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 accel
'/>"/>

SOURCE Osteotech, Inc.
Copyright©2009 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3

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:12/3/2009)...WARRENDALE, Pa., Dec. 3 Radiology imaging leader ...ntegration capabilities at the November 2009 Radio...nnect.PACS(TM) product, enabling the first radiol...atest release in the company,s newly branded Cert...p://www.newscom.com/cgi-bin/prnh/20091203/NE20631 ...
(Date:12/3/2009)... HOERSHOLM, Denmark and SAN DIEGO, California, D...iR-122, a microRNA Important for,Hepatitis C Viral...itis C,Virus in the Bloodstream in Chimpanzees Chr... - SPC3649 Demonstrates Efficacy With No Evidence ...in the Treated Animals - Signaling a Potential,Ben...
(Date:12/3/2009)....C., Dec. 3 In response to the increasingly criti... the evolving healthcare delivery system, Duke Med...matics (DCHI) to provide a campus focus for health...rdisciplinary approach to education that will prod...lthcare administrators with an expertise in the us...
Breaking Medicine Technology:MEDRAD Demonstrates PACS Injection-Record Integration at RSNA 2009 2MEDRAD Demonstrates PACS Injection-Record Integration at RSNA 2009 3New Data Shows Breakthrough microRNA-Targeted Therapy Developed Using Santaris Pharma A/S Proprietary LNA Technology Holds Promise as New Treatment for Hepatitis C 2New Data Shows Breakthrough microRNA-Targeted Therapy Developed Using Santaris Pharma A/S Proprietary LNA Technology Holds Promise as New Treatment for Hepatitis C 3New Data Shows Breakthrough microRNA-Targeted Therapy Developed Using Santaris Pharma A/S Proprietary LNA Technology Holds Promise as New Treatment for Hepatitis C 4New Data Shows Breakthrough microRNA-Targeted Therapy Developed Using Santaris Pharma A/S Proprietary LNA Technology Holds Promise as New Treatment for Hepatitis C 5Duke Medicine to Train Healthcare Professionals in Health Informatics 2Duke Medicine to Train Healthcare Professionals in Health Informatics 3Drop in Certain Visual Skills May Precede Alzheimers 59310 1Drop in Certain Visual Skills May Precede Alzheimers 59310 2With Hormone Therapy Tender Breasts May Signal Cancer Risk 59307 1With Hormone Therapy Tender Breasts May Signal Cancer Risk 59307 2With Hormone Therapy Tender Breasts May Signal Cancer Risk 59307 3Slavica Bio Chem 28HTDS 29 Subsidiary Medical Team Message 59304 1Slavica Bio Chem 28HTDS 29 Subsidiary Medical Team Message 59304 2Slavica Bio Chem 28HTDS 29 Subsidiary Medical Team Message 59304 3Slavica Bio Chem 28HTDS 29 Subsidiary Medical Team Message 59304 4
...15 Pre-mixed insulin,analogues, a modified form o...ffective than long-acting analogues for controllin...with type 2 diabetes, according to a report,funded..., part of the U.S.,Department of Health and Human ...however, appears to be equally,effective as pre-mi...
.... 15 , -- Results inconclusive, as primary outcom...ther donepezil or AZD3480; results impacted by ...own on secondary outcome measures ADCS-CGIC and MM...mparable to placebo, with fewer GI-related AEs...alysis of full dataset and planned discussions...
Other Medicine Technology:Modified Insulin Most Effective For Controlling Post-Meal Blood Sugar Levels 2Modified Insulin Most Effective For Controlling Post-Meal Blood Sugar Levels 3AstraZeneca and Targacept Announce Top-Line Results from Phase IIb Study of AZD3480 in Alzheimer's Disease 2AstraZeneca and Targacept Announce Top-Line Results from Phase IIb Study of AZD3480 in Alzheimer's Disease 3AstraZeneca and Targacept Announce Top-Line Results from Phase IIb Study of AZD3480 in Alzheimer's Disease 4
(Date:12/5/2009)... Wind Turbines are popping ...g from growing mushrooms, making wine to keeping p...B) December 5, 2009 -- Who would have thought that...rom Wind Turbines? Wind Inc. of Fort Worth, Texas ... end users, not wind farms. "Using a technology d...
(Date:12/4/2009)... , PEMBROKE, Bermuda, Dec. 4 Allied World ...ay announced that Scott Carmilani,President and Ch... Vice,President and Chief Corporate Strategy Offic....S. Financial Services Conference being held at th... on Tuesday, December 8, 2009. ,, About Allied...
(Date:12/4/2009)... , ANAHEIM, Calif., Dec. 4 Pamela Bowen, Chief...elected as a finalist for the "Chief Innovation Of...ness with the power of cloud computing. Appy Award...e usage of Salesforce CRM or the Force.com platfor...eir sales, marketing, partner, service, support or...
(Date:12/4/2009)...Working with mice, scientists at Johns Hopkins pub...shown that a protein made by a gene called "Twist"...y distinguish stem cells that drive aggressive, me...lls. , Building on recent work suggesting that it...east tumors that drives breast cancer, scientists ...
(Date:12/4/2009)...comes same whether procedure done immediately or 3... 4 (HealthDay News) -- Timing of surgical repair o...s may not affect patient outcome, a new study has ...om traumatic knee dislocations that can occur in h...ptimal time to perform surgery to repair these inj...
Breaking Medicine News(10 mins):Health News:Distributor Announces New Applications for Wind Turbines 2Health News:Distributor Announces New Applications for Wind Turbines 3Health News:Allied World to Present at the 2009 Goldman Sachs U.S. Financial Services Conference 2Health News:Crescent CIO '09 Dreamforce Conference Speaker and Award Finalist 2Health News:Potential new 'twist' in breast cancer detection 2Health News:Potential new 'twist' in breast cancer detection 3Health News:Timing of Multiple-Ligament Knee Surgery May Not Matter 2
... AFL ) announced today that it will make a present...y-Fourth Annual Strategic Decisions Conference,200...loninger III will,represent Aflac Incorporated, an...ny,s outlook for 2008 and its strategy for,growth ...
...stopher Georgacas and Mark Mi...At its Board Meeting earlier today,the Board of Di...llion in,new grants to expand QUITPLAN(R) Services...ard also welcomed three new,Board Members, the Hon...
... allergy symptoms, PROVIDENCE, R.I., May 21 Apri......sneezes?, For those allergy sufferers out ther...the end of cold weather and snow is certainly welc... Month,and CleanBrands, creators of The World,s Cl...
...erations and new agr...TC,Bulletin Board: ISCR), a leading distributor of...ll, life-saving prescription drugs and a developer...t,highlights include:, -- Revenue grew by 258% i...
...reast Cancer Research Fund, WEST CHESTER, Pa., Ma...y when leading multimedia retailer QVC(R) once aga...7 at 1 AM (ET) and 6 PM,(ET). These two one-hour p...newscom.com/cgi-bin/prnh/20070923/NESU001LOGO ), ...
... played,host to nearly 300 guests at its PowerPlex...ent speaker who provided a poignant report on the ...newscom.com/cgi-bin/prnh/20070627/CLW071LOGO ), ...His remarks included the findings of a survey cond...
Other Medicine News:Health News:Aflac Incorporated to Present at the Sanford C. Bernstein & Co., LLC Twenty-Fourth Annual Strategic Decisions Conference 2008 2Health News:ClearWay Minnesota(SM) Board Approves $1.4 Million in New Grants to Reduce Tobacco's Harm 2Health News:ClearWay Minnesota(SM) Board Approves $1.4 Million in New Grants to Reduce Tobacco's Harm 3Health News:Spring Allergies Got You Down? Try Some of These Drug-Free Options 2Health News:InstaCare Corp. in Turnaround Reports 258% Revenues Increase in 1Q 2008 2Health News:InstaCare Corp. in Turnaround Reports 258% Revenues Increase in 1Q 2008 3Health News:InstaCare Corp. in Turnaround Reports 258% Revenues Increase in 1Q 2008 4Health News:InstaCare Corp. in Turnaround Reports 258% Revenues Increase in 1Q 2008 5Health News:A Touch of Pink Never Looked So Good 2Health News:PowerPlex 2008 User Conference Features Manufacturing Survey by Leading Publication Managing Automation 2Health News:PowerPlex 2008 User Conference Features Manufacturing Survey by Leading Publication Managing Automation 3
Teardrop punch, Left
Meniscus Screw
Biosteon™ (HA/PLLA) Wedge Interference Screws
Graft Workstation
Medicine Products: