Navigation Links
KENSEY NASH Receives FDA 510(k) Clearance for ECM Product, Meso BioMatrix Surgical Mesh
Date:5/26/2010

EXTON, Pa., May 26 /PRNewswire-FirstCall/ -- 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 that it has received 510(k) clearance from the U.S. Food and Drug Administration for its second extracellular matrix (ECM) product, the Meso BioMatrix™ product. The clearance allows for the use of Meso BioMatrix in general surgery for the reinforcement and repair of soft tissue, including hernia repair, plastic and reconstructive surgery, and urologic, gynecologic and gastroenterologic applications.

The Meso BioMatrix product is a porcine-based mesothelium (Meso) extracellular matrix designed to reinforce soft tissues where weakness exists in patients requiring soft tissue repair.   Medeor™ Matrix, the Company's previously cleared dermal matrix product, and the Meso BioMatrix product are manufactured using Kensey Nash's proprietary Optrix™ process, which gently disinfects tissues, inactivates viruses and removes cells while preserving extracellular matrix components.  Kensey Nash is currently evaluating partnering opportunities for the Meso BioMatrix products in the urogynecology, wound care, orthopaedic and other markets.  

"This regulatory clearance represents another important milestone in our plans to build upon Kensey Nash's leadership position as a developer of innovative regenerative medicine products," commented Doug Evans, Chief Operating Officer of Kensey Nash. "Meso BioMatrix and Medeor Matrix represent two distinct product platforms that put Kensey Nash in the unique position to provide surgeons multiple options with respect to tissue source and handling characteristics when selecting a biologic mesh.  We expect these efforts to yield new collaborative partners and additional products in the rapidly growing biosurgery market that will provide continued diversification and expansion of our business in the future. As a Company, we remain committed to developing unique and effective therapies that address the clinical needs of physicians and patients around the world," he concluded.  

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.


'/>"/>
SOURCE Kensey Nash Corporation
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Kensey Nash to Present at the Ninth Annual JMP Securities Research Conference
2. Kensey Nash Corporation Announces the Addition of Donald Morel, Jr., Ph.D. to Its Board of Directors
3. Kensey Nash To Participate in the Sidoti Fourteenth Annual New York Emerging Growth Institutional Investor Forum
4. Kensey Nash to Present at the Canaccord Adams Musculoskeletal Conference
5. Kensey Nash Announces $30 Million Share Buyback
6. Kensey Nash Reports Second Quarter Fiscal Year 2010 Financial Results
7. Kensey Nash Receives FDA 510(k) Clearance for Porcine Dermis Biologic Product
8. Kensey Nash Corporation Announces Its First Quarter Fiscal Year 2010 Earnings Release Date and Teleconference
9. Kensey Nash Announces Presentations on its Cartilage Repair Device at the International Cartilage Repair Society Meeting
10. Kensey Nash Announces IDE Submission for Cartilage Repair Device
11. HealthWarehouse.com Receives VIPPS Accreditation From The National Association of Boards of Pharmacy
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/19/2017)... LOUISVILLE, Ky. , Sept. 19, 2017   ZirMed ... and predictive analytics, today announced that it has been ranked ... the Black Book™ Rankings 2017 User Survey. ZirMed ... software solution for large hospitals and medical centers over 200 ... in Black Book,s healthcare technology user survey history. ...
(Date:9/13/2017)... , Sept. 13, 2017   OrthoAtlanta has been ... Atlanta Football Host Committee (AFHC) for the 2018 College Football ... 8, 2018, at Mercedes-Benz Stadium in Atlanta, Georgia ... the AFHC "I,m In" campaign, participating in many activities leading ... ...
(Date:9/12/2017)... 12, 2017  ValGenesis Inc., the global leader ... pleased to announce the appointment of Dr. ... Board of Directors and Chairman of Advisory Board ... science companies to manage their entire validation lifecycle ... in this process. Furthermore, ValGenesis VLMS enables rigorous ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... 13, 2017 , ... As health professionals work to improve their approach to ... is doing more than filling out a survey; in many cases health professionals and ... in health care and research on the importance of active engagement with patients and ...
(Date:10/13/2017)... ... 2017 , ... The International Association of Eating Disorders Professionals ... the field of eating disorders, announces the opening of early registration for the ... at the Omni Resort at ChampionsGate. , The annual iaedp™ Symposium ...
(Date:10/13/2017)... ... October 13, 2017 , ... Lori R. Somekh, founder of the Law ... organization of elder law and special needs planning attorneys. “Membership in ElderCounsel helps our ... a forum to network with elder law attorneys nationwide,” said Somekh. , ...
(Date:10/13/2017)... RIDGE, N.J. (PRWEB) , ... October 13, 2017 , ... ... annual Holly Day Market. Featuring a collection of specialty vendors and unique items from ... of personalized and quality-focused health and wellness services offered by the VNA. The ...
(Date:10/13/2017)... ... October 13, 2017 , ... Yisrayl Hawkins, Pastor and Overseer at ... of the most popular and least understood books in the Holy Scriptures, Revelation. The ... that have baffled scholars for centuries. Many have tossed it off as mere rubbish, ...
Breaking Medicine News(10 mins):