CrossCart Announces FDA Approval of Pivotal Clinical Trial and Appointment of Roy Fiebiger as CEO

CrossCart, Inc., a leading developer of xenograft tissue technology, announced today that it received conditional FDA approval to conduct a pivotal clinical trial for its Z-LigTM porcine derived anterior cruciate ligament (ACL) device. Separately, CrossCart announced that Roy Fiebiger has been named chief executive officer.

San Francisco, CA (PRWEB) October 15, 2004 -- CrossCart, Inc., a leading developer of xenograft tissue technology, announced today that it received conditional FDA approval to conduct a pivotal clinical trial for its Z-LigTM porcine derived anterior cruciate ligament (ACL) device. Separately, CrossCart announced that Roy Fiebiger has been named chief executive officer.

ACL surgery is performed over 500,000 times each year around the world. Most ACL surgeries performed today use the patients own patellar tendon ligament (autograft) to reconstruct the damaged ACL, requiring the surgeon to open an additional surgical site. This additional surgical site imposes its own recovery and rehabilitation requirements on the patient and may lead to permanent reduction of function. An alternate technique involves the use of allograft tissue harvested from cadavers.

If approved for commercial use, CrossCarts Z-LigTM device would provide a safe and effective alternative to autograft and allograft ligaments. The Z-LigTM device is prepared using CrossCarts proprietary Z-ProcessTM tissue treatment. CrossCarts Z-ProcessTM involves antigen removal and additional tissue treatments that are designed to minimize immune response and encourage normal healing and human cell integration into implanted animal derived tissue. The surgical technique of ACL repair using the Z-LigTM is consistent with current surgical techniques. The Z-Lig pivotal trial will be a controlled, randomized double-blind study involving approximately 325 subjects in up to ten clinical sites around the United States.

Fiebiger comes to CrossCart with over twenty years of operating experience in the medical device industry. Most recently, Fiebiger served as President and CEO of NeuColl, Inc., a private medical device company engaged in the development and commercialization of collagen-based products for orthopedic and spinal applications. Fiebiger grew NeuColl from its inception in 1998 through profitability and recently completing its sale to Angiotech Pharmaceuticals, Inc. Prior to NeuColl, Fiebiger served with a variety of other medical device companies, including: Laserscope, Inc., Envision Surgical Systems, Inc., Norian Corporation, TechMedica, Inc., and Johnson & Johnson, Inc.

Roys leadership in the tissue-based device field will help us to accelerate the commercialization of our core antigen stripping technology", said Kevin R. Stone, M.D., CrossCarts founder and Chairman. Fiebigers focus will be on expanding CrossCarts product portfolio, developing its manufacturing capabilities and evaluating capital raising and strategic partnering opportunities. Fiebiger is expected to continue his outside consulting practice with other non-competitive medical device firms.

Roys hiring is part of our continuing commitment to broaden our management team", according to Stone. Earlier this year, CrossCart hired Adam C. Spiegel as its Chief Operating Officer and Chief Financial Officer. Spiegel brings over twelve years of transactional finance experience, most recently as an investment banker with Credit Suisse First Boston.

About CrossCart:
CrossCart is a private, venture backed company that has developed proprietary antigen removal and sterilization techniques which safely allow the use of animal tissue in humans. CrossCarts technology is applicable to a variety of medical devices in the orthopaedics, cardiovascular surgery and aesthetic fields, including ligaments, cartilage, bone, heart valves, soft tissue patches and injectable porcine collagen for use in dermatologic (wrinkle removal) procedures. CrossCarts first product, the Z-Lig, is a device for the reconstruction of anterior cruciate ligaments. The Z-Lig is currently in human clinical trials.

For further information, contact Adam C. Spiegel at (415) 923-6444

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