GI Dynamics, Inc. Provides 2017 Business Outlook and 2016 Review
January 11 2017 - 8:13AM
Business Wire
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.
Forward-Looking Statements
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.
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Investor RelationsGI Dynamics, Inc.United States:Monica
Bellevue, +1 781-357-3246
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