CrossCart,
Inc. has developed proprietary
antigen stripping 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, general surgery,
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-LigTM,
is a device for the reconstruction of anterior cruciate ligaments. The Z-Lig
is currently in human clinical trials.
Technology
Description:
The major stumbling block for transplantation of animal tissues into
humans has been tissue rejection. The primary cause of this rejection has
been identified as a cell and matrix surface carbohydrate antigen called
alphagalactosyl epitope ("a-Gal"). The a-Gal antigen is
recognized as foreign by the human immune system and causes immunologic
rejection of transplanted animal tissue. Dr. Kevin Stone developed and
patented an enzymatic method to permanently remove a-Gal from de-vitalized
porcine connective tissues. Dr. Stone and Dr. Uri Galili, CrossCart Senior
Scientist and a leading expert on transplantation immunology, completed a
series of scientific studies that showed elimination of implant rejection
through removal of the a-Gal epitope. Additional proprietary treatments
further diminish tissue specific antigen recognition and modulate the
cellular response to encourage normal healing. CrossCart's technology is
protected by an extensive intellectual property portfolio, which includes
nineteen issued and eleven pending U.S. patents, and applicable
international filings.
The Z-Lig is a porcine-based device for the reconstruction of ruptured anterior cruciate ligament. The Z-Lig is manufactured using the Z-ProcessTM, CrossCart's proprietary antigen removal process. The Z-Process, based on eight years of pre-clinical and pilot clinical research, is a proprietary tissue treatment that enables animal tissue to be implanted successfully in humans without rejection.
ACL surgery is performed over 500,000
times each year worldwide, creating a potential market for source tissue
of well over a billion dollars a year. The current standard of care
involves using either the patient's own tissue (autograft) or donor
cadaver tissue (allograft). Harvesting the patient's own tissue requires a
second site for surgery and thus involves longer surgery, longer and more
painful rehabilitation and slower recovery. The use of cadaver tissue is
limited by a scarcity of donor tissue and is hampered by inconsistent
tissue quality and a low but persistent risk of disease transmission.
Previous attempts by others to develop synthetic ligaments have failed.
The Z-Lig device has been engineered
to stabilize the knee upon implantation and to act as a dynamic scaffold
for gradual cellular repopulation and remodeling of the graft. The Z-Lig
device is replaced by the patient's own tissue. This is the same mechanism
underlying the success of autograft and allograft reconstructions. The Z-Lig
device will provide surgeons and patients an option to eliminate the pain,
complications and expense associated with harvest site surgery. The Z-Lig
device, if successful in pivotal trials, would provide an abundant source
of sterile devices with consistent biomechanical properties comparable in
strength to a graft originating from a young donor.
A multi-site, controlled double-blind
pivotal study has received approval from the FDA and is
expected to start in 2005.
Other Applications:
CrossCart's technology for rendering porcine tissues immunocompatible is
suitable for many additional applications. Initial feasibility evaluations
have been performed and product development is being pursued in
applications in the orthopaedics, general surgery, cardiovascular surgery,
and aesthetics fields.