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COLLEGEVILLE, Pa.–(BUSINESS WIRE)–Sep 25, 2018–Synergy Biomedical, LLC, a developer of avant-garde biomaterial products, appear today that it has accustomed FDA 510(k) approval of BIOSPHERE ® FLEX. Based on Synergy’s patented BioSphere ® Technology, BIOSPHERE ® FLEX is a strip-format cartilage affix artefact composed of porous, bioactive bottle that is dimensionally chip aural a collagen and sodium hyaluronate scaffold. The porosity of the BIOSPHERE ® FLEX cartilage affix was accurately advised for optimized assimilation of cartilage bottom aspirate. BIOSPHERE ® FLEX is anon in final alertness for bartering barrage in the 4 th division of 2018.

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This columnist absolution appearance multimedia. View the abounding absolution here: https://www.businesswire.com/news/home/20180925005261/en/

BioSphere Flex and BioSphere Granules (Photo: Business Wire)

“The FDA approval of BIOSPHERE ® FLEX adds a key artefact to Synergy’s constructed cartilage affix portfolio,” declared Dr. Mark Borden, Ph.D., President/CEO of Synergy Biomedical. “The BioSphere ® artefact band provides surgeons with a abounding spectrum of cartilage affix forms that can be tailored to a array of surgical techniques while leveraging the accurate advantages of Synergy’s amount bioactive technology. These options accommodate BIOSPHERE ® PUTTY (a able-bodied cartilage affix actual that can be acclimated abandoned or accumulated with autograft), BIOSPHERE ® MIS PUTTY (with a commitment arrangement accurately advised for targeted affix adjustment in minimally invasive surgery), and now BIOSPHERE ® FLEX (developed to be acclimated by surgeons who adopt the characteristics of a adjustable band anatomy and the adeptness to augment with cartilage bottom aspirate).”

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“The accession of BIOSPHERE FLEX to the artefact portfolio provides Synergy added advantage of the cartilage affix market,” declared Kevin Booth, VP of Sales. “With the BioSphere ® artefact line, surgeons accept admission to next-generation cartilage affix technology that is accordant with a array of cartilage grafting techniques.”

BIOSPHERE ® FLEX utilizes Synergy’s patented BioSphere ® Technology which is based on an avant-garde all-around anatomy of bioactive bottle that allows for ideal and absolute ascendancy over the osseous healing process. The BioSphere ® granules activated in BIOSPHERE ® FLEX accept a different and avant-garde affirmed apple anatomy that provides an optimal porosity for cartilage advance through the granules. BIOSPHERE ® FLEX has one of the accomplished bioactive bottle capacity on the bazaar due to its added atom body compared to added absorptive cartilage affix sheets. Additionally, the use of a accurately formulated collagen and sodium hyaluronate carrier in BIOSPHERE ® FLEX permits the implant to become adjustable and adaptable back hydrated with cartilage bottom aspirate. This aids in affix placement, and enables the implant to accommodate to aberrant cartilage surfaces for best affix chain and healing potential.

BIOSPHERE ® FLEX utilizes patented bioactive bottle spheres that accept been apparent in vivo to aftereffect in faster and added able-bodied cartilage formation. The artefact provides surgeons with a next-generation cartilage affix actual with the alive characteristics of a adjustable band that is advised to blot and authority cartilage bottom aspirate in absolute acquaintance with absorptive bioactive bottle granules.

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About Synergy Biomedical, LLC

Founded in 2011, Synergy Biomedical is a privately-held medical accessory aggregation focused on bringing avant-garde biomaterial-based articles to the musculoskeletal market. The Company’s BioSphere ® Technology has broad, cross-platform surgical applications in the orthopaedic, spine, sports medicine, and collective arthroplasty markets. This technology represents a different access to advancing cartilage healing and convalescent accommodating outcomes.

View antecedent adaptation on businesswire.com:https://www.businesswire.com/news/home/20180925005261/en/

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CONTACT: Synergy Biomedical, LLC

Mark Borden, Ph.D.

President/CEO

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484-902-8141

www.synergybiomedical.com

[email protected]

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KEYWORD: UNITED STATES NORTH AMERICA PENNSYLVANIA

INDUSTRY KEYWORD: SURGERY HEALTH BIOTECHNOLOGY MEDICAL DEVICES

SOURCE: Synergy Biomedical, LLC

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Copyright Business Wire 2018.

PUB: 09/25/2018 10:00 AM/DISC: 09/25/2018 10:01 AM

http://www.businesswire.com/news/home/20180925005261/en

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Copyright Business Wire 2018.

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