Bio-Implant Solutions O V E R V I E W
SAVING LIVES AND RESTORING HEALTH ARE OUR BUSINESS LifeNet Health is a leading non-profit organ and tissue donation agency. In addition, we are a global leader in regenerative medicine and one of the worldâ€™s largest providers of bio-implants. Our full line of allograft bio-implants provides surgeons with the tools they need to improve the lives of patients. Furthermore, we provide exemplary service to clinicians and hospitals by making the finest quality allograft implants easily accessible. We work tirelessly to advance the field of tissue engineering and processing for a wide range of allograft bio-implants. This is because our fundamental mission is to help save lives and restore health to patients around the world. With LifeNet Health as your primary bio-implant supplier, you are investing in the best possible value to ensure the well-being of your patients and the reputation of your hospital. Every year LifeNet Health distributes over 300,000 bio-implants to meet the urgent needs of hospitals and patients around the country. Our record of safety is unmatched. And our philosophy is simple: When partnering with a bioimplant supplier, your decision should not be based solely on fee, but rather on the overall value you and your patients expect and deserve. At LifeNet Health, we deliver that value by excelling in four critical areas: | Safety | Quality | Innovation | Service
LifeNet Bio-Implants | 3
THE LIFENET HEALTH SAFETY ADVANTAGE
An Extensive Network of Recovery Partners • LifeNet Health only accepts donors from federally designated Organ Procurement Organizations (OPOs) or qualified tissue recovery partners. • Audited to guarantee that their recovery process meets current FDA regulations, AATB standards and LifeNet Health’s own guidelines.
Stringent Screening and Review LifeNet Health has a comprehensive range of measures in place to en‑ sure the safety of your allograft bio‑implant. It’s no coincidence that we have distributed over 2.0 million allograft bio‑im‑ plants since 1995 without an incidence of disease transmission.
• A rigorous screening process, including medical history and behavioral risk assessment. • A complete donor report obtained from the next of kin and/ or person most qualified to provide accurate information on the donor, including any autopsy results. • Reviewed and signed by LifeNet Health medical director.
Comprehensive Recovery Protocol • A specialized team is dispatched to recover the tissue under strict LifeNet Health guidelines, including a physical assessment and thorough review of all medical records. • Donor tissue is recovered using the safest recovery techniques and sterile equipment to minimize any bioburden contamination. • Recovered tissue is sampled and tested for microbiological contamination. Blood and other samples are obtained for serological testing. • Sterile wrapping and storage of the tissue at appropriate temperatures.
Cleaning and Sterilization With Allowash XG® • A patented and validated process that removes greater than 99 percent of bone marrow and blood elements from the internal bone matrix. • Along with chemical treatment and other sterilization measures, Allowash XG has been shown to render a Sterility Assurance Level (SAL) of 10-6 and to inactivate viruses without compromising the biomechanical or biochemical properties of the tissue.
4 | LifeNet Bio-Implants
THE LIFENET HEALTH QUALITY ADVANTAGE
Controlled Tissue Environment • State-of-the-art facilities engineered to eliminate the possibility of cross-contamination. • Strict attention to hygiene and cleanliness. • LifeNet Health exceeds regulatory requirements.
Focused Product Development • A comprehensive design process, including computer-aided drawings (CAD), focused engineering and meticulous product testing.
At LifeNet Health, our
• No bio-implant can be released until going through a multidisciplinary review.
touches everything we
commitment to quality
• Analytic testing is performed on demineralized tissue to ensure that residual calcium levels are within AATB guidelines.
do, from our work envi‑
• Freeze-dried tissue is tested to be certain residual moisture levels are below six percent as measured by gravimetric analyses.
process to the final prod‑
ronment to our design uct we deliver to you.
• Ensures that all products meet your specific surgical needs and preferences.
Flexibility and Selection • Wide selection of bio-implants for surgeons according to specific criteria and graft sizes.
Validated Storage and Shipping Methods • Precise storage, packaging and shipping requirements in line with specific bio-implant type. • Shipped products include specific instructions for safe storage and preservation at hospital.
Accreditations and Certifications • American Association of Tissue Banks (AATB) accreditation • Food and Drug Administration (FDA) registration • United Network for Organ Sharing (UNOS) member • Association of Organ Procurement Organizations (AOPO) member • Licensed in required states • International Organization for Standardization (ISO) 13485 certified LifeNet Bio-Implants | 5
THE LIFENET HEALTH INNOVATION ADVANTAGE
Innovation in Cleaning Processes Our patented sterilization process renders allograft bio-implants sterile, without compromising biomechanical or biochemical properties .
Innovation in Preservation Technology
As part of our commit‑ ment to advancing alloen‑ gineering, LifeNet Health invests heavily in research and development. Cur‑ rently, we hold more than 45 patents, and our pipeline holds great prom‑ ise for the future. When partnering with LifeNet Health, you’ll have access to all our innovations, and be the first to benefit
Our proprietary preservation solution allows bio-implants to be stored in a fully hydrated state at ambient temperature. This eliminates the need for lengthy rehydration and saves valuable OR time.
Innovation in Demineralization Technology Patented technology provides precise bone demineralization to achieve the ideal residual calcium level of 1–4 percent. This controlled process protects bone morphogenetic proteins (BMPs) while ensuring optimal osteoinductivity.
Innovation in Decellularization Technology A patented and validated process renders allograft bio-implants acellular, without compromising the biomechanical or desired biochemical properties of an allograft bio-implant for its intended surgical application.
from any new discoveries
Innovation in Textured Bio‑Implant Technology Finally, we’ve also been hard at work developing brand new methods for making and using textured bone allografts and composite bone grafts. And our work doesn’t stop there. We are developing new methods and processes all the time as we look for new ways to help you restore life and health to all the patients you treat.
6 | LifeNet Bio-Implants
THE LIFENET HEALTH SERVICE ADVANTAGE
Access and Ordering • Dedicated customer service team available every day from 7 A.M. to 7 P.M., plus 24-hour on-call support for emergencies. • Free 3-day select shipping on freeze-dried orders. All frozen bioimplants are shipped next day, free of charge. • Bio‑implant locator service. • Flexible return policy. • Three strategic inventory alternatives: direct invoicing, delayed billing invoicing and on-site consigned inventory.
At LifeNet Health, when we say service, we mean
Dedicated Staff and Partners
over 25 years of proven
• On-site bio‑implant specialist to consult with implanting surgeons, or conduct in-services at customer’s request.
support. We have a variety
• Training center at Virginia Beach facility covers topics such as tissue banking history, practices, quality assurance, donor screening and clinical application of human tissues. • Continuing education provided to staff on an ongoing basis.
of programs and policies in place to earn your con‑ fidence and ensure your complete satisfaction.
Education for Your Employees • Continuing education for nursing and technical staff at no charge. • Specific in-service programs designed to train OR staff in the reconstitution of allograft bio-implants, proper use and handling, and more. • Variety of manuals, in-service presentations and other resources for dissemination or presentation to your employees.
Donor Family Support and Assistance • Dedicated to supporting the recipients touched by this process and the donors who make this wonderful gift possible, through continuous communication, workshops and support groups. • Our Web site, www.HealingTheSpirit.org, is available to all who mourn the death of a loved one, and contains information to aid in the grieving process. • “ Thanks to You” program allows recipients to send a thank you letter to the donor families, coordinated and facilitated by LifeNet Health.
LifeNet Bio-Implants | 7
LifeNet Health, a non-profit global leader in regenerative medicine, is the worldâ€™s largest provider of bio-implants and organs for transplantation whose mission is saving lives and restoring health by advancing the field of tissue engineering. LifeNet Health Bio-Implants Division is a leader in the engineering and processing of dental, cardiovascular, spinal and orthopedic bioimplants and distributes more than 300,000 bio-implants every year to restore health to patients around the world.
1864 Concert Drive, Virginia Beach, Virginia 23453 888-847-7831 | LifeNetHealth.org | AccessLifeNetHealth.org