The PBC Biomed affiliate company has developed an injectable bone filler to fix joint fractures or defects.
A key medical product by Biomimetic Innovations (BMI) has received a key designation by the US Food and Drugs Administration (FDA).
The company’s OsStic bone tissue glue has been granted Breakthrough Device designation by the FDA, which will help Biomimetic speed up the development of this product.
OsStic is an injectable bone adhesive that aims to fix joint fractures or defects to enhance structural stability. This structural adhesive is designed for bone issues where “standard fixation alone” is not enough to help return functional mobility to the joint.
“OsStic pioneers the evolution of structural orthobiologics, to the point where surgeons can now use this material as an aid for the reduction, provisional fixation and void filling of peri-articular fractures,” said BMI CMO Dr Thomas A Russell. “This is the first calcium phosphate that meets all these clinical requirements.”
The FDA’s Breakthrough Devices Programme aims to give patients and healthcare providers timely access to medical devices by speeding up the development, assessment and review of devices for premarket approval.
“This Breakthrough Designation of our disruptive technology fuels our passion for earlier mobilisation of trauma patients,” said BMI director Paul Burke.
Biomimetic Innovations is an affiliate of PBC Biomed, which is an Irish-headquartered medical device company founded in 2010 to drive innovation in medical devices, biomaterials and pharma companies.
Gaining FDA approval is a significant boon for medical companies, as it can help bring their products to market and can eventually open up the US market for these companies.
Neurovalens, a Belfast-based company that specialises in non-invasive neuroscience-influenced medical devices, received approval from the FDA in October 2023 for its Modius Sleep product, which aims to treat chronic insomnia by delivering a small electrical pulse to the head for a period of 30 minutes.
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