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TUESDAY, MARCH 19, 201 3

VOL. 17, NO. 53

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Cook Medical reports expanding its presence in sialendoscopy market

MRI Interventions continues rollout of ClearPoint system

By OMAR FORD Medical Device Daily Staff Writer Cook Medical (Bloomington, Indiana) reported that it has launched a suite of salivary duct products that could advance the sialendoscopy procedures. The applications offer minimally invasive options for the treatment of obstructive salivary gland disease and are the first products launched as part of Cook’s new Otolaryngology—Head and Neck Surgery (OHNS) clinical division. “We’re trying to help advance a new procedure here in the U.S [sialendoscopy]...,” Thomas Cherry, global division leader for Cook Medical’s OHNS division, told Medical Device Daily. “That procedure entails putting a very small endoscope into the salivary ducts within a patient’s mouth. What we’re trying to address is obstructive salivary gland disease.”

By AMANDA PEDERSEN Medical Device Daily Senior Staff Writer It’s a scary thought but a lot of brain surgery today is still done while patients are awake and without real time visualization guidance, so the neurosurgeon is performing the procedure essentially based on blind guesses. MRI Interventions (Memphis, Tennessee) has developed the ClearPoint system to take the guesswork out of neurosurgery. MRI Interventions says ClearPoint is the only system that allows for high-resolution visualization in real time in the MRI suite. “What a lot of people don’t know, or don’t realize, is that neurosurgery is done essentially through blind guesses and we take that guesswork out,” Kimble Jenkins, CEO of MRI Interventions, told Medical Device Daily. “Neuroscience

See Cook, Page 4

See ClearPoint, Page 5

Report from Israel

Washington roundup

Israel Biomed Conference plans to crowdsource

FDA to demand certificate of necessity for Stryker Neptune

By JONATHAN GOLDSTEIN Medical Device Daily Israel Editor As one walks through the market district of modern Jerusalem, one frequently hears a salesman trying to attract customers with one of the market’s standard Hebrew phrases: “The stall owner’s gone crazy – don’t miss the low price opportunity!” Perhaps years of these absurd vociferous pleadings – marketing at its best, no doubt – have had an effect on the Israeli med-tech community’s marketing approach. Either that . . . or the new format of the upcoming IATA Biomed Conference (Tel Aviv) is blazing its way towards a first in the industry. This year’s conference is planned for early June. Apart from a handful of top-quality international keynote

By MARK McCARTY Medical Device Daily Washington Editor FDA announced March 15 it would require providers to offer a certificate of medical necessity to justify the use of the Neptune waste management system by Stryker Instruments (Kalamazoo, Michigan). Stryker reported it had received a warning letter in connection with a recall of the device (Medical Device Daily, March 13, 2013), and the latest announcement says that Stryker and FDA are both “particularly concerned” about recent reports of death and injury in connection with the devices. FDA says it has issued a requirement for certification of medical necessity “to ensure that all users are adequately trained and have implemented the use of the pre-use checklist.”

See Israel, Page 6

See Washington, Page 7

Don’t miss today’s MDD Extra: Cardiology



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Deals roundup

Cynosure to acquire Palomar for $294 million in cash and stock

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Coming Wednesday in MDD Perspectives

A Medical Device Daily Staff Report Cynosure (Westford, Massachusetts) reported that it is acquiring Palomar Medical Technologies (Burlington, Massachusetts) in a cash-and-stock deal valued at about $294 million. Both firms specialize in the aesthetic laser and lightbased technologies. Palomar shareholders will receive $13.65 per share of Palomar common stock: $6.825 per share in cash and $6.825 per share in Cynosure common stock (subject to adjustment and collar provisions described in the definitive agreement). Cynosure will issue approximately 5.2 million shares in the transaction and fund the roughly $147 million in cash consideration through existing cash balances. The acquisition price of $13.65 represents a premium of approximately 23% above Palomar’s average closing price and a premium of approximately 34% over Palomar’s average enterprise value (excluding cash) since the announcement of Palomar’s 2012 year-end results on Feb. 7. The acquisition is expected to be accretive to Cynosure in calendar 2014 with the implementation of $8 million to $10 million in projected synergies. “We believe the acquisition of Palomar creates a substantial opportunity to generate profitable, longterm growth for our Company and drive value for our stockholders,” said Michael Davin, Cynosure’s chairman/ CEO. “Combining with Palomar complements our product portfolio and customer base, adding new product and service revenues, strengthening our global distribution network, creating new cross-selling opportunities and enhancing our intellectual property position with the addition of more than 40 patents.”

1st jury award in J&J hip case is a chilling statistical benchmark The recent decision by a Los Angeles jury in the first case to be decided pitting Johnson & Johnson (J&J; New Brunswick, New Jersey) against what is a cast of thousands of litigants is nothing short of chilling. Then there’s the trust thing – from both the public (consumer) and user (surgeon) perspectives. To read more, see tomorrow’s edition of MDD Perspectives, an op-ed e-zine that provides fresh commentary from the MDD Perspectives blog, Plus, you’ll have access to free articles from Medical Device Daily. If you don’t already receive this complimentary e-zine, go to to opt in. Cynosure and Palomar have a total combined installed base of more than 20,000 aesthetic laser systems worldwide, with a distribution network that spans over 100 countries. The combined revenue of the two companies in calendar year 2012 was more than $234 million with 52% of product revenue coming from North America and 48% originating from the international markets. “Our board of directors and management team believe that this transaction makes strategic sense for our company, offers an attractive premium to our shareholders and creates exciting opportunities for our employees,” said Joseph Caruso, chairman/president/CEO of Palomar. “Both companies share the same passion for innovation, and this

MEDICAL DEVICE DAILY™ (ISSN# 1541-0617) is published every business day by AHC Media, 3525 Piedmont Road, Building Six, Suite 400, Atlanta, GA 30305, U.S.A. Opinions expressed are not necessarily those of this publication. Mention of products or services does not constitute endorsement. MEDICAL DEVICE DAILY™ is a trademark of AHC Media, a Thompson Media Group, LLC company. Copyright © 2013 AHC Media. All Rights Reserved. No part of this publication may be reproduced without the written consent of AHC Media. (GST Registration Number R128870672) ATLANTA NEWSROOM: Executive Editor: Holland Johnson. Washington Editor: Mark McCarty. Staff Writers: Omar Ford, Amanda Pedersen. Senior Production Editor: Robert Kimball. BUSINESS OFFICE:


Senior Vice President/Group Publisher: Donald R. Johnston. Director of Brand Management: Beth Schilling. Product Marketing Manager: Sarah Cross. Marketing Coordinator: Tessa Turner. Account Representatives: Matt Hertzog, Greg Rouse, Chris Wiley.

See Deals, Page 8

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International report

ETView cleared in China for VivaSight-SL distribution A Medical Device Daily Staff Report ETView (Tel Aviv, Israel) has received PMA clearance with the Chinese State Food and Drug Administration (SFDA) for the VivaSight-SL. VivaSight-SL is a single-use disposable single lumen ventilation tube with an integrated continuous high resolution video imaging system for use in lung isolation procedures. VivaSight-SL has been cleared for commercial distribution by the FDA and has received CE pre-market clearance. Lung isolation is employed to provide onelung ventilation in patients undergoing thoracic, cardiac, vascular or esophageal surgeries. It is estimated that more than 1.9 million lung isolation procedures are conducted world-wide annually, accounting for more than $250 million in single-use medical disposables. The device will be exclusively distributed throughout China by the China National Pharmaceutical Group Corporation, SINOPHARM. Additional pre-market regulatory clearances world-wide are anticipated during 2013. “We are excited to have reached this milestone,” said Bill Edelman, CEO of ETView. “VivaSight-SL is now available to the Chinese thoracic surgical community following SFDA clearance of our pre-market application. We anticipate significant clinical interest for this innovative technology in the markets where VivaSight-SL is cleared for commercial distribution. With our line of VivaSight products available in the U.S., South America, Europe and now China, ETView offers a complete airway management solution for 100% of lung-isolation surgeries. We look forward to additional regulatory clearances world-wide which will expand the market for our VivaSight portfolio.” ETView Medical combines airway management with continuous direct airway visualization for medical professionals. China National Pharmaceutical Group Corporation, SINOPHARM, is the largest pharmaceutical and healthcare group under State-Owned Assets Supervision and Administration Commission of the State Council in China.

RAPS to devise training in Southeast Asia The Regulatory Affairs Professionals Society (RAPS; Singapore) is partnering with five Singapore government agencies to develop and implement a new medical device regulatory affairs (MDRA) training program by the end of 2013. In addition to covering the regulatory systems of the U.S., Europe and Asia Pacific markets, the training program will be the world’s first to offer instruction focused on the medical device regulatory requirements across Southeast Asian markets.

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The five agencies involved are the Agency for Science, Technology and Research, Health Sciences Authority, Singapore Economic Development Board (EDB), SPRING Singapore and the Singapore Workforce Development Agency. For medical device companies seeking access to markets in Asia, skilled and knowledgeable regulatory talent is becoming increasingly critical to successfully navigate the fragmented regulatory environment. “RAPS is a global leader in the training and development of regulatory professionals and we are highly supportive of their plans to develop the region’s first MDRA training program in Singapore. This program will build up regulatory capacity available in Singapore and the region, to facilitate the market adoption and innovation of new medical devices,” said Kevin Lai, director, biomedical sciences, EDB. RAPS’ proposed training program will take a blended learning approach, combining elements of online learning with in-person lectures, interactive seminars and casestudy-based learning by renowned regulatory experts from Asia, Europe and North America. This program will be jointly implemented by RAPS and a training partner in Singapore. RAPS helps companies to establish the regulatory profession and continues to actively support the professional and lead the profession as a neutral, nonlobbying nonprofit organization. Q

Clarifying the Regulatory Road for Combination Products A FREE Webinar from Medical Device Daily and BioWorld Today Tuesday, April 9, 2013 Y 1:00 p.m. to 2:30 p.m. EST Through Sponsorship by Novella Clinical Novel combination products offer new innovative diagnostic and treatment options for patients and are becoming more prevalent. Register for this FREE webinar as experts from Novella Clinical and TARIS Biomedical explain the regulatory challenges surrounding combination products and provide you with strategies and recommendations for avoiding costly mistakes. Key Learning Points: t -FBSOIPXDPNCJOBUJPOQSPEVDUTBSFEFëOFECZ'%" t &YQMPSFTUSBUFHJFTUPPCUBJOUIFQSFGFSSFE3FRVFTUGPS  %FTJHOBUJPO 3'% SFTQPOTFBOEUIFQSPDFTTTUFQT t *EFOUJGZDMJOJDBMSFRVJSFNFOUT UJNJOHBOE implications for sponsors t -FBSOXIFOUPFOHBHFB$30QBSUOFS Learn more and register today at or call customer service at 1-800-477-6307

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Continued from Page 1 Cherry told MDD that these tools build off of the work of med-tech firm Karl Storz (El Segundo, California) in the space. Karl Storz is a pioneer in developing small endoscopes for the salivary ducts. “Where Cook comes into play and what we’re excited about is that we get to advance this procedure. We applaud Karl Storz for developing the small endoscope to see the salivary ducts,” Cherry said. “We get to provide therapeutic tools so that now we can start treating and do more intervention inside the salivary ducts.” Cook said that the most prevalent obstructive salivary gland disease is obstruction by salivary duct stones. Salivary duct stones account for about 50% of major salivary gland diseases. Obstruction by salivary duct stones is known as sialolithiasis and affects men (generally, middle-aged males) twice as often as women. If sialolithiasis is not treated, the obstructed area can become infected. The devices in Cook’s product line include a soft-tip wire guide, a serial dilator set, the Kolenda Salivary Access Introducer Set and the NGage and NCircle salivary stone extractors. Physicians use these products in sialendoscopy, a minimally invasive procedure for visualizing and treating obstructive salivary gland disorders through the salivary ducts. Sialendoscopy can be performed in the physician’s office in an outpatient procedure and has been shown to reduce the risks of facial nerve paralysis and morbidity. “Because the salivary ducts are so small, these clinicians have not had the right tools to help perform this procedure in a completely minimally invasive and percutaneous manner,” Cherry said. Cook’s new salivary duct access tools create a working channel through which physicians can treat obstructive salivary gland disease. The soft-tip wire guide is used to access the salivary duct through the duct opening and maintain ductal access throughout the procedure. Flexible serial dilators are introduced over the wire to expand the opening and prepare the salivary duct for the introduction of procedural instruments. The Kolenda introducer sheath is passed over the wire to create an open working channel into the salivary duct. The sheath serves to protect the ductal wall and allow for easy insertion and removal of the procedural instruments. The stone extractors, including the NGage and the NCircle, have baskets that are made of nitinol “memory” wire, which allows the baskets to retain shape following torsion. The baskets are used to manipulate and remove salivary stones. The salivary duct access products are available to doctors internationally and are among the new minimally invasive devices that Cook has launched as part of its OHNS clinical division. Initially, Cook Medical OHNS will focus

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on products that are used to treat salivary gland disease, chronic sinusitis, vocal cord paralysis and obstructive sleep apnea, as well as products used for soft tissue repair and in interventional airway and esophageal procedures. Cherry said that to date, physicians and clinicians have been enthusiastic about the product and have given the company a tremendous amount of support and positive feedback regarding the tools. “We have been completely embraced by the community of otolaryngologists and ENT surgeons that are pioneering or just starting this work,” he said. “We’ve been embraced because they see and they understand what Cook’s manufacturing capabilities are and what we can bring to advance this procedure. The feedback has been tremendous.” He also noted that there was tremendous potential for Cook in the sialendoscopy space. “We’re just starting [in this market],” Cherry told MDD. “We’re just really starting to scratch the surface [with this technology].” Q Omar Ford; 404-262-5546;


Biomet, OrthoSensor in co-promotion partnership A Medical Device Daily Staff Report Biomet (Warsaw, Indiana), a developer of orthopedic and biotechnology products, and OrthoSensor (Sunrise, Florida), a developer of intelligent orthopedics, reported a co-promotion partnership with Biomet’s Vanguard Complete Knee System and OrthoSensor’s Verasense. OrthoSensor Verasense is a trial bearing designed for use with the Vanguard Complete Knee System, which is embedded with sensors and microelectronics to provide surgeons with real-time knee kinetic data. The sensors wirelessly transmit information to a graphic display, allowing surgeons to quantify soft-tissue loads throughout the range of motion. This enables the surgeon to make informed adjustments to the soft tissues and implant placement in order to allow for overall knee balancing. Research has shown that soft tissue balance may aid in the reduction of pain, polyethylene wear, and aseptic loosening while improving patients’ proprioception. Jay Pierce, CEO of OrthoSensor, said, “Combining Biomet’s Vanguard Knee System with Verasense takes knee replacement surgery to a new level of precision by providing surgeons with actionable, intraoperative data to quantify and verify that they balance a knee implant properly during total knee replacement surgery. We are extremely pleased to partner with Biomet and expand access to OrthoSensor’s technology for surgeons using the Vanguard system.” Q

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Continued from Page 1 is the last great frontier in medicine and we’re really excited to be in a good position to participate in that, exploring and conquering that last great frontier.” The ClearPoint system was cleared by the FDA in 2010 (Medical Device Daily, June 30, 2010) and has also received the CE mark for sale in Europe. ClearPoint is an integrated system of reusable components, disposable and intuitive menu-driven software, designed to provide guidance for the placement and operation of instruments during neurological procedures performed within the MRI environment. Using the ClearPoint system, a surgeon sees and selects a neurological target, aims the ClearPoint targeting device, and watches as the surgical instrument is advanced to the target. By the end of 2012 the company had 20 ClearPoint installations, Jenkins told MDD, 18 in the U.S. and two in Europe. The idea is for the system to do for brain surgery what the use of image-guidance has done for other fields over the last 20-plus years, like cardiology for example. “Stents don’t work if you can’t see where you’re placing the stent,” Jenkins said. Without the ClearPoint system, even the delivery of drugs into brain tumors is done without knowing if the infusion cannula is inserted in the exact right place to deliver the drug directly into the tumor, Jenkins said. “With ClearPoint, the doctor sees the tumor in real time, he sees the cannula inserted inside of the tumor in real time and then as the drug is infused he watches the drug being delivered in real time.” Another area where ClearPoint is bound to make a difference in the treatment process is movement disorders such as Parkinson’s disease, where the current leading treatment is deep brain stimulation (DBS). ClearPoint is used to assist with the implantation of DBS leads. The traditional surgical technique for implanting DBS leads has been performed without intra-procedural visualization, meaning that the surgeon cannot see the neurological target and surgical devices inside the brain while the procedure is being performed. By contrast, the next generation ClearPoint system provides surgeons with direct, real time visualization of the patient’s anatomy and the surgical devices throughout the procedure. Using the ClearPoint system, the surgeon sees and selects the neurological target, aims the ClearPoint targeting device, and watches via MRI as the surgical tool is advanced to the target (MDD, Sept. 24, 2012). Jenkins said the feedback from physicians who have used ClearPoint has been very positive. “Physicians really like ClearPoint,” he said. “The most common comment I get from neurosurgeons is ‘this is the future of the field’, real

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time visualization is the future of the field.” Earlier this year the company reported that it has entered into a definitive securities purchase agreement with a group of investors, including both new and existing investors, for the private placement of about 9.1 million shares of its common stock and warrants to purchase roughly 4.6 million shares of its common stock. MRI Interventions noted that proceeds from the private placement would enable the company to continue to expand its sales and marketing efforts for its ClearPoint neuro intervention system, a nextgeneration platform for performing real time, MRI-guided minimally invasive neurosurgery. The proceeds will also strengthen the company’s balance sheet and enable it to complete the commercial roll out of the ClearPoint system (MDD, Jan. 23, 2013). The company also reported during its recent fourth quarter earnings call with investors that it is participating in two new trials for the direct delivery of gene therapies to treat Parkinson’s disease. “We’re tremendously excited about our opportunity to really make a meaningful impact in this field,” Jenkins told MDD. In a trial sponsored by the National Institute of Neurological Disorders and Stroke, which is part of the National Institutes of Health (NIH), the ClearPoint system will be used to deliver of AAV2-GDNF into the putamen of patients suffering from Parkinson’s disease. Glial cell line-derived neurotrophic factor (GDNF) is a chemical that may help protect and strengthen brain cells that produce dopamine. Dopamine is a chemical that affects brain function. Patients suffering from Parkinson’s disease have problems producing dopamine in the brain and researchers hope that gene transfer can help carry GDNF into the area of the brain that is damaged by the disease. The gene transferred in this study may help produce GDNF to protect the damaged brain cells. Initial cases in this Phase 1 open-label dose escalation safety study will be conducted at the NIH. In a trial funded by The Michael J. Fox Foundation, neurosurgeons will use the ClearPoint system in the delivery of adeno-associated virus encoding human aromatic L-amino acid decarboxylase (AAV2-hAADC) into the putamen of patients with Parkinson’s disease. In Parkinson’s disease, the progressive loss of dopamine-producing neurons leads to symptoms including tremor, bradykinesia, rigidity, and postural instability. These symptoms arise due to loss of the enzyme AADC as the dopamine neurons die off, resulting in a reduction in the conversion of levodopa, a drug prescribed to Parkinson’s patients, into dopamine. It is hoped that gene therapy to replace AADC will provide significant clinical benefit to patients with Parkinson’s disease by potentially reducing the required levodopa dose level, and dyskinesias associated with high See ClearPoint, Page 8

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Continued from Page 1 speakers, it is planned to host over two hundred 20-minute slots for invited members to take the podium, and to share their messages, issues, or new approaches on any subject associated with the worlds of medical device and/or life science. For the first time ever (we are told, for a healthcare event of this size), merely by submitting a short abstract on the topic of their choice, a proposer may obtain a speaking slot, or perhaps even design a full panel discussion. International (and Israeli) biomed companies, scientists and entrepreneurs will be given the ‘Chance-To-Speak’ and present their latest perspectives and innovations at this high-profile conference, using the ‘crowdsourcing’ concept to guide the schedule. Crowdsourcing is a modern approach, involving the use of a community – often an online community – to decide/ vote on a subject, rather than leaving it to a select group of decision-makers at the helm of an organization. “We saw it as very appealing, to utilize our public – in our case, a very well-informed and involved biomed public – to crowdsource their opinions, in order to direct us to what they see as the attractive side of the world of biomed, and its future direction,” Ruti Alon, the IATI-Biomed Co-Chairperson, and General Partner at Pitango Venture Capital (Herzliyya) told Medical Device Daily. This highly successful Biomed conference was previously named ILSI Biomed, and now part of the more influential Israel Advanced Technology Industries (IATI, Herzliyya) umbrella group. It is in its twelfth year, and recently announced its novel approach. “We think the conference structure will reflect changes in how ideas should be prioritized, and how innovation is democratized,” Alon added. “We see that the guests at our annual conference are not just visitors from Israel and abroad, they are invariably wonderful entrepreneurs, advisers, corporations and investors. Why should we not use these people to help propose to us what the agenda of their conference should be?” David Jackson, founder/CEO of Seeking Alpha, a leading service for analysis of stocks, including biotech and medical device stocks, which pioneers the application of social media tools to the investor community, agreed with this positive approach. With extensive experience in crowd-based consensus-building and ranking, Jackson told MDD: “When I heard about this, I thought to myself: it just makes so much sense.” Jackson continued to explain that a limitation of the value of crowdsourcing could perhaps be mitigated in this biomedical conference. “With many such events, the fear is that a crowd’s decision may be largely affected by less-involved members.” While not confirmed by the conference organizers, it appears that this conference could offer crowdsourcing (i.e. voting) rights exclusively to the signed-up members, or to those active in

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a past event, ensuring that the voting crowd has a high level of understanding of, and commitment to, the event. Jackson commented: “The audience of the conference is probably the best group to determine what they wish to hear, in order to make their conference enjoyable and valuable.” The only remaining question may be whether the chosen speakers will deliver the voters’ goals – a common concern in any democratic environment (and especially with Israel’s new coalition cabinet sworn in this week). The conference website explains that once this ‘Chanceto-Speak’ platform will reach its submission deadline date (end of March), the list of proposed subjects will be sent to the voters, with the most popular choices shaping the event. “We want people who can show how their work is changing the international medtech and life science sphere, and promote themselves in our hub of change here at IATI Biomed,” Benny Zeevi, managing general partner, DFJ Tel Aviv Venture Partners, and co-chair of IATI and of the Conference, told Medical Device Daily. “Using this new approach, we are hoping to attract individuals from a broader background and geography, in what is already a truly globally-represented medical summit,” he said. MDD asked an additional leading social media expert, Zack Miller, Head of Partnering at Israeli crowdsourcingbased funding house OurCrowd (Jerusalem), and experienced Internet blog writer-entrepreneur. Miller had encountered this crowdsourcing approach in one other large technology conference. “The conference sounds similar to the South by Southwest Interactive Conference (SXSW, Austin, Texas), an extremely popular conference for the tech community that’s been growing 40% year on year for many years already. That success can be attributed to how the conference nominates and votes on speakers/ panelists. Its ‘PanelPicker’ encourages the SXSW community to enter proposals for programming, and then voting on them takes place.” What did Miller think of this as a concept? “This is a savvy move that the IATI-BioMed 2013 conference has taken. Crowdsourcing the panelists incentivizes motivated speakers to mobilize their fans to get votes and spread the event virally – that’s good for the speaker and great for the conference, as the speakers often share in the ‘heavy-lifting marketing’ to get the word out about the event.” Miller explained that crowdsourcing is about tapping wisdom of the crowds. “We have seen the use of the crowd in solving complex medical problems in a group like Innocentive (Waltham, Massachusetts), as well as in improving advanced artificial intelligence or Internet issues, in an annual competition run by Netflix (Los Gatos, California). Crowdsourcing many of the slots at an event like Biomed Israel should make for better programming, but also a better event in general, as attendees are empowered as active contributors to the process.” Jackson of Seeking Alpha agreed: “if you’re trying to See Israel, Page 8

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Continued from Page 1 The FDA statement informs providers they should not use the Neptune 1 Silver or the Neptune 2 Ultra waste management system “unless there is no alternative suction device or waste management system available.” FDA explained that incorrect use of the devices “can cause hemorrhaging and soft tissue, muscle, and vital organ damage that can lead to serious injury and/or death.” One death has been reported in connection with the devices, FDA says.

Draft infusion pump guidance resurfaces FDA reported in the March 18 edition of the Federal Register a draft guidance for infusion pumps, a resurrection of a prior release of the draft that the agency states drew only one comment. The FR notice remarks that the March 26, 2010, announcement of the draft estimated the burden for comment at an hour, but notes in the latest announcement that it will take “significantly longer than one hour to conduct assurance case reports for each of the 56 potential hazards identified.” FDA remarks that one example of a driver of time consumption in filing responses is the “iterative nature of the assurance case report process,” stating further that “each of the applicable hazards will need to be re-evaluated at multiple stages of the development process.” The agency also acknowledged that respondents will find it difficult “to estimate the time required to conduct an assurance case report without specific guidance on the assurance case reports.” FDA indicated that it agrees with the comment that more than one hour is needed to address each of the 56 identified hazards, but asserts nonetheless “that the burden associated with this new recommendation to present data is the time and effort necessary” to file a new 510(k) or 510(k) supplement for pumps already on the market assuming no assurance case has been generated. The announcement therefore offers two hours per identified hazard, or 112 total hours per respondent. Those who wish to comment for the record have until May 17 at using docket number FDA-2010-D-0194.

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statement explains that the FTC commission voted 4-0 to join the State of Idaho in filing the complaint with the U.S. District Court for the District of Idaho. FTC’s Richard Feinstein said in the statement that the acquisition would give the combination nearly 60% of the market in Nampa, adding, “the result of the acquisition will be higher prices for the services that those physicians provide, with costs ultimately passed on to Nampa employers and their employees.” St. Luke’s is said to have acquired all the personal property and equipment held by Saltzer as of Dec. 31, 2012, and Saltzer’s physicians are working under a fiveyear professional services agreement with St. Luke’s. FTC says that a pair of provider groups in competition with St. Luke’s, including Treasure Valley Hospital Limited Partnership (Boise, Idaho), have already filed suit in federal district court in Boise to block the acquisition. The district court declined to enjoin the acquisition, FTC says, and the suit will be heard in July. FTC notes that it will ask the district court to consolidate the two actions for both discovery and trial.

TGA advises Adept head revisions high The Adept modular head system manufactured by Depuy Orthopaedics (Warsaw, Indiana) is no longer available in Australia, but the Therapeutic Goods Administration offered an update on the rate of revisions of the device in a March 18 statement explaining that the three-year rate of revision had reached 7.1% by September 2012, according to data from an Australian national registry. TGA states that eight of the 121 total hip replacements using the Adept 12/14 modular heads with the Adept acetabular component were revised, with half of those caused by loosening. Of the remaining four, two were for infections, and one each for pain and dislocation of the prosthesis. Depuy acquired the Adept from Finsbury Orthopaedics (Surrey, UK) in 2009. TGA notes that the seven-year revision rate for the Adept in the UK is reported to be 12%, adding that the rate of revision “was high regardless of which femoral stem was used.”

MHRA opens ‘innovation office’ FTC to block hospital acquisition Device makers that see provider consolidation as another source of price pressure may be heartened to hear that the Federal Trade Commission announced March 12 it would formally oppose the acquisition of Saltzer Medical Group (Nampa, Idaho) by St. Luke’s Health System (Kansas City, Missouri) as an anti-competitive combination. Saltzer is described as “the largest independent, multispecialty physician practice group” in Idaho, and FTC states that the acquisition would St. Luke’s sufficient leverage in the market to obtain higher rates for primary care physicians in the Nampa area, which the agency argues would lead to higher healthcare costs for consumers. The

The UK’s Medicines and Healthcare Products Regulatory Agency announced March 11 it has established an “innovations office” to foster dialogue between government and industry in the hopes of prompting “early dialogue” between developers and MHRA. Among the subjects of interest are novel drugs and devices as well as novel manufacturing technologies. MHRA says that the “office” will be accessible via a web portal where sponsors can fill in “a simple form which will be submitted confidentially to the most appropriate person.” Q Mark McCarty, 703-361-2519

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Continued from Page 2 combination creates a single, unified organization that is positioned for continued success.” Analysts with Leerink Swann said that the acquisition was a good strategic fit. “Generally, we view consolidation in the sector as a good thing…,” Richard Newitter, an analyst with Leerink Swann said. “Given significant product overlap between the companies in this space, duplicative cost structures, and lots of “me-too” products in the aesthetic device space, the industry is ripe for consolidation in our view.” Newitter adding, “we are not all that surprised by the deal announcement or the target, as management has been pretty vocal about intentions to pursue strategic M&A following the company’s 11/2012 follow-on equity offering. Specifically, the company had mentioned IPL technology as an area in which it would be interested, and given Palomar’s technology expertise in this segment (not to mention Diode laser technology and fractionated skin resurfacing), we view Palomar as a solid choice. In other dealmaking activity: • Cardinal Health (Dublin, Ohio) said it has enhanced its ability to serve the growing population of aging and chronically ill patients by completing its $2.07 billion acquisition of privately held AssuraMed (Twinsburg, Ohio), a provider of medical supplies to patients in the home. Cardinal Health first reported the deal in February (Medical Device Daily, February 15, 2013). “We are very excited to welcome the AssuraMed team to the Cardinal Health organization,” said George Barrett, chairman/CEO of Cardinal Health. “The acquisition of this industry leader allows us to serve the growing number of Americans treated in home settings – particularly those patients recovering from acute episodes and those suffering with chronic diseases. This is a key platform opportunity for Cardinal Health products and services, which will be increasingly important as the delivery of care continues to move to more cost-effective settings.” All members of the AssuraMed management team have joined Cardinal Health, and the business will continue to be led by Michael Petras Jr. as president, AssuraMed. Financial results of AssuraMed will be reported as part of the Medical segment. With proforma annual sales in calendar year 2012 of approximately $1 billion, AssuraMed currently serves more than 1 million patients nationally with more than 30,000 products. The company will continue to operate through two separate businesses: Edgepark, a mail-order, direct-to-home provider of disposable medical supplies, and Independence Medical, a wholesale medical supplies distributor providing services to home health agencies, providers, retailers, and home medical equipment customers. The base of the company’s operations will remain in Twinsburg, Ohio.

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• Healthcare Trust of America (HTA; Scottsdale, Arizona) said that on March 11 it acquired the Forest Park Tower in Dallas, Texas for about $48.7 million. The Tower is a 130,000 square foot class. The Tower represents the second high quality, oncampus medical office building that HTA has acquired from affiliates of Forest Park. The Tower was 100% leased at closing, with a mix of Forest Park and individual physician tenancy. Forest Park is a health system consisting of physician-owned hospitals located throughout Texas. The Dallas campus is strategically located in the North Dallas medical community. Forest Park also operates a hospital in Frisco, Texas, and has several additional hospitals under development. The acquisition was funded with proceeds raised through the company’s equity at-the-market program raised in March. Q


Continued from Page 5 levodopa administration. The initial cases for this Phase I bridging study will be conducted at the University of California, San Francisco. If successful, the study is expected to enable a multi-center, randomized, sham surgery-controlled Phase II safety and efficacy trial. “Our participation in these two new trials is a very significant development for MRI Interventions,” said Jenkins. “Our ClearPoint system is already being utilized in three drug trials for the treatment of brain tumors. These two new trials expand our involvement into gene therapies to treat Parkinson’s disease. We believe these five trials further underscore the clinical importance of our ClearPoint system for the delivery of promising drug and gene therapies to the brain.” Q Amanda Pedersen, 912-660-2282;


Continued from Page 6 ensure satisfaction of your crowd, why not ask them to determine what they want to see?” he challenged. “What’s taking the conference world so long?” he asked. Last year’s event drew 6,000 industry players, VCs, engineers and scientists, with 1,000 participants from over 40 countries and in excess of 3,500 one-on-one networking meetings. This year’s organizers will be expecting a similar figure. The test of this 2013 crowdsourcing experiment will be – what will the programming, and the attendance, of IATI Biomed Israel 2014 look like? Q

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Patent watch

Financings roundup

DioGenix gets protection for neurological sequencing assay

HeartWare completes public offering of 1,725,000 shares

A Medical Device Daily Staff Report

A Medical Device Daily Staff Report

DioGenix (Gaithersburg, Maryland) said the U.S. Patent and Trademark Office has issued a patent that broadly protects DioGenix’ next-generation sequencing assay, MS Precise, that has shown in recent clinical studies to accurately identify patients with multiple sclerosis (MS) at first clinical presentation. U.S. Patent 8,394,583 titled “VH4 Codon Signature for Multiple Sclerosis” claims and describes the use of DNA mutational analysis to profile the immune response of patients suspected of MS across a variety of biosamples (including cerebral spinal fluid and blood) and resulting biomolecules (DNA and RNA). Specific “hot spots” are identified where the mutational frequency of DNA changes are more prevalent in patients with MS than in other similar neurological diseases and healthy controls. “This patent, combined with DioGenix’ expertise in developing novel molecular tests, is a strategic necessity, as our lead clinical trial advances to validate the accuracy of MS Precise in real-world populations being evaluated for a variety of neuroimmune diseases like MS. These rights are merely the first in a growing patent estate based on novel insights into human neurology from a series of clinical studies initiated by the combined team at DioGenix and the University of Texas Southwestern Medical Center (UTSW),” said Larry Tiffany, president/CEO of DioGenix. “Indeed, this patent is a cornerstone of our intellectual property portfolio that allows the company to pursue a longerterm strategy; building a comprehensive pipeline of tests for a variety of immune-mediated neurological diseases.” MS Precise is based on the work of Nancy Monson of UTSW now using next-generation sequencing to measure DNA mutations found in rearranged immunoglobin genes in immune cells initially isolated from cerebrospinal fluid. MS Precise would augment the current standard of care for the diagnosis of MS by providing a more specific measurement of a patient’s immune response to a challenge within the central nervous system. This novel method of measuring changes in adaptive human immunity may also be able to discern individuals whose disease is more progressive and requires more aggressive treatment. DioGenix makes molecular tests using applicationspecific, high-resolution state-of-the-art technologies that measure well-established human biology. Q

HeartWare International (Framingham, Massachusetts and Sydney, Australia) said it has completed a public offering of 1,725,000 shares of common stock at $86.45 a share. This amount includes 225,000 additional shares of common stock sold pursuant to the underwriters’ exercise in full of their option to purchase additional shares of common stock to cover over-allotments. HeartWare said it intends to use the net proceeds from the offering for working capital and general corporate purposes, including, but not limited to, R&D, expansion of manufacturing capabilities, selling and marketing activities, capital investments in information systems, facilities and infrastructure, and general and administrative support growth and the acquisition of licensing of or investment in complimentary products, technologies or businesses. J.P. Morgan Securities acted as the sole book-running manager for the offering. Canaccord Genuity, Credit Suisse Securities (USA) and Lazard Capital Markets acted as comanagers of the offering. Perella Weinberg Partners served as independent capital markets advisor to HeartWare on this offering. In other financing activities, IMRIS (Winnipeg) said it has closed its underwritten public offering of 5.75 million common shares at a public offering price of $3.50 a share. The gross proceeds to IMRIS, before underwritten commissions and other offering expenses, were about $20.1 million. Canaccord Genuity acted as sole book-running manager for the offering and Cowen and Company, acted as co-manager. IMRIS intends to use the net proceeds from this offering for working capital and general corporate purposes, including commercialization activities of new products, R&D programs and working capital needs. Q

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Product Briefs • Ariosa Diagnostics (San Jose, California), the maker of the non-invasive Harmony Prenatal Test for risk assessment of common genetic conditions, reported the expansion of the Harmony Prenatal Test to include the option of Y-chromosome analysis, which can provide information on fetal sex and aneuploidy as early as 10 weeks gestation. The new “Harmony with Y test” will offer patients and their prenatal care providers with evaluation of the Y-chromosome through which fetal sex can be determined with greater than 99% accuracy. The test also assesses the risk of Y aneuploidy, such as XYY, which is due to an extra copy of chromosome Y. Y aneuploidy is estimated to be present in around 1 out of every 1,000 male newborns. The new Y test follows the recent announcement by Ariosa Diagnostics of expanding the Harmony test to allow for both self and non-self IVF pregnancies. • Quidel (San Diego) and Life Technologies (Carlsbad, California) have received FDA clearances to market the Quidel Molecular Direct C. difficile Assay with Life Technologies’ QuantStudio Dx and 7500 Fast Dx Applied Biosystems Real-Time PCR Instruments. Clostridium difficile bacterial infections are life-threatening, especially for the elderly, immunocompromised populations, and for patients on a prolonged antibiotic regimen. C. difficile infection (CDI) is frequently associated with antibiotic therapy and extended hospital stays. The Quidel Molecular product line offers PCR reagent kits for use by molecular diagnostic laboratories, including Life Technologies’ QuantStudio Dx and 7500 Fast Dx. The Quidel Molecular Direct C. difficile Assay kit includes an extraction-free, three-step sample preparation process that requires no heat step, no timed step, and no centrifugation as an added benefit. The QuantStudio Dx Real-Time PCR instrument’s touch screen, reagent and sample tracking, and LIMS (Laboratory Information Management Systems) interface are specifically designed for ease of use, and the six-color feature allows for a multiplex of six targets in one reaction. • Thoratec (Pleasanton, California) has completed the first human use of HeartMate PHP (Percutaneous Heart Pump). The first PHP patient was supported for more than 60 minutes during a high-risk percutaneous coronary intervention (HR PCI). The patient was hemodynamically stable during the procedure, which involved three-vessel intervention on a patient with an ejection fraction less than 30%. The HeartMate PHP system is a catheter-based heart pump designed to provide hemodynamic left ventricular support. Upon insertion into the femoral artery via an integrated 12F introducer sheath, the PHP catheter is advanced into the left ventricle where the distal end of the catheter expands to 24F, allowing for enhanced blood flow with low levels of hemolysis. Thoratec has designed the PHP

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system to facilitate rapid insertion using an intuitive control console and to provide 4-5 liters per minute of mean flow for support durations up to several days.

People in the News • Integra LifeSciences (Plainsboro, New Jersey) reported that its board appointed Lloyd Howell, Jr. as a director of the company, which will return the Board to 10 total members. Director Anne VanLent has decided not to seek re-election to Integra’s board, but will continue to serve until her current term expires. The board nominated Barbara Hill for election as a director at the 2013 annual meeting of stockholders scheduled for May 22. Howell is an executive VP at Booz Allen Hamilton, where he has held a variety of leadership positions since originally joining the firm in 1988 as a consultant. Hill is currently an operating partner of Moelis Capital Partners, a private equity firm, where she focuses on healthcare-related investments and providing strategic operating support for its healthcare portfolio companies. Integra offers solutions in orthopedics, neurosurgery, spine, reconstructive and general surgery. • SinuSys (Palo Alto, California) reported recent additions to its management team. The company has named Michael Daniel as acting VP, regulatory; Eric Schaefer as director, commercial development; and Sagar Pushpala as operations advisor. Daniel has more than 30 years of regulatory, clinical, and quality system experience and has served as VP of regulatory and clinical affairs on a full-time or a part-time consulting basis for a number of medical device companies. Schaefer most recently was director, national sales for ArthroCare’s ENT business unit. Pushpala is currently CEO of TSI Semiconductors. SinuSys makes medical device therapies to improve the health of millions of patients suffering from chronic sinusitis. • Techne (Minneapolis) has named Charles Kummeth as CEO and a director of the company, effective April 1. Gregory Melsen, who has served as the company’s interim CEO since November 2012, will continue to serve as VP of finance and CFO. Kummeth has served as president of Mass Spectrometry and Chromatography at Thermo Fisher Scientific from September 2011. Techne has two operating subsidiaries: Research and Diagnostic Systems and R&D Systems Europe. Access Medical Device Daily Archives Online! You have FREE access to articles dating back to 2005 — perfect for company research or for finding supporting data for presentations and reports. Go to for access.

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Keeping you up to date on recent developments in cardiology Neovasc advances clinical trial of refractory angina device . . . Neovasc (Vancouver, British Columbia) reported that the clinical protocol for its COSIRA (coronary sinus reducer for treatment of refractory angina) trial has been published in the peer-reviewed journal Trials. COSIRA is a double-blind, randomized, multicenter trial that is further assessing the efficacy and safety of the Neovasc Reducer, a percutaneous device for the treatment of refractory angina. The COSIRA trial is currently enrolling patients in the UK, Europe and Canada. “COSIRA was designed as a rigorous, sham-controlled study to provide definitive evidence of the efficacy of the Reducer device, and we are pleased that the protocol is being recognized as noteworthy by the clinical research community,” said Shmuel Banai, MD, chief medical officer of Neovasc. “We are on target for completion of patient enrollment in the second quarter of 2013, with six-month follow-up data from all patients expected to be available around year’s end.” The Reducer has received a CE mark designation in Europe for the treatment of refractory angina. The COSIRA trial is designed to further demonstrate the efficacy of the Reducer and to support additional regulatory applications. Neovasc is also following Reducer patients in two open-label registries being conducted in Europe and Israel. “Patient outcome data from our pilot studies and registry patients enrolled to date has been very promising, and we look forward to reporting the results of the COSIRA study in the coming months,” Neovasc CEO Alexei Marko said. “If these results are consistent with past experience, we will be able to move forward with the commercialization of this exciting new product that has the potential to help alleviate painful and debilitating symptoms in millions of angina patients around the world who have no current options for effective therapy.”

PAPP-A associated with higher risk of cardiovascular events in people with chest pain originating from heart disease . . . Higher levels of pregnancy-associated plasma protein A (PAPP-A) were associated with an increased risk of cardiovascular events in people with cardiac chest pain that developed as a result of heart disease/coronary artery disease, according to a study published in Canadian Medical Association Journal (CMAJ). PAPP-A, used to screen for Down syndrome in pregnant women, has been suggested as a marker of unstable plaque in coronary arteries. The study was conducted in 2,568 patients in Tübingen, Germany, to determine if the presence of PAPP-A could help predict cardiovascular events. The study included patients who visited hospital with cardiac chest pain between December 2007 and April 2009. All patients had an echocardiogram and blood samples drawn for analysis. Previous studies have been smaller in scale, with the largest including 670 patients. More than half (52%) of patients had stable angina and the remaining 48% had acute coronary syndrome. The normal serum value for men and non-pregnant women is < 14 mIU/L. Serum levels in patients who had cardiovascular events in the three months following initial hospital admission, such as a heart attack, stroke or death, were higher compared with those who did not. “PAPP-A remained a significant independent predictor of major cardiovascular events...[as did] a history of diabetes mellitus...and atrial fibrillation,” writes Dr. Stephan von Haehling, Department of Cardiology, Charité Medical School (Berlin), with co-authors. “PAPP-A remained the strongest predictor of major cardiovascular events when we restricted the analysis to patients with stable angina...and when we restricted it to patients with acute coronary syndrome.” The authors suggest that PAPP-A levels could help in evaluating risk levels of patients who present to emergency departments with cardiac chest pain.

Brain aneurysm treatment used to stop irregular heart rhythms . . . For the first time, a UCLA team has used a technique normally employed in treating brain aneurysms to treat severe, life-threatening irregular heart rhythms in two patients. This unique use of the method helped stop ventricular arrhythmias - which cause “electrical storms” – that originated in the septum, the thick muscle that separates the heart’s two ventricles. This area is virtually impossible to reach with conventional treatment. The research was published recently in Heart Rhythm, the official journal of the Heart Rhythm Society, and is highlighted on the cover. Many people suffer from ventricular arrhythmias, which are one of the leading causes of death in the U.S., claiming 400,000 lives annually. These arrhythmias can usually be controlled by medications, by implanting a cardioverter defibrillator device that automatically shocks the heart back into normal rhythm, or by a procedure called catheter ablation, which involves a targeted burn or the application of extreme cold to the tiny area of the heart causing the irregular heart beat. None of these traditional treatments worked for the two patients featured in this report, who suffered from a severe form of arrhythmia called ventricular tachycardia, which causes a dangerous rapid heartbeat. Instead, the UCLA team of cardiologists and interventional neuroTo subscribe, please call MEDICAL DEVICE DAILY™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (404) 262-5476. Copyright © 2013 AHC Media. Reproduction is strictly prohibited. Visit our web site at




radiologists used coil embolization, a minimally invasive method originally developed at UCLA and now commonly used around the world to treat brain aneurysms. “We have to think outside the box to help patients with severe arrhythmias located in hard-to-reach areas of the heart,” said senior author Dr. Kalyanam Shivkumar, director of the UCLA Cardiac Arrhythmia Center and a professor of medicine and radiological sciences at the David Geffen School of Medicine at UCLA. “We hope that this treatment will offer new hope for these heart patients, who previously had few options.” As is common with other arrhythmia procedures, the team first took colorful images of the electrical system of each patient’s heart using wires within the arteries of the heart muscle, which helped pinpoint the exact origin of the arrhythmia and served as a road map for the medical team. During the coil embolization procedure, the team inserted a tiny catheter through a small incision in the groin, then guided it up to the heart and into the small arteries known as septal perforators, which supply blood to the area of the septum wall in which the arrhythmia originated. Once positioned, the team carefully guided tiny, soft-metal coils – just slightly larger than the width of a human hair – through the catheter and into the arteries. The doctors filled each targeted artery with coils, thereby cutting off the blood supply to the region where the arrhythmia originated and stopping it. Similarly, during coil embolization for a brain aneurysm - an abnormal bulge in a blood vessel caused by a weakening in the vessel wall - coils are guided into the aneurysm to fill it. In this way, the aneurysm is sealed off, eliminating the danger that the ballooning area of the vessel will burst in the brain. This procedure also employs a catheter inserted in the groin.

Columbia researchers develop method to build complex cell microenvironments . . . Researchers at Columbia Engineering have developed a new plug-and-play method to assemble complex cell microenvironments that is a scalable, highly precise way to fabricate tissues with any spatial organization or interest – such as those found in the heart or skeleton or vasculature. The study reveals new ways to better mimic the enormous complexity of tissue development, regeneration, and disease, and is published in a recent Early Online edition of Proceedings of the National Academy of Sciences (PNAS). “George Eng, an MD/PhD student in my lab who just received his doctoral degree, designed a lock-and-key technique to build cellular assemblies using a variety of shapes that lock into templates much the way you would use LEGO building blocks,” said Gordana Vunjak-Novakovic, who led the study and is the Mikati Foundation Professor of Biomedical Engineering at Columbia Engineering and professor of medical sciences. “What is really important about this technique is that these shapes are tiny – just a fraction of millimeter, the thickness of a human hair – and that their precise arrangements are made using cell-friendly hydrogels.” Tissue cells in the human body form specific architectures that are critical for the function of each tissue. Cardiac cells, for example, are aligned to create maximum force acting in one direction. Cells without specific spatial organization may never become fully functional if they do not recapitulate their intrinsic organization found in the body. The Columbia Engineering technique enables researchers to construct unique and controlled cell patterns that allow precise studies of cell function, so that, Vunjak-Novakovic adds, “we can now ask some of the more complex questions about how the cells respond to the entire context of their environment. This will help us explore cellular behavior during the progression of disease and test the effects of drugs, stem cells, and various other therapeutic measures.” Eng, who is the lead author of the PNAS paper, used computer-chip-fabrication technologies to make micrometer-sized subunits containing living cells and bioactive molecules, in specific building-block geometries, such as cylinders or cubes. Each shape is prepared to have its own unique biological properties and is then placed into its geometrically matching well on the hydrogel template. The assembling technique is simple: a mixture of various types of shapes is pipetted onto a template with a specific arrangement of the matching wells and placed on a laboratory shaker for a few minutes. Each shape can dock only into its matching well - the rectangular blocks dock only into the exact same rectangular wells, cylindrical blocks into cylindrical wells, and so on, in a lock-and-key manner. After up to ten short cycles of shaking, the template becomes filled with shapes to form a precisely defined pattern. This docking technique thus allows rapid assembly of a large number of subunits to create new tissues. “We used a LEGO-like lock-and-key docking system to spatially localize different cell populations with high specificity and precision,” Eng said. “And, since each shape is docking independent of each other, large tissues can be organized simultaneously, instead of having to create a sequential, brick-by-brick type of organization. With this method, we can design and create better tissues for potential organ replacement.”

— Compiled by Amanda Pedersen, MDD Senior Staff Writer

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Crowdsourcing for the next Biomed conference  
Crowdsourcing for the next Biomed conference  

Israel Biomed Conference of 2013 plans to fill most of its slots using crowdsourcing