Navigation Links
Osteotech Receives FDA Clearance for Plexur M(TM) Biocomposite
Date:3/4/2008

EATONTOWN, N.J., March 4 /PRNewswire-FirstCall/ -- Osteotech, Inc. (Nasdaq: OSTE), a leader in the emerging field of biologic solutions for regenerative medicine, announced today that the Food and Drug Administration ("FDA") has cleared its 510(k) submission for its Plexur M(TM) Biocomposite. Adapting the Company's proprietary Plexur(R) Technology, Plexur M(TM) is intended for use in filling bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. During the healing process, Plexur M(TM) is remodeled and replaced by host bone.

Plexur M(TM) is a uniquely flexible biomaterial composed of mineralized cortical fibers bound in a resorbable polymer. When heated, this biocomposite becomes moldable and pliable allowing a surgeon numerous options for use during surgery. During the cooling process, Plexur M(TM) hardens providing a versatile porous scaffold to assist in regeneration of damaged and diseased bones. It is an ideal medium for placing screws with no cracking or resultant particulate shedding and can be reamed and reverse-reamed without dislodging the graft or damaging the surrounding bone. Plexur M(TM) uses proprietary processing steps that have been shown to inactivate viruses and is terminally sterilized.

Sam Owusu-Akyaw, Osteotech's President and Chief Executive Officer, stated, "We are very pleased to be able to introduce the Plexur M(TM) Biocomposite. Our internal team has done an excellent job to develop this product and receive FDA clearance for orthopedic applications. We anticipate filing an additional 510(k) submission for the use of Plexur M(TM) in spinal applications in the first part of the second quarter. We plan to continue our research and development activitie
'/>"/>

SOURCE Osteotech, Inc.
Copyright©2008 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3

Related biology technology :

1. Osteotech to Present at the Canaccord Adams Small-Cap Orthopedics Conference in San Francisco
2. Osteotech Reports 2007 Full Year and Fourth Quarter Financial Results; Full Year Revenue of $104.3 Million Exceeds $100 Million Milestone; Diluted Earnings Per Share Was $.15 in 2007
3. Osteotech Announces Fourth Quarter and Full Year Earnings Release and Conference Call Schedule
4. Osteotech to Present at Sidoti Conference in San Francisco
5. Osteotech to Present at Roth Capital Partners 2007 New York Investor Conference
6. Ventria Receives Friends of Education Award From Geary County School District
7. STAAR Surgical Receives Approval to Market Visian(R) Toric Implantable Collamer Lens in China
8. Actavis Receives Approval for Irinotecan Hydrochloride Injection; Extends US Portfolio with First Injectable Product
9. Kyowa Hakko Receives Not Approvable Letter from FDA for Istradefylline (KW-6002)
10. Vermillion Receives NASDAQ Notice of Non-Compliance
11. Purchase Agreement for Antibody Manufacturing Facility Receives Antitrust Clearance

Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/8/2009)...IN VIEW, Calif. Nov. 5, 2009 Complete Genomics, ..., today announced publication of a report in the j...quencing platform, including analysis of sequence ...ables cost for these three genomes sequenced on th... from $8,005 for 87x coverage to $1,726 for 45x co...
(Date:11/6/2009)...ass., Nov. 6 Myriant Technologies ...er and manufacturer of renewable bio-chemicals, U...ology provider Uhde GmbH, one of the world,s leadi...nced an alliance for the engineering, procurement ...cinic Acid plants based on renewable feedstocks. ...
(Date:11/6/2009)...Calif., Nov. 6 Intarcia Therapeuti...ITCA 650 (DUROS® continuous delivery of exena... at the Ninth Annual Diabetes Technology Meeting i...com.com/cgi-bin/prnh/20050301/SFTU126LOGO ) ,, ...a ITCA 650 Lowers Plasma Glucose, HbA1c and Reduce...
(Date:11/5/2009)...Y, N.J., Nov. 5 DSM Pharmaceutical...acturing alliance with Galenix, Saint Jean D,Illac...al scale manufacturing partner for Galenix commerc...nix will collaborate on business development oppor...logies, based on the strength of Galenix in drug p...
Breaking Biology Technology:Complete Genomics publishes in Science on low-cost sequencing of 3 human genomes 2Myriant Technologies LLC, Uhde Corporation of America and Uhde GmbH Announce Alliance for Engineering, Procurement & Construction of World Scale Renewable Succinic Acid Plants 2Myriant Technologies LLC, Uhde Corporation of America and Uhde GmbH Announce Alliance for Engineering, Procurement & Construction of World Scale Renewable Succinic Acid Plants 3Intarcia Therapeutics, Inc. Presents Positive Results from Two Studies of ITCA 650 for the Treatment of Type 2 Diabetes at the Ninth Annual Diabetes Technology Meeting 2Intarcia Therapeutics, Inc. Presents Positive Results from Two Studies of ITCA 650 for the Treatment of Type 2 Diabetes at the Ninth Annual Diabetes Technology Meeting 3Intarcia Therapeutics, Inc. Presents Positive Results from Two Studies of ITCA 650 for the Treatment of Type 2 Diabetes at the Ninth Annual Diabetes Technology Meeting 4Intarcia Therapeutics, Inc. Presents Positive Results from Two Studies of ITCA 650 for the Treatment of Type 2 Diabetes at the Ninth Annual Diabetes Technology Meeting 5DSM Pharmaceutical Products Forms Manufacturing Alliance With Galenix 2DSM Pharmaceutical Products Forms Manufacturing Alliance With Galenix 3
... and Larissa Tan, Bio-Rad Laboratories, Inc.,He... General Information , The polymerase... tool , in molecular biology. The use of ... advances in gene discovery, diagnostics, and g...ew techniques that build on PCR have further expan...
...sta, TATAA Biocenter, Medicinaregatan 7A/B,405 ...tion , A technique for antigen detectio...Sano et al. (1992). It combines the molecular reco... amplification capability of PCR. The procedure is...immunosorbent assays (ELISA) but allows , ...
...gel electrophoresis (DIGE) is a relatively straigh...beling of protein samples using fluorescent , ...Unlu et al. (1997), uses , cyanine (Cy) d...2-D gel , electrophoresis. Following labe... can be achieved by scanning the multiplex gel...
Other Biology Technology:Real-Time PCR: General Considerations, Rev A 2Real-Time PCR: General Considerations, Rev A 3Real-Time PCR: General Considerations, Rev A 4Real-Time PCR: General Considerations, Rev A 5Real-Time PCR: General Considerations, Rev A 6Real-Time PCR: General Considerations, Rev A 7Real-Time Immuno-PCR on the iCycler iQ System, Rev A 2Real-Time Immuno-PCR on the iCycler iQ System, Rev A 3Real-Time Immuno-PCR on the iCycler iQ System, Rev A 4Real-Time Immuno-PCR on the iCycler iQ System, Rev A 5Imaging and Analysis of DIGE Product Information Sheet, Rev B 2Imaging and Analysis of DIGE Product Information Sheet, Rev B 3Imaging and Analysis of DIGE Product Information Sheet, Rev B 4Imaging and Analysis of DIGE Product Information Sheet, Rev B 5Imaging and Analysis of DIGE Product Information Sheet, Rev B 6Imaging and Analysis of DIGE Product Information Sheet, Rev B 7
(Date:11/9/2009)...ith cancer, the hopeful news is that pediatric sur...ong the bad newstreatments that enable survival of...ancer who have reached puberty currently have an o...ergoing cancer treatment, they may have their seme...s, however, do not produce sperm, although their t...
(Date:11/9/2009)....S. Department of Energy (DOE) has announced plans...Birmingham (UAB) School of Engineering on technolo...ns through the capture and permanent safe storage,...oject is in collaboration with Southern Company, t...the DOE through the 2009 American Recovery and Rei...
(Date:11/9/2009)...urwissenschaften is publishing a special issue "B...y" to commemorate Darwin,s On the Origin of Specie...59. Guest editor and author of the lead article is...gy and evolutionary biology at the University of K...ue are available free of charge until 30 December ...
Breaking Biology News(10 mins):For young boys with cancer, testicular tissue banking may be option to preserve fertility 2For young boys with cancer, testicular tissue banking may be option to preserve fertility 3UAB, partners seek safe carbon dioxide storage for 'greener' power generation 2UAB, partners seek safe carbon dioxide storage for 'greener' power generation 3Severe Swine Flu Could Lead to Blood Clots in Lungs 3A Study 59480 1Severe Swine Flu Could Lead to Blood Clots in Lungs 3A Study 59480 2Severe Swine Flu Could Lead to Blood Clots in Lungs 3A Study 59480 3Severe Swine Flu Could Lead to Blood Clots in Lungs 3A Study 59480 4Gentle touch may aid multiple sclerosis patients 59477 1Gentle touch may aid multiple sclerosis patients 59477 2Side Effects in Statin Users Linked to Gene Mutation 59474 1Side Effects in Statin Users Linked to Gene Mutation 59474 2
... 250,000 people in the United States have some for...hy (DMD) is the most common type of the disease, p...ose the ability to walk by their teens and typical... have studied the use of gene therapy as a possibl...dles such as the need to treat all muscles in the ...
...teoporosis, the largest scientific conference devo...er 3rd in Bangkok with a special session focused o... Professor Cyrus Cooper, Director of the MRC Epid...hampton; and Norman Collisson Chair of Musculoskel...eak on the developmental origins of osteoporosis. ...
...ted that amphibians, whose moist permeable skins m...ronment, might be good bellwethers for impending a...ange. , Now two University of California biologis...itive group of animals in a global study of specie...ppears this week in the advance online version of ...
Other Biology News:Scientist clears hurdles for muscular dystrophy therapy 2Scientist clears hurdles for muscular dystrophy therapy 3Nutrition and bone health session to open the IOF World Congress on Osteoporosis in Bangkok 2Study confirms amphibians' ability to predict changes in biodiversity 2
Porcine IFN-gamma ELISpot Kit from R&D Systems
... contains the basic components required for the de...d recombinant canine Monocyte Chemotactic Protein ...ach kit contains sufficient materials to run ELISA...d that the following conditions are met:2 1. F...
Rat Anti-CCR5 Monoclonal Antibody, Unconjugated, Clone HEK / 1 / 85a from Abcam
...designed for use with the ProQuest Two-Hybrid Syst...s deletions in the endogenous GAL4 and GAL80 genes...train also has leu2 and trp1 mutations for selecti...ins three GAL4 inducible reporter genes, providing...
Biology Products: