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GI Dynamics, Inc. Provides 2017 Review and 2018 Business OutlookGI Dynamics®, Inc. (ASX:GID), a medical device company that is developing EndoBarrier® provides shareholders with a review of 2017 activities and its 2018 business outlook. GI Dynamics is preparing to submit an Investigational Device Exemption (IDE1) application to the US Food and Drug Administration (FDA) for a new pivotal trial of the EndoBarrier. In addition, GI Dynamics is focused on taking all appropriate measures to address the withdrawal of the EndoBarrier CE Certificate of Conformity which enabled the company to CE Mark the EndoBarrier and sell the product in Europe and select countries in the Middle East. GI Dynamics is making efforts to reduce monthly cash expenses and continues to evaluate multiple financing options. As detailed in recent 10Q filings, GI Dynamics continues to operate with substantial doubt about its ability to continue as a going concern.
CE Mark Most notably, GI Dynamics expects that all patients with current EndoBarrier implants will be allowed to continue the full twelve-month treatment duration. GI Dynamics underwent an audit by SGS in October 2017. As part of the audit process, SGS audited GI Dynamics to full ISO 13485:20034 and MDD 93/42/EEC5 standards. GI Dynamics fully passed the ISO 13485:2003 audit and the quality requirements of the MDD 93/42/EEC. The company's contract manufacturer Proven Process Medical Devices, Inc. (PPMD) also successfully participated in the audit. Despite the positive results of the quality system audit, SGS did not consider that GI Dynamics fulfilled revised clinical evaluation obligations. GI Dynamics is evaluating legal remedies to protect its rights and those of its shareholders. The company has been in contact with other notified bodies in Europe, with the intent of obtaining a new CE Certificate of Conformity for EndoBarrier. 2017 Highlights
Financing
Board of Directors Dr. Stuge brings significant experience in medical devices and specifically in type 2 diabetes and obesity. He has also lead successful clinical development programs and global commercialization efforts and has held executive and board positions with numerous medical device companies over the past 30 years, such as Medtronic Plc and Abbott Laboratories, Inc. As a director, he has helped lead several successful company exits, raised significant capital and launched an IPO. Ms. Thompson has advised and raised capital for healthcare companies for more than 20 years and founded Code Securities, a healthcare investment banking firm that was sold to Nomura. In addition to GI Dynamics, Ms. Thompson also serves as NED for Nexstim Limited, NED for Novacyt SA, and is the chair of Premier Veterinary Group Plc. The company saw the departures of directors Mike Carusi, Graham Bradley and Anne Keating.
Clinical Data The clinical data sourced from multiple investigator-initiated clinical trials, two ongoing registries, and a recent comprehensive meta-analysis continues to underscore EndoBarrier positive risk: benefit profile. The clinical data focuses on expanding studies on the use of EndoBarrier within the type 2 diabetes and obesity population, reports post-removal efficacy, studies the effects on non-alcoholic fatty liver disease6 patients, evaluates serial EndoBarrier treatment, and releases the first data on an adolescent obesity study. More detailed clinical information is further summarized at the end of this press release.
SAB The GI Dynamics SAB was created to help the company advance the body of evidence supporting clinical use of EndoBarrier, ask and answer relevant questions about the treatment paradigm and advance the state of patient care for type 2 diabetes and obesity.
PPMD
Patents Priorities for 2018
Closing Remarks "While significant progress was made across all fronts in 2017 including conducting a comprehensive analysis of the science around EndoBarrier and moving towards an IDE filing, we did not achieve the desired outcome of continuing to CE Mark the EndoBarrier in Europe. Despite this issue, EndoBarrier continues to produce significant clinical data through numerous clinical studies," said Scott Schorer, president and chief executive officer. "We have taken necessary steps to further reduce cash burn and are focused on appropriately capitalizing the company." "EndoBarrier has the potential to remain the most advanced treatment for patients with type 2 diabetes and obesity who are not adequately managed by pharmacotherapy alone," Schorer continued, "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." Further Details of Released Studies
Meta-Analysis: This meta-analysis reviewed randomized, controlled trials and cohort studies found in MEDLINE, EMBASE and Web of Science published through 1 November 2016 that assessed outcomes of EndoBarrier in patients with type 2 diabetes and obesity. Data was pooled using a mixed-effect model or a random-effect model for high heterogeneity. Of 593 eligible studies, 18 were included and seven studies provided additional data. The Meta-Analysis showed a mean reduction in HbA1c of 1.3% from baseline to removal, a mean reduction in HbA1c of 1.0% from baseline to six months post removal, a mean 12.6kg and 14% reduction in body weight, and other significant hormonal measures.
Treatment Durability: Twelve patients completed a 12-month implantation of EndoBarrier and were evaluated six months following explantation; 75 percent of patients (nine out of the 12) sustained considerable metabolic improvements, including weight loss, body mass index reduction and lower glucose levels. EndoBarrier Compared to Gastric Plication: At the 53rd Annual Meeting of the European Association for the Study of Diabetes Anna Cinkajzlova, M.D., from the Centre for Experimental Medicine, Institute for Clinical and Experimental Medicine presented "Circulating Lipopolysaccharide and Gut Permeability in Obese Subjects with Type 2 Diabetes: The Influence of Surgical and Endoscopic Interventions," an analysis that compared gastric plication to EndoBarrier. Cinkajzlova conducted a basic scientific assessment of circulatory levels of lipopolysaccharide binding protein, fatty acid binding protein 2 and sCD14 following assigned weight-reducing treatments combined with quantification of adipose tissue macrophages. In addition, the study compared clinical outcomes across multiple health metrics and biomarkers between surgical gastric plication, a form of gastric restriction, and EndoBarrier.
Re-implantation of EndoBarrier: Five patients participated in this study. Each patient completed an initial course of EndoBarrier treatment for a 12-month period. The device was explanted and the patients were monitored for four months. A second EndoBarrier was then implanted for a 12-month course of treatment and subsequently removed.
About GI Dynamics
Forward-Looking Statements
1 IDE: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/default.htm View source version on businesswire.com: http://www.businesswire.com/news/home/20180115005393/en/ |