Healthcare Industry News:  diabetic foot ulcers 

Devices Wound Care Regulatory

 News Release - December 13, 2007

Pegasus Biologics Receives CE Mark for Diabetic Foot Ulcer Treatment

IRVINE, Calif.--(HSMN NewsFeed)--Pegasus Biologics, Inc., a privately held developer of unique collagen scaffolds for soft tissue repair, announced today that it has received CE Mark certification for the EU commercial sale of its Unite™ Biomatrix collagen wound dressing for treatment of diabetic foot ulcers.

Unite™ Biomatrix is a novel collagen wound dressing with uncompromised strength to support the natural healing environment. The innovative science behind Pegasus Biologics’ proprietary stabilization and sterilization technologies makes the Unite™ Biomatrix a pliable but durable, safe and biocompatible collagen wound dressing that can easily be secured by the physician to the wound. Launched in the U.S. early this year, the Unite™ Biomatrix continues to gain attention from top wound care specialists.

“Receiving CE Mark approval for Unite is a major milestone for Pegasus Biologics,” stated Michael Will, Pegasus’ CEO. “It opens the door for a tremendous opportunity for our company. European surgeons have been looking for new options for the treatment of diabetic foot ulcers and have greatly anticipated the release of the Unite™ Biomatrix outside of the US. According to the World Health Organization, the incidence of diabetes is expected to more than double by 2030. With this, the prevalence of diabetic ulcers and other disease related complications continues to rise. We are pleased that we can now offer diabetic patients outside the U.S. this new treatment.”

Earlier this year, Pegasus Biologics also received CE Mark certification for the OrthADAPT™ Bioimplant product line which is cleared for the repair, augmentation and reinforcement of ligaments and tendons. The CE Mark is an indication that Pegasus Biologics has met essential health, safety and performance protection requirements detailed in the European Medical Device Directive 93/42/EEC. The CE Mark allows Pegasus Biologics to gain access to the EU market, assuring patients of the safety and efficacy of the designated products.

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.


Source: Pegasus Biologics

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