GI Dynamics Press Release - October 15, 2010
GI Dynamics Receives European CE Mark Approval for 12 Months of EndoBarrier™ Treatment of Type 2 Diabetes and Obesity; Announces U.K. Launch
Innovative Medical Device Offers Patients a Catalyst for Regaining Control of Diabetes and Weight; Targeted Rollout Begins with Centers of Excellence
Lexington, Mass., October 15, 2010 – GI Dynamics, a leader in non-surgical, endoscopic treatments for type 2 diabetes and obesity, today announced that it has received European CE mark approval for the EndoBarrier, a non-surgical therapy to treat type 2 diabetes and obesity. This approval is specific to up to 12 months of treatment with the EndoBarrier; the product has already received CE mark approval for three and six months of treatment. Through its commercial partner, Elemental Healthcare, GI Dynamics has also announced the launch of the EndoBarrier in the United Kingdom.
Alberic Fiennes, M.D., consultant bariatric surgeon at St. Anthony's Hospital in Surrey, said: “This new procedure is pioneering in that it works as a metabolic regulator directly treating type 2 diabetes and associated weight-gain, giving patients a chance to drastically improve their condition. I was excited when I first heard about EndoBarrier and impressed at the results produced by clinical studies that showed that as early as the first week post procedure, patients can experience a significant effect on their diabetes.”
Clinical trials involving more than 300 patients have demonstrated the significant weight loss and diabetes improvement achieved with the EndoBarrier Gastrointestinal Liner. In fact, the EndoBarrier has been clinically proven to lower HbA1c levels (data presented at Digestive Disease Week 2010) and achieve weight loss of more than 20.0 percent of total body weight during 12 months of treatment (data presented at the International Federation for Surgery of Obesity and Metabolic Disorders 2010 World Congress, and Obesity 2010: 28th Annual Scientific Meeting of The Obesity Society). The EndoBarrier procedure is quick, incisionless and reversible, and many patients often go home the day of the procedure. In recent clinical trials, there have been no serious adverse events and the most common potential side effects include pain, nausea and vomiting, which generally resolves in the first two weeks of treatment.
The EndoBarrier is suitable for patients who have type 2 diabetes with a BMI of 30 to 50. It is initially being offered to private patients at St Anthony’s Hospital in Surrey and is hoped to become available on the National Health Service in due course, following trials at three NHS hospitals that have been designated Centers of Excellence: Imperial College St. Mary’s Hospital, Southampton University Hospital and Trafford General Hospital, Manchester. People living in the U.K. and interested in learning more about taking part in one of the NHS trials can email patients@EBstudy.co.uk or call freephone 0800 096 2418.
“We believe the EndoBarrier, as part of a multidisciplinary approach, has the potential to change the treatment paradigm for type 2 diabetes and weight problems,” stated Julian Teare, M.D., FRCP, consultant gastroenterologist, Imperial College, London, and principal investigator of the NHS trial. “Based on the data to-date and its unique profile as a non-surgical and non-pharmaceutical treatment option, the EndoBarrier appears to provide many of the benefits of gastric bypass surgery through an endoscopic approach. We are delighted to be among the first in Europe to have access to the EndoBarrier as a new treatment option in our fight against these epidemics.”
With the EndoBarrier, GI Dynamics is defining a new class of metabolic treatment options that fit between pharmaceutical regimens and surgery, called non-surgical therapeutics. Non-surgical therapeutics are designed to eliminate or reduce the risks and side effects associated with pharmaceutical regimens as well as surgical options. This new class of treatment can be performed easily and quickly without any incisions, thus reducing patient anxiety and recuperative time. Additionally, non-surgical therapeutics hold the potential to improve the patient’s overall health, by providing the control necessary to institute lifestyle and nutritional improvements to maintain therapeutic effect, while being easily removed once the desired effect has been attained and lifestyle changes implemented.
“This European approval for 12 months of EndoBarrier therapy to treat type 2 diabetes and obesity is another key milestone for GI Dynamics as we launch the product in the U.K.,” stated Stuart A. Randle, chief executive officer of GI Dynamics. “The data presented last month at IFSO demonstrate the significant potential for EndoBarrier to offer a much needed alternative to traditional interventions such as pharmaceutical treatments and surgery. We look forward to training additional centers in Europe over the next year and making the EndoBarrier available more broadly in the near future.
About the EndoBarrier™ Gastrointestinal Liner
The patented EndoBarrier Gastrointestinal Liner is a non-surgical medical device based on the EndoBarrier Technology platform for treating type 2 diabetes and obesity. The EndoBarrier Gastrointestinal Liner is approved for use in Europe and is an advanced investigational device in the United States. The EndoBarrier Gastrointestinal Liner is placed in the GI tract endoscopically (via the mouth) to create a barrier between food and the wall of the intestine. Physicians believe that preventing food from coming into contact with the intestinal wall may alter the activation of hormonal signals that originate in the intestine, thus mimicking the effects of a Roux-en-Y gastric bypass procedure without surgery. A growing body of preclinical and clinical evidence supports the potential for EndoBarrier Gastrointestinal Liner to change the treatment landscape for people living with one or more of the of following conditions: type 2 diabetes, obesity and at risk for type 2 diabetes, and severe weight problems.
About GI Dynamics
GI Dynamics is focused on developing effective, non-surgical therapeutics for treating type 2 diabetes and obesity. The company’s patented EndoBarrier™ Technology has the potential to deliver medical interventions for people combating weight problems and diabetes or diabetes risk factors. Data from clinical trials demonstrate that the EndoBarrier™ Gastrointestinal Liner may provide rapid improvement in glycemic control and significant weight loss by modifying metabolic pathways.
Based in Lexington, Massachusetts and founded in 2003, GI Dynamics is backed by top-tier investors including Advanced Technology Ventures, Catalyst Health Ventures, Cutlass Capital, Domain Associates, Johnson & Johnson Development Corporation, Medtronic, Inc. and Polaris Venture Partners. For more information, visit GI Dynamics online at www.gidynamics.com.