Kensey Nash Introduces A Novel Biomaterial, Meso BioMatrix™ Acellular Porcine Peritoneum, For Plastic And Reconstructive Surgery
Apr 24, 2012, 01:26 ET
EXTON, Pa., April 24, 2012 /PRNewswire/ -- Kensey Nash Corporation (Nasdaq: KNSY), a leading medical technology company that provides innovative resorbable biomaterial technology for a wide range of medical procedures, today announced the achievement of several milestones for its Meso BioMatrix™ surgical mesh including the first clinical implant of the product. The Meso BioMatrix™ product is indicated for use in the United States for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair and reinforcement in plastic and reconstructive surgery. The procedure was performed by Dennis Hammond, M.D. of Partners in Plastic Surgery in Grand Rapids, Michigan. "The Meso BioMatrix™ product offers several advantages for use in plastic and reconstructive surgery including strength with just the right amount of pliability, and easy re-draping around corners and complex contours. It will serve as an excellent adjunct in plastic and reconstructive surgery," commented Dr. Hammond.
Kensey Nash will be exhibiting the Meso BioMatrix™ product May 5th-7th at the American Society of Aesthetic Plastic Surgery Meeting in Vancouver, BC.
The Meso BioMatrix™ surgical mesh is manufactured using Kensey Nash's proprietary Optrix™ process, which gently disinfects tissues, inactivates viruses and removes cells while preserving extracellular matrix (ECM) components. It is a unique tissue derived from porcine peritoneum, with a thinner profile, and desirable handling characteristics. Pre-clinical studies have shown more rapid cellular infiltration when compared to dermis based xenograft materials[1].
In addition, Kensey Nash has received 510k clearance for its Meso BioMatrix™ Wound Matrix. This clearance allows for the use of the Meso BioMatrix™ device in the management of topical wounds. Next steps for the technology include CE Mark submissions for both wound and breast surgery applications, and the initiation of an Investigational Device Exemption (IDE) feasibility clinical study for the use of Meso BioMatrix™ for soft tissue reinforcement in two-stage post-mastectomy breast reconstruction surgery. The Company has received conditional approval on the IDE protocol from the FDA and has begun clinical site qualifications.
"The Meso BioMatrix™ products and the previously launched porcine dermis products demonstrate the versatility of the OPTRIX™ processing technology to provide a full spectrum of ECM products with a diverse range of properties for multiple surgical applications. Surgeons have responded favorably to now having an option of biologic materials to meet an array of surgical needs. We anticipate that these efforts will allow Kensey Nash to explore various partnership opportunities in these growing biologic markets," commented Doug Evans, Chief Operating Officer.
About Kensey Nash Corporation. Kensey Nash Corporation is a medical device company primarily focused on regenerative medicine utilizing its proprietary collagen and synthetic polymer technology. The Company is recognized as a leader for innovative product development and unique technology in the field of resorbable biomaterials. The Company has an extensive range of products, which are sold through strategic partners in multiple medical markets, including, the cardiology, orthopaedic, sports medicine, spine, endovascular and general surgery markets.
Cautionary Note for Forward-Looking Statements. This press release contains forward-looking statements that reflect the Company's current expectations about its prospects and opportunities. The Company has tried to identify these forward looking statements by using words such as "expect," "anticipate," "estimate," "plan," "will," "would," "forecast," "believe," "guidance," "projection" or similar expressions, but these words are not the exclusive means for identifying such statements. The Company cautions that a number of risks, uncertainties and other important factors could cause the Company's actual results to differ materially from those in the forward-looking statements including, without limitation, the Company's continued success in its research and development efforts in its cartilage repair and extracellular matrix technologies programs, the Company's ability to enter into new partnering relationships with respect to its extracellular matrix products and the success of existing and new partners in selling the Company's extracellular matrix products, the completion of additional clinical trials in both the U.S. and Europe to support regulatory approval of future generations of its products and competition from other technologies, current economic conditions, and foreign currency fluctuations. For a detailed discussion of factors that could affect the Company's future operating results, please see the Company's SEC filings, including the disclosures under "Risk Factors" in those filings. Except as expressly required by the federal securities laws, the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason.
[1] Data on file at Kensey Nash
Meso BioMatrix™ and Optrix™ are trademarks of Kensey Nash Corporation
SOURCE Kensey Nash Corporation