New Suture Anchors, Industry’s First U.S.-Cleared Non-Permanent Compression Staples and Additional Compression Screws to Join Previously Launched Products That Leave Nothing Permanent Behind in Various Surgeries

WOBURN, Mass.--(BUSINESS WIRE )--OSSIO, Inc., the Israeli-American orthopedic fixation technology start-up based near Boston in the United States and in Caesarea, Israel, announced today that the company has achieved another significant commercial milestone with its third regulatory clearance from the U.S. Food and Drug Adminstration (FDA) for the OSSIOfiber® product family in the past four months, clearing a path to expand patient and surgeon access to additional implants made from OSSIOfiber® Intelligent Bone Regeneration Technology over the next six months.

“With more than 6,000 implantations of OSSIOfiber® products performed to date, we have already achieved considerable momentum and market penetration in the United States, demonstrating meaningful adoption of our novel, innovative and proprietary orthopedic fixation technology,” said OSSIO’s chief executive officer, Brian Verrier. “Naturally, we’re thrilled with the demand for OSSIOfiber® implants—and with these recent FDA clearances, we expect additional uptake of our growing portfolio of bio-integrative products, bringing further clinical and economic benefits to more patients, surgeons, providers and payors.”

OSSIO’s three most recent FDA clearances have been granted since December 2021:

With the addition of these three new FDA cleared product platforms, OSSIO is doubling the size of its commercial product portfolio, increasing surgeon and patient access to “all-natural” treatment options and significantly expanding the company’s total addressable market opportunity.

Previously launched OSSIOfiber® implants include the following compression screws, trimmable fixation nails and hammertoe fixation system:

All OSSIO implants are made with OSSIOfiber® Intelligent Bone Regeneration Technology, a breakthrough in fixation material that provides the first credible solution to the shortcomings of permanent metal hardware, conventional resorbable and allograft implants, combining unparalleled mechanical strength and natural bone healing in a non-permanent implant. Made from a proprietary mineral fiber matrix held together by a naturally degradable polymer, its bio-integrative material properties provide surgeons with a more biologically friendly way to restore patient stability and mobility while leaving nothing permanent behind.

OSSIOfiber® Intelligent Bone Regeneration Technology can address many surgical applications through the manufacturing of endless implant designs, including nails, screws, staples, anchors and plates. The company intends to pursue multiple applications in the distal extremity, trauma, sports, reconstruction, pediatrics and spine segments. For more information on OSSIOfiber® please visit www.ossio.io.

About OSSIOfiber® Intelligent Bone Regeneration Technology

Designed for rapid bone in-growth, regeneration and replacement, OSSIOfiber® Intelligent Bone Regeneration Technology is a first-of-its-kind implant material stronger than cortical bone that leaves nothing permanent behind. OSSIOfiber® is engineered to provide the strength required for functional fixation and allows for full integration into the native anatomy without adverse biological response. OSSIOfiber® implants utilize existing reimbursement and surgical techniques.

OSSIO is an orthopedic fixation company committed to transforming the orthopedic experience for patients, physicians and payors. Founded in 2014, its vision is to provide the first credible replacement to metal implants in the multibillion-dollar global orthopedic fixation market with its OSSIOfiber® Intelligent Bone Regeneration Technology. OSSIO’s development headquarters is located in Caesarea, Israel, and its commercial headquarters is in Woburn, Mass. (USA). For more information on the company, visit www.ossio.io.

Forward-looking statements contained herein are based on estimates and assumptions of OSSIO management and are believed to be reasonable, though they are inherently uncertain and difficult to predict.

Joe McGrath Scope Strategic Communications contactmcgrath@gmail.com +1.612.819.6421

Joe McGrath Scope Strategic Communications contactmcgrath@gmail.com +1.612.819.6421