RegulatorySpine

Innovasis Announces FDA 510(k) Clearance of LxHA™ Lateral Interbody Fusion Device

 SALT LAKE CITY, June 25, 2019 –Innovasis, Inc. an integrated research, development and manufacturing spinal device company, received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use of its LxHA™ Lateral Interbody Fusion Device.

The LxHA™ lateral interbody is comprised of PEEK OPTIMA® HA Enhanced*, providing osteoconductive properties that may improve fusion**. The company anticipates full commercialization later in Q3 2019.

We are thrilled to be able to expand our market leading footprint in the HA PEEK market. The LxHA™ addition will allow surgeons to use this technology in the lateral market giving them access to the same great outcomes we have seen with our other HA PEEK products,” said Mike Wheelock, Vice President of Sales. “The LxHA™ interbody combined with our new next generation retractor system launched later in 2019 will provide the next disruptive clinically beneficial technology to the market.”

The LxHA™ interbody features a bullet shape nose for ease of insertion, a large central graft window for maximum graft packing capabilities, and pyramid shaped teeth that resist migration. These implants are used to facilitate fusion in the lumbar spine and are placed using a lateral approach. This device is intended to be used with internal supplemental spinal fixation systems such as the Innovasis Excella® Spinal System. The interior of the implant device is intended to be packed with autograft.

About Innovasis, Inc.

Innovasis is a groundbreaking company engaged in the research, development, manufacturing, and marketing of spinal implant devices and related products. Innovasis offers a spinal product line with implants and instruments that address the major pathologies and focus areas of traditional spinal surgery.

Innovasis Media Contact

Hayley Hendrix, 801-261-2236

hhendrix@innovasis.com

*PEEK OPTIMA® is a registered trademark of Invibio Ltd.

**Study evaluated the in vivo response to PEEK-OPTIMA Natural, PEEK-OPTIMA HA Enhanced and allograft in a cervical spine fusion model in sheep. Data on file at Invibio. This has not been correlated with human clinical experience.

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Mason Krell

Mason began his career in the Orthopedic Industry in 2017 when he joined The De Angelis Group as a Research Manager. He has developed a strong network within the industry and is very dedicated to helping companies maximize opportunities and disrupt markets.

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