith. ABIGO Medical is a business group with several subsidiaries in Sweden,

Artur Aira

Norway, Denmark and Finland. ABIGO Medical will continue all operations as a stand-alone company with research and development from the headquarters in Gothenburg.

Success is caring about local development ABIGO Medical was founded in 1989 and after three decades of development the business is still highly focused on the same type of products but with more areas of application. ABIGO started out as a pharmaceutical company offering vitamins, and thanks to good results within this business the technology behind Sorbact was aquired. ABIGO is still developing vitamins and pharmaceuticals to treat illnesses related to ear, nose and throat (ENT). The pace of innovation is high with several new products being launched each year. “Although we have a long history in pharmaceutical development as well, the core business is built on the Sorbact® wound care products. They generate the greatest revenue, and they also form the fastest growing product range. All

manufacturing of the Sorbact® range takes place in our own factory located in Askersund, which is Sweden’s only plant of this kind”, informs Artur Aira, ABIGO Medical CEO as from May, 2020.

witnessed many changes in the way things work within Big Pharma as well as in smaller biotechnology companies. ABIGO Medical attracted his attention largely thanks to the company’s strong entrepreneurship and innovation climate.

Evidently, success is caring about local development. ABIGO has dedicated a lot of resources to Askersund, and in recent years the factory has expanded both in terms of premises and staff. As the Sorbact® family of products expands, so does the manufacturing plant and thus creating more jobs locally.

“I want to make a difference. At ABIGO, we focus on what is most important – people. We develop products that improve people’s health and quality of life. The people at ABIGO Medical are thriving as the company culture allows for personal development as well. It is truly an amazing place to work”, says Artur Aira.

An amazing place to work Artur Aira has worked in large medical corporations for decades. He has

A force to be reckoned with There is a unique drive within ABIGO

Medical that permeates the entire organisation, and it has been present ever since the company was founded by brothers Jan G. Smith and Leif Smith. “I dare say that ABIGO greatly contributes to developing Sweden’s collective competitiveness in Life Science. We move much faster than our competitors. We have the strength, the expertise, and the drive to take lead in medical development”, declares Artur Aira, and asserts that ABIGO Medical will remain a force to be reckoned with. “As we operate our research and development from Gothenburg, we contribute to placing the city on the map of prominent Life Science hubs, not just in northern Europe but globally”.

Making a difference in modern healthcare Continuously growing numbers of multi-resistant bacteria form a massive threat in healthcare worldwide. The over-consumption of antibiotics births a new endemic disease where bacteria grows uncontrollably, causing infections that are hard to treat. ABIGO Medical addressed this challenge over 20 years ago by introducing a revolutionary wound dressing, Sorbact®, which evolved into an entire family of products for advanced and effective wound care.

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rothers and entrepreneurs Jan G. Smith and Leif Smith brought some of the world’s most efficient and reliable products in wound care to market. When they founded ABIGO their minds were set on creating something new and revolutionary in healthcare. “The main goal was not to build something that would generate enormous amounts of revenue, but rather to make a difference in modern healthcare. From the very beginning, my brother Leif and I worked hard to establish a new way of thinking in terms of business, and we stay true to that as ABIGO continues to grow”, says Jan G. Smith. “Our business model is based on long-term goals and achievements that actually create more value for patients as well as the healthcare system”, Jan G. Smith continues. “In order to be the best, we must have the best expertise. We can only attract the very best expertise if we can offer an attractive and inspiring place to work. People want to make

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a difference, and we give them the opportunity to do that. We have successfully created a company culture where we see each individual and reward hard work”.

Making Sorbact the given choice The company culture and the business approach make ABIGO stand out. So does the products, which range from off-the-shelf and prescription pharmaceuticals for treating various diseases to advanced medical technology products in wound care and ear, nose and throat (ENT). The unique and patented wound care products within the Sorbact family improve healing times and bind bacteria without the risks of developing resistance to antibiotics. The entire product line, which consists of 13 different products, is based on a unique mechanism called Sorbact technology. The product range is now available in 65 countries, and the aim is to make Sorbact® the

given choice within healthcare worldwide.

ming years”, reveals Jan G. Smith.

Sorbact® is a state of the art innovation completely independent of antibiotics. The philosophy is to remove bacteria without the release of chemicals, not actually killing bacteria but effectively removing them from the infected area. Sorbact® interacts with bacteria in a completely different way to antibiotics, therefore no resistance can be developed.

“There are no similar solutions available on the market today, despite the critical need. It is therefore our duty to ensure that the Sorbact® technology is developed further addressing new areas of care”.

Addressing new areas of care Being able to treat wounds and infections effectively without the use of antibiotics is an important step in order to overcome the accelerating problem with multi-resistant bacteria. ABIGO is already one of the leading international companies in the field, but there is more to be done. “Based on the Sorbact® technology, we are planning for further introductions of new, innovative solutions in the antimicrobial field in the upco-

Entrepreneur Jan G. Smith


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Transforming healthcare into tailored and patientcentred wellbeing As society’s challenges become increasingly complex, more innovators are needed, but also a powerful innovation partner to support them in progress. The various activities within RISE constitute a unique pool of forces to increase the pace of innovation. This is exceedingly important in Life Science, particularly in the development of the next generation cell- and gene therapies.

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The utmost goal is to create increased innovation power through several different channels, the main being cross-functional research and collaboration between different areas of knowledge, a stronger national collaboration between industry, academia and research institutes, increased international collaboration with world-leading universities, institutes and companies.

Gothenburg-based research can change the future The presence of a large research institute in Borås, which is considered part of the West-Sweden Life Science arena, brings power to the Gothenburg region. Various RISE-projects are connected to Chalmers and the University of Gothenburg, for instance. Many projects are of national and even international nature. RISE has a group of researchers based in Gothenburg, under the biology division. Two of them are Jukka Lausmaa and Jim Lund, both with interest in the development of future treatments based on cell and gene therapy. “The pharmaceutical industry of the future must be able to supply much more than just pills. The pharmaceutical drugs of the future will be more individualised, and to a large extent much more advanced with the help of the patient’s own cells. For instance, it is already possible to create powerful cancer treatments using the patient’s own defence cells but modified to attack only cancerous cells”, says Jim Lund. Imagine what this means for the future. We could in a few years have access to safe and efficient cancer treatments that are so personalised and targeted to a specific function that there are few, if any, side-effects to be had. This in turn brings about a whole new world of possibilities.

A future of more collaboration The RISE presence in the region provides increased availability of the entire RISE research and development services. Through close cooperation between institutes and the business community, mutual insight and understanding of each other’s activities increases. In the long run, this could lead to many new research and development initiatives in the Gothenburg region. “At RISE, we are an important resource for companies in the region. We assist with knowledge and research that leads them in the right direction in their own innovation process. We have numerous collaboration projects ongoing, where business meets academia and research is branched out as a result. We believe in a future of more collaboration”, says Jukka Lausmaa.

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Ulf Järnberg, CEO of Neoventa.

Neoventa wants to improve obstetric care worldwide Neoventa has been a key player in improving obstetric care for decades. The product portfolio consists of fetal monitoring solutions and support services, including training and education. An understanding of fetal physiology is crucial for optimal foetal monitoring. To increase knowledge and skills Neoventa has developed a training program in CTG and ST-Analysis interpretation to guide professional health care providers. The training program is used in maternity units all over the globe.

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ithin RISE Research Institutes of Sweden there are several research nodes (institutes) and hundreds of test beds and demonstration environments that, gathered into one organisation, form an innovation partner with expanded opportunities to meet the business community and society’s challenges.

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he purpose of foetal monitoring during labour is to prevent oxygen deficiency that can lead to serious brain damage or fetal death. CTG has been used for over 50 years and is currently the most common fetal monitoring method. However, using only CTG monitoring has its limits. The fetus’ pulse can be affected by factors other than lack of oxygen. Most specialists in obstetrics agree that CTG does not give enough information and therefore needs to be complemented with other methods to avoid unnecessary risks and operative deliveries.

What difference does ST-Analysis make? The ST Analysis, offered by Neoventa, is a direct measurement of foetal reaction to the stress of labour and is a unique method for fetal monitoring, serving as an adjunct to CTG. It helps clinicians detect foetuses at risk of oxygen deficiency during labour through automatic detection and alerts. ST Analysis always works in parallel with the information from the foetal ECG waveform, adding valuable information about the foetal state to the CTG tracing. In this way, ST Analysis provides a continuous, individual and central message from the fetal heart, minute by minute.

Wireless and mobile fetal monitoring In 2017, the next generation STAN monitors were introduced by Neoventa, a complete, compact and portable device that enhances mobility during labour. The latest STAN monitors are wireless and make it possible to monitor the mother and baby throughout the labour process.

Safer and better obstetric care Hospitals have successfully integrated the equipment into daily routine practice and improved perinatal outcomes which also have positive cost effects for the hospital. ST Analysis is the only adjunctive test that has been shown to reduce the rate of neonatal metabolic acidosis, foetal scalp blood sampling and operative vaginal births. This was demonstrated in a systematic review which analysed six randomized control trials. The studies included more than 26,000 women altogether. Introducing ST Analysis as a method and way of working in a delivery ward also has positive side effects such as increased staff knowledge of fetal physiology and CTG interpretation. “ST Analysis is a great support for the obstetric staff as ‘a second pair of eyes’ providing valuable information about the fetus’s wellbeing during labour” says Ulf Järnberg, CEO of Neoventa. “The scientific evidence is clear on this point, by applying ST Analysis as an adjunct to CTG the number of babies born with oxygen deficiency, as well as the number of operative deliveries can be lowered significantly”. Neoventa is committed to making every baby’s journey into the world as safe as possible. ST Analysis is a crucial tool for obstetric staff in achieving this mission, helping them to perform proper interventions at the right time – ensuring that more healthy babies are born and making vaginal births possible for more women.

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Experience the world’s most advanced bone-anchored hearing systems

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ticon Medical has been a driving force in the development of bone anchored hearing systems during the last decade. The concept was originally developed in the early 1980s through a research collaboration between Anders Tjellström at Sahlgrenska University Hospital in Gothenburg and Bo Håkansson at Chalmers University of Technology. Based on innovations on both the titanium implant design and hearing technology – the system was developed further at the hearing division of Nobel Biocare. With the introduction of for example digital sound processors and minimally invasive surgical techniques, Oticon Medical was founded while Nobel Biocare continued on a different path.

Creating lifelike hearing systems

Martin Johansson, Senior Translational Research Manager.

Over a century’s worth of gathered experience in audiology and sound processing makes Oticon Medical, part of the world-leading hearing healthcare group Demant, what it is today. For a lot of people this Swedish medical technology company makes a life-changing difference. The bone-anchored and cochlear implant systems developed by Oticon Medical are among the world’s most advanced, and all completely tailored to each patient’s needs.

Improving the quality of life for people with hearing impairments or hearing loss is the main focus for the companies that are a part of the Demant group. The company was the first in the world to develop complete systems for sound experience in 360°, thus creating a whole new world of opportunities for people with all kinds of hearing impairments. Oticon Medical is not and will never be content with the simplest solution. By focusing on user needs and experiences of their hearing loss, Oticon Medical develops completely individualised systems. Everything is built on the brain’s ability and capacity of sound processing. This makes it possible to create lifelike hearing systems that

work in all kinds of environments, and for people of all ages. Children and adults do not have the same conditions when it comes to the brain’s ability to perceive and process sound. Therefore, there are several different variations of Oticon hearing aids and the technology is constantly evolving. There is no other system on the market today, with the same lifelike sound reproduction as the Oticon systems.

Operating in the capital of bone anchored implants The legacy of Per-Ingvar Brånemark, who discovered that titanium could interact and become part of living bone, is still very evident and strong at Oticon Medical. Headquartered in Gothenburg, the city often referred to as the capital of bone anchored implants, Oticon Medical has access to decades of experience in the field of implantable hearing solutions – not only by members of the company’s own development team but also by specialists operating on a global basis. Søren Kamaric Riis, CRO.

Safer and faster diagnosis of brain injury developed to save more lives

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An injured brain needs to come under appropriate care as quickly as possible. Faster treatment leads to less brain damage and a faster recovery for the patient. Minutes of delay can make the difference between lifelong disablement and an independent life. The greatest challenge is to speed up the diagnostics process both pre-hospital and in hospital.

o accurately screen patients with suspected brain injury, such as stroke or due to trauma, and differentiate patients with severe injuries acutely requiring specialised care, would reduce both mortality and societal cost. If equivalent testing could be done sooner, perhaps as early as at the scene of the accident, more lives could be saved. Two million brain cells die every minute at the beginning of a stroke. Applying tools for early diagnosis and treatment can in

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rope and the rest of the world, and is approved to be used on patients in clinical studies. Next and final step is to be CE-approved for clinical use. “Our most important goal is for the product to become widely available so that more patients can be diagnosed quickly, and the right care is provided without delay. This is what we have been striving and working so hard to achieve for almost a decade, and now we are almost there”, says Stefan Blomsterberg, Medfield Diagnostics CEO.

some cases save up to hours, during which the patient otherwise would be more or less untreated.

About to become widely available The Swedish medical technology company Medfield Diagnostics has dedicated ten years of research to the development of a new and patented technology for early diagnosis of brain injury. The technology originates from research at Chalmers University of

Stefan Blomsterberg, Medfield Diagnostics CEO.

Works in almost any environment

Technology in Gothenburg. It is based on applying microwaves of the same type as those used in a cellphone and directing them to identify possible bleeding and cloth in the brain. The product has been developed, tried and tested in Sweden and several other countries in Eu-

The Strokefinder only weighs six kilograms and can be moved and carried easily. It is a highly mobile tool excellent for prehospital screening, either at the scene or in the ambulance. The product is battery powered and can be used in almost any environment, regardless of spa-

ce availability. This makes it suitable for use onboard any carrier like ships, planes and other transport. “The great advantage is being able to take the equipment to the patient, and not the other way around. There has been no similar product on the market before, neither in Sweden nor globally. We are pioneers and the need is widely discussed and defined. Stroke is one of the most common causes of death in Sweden alone, and statistics show that many survivors suffer severe disabilities after a stroke. They are often left with complications such as altered motor skills and speech impediments. Faster diagnostics can change the prospects significantly”, states Stefan Blomsterberg. Further testing is presently carried out in Sweden, Norway, UK and Australia. The much longed-for outcome will be a fully approved CE-product available worldwide.


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Doctors practice on our simulators & not on you.

SW E DISH I M PL A NT TEC H N OLOGY

The well proven Osstera® products are manufactured in Sweden and characterized by Swedish premium quality. Osstera´s five different product lines are designed to suit every clinical situation and are compatible with the most commonly used implants on the market.

www.osstera.se

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Every baby deserves a good start in life

2020-08-31 11:18

Meet the specialists in Osseointegration The discovery of the medical and technical phenomenon osseointegration has made Gothenburg what it is today when it comes to implant technology and development. Integrum has refined the osseointegration method for almost 30 years and is continuously improving quality of life for people around the world using the next generation implant system- The OPRATM Implant System.

That is why we have developed the STAN fetal monitor. Every day it provides enhanced decision support for obstetric professionals around the world. For healthier babies

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itanium implants would not be used routinely and globally today if not for the pioneering work of Swedish physician Per-Ingvar Brånemark. In the 1960s, he was the first to observe that the human body would not only tolerate titanium, but even integrate it into living tissue in a process he called osseointegration. This insight has revolutionised the fields of dental, maxillofacial and orthopaedic rehabilitation.

Improving intuitive control and sensory Based on Per-Ingvar Brånemark’s original scientific findings, innovative bone-anchored restorative solutions have improved the quality of life for millions of people around the world for decades. Integrum takes the technology and very idea of osseointegration further by developing the e-OPRATM Implant system, a system so advanced it can even restore touch in prostheses. This is as close to a real life feeling as possible with today’s technology. United

The e-OPRATM Implant System allows simultaneous connection to bone, muscles, and nerves for long-term home use. This technology, in addition to providing intuitive and natural control, also provides sensory feedback by stimulating the severed nerves. But Integrum wants to take it further, aiming to regenerate life-like sensory and control as close to nature as possible.

The only FDA-approved supplier The OPRATM Implant System is the pioneering technology in bone-anchored prostheses and the only FDA-approved (Humanitarian Device Exemption) bone-anchored system available in the United States.

“The United States is the key market for Integrum and being the only FDA-approved supplier gives us a clear advantage when we take our technology to the next level. Our vision at Integrum is to States be a global player in orthopaedics, with is a special focus on large and emerging mar”Modern prostheses are now capable key market kets. With a complete FDA-approval we of mimicking fine movements and are free to commercialise our products grips, but the level of intuitive control and sen- without limitations, and this is what we are strisory feedback is still limited. This is one of the ving for now in the near future”, says Maria Elena biggest challenges for Integrum, and remains core Lopez, Integrum CEO. Integrum headquarters are focus for our future development”, says Rickard to remain in Mölndal in the Gothenburg region, Brånemark, Founder of Integrum. with supporting development offices in USA.

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Meet the Champions of Medical Simulation Does it really come as a surprise that a small, Gothenburg-based company would hold a World Champion title in Medical Simulation, if there was such a title to be had? Not when you are aware of the company’s track record and of the expertise embedded at the core.

Göran Malmberg, CEO and President at Mentice.

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entice may be a small company in terms of numbers but looking past the figures and scrutinising the very essence of what makes Mentice truly unique will provide a good indication of the company’s worth. Mentice is the only company in the world solely dedicated to endovascular medical simulation. Interestingly, the founders of Mentice foresaw future needs in healthcare long before these needs were up for discussion.

Medical simulation is to doctors, what flight simulation is to pilots Back in 1999, Mentice was founded and the base for the technology used in today’s simulation training systems was created. Mentice is likely to be the only provider of complete simulation technology aimed at endovascular and minimally invasive procedures, with the key mission to provide the means for both safer and more efficient operations through better and more relevant training. “Simply put, we can compare the need for simulating surgical procedures for training purposes to the importance of flight simulation for pilots. Becoming a pilot for operating commercial flights requires experience. You would never accept pilots to practice while flying real planes with passengers. Simulation has helped making aviations one of the safest environments we have. The same principle should apply to surgeons and physicians. Therefore, at Mentice we strive to provide the simulation systems needed to ensure the very best care for all patients”, explains Göran Malmberg, CEO and President at Mentice.

It is all about improving safety and performance Endovascular performance can be measured in terms of experience. Straight to the point – you would not trust a pilot without hands-on experience to fly a plane. The simulation training systems delivered by Mentice can significantly improve patient care and safety as they enable medical practitioners to perfect their skills by simulating

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surgical procedures over and over in an environment safely away from patients. Mentice can also meet a universal challenge in all healthcare, which is comprised by an urgent need to become more efficient and proficient. Hospitals are today under constant pressure to reduce costs and improve their operational efficiency. “There is a need to relate investments in skills and technology to actual outcomes. As Lean Production-related philosophies are applied even in healthcare, the desire to find more efficient, less time-consuming treatments has become more evident”, Göran Malmberg continues. “Endovascular intervention enables surgeons to reach and treat most vital organs without the need for open surgery. Our role is to provide solutions to ensure correct and reliable training of physicians and related teams”.

Supporting Gentle Ventilation of Newborns Monivent is a young medtech company dedicated to improve the care given to newborn babies in need of respiratory support at birth.

Champions of Medical Simulation By applying simulation systems, time and money can be saved, and more importantly – human lives. Therefore, it is no exaggeration to describe Mentice as a Champion of Medical Simulation. Mentice sets standards high on all accounts. Naturally this also involves employing only the best. And in this case, the best involves an Academy Award winner in simulations used in one of the world’s largest motion pictures, as well as a gold medal winner in the International Mathematical Olympiad. Mentice has taken a stand and proven to be able to make a difference. The next step is to become more involved in the clinical process, as well as perfecting the systems for training purposes. “Our most important goal for 2020 is to take a larger step for patient-specific simulation and to become a natural and integral part of sales and new treatments for endovascular procedures. This takes us from training and further into the clinical process and allows us to be integrated with other treatment equipment as well”, Göran Malmberg concludes.

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Swedish implant technology at its very best Osstera was born out of a desire to provide sophisticated dental implant products at a competitive price. Cutting costs does not mean cutting corners on quality or precision, quite the contrary. Osstera is a small company with great capacity, a slim and smart organisation of professionals sharing the same goal: to provide the very best implant products based on Swedish quality and research.

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ver ten years of research is embedded into the Osstera range of dental implant products. The products are widely implemented across Europe as from five years, with steady annual increase both in numbers of products and market share.

The birthplace of osseointegration In Sweden, and in Gothenburg in particular, there is a well-established business for developing implant technology, systems and materials. The discovery of osseointegration, that titanium implants can interact and become integrated into living bone, was made in Gothenburg. Since then, a lot of applications have been developed by various independent companies, where Osstera is one.

What makes the Osstera portfolio unique

What makes the Osstera portfolio unique is the patented surface applied to every product, which allows the Osstera surface to replicate nature itself very closely. The ten years of research that lies behind the Osstera portfolio has time and again shown successful osseointegration and excellent clinical long-term results.

The function of all dental implants is to mimic the patient’s natural teeth to such an extent that no difference can be made between them. Although the ambition is the same for all dental implant manufacturers, the prosthetic mount is often unique.

ARFOLITIXORIN

This is the case at Osstera, providing excellent dental implant solutions for every clinical situation possible.

Ensuring high quality and low cost

More patients can benefit Today, Osstera operates from its headquarters in Gothenburg but also has a subsidiary in the UK. In addition, the company is successively building

sales and distribution channels across Europe. “The assortment of implants is ever increasing, as well as the need for the products. When the implants are more affordable and widely available, more patients can benefit from an amazing technological breakthrough. This is our core value at Osstera, we believe that implants should be developed in a way that ensures quality but cut costs”, says Villy Roghell, CEO, Osstera. So far, dental implants have been the core focus, but Osstera may embark on a journey to include a wider range of products.

A DRUG CANDIDATE FOR TREATMENT OF COLORECTAL CANCER

See how arfolitixorin works in cancer cells

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innovation is high and new products as well as improvements on existing products are launched several times a year.

Metenova ensures perfect mixing results every time The Swedish technology company Metenova is the perfect example of how powerful the innovation process can be in Life Science. Thanks to innovations developed by Metenova, pharmaceutical manufacturer and process developers can obtain perfect results time after time. The secret is in the mixing process.

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hen it comes to pharmaceuticals, and especially the new protein-derived biopharmaceuticals, the mixing process is absolutely crucial. It is not only a question of mixing just to distribute

the ingredients evenly in large batches, but more importantly to optimise the properties of the substance so that they become effective to the best of their ability and in addition obtain the best possible stability over time.

Nothing left to chance Nothing is left to chance in developing pharmaceuticals. The entire process, from the initial laboratory testing to the last stages of human trials and then on to market launch, is highly regulated. The process of creating, testing and building the equipment used in pharmaceutical development and manufacturing is just as regulated. Meeting and exceeding high requirements – that is all in a day’s work for Metenova. “We focus solely on aseptic and sterile drug manufacturing as a niche company specialised in developing mixing equipment. Traditional pharmaceutical drugs,

“We are most definitely in a growth phase where we work with pharmaceutical companies all over the world. They know that our innovations are the best technical solution for mixing in all stages of pharmaceutical production. We provide a secure product and we are a stable and reliable supplier, all of which are very important properties today. We have what it takes to succeed globally when it comes to company structure – as well as the best technical solution”, states Johan Westman.

Slim organisation with great impact The Metenova team may be slim if compared to market share, consisting of 25 technicians and experts, but the capacity of what they can achieve is great. “We do indeed have a slim organisation, but we are determined to grow further. Our growth will perhaps not be in terms of numbers, but in terms of market impact and technological advancement. We aim to simply be the global market’s first choice when it comes to mixing equipment in all areas of pharmaceutical production”, explains Johan Westman.

biopharmaceuticals, and vaccines – we provide the best mixing solutions for all requirements, and we have taken the development to the next step when it comes to advanced mixing solutions”, says Johan Westman, CEO, Metenova.

What it takes to succeed globally

This may seem like an ambitious goal, but it is perfectly reasonable if you look at past success stories in Metenova’s history. The company is experiencing an all time high at present, and the need for pharmaceutical production, particularly in biopharmaceuticals and vaccines, has never been greater than today. Metenova clearly has a bright future ahead.

Although Metenova was established in 2009, the roots of the company go several decades back. In other words, a lot of experience and knowledge is the basis for today’s Metenova. The technical solution has been developed through several generations of mixers, leading up to today’s third generation mixers. The degree of

INNOVATION by Breas

Here at Breas, we are dedicated to continuous development for a better life for respiratory patients. Innovation is central to our mission – we put great focus into ensuring every innovation will improve the experience for patients and make work more effective for clinicians. Three guiding stars define the value of our solutions to patients and clinicians and set us apart from competition. COMFORT Everything we do is motivated by a commitment to technology that harmonizes with the patient.

Curious about Breas and career opportunities? Visit us at Breas.com or EducationbyBreas.com

SIMPLICITY Simplicity is what happens when we design things around people. COMMUNICATION Excellent care demands seamless communication between people and systems. Curious about Breas and career opportunities? Visit us at Breas.com or EducationbyBreas.com Vivo by Breas is a trademark of Breas Medical AB © 2020 Breas Medical – All rights reserved.

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Företagsvägen 1 · SE-435 33 Mölnlycke · Sweden Phone +46 31 86 88 00 www.breas.com


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High-tech from start to end Elos Medtech provides qualitative development and production services to some of the world’s key industries. Dental and orthopedic implants, instruments and diagnostic products are some of the key product categories. And it is all high-tech, from start to end.

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los Medtech is a specialized development- and production partner in medical technology applications worldwide. Having extensive experience and expertise since decades of product development, design of medical devices in selected markets such as dental implants, orthopedic products Elos Medtech is a valued partner for any company wishing to expand in these areas. “Our reputation for quality is the result of an approach that builds it into every step of the process”, initiates Jan Wahlström, CEO and President at Elos Medtech.

Creating life-changing effects The products manufactured by Elos Medtech for customers in the medtech industry are used to treat millions of patients all over the world. The products are used for a multitude of health-improving purposes. Creating better quality of life has always been the very core of Elos Medtech operations, as specified in the company vision and mission. “Our slogan is “Our world continues to

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change – our passion remains the same”. Making a concrete difference in people’s lives is a core value of that passion”, says Jan Wahlström. The Elos Medtech way of working is not market- or product-specific, but rather based upon commitment to complete performance, and meticulous, proven processes. “We support the development and production of any medical technology that falls within our service and manufacturing capabilities. Our operators are well-trained, and accustomed to working with high quality standards”, says Malin Gustavsson, Marketing Director, and continues: “We work closely with our customers as well as engineering specialists to ensure optimal manufacturing processes and production technologies. As different projects have different design and manufacturing requirements, we choose to be flexible throughout the process”. “We operate solely and strictly on our belief that a tiny device, or even just a component, can have life-changing effects”.

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Always operating at the forefront Healthcare demands change continually, and sometimes rapidly. Manufacturing and introducing successful, innovative healthcare products require flexibility and versatility. Not least during a crisis. This is everyday working practice at Elos Medtech, always operating at the forefront of technological advancement. As an example, dental implant treatment of tomorrow will be tailored to each patient using 3D-technology. For a natural look, the new implants are created using each individual patient’s natural teeth and bone structure. The same principles are applied when creating new hearing implants as well as orthopedic implants. Aside from the development and production of instruments, , and implants for advanced dental and fracture surgery, Elos Medtech also offers components for bone-anchored hearing implants, diagnostic products and multi-use injection systems. The company will continue to support medical technology companies of the future with innovative development and manufacturing services.

Fast and predictable market access with Kickfile and Devicia market. As nominated experts working globally with standardisation, our place at the table provides our clients with an inside perspective to the changing regulations”, says Sofia Nordgren, CEO at Kickfile.

Sofia Nordgren, CEO at Kickfile.

In a fast-paced, competitive environment where the requirements for medical devices are changing rapidly, the need for a reliable and flexible partner is evident. Kickfile and Devicia are dedicated to the development, testing, and market launch of medical devices. The companies are in fact among the very few with direct access to the experts who write new standards in the medical device industry.

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he pharmaceutical industry has many well-established Contract Research Organisations, CROs, and there is a long tradition to engage their services. However, when it comes to the medical device industry, there are only a few suppliers able or willing to offer comprehensive CRO-services specifically intended for medical devi-

ces. Devicia breaks the trend and has been doing it since 2012. “The needs of pharmaceutical developers are in many aspects different to the needs of medical device developers. That is why we are focused exclusively on medical devices where we offer support through all phases, from idea to

For empowerment of patients Devicia was founded by EY Entrepreneur of the Year nominee Elisabeth Liljensten to meet a gap in the market, but even more importantly to meet the needs of developers of medical technology and devices. Most importantly, Devicia plays a crucial part in the empowerment of patients, as more and better medical devices can be introduced thanks to the company’s wide range of services. Sofia Nordgren explains: “At Devicia, we employ experts in clinical studies, regulatory affairs, quality assurance and medical writing to take customers’ projects all the way from idea to market. However, it is one thing to make it to the market, and yet another to remain on the market. We help our clients develop strategies and direct their efforts to where they are

best needed, which is absolutely crucial in most cases where resources are limited”.

Licensing tools for MedTech projects The services provided by Devicia are consultancy-based. It is an excellent way for innovators, research teams and medical device manufacturers to obtain expert advice on tap, fast and reliable. Clients range from start-ups to large corporations. For the small- to medium-sized enterprises, where resources are scarce, the ability to hire consultants may be limited. To meet their challenges, Kickfile (a sister company to Devicia) was established, where customers are able to licence or buy the support systems needed to take their medical device project further in their own time and using their own staff. “Through Kickfile we offer complete systems for e.g. clinical evaluations and clinical investigations. All tools can be

licenced or purchased for the customer to perform the tasks correctly in-house or with a mix of in-house and consultant resources. By using Kickfile they get instant access to up-to-date systems that has been audited and used operationally in both EU and US”, declares Sofia Nordgren. After spending the last years developing its products, Kickfile has this year shifted focus to commercialisation. “Even though 2020 can be seen as our first year from a business point of view, we already have customers in both EU and US who either licence, or buy the entire system of quality management documents. We have got off to a flying start this year and are ramping up resources to meet our customer’s needs ”, says Sofia Nordgren. When medical device standards change, as they often do, both Devicia and Kickfile are indispensable partners for forward-thinking companies developing the medical devices of the future.

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Supporting gentle ventilation of newborns About 3 to 6 % of newborns require manual ventilation support to start breathing. Up until now, manual ventilation is rarely monitored, and it is up to the caregiver to estimate the volumes given trusting his or her expertise and experience. Considering that both under- and overventilation can seriously damage the lungs and brain, a well-documented solution to support gentle ventilation is most welcome.

Innovative ventilation helps people make the most out of every day Johanna Ortgren, Technical Product Manager at Breas Medical

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onivent was founded in 2013 by two neonatologists and one researcher in lung physiology who turned to students at Chalmers University for help to develop a product for manual ventilation of newborns. The idea was to improve the way respiratory support was given within the very first minutes of a baby’s life, ensuring that the amount of air given is well-monitored and tailored to the baby’s needs.

able to pass yet another of the milestones we communicated before the listing of the company on Spotlight Stock Market. We will now conduct studies together with leading neonatal centres in Europe. When these studies are completed, we look forward to the introduction of Neo100 in selected markets where we have already experienced great interest from potential customers”.

Ever since, Monivent has developed a unique solution where the airflow is measured directly in the face mask and feedback on the ventilation parameters is displayed numerically and graphically in real-time on an external monitor.

Monivent will set up a distribution network to sell their products and they recently signed an evaluation agreement with a German distributor for distribution of the product Neo Training. The company has a similar partnership with several other distributors in Europe and in Australia and all distributors are selected to be able to also take on Neo100. Karin Dahllöf comments: “We are very fortunate that we have found partners who are happy to sell our products and are the market leaders on respective market. As we are first with a solution to support ventilation in the delivery room and as we are in a niche market, it is vital for us to engage key opinion leaders and work with important research groups who want to see change and who will hopefully spread the word for us. Our partners have these contacts already and will be of outmost importance for our success when introducing Neo100”.

Market launch of the first product for clinical use In July this year, Monivent CE-marked and launched Neo100, their first product for clinical use. Since before, Monivent provides Neo Training, a product to improve simulated ventilation training on manikins. The first units of Neo100 where delivered to clinics in France and Austria to be used in studies for marketing support together with clinical partners. Karin Dahllöf, the CEO of Monivent says: “We are incredibly happy to now have a CE marked product ready for use in the delivery room. It is a huge step for us being

Sales through distribution partners


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Outcome of advanced oncological treatments to change significantly Isofol Medical AB is a small Swedish biotech company with the potential to significantly change the outcome of advanced oncological treatments. The main target is colorectal cancer, which is one of the most aggressive and deadly forms of cancer in the world today.

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round 1.8 million people are diagnosed with colorectal cancer each year and statistics show that in 20 years time, the numbers will at least have doubled. Of the current 1.8 million cases of today, around 320.000 are in the advanced metastatic form for whom the survival rate is low. Only around 10 per cent of these patients are likely to live for over five years, and most of them with a great impact on their lives. The standard treatment for colorectal cancer, using the pharmaceutical substance leucovorin, has been around for over 40 years. It is tried and tested but nonetheless it does not work successfully for most patients. The need for a safe and efficient treatment of advanced colorectal cancer is evident.

Ulf Jungelius, Managing Director at Isofol Medical AB

Breas Medical helps people with chronic respiratory conditions make the most out of every day, at work, school and at home, thanks to a generous portfolio of tailored and completely mobile sleep, ventilation and airway clearance systems.

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he very initiation of Breas stems from the technological interest of a patient who was prescribed a CPAP; a sleep ventilation system supporting the patient’s respiratory function at night, and a motivated engineer wishing to improve such systems. Three decades later, Breas provides innovative solutions for all respiratory conditions and needs from its global headoffice in Mölnlycke, Sweden.

Providing Comfort, Simplicity and Communication The essence of Breas’ development process lies in a strong belief that patients’ needs should determine how the product is to be developed, how it works and integrates with the patients in their daily lives. The perfect ventilation system is that which goes unnoticed, which provides respiratory support in a way that feels as natural as possible. That is why all new ho-

As opposed to many other forms of cancer, such as breast cancer, the innovation rate within colorectal cancer treatments has so far been low. Isofol develops the pharmaceutical drug candidate arfolitixorin, primarily used as a treatment for colorectal cancer and as a rescue drug after high-dose methotrexate treatment of bone cancer. Other

me-care systems developed by Breas are small in size and mobile. “Our core product vales are to provide Comfort, Simplicity and Communication, between people as well as human – machine communication. Our solutions are easy to install and use, both for patients and for care givers. As a medium-sized company we can move fast and we can tailor almost any product to that of a patient’s specific needs”, says Roger Nyström, Global Product Manager at Breas. Breas was founded in Sweden but is a global player with sales channels all over the world. Most of the technology development and manufacturing activities are carried out in Sweden. “Our business is strongly regulated and our products are CE-marked, complying with the regulatory requirements on

potential uses for arfolitixorin also includes the treatment of pancreatic cancer, breast cancer, stomach cancer, and head and neck cancers.

May turn a deadly disease into a chronic one Now, at the initial stage, Isofol is focusing on developing treatments for colorectal cancer in advanced stages of metastatic development. Isofol is now focused on the ongoing global Phase 3 study, currently recruiting patients in the USA, Canada, Europe, Australia and Japan. Approximately 90 hospitals are participating in recruiting around 440 patients who will receive first line treatment for metastatic colorectal cancer. By the end of July 2020, 330 patients had started treatment in the study. The study involves two treatments and will aim to compare the outcome of each one. The first patient group will be treated with arfolitixorin and the second with leucovorin, both in combination with the 5-FU and oxaliplatin chemotherapeutic agents and the biological therapy, bevacizumab.

the market. We always work to exceed expectations when it comes to quality, which also includes usability and safety”, explains Anne Mari Nedevska, Breas Quality Assurance Engineer.

An innovative workplace When it comes to innovative care for patients with respiratory conditions, few can compete with Breas Medical. Over 30 years of experience has created an innovative culture that permeates the entire company. This also makes a strong impact on Breas as a workplace of innovation and continuous development. “We have such high demands on our products that continuous improvement is a matter of pure survival for us. Breas is an exciting workplace because we work in the borderland between software development and integration, and with communication between man

The primary focus of the study will be to measure the percentage of patients who experience tumour size reduction, (Objective Response Rate, ORR). The secondary endpoint will be the measurement of Progression Free Survival (PFS), that is the time until the tumour begins to grow again or the patient dies. “A statistically significant tumour shrinkage in 55-60 per cent of patients should be demonstrated. Our objective is to achieve a 10-15 per cent improvement in ORR in those patients treated with arfolitixorin in comparison with those treated with leucovorin”, explains Ulf Jungelius, Managing Director at Isofol Medical AB. “What we are hoping to prove, after several years of research and development, is that we can turn a deadly disease into a chronic disease. We can certainly not cure the disease completely, but we can help relieve symptoms and we can prolong the lives of significantly more patients than what has been possible to do in the past”, says Ulf Jungelius.

and machine. This is a challenge that really attracted me to join the team”, says Johanna Ortgren, Technical Product Manager. The company vision at Breas is to provide “Innovation for better breathing and quality of life”, aiming to enable people with chronic respiratory conditions to live life to the fullest”. The fact that Breas helps to improve the quality of life for people with chronic respiratory diseases is most likely the strongest driving force for everyone who works at the company today. “We develop, test, evaluate and manufacture products completely according to patient-specific needs. The patient is always in focus and it is rewarding to work for a company that has such values”, confirms Sebastian Mommers, Managing Director at Breas Sweden.

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here are various CROs out there, but IRW is most passionate about becoming a preferred partner in the Nordic countries. Providing support from its offices in Sweden, Denmark, Norway and Finland, IRW is concentrating on clients and projects close to home, sharing the aim to strengthen Nordic Life Science companies of all sizes.

jects related to medical device investigations as well as rare diseases. Oncology is still widely represented through the project portfolio, as it was the base on which IRW was founded, but there is a significant increase in early stage projects related to the development of medical devices and treatments for rare diseases.

A full-service CRO

“The year 2020 started off with a healthy increase in new projects for us at IRW. There seems to be a great interest among international companies wanting to conduct clinical studies in the Nordic countries. We are often a preferred partner in these projects, and I personally think that this has a lot to do with our ability to take clinical projects all the way to market”, says Ola Jeppsson.

As a full-service agency, IRW can manage projects from start to end. Clients range from start-up companies to multinational pharmaceutical corporations. “Our local expertise and contacts mean that we can help our clients to conduct phase I to phase IV studies, including paediatric and non-interventional studies, as well as medical device investigations, according to both international and country-specific guidelines”, says Ola Jeppsson, CEO of IRW Consulting.

Ola Jeppsson, CEO of IRW Consulting.

Bringing over two decades of experience, the clinical research organisation IRW Consulting can take projects all the way from the very earliest stages to late stage validated product. IRW manages clinical trials from start to finish and can also act as an integrated part of a client’s research team in-house.

“We are able to meet the high demands of our clients and maintain projects efficiently. We have sufficient resources in the form of experienced staff and management teams. We have secured stable business through the years, large parts of the success being due to efficient and strategic planning on our part. We are ready to take on almost any clinical project and bring it through all stages of trials and development”, Ola Jeppsson continues.

Increase in medical device and rare diseases Lately, IRW has taken a much more prominent role in pro-

Expanding staffing solutions IRW is currently recruiting, with opportunities for clinical research associates and clinical research managers in Denmark, Finland, Norway and Sweden. “We have started investing more in various staffing solutions where we perform research services in-house in our customers’ facilities. Our expertise ranges from early drug candidate development to late stage testing of medical devices, basically. We can staff almost any laboratory, of any size, almost anywhere in northern Europe. Our strategy is to keep building strong research teams in our own and our clients’ facilities”, Ola Jeppsson concludes.

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Better regulatory understanding with Mediteq quality management as well as provide services like PRRC and customer adapted training”, explains Helen Sandelin, CEO and Senior Consultant at Mediteq. Helen states the advantages of working with Mediteq: “With our help medical device projects, companies and clinical scientists can avoid costly mistakes. It is all about doing the correct type of testing and clinical validation, include it in the technical documentation and thereby showing that your product complies with safety requirements for the selected markets”.

For a small medical device company, it may be a challenge to keep track of everything that has to do with regulatory procedures and documents, but with Mediteq as a supporting partner anything is possible.

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egulatory procedures can be complex and new legislation can change the requirements significantly. The pace is usually high when it comes to design and development projects of medical devices and a lot of time and money may be wasted if projects are taking the wrong turn. But how can small and medium-sized companies with limited resources determine which path is right? Mediteq has the answer.

Getting things done the right way Too many medical device projects end up with a giant hole in the budget due to expensive and time-consuming development, verification, and

clinical validation processes. Mediteq offers guidance and support in a personal, professional, and customer-oriented way, by always ensuring that the path taken is the very best for the customer in the long run. “What we do is essentially to guide our customers through regulatory requirements for medical devices. We help them identify the gaps in the current documentation and compile the necessary information. We guide customers through regulatory requirements, market access worldwide and CE marking of medical devices. We can provide answers to questions about product documentation,

Based on solid experience Mediteq gives customers control over their regulatory process from the start. Helen Sandelin explains why this is so important: “All manufacturers of medical devices are responsible for ensuring that the product is safe to use and must also demonstrate that it fulfils its purpose. This must be verified and well documented. The main challenge is to compile, and document correct and sufficient data from testing and validation activities. This is our core expertise”. Helen Sandelin’s experience in medical devices and systems goes all the way back to 1995. She established Mediteq in 2007 and has built up a strong team of experts in the field. The company is operating from Jonsered, just outside of Gothenburg. Aside from being a partner to companies in medical technology, Mediteq shares knowledge in the

competence network Mediteq Forum. Having access to the right knowledge at the right time can make a whole world of difference, especially when it comes to introducing medical devices on different markets.

Meeting new requirements with PRRC Quality assurance, regulatory affairs, medical device design control and related IT-services are some examples of key competences at Mediteq. For companies with less than 50 employees Mediteq also offers a comprehensive PRRC-service. Having an appointed PRRC, person responsible for compliance with the regulations, is a new requirement for MDR and IVDR. “Manufacturers and authorised representatives must have at least one designated person with regulatory competence who is responsible for compliance with the regulations. The tasks include ensuring that required technical documentation is drawn up and kept up to date, and that PMS, vigilance and reporting obligations are complied with. In addition, the conformity of the products must be checked before they are placed on the market”, explains Petra Rosén, Senior Consultant at Mediteq. Micro- and small-scale manufacturers will be able to subcontract their PRRC functions to third parties that meet the qualifications specified. At Mediteq, the required expertise is available to act on behalf of the customer.

The fastest LINK from early development to market Many companies, from the smallest Biotech one-person team to the largest corporate teams in Big Pharma, often lack a fully developed target product profile during early product development. The result is often wasted resources, sometimes even leading companies to abandoning good projects. As a strategic partner, LINK Medical can take projects from idea to market.

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INK Medical is a northern European full-service CRO, teaming up with some of the most prominent players in medical research to take projects from early development to market. By specialising in early development, LINK Medical goes towards the current in offering all-inclusive strategic services from early development and on through all clinical phases to post-marketing.

A smoother journey from idea to market The company’s experience in the medical industry and broad expertise strengthen each part of the LINK Medical portfolio. “What makes us different from our competitors and colleagues is that we at LINK Medical have all the competences for early development in place. We have expertise in all pre-clinical phases, regulatory, medical writing and everything beyond which successfully takes projects into clinical development. We are aware of challenges and threats that most pharma, MedTech and biotech companies can face along the way to success. Our experience can be the difference between success to that of total failure”, says Yngve Mikkelsen, Executive Vice President of Medical Operations.

Yngve Mikkelsen, Executive Vice President of Medical Operations.

More precisely, expertise in the early stages of development is essential to completing the journey from idea to

market as efficiently as possible. The experience in health economics and post-marketing projects is key to understanding the strategy required throughout the entire development process to ensure value for all stakeholders in the value chain.

of CROs. What makes LINK Medical different from the rest is the offer of a full understanding of the importance of accurate planning, fulfilling the needs of regulatory and payer stakeholders, before and during the early development phase of the product lifecycle.

Companies choose LINK Medical to take advantage of our broad knowledge and experience in complex projects across many therapeutic areas. Specific early development competencies teamed up with a natural client-oriented environment, makes LINK Medical suitable as a strategic partner and not just a traditional service provider.

LINK Medical has already taken a leading role as a trusted partner in projects involving several nations across Europe. The next step is to establish the LINK Medical brand as the best Northern European CRO, with particular focus on areas such as oncology, neurology and immunology.

“Us being a partner in the early development stages will often lead to an on-going collaboration, where we bring the project closer to market much faster than most of our competitors”, Mikkelsen continues.

Targeting large European economies Like any successful company, LINK Medical is striving to develop its market presence continually. After thousands of successful projects throughout Scandinavia, LINK Medical is looking to expand across Northern Europe, the main targets being large economies such as Germany and the United Kingdom. Germany and the United Kingdom are both complex markets with a large pool

With over 4,000 regulatory projects on-going every year, LINK Medical generally pursues over 250 early development clinical projects. The industry, in general, is under pressure to address the high attrition rates during product development successfully. Reducing the number of efficacy- and safety-related failures come down to good planning and strategy development fulfilling all stakeholder needs during the whole development process. “We are ready to take the next step, with strong teams consisting of experts in all relevant fields from clinical insight, regulation, quality control, medical writing, medical devices and pharmacovigilance”, Yngve Mikkelsen concludes.

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Are you part of the research team that finds the cure for cancer? Franklins Gymnasium, a senior high school solely dedicated to Life Science.

Mölndal is home to some of the world’s largest companies in the Life Science industry. AstraZeneca is a well-known trademark globally, as well as Nobel Biocare. The City of Mölndal wants to strengthen collaboration between industry and academia, and has therefore established Franklins Gymnasium, a senior high school solely dedicated to Life Science.

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magine being part of the research team that finds the cure for cancer. Swedish medical researchers and pharmaceutical developers have long been at the forefront of the global Life Science industry. The stakes are high, and ambitions are even higher. This is why the City of Mölndal, a part of the Gothenburg region and its growing Life Science cluster, has introduced Sweden’s first senior high school with a clear Life Science perspective.

Providing unique opportunities Franklins Gymnasium has only been open for one year, but the interest in the school has been and remains great. The number of pupils wishing to study at Franklins is much greater than the current capacity, but the principal hopes to be able to expand in the upcoming years.

technology, medicine and related industries”, states Maria Solerius, Principal at Franklins Gymnasium. The very idea of Life Science is to improve quality of life for more people. With technological advancement we can live healthier and longer. Diseases can be cured and even eliminated completely. Working in the Life Science industry means working towards a better and more sustainable future for everyone, and this is something that young people of today are very interested in.

Making a difference

At Franklins there are two national senior high school programs, namely the Natural Sciences program or the Technology program. Both with a prominent Life Science profile, and both study preparation programs.

With the establishment Franklins Gymnasium, the City of Mölndal strongly indicates the vision and will to be a driving force in establishing a strong Life Science cluster in the Gothenburg region. “Our ambition is not only to offer a Life Science profile that is unique to the school, but also be the best senior high school in Sweden. We are dedicated to the advancement of the Life Science cluster in our region, and we believe that we can make a difference in its further development”, says Maria Solerius.

“Although the idea is to prepare pupils for further studies at university level, the programs here at Franklins have a very high level of collaboration with the industry. This provides unique opportunities to establish contact with future employers at a very early stage, but perhaps more importantly it establishes a genuine interest in

Anyone who has an interest in technology, is curious about the human body, has a mathematical ability or interest in artificial intelligence can be one of those who create the life-saving and life-improving innovations of the future. Franklins Gymnasium makes it possible.

RISE has extensive quality assured laboratory facilities, and a large number of technicians and scientists devoted to assisting Life Science companies. One of these is Yalda Bogestål, PhD in Medical Science. Here she is showing a 3D-bioprinted scaffold, used for studying cancer cells and cancer drug candidates.

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Anna Nordelöf, Area Manager Quality and Project Management at Semcon in company with Johanna Burström at Digital Services, Semcon Gothenburg.

The importance of always putting people first The technology consulting company Semcon is on an exciting journey together with its customers and employees. By always putting people first, Semcon ensures that the right solution is provided for each end user – and the right assignment for each employee.

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echnology has no purpose of its own, it is the value it gives to people that is most important. This is Semcon’s belief and it shows in each of the company’s projects. Already during project planning, the value of focusing on the end users, is emphasized. Because they are the ones who will be using the solutions in the end. Satisfied end users means happy customers.

Success by putting people first Semcon works closely with customers in almost all industries in many different markets. Life Science is a fast-growing business and Semcon has been a part of it for decades, now being one of the leading consulting companies in the industry in Scandinavia. “In Life Science, personal contacts and relationships matter more than anything, as this line of business requires trust, integrity and confidentiality”, says Anna Nordelöf, Area Manager Quality and Project Management at Semcon in Gothenburg. As a technology company, Semcon operates in an extremely competitive market. This makes it even more important to compete with healthy values, such as being a fair employer. The strategy “People first, then technology” also applies to Semcon’s own company cul-

ture. Because employees who thrive and feel involved at work will grow as people, and perform better.

amounts of data, connections and predict events before they happen.” says Johanna Burström at Digital Services, Semcon Gothenburg.

“For us to be able to attract the best new employees, we must show that we put them first. We have exciting assignments and development opportunities for our employees, and we let each employee become involved in deciding how Semcon as a company should move forward. One important aspect of being an attractive employer and at the same time the customers’ first choice, is our success in matching each assignment with the right skills and with the right person for that particular assignment”, explains Anna Nordelöf.

With extensive experience in the field of User Experience (UX), combined with skills in both physical solutions as well as digital services, Semcon can make a real difference in helping Life Science companies to improve people’s lives.

“We make a difference” Semcon offers a wide range of competencies and is actively looking for employees who want to take part in building the technical solutions of the future for Life Science companies of all sizes. They help their customers to analyse their requirements and needs for IT solutions, and can then lead and implement these solutions in the form of websites, apps and product information systems, for example. “At Semcon we have deep competence in AI and Machine Learning, which is big in the Life Science sector right now, and can analyse huge

“Furthermore, we offer validation of IT systems and evaluation of connected smart devices which communicate with other devices, with health care professionals and with patients. We work with all types of companies, from Big Pharma to small teams in academic research”, says Johanna Burström and continues: “Optimising digital investments to streamline processes is often the goal, and we do this together with the customer and with those who will use the new systems. Whether we are involved in building entire communication platforms for patients, doctors and other health care providers or validating technical information on a medical device, we make a difference in people’s lives and we are proud of it.”

Your partner for compliance – from idea to product in use Mediteq Forum invites you to the webinar – Regulatory strategy for innovations 27/10 2020. Mediteq are experts in quality and regulatory affairs for medical devices and IT-systems. Mediteq delivers consultant services, training, PRRC services and facilitates the competence network Mediteq Forum.

Visit us at mediteq.se to read more or sign up for next activity. 17


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Volvo Cars meets Life Science in Sector Convergence Volvo Cars purpose is to offer everyone the ultimate “ freedom to move, in a personal, sustainable and safe way”. It is not enough to just develop and build great personal cars. Volvo Cars is striving to become a comprehensive mobility provider, and this entails a more direct approach and contact with end users. The ability to provide customer care has never been more important.

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he tremendous and vast experience of human and machine interaction that has accumulated within the Life Science industry is something of a treasure chest for Volvo Cars. The evolution of health, safety and well-being inside personal cars brings Volvo Cars closer and closer to Life Science, sharing the same vision of improving quality of life.

Why sector convergence is important Andreas Strasser, Investment Director EMEA at Volvo Cars, has previously explained the possibilities of using technology to achieve both safe and sustainable driving at an event at Sahlgrenska Science Park. He explained that around five decades ago, the seat belt was at the forefront of technological advancement inside personal cars. Between 2010 and now, wellness has played a key part. From 2020, we are advancing quickly.

The fifth industrial revolution We have only just been introduced to Industry 4.0, or the fourth industrial revolution where digital replaces manual applications. Through even more collaboration and convergence between advanced technologies and people, the fifth industrial revolution moves from fantasy to fact. Volvo Cars strives to become one of the key players in the move towards deeper convergence. Gothenburg is the birthplace of Volvo. The Gothenburg region has unique capabilities when it comes to harvesting and enabling hightech innovations and solutions. According to the 2019 Tech Trends Annual Report, Gothenburg is the second smartest city in the world. But venture capital lags behind.

“The growing interest in the region’s innovative ecosystem is something we must seize and take advantage of. In order to make the most of our region’s abilities when it comes to technology and development, we must bring key stakeholders closer to one another. That is why Volvo Cars is so keen to promote collaboration in multi-arenas Sensors for Further, using biosensors, the wellbeing of humans inside of science”, says Pär Nilsson, Technical Expert, Protectiaccident the car can be monitored and documented to help improve prevention ve Safety Sensing and Control, Emerging Technologies, traffic safety. Real-time alerts for example can be sent to Volvo Cars. hospitals nearby, and so on. It is not science fiction – it is reality Some examples of evolving platforms for collaboration in the Gotoday, at least at R&D level, and Volvo Cars is the enabler together thenburg region is Lindholmen Science Park, Sahlgrenska Life and with researchers and development companies in Life Science. This Johanneberg Science Park. Volvo Cars is involved in collaboration is why sector convergence in this sense is so important. with all of them. From now on and five years ahead, we are moving beyond personal wellness and safety inside the car. With sensor technology it is possible to prevent accidents on the road. Where human ability fails, technology can pick up the pace.

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Care for the most critical patients using cutting-edge medical technology

A group of innovators.

Global technology leader in pharmaceutical processing solutions.

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The importance of having a global outlook MultiHelix is a Lund-based knowledge-oriented company with a global outlook. Through its activities and channels, more precisely the Twins’ International MultiHelix initiative (TIM), and the MultiHelix Think Tank (MTT), MultiHelix makes a significant difference to a lot of clusters and companies in Life Science.

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rsula Hultkvist Bengtsson founded MultiHelix in 2016 based on the need of obtaining expertise and contacts across borders. Almost all companies operating within the Life Science industry can benefit from international contacts. However, obtaining these contacts can be tricky. “Setting up business in another country, perhaps even on another continent, will most likely present some difficult hurdles. Our role is to help companies get around these hurdles as efficiently and quickly as possible. Therefore cross-border networks are so important to us at MultiHelix”, says Ursula Hultkvist Bengtsson.

population and its impact on healthcare systems. Developing healthcare systems of the future is also the key subject of MTT as from 2020. Initially, only Swedish members attended the MTT-activities. In fall 2019, the members representing each nation were able to attend the TIM annual meeting and for the first time take part in an elaborate Think Tank on the theme future healthcare. The annual meeting was synchronised with the Nordic Life Science days in Malmö, Sweden, in September 2019. “The outcome of our first international MTT activity exceeded all expectations. Our ambition is to have at least one international meeting or webinar within MTT each year, as well as our regional five”, says Ursula Hultkvist Bengtsson.

Future healthcare in MultiHelix activities MTT is a great resource of knowledge with its >100 members and ideally an environment of mind expansion. Some examples of common themes discussed during previous MTT-events are future healthcare and digital systems, food in connection to health and sustainability, prevention of disease and promotion of health, and everyone’s right to healthy lives and well-being according to the United Nations’ sustainable development agenda 2030.

Global partner in development & design and manufacturing of medical devices Through high expertise and advanced technology, we contribute to improved quality of life for people around the world.

Elos Medtech is headquartered in Gothenburg and is listed on NASDAQ Stockholm AB. www.elosmedtech.com

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Ursula Hultkvist Bengtsson, the founder of MultiHelix.

Looking at healthcare systems of the future The very idea of MultiHelix is for its members, in MTT as well as in the TIM-network, to look at challenges in unison and possibly develop solutions that work in all regions. TIM started out as a close collaboration platform of five countries in Europe and North America in 2016. Today it includes ten countries over three continents: Europe, North America and Asia. Interestingly, one of the most prominent challenges faced by all regions is that of an aging

Future healthcare and the development of tomorrow’s sustainable healthcare systems will be the core of MTT activities from now on. Members of TIM will create an international value chain focusing on various areas where the development of future healthcare and related sectors are in the forefront. “The challenges that come with an aging population are present in all TIM members’ nations. Being able to achieve the goals outlined in the United Nations’ sustainable development agenda 2030 has everything to do with being able to meet these challenges. Therefore, we will focus on supporting the creation of future healthcare in MultiHelix activities ahead”, Ursula Hultkvist Bengtsson concludes.

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Service engineers with flair Service provider N4 continues to expand in collaboration with leading innovators and corporations within Life Science. Initiated by former employees of AstraZeneca, N4 has quickly made progress throughout Biovation Park in Södertälje and Medicon Village in Lund.

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edicon Village, just like Biovation Park, is a hub for innovation and development within Life Science and related industries. N4 was founded to support laboratory operations of scientific and technical companies. There is a need to perform a wide range of tasks for a laboratory to run smoothly. These tasks are not value adding activities for the company. N4 has the capacity and knowledge to perform such Scientific Services.

Having the right capacity in the right place What is it that N4 can offer to boost the value of client processes? “Our business is built on close interactions with companies in our vicinity, more specifically companies operating here at Medicon Village. We make sure that they can go about their daily business in a smooth and trouble-free manner, by delivering basically everything they need to become more agile and efficient. This means that we practically handle everything from calibration of advanced measuring instruments to the set-up of entire laboratory environments”, explains Paul Hasselgren, Head of Scientific Services at N4 in Lund.

right capacity and qualifications are used in the right place. An over-explicit example would be to have a PhD researcher perform the task of sorting mail or similar. Tasks like these are what N4 can take care of, and the researcher can instead devote his time to develop new drug candidates for instance.

Why N4? N4 offers support, servicing and maintenance of laboratory equipment, also taking care of ordering, re-stocking, and even outsourcing of research services. Thanks to an expansive network of trusted partners and subsidiaries N4 can not only build an entire laboratory, but staff it as well.

It is simply all about freeing one of the most valuable resources that Fredrik Stråhle, service technician at N4.

companies have; time, so that the

Customers shall save money

N4 also designs entire operations and maintenance plans so that the client never has to worry about whether the equipment really works, or if data is reliable based on the tools available. N4 ensures that the entire laboratory is up to standards. “The underlying idea of what we do is that the customers should never

have to pay too much for operation and maintenance, our goal is to always focus on minimizing operational cost. And this is exactly why any forward-striving scientific developer should choose to collaborate with N4”, says Paul Hasselgren. N4 has grown constantly ever since the company was established and has been awarded the Di Gasell Award by Dagens Industri in 2016, 2017 and 2018.

Partner in growth Considering current developments at Medicon Village and other Life Science clusters in Sweden, the question is what kind of future N4 is likely to meet. “There are many ways in which our clients can influence what kind of expertise we will employ, as our business concept is to provide a full-time service that streamlines their businesses. In summary, it can be stated that through our role and our services we have become an asset to every client, in that we evidently cut their costs and increase productivity. We will continue the development of our core competencies and remain a partner in growth for companies in innovative environments such as Medicon Village”, concludes Paul Hasselgren.

Early planning for future market success Developing a successful pharmaceutical or medical device product does not happen overnight, it requires careful planning and a clear strategy from the very beginning. A strategic partnership with LINK Medical offers the expertise and guidance you need to accelerate your time to market. Our teams of regulatory professionals, health economists, early development experts, statisticians and medical doctors will help you develop a strategy so you can focus on the right things and avoid common early development pitfalls. Contact us today to find out how LINK Medical can offer a strategic partnership through every step of product development processes. +46 739 402 227 info@linkmedical.eu or visit www.LINKMedical.eu

Your LINK to // competence & technology LINKMEDICAL.EU

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Patenting has long been and is still a central part of the life science industry’s core activities and funding. The business and impact of patents has however changed with time, as more and more ideas go digital. The biggest challenge with this development is to know how and when to protect valuable knowledge, as IP, so that the knowledge can benefit the company goals and boost further development, commercially and scientifically. Christopher Nävås, Synergon

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ew solutions of today are often based on digital innovations that are generally more difficult to protect than for example pharmaceutical compounds. Sometimes it is not even possible to patent a digital product, due to the fact that the product is lacking the technical effect that is a general requirement for patenting. In such cases, other frameworks for protection might be applicable, such as copyright or structures for trade secret protection. Keeping track of what can and should be patented as well as be protected by other means pose a major challenge for today’s companies within Life Science, often operating somewhere in between the physical laboratory and the digital sphere. Due to the complexity of these innovations, it is often necessary to create a patchwork of different ways to protect the different components the innovation consists of. In cases where it is still possible to obtain patent protection, it can in some cases be unfavourable to go down this path since the technology is advancing so fast that the patented

Photo: Markus Spiske/Unsplash

SYNERGON addresses challenges in protecting valuable knowledge invention may become outdated before the product even reaches the market.

What about Open Source? Almost everyone who builds software today uses the help of open source libraries in their development. Source code is almost always protected by copyright, even if the source code is distributed under an open source license. Since the open source license is an agreement between the copyright holder and whoever implements the source code in a software, the use of the code is subject to certain provisions stated in the terms of the license. “If you have used Open Source in any parts of your development, then special conditions may apply to how the product may be used or distributed. There is a lot to keep track of, often far too much for a single executive with responsibility for a team of developers. Therefore, we suggest to our clients that they use tools for tracking of open source libraries in their repositories, to ensure the compliance with the terms in the licenses.”, says Christopher Nävås.

Protecting valuable knowledge By distributing a software containing open source components without knowing the terms in each of these licenses, the company is exposing itself to a potentially significant legal risk with regards to lawsuits with possibly severe consequences for the business. In addition, one should be aware of that open source components are also accessible for hackers, hence, without proper management, the open source components might be a security vulnerability in the software. Therefore, it is essential for all companies developing software to have an organisational structure in place for managing open source components and tools in place that assures a correct management of licenses and vulnerabilities. Getting these structures in place can be both time consuming and costly, however, by being strategic when setting up the structure this can be made rather cost efficient. SYNERGON is specialised in setting up these structures. “Because the answer is not to stop using open source, but to manage it correctly.” says Christopher Nävås.

SYNERGON is an IP department on demand, focused on Life Science and digital innovations. SYNERGON assists their clients in all types of IP-strategic issues, such as patent portfolio management and planning, IP-budgeting and management of trade secrets, with a high focus on commercial viability.

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AstraZeneca plays a key part in developing the Swedish life science ecosystem The AstraZeneca R&D centre in Gothenburg is already one of the best sites in the world when it comes to advanced research and innovations development. It is one of three global priority R&D centres at AstraZeneca, together with the sites at Gaithersburg in Washington, USA, and Cambridge in England, UK.

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othenburg is an excellent place for developing strong life science clusters. The region does not, however, obtain the same reputation as Washington or Cambridge – at least not yet. AstraZeneca is currently on a journey, aiming to change the way the Gothenburg region is seen globally. “Gothenburg has in fact been the heart of AstraZeneca’s innovations development for over five decades. The main difference today, compared to the past and up until now, is that the climate for innovation has changed. This is largely connected and due to two major aspects; the digital revolution and the scientific revolution within life science, which includes the development towards perso-

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nalised medicine”, says Matti Ahlqvist, AstraZeneca Site Manager in Mölndal, Gothenburg.

“Both revolutions are changing the way we deliver value”

in large life science regions such as Washington and Cambridge. AstraZeneca wants to implement the same feeling and the same advantageous and collaborative environment in Gothenburg.

The world’s best place for life science

The digital revolution involves the development of systems for faster and more secure sharing of patient data, better communication and decision making based on that data, and it can also provide patients with better insight into their own care and how to manage parts of it using digital tools.

Initiatives such as mentoring programs and open innovation platforms are not new at AstraZeneca. They play an important role in bringing Gothenburg to the forefront of the Swedish life science industry and its development. However, to be a global player in life science R&D, Gothenburg needs more.

The scientific revolution involves entirely new biological mechanisms for developing treatments, with a shift in focus from merely treating symptoms to actually being able to cure more and more diseases. This branches out in the development of more personalised medicine, where very small patient groups obtain the same treatment. Some treatments are even adjusted at individual level, meaning they are entirely unique for each person.

“Over five years ago we founded BioVenture Hub, a place within our own grounds where external life science companies can grow. Emerging companies within pharmaceutical development, medical devices, digital health systems and diagnostics are working together in this unique environment to develop the technology, products and treatments that future healthcare providers and patients will require. And we at AstraZeneca are at the heart of all this development”, explains Matti Ahlqvist.

“Both revolutions are changing the way we deliver value to healthcare systems and patients. If we are to take advantage of the opportunities that these developments bring, we must work much closer to others, both in the healthcare sector and in the private business sector, and not least involving the academic side. The benefits are many and we call this the cluster effect”, says Matti Ahlqvist. The cluster effect of which he speaks is already widely known

It does not end here. AstraZeneca has a lot more on the go, and a lot more to share to make Gothenburg the world’s best place for life science research and development. Another example is the GoCo Health Innovation City project, which was initiated by AstraZeneca and in time developed into a new health innovation cluster for the Gothenburg region. The future of innovative health starts in Gothenburg, no doubt.


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Emerging companies welcome at the AstraZeneca BioVentureHub With increasing focus on precision medicine, patient centricity and preventative care, it’s not efficient nor sustainable to develop drugs, devices, diagnostics and digital health solutions in isolation. With its BioVentureHub, AstraZeneca is building a new structure for cross-sector collaboration that is catalysing innovation and an inclusive approach to designing healthcare solutions for the future.

Magnus Björsne, AstraZeneca BioVentureHub.

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ased on an innovative public-private-partnership model and located at the heart of the AstraZeneca site in Gothenburg, the BioVentureHub gives emerging biotech, medtech and digital health companies and academic groups from Sweden and abroad a unique opportunity to co-locate with−and tap into−the power of AstraZeneca’s world-class scientists and state-of-the-art lab facilities and infrastructure, and with each other. Emerging life science companies are welcome to become a part of the BioVentureHub. More specifically, any growing company that has its patents in order and is currently developing interesting technologies, products or treatments in the pharmaceutical business, medical devices, digital health systems or diagnostics area, is welcome to set up in the BioVentureHub.

“We created the BioVentureHub environment for innovation and development at the heart of AstraZeneca Gothenburg, five years ago. Support from our stakeholders, including Vinnova and Region Västra Götaland, has been invaluable along our journey. A common goal was, and still is, to help build a strong life science collaborative cluster in Gothenburg, ensuring that the region is an essential part of the Swedish life science ecosystem,” explains Magnus Björsne, CEO of the BioVentureHub.

Unique innovation hub The BioVentureHub is one of very few innovation hubs focusing on emerging companies rather than start-ups. Moreover, it brings together ideas and innovations from four different sectors together in the same place, namely pharmaceutical drug development, med-

tech/devices, digital health systems and diagnostics. “Working across boundaries and sectors is necessary as future healthcare will be much more personalised. Future treatments are likely to include a combination of all four sectors, and we have created the environment to facilitate this cross-sector convergence and collaboration. says Magnus Björsne. He explains further, “Anyone working for the companies in the BioVentureHub has access to world-class R&D facilities and to the scientific expertise and know-how of the AstraZeneca staff. Developing and sharing ideas and knowledge is what drives us and motivates us. We hope this helps to put Gothenburg on the map as a global centre for life science.”

Welcome to Mölndal – home of Life Science business development The city of Mölndal is one of the Gothenburg region’s most expansive municipalities – not least when it comes to business development within Life Science. In this city some of the region’s largest companies are operating in the Life Science industry, focusing on everything from pharmaceutical development to advanced health innovations.

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t seems like the sky is the limit when it comes to development opportunities in Mölndal.

Creating an essence of collaboration Large Life Science-oriented companies have put Mölndal on a global map of medical technology, drug development and prominent research in health innovations at large. It comes as no surprise that the municipality, the City of Mölndal, is keen to create an essence of collaboration that goes beyond geographical boundaries.

Carina Kloek Malmsten, Business Developer at the City of Mölndal.

“With our stakeholders in Life Science, such as the large pharmaceutical developers and the Mölndal-based experts in medical research, devices and implants, we are building a network of

partners in collaboration. Instead of being limited to Mölndal and Gothenburg we include all of west Sweden”, says Carina Kloek Malmsten, Business Developer at the City of Mölndal.

Nurturing a legacy Mölndal truly is the home of a thriving Life Science industry in Sweden. Around 80 per cent of all job opportunities in the West-Sweden Life Science cluster are in Mölndal. Some of Europe’s largest biomedical and pharmaceutical companies were born here. Their legacy and presence attract other companies who share the vision of becoming world leaders in their field. “In time, we will have a fully developed Life Science cluster here at the heart of the Gothenburg region. Our role mo-

dels are other prosperous clusters in the world and in Sweden for example Medicon Valley Alliance in the Oresund region, and the Stockholm – Uppsala cluster which is the largest in Sweden. We strongly believe that Mölndal will become the capital of West-Sweden’s Life Science cluster”, says Carina Kloek Malmsten.

The journey has just begun The West-Sweden Life Science cluster is in the making, and it is likely to attract some of the world’s best talents in key areas such as dental implants, cochlear and bone-integrated hearing systems, pharmaceutical drug development and medical devices. The journey has just begun.

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Establishing a new and unique method of cancer treatment The Swedish biopharmaceutical company Immunicum has developed a completely unique set of treatments for cancer. Ilixadencel is so far the company’s main product, and it is a new treatment based on immune cells delivered into the patient’s tumour to treat cancer at the source. What makes it unique is that it comes from healthy donors yet creates a personalized therapy for patients. Associate professor Alex Karlsson-Parra, co-founder and Chief Scientific Officer (CSO) of Immunicum.

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mmunicum’s goal is to increase the survival among cancer patients by giving the immune system a head start with a stronger immune response to recognize and fight the cancer. Ilixadencel is the main breakthrough component of this strategy. Ilixadencel is specific enough to target cancer at its core through injecting it directly into the tumour, and at the same time it can be applied to various types of cancer treatments as it is not limited to any specific type of tumour. Thus, it can be administered to any cancer patient. Cancer cells are generally difficult to be detected by the patient’s immune system, however when ilixadencel is injected into the tumour, an inflammatory reaction is created within the tumour. This treatment reactivates the immune system which causes the tumour cells to be destroyed by the body’s immune response, according to the findings of recent studies.

Gathering clinical data Illixadencel is an immune activating therapy, or immune primer, that is being studied in kidney cancer, liver cancer, gastrointestinal stromal tumors (GIST), lung cancer, head and neck cancer and gastric cancer, with the next wave of results due in the second half of 2020. The prospects for the drug candidate have risen over the last year due to the results from the large MERECA trial and smaller GIST trial, previously presented in various articles.

Data from Phase II of the MERECA Renal Cell Carcinoma trial that evaluated the safety and efficacy of ilixadencel in combination with Sutent® (sunitinib) in patients with newly diagnosed mRCC were presented in February at the ASCO-SITC Clinical Immuno-Oncology Symposium 2020 in Orlando, Florida. The data indicates a separation in Kaplan-Meier survival curves in favor of the ilixadencel treatment group and the confirmed objective tumor response rate (ORR) for the ilixadencel treatment group was 42.2% (19/45) versus 24.0% (6/25) for the sunitinib control group. Based on these data Immunicum received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) In May 2020 for the treatment of metastatic mRCC with ilixadencel. The advantages of the RMAT designation include all the benefits of the Fast Track and Breakthrough Therapy Designation programs including guidance and early interactions with the FDA to discuss potential surrogate or intermediate endpoints to support accelerated approval as well as potential ways to satisfy post-approval requirements. “We are very excited to have received the RMAT designation for ilixadencel in kidney cancer as it recognizes both the potential of our novel therapeutic approach as well as the clear need for viable therapies to address this difficult-to treat disease. As a designation similar to the FDA’s Breakthrough Therapy Designation, we will now also have the opportunity to receive direct guidance from the FDA which will inform key develop-

ment decisions and ultimately bring us closer to delivering ilixadencel to patients in need,” commented associate professor Alex Karlsson-Parra, co-founder and Chief Scientific Officer (CSO) of Immunicum.

immune activating drug. One notable advantage is that it does not seem to add side effects on top of other drugs. Thus far, the signs from the drug candidate are therefore promising in both safety and effects.

The next step for ilixadencel is a Phase Ib/II ILIAD trial where it is currently being evaluated for safety in combination with checkpoint inhibitors, another immunotherapy that is becomes the standard-of-care in many indications. This is an important part in advancing Immunicum’s goal of improving the survival of cancer patients.

The future looks promising for Immunicum, and Alex Karlsson-Parra agrees: ”Looking ahead, we are well-positioned as we have a candidate that is broadly applicable and continues to be validated as a backbone to cancer therapy”.

Advantageous positioning The Immunicum team strongly believes that ilixadencel will be the first choice of immune primers and is well positioned to align with the future of combination therapies. Whereas current cancer treatments merely reduce cancer’s ability to grow, ilixadencel actively pursues to eliminate cancer cells through the power of the immune system. The best way to utilise ilixadencel is to pair it with other treatments that help with battling immune suppression. “We are very confident in this combined approach. The current data on ilixadencel is promising in showing more durable immune responses and higher long term survival rates”, Karlsson-Parra underlines. So far, almost 100 patients have been treated with ilixadencel with only limited side effects, such as fever, which is expected when treated with an

607460 Xvivo_Layout 1 2020-08-27 20:43 Sida 1

The XPS™ incorporates all necessary equipment to perform EVLP 24

A market on the rise Immunicum is not just well positioned with their products. The company is also poised to make a big impact in the fast-growing pharmaceutical industry. According to recent reports, Immunicum’s main pharmaceutical market, immuno-oncology, is rapidly expanding at 13 per cent per year and has an expected valuation of $150 billion dollars by 2025. High valued acquisitions and licensing deals continue to bring in large amounts of revenue for smaller biotechnology companies such as Immunicum, as well as being in a healthy capitalized industry. ”As the immuno-oncology therapeutic landscape continues to evolve, we aim to consider all strategic options. We will also continue to explore collaboration opportunities for our products and interact with potential partners as we move forward towards the market” states Alex Karlsson-Parra.


G O T H E N B U R G

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Cancer Diagnostics and Regenerative Medicine at the next level Cline Scientific AB is a Gothenburg-based company with a very interesting history and an even more interesting future. The initial mission and business concept were based on a method to produce nanoscale surface gradients, developed at Gothenburg University and Chalmers University of Technology.

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ell research plays a powerful role in the life sciences, whether it is as a tool for producing biological drugs, as the basis of cell-based therapeutics, or to understand the basis of cancer metastasis. Today, Cline is a leading commercial developer of advanced cancer diagnostics and regenerative medicine treatments based on cell therapy.

Regenerative medicine is not science fiction As mentioned before, Cline has two main applications for its stem cell technology; cancer diagnostics and regenerative medicine based on recreating stem cells.

There is a major challenge in today’s cancer diagnostics, namely that there are no reliable methods for identifying the risk of metastases spreading in earlier stages. This is a need which Cline seeks to meet with the help of nanotechnology and cell therapy. The first clinical trials have begun with cultured cells and are now being followed by tests on human biopsies.

Although researchers have been able to culture stem cells for twenty years or more, they have up until now not been able to create cells that can be planted safely into humans. That is because these differentiated cell populations are often not homogenous and there can still be pluripotent cells able to divide uncontrollably and form teratoma, a form of cancer, if implanted in patients. Researchers at Cline have succeeded in circumventing the problem, and have proven that regenerative medicine treatments, where cells and cellular functions are completely regrown and thus restored, is everything but science fiction.

“Our technology provides a predictive indicator of metastasis. We are able to use and adapt nanoscale surface engineering to actually map the migration of cancerous cells, which is something that has never been done before. Our aim is to offer a complete cancer diagnostic tool based on this technology within three years”, says Patrik Sundh, CEO and co-founder of Cline Scientific.

“Within five years, there may be a full-scale operational treatment in regenerative medicine, based on our research here at Cline followed by a successful project acquisition by a major player. We are about to enter clinical phase I in our stem cell therapy project, and assuming the results turn out as expected, we will then go ahead with the sale of this project”, says Patrik Sundh.

Addressing the major challenge in cancer diagnostics

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Intuitive painting is a process that has repeatedly proven as healing, not only for myself but for my course participants over the years”, says artist Alina Witwitzka.

Intuitive artist promotes an inner healthy force through the painting process Artist Alina Witwitzka wants to share the joy, the energy and healthy power that painting has given her through the years. There is a strong connection between arts and crafts and mental wellbeing, a phenomenon that has interested and baffled scientists for generations.

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lina Witwitzka has studied arts in the context of its impact on our mental health for decades. “It is important to describe the basis of my business to understand the impact that the practice of art can have on our health”, she says initially.

“At my time at the art academy, I was missing something in my education that I then had no words for. I sought to develop myself and my painting process, and specifically sought an inner process that would lead to a state of joy, energy and healthy power. I knew early on that this was what I wanted to achieve and later share with others”. This unique mindset became the very foundation of Creare - Creativity Center (Creare – Skapande Centrum), Alina’s lifework that was established in the 1980s in Stockholm and from 2003 still operates at the heart of Gothenburg.

Strong need for sharing knowledge Early on in her art studies, Alina began to paint intuitively and freely, without being limited by conventional techniques.

No doubt, Alina Witwitzka started her journey towards a totally unique creative arts process and style very early.

“I have always had a strong need to share my knowledge and I have been told that it is typical of a leader. I like to see myself as an artistic leader as well as some form of healer in terms of providing guidance to the powers of healing art”.

“I have always chosen my own path and early on established my own style in my painting. This has set me aside from my peers, but also created a basis upon which I have been able to create something that makes a big difference to the lives and wellbeing of many people”.

“Intuitive painting usually refers to painting where from the beginning you do not have a clear plan for what the motif will be. This is a process that has repeatedly proven as healing, not only for myself but for my course participants over the years”, says Alina.

A business built on joy, energy and healthy power

Promoting an inner healthy force The fact that intuitive painting has a positive effect on mental health is something that researchers have acknowledged. Alina has previously worked with people who have had difficult mental challenges and seen great results in their process. She has also recorded some of the feedback from clients over the years. One of them stated: “In the pictures appeared colours, shapes, symbols that I did not always understand myself but which with Alina’s safe guidance, questions, methods and so on gained insight into. Understanding myself and my inner self gave me a chance to heal and could even turn self-hatred into self-love and care”. The statement from Alina’s client gives a clear description of how strong negative emotions could be turned into positive ones. “In the creative painting process, people have been able to find a refuge and gradually build themselves up from within. This is a great journey and a process that I start every time I start a new course at Creare. I want to convey and lay the foundation for an inner healthy force through my courses”, Alina explains. For more information about Alina and her courses, please visit her websites. www.creare.nu, www.alina.witwitzka.com

Pioneering unique allogeneic, off-the-shelf cell-based immunotherapies that target cancer through a personalized immune priming strategy ⇢ currently in Phase 2 clinical development Immunicum AB 26

www.immunicum.com

Stockholm / Gothenburg, Sweden


G O T H E N B U R G

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S C I E N C E

Creative activities are clearly health-promoting It is scientifically established that creative activities such as pottery have a positive impact on our mental health. Researchers have long worked to map out why creative activities are so powerful in the maintenance of good mental health. The general conclusion is that the practice of arts and crafts has a calming effect, which is something that ceramicist Ulrica Elmberg can attest to.

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reative activities repeatedly end up high on the list of health-promoting activities. Pottery is considered by many researchers to be as healthy as working in the garden for example. Artist and ceramicist Ulrica Elmberg tells us about her creative journey from hobby enthusiast to pottery course leader and exhibitor. “Pottery has been close at hand for me since I was 18 years old. It has certainly often played its part in the background but still been present through most of my life. Over the years, I have spent a lot of time developing my own craft through courses, and the idea of developing it into a full-time business was born only a few years ago”.

An artist goes her own way Ulrica explains further that it was in connection with a major change in her work situation in the hotel industry that she finally made the decision to start something new. “I decided to go my own way and invest more into my main hobby which was pottery. After the magazine Residence fronted my creations in a major report, I was somehow noticed overnight, and then I realised that my love for ceramics could actually develop into a livelihood”. After investing in a kiln to fire stoneware, Ulrica started offering children’s courses in her workshop in Sävedalen just outside of Gothenburg. They were soon to be followed by adult courses and today there is a comprehensive list of courses offered by Ulrica through her company MUNK Form och Fason.

Aside from the regular course activities during the fall and spring, as well as workshops and special events throughout the year, Ulrica sets up art exhibitions using both her own and other artists’ works in the permanent showroom Grindstugan in Jonsered, a short drive from Gothenburg city centre.

How can pottery affect us positively? Researchers agree that it is a very special feeling that occurs when engaging in creative activities. Ulrica explains her own experience: “For me, pottery contributes to a calm that in turn has a healing effect. Whereas many people feel stress in their daily life, crafts can provide good refuge. I strongly believe that internal imbalance can be curbed with the help of pottery and other crafts”. Ulrica Elmberg has always cared about the well-being of others, and she worked in the hotel industry with customer focus and experiences for a long time. Through the course activities in Sävedalen and the exhibition activities in Grindstugan, she now gets to meet people of all ages, in most professional categories and with very different life experiences. “I am most certain that almost everyone can get something out of trying out pottery. I want to help people see the healthy instead of focusing on the unhealthy. Arts and crafts work to prevent good mental health and pottery is a process that everyone can benefit from, no matter where you are in life and what knowledge and experiences you already have”.

PEOPLE FIRST. THEN TECHNOLOGY. Med över 35 års erfarenhet inom life science hjälper vi företag att utveckla läkemedel och medicinteknik som gör det lättare att må bättre. Och att leva livet som man vill. För vi är övertygade om att användarupplevelsen är det sanna beviset på kvalitet. Därför utgår

vi alltid från mänskliga behov och beteenden när vi utvecklar produkter och processer. Vi förenar design, validering och digitala lösningar på ett unikt sätt, och hjälper våra kunder att skapa upplevelser av teknik Ceramicist Ulrica Elmberg, at right. som gör skillnad för de som behöver det som mest.

Semcon.com/lifescience

Nanotechnology for molecular precision in cancer research and stem cell therapy development. Carl Skottsbergs gata 22B, 413 19 Göteborg 

www.clinescientific.com 

+46 31 387 55 55

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The Department of Biomaterials Institute of Clinical Sciences, Sahlgrenska Academy

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he Department of Biomaterials, Institute of Clinical Sciences, University Gothenburg, is an unique interdisciplinary research and educational environment within the Sahlgrenska Academy. Its mission is to generate and provide new ideas, knowledge and educated individuals in the field of medical devices, thus contributing to an improved quality of life and a sustainable development in the field. Although belonging to the academic organization, the department is located in the BIOTECH house of the Sahlgrenska Science Park, along with the manifold, young and creative pharma, vaccin and medtech companies. The roots of the environment trace back to P-I Brånemark´s academic work on osseointegration which revolutionized oral health care globally. The department has an internationally

Interactions between biomaterials and body

leading position in the field of tissue regeneration and integration of implants and prostheses in the human body. The research groups use both ”bottom-up” and applied approaches. Knowledge on the mechanisms for tissue regeneration and implant integration is not only curiosity-driven but provides essential input to the future selection of optimal material properties in order to enable long-term patient safety and benefit. Key assets to this development are advanced methods and skills within the microscopy, laboratory and staff of the Chalmers Materials and Electron Microscopy, the Sahlgrenska Academy Core facilities and the Department of Biomaterials. The national and international interdisciplinary projects with material science experts, clinicians and medtech industry provide valuable translational routes from idea to bedside and vice-versa.

Exploring the next generation of implants

The research group of Thomsen is dedicated to the understanding of the interactions between the properties of biomaterials and the molecules, cells and tissues after insertion in the body. The scientific questions include: How do cells sense the implanted material surface properties in vivo? Which cellular pathways direct tissue regeneration and implant integration vs protracted inflammation and implant failure? How do different modes of cellular communication (e.g. chemokines, cytokines and extracellular vesicles) affect the sequential stages of the biological processes after implantation? On-going larger projects are supported by Vetenskapsrådet (VR), the Swedish Foundation for Strategic Research (SSF), Vinnova and EU. They include studies on the mechanisms of osteoinduction by in vivo resorbable bioceramics and the biocompatibility of novel bioceramic+amino acid ”bone glue”.

Guided Bone Regeneration (GBR) is a surgical principle where a membrane (M) is surgically placed between the soft tissue (S) and jaw bone (B) to help the regeneration of lost bone (D) (shown schematically). The original biological principle was discovered and explored in the late 1980’s at the Sahlgrenska Academy. GBR is used in approximately 40% of all implant surgeries performed globally, representing approximately 4 million GBR surgeries per year. The research group at the Department of Biomaterials, led by Professor Christer Dahlin, continues to explore the next generation of membranes taking advantage of the unique environment with industry and some of the most respected implant centres in the world which are located in the Region Västra Götaland.

Peter Thomsen

Christar Dahlin

Understanding the structure-function relationship of the material-tissue interface

Infection control of medical devices

The research group of Associate Professor Anders Palmquist is focused on the understanding of the structure-function relationship at the interface between biomaterials and tissue. The long-term clinical function relies on effective load transfer and an adaptive tissue interface, capable of remodeling, hence having a cellular infrastructure. Ongoing projects are supported by the faculty, STINT, Vinnova and EU and include the impact of diabetes on implant healing, the mechanics of the interface, the use of additive manufacturing and reducing biomaterial associated infections by antimicrobial surfaces (www.bioremia.eu).

The research group led by Associate Professor Margarita Trobos focuses at understanding the causes of infections related to medical devices and evaluating new diagnostic and antimicrobial strategies, through clinical studies and experimental models. Infection on implants is one of the worst complications and numbers are increasing due to the large elderly population, representing more than half of hospital-acquired infections. These infections are caused by microorganisms that grow in biofilms and are difficult to diagnose and treat. The global rise on antibiotic resistance challenges their control and require urgent innovative alternatives to antibiotics. In collaboration with industrial partners, the group is currently addressing alternative treatments for chronic wounds to stop bacterial communication and virulence. Further, a new diagnostic method is under evaluation to guide treatment decisions of orthopaedic infections caused by biofilms. The joint program Chalmers–GU and BIOREMIA are research and educational training programmes to develop biofilm-resistant materials for bone implant applications. For these projects funding has been provided from CARe, SSF, VGR, Area of Advance Materials and EU.

Osseointegration: From macro to nano. Scan to watch clip at Youtube.

Anders Palmquist

https://biomaterials.gu.se

Margarita Trobos

Profile for Affärstidningen Näringsliv

Gotenburg Life Science  

The West Sweden region has traditionally been a hotbed for people looking for a better life for themselves and their families. For centuries...

Gotenburg Life Science  

The West Sweden region has traditionally been a hotbed for people looking for a better life for themselves and their families. For centuries...

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