Clinical Trials

Date: 2017-07-10

Type of information: Initiation of development program

phase:

Announcement: initiation of development program

Company: Defymed (France)

Product: ExOlin®

Action mechanism:

medical device. ExOlin® is an insulin delivery medical device. It is composed of a biocompatible membrane, nonbiodegradable and permeable to insulin. It will be implanted into the patient’s abdomen and will enable insulin to be delivered to a physiological site by simply injecting the insulin through the skin. ExOlin® has considerable advantages for patients, who can continue their normal injection methods (syringe, pen, pump, etc.) and better stabilize their blood sugar levels in the long term. Unlike pens or external pumps that deliver insulin sub-cutaneously, the innovative ExOlin® device delivers insulin in a much more physiologically suitable location.
This medical device is suitable for a wider range of applications than just diabetic patients. It could also be adapted for other applications and pathologies requiring a physiological delivery method for drugs or active ingredients.

Disease: type 1 diabetes, type 2 diabetes

Therapeutic area: Metabolic diseases

Country:

Trial details:

Latest news:

• On July 10, 2017, Defymed announces the development of ExOlin®, a new insulin delivery device targeted at persons suffering from diabetes (Type 1 diabetics and some Type 2 diabetics) needing to administer insulin. Following the established roadmap, this device, which shall enter the clinical phase in 2018, should be available on the market by the end of 2020.
Currently in the advanced preclinical phase, Defymed shall enter the clinical phase in 2018 with 8 patients in Europe, with aims to extend the study to a larger number of patients. By the end of 2020, Defymed aims to obtain the CE mark and then launch ExOlin® onto the market in Europe. Following this, it will pursue FDA approval in the United States. To achieve this, Defymed intends to raise € 10 million in funds for the clinical development of ExOlin®. This should also allow Defymed to continue with the preclinical development of the MailPan® bioartificial pancreas, combined with several insulin-secreting cell candidates derived from stem cells, to enable a clinical phase to begin in the United States with the best cell(s).