BOSTON — November 5, 2020 — GI Dynamics® Inc. (“GI Dynamics” or the “Company”), a medical device company that is developing EndoBarrier® for patients with type 2 diabetes and obesity, has appointed Joseph Virgilio as president and chief executive officer of GI Dynamics, Mark Lerdal as chairman of the Board of Directors (“the Board”) and Ginger Glaser as non-executive director to the Board. Mr. Virgilio will also be appointed to the Board.
Mr. Virgilio began his medical device career in 2001 with Boston Scientific, followed by a tenure of almost a decade with Medtronic in a variety of roles of increasing responsibility. After Medtronic, Mr. Virgilio worked as an executive within several investor backed medical device companies. At Aptus Endosystems he served as vice president of sales and global marketing, prior to its acquisition by Medtronic in 2015. He then joined Angiotech/Surgical Specialties Corporation (acquired by Vivo Capital) as vice president of sales for the Americas. Most recently, Mr. Virgilio served as president and general manager for Amann Girrbach North America, a market leader in digital CAD/CAM dentistry.
Mr. Virgilio has an extensive background in the development of commercial and operational strategies as well as in depth knowledge of the clinical pathways required to bring novel, minimally invasive therapies to market.
“I am excited and honored to join the talented team at GI Dynamics. Type 2 diabetes and associated comorbidities, including obesity, impact almost 500 million people around the globe. We believe there remains a significant treatment gap between medical management and invasive surgery. It is within this gap that EndoBarrier has the potential to make the most significant impact on patients’ lives,” said Mr. Virgilio president and chief executive officer. “With approximately four thousand patients already treated to date, published studies indicate that EndoBarrier has demonstrated efficacy in lowering HbA1c, BMI, and insulin use.”
GI Dynamics appointed Mark Lerdal as chairman of the Board on August 10, 2020. Mr. Lerdal brings extensive knowledge and experience as a board director in financial and business development, as well as a proven track record leading multiple mergers and acquisitions.
“We are excited to welcome an executive of Joseph’s talent and experience to GI Dynamics’ team at this important time in the company’s development,” stated Mark Lerdal, chairman of the Board. “His unique set of skills allows us to both pursue the regulatory approvals the company requires, while at the same time preparing for commercialization of this valuable product in the fight against type 2 diabetes and obesity. We are fortunate to have attracted a gentleman of such high caliber during the COVID-19 pandemic.”
GI Dynamics also appointed Ginger Glaser to join the Board of Directors as a non-executive board member. Ms. Glaser brings over 25 years of quality and regulatory experience, leading successful medical device organizations, as well as a breadth of knowledge in clinical affairs and engineering.
GI Dynamics confirms these changes to the Board of Directors and appointing its new president and chief executive officer doesn’t change its business objectives for the fourth quarter. GI Dynamics remains focused on attaining a CE mark for EndoBarrier, initiation of the I-STEP trial in India and resumption of the STEP-1 pivotal trial in the United States, pending the removal of COVID-19 related restrictions.
About GI Dynamics
GI Dynamics®, Inc. is the developer of EndoBarrier®, the first endoscopically delivered medical device for the treatment of type 2 diabetes and the reduction of obesity. EndoBarrier is not approved for sale and is limited by federal law to investigational use only in the United States. EndoBarrier is subject to an Investigational Device Exemption by the FDA in the United States and is the subject of a pivotal trial in the United States and a future pivotal trial in India.
Founded in 2003, GI Dynamics is headquartered in Boston, Massachusetts. For more information please visit the Company website at www.gidynamics.com.
This announcement may contain forward-looking statements. These statements are based on 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
ability of the Company, its critical vendors, and key regulatory agencies to resume operational capabilities subsequent to the removal of COVID-19 pandemic restrictions; the Company’s ability to continue to operate as a going concern; the Company’s ability to raise sufficient additional funds to continue operations; the Company’s ability to maintain compliance with its obligations under its existing convertible note agreement executed with Crystal Amber, including its obligation to repay the convertible note, which matures on June 30, 2022; the Company’s ability to conduct the planned pivotal trial of EndoBarrier in the United States (STEP-1); the Company’s ability to execute STEP-1 under the FDA’s Investigational Device Exemption; the Company’s ability to enlist clinical trial sites and enroll patients in accordance with STEP-1; the risk that the FDA stops STEP-1 early as a result of the occurrence of certain safety events or does not approve an expansion of STEP-1; the Company’s ability to enroll patients in accordance with I-STEP; the Company’s ability to secure a CE Mark; obtaining and maintaining regulatory approvals required to market and sell the Company’s 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 the Company’s products; product pricing; timing of product launches; future financial results; and other factors, including those described in the Company’s filings with the SEC.
Given these uncertainties, one should not place undue reliance on these forward-looking statements. The Company does 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 it is required to do so by law.