Swedish company Corline Systems AB, maker and distributor of a proprietary and unique heparin coating technology for use in Regenerative Medicine and for medical devices, has submitted a Drug Master File to the US Food and Drug Administration for its heparin conjugate, the main critical reagent of the coating technology.
“As a service to our US customer base we can now offer the possibility to refer to our Drug Master File (Assigned DMF number #026677). This will facilitate a more expedient and straightforward communication with the relevant regulatory authorities, both for our medical device and Regenerative Medicine customers”, comments CEO Henrik Nittmar.
The subject matter of the DMF is the ‘CORLINE HEPARIN CONJUGATE’, which is a Corline proprietary reagent produced in Uppsala being used by Corline’s licensees to apply and use the Corline Heparin Surface on their medical device products and biologics (coated cells, tissue segments, etc.).
“The development of the Drug Master File and its future maintenance represent a significant investment and reflects the fact that we are now seeing increasing activity by our US customers. We want to offer our full support for those committed to using our technology and the DMF is an important and valuable tool for us in this market”, concludes CEO Henrik Nittmar.
About Corline and CHS
Corline is a biotechnology company based in Uppsala, Sweden, that develops, manufactures and distributes a proprietary patent protected heparin conjugate surface (CHS) that can be used both for medical devices and for Regenerative Medicine (cell therapy and tissue engineering). In 2011 the market for Regenerative Medicine totaled a 3.5 bn USD turnover, with a 80 % share being focused in the US. The US based market analysis company Life Science Intelligence, estimates the total potential to be over 100 bn USD.
CHS can be used to coat living cells and tissue without compromising their biological functions. CHS helps attenuate the local inflammation that is formed on and around grafts at transplantation, and promotes new blood vessels to grow more quickly to support the graft. For the patient, CHS potentially means better clinical outcome and a more rapid recovery from treatment.
Corline conducts pre-clinical and clinical studies within a number of cell and tissue therapy areas. These studies are a first step towards realizing the company’s vision of having its CHS platform technology widely used within the future Regenerative Medicine market. The CHS technology is protected by more than 20 granted and pending patents.
Corline is a privately held company, financially backed by members of the Crafoord family, primarily known for the development of Swedish medical device company Gambro (founded by Holger Crafoord), and Lars Sunnanväder, a well-known entrepreneur who has founded several medical device and biotechnology companies, e.g. heart/lung assist and coronary surgical device manufacturer Jostra, lung assist device manufacturer Novalung, Jotec, Jolife, Joline and other companies within this field.
For more information, please contact:
Henrik Nittmar, CEO
Tel. +46 (0)18 71 30 90