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Local biotech firm approved to sell product in Europe
April 22, 2014

Daniel Lee, CEO of Aperion Biologics Inc., Photo by Erik Reyna

By Mike W. Thomas, San Antonio Business Journal

It took longer than expected, but a San Antonio-based medical device company has finally garnered approval to sell its lead product in the European Union and other countries that accept the CE Mark.

Aperion Biologics Inc. is a biotech startup that seeks to address needs for alternatives for human tissue grafts in the sports medicine market. The company has a patented process for sterilizing and "humanizing" animal tissues so they can be used as graft material in humans without the fear of rejection.

The Z-Lig£ is the first engineered biologic device for treatment of revision and multiligament anterior cruciate ligament (ACL) knee reconstruction to be granted approval anywhere worldwide.

Aperion has conducted clinical trials around the world using parts from pigs to fashion tendons and ligaments for use in ACL reconstruction of the knee.

"The international trial and CE Mark approval independently confirm the successful results we saw in our U.S. pilot study which now has patients with Z-Lig£ devices 10 years after implantation," says Kevin R. Stone, M.D., the founder of Aperion Biologics.

More than 600,000 ACL reconstruction surgeries are performed around the globe annually with about half being done in the United States.

 

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