IRVINE, Calif.--(BUSINESS WIRE)--Pegasus Biologics, Inc., a privately held developer of unique bioimplants for soft tissue repair, and wound care for diabetic ulcers, announced today that it has received CE Mark certification for the commercial sale of its OrthADAPT™ Bioimplant.
The OrthADAPT™ Bioimplant is a highly organized Type I collagen scaffold used for the repair, reinforcement and augmentation of soft tissues including tendons and ligaments. The Bioimplant is processed using Pegasus Biologics’ proprietary crosslinking and sterilization technologies that make it resistant to premature enzyme degradation and biocompatible to allow remodeling.
“Receiving CE Mark approval is a major milestone for our Company. European surgeons will have a new option for the treatment of soft tissue repairs which their U.S. counterparts have been utilizing for the past year and a half,” said Pegasus Biologics President and Founder, France Dixon Helfer. “These surgeons are looking for ways to augment their patients’ repairs; the damaged tissue which oftentimes is weakened, or of poor quality. The OrthADAPT™ Bioimplant will provide them with a safe and effective solution for treating their patients. Our products and technologies are being enthusiastically embraced by surgical communities here in the U.S. and we anticipate a similar response abroad.”
Al Weinstein, Executive Vice President of Sales added, “This is a significant milestone for our Company as we can now expand our market presence throughout the European Community and in many other countries accepting the CE Mark. The OrthADAPT™ Bioimplant has applications in thousands of orthopedic procedures, including ligaments and tendons, sports medicine, as well as foot and ankle soft tissue procedures. With our competitive advantages and core platform technologies, we are well positioned to capture a significant share of the OUS business as we gear up our international distribution network.”
Pamela Misajon, Vice President of Regulatory and Clinical Affairs stated, “The CE Mark is an indication that our company has met essential health, safety and performance protection requirements detailed in the European Medical Device Directive 93/42/EEC. The CE Mark allows our products to gain access to the EU market, assuring patients of the safety and efficacy of the designated products.”
Pegasus Biologics reports that the OrthADAPT™ Bioimplant has been used in the treatment of more than 2,500 patients since its formal launch last year.
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
Pegasus Biologics, Inc. Paul Williams, 949-916-6880
