Press releases
curasan gains access to the US market
Kleinostheim, March 11, 2002 - Curasan AG (WKN 549 453) - specialists in regenerative biomedicine - have exercised their option agreement concluded 14 months ago with the US-based firm Miter Inc, Warsaw, IN, and today acquired regulatory approval for the medical products Augmen™ and Peri-Oss™. Augmen™ and Peri-Oss™ have been approved by the US authorities as so-called PMA products (Pre-Marketing Approval products). They are related to curasan's bone substitute material Cerasorb®.
At the same time when approval was granted to curasan, the company filed an application with the FDA to switch the products over to Cerasorb®. The PMA process is far more stringent than gaining approval by referencing through the so-called 510K process, but has the advantage for the licensee that competitors are not able to obtain their own approval by referring to the submission dossier.
Curasan AG Chairman Hans Dieter Rössler is of the opinion that this head start has produced the perfect conditions for being able to attain a market-leading position in maxillofacial surgery bone regeneration in the US. Rössler explains: "Four years ago, when we were an unknown company in the dentistry sector, we began with Cerasorb®, a totally new product in Germany at that time. Owing to its outstanding properties - bone deficiencies filled with Cerasorb® are completely regenerated with renewed bone as the material is simultaneously broken down - we are already the European market leader in synthetic bone regeneration materials within the dental sector. We intend to carry this success forward to the US with the help of a strong partner while continuing to grow substantially in our current markets."
The market volume of cranio- and maxillofacial bone regeneration amounts to 49 mio US dollars according to an estimate by the Millenium Research Group. The actual potential is much higher. The anticipated sales and profit figures published for 2002 do not include any revenues in the US. Nevertheless, first sales are now considered possible for 2002.
Curasan AG is currently intensifying its contacts with potential distribution partners in North America. In addition, a new curasan branch office is being established in the US which will serve as a coordination centre. At the Annual Congress of the American Academy of Orthopedic Surgeons (AAOS) in Dallas, Texas, in February 2002 it became clear that synthetic bone regeneration materials are meanwhile finding a very responsive market in the US.
The parties have agreed not to divulge the financial details surrounding the obtaining of approval. The total costs of the project were already essentially dealt with in the 2001 financial year. Costs incurred in the 2002 financial year are budgeted for and should not overly burden either liquidity or operating profit.
