Orthofix Announces 510k Clearance and Full Commercial Launch of OsteoCove, an Advanced Bioactive Synthetic Graft for use in Spine and Orthopedic Procedures

LEWISVILLE, Texas, October 12, 2023–(BUSINESS WIRE)–Orthofix Medical Inc. (NASDAQ:OFIX), a number one international spine and orthopedics firm, at the moment introduced the 510k clearance and full business launch of OsteoCove^™, a complicated bioactive artificial graft. Accessible in each a putty and strip configuration, OsteoCove was fastidiously formulated to supply superior bone-forming capabilities with best-in-class dealing with traits for a variety of spine and orthopedic procedural purposes.

“Utilizing the identical disciplined R&D method we have now traditionally taken with our internally processed demineralized bone matrix options, we created a product that challenges the efficiency expectations of typical artificial bone graft substitutes,” stated Dr. Frank Vizesi, Chief Scientific Officer for Orthofix. “OsteoCove is one other prime instance of leveraging our strengths in product improvement together with our vertically built-in manufacturing experience.”

Made from biphasic ceramic granule comprised of β-tricalcium phosphate (ß-TCP) and hydroxyapatite (HA) mixed with type-I bovine collagen, OsteoCove includes a specialised granule floor topography designed to elicit a bone-forming response, as evidenced by its capability to develop bone in a difficult muscle pouch mannequin. This specialised floor chemistry and microporosity are proven to advertise superior bone formation when in comparison with different commercially accessible superior artificial grafts.¹

“Orthofix is a pacesetter in each the demineralized bone matrices (DBM) and mobile allograft markets, and the launch of OsteoCove considerably strengthens our biologics portfolio and builds on our mission to ship best-in-class merchandise in each main bone grafting class,” stated Tyler Lipschultz, President, Orthofix World Biologics. “With the introduction of OsteoCove, we count on robust progress on this massive market phase as we proceed to ship on our dedication to supply surgeons a complete providing of biologic options to satisfy the wants of their sufferers.”

The U.S. artificial bone graft market is estimated to be $300 million.²

Orthofix invitations these attending the North American Backbone Surgeon Annual Assembly in Los Angeles, October 18-21, 2023, to go to sales space #1711 to study extra concerning the Firm’s portfolio of biologic options.

^1,2Information on file

About Orthofix

Orthofix and SeaSpine merged in January 2023 to type a number one international spine and orthopedics firm with a complete portfolio of biologics, modern spinal {hardware}, bone progress therapies, specialised orthopedic options and a number one surgical navigation system. Its merchandise are distributed in roughly 68 nations worldwide.

The Firm is headquartered in Lewisville, Texas, the place it conducts normal enterprise, product improvement, medical training and manufacturing, and has main places of work in Carlsbad, CA, with a concentrate on spine and biologics product innovation and surgeon training, and Verona, Italy, with an emphasis on product innovation, manufacturing, and medical training for orthopedics. The mixed firm’s international R&D, business and manufacturing footprint additionally contains services and places of work in Irvine, CA, Toronto, Canada, Sunnyvale, CA, Wayne, PA, Olive Department, MS, Maidenhead, UK, Munich, Germany, Paris, France, and São Paulo, Brazil. To study extra, go to Orthofix.com.

Ahead-Trying Statements

This information launch might embrace forward-looking statements inside the that means of Part 21E of the Securities Alternate Act of 1934, as amended, and Part 27A of the Securities Act of 1933, as amended. In some instances, you may determine forward-looking statements by terminology reminiscent of “might,” “will,” “ought to,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “initiatives,” “intends,” “predicts,” “potential,” “proceed” or different comparable terminology. Orthofix cautions you that statements included on this information launch that aren’t an outline of historic details are forward-looking statements which can be primarily based on the Firm’s present expectations and assumptions. Every forward-looking assertion contained on this information launch is topic to dangers and uncertainties that would trigger precise outcomes to vary materially from these expressed or implied by such assertion. Relevant dangers and uncertainties embrace, amongst others: the power of newly launched merchandise to carry out as designed and meant and to satisfy the wants of surgeons and sufferers, together with on account of the dearth of strong medical validation; and the dangers recognized beneath the heading “Danger Components” in Orthofix Medical Inc.’s Annual Report on Type 10-Ok for the fiscal yr ended December 31, 2022, which was filed with the Securities and Alternate Fee (SEC) on March 6, 2023. The Firm’s public filings with the Securities and Alternate Fee can be found at www.sec.gov. You might be cautioned to not place undue reliance on forward-looking statements, which communicate solely as of the date when made. Orthofix doesn’t intend to revise or replace any forward-looking assertion set forth on this information launch to mirror occasions or circumstances arising after the date hereof, besides as could also be required by regulation.