Press release

OSSIO expands portfolio of highly differentiated bio-integrative fixation implants with small compression staples to enhance bunion repair patients’ satisfaction

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OSSIO, Inc., a fast-growing medical technology company focused on evolving orthopedic surgery with bio-integrative fixation implants that leave no permanent implant behind, recently expanded its offering with the launch of OSSIOfiber® small compression staples for use in both hand and foot procedures, especially for bunion repair with a surgical technique known as the Akin osteotomy.

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OSSIOfiber Small Compression Staple & Inserter

OSSIOfiber Small Compression Staple & Inserter

Bradley Lamm, DPM, director of the Foot and Ankle Deformity Center at the Paley Institute in West Palm Beach, Fla., and Selene Parekh, MD, a professor of orthopedic surgery specializing in foot and ankle procedures at the Rothman Institute in Princeton, N.J., and Philadelphia, were among the first clinicians to use the new staples in an Akin bunion procedure.

“By design, OSSIOfiber small compression staples are remarkably easy to insert during Akin bunion repair,” said Dr. Lamm. “This new OSSIOfiber product line increases the opportunities for surgeons to use a cutting-edge fixation technology that is replaced by bone over time, without the inherent risks of metal implants. Patients appreciate the no-metal footprint just as much as we surgeons do.”

Dr. Parekh added: “I have used several different small compression staples during my many years as a foot and ankle surgeon. For me, the most important reason to use OSSIOfiber bio-integrative implants in orthopedic surgery is the opportunity to dispense with metal without sacrificing compression strength. Not having to worry about hardware irritation after an Akin bunion repair and the need for a secondary surgery is extremely attractive to patient and surgeon alike.”

OSSIOfiber Portfolio Expansion

Cleared by the U.S. Food and Drug Administration (FDA) in November 2023, OSSIOfiber small compression staples ― the company’s latest offering for orthopedic fixation ― expands the company’s product portfolio, which already includes larger compression staples, as well as suture anchors, compression screws, trimmable fixation nails and a hammertoe fixation system.

All OSSIOfiber implants are made with the same bio-integrative fiber matrix, a revolutionary advance in material science. Combining this highly differentiated technology with exceptional instrumentation, OSSIOfiber small compression staples were intentionally designed for ease of use, for compression strength that matches or exceeds nitinol staples, and with all the advantages of a non-permanent implant that patients prefer.

“Our mission at OSSIO is nothing less than transforming the experience of patients who must undergo orthopedic surgery where internal fixation is required,” said OSSIO CEO Brian Verrier. “With more than 40,000 OSSIOfiber implants performed to date, just five years since commercializing our first product in 2019, we launch this new small compression staple platform, further expanding patient access to a metal-free alternative for orthopedic fixation.”

OSSIOfiber small compression staples are indicated for 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.

Intelligent Bone Regeneration Technology

OSSIOfiber relies on Intelligent Bone Regeneration Technology, a breakthrough in fixation material that provides the first credible solution to the shortcomings of permanent metal hardware, conventional absorbable 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 bio-friendly polymer, OSSIOfiber implants feature bio-integrative material properties that provide surgeons with a more biologically friendly way to restore patients’ stability and mobility while leaving nothing permanent behind.

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. It is engineered to provide the strength required for functional fixation while allowing for full integration into patients’ native anatomy without adverse biological response and can address many surgical applications through the manufacturing of endless implant designs, including nails, screws, staples, anchors and plates.

Looking ahead, OSSIO intends to pursue multiple applications for OSSIOfiber implants in all major segments of orthopedics, such as foot and ankle, hand and wrist, upper extremity and trauma, pediatrics, sports medicine and reconstruction.

Notably for U.S. healthcare providers and payors, OSSIOfiber implants utilize existing reimbursement codes and surgical techniques.

About OSSIO

OSSIO is an orthopedic fixation company committed to transforming the surgical experience for patients, physicians, providers and payors. Founded in 2014, the company’s vision is to provide the first credible replacement for metal implants in the multibillion-dollar global orthopedic fixation market with OSSIOfiber Intelligent Bone Regeneration Technology.

For more information on OSSIOfiber implants and OSSIO, which has development headquarters in Caesarea, Israel, and commercial headquarters in Woburn, Mass., visit www.ossio.io.

DISCLAIMER

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.