BOSTON and SYDNEY — 29 March 2019 — GI Dynamics® Inc. (ASX:GID), a medical device company that is developing EndoBarrier® for patients with type 2 diabetes and obesity, is pleased to announce positive results on one-year data from the Association of British Clinical Diabetologists (ABCD) EndoBarrier Obstructive Sleep Apnea Study (End-OSA Study). Principal and chief investigator, Robert Ryder, MD of Sandwell and West Birmingham Hospitals presented the results at the Diabetes UK Professional Conference 2019. The data show a significant reduction in weight and body mass index (BMI), as well as reduction in obstructive sleep apnea (OSA) events and HbA1c.

The aim of this study, titled “One-year Results of the Association of British Clinical Diabetologists (ABCD) Sponsored EndoBarrier in Type 2 Diabetes/Pre-Diabetes with Obstructive Sleep Apnoea (OSA) Study,” was to investigate whether weight loss associated with EndoBarrier would reduce OSA events for patients with type 2 diabetes or pre-diabetes who are treated with continuous positive airway pressure (CPAP).

The study consists of data collected from 12 patients who each received 12 months of EndoBarrier treatment. All patients were recruited and studied at Birmingham’s City Hospital (UK). Baseline criteria included patients diagnosed with moderate OSA (apnea hypopnea index [AHI] 15 – 29 events/hour) treated with CPAP, type 2 diabetes or pre-diabetes, and obesity (BMI ≥30 and ≤45 kg/m2). Of the 12 patients, eight had type 2 diabetes and four had pre-diabetes.

 

 

Following a 12-month EndoBarrier treatment, 10 out of 12 (83 percent) patients saw their AHI events fall below the moderate OSA threshold of 15 AHI events/hour, allowing them to discontinue the use of CPAP, according to NICE guidelines[1]. Of the remaining two patients, one discontinued CPAP usage at 18 months (six months post-explant); the second patient partially discontinued CPAP usage at nine months.

“These one-year results are very encouraging,” said Ryder. “EndoBarrier can provide great benefit to patients who are in need of an alternative treatment. Discontinuing the use of CPAP is not only beneficial for patients in terms of significant clinical and lifestyle benefits, but also is financially beneficial for health services. I believe EndoBarrier to be a novel treatment option that fills a large need for many patients.”

“The outcomes we have seen from Dr. Ryder’s studies show promising results reducing associated health risks for patients with obstructive sleep apnea, type 2 diabetes and obesity,” said Scott Schorer, president and chief executive officer of GI Dynamics.  “This study represents the first prospective obstructive sleep apnea study of EndoBarrier, and the results are highly encouraging for future analysis.”

 

About GI Dynamics

GI Dynamics, Inc. (ASX:GID), is the developer of EndoBarrier, the first endoscopically delivered device approved for the treatment of type 2 diabetes and obesity. EndoBarrier is approved and commercially available in multiple countries outside the United States. EndoBarrier is not approved for sale in the United States and is limited by federal law to investigational use only in the United States. Founded in 2003, GI Dynamics is headquartered in Boston, Massachusetts. For more information, please visit www.gidynamics.com.

Forward-Looking Statements

This announcement may contain forward-looking statements. These statements are based on GI Dynamics management’s current estimates and expectations of future events as of the date of this announcement. Furthermore, the estimates are subject to several risks and uncertainties that could cause actual results to differ materially and adversely from those indicated in or implied by such forward-looking statements.

These risks and uncertainties include, but are not limited to, risks associated with our ability to continue to operate as a going concern; our ability to raise sufficient additional funds to continue operations and to conduct the planned pivotal trial of EndoBarrier in the United States (18-1 study); our ability to execute the 18-1 study under FDA’s Investigational Device Exemption; our ability to enlist clinical trial sites and enroll patients in accordance with the 18-1 study; the risk that the FDA stops the 18-1 study early as a result of the occurrence of certain safety events or does not approve an expansion of the 18-1 study; our ability to maintain compliance with our obligations under our existing convertible note and warrant agreements executed with Crystal Amber Fund Limited, including our obligations to make payment on the relevant note that is due in March 2019; our ability to restructure the terms of the convertible note with Crystal Amber Fund Limited that is due in March 2019 if we are unable to raise sufficient funds to enable us to fully repay such note when due; obtaining and maintaining regulatory approvals required to market and sell our products; the possibility that future clinical trials will not be successful or confirm earlier results; the timing and costs of clinical trials; the timing of regulatory submissions; the timing, receipt and maintenance of regulatory approvals; the timing and amount of other expenses; the timing and extent of third-party reimbursement; intellectual-property risk; risks related to excess inventory; risks related to assumptions regarding the size of the available market; the benefits of our products; product pricing; timing of product launches; future financial results; and other factors, including those described in our filings with the U.S. Securities and Exchange Commission.

Given these uncertainties, one should not place undue reliance on these forward-looking statements. We do not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information or future events or otherwise, unless we are required to do so by law.

 

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[1] https://www.nice.org.uk/guidance/ta139/chapter/2-Clinical-need-and-practice