TORONTO--(BUSINESS WIRE)--Cohesys Inc., a Toronto-based medical device developer of resorbable fixation technologies, today announced that the first participants have undergone treatment with BoneTape™, an investigational device designed for the fixation of non-load-bearing craniofacial fractures. The procedures were completed as planned and mark the first clinical use of this drill- and screw-free fixation system.
"Reaching this milestone is significant for Cohesys as we evaluate BoneTape’s potential to offer a simpler, patient-friendly approach to fracture repair,” said Dr. Michael Floros, CEO of Cohesys. “The data from this study will inform our regulatory strategy and commercialization pathway.”
“This marks an exciting step forward for the study, and it’s a privilege to be part of an effort exploring new techniques in facial-fracture treatment,” said Dr. Jeffrey A. Fialkov, MD, MSc, FRCSC, Head of the Division of Plastic and Reconstructive Surgery at Sunnybrook Health Sciences Centre, Associate Professor in the Department of Surgery at the University of Toronto, and Principal Investigator for the study. “BoneTape’s hardware-free approach is intended to simplify surgery and may improve the recovery experience for patients.”
Device- and procedure-related risks—including infection, non-union, and re-operation—will be actively monitored throughout the study’s follow-up period.
Dr. Janaina Bortolatto, VP, Clinical Operations for Cohesys noted, “The completion of these first cases with BoneTape reflects the dedication of our team and our clinical partners. We are focused on gathering the clinical data needed to evaluate BoneTape for potential future use.”
BoneTape is applied with a handheld applicator that affixes the resorbable fixation device to bone surfaces without drilling or screws. The study will determine whether this design performs as intended, potentially sparing patients from device-related complications and the need for hardware-removal procedures.
About Cohesys
Cohesys Inc. develops advanced resorbable fixation solutions aimed at simplifying surgery and improving bone healing. BoneTape, the company's primary technology, is currently under clinical investigation. For more information, visit www.cohesys.com. BoneTape™ is a trademark of Cohesys Inc.
Regulatory Status
BoneTape is an investigational device; it is not licensed for commercial sale. Its use in this clinical study has been authorized by Health Canada under an Investigational Testing Authorization (ITA). Safety and effectiveness have not been established.
ClinicalTrials.gov Identifier: NCT06600854
Contacts
Company Contact: info@cohesys.com
