OssDsign's bioceramic Cranioplug gains FDA approval

24 November 2014

Stockholm-based OssDsign AB has announced that its Cranioplug, a bioceramic plug for re-fixing skull bone after brain surgery, has received 510(k) clearance by the US FDA.

Cranioplug, based on bone-like ceramic materials, has the potential to integrate with the surrounding bone, in contrast to metal-based products that are currently used. 

There are estimated to be around 500,000 open brain surgeries carried out annually worldwide. Burr holes and circular cuts between the burr holes are made to allow the surgeon to remove a piece of the skull — the bone flap — and thereby access the brain for the intended intervention.

The bone flap is then re-anchored to the surrounding skull bone after the procedure is completed. Cranial fixation today uses metal-based devices that anchor the bone flap to the skull. These devices typically leave the burr hole open, to the cosmetic and psychological detriment of patients.

Bo Qwarnström, CEO, OssDsign, said, “Through its innovative design, Cranioplug provides effective fixation as well as excellent cosmetic results. The clearance from the FDA demonstrates OssDsign can effectively navigate the FDA regulatory process and access the world’s largest market. It enables us to continue our preparations for the upcoming launch of our innovative products in the United States.“ 

“Founded only three years ago, OssDsign has already been able to get their first product through the US regulatory process. This is a good example of how a management team with a proper blend of competent project management, commercial experience and regulatory knowledge can achieve significant value creation within a very short timeframe”, said Bruno Lucidi, CEO, Karolinska Development. Karolinska Development owns 26% of the company, including indirect ownership through KCIF Co-Investment Fund KB.

Source: Ossdsign


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