LEXINGTON, Mass. & SYDNEY--(BUSINESS WIRE)--GI Dynamics, Inc. (ASX: GID), a company pioneering the development of effective non-surgical approaches for treating type 2 diabetes and obesity, announced today that shares in the company (in the form of CHESS Depositary Interests or CDIs) have commenced trading on the Australian Securities Exchange (ASX) under the stock symbol “GID.”
GI Dynamics recently raised A$80 million through a successful initial public offering (IPO) and U.S. private placement and is using the funds to expand the global commercialization of its flagship product, the EndoBarrier® Gastrointestinal Liner. The EndoBarrier presents a unique, non-pharmaceutical, non-surgical alternative for reducing blood glucose levels and effecting weight loss in diabetic and obese patients, a large, underserved and growing global patient population.
“We believe the strong support we received during our recent IPO recognizes the outstanding commercial potential for the EndoBarrier,” said Stuart A. Randle, chief executive officer of GI Dynamics. “With the successful completion of our IPO, we believe we are well positioned to execute our plans for achieving broader adoption in markets where the EndoBarrier has been launched and expanding into new markets, as well as to advance clinical development in the United States.”
Mr. Randle continued, “We are very pleased with the feedback we are receiving from our initial launch sites in Europe and the results physicians are reporting for both blood sugar control and weight loss in their patients. Our phased approach to the commercial rollout of EndoBarrier is allowing us to train physicians on the use of EndoBarrier, certify Centers of Excellence and monitor early outcomes in these markets. We look forward to expanding these efforts in the months ahead to drive product sales and bring the EndoBarrier to the growing number of people around the world in need of a new treatment for type 2 diabetes and obesity.”
The lead manager of the IPO was Inteq Limited, a Sydney-based boutique advisory house, and the lead Australian broker to the IPO was Bell Potter Securities Limited.
About the Global Type 2 Diabetes and Obesity Markets
Type 2 diabetes and obesity are two of the most prevalent global healthcare concerns today. The International Diabetes Federation estimates that more than 250 million people worldwide have type 2 diabetes, and the World Health Organization (WHO) estimates that diabetes-related deaths will double from 2005 to 2030. It is also estimated that 1.5 billion adults are overweight and over 500 million are obese and at risk of developing type 2 diabetes. Currently available options for the treatment of type 2 diabetes and obesity fall short of optimal – with efficacy issues, adverse events and a tighter regulatory environment restricting the use of pharmaceuticals, and the risks of surgery outweighing the benefits for many. There is a clear need for new treatment alternatives for this large, underserved and growing patient population.
About the EndoBarrier® Gastrointestinal Liner
The EndoBarrier Gastrointestinal Liner represents a novel approach for the treatment of type 2 diabetes and obesity. Easily inserted and removed endoscopically (via the mouth), the EndoBarrier is placed in the GI tract, forming a barrier between food ingested and the upper section of the intestinal wall, thus mimicking the effects of a gastric bypass procedure without the surgery. Data from extensive clinical studies suggest that the EndoBarrier’s significant effects on blood glucose levels and weight loss could be a result of its ability to affect and possibly reset key metabolic pathways. In addition, data demonstrate improvements in risk factors including levels of insulin, cholesterol, LDL and triglycerides; patients treated with the EndoBarrier are also often able to reduce or cease their diabetes medications during the implant period.
The EndoBarrier has received CE mark approval in Europe for implant periods of up to 12 months of treatment for type 2 diabetes and obesity, and recently received TGA approval in Australia. The EndoBarrier is currently commercially available in Chile, Germany, the United Kingdom and the Netherlands, and GI Dynamics has also received an investigational device exemption approval to commence a pilot trial of the EndoBarrier in the U.S. For more information, please visit www.endobarrier.com.
About GI Dynamics
GI Dynamics, Inc. (ASX: GID) is pioneering the development and commercialization of effective, non-surgical treatments targeting the large and growing global patient populations with type 2 diabetes and obesity. The company’s flagship product, the EndoBarrier®, is a novel, non-surgical device proven to lower blood glucose levels and promote weight loss in diabetic and obese patients during the implant period. GI Dynamics currently markets the EndoBarrier in select regions in Europe and South America and is planning significant near-term commercial expansion into Australia and additional European countries. Founded in 2003, GI Dynamics is headquartered in Lexington, Massachusetts. For more information, please visit www.gidynamics.com.
This announcement contains or may contain forward-looking statements that are based on management’s beliefs, assumptions and expectations and on information currently available to management. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including without limitation our expectations with respect to our ability to commercialize our EndoBarrier® including our estimates of potential revenues, costs, profitability and financial performance; our ability to develop and commercialize new products including our ability to obtain reimbursement for our products; our expectations with respect to our clinical trials, including enrolment in or completion of our clinical trials and our associated regulatory submissions and approvals; our expectations with respect to the integrity or capabilities of our intellectual property position. Management believes that these forward-looking statements are reasonable as and when made. You should not place undue reliance on forward-looking statements because they speak only as of the date when made. GI Dynamics does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. GI Dynamics may not actually achieve the plans, projections or expectations disclosed in forward-looking statements, and actual results, developments or events could differ materially from those disclosed in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, described in “Risk Factors” in our Prospectus lodged with the Australian Securities & Investments Commission on 3 August 2011.