New Category Offers Surgeons Strong, Secure Fixation and
“Biologically Friendly” Approach to Restoring Patient Stability and
Mobility with No Permanent Implant Left Behind
WOBURN, Mass.–(BUSINESS WIRE)–OSSIO, Inc., an orthopedic fixation company, today announced the U.S.
launch and first commercial use of the OSSIOfiberTM
Bone Pin Family for maintenance of alignment and fixation of bone
fractures, osteotomies, arthrodesis and bone grafts. The first
commercial cases were hammertoe repairs successfully performed at
Polaris Surgery Center in Westerville, Ohio by Gregory Berlet, MD,
Christopher Hyer, DPM, and Mark Prissel, DPM, foot and ankle surgeons
and partners at the Orthopaedic
Foot & Ankle Center in Worthington, Ohio.
The OSSIOfiberTM Bone Pin Family received 510(k)
market clearance from the U.S. Food and Drug Administration (FDA) in
January and the initial product offering is applicable for use in the
foot and ankle segment for the treatment of forefoot conditions where
hardware removal surgeries are prevalent. Offering a new category of
non-permanent fixation material, the OSSIOfiberTM
Intelligent Bone Regeneration Technology features a first of its kind,
proprietary bio-integrative material that provides stability and secure
bone fixation during the healing process and gradual integration into
the native anatomy, ultimately leaving no permanent hardware behind.
Combining unparalleled mechanical strength and natural bone healing in a
non-permanent implant, OSSIOfiberTM is designed to
fully incorporate into the native anatomy without any adverse biologic
“OSSIOfiber TM brings forward a real paradigm shift in
how we approach bone fixation. The new bio-integrative implant is truly
unique in that it provides immediate stable fixation that
physiologically adapts with the bone during the healing process,” said
Dr. Berlet. “I am honored to have performed the inaugural cases in the
United States together with Drs. Hyer and Prissel and look forward to
adding implants made from this innovative bio-material technology to my
Additional procedures utilizing the OSSIOfiberTM
platform are planned in limited markets in the coming weeks, with full
commercialization and availability in all states set to occur in the
third quarter of 2019. Over the next year, OSSIO anticipates streamlined
adoption of OSSIOfiber TM among the orthopedic and
podiatric surgeon communities, given the implant’s innovative
bio-integrative design and overall ease-of-use, requiring no changes to
surgeons existing techniques.
“While forefoot disorders are highly treatable, secondary procedures to
remove hardware are often warranted, causing a significant cost burden
on the patient, physician and healthcare system as a whole,” said Dr.
Hyer. “We’ve been waiting for a new option in the orthopedic fixation
space for decades and OSSIOfiberTM shows real promise
to become the first credible replacement to permanent implants. Having
this new treatment option at the ready will fundamentally impact our
approach to treating these patients by avoiding permanent device-related
post-operative complications and secondary removal surgeries.”
Since receiving FDA clearance, OSSIO has made significant headway in
executing against key commercial related milestones, including:
Hiring experienced area sales directors and independent sales
- Securing $22 million in financing to accelerate strategic growth
- Completed all manufacturing validations to meet anticipated demand
Identified the first 25 sites ready to participate in early limited
- Completed enrollment in the European Hammertoe Clinical Trial
“The U.S. market anticipation for OSSIOfiberTM has
been overwhelmingly positive to date,” said Brian Verrier, CEO, OSSIO.
“We are poised to initiate broader U.S. commercialization of the implant
system in the coming weeks, offering surgeons and their patients a new
standard of care in orthopedic fixation.”
The proprietary OSSIOfiberTM technology can
address many surgical applications through the manufacturing of endless
implant designs, including pins, screws and plates. The company intends
to pursue multiple applications in the distal extremity, trauma, sports,
reconstruction, pediatrics, and spine segments. For more information on
OSSIOfiberTM please visit www.ossio.io.
About OSSIOfiberTM Intelligent Bone
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. OSSIOfiberTM 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. The OSSIOfiberTM Bone Pin Family
represents the first of several regulatory approvals for the company and
is cleared for use in the United States for maintenance of alignment and
fixation of bone fractures, osteotomies, arthrodesis and bone grafts in
the presence of appropriate additional immobilization.
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 multi-billion-dollar global orthopedic fixation market
with its OSSIOfiberTM Intelligent Bone Regeneration
Technology. OSSIO’s development headquarters is located in Caesarea,
Israel, and its commercial headquarters is in Woburn, Massachusetts. 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.