OSSIO Achieves Third FDA Clearance in 4 Months for OSSIOfiber® Implants; Prepares to Expand Patient Access to Bio-Integrative Orthopedic Fixation Technology Portfolio in Q2/Q3

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:

• OSSIOfiber^® Suture Anchors. 4.75–5.5mm. FDA cleared March 2022 for use in “fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow” in a variety of specific orthopedic procedures. U.S. launch planned Q2 2022.
• OSSIOfiber^® Compression Staples. 11–25mm bridge lengths; 15–22mm leg lengths. FDA cleared January 2022 for use in “fixation of arthrodesis, osteotomies and fractures in hand or foot surgery in the presence of appropriate brace and/or immobilization. The number and size of the OSSIOfiber^® Staples must be adapted to the indication.” U.S. launch planned Q3 2022.
• OSSIOfiber^® 3.5mm Compression Screws. 14–50mm lengths, 3.5mm diameter. FDA cleared December 2021 for use in “maintenance of alignment and fixation of bone fractures, comminuted fractures, fragments, osteotomies, arthrodesis, and bone grafts, of the upper extremity, fibula, knee, ankle and foot in the presence of appropriate brace and/or immobilization.” U.S. launch planned Q3 2022.

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:

• OSSIOfiber^® Compression Screws. Available in 26–60mm lengths, 4.0mm diameter. FDA cleared July 2020 for use in same indication as 3.5mm compression screws listed above. U.S. launch for 4.0mm size matrix Q1 2021.
• OSSIOfiber^® Trimmable Fixation Nail Family. Cannulated 3.0x50mm & 4.0x70mm and Solid Core in 2.4x30mm, 2.4x50mm and 4.0x50mm. Solid Core FDA cleared January 2019; Cannulated FDA cleared November 2020. Indication for both specifies “maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis, and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).” U.S. launch Q2 2020 and Q2 2021, respectively.
• OSSIOfiber^® Hammertoe Fixation System. 2.5, 2.9, 3.2mm straight and 10 degree angled implants. FDA cleared March 2020 for use in “maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis, and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).” U.S. launch Q2 2020.

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.

About OSSIO

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.

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