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 The leading web portal for pharmacy resources, news, education and careers August 17, 2017
Pharmacy Choice - Pharmaceutical News - Amend Surgical Announces 510K Clearance for NanoFUSE BA - August 17, 2017

Pharmacy News Article

 3/15/17 - Amend Surgical Announces 510K Clearance for NanoFUSE BA

By a News Reporter-Staff News Editor at Biotech Week Amend Surgical, Inc., a medical device company focused on enhancing the regenerative capacity of bone replacement products, announced that they have received 510(K) clearance to market NanoFUSE BA as a bone graft extender for spine and orthopedic applications (see also Amend Surgical, Inc.).

NanoFUSE BA is a novel composite containing 45S5 Bioactive Glass and a patent protected carrier that provides optimal surgical handling performance and graft stability. Bioactive glass facilitates operative site graft containment through rapid bone bonding and the subsequent activation of cellular osteogenesis (bone formation). It creates a highly favorable environment for bone fusion as it remodels into the recipient's skeletal system and is an important tool for the orthopedic surgeon. With this most recent clearance Amend Surgical now has two U.S. Food and Drug Administration (FDA) cleared product lines.

"NanoFUSE BA offers our surgeons and their patients a synthetic alternative to NanoFUSE Bioactive Matrix," stated Robby Lane, president and chief executive officer of Amend Surgical. "We are continuing to expand our market presence with the only demineralized bone bioactive glass combination product on the market and are excited about the opportunities offered by the launch of NanoFUSE BA. This product provides surgeons the superior handling characteristics they expect with the long and successful clinical history of bioactive glass." About Amend Surgical Amend Surgical is a specialty medical device company focused on enhancing the bone healing and regenerative capacity of bone grafts, including allograft, xenograft tissues and synthetic materials. The company's pipeline includes novel, clinically evaluated, osteoinductive bone extracts, and will expand in the future to disruptive products based on discovery and development of novel therapeutic additives with tissue-specific regenerative characteristics. View source version on businesswire.com: http://www.businesswire.com/news/home/20170302005450/en/

Keywords for this news article include: Surgery, Bone Research, Medical Devices, Amend Surgical Inc., Surgical Technologies.

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