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VySpine Announces FDA Clearance for UniVy OsteoVy-Ti Cervical IBF with NanoVy-HA

TALLAHASSEE, Fla.–(BUSINESS WIRE)–VySpine, a spine innovation leader using differentiated materials and designs, announced today that it has received 510(k) clearance from the FDA for its UniVy OsteoVy-Ti NanoVy-HA Cervical IBF System which is indicated for intervertebral body fusion for use at one level in the cervical spine, from C3 to T1, for the treatment of degenerative disc disease (DDD).

The UniVy OsteoVy-Ti NanoVy-HA Cervical IBF System features VySpine’s NanoVy-HA technology in partnership with Promimic AB. NanoVy-HA is a process in which the 3D printed UniVy OsteoVy-Ti implant is surface-treated with hydroxyapatite. Traditional coating is typically 50 micrometers, while NanoVy-HA surface treatment is a mere 20 nanometers thick. The NanoVy-HA technology is engineered to facilitate enhanced bone integration and quality to the entire surface of the UniVy OsteoVy-Ti implant.

The NanoVy-HA coating penetrates the unique porous lattice structure of the UniVy OsteoVy-Ti implant. NanoVy-HA’s combination of high wettability and optimal surface chemistry, with optimized nano-roughness, mediates bioactivity and specific protein adsorption to the implant. These properties regulate cell behavior and influence tissue regeneration by increasing the osteoblast functions, building more bone faster.

The UniVy OsteoVy-Ti NanoVy-HA Cervical IBF System features optimal pore size and structure. It is offered in a vast array of footprints for nearly any cervical interbody approach. Additionally, it is available in a range of sizes, heights, and lordotic angles.

About VySpine

VySpine was created through active internal development and the licensing of various proven technologies using innovative materials and designs. This comprehensive line of core spine products and newly developed specialty products allow us to meet the needs of both health care providers and surgeons. The company strives to outpace the competition by collaborating with key spine innovators while providing a flexible, cost-effective approach to spine care. Learn more at vyspine.com

About Promimic AB

Promimic AB is a growth company that develops and markets biomaterials for improved osseointegration to leading companies in the fields of dental and orthopedic implants. The main product HAnano Surface has been developed from cutting edge research at Chalmers University of Technology in Sweden. The technology is proven to improve osseointegration in over 30 scientific studies and with over 900,000 implants in clinical use. Promimic has offices in Mölndal, Sweden and Austin, Texas, USA. For more information visit www.promimic.com

“VySpine,” “UniVy OsteoVy-Ti” and “NanoVy” are registered trademarks of VySpine.


Media Contact: Paul Williams, 310-569-0023, paul@medialinecommunications.com

SOURCE: Business Wire, April 25

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