OssDsign has received 510(k) clearance by the US FDA for marketing of OSSDSIGN Cranial PSI in the USA.
“Receiving FDA clearance for our flagship product OSSDSIGN Cranial is extremely positive news. This means we can continue working according to our existing plan of launching OSSDSIGN Cranial on the US market in Q1 2017. We are in the final stages of setting up an experienced distribution network that will enable OssDsign to rapidly bring the benefits of OSSDSIGN Cranial to surgeons, patients and healthcare systems across the US,” said Anders Lundqvist, CEO of OssDsign.
OSSDSIGN Cranial is a patient-specific medical implant intended for reconstruction of cranial defects, a surgical procedure known as cranioplasty. Cranioplasty is traditionally performed by neurosurgeons using the patient’s own bone or by using implants made from inert plastic or metal materials, such as PEEK or titanium. These techniques are known to have a high rate of complications, especially infections, which sometimes necessitates removal of the implant and further surgery. Every OSSDSIGN Cranial implant is made to each patient’s unique requirements based on the patient’s computer tomography (CT) information. OssDsign uses computer-assisted (CAD) design and 3D-printing technologies to produce each device. The implant is made from a proprietary calcium phosphate composite, which is reinforced by a strong titanium skeleton.
“I believe that OSSDSIGN Cranial is a very promising product for cranial bone reconstruction that has led to positive results with two years follow up after introduction. We have used OSSDSIGN Cranial since it was introduced in Sweden; not only does it have good handling characteristics, it also substantially contributes to good outcomes in complex patient groups,” said Lars Kihlström, MD, Senior Consultant of Neurosurgery at Karolinska University Hospital.
OSSDSIGN Cranial and other OssDsign products have been introduced step-wised in Europe since 2014. These products are already available in Germany, the UK and Nordic region, as well as Singapore and Israel. Earlier this month OssDsign announced that it had entered into new commercial partnerships to distribute its medical implants in Italy, Spain, Switzerland, Austria and the Netherlands.
“Today’s announcement represents more positive news for OssDsign, as the Company prepares to launch OSSDSIGN Cranial in the US market over the coming months,” said Viktor Drvota, Chief Investment Officer at Karolinska Development.