curasan AG: Market clearance for Osbone in Japan

DGAP-News: curasan AG / Key word(s): Regulatory Approval

24.01.2019 / 15:35

The issuer is solely responsible for the content of this announcement.


Clearance of synthetic bone graft material Osbone

Expanded product portfolio for the Japanese market

 

Kleinostheim, 24 January 2019 – curasan AG, Germany, a leading specialist for medical products in the field of orthobiologics, has received news that the Japanese Pharmaceutical and Medical Devices Agency (PMA) has approved Osbone for distribution to the local market.

The approval process, which is particularly complicated in Japan, was successfully completed within the expected timeframe.

By this, the Japanese sales partner of curasan AG, Hakuho Co. Ltd., can offer another product in addition to Cerasorb M granules.

Osbone is a purely synthetic material and thus free of risks for allergies and disease transmission. It consists of hydroxyapatite, which has a particularly high porosity, comparable to human bone. Osbone also has a high volume stability and can therefore be loaded immediately. This property is an important criterion for positioning in the market. Competitor products also have this stability, but consist of animal hydroxyapatite.

Preparations for the market launch planned for the end of the first quarter are already underway. Due to the complexity of the introduction and listing processes, no significant revenues are expected in the first year.

Contact curasan AG:
Andrea Weidner
Investor Relations &
Corporate Communications
+49 6027 40 900-51
ir@curasan.com

About curasan AG:
curasan develops, manufactures and markets biomaterials and medical devices in the field of bone and tissue regeneration, wound healing and osteoarthritis therapy. As a pioneer and global technology leader in the growing field of regenerative medicine, curasan is specialized primarily on biomimetic bone grafting materials for dental, oral/maxillofacial, orthopedic and spinal applications, i.e. materials mimicking biological structures. Numerous patents and a broad record of scientific publications demonstrate the clinical success of the products and the highly innovative strength of curasan. Dental and orthopaedic clinicians worldwide benefit from the broad range of the premium quality and easy to use portfolio offered by the technology leader curasan. curasan maintains its own high-tech facilities for research, development and manufacturing of biomaterials in Frankfurt/Main, Germany. In addition to its headquarters, the company has a subsidiary, curasan, Inc., in Wake Forest, near Raleigh, N.C., USA. curasan’s innovative products are cleared by the US Food and Drug Administration (FDA) and many other international authorities and available in almost 50 countries worldwide. curasan AG is a public company listed in the General Standard at the Frankfurt Stock Exchange.


24.01.2019 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG.
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Language: English
Company: curasan AG
Lindigstraße 4
63801 Kleinostheim
Germany
Phone: 06027/40 900 0
Fax: 06027/40 900 29
E-mail: info@curasan.de
Internet: www.curasan.de
ISIN: DE0005494538
WKN: 549453
Listed: Regulated Market in Frankfurt (General Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange

 
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