Pegasus Biologics, Inc., a developer of unique collagen scaffolds for soft tissue repair, announced today that its OrthADAPT® PR Bioimplant, a Class 2 medical device, has now been utilized by surgeons in a first-of-its kind rotator cuff repair procedure. Pegasus’ biologically based surgical mesh is specifically engineered for arthroscopic delivery and utilizes Pegasus’ existing OrthADAPT collagen matrix combined with a special polymer mesh for added strength and to facilitate surgical delivery.
The procedure was performed last week by US-based orthopedic surgeon, Luis Vargas, M.D., in Caracas, Venezuela, to teach two South American surgeons the new technique. Dr. Vargas is Director of Research and Education for Sports Medicine at Baptist Doctors’ Hospital in Miami, and is a fellow of noted orthopedic surgeon, John Uribe, M.D.
“This new product offers the benefit of a biologic enhancement (biologically enhanced repair) through an arthroscopic technique with more tendon to bone fixation than double row techniques,” said Dr. Uribe.
Dr. Vargas’ promising use of OrthADAPT PR to repair a human patient’s torn rotator cuff follows on the heels of recent news that the proprietary Pegasus Biologics technology has also received CE Mark certification, allowing Pegasus to gain access to the European market.
"Dr. Vargas’ groundbreaking use of our OrthADAPT PR scaffold, as well as the technology’s CE Mark approval, are major milestones for Pegasus Biologics,” said Michael Will, Pegasus’ CEO. “Our technology addresses two significant challenges reported in the literature on rotator cuff procedures: reinforcement at the suture-tendon interface and healing at the tendon-bone interface. It also establishes the largest footprint available, while providing the biologic benefits of adding OrthADAPT collagen to the repair, plus even further added strength through its polymer reinforcement. That we can now also offer orthopedic surgeons and their patients in Europe this new treatment option, as well, is particularly rewarding.”
“Pegasus’ OrthADAPT PR Bioimplant material is a safe, sterile and biologically conductive scaffold that I can now use in my arthroscopic rotator cuff repairs,” said Dr. Vargas. “I believe this product will provide patients with the potential of minimal pain and swelling and a stronger repair over time. OrthADAPT PR enables, for the first time, a biosurgical mesh for rotator cuff repairs that can be delivered arthroscopically, which is exactly what we have been looking for with these types of procedures.”
This product has not been cleared by the FDA and is not available in the United States at this time.
About Pegasus Biologics, Inc.
Pegasus Biologics, Inc. (Irvine, CA) is a privately held company focused on the research, development and commercialization of next generation biologics utilizing the Company’s unique and patented technologies. Additional information on the Company can be found at www.pegasusbio.com.
Contacts:
Paul Williams, 949/916-6880
