curasan receives market clearance for orthopedic product in the strategically important US market

  • FDA clearance of bone graft material CERASORB Ortho FOAM faster than expected
  • Green light for marketing and sales campaign in the United States
  • Structural reorganization of the US subsidiary successfully completed

Kleinostheim, 7 December 2016 – curasan AG (ISIN: DE0005494538), a leading specialist for medical products in the field of orthobiologics, has received the market clearance of the American Food and Drug Administration (FDA) and thus the authorization to market its synthetic bone regeneration material CERASORB Ortho FOAM in the United States.

The innovative product made of resorbable ceramic and porcine collagen can now be used for bone defect treatment in extremities and pelvis on the US market as well as in all other countries where the FDA certification is recognized. curasan has been actively preparing the market launch of the product in recent months. Back in May, Shane Ray, an experienced sales and marketing executive in the field of orthopedic regenerative medicine, was appointed as the president and CEO of the US subsidiary curasan Inc. Consequently, the company optimally aligned its own sales channels in the United States. “The FDA clearance of CERASORB Ortho FOAM is an extremely important milestone for us in the re-orientation of our US business, which will open up a potential market worth more than USD 900 million,” emphasized Michael Schlenk, CEO of curasan AG. “Even before the clearance, major customers indicated during exploratory discussions that the flexible and mouldable version of CERASORB meets the demands of the US customers  perfectly, much more so than any of our other products.”

Ahead of the market launch of the product the American subsidiary also successfully completed its structural reorganization in the fourth quarter to align the ability to be successful in dental and orthopedics business within North America. The approval of CERASORB Ortho FOAM by the FDA came faster than expected. “We had actually anticipated this only for the first quarter of 2017”, said Michael Schlenk. “We are all the more pleased about it.  Being already able to report this important strategic milestone still in the fourth quarter is due to the profound expertise of our internal approval department, which was optimally prepared for the dialogue with the FDA and could answer all of their questions quickly.  I’m very proud of our team!”

The enhanced presence of curasan in the US orthopedic market is a core component of the growth strategy of the company for 2017. The company will publish a detailed forecast of the expected growth in sales and results for the coming year when the preliminary figures for business performance in 2016 are available towards the end of February 2017.

 Your contacts at curasan AG:
Ingo Middelmenne
Head of Investor Relations
+49 6027 40 900-45
+49 174 90 911 90
ingo.middelmenne@curasan.com

Andrea Weidner
Head of Corporate Communications
+49 6027 40 900-51
andrea.weidner@curasan.com

 About curasan AG:
curasan AG develops, manufactures and markets biomaterials and other medical products in the field of bone and tissue regeneration. A pioneer in its industry, curasan is specialized primarily on synthetic bone grafting ­materials for dental and orthopaedic applications. Numerous patents and a comprehensive list of scientific documentation prove the clinical success of the products and the highly innovative strength of curasan. Surgically active dentists, implantologists and oral, maxillary and dentofacial surgeons, as well as orthopaedics, traumatologists and spinal column surgeons worldwide benefit from the broad range of the premium quality and user-oriented portfolio offered by the technology leader. curasan maintains its own high-tech facilities for research, development and manufacturing in Frankfurt/Main, Germany, which are approved by the Food and Drug Administration (FDA) and other international authorities. In addition to its headquarters, the company has a subsidiary, curasan Inc., in the Research Triangle Park, near Raleigh, N.C., USA. The shares of curasan AG are listed in the General Standard at the Frankfurt Stock Exchange.