Companion Medical receives FDA clearance
Diamyd Medical (Nasdaq Stockholm First North, DMYD B) announced today that Companion Medical,Inc receives 510(k) clearance from the FDA for the InPen® system, an intelligent insulin administration system and smartphone application. Diamyd Medical owns 8.5% of Companion Medical and holds the distribution rights for future products in the Nordic countries.
Companion Medical’s InPen® is cleared in the US for use with Ely Lilly’s Humalog® or Novo Nordisk’s Novolog® rapid acting insulin. The InPen® application is cleared for Apple iOS and an Android version is planned for later in 2016. Companion Medical has also applied for a CE Mark for market approval in Europe.
Diamyd Medical owns 8.5% of Companion Medical and holds the distribution rights to Companion Medical’s future products in the Nordic countries.
For additional details regarding the FDA clearance see Companion Medical’s press release, www.companion-medical.com.
About Diamyd Medical
Diamyd Medical is dedicated to finding a cure for autoimmune diabetes through pharmaceutical development and investments in stem cell and medical technology.
Diamyd Medical develops the diabetes vaccine Diamyd®, an Antigen Based Therapy (ABT) based on the exclusively licensed GAD-molecule. The Company’s licensed technologies for GABA and Gliadin have also potential to become key pieces of the puzzle of a future solution to prevent, treat or cure autoimmune diabetes, and also certain inflammatory diseases. At this time six clinical studies are ongoing with Diamyd®. Diamyd Medical is one of the major shareholders in the stem cell company Cellaviva AB. Stem cells can be expected to be used in Personalized Regenerative Medicine (PRM), for example for restoration of beta cell mass in diabetes patients where the autoimmune component of the disease has been arrested. Diamyd Medical also has holdings in the medtech company Companion Medical, Inc., San Diego, USA and in the gene therapy company Periphagen, Inc., Pittsburgh, USA.
Diamyd Medical’s B-share is traded on Nasdaq Stockholm First North under the ticker DMYD B. Remium Nordic AB is the Company’s Certified Adviser.
For further information, please contact:
Ulf Hannelius, President and CEO
Phone: +46 736 35 42 41. E-mail: email@example.com
Diamyd Medical AB (publ)
Kungsgatan 29, SE-111 56 Stockholm, Sweden. Phone: +46 8 661 00 26, Fax: +46 8 661 63 68
E-mail: firstname.lastname@example.org. Reg. no.: 556242-3797. Website: www.diamyd.com.