Biomimetic Innovations Marks First Clinical Use of its Injectable Bone Void Filler

Biomimetic Innovations Ltd. today announced the first-in-human application of its OsStic Injectable Synthetic Bone Void Filler. Professor Peter Giannoudis, with the University of Leeds Teaching Hospital, performed the initial procedure on Aug. 7.

The first patient underwent a knee joint reconstruction—i.e., a lateral tibial plateau fracture (split depression injury). Professor Giannoudis said the patient was discharged home on the second day after surgery. “We are pleased to have successfully completed the first case using OsStic as part of this important clinical trial,” said Giannoudis, principal study investigator. “Innovative technologies like this have the potential to transform the way we approach fracture fixation, particularly in complex cases where conventional methods may have limitations.”

The unidentified patient is the first to be enrolled in a clinical trial that will evaluate OsStic’s safety, performance, and clinical outcomes in patients with periarticular fractures. The study is fully funded and sponsored by Biomimetic Innovations Ltd. and represents an important step in building the clinical evidence base for OsStic, executives said.

“This First-in-Human use of OsStic represents a major milestone for our company and our mission to bring meaningful solutions to orthopedic care. We are excited to partner with clinicians and institutions to evaluate the potential of this technology to improve patient outcomes,” Biomimetic Innovations Managing Partner stated.

The first human case involving OsStic is considered a significant advancement in developing next-generation bone fixation technologies, Biomimetic administrators claim. OsStic hardens rapidly, conforms to irregular defect geometries, and provides immediate mechanical support to the subchondral bone, while promoting bone ingrowth and remodelling over time. OsStic is part of Biomimetic Innovations Ltd.’s pipeline of medical technologies designed to enhance patient wellbeing.

Biomimetic Innovations is an affiliate of PBC Biomed, an ISO 13485-certified medical device company that designs, develops, manufactures, and commercializes products. Through its advanced medical service portfolio, PBC Biomed partners with medical device, biologic, pharmaceutical, and combination product firms to accelerate technology through the product lifecycle stages. PBC Biomed is headquartered in Shannon, Ireland, with offices in Memphis, Tenn.; Chamonix, France; London; and New South Wales, Australia. PBC Biomed has a proven track record in developing and commercializing new technologies, bringing the N-Force Fixation/iN3 Cement to market through its affiliate company, CelgenTek Innovations (acquired by Zimmer Biomet in 2016), and more recently bringing ReFeel to market as a nerve regeneration solution, with partner company Mochida Pharmaceuticals Ltd. (Japan).