BOSTON and SYDNEY — 11 January 2017 — GI Dynamics, Inc., (ASX:GID), a medical device company that has commercialized EndoBarrier® in Europe for patients with type 2 diabetes and obesity, today released a 2017 business outlook and recap of 2016 accomplishments.
2017 marks the first full calendar year with the company’s new management team following the 2016 appointment of Scott Schorer as president and CEO. Schorer subsequently appointed industry veteran Jim Murphy as chief financial officer and Brian Callahan as chief compliance officer to help usher in a new era and re-establish key corporate priorities in driving commercial growth of EndoBarrier®, the first endoscopically-delivered device therapy for the treatment of type 2 diabetes and obesity. In addition, Dan Moore, an experienced medical device executive, was named chairman last year, and Oern Stuge, MD, MBA, was appointed to the board at the beginning of the 2017.
“There is a significant need for effective therapeutic options for the more than 300 million patients worldwide with type 2 diabetes and obesity,” said Schorer. “With more than 3,700 implants shipped as of year-end 2016, and a growing body of evidence demonstrating meaningful reductions in hemoglobin A1c (HbA1c) levels and weight, our focus this year is on enhancing commercialization in the United Kingdom, Germany and the Middle East, building on and harnessing the growing body of efficacy and safety data, and continuing dialogue with the FDA toward U.S. regulatory approval.”
Priorities for 2017 include the following:
- GI Dynamics will support commercialization, market access and reimbursement efforts underway in the United Kingdom, Germany, the Middle East, and select European countries.
- GI Dynamics will continue building relationships with regulatory agencies in Europe and the United States, especially as the company finalizes the protocol for its pivotal U.S. investigational device exemption (IDE) trial in anticipation of initiating and beginning to enroll the trial this year.
- GI Dynamics will raise capital to secure funding for executing U.S. clinical development and commercial plans.
- GI Dynamics will establish a scientific advisory board comprised of leading experts in treatment and management options for patients with type 2 diabetes and obesity to aid both clinical development and commercial strategies.
- GI Dynamics will bolster the efficacy and safety profile for EndoBarrier with presentations and publications based on data generated from multiple post-marketing and investigator-initiated studies.
- · GI Dynamics will continue to evolve and add to its team.
Highlights from 2016
The new leadership team began work immediately by slashing costs across the board to stabilize the company and extend the cash runway through the end of Q3 2017. A $1.1 million placement on the ASX in December together with a Security Purchase Plan (SPP) investment vehicle, which is still in process, should allow us sufficient capital to operate the company through the end of 2017. The company expects to continue to operate on a lean basis with regard to cash burn.
In 2016, GI Dynamics made promising clinical advancements through continued support of investigator-initiated studies worldwide and strengthened regulatory relationships with the FDA and its European Notified Body.
The company also announced positive data demonstrating improved outcomes in both A1c and weight reduction as well as reinforcing the EndoBarrier safety profile. In addition to revamping the management team, the company made significant strides in streamlining operations and reducing expenses.
Specific accomplishments include the following:
- GI Dynamics continued to build its intellectual property protection around EndoBarrier—the company was granted a total of eight allowances for patents from the U.S. Patent Office and the European Patent Office.
- GI Dynamics presented data from the German EndoBarrier Registry during the annual meeting of the European Association for the Study of Diabetes from 234 patients showing clinically relevant results. Data indicated a lowering of the absolute A1c mean from 8.5 percent to 7.2 percent in concert with a lowering of antidiabetic medication in 78 percent of patients while reducing the dose of insulin by 42 percent on a mean basis.
- GI Dynamics presented results of the ENDO Trial at the American Diabetes Association’s (ADA’s) 76th Scientific Sessions that demonstrated clinically meaningful improvements in A1c levels and weight reduction compared with the sham-treated group. These outcomes were achieved with only 325 of the planned 500 subjects being randomized into the trial because the company halted the trial due to a higher than anticipated rate of hepatic abscess (HA). The overall safety profile was positive, and of note, no adverse events led to long-term sequelae or mortality. The data presented included the following:
-statistically and clinically significant efficacy—1.1 percent absolute reduction in HbA1c;
-statistically and clinically significant efficacy—7.7 percent reduction in body weight; and
-data showed that 34.8 percent of patients achieved the ADA target of A1c ≤ 7.0 percent after 12 months.
The company expects to continue releasing new clinical information on a regular basis throughout 2017.
“Building on this clinically meaningful data and developing and enhancing relationships with investigators, providers and patients will help continue to expand the clinical support for EndoBarrier and help expand access to treatment,” said Schorer. “We are well on our way towards achieving the clinical, regulatory, commercial and operational goals we set out to accomplish at the outset and look forward to sharing that news with the market.”
About GI Dynamics
GI Dynamics, Inc. (ASX:GID), is the developer of EndoBarrier, the first endoscopically-delivered device therapy 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.
This announcement contains forward-looking statements concerning our development and commercialization plans, potential revenues and revenue growth, costs, excess inventory, profitability and financial performance, ability to obtain reimbursement for our products, clinical trials and associated regulatory submissions and approvals, the number and location of commercial centers offering the EndoBarrier, and our intellectual property position. These forward-looking 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 the consequences of terminating the ENDO trial and the possibility that future clinical trials will not be successful or confirm earlier results. Further risks are associated with obtaining funding from third parties; the timing and costs of clinical trials; the timing of regulatory submissions; and the timing, receipt and maintenance of regulatory approvals. The timing and amount of other expenses and the timing and extent of third-party reimbursement risks associated with commercial product sales, including product performance, competition, risks related to market acceptance of products, intellectual-property risk; risks related to excess inventory; and 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.