Gi Dynamics (PC) (fka GIDYL)

[Renee]

GIDYL: CUSIP suspended. FINRA deleted symbol:

https://otce.finra.org/otce/dailyList?viewType=Deletions

[ALERTS100%to10000%GAIN]

GIDYL~~Gastroenterology http://gidynamics.com/company/scientific-advisory-board/

[ALERTS100%to10000%GAIN]

GIDYL~~Metabolic Surgery http://gidynamics.com/company/scientific-advisory-board/

[ALERTS100%to10000%GAIN]

GIDYL~~Endocrinology http://gidynamics.com/company/scientific-advisory-board/

[ALERTS100%to10000%GAIN]

GIDYL~~Scientific Advisory Board http://gidynamics.com/company/scientific-advisory-board/

[ALERTS100%to10000%GAIN]

GIDYL~~EndoBarrier Gastrointestinal Liner in Type 2 Diabetic Patients Improves Liver Fibrosis as Assessed by Liver Elastography.
Gollisch KS, Lindhorst A, Raddatz D.
Abstract
Many obese people with type 2 diabetes develop non-alcoholic fatty liver disease, which may progress to liver fibrosis. EndoBarrier gastrointestinal liner is an innovative interventional treatment option for type 2 diabetic patients, which could affect diabetes associated liver disease. The aim of this retrospective study was to analyze the effect of 1-year EndoBarrier therapy on liver fibrosis and steatosis. As an indicator of fibrosis, liver stiffness was assessed by liver elastography at baseline, 2 weeks after EndoBarrier implantation and then every 3 months until explantation. 13/19 patients had elevated liver stiffness at baseline, corresponding to liver fibrosis grade 2 to 4. In these patients, liver stiffness reduced significantly during EndoBarrier therapy from 10.4?kPa (IQR 6.0-14.3) at baseline to 5.3?kPa (IQR 4.3-7.7, p<0.01) by the time of EndoBarrier explantation, corresponding to a normalization of the initially pathologic findings in most patients. Liver steatosis was also assessed by elastographic measurements in terms of the controlled attenuation parameter. In all patients, baseline measurements showed high grade steatosis. Improvements were seen from initially 343?dB/m (IQR 326-384) to 317?dB/m (IQR 269-375, p<0.05) by the time of explantation. However, most patients were still classified high grade steatosis after completion of EndoBarrier treatment. In this observational study, we show that liver fibrosis is a common condition in obese patients suffering from type 2 diabetes, and that EndoBarrier gastrointestinal liner substantially improves liver fibrosis in these patients.

[ALERTS100%to10000%GAIN]

GIDYL~~TODAY'S NEWSSSS GI Dynamics Announces Details of Special Meeting of the Company’s Stockholders
Feb 7, 2018 | Press Releases

BOSTON and SYDNEY — 07 February 2018— GI Dynamics®, Inc. (ASX:GID), a medical device company that is developing EndoBarrier® is pleased to confirm that, further to its announcement released on 23 January 2018, the attached proxy statement and notice of a special meeting of stockholders (Special Meeting) has been filed with the U.S. Securities and Exchange Commission. The proxy materials, including this proxy statement and the voting instruction cards will be mailed to stockholders on or about 8 February 2018.

The Special Meeting is to be held on Wednesday 21 February 2018 at 3:00pm United States Eastern Standard Time, (22 February 2018 at 7:00am Australian Eastern Daylight Time) at the offices of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., One Financial Centre, Boston, Massachusetts 02111.

If not attending in person, the meeting can be accessed through a teleconference line.

Accessing via teleconference:

For those preferring to listen by telephone, please dial in five minutes prior to the start of the call. Regional dial in number are as follows:

United States Dial Toll Free 877.407.6184

Australia Dial Toll Free 1.800.687.004

Germany Dial Toll Free 0.800.182.0040

United Kingdom Dial Toll Free 0.800.756.3429

Switzerland Dial Toll Free 800.835.525

Other International Dial Toll 201.389.0877



About GI Dynamics

GI Dynamics®, Inc. (ASX:GID) is the developer of EndoBarrier, the first endoscopically-delivered device therapy for the treatment of type 2 diabetes and obesity. EndoBarrier is not approved for sale and is limited by federal law to investigational use only. 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. 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 our ability to continue to operate as a going concern, our ability to maintain compliance with our obligations under the Convertible Loan Note executed with Crystal Amber Fund Limited, obtaining and maintaining regulatory approvals required to market and sell our products; obtaining funding from third parties; the consequences of stopping the ENDO trial and 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; 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.

[ALERTS100%to10000%GAIN]

GIDYL~~Our Approach,,Our revolutionary EndoBarrier® is a testament to the GI Dynamics mission. The first endoscopically inserted treatment for the management of type 2 diabetes and obesity. Both minimally invasive and completely reversible. EndoBarrier bridges the gap between pharmaceuticals and surgery by providing a safer and more effective way to control glucose and weight loss for individuals who are underserved by drugs and injections, but for whom surgery is not an option.

http://gidynamics.com/company/who-we-are/

[ALERTS100%to10000%GAIN]

GIDYL~~Successful track record of developing and commercializing innovative and clinically significant healthcare technologies.

http://gidynamics.com/company/management-team/

[ALERTS100%to10000%GAIN]

GIDYL~~HUGE WEBSITE~~http://gidynamics.com/2018/01/15/gi-dynamics-inc-provides-2017-review-2018-business-outlook/

[ALERTS100%to10000%GAIN]

GIDYL~~HUGE NEWS!!!GI Dynamics Announces AUD $2.05m Private Placement and Close of First Tranche of AUD ~$1m

Jan 22, 2018 | Press Releases


BOSTON and SYDNEY — 23 January 2018— GI Dynamics®, Inc. (ASX:GID), a medical device company that is developing EndoBarrier® is pleased to announce that it has received binding commitments for a private placement of 58,780,619 CHESS Depositary Interests (CDIs) of the Company (representing 1,175,612 shares of common stock) at an issue price of AUD $0.035 per CDI to sophisticated and professional investors in Australia, the United States, and the United Kingdom to raise approximately AUD $2.05 million (representing approximately USD $1.6 million) (Placement).

The issue of CDIs under the Placement will occur in two tranches. The first tranche closed on the morning of 23 January 2018, resulting in the raising of AUD $996,347 (USD $779,442) by the issue of 28,467,063 CDIs (representing 569,341 shares of common stock). The second tranche, expected to result in the raising of AUD $1,060,974 (USD $830,000) by the issue of 30,313,556 CDIs (representing 606,271 shares of common stock) will be subject to shareholder approval at an Extraordinary General Meeting (EGM). The EGM date will be announced concurrently with filing of the proxy. Please refer to the Company’s EGM proxy statement that will be available on the Company’s website.

The funds raised under the Placement will be used by GI Dynamics to fund the continued development of EndoBarrier and for general working capital purposes.

As detailed in the Company’s recent 10Q filings, GI Dynamics continues to operate with substantial doubt about its ability to continue as a going concern.

“We are focused on securing approval for a study from the FDA for a new pivotal clinical trial of EndoBarrier,” said Scott Schorer, president and chief executive officer of GI Dynamics. “The leadership team, employees, and directors of GI Dynamics remain resolved in our commitment to continue to develop EndoBarrier for the millions of patients who have no viable treatment option for type 2 diabetes and obesity.”



Placement

The CDIs under Tranche 1 of the Placement comprise 28,467,063 CDIs (representing 569,341 shares of common stock). The CDIs were issued the morning of 23 January 2018 and will rank equally in all respects with CDIs on issue at the time of allotment.

The CDIs that have been subscribed for under Tranche 2 of the Placement comprise 30,313,556 CDIs (representing 606,271 shares of common stock) are subject to shareholder approval during the upcoming EGM. It is expected that the Tranche 2 CDIs will be issued within 5 business days of the date of the EGM (should shareholder approval be obtained) and will rank equally in all respects with CDIs on issue at the time of allotment.



Restrictions on Resale of Securities in the United States

The securities to be offered have not been registered under the Securities Act of 1933, as amended (Act), or any state securities laws, and until so registered may not be offered or sold in the United States except pursuant to an exemption from the registration requirements of the Act and applicable state securities laws. This announcement is not an offer to sell, nor a solicitation of an offer to buy any securities, nor shall there be any sale of these securities in any state or jurisdiction in which the offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction or an applicable exemption therefrom.



Forward-Looking Statements

This announcement contains forward-looking statements. 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 our ability to continue to operate as a going concern, our ability to maintain compliance with our obligations under the Convertible Loan Note executed with Crystal Amber Fund Limited, obtaining and maintaining regulatory approvals required to market and sell our products; obtaining funding from third parties; the consequences of stopping the ENDO trial and 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; 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.

###

[ALERTS100%to10000%GAIN]

GIDYL~~Our Mission
Since GI Dynamics’ founding in 2003, our mission has been to alleviate the symptoms of type 2 diabetes and obesity for patients fighting these global epidemics worldwide.

Our Approach
Our revolutionary EndoBarrier® is a testament to the GI Dynamics mission. The first endoscopically inserted treatment for the management of type 2 diabetes and obesity. Both minimally invasive and completely reversible. EndoBarrier bridges the gap between pharmaceuticals and surgery by providing a safer and more effective way to control glucose and weight loss for individuals who are underserved by drugs and injections, but for whom surgery is not an option.

Our Team
GI Dynamics is headquartered in Boston, Massachusetts, with offices in Europe and Australia. Our team of business experts and industry veterans have a successful track record of pioneering and commercializing breakthrough healthcare technologies.