MHRA Approves Study of Biomimetic Innovations’ Injectable Synthetic Bone Void Filler

PBC Biomed affiliate Biomimetic Innovations Ltd. has secured MHRA approval for a first-in-human clinical study evaluating the safety and early performance of OsStic in periarticular fractures.

The study will focus on tibial plateau fractures—complex periarticular injuries that often involve joint surface depression and subchondral bone support loss. After elevating the articular surface during surgery, physicians are frequently left with a metaphyseal void that must be filled to maintain reduction and prevent secondary collapse.

Existing solutions, such as autograft, allograft, and conventional synthetic bone substitutes each have recognized limitations, including donor-site morbidity, inconsistent availability, brittleness, or suboptimal biological integration.

OsStic has been developed to address these challenges. The material is designed to harden rapidly, conform to irregular defect geometries, and provide immediate mechanical support to the subchondral bone, while promoting bone ingrowth and remodeling over time.

The MHRA-approved clinical investigation will be conducted at Leeds University Teaching Hospital in the United Kingdom. The principal investigator is professor Peter Giannoudis.

“Along with my colleagues, I am very excited to perform this first-in-human study at Leeds Teaching Hospitals. OsStic represents a fifth-generation biomaterial, and its unique properties are expected to revolutionise patient care and outcomes,” Giannoudis said.

The study’s primary objective is to evaluate device safety, including early adverse events, implant-site reactions, and device-related complications. Secondary objectives include assessing the maintenance of fracture reduction, radiographic evidence of bone healing and remodelling, functional recovery, pain outcomes, quality of life, and exploratory gait analysis using plantar pressure mapping.

Patient recruitment has begun, and organizers expect the study to be completed by 2028. The study is fully funded and sponsored by Biomimetic Innovations Ltd. and represents an important step in building the clinical evidence base for OsStic ahead of future, larger comparative trials.

“We are delighted to take this next step on the OsStic journey with our principal investigator, professor Giannoudis at the Leeds University Teaching Hospital,” PBC Biomed Managing Partner Paul Burke stated. “Through our Educational Platforms and Clinical Development Board, we have now taken OsStic to where it can truly impact patients’ lives. This is just the beginning.”

Biomimetic Innovations Ltd. is an affiliate of PBC Biomed, a 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 innovators to accelerate technology through the product lifecycle stages.

An ISO 13485 certified company, PBC Biomed is headquartered in Shannon, Ireland, with offices in Memphis, Tenn.; and Chamonix, France. PBC Biomed has developed and commercialized 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).