AlloSource First Tissue Bank to Provide Sterile Soft Tissue Allografts Using Low Dose, Low Temperature Gamma Irradiation.

CENTENNIAL, Colo. -- AlloSource Continues to Be an Industry Leader in Providing Safe, Sterile, Life Enhancing Allografts 

AlloSource announced it is the first tissue bank to process and distribute 100% sterile soft tissue allografts using a low dose, low temperature gamma irradiation process. Though irradiation is a common procedure for allograft sterilization, supported by findings in sponsored studies, AlloSource has become the first processor to use the lowest dose of irradiation (10-13 kGray) that does not alter the biomechanical, structural or functional properties of allografts. The application of this technology is being applied first to soft tissue allografts, including tendons, tendon with bone attached and fascia.

In general, allografts are extremely safe and complications due to infection transmission are rare. However, at the present time, tissue processors use relatively high levels of irradiation (up to 50 kGray) to sterilize allografts. According to AlloSource, Colorado State University and Dr. Jon E. Block of San Francisco, levels of irradiation above 20 kGray have proven to be detrimental to the biomechanical properties of the allografts.

"The research we sponsored and the improved procedures we have put in place are all part of our mission to process and distribute the safest and most effective allografts possible," said Kevin Cmunt, vice president of Customer and Business Development for AlloSource. "AlloSource customers and allograft recipients will now receive sterile allografts with all their inherent characteristics intact. AlloSource's soft tissue allografts can be considered by clinicians and risk managers to be as safe as any sterile medical device."

Recently, AlloSource sponsored two studies that have led to the improved sterilization process. In the study, "Effects of Irradiation Dose on the Initial Structural Biomechanical Properties of Ovine Bone - Patellar Tendon - Bone Allografts," conducted by Colorado State University Orthopaedic Bioengineering Research Lab, there were no statistical differences found in the biomechanical properties of allografts treated with 15 kGray compared to aseptically processed (non-irradiated) allografts. However, allografts irradiated at 25 kGray were statistically different from the non-irradiated controls in stiffness, ultimate load and ultimate stress.

In a review of published literature performed by Jon E. Block, Ph.D., entitled "Irradiation of Musculoskeletal Allografts," use of lower doses of irradiation (i.e., 10-15 kGray) avoids the potential of tissue damage while maintaining bactericidal coverage. According to Dr. Block, lower doses of irradiation are also more likely to result in good biologic incorporation and integration.

For over 10 years, AlloSource has been a leader in the human tissue industry by developing, processing and distributing life-enhancing bone and tissue allografts with an emphasis on servicing the needs of its donor communities. All soft tissue allografts processed by AlloSource as of September 1, 2004, will undergo the new low dose, low temperature sterilization process and will be available to customers immediately.

Organs and tissue donated by a single person can save and enhance the lives of as many as 60 people. Every year the lives of more than 500,000 Americans are saved or enhanced by organ and tissue donation. Laws that govern donation vary from state to state, therefore, contact the Coalition on Donation (www.shareyourlife.org) to find local coalitions and learn how to donate.

About AlloSource

Centennial, Colo. based AlloSource brings together five of the country's most reputable organ and tissue procurement groups -- Mid-America Transplant Services of St. Louis; Donor Alliance of Denver; Gift of Hope Organ and Tissue Network in Chicago; the Lifesharing Community Organ and Tissue Donation in San Diego; and most recently Upstate New York Transplant Services in Buffalo. AlloSource and its partners are American Association of Tissue Banks accredited and bring more than 100 years of combined experience in the tissue banking industry. For more information, visit the company's Web site at www.allosource.org.