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,
CrossCart’s Z-LigTM device would provide a safe and effective alternative to
autograft and allograft ligaments. The Z-LigTM device is prepared using
CrossCart’s proprietary Z-ProcessTM tissue treatment. CrossCart’s 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.
“Roy’s 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., CrossCart’s founder and Chairman. Fiebiger’s focus will be
on expanding CrossCart’s 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.
“Roy’s 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.
CrossCart’s 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. CrossCart’s 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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Source : http://www.prweb.com/releases/2004/10/prweb167949.htm