Navigation Links
Osteotech Initiates Pivotal Clinical Trial for DuraTech(TM) BioRegeneration Matrix
Date:1/7/2009

First of Several Products in Development Based On Osteotech's Proprietary Human Collagen Technology to Stimulate Natural BioRegeneration; FDA Filing Anticipated in Third Quarter 2009

EATONTOWN, N.J., Jan. 7 /PRNewswire-FirstCall/ -- Osteotech, Inc. (Nasdaq: OSTE), a leader in the emerging field of biologic products for regenerative healing, announced today that it has initiated a pivotal clinical trial for its DuraTech(TM) BioRegeneration Matrix. The first five patients in this 60-patient trial have already been enrolled. During the study's initial cranial surgical procedures, the patients' dura mater (the tough, outermost membrane surrounding the brain and spinal cord) was successfully repaired by surgeons using the DuraTech BioRegeneration Matrix.

This pivotal clinical trial will evaluate 60 surgical patients at 30 and 90 days post-operatively to assess the safety and efficacy of the DuraTech BioRegeneration Matrix compared to historical surgical procedure outcomes. Once this trial is completed, Osteotech plans to file a medical device premarket submission, or 510(k), with the United States Food and Drug Administration (FDA). Osteotech anticipates filing the 510(k) during the third quarter of 2009 to secure marketing clearance.

"DuraTech is the first of several extremely promising products that we have in development based on our innovative human collagen technology platform," stated Sam Owusu-Akyaw, Osteotech's President and Chief Executive Officer. "Our human collagen platform positions Osteotech as first-in-class with this new biomaterial and enables us to respond to the growing surgeon demand, and address patient need, for safe and clinically effective regenerative healing surgical products."

"DuraTech is designed to stimulate the body's natural bioregenerative processes that accelerate healing and reduce the potential for immune reactions," added Mohammed Attawia, M.D., Osteotech's Vice President of Product Development. "Additionally, surgeon feedback during these preclinical trials indicate that DuraTech is easier to handle and provides greater flexibility during surgery than competitive products."

The DuraTech BioRegeneration Matrix is the leading product in Osteotech's collagen platform, which is based on Osteotech's breakthrough and proprietary human collagen technology.

DuraTech will also provide surgeons with the clinical flexibility to cut, shape and suture the material to fit each patient's needs. Based on available data, Osteotech estimates that the market for dural repair substitutes is approximately $100 million.

In addition to the DuraTech BioRegeneration Matrix, which is expected to launch late this year, Osteotech plans to introduce additional human collagen-based tissue products over the next several years that address patient needs and expand the addressable market for this innovative technology, including: rotator cuff repair, wound care applications and abdominal wall reconstruction.

About DuraTech(TM) BioRegeneration Matrix

Utilizing Osteotech's collagen technology, DuraTech is an engineered nano-structure human collagen material that provides a porous scaffold for rapid cellular in-growth to facilitate healing. The DuraTech BioRegeneration Matrix is the lead product in Osteotech's collagen platform and is designed to be utilized to repair the dura mater, a fibrous membrane that protects the brain and the spinal cord, when the dura mater has been compromised due to injury or surgery. Osteotech's proprietary collagen technology platform is supported by three pending patent applications.

About Osteotech

Osteotech, Inc., headquartered in Eatontown, New Jersey, is a global leader in providing OsteoBiologic solutions for regenerative medicine to support surgeons and their patients through the development of innovative therapy-driven products that alleviate pain, promote regenerative and biologic healing and restore function. For further information regarding Osteotech or this press release, please go to Osteotech's website at www.osteotech.com.

Certain statements made throughout this press release that are not historical facts contain forward-looking statements (as such are defined in the Private Securities Litigation Reform Act of 1995) regarding the Company's future plans, objectives and expected performance. Any such forward-looking statements are based on assumptions that the Company believes are reasonable, but are subject to a wide range of risks and uncertainties and, therefore, there can be no assurance that actual results may not differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, the Company's ability to develop and introduce new products, differences in anticipated and actual product and service introduction dates, the ultimate success of those products in the marketplace, the continued acceptance and growth of current products and services, the impact of competitive products and services, the availability of sufficient quantities of suitable donated tissue and the success of cost control and margin improvement efforts. Certain of these factors are detailed from time to time in the Company's periodic reports filed with the Securities and Exchange Commission. All information in this press release is as of January 7, 2009 and the Company does not intend to update this information.


'/>"/>
SOURCE Osteotech, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Carrington Subsidiary DelSite Initiates Critical Toxicology Studies of Its Nasal Powder Bird Flu Vaccine
2. Romark Initiates Clinical Trial of Alinia(R) for Chronic Hepatitis C in the United States
3. Millennium Initiates Clinical Trial to EVOLVE the Treatment of Patients with Newly Diagnosed Multiple Myeloma
4. Allos Therapeutics Initiates Study of PDX in Patients with Cutaneous T-Cell Lymphoma
5. MedImmune Initiates Phase 2a Multi-Dose Study in Patients with Asthma
6. Genta Initiates Phase 3 AGENDA Trial of Genasense(R) for Patients with Advanced Melanoma
7. Nuvelo Re-Initiates SONOMA-3 Trial of Alfimeprase in Patients With Catheter Occlusion
8. TorreyPines Therapeutics Initiates a Phase I Multiple Dose Clinical Trial of Tezampanel
9. Prolexys Pharmaceuticals Initiates Phase 1 Study
10. Isis Initiates Phase 1 Study of ISIS 325568 Targeting Glucagon Receptor to Treat Type 2 Diabetes
11. Lpath Demonstrates Preclinical Efficacy of Lpathomab(TM) and Initiates Humanization Process
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/10/2017)... -- NDS received FDA 510(k) clearance in May 2017 for its highly ... designed for endoscopy environments. An innovative secondary monitor solution, ZeroWire ... support the improvement of patient outcomes, procedural efficiency, and the lowering ... ... ...
(Date:10/4/2017)... 4, 2017  South Korean-based healthcare product Development Company ... "cprCUBE" on Kickstarter. The device will educate the user ... with better efficiency compared to the dated and pricey ... on efficacy of the compression for a more informed ... goal to raise $5,000. ...
(Date:10/2/2017)... 2017  Eli Lilly and Company (NYSE: ... third quarter of 2017 on Tuesday, October 24, 2017. ... day with the investment community and media to further ... call will begin at 9 a.m. Eastern time. Investors, ... webcast of the conference call through a link that ...
Breaking Medicine Technology:
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Apple ... care services, staged a mock evacuation of the facility as part of a disaster ... Fire Department, Echo Hose EMS and Shelton City Emergency Manager, as well as the ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Global Healthcare Management’s ... Alexandria Park in Milford, NJ. This free event, sponsored by Global Healthcare Management’s ... The fun run is geared towards children of all ages; it is a ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the ... danger possible to save lost souls in the Philippines. “The Journey: From the Mountains ... a dedicated teacher of the Bible. She has taught all ages and currently teaches ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest and ... plans to open a flagship location in Covington, LA at 401 N. U.S. Highway ... store next to Office Depot in the Holiday Square shopping center. Its location allows ...
(Date:10/12/2017)... ... 2017 , ... Asante, a nationally recognized health system in ... existing home health joint venture through an agreement, effective October 1, 2017, to ... home health company with Asante, delivering clinically integrated care, for the past eight ...
Breaking Medicine News(10 mins):