OssDsign receives CE mark approval for Cranioplug

OssDsign AB today announced that the company has received CE mark approval for its bio-ceramic burr hole plug - Cranioplug.

Uppsala, Sweden 27 January 2016 – OssDsign AB, a Swedish designer and manufacturer of innovative implants and technology for bone regeneration, today announced that the company has received CE Mark approval for its bio-ceramic burr hole plug – Cranioplug. The product will complement OssDsign’s lead products OssDsign Cranial and OssDsign Facial, which are available in Germany, the UK, and the Nordic countries, with further market expansion ongoing.

”This is an important step in our continuing efforts to lead the transformation of the cranioplasty market away from bone repair, and into bone regeneration”, says Anders Lundqvist, CEO of OssDsign. ”This device is the result of a patient oriented design approach combined with our proven bio-ceramic material. It will satisfy surgeons needs by filling a gap in the market, while also being a perfect strategic fit with our existing product offering.”

Cranioplug is intended to be used to cover and plug holes drilled into the skull during neurosurgical procedures and to reattach a temporarily removed bone flap. Traditional devices used to reattach bone flaps leave the burr holes exposed, which can have negative aesthetic outcome and contribute to patient dissatisfaction and the need for further surgical procedures.

The proprietary bio-ceramic material used in all OssDsign devices integrates with surrounding native bone and has shown osteoinductive properties, as well as excellent soft tissue compatibility. Ongoing clinical trials aim to further prove the clinical advantage, patient benefits and health economic value of these characteristics. Cranioplug will be launched in selected European markets during 2016.

For further information, please contact:
Anders Lundqvist, CEO, OssDsign AB
Phone: +46 73 206 98 08, email: al@ossdsign.com

About OssDsign AB
OssDsign is a Swedish medtech company dedicated to creating regenerative implants for improved healing of bone defects and deficits in skull, facial and other types of surgery. OssDsign has successfully launched its first patient specific products OssDsign Cranial and OssDsign Facial in Germany, the UK and the Nordic countries, and further global market expansion is ongoing. By combining clinical insight with proprietary material technology and patient adapted design, OssDsign supplies an expanding range of tailored solutions for cranial repair and facial bone reconstruction. OssDsign’s technology is the result of collaboration between clinical researchers at the Karolinska University Hospital, Stockholm, and material science experts at the Ångström Laboratory at Uppsala University. For more information: www.ossdsign.com