Statement issued by the company (Announcement)
Biomimetic Innovations Ltd, an affiliate of PBC Biomed, an Irish medical device company specialising in biomimetic materials, today announced approval by MHRA 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 depression of the joint surface and loss of subchondral bone support. Following elevation of the articular surface during surgery, surgeons 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 recognised 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 remodelling over time.
The forthcoming clinical investigation will be conducted at Leeds University Teaching Hospital in the United Kingdom, the Principal Investigator being Professor Peter Giannoudis.
Professor Giannoudis commented:
“Along with my colleagues, I am very excited to perform this first-in-human study at Leeds Teaching Hospitals. OsStic™ represents a 5th generation biomaterial and its unique properties are expected to revolutionise patient care and outcomes.”
The primary objective of the study is to evaluate device safety, including early adverse events, implant-site reactions, and device-related complications. Secondary objectives include assessment of 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 is expected to begin in the coming weeks, with study completion anticipated 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.
Paul Burke, Managing Partner at PBC Biomed, said:
“We are delighted to take this next step on the OsStic™ journey with our Principal Investigator Professor Giannoudis at the Leeds University Teaching Hospital. 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.”
About Biomimetic Innovations Ltd and PBC Biomed
Biomimetic Innovations Ltd is an affiliate of PBC Biomed, a medical device company involved in design, development, manufacturing and commercialisation of Innovative products. PBC Biomed, through its advanced medical service portfolio, partners with medical device, biologic, pharmaceutical and combination product innovators to accelerate technology through the product lifecycle stages.
PBC Biomed, an ISO 13485 certified company, is headquartered in Shannon, Ireland, with offices in Memphis, Tennessee and Chamonix, France. PBC Biomed has a 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).
For more information, please visit http://www.pbcbiomed.com and http://www.pbcbiomed.com/affiliates/biomimeticinnovations/.
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/4a80b213-ad14-4320-905e-cb2d2126fe35
Contact Information: Bronagh O'Doherty Global Product Manager bronagh@pbcbiomed.com
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