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
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
“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.