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Vallum Gains FDA Clearance of Nanotextured PEEK Interbody

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Vallum received FDA 510(k) clearance to market a polyetheretherketone (PEEK) interbody fusion device with a PEEKplus® nanotextured surface created with proprietary Accelerated Neutral Atom Beam (ANAB) technology.

This reportedly represents the first FDA-cleared nanotextured surface on a PEEK interbody.

In the PEEKplus process, nanoscale concavities of 20 to 50 nanometers are created by the impact of argon atoms across the entire microsurface of the PEEK. PEEKplus is not a coating, is not porous and no chemicals are infused into the PEEK. This nanotexturing technology may be applied to any fully-manufactured PEEK interbody device without altering its design or size, and without affecting mechanical or chemical properties.

Per the company's website, the ANAB processor is an additional manufacturing step for the device and is performed last. The entire manufacturing process prior to ANAB processing is identical to the predicate device.

Vallum management believes that its technology and processing protocols can be developed to improve other orthopaedic devices.

Vallum was established in 2015. Per SEC filing Form D, the company raised just over US $6MM in equity financing at the end of 2017.

Sources: Vallum Corporation, SEC.gov, vallumcorp.com