KLEINOSTHEIM, Germany, Jan. 13, 2004 (PRIMEZONE) -- The synthetic bone regeneration material Cerasorb(R)DENTAL, developed by curasan AG (WKN 549 453), is available for distribution within the US dental sector following a PMA (Premarket Approval) issued by the Food and Drug Administration (FDA). Thus, curasan is able to access the entire market for bone regeneration, as the company has already gained 510K approval for the area of orthopaedics and veterinary medicine.The Premarket Approval process is far more complex and protracted than a substantial-equivalence approval as part of the 510K procedure. One of the main advantages for the holder of a PMA is that competitors are not able to gain approval of their own products by simply referring to the approval dossier. This provides curasan with a lead over potential competitors.
According to estimates, the market volume for bone regeneration within the area of oral and maxillofacial surgery is well above 100 billion US dollars. The market potential within this area is considered to be considerably higher. Market researchers have forecast substantial annual growth rates. The trend witnessed within this area is that biological bone replacement materials are increasingly being superseded by synthetic products such as Cerasorb(R)Dental and Cerasorb(TM)ORTHO.
curasan has now established a sales & marketing organization in North Carolina. Alongside its activities as a distribution centre for Cerasorb(R)Dental, this unit will also act as a coordination point for sales partners operating in the area of orthopaedics and veterinary medicine.
The company has been preparing the full range of marketing and sales activities over the course of the last two years. As a result, market lunch is expected to commence at the International Congress of Oral Implantologists Symposium from 22 to 25 January 2004 in New Orleans.
About curasan AG:
curasan AG (ISIN: DE 000 549 453 8), an exchange-listed company, is a leading innovator within the growth market of bone and tissue regeneration. The company has developed a comprehensive product range centred around its synthetic bone regeneration material Cerasorb(R), for use in soft and hard tissue. curasan AG's main goal is to occupy a leading position as a global specialist in Regenerative Medicine. For further information, please visit curasan's corporate website at: www.curasan.de
-0-
CONTACT: Ralph Wintermantel, curasan AG,
Tel. 06027/46 86 468
eMail: ir@curasan.de
Helmut Trahmer, curasan AG
Tel. 06027/46 86 0
eMail: ir@curasan.de