Navigation Links
IsoTis Receives FDA Clearance for Accell Family of Products
Date:8/20/2007

IRVINE, California, August 20 /PRNewswire-FirstCall/ -- IsoTis, Inc. (NASDAQ: ISOT) ("IsoTis"), an orthobiologics company, today announced that it received a letter dated August 15, 2007 from the US Food and Drug Administration ("FDA"), clearing the Accell Family of Products for marketing in the US as Class II medical devices.

The Accell Family of Products includes Accell 100, Accell Connexus and Accell Total Bone Matrix, as well as a new Accell product that is not currently marketed. The products are indicated for use as bone graft extenders in the spine, extremities and pelvis, or as bone void fillers in extremities and pelvis.

Pieter Wolters, President and CEO of IsoTis said, "We are very pleased with the final outcome of our discussions with the FDA. With the clearance of the Accell Family of Products we can now focus on advancing the clinical benefits of Accell for both patients and surgeons. The expected merger with Integra LifeSciences will further enhance our ability to successfully market these products going forward. "

About IsoTis

IsoTis is an orthobiologics company that develops, manufactures and markets proprietary products for the treatment of musculoskeletal diseases and disorders. IsoTis' current orthobiologics products are bone graft substitutes that promote the regeneration of bone and are used to repair natural, trauma-related and surgically-created defects common in orthopedic procedures, including spinal fusions. IsoTis' current commercial business is highlighted by its Accell line of products, which the company believes represents the next generation in bone graft substitution.

On August 7, 2007 Integra LifeSciences Holdings Corporation (NASDAQ: IART) ("Integra") and
'/>"/>

SOURCE IsoTis Inc

Copyright©2007 PR Newswire.

Page: 1 2 3 4

Related biology technology :

1. Medical College receives $377K to study brain disease
2. Lucigen receives $750K grant to boost biofuel yields
3. Medical College receives $1.4M cancer grant
4. Wisconsin biotech firm receives $107K NIH grant
5. InvivoSciences receives NIH grant for heart technology
6. Medical College receives $11 million grant to study high blood pressure
7. Madison business receives $115,000 of new state biofuels funding
8. Superior receives funds for technical training
9. UWM receives state funding for plastics research
10. GEs Centricity EHR receives federal certification
11. WHIE receives state eHealth Initiative contract
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/22/2015)... , Jan. 22, 2015   Cypher Genomics, ... Sequenom, Inc. (NASDAQ: SQNM ), the ... agreement for next generation noninvasive prenatal tests (NIPT). ... interpretation technology, called Mantis™, to advance analysis of ...
(Date:12/24/2014)...  United Therapeutics Corporation (NASDAQ: UTHR ) announced ... has submitted a pre-market approval application to the U.S. ... Medtronic,s SynchroMed ® II implantable drug infusion system ... Therapeutics, Remodulin ® (treprostinil) Injection delivered intravenously to ...
(Date:12/24/2014)... GMO corn cases filed across the United States, and ... being consolidated in a Kansas federal court for pretrial proceedings. ... Corn Litigation, MDL No. 2591 in the U.S. District Court ... GMO corn multidistrict litigation (MDL) has been handed over to ...
(Date:12/24/2014)... Dallas, Texas (PRWEB) December 23, 2014 ... mercaptan such as its definition, classification, application and ... manufacturing process, and product cost structure. Production is ... also covers upstream raw materials, equipment, downstream client ...
Breaking Biology Technology:Cypher Genomics and Sequenom Announce Development Agreement 2Cypher Genomics and Sequenom Announce Development Agreement 3Cypher Genomics and Sequenom Announce Development Agreement 4United Therapeutics Announces Submission Of Pre-Market Approval Application For Implantable Drug Infusion System To Deliver Remodulin 2United Therapeutics Announces Submission Of Pre-Market Approval Application For Implantable Drug Infusion System To Deliver Remodulin 3United Therapeutics Announces Submission Of Pre-Market Approval Application For Implantable Drug Infusion System To Deliver Remodulin 4Carey Danis & Lowe Reports on Syngenta GMO Corn Transfer Order 2Worldwide Methyl Mercaptan Market 2015-2020 Forecasts on Development & Trends Now Available at ReportsnReports.com 2
... 27 Alfacell Corporation (OTC Bulletin Board: ACEL) today ... the U.S. Food and Drug Administration (FDA) to discuss ... the ONCONASE rolling New Drug Application (NDA) for the ... the pre-NDA meeting, the FDA provided guidance to the ...
... for Tuesday, February 3, 2009 SAN DIEGO, Jan. 27 ... announced today that the Company will report its fourth ... market closes on Tuesday, February 3, 2009. Neurocrine will ... discuss its financial results and provide a Company update ...
... in Shortest Period of TimeWASHINGTON, Jan. 27 ... in targeted therapies that utilize personalized medicine to ... by the Deloitte Center for Health Solutions found ... to produce a positive return on investment across ...
Cached Biology Technology:Alfacell Provides ONCONASE(R) NDA Submission Update 2Alfacell Provides ONCONASE(R) NDA Submission Update 3Neurocrine Biosciences Announces Conference Call and Webcast to Present Fourth Quarter and Year End 2008 Financial Results 2Adoption of Personalized Medicine May Yield Significant ROI; Time to Achieve Benefit Varies Among U.S. Health Care Stakeholders, According to Deloitte Report 2Adoption of Personalized Medicine May Yield Significant ROI; Time to Achieve Benefit Varies Among U.S. Health Care Stakeholders, According to Deloitte Report 3Adoption of Personalized Medicine May Yield Significant ROI; Time to Achieve Benefit Varies Among U.S. Health Care Stakeholders, According to Deloitte Report 4
(Date:12/19/2014)... 2014 Research and Markets ( http://www.researchandmarkets.com/research/8kmfcn/iphone_5s ) ... Fingerprint Sensor - Apple/AuthenTec TMDR92 & Sapphire - Technology ... http://photos.prnewswire.com/prnh/20130307/600769 Following the acquisition ... reading feature with the iPhone 5S. It is currently ...
(Date:12/19/2014)... , Dec. 18, 2014   LaunchKey , the ... the post-password and Internet of Things era, today announced ... The venture round was led by Metamorphic Ventures with ... Venture Partners, VegasTechFund, and others.  LaunchKey has raised $4 ...
(Date:12/17/2014)... YORK , Dec. 15, 2014  HITLAB SM ... (GCP) audit to confirm its adherence to current U.S. ... HITLAB to conduct regulated smart device and smart phone ... and research quality. "HITLAB is determined to ...
Breaking Biology News(10 mins):iPhone 5S Fingerprint Sensor - Apple/AuthenTec TMDR92 & Sapphire - Technology Report 2LaunchKey Raises $3 Million in Additional Funding Led by Metamorphic Ventures 2LaunchKey Raises $3 Million in Additional Funding Led by Metamorphic Ventures 3HITLAB Completes GCP Audit for FDA Smart Device & App Compliance 2
... disorders are almost five times more common among boys than ... $15 million National Institutes of Health (NIH) grant awarded to ... (ACE) research program. Led by principal investigator Kevin ... is part of a $100 million National Institutes of Health ...
... - Influenza outbreaks in the United States typically begin ... spread in seasonal waves across geographic zones. But the ... to the next has baffled scientists. In a ... Obscure Consequence," Elena Naumova, Ph.D., professor of civil and ...
... SAN FRANCISCO, Sept. 6, 2012 -- After last year,s accidental ... State researchers are conducting an elaborate experiment to learn more ... are tagging infected bees with tiny radio trackers, and monitoring ... hive on top of the Hensill Hall biology building on ...
Cached Biology News:Influenza research: Can dynamic mapping reveal clues about seasonality? 2SF State biologists tag 'zombees' to track their flight 2SF State biologists tag 'zombees' to track their flight 3
... Monoclonal Mouse Antibody to Cytokeratin 5 ... is a high molecular weight, basic type ... and the superficial cell layers of stratified ... epithelia and in mesothelial cells and mesothelioma. ...
...
Aldolase A (N-15)...
Bovine Renal Artery Endothelial Cells (BRAEC) (>500,000 cells)...
Biology Products: