Business

Tepha has received a number FDA 510(k) clearances for medical devices made from its lead biomaterial, TephaFLEX polymer. The first was a clearance of an absorbable monofilament suture, which then provided a foundation for the Company and its partners to develop additional devices using the 510(k) path. Since that time, regulatory clearances have been received for a monofilament surgical mesh, a tissue separation film, and other products by the Company. In the same time frame, Tepha’s corporate partners have also been receiving 510(k) clearances of TephaFLEX based devices.

Tepha has a hybrid product development and commercialization strategy. The company is able to develop and manufacture medical device components, as well as many finished goods, made from its proprietary biomaterials; although to date the company has primarily been identifying corporate partners for distribution of Tepha products. In addition, the company also often collaborates with leading medical device manufacturing companies which have products on the market, or products in development, that would benefit from incorporating Tepha’s absorbable biomaterials technology. Hence, the company has been forming corporate partnerships in a number of fields.

For more information on Tepha’s partnering activities, please email us at contact@tepha.com.