Defymed Receives Support from JDRF to Fight Type 1 Diabetes

NEW YORK, July 12, 2016 /PRNewswire-USNewswire/ -- Defymed, a French biotechnology company specializing in the development of bioartificial organs today announced a partnership with JDRF, the leading global organization funding type 1diabetes (T1D) research. This new investment gives Defymed the opportunity to advance its pre-clinical studies in order to demonstrate the MAILPAN^® immunoprotection properties, safety and function. This is an essential step before beginning the clinical trials on humans.

"JDRF is known as the number-one worldwide public foundation fighting type 1 diabetes. We are more than honored to be working with them for the necessary pre-clinical tests before starting the MAILPAN^® clinical phase," explains Dr. Séverine Sigrist, CEO of Defymed. "More than financial support, JRDF brings to us  considerable visibility within the U.S. market and also provides strategic support in regards to finding a solution to encapsulating insulin-secreting cells to derive the benefits offered by this therapy to patients suffering from type 1 diabetes."

With this support, Defymed will move significantly forward with clinical trials in humans. This new project, scheduled to take up to 24 months, will be conducted simultaneously as other research and development programs currently in progress at Defymed. It will allow Defymed to test the MAILPAN^® bioartificial pancreas designed for type 1 diabetics through the preclinical phase in order to:

• Strengthen the results on MAILPAN^®'s immunoprotection properties in combination with insulin-secreting cells.
• Confirm collected data on the MAILPAN^®'s functionality and safety, also in combination with insulin-secreting cells.

MAILPAN^®, a disruptive technology for a better life
Almost 25 million people around the world suffer from type 1 diabetes. MAILPAN^®, an implantable bioartificial pancreas, is a serious alternative to existing treatments. This medical device is designed to restore normal and continuous insulin production in diabetic patients. Implanted in the abdomen, it takes the shape of a pouch containing insulin-secreting cells. The potential of MAILPAN^® will bring numerous advantages in comparison to current treatments (e.g., no anti-rejection drugs in case of pancreatic transplants, absence of multiple insulin injections per day).

The bioartificial pancreas' underlying principle' is to encapsulate insulin-secreting cells between membranes impermeable to the immune system, but permeable enough for oxygen, nutrients, glucose and insulin. A bioartificial pancreas must fulfill three prerequisite functions: to protect transplanted cells from the patient immune system, to protect the patient from transplanted cells, and to maximize the function of the transplanted cells. The goal of the project is to ensure the function and safety of the medical device, utilizing Defymed's expertise in the biomaterial and cell transplant, as well as preclinical validation and non-invasive imaging technologies.

This strategic step for Defymed confirms the therapeutic interest of the MAILPAN^® and will generate preclinical data that is absolutely necessary to build strong regulatory documentation for the MAILPAN^®, associated with insulin-secreting cells, which will be necessary to bring it to clinical trials in humans.

"JDRF is excited to announce its support of Defymed as it seeks preclinical validation of its MAILPAN® device, a project which is well aligned with JDRF's Beta Cell Replacement strategy," said Derek Rapp, JDRF president and CEO. "By funding this type of research, we firmly believe we are moving one step closer to our goal of creating a world without type 1 diabetes."

Major challenges for Alsatian biotech
JRDF support appears as a testament of confidence and represents an important opportunity for Defymed to make significant strides in the biotech world. It will indeed bring more visibility and awareness to French biotech on an international platform. From a strategic standpoint, this financial support will also allow Defymed to pursue its development in Europe but also to prepare its entry in its new target market, the U.S.

Defymed has also become a member of the encapsulation consortium, a key JDRF initiative. Its goal is to accelerate the development of a bioartificial pancreas for individuals living with type 1 diabetes.

About Defymed:

Defymed is a spin-off of CeeD (Centre européen d'étude du Diabète – European Center for Diabetes Studies), and a biotechnology company founded in March 2011. Defymed is specialized in the design and development of innovative bioartifical medical devices. The company focuses first on an application for the treatment of type 1 diabetes.

Defymed's first product is MAILPAN©, an implantable bioartificial pancreas made to restore a normal insulin production in the patient suffering from type 1 diabetes. The prototype has been created thanks to financial support from the European commission. The company owns an exclusive technology allowing to shape these medical devices to answer other therapeutic needs. Defymed's strength resides in its national and international network of partners.

Defymed has received several awards since its inception:
First prize  «Tremplin entreprise » at the French Senate, category «  Life science » (2011)
The Technology Fast 50 de Deloitte-In Extenso Award (2014)
First laureate of the « Inventer demain » Award (2015)
Special award from INPI and gold medal with the jury mention at the 44th international inventions tradeshow in Geneva (2016)

www.defymed.com

About JDRF
JDRF is the leading global organization funding type 1 diabetes (T1D) research. Our mission is to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications. To accomplish this, JDRF has invested nearly $2 billion in research funding since our inception. We are an organization built on a grassroots model of people connecting in their local communities, collaborating regionally for efficiency and broader fundraising impact, and uniting on a national stage to pool resources, passion, and energy. We collaborate with academic institutions, policymakers, and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. Our staff and volunteers throughout the United States and our six international affiliates are dedicated to advocacy, community engagement and our vision of a world without T1D. For more information, please visit jdrf.org or follow us on Twitter: @JDRF

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