GI Dynamics Appointed New Vice President of Clinical and Regulatory Affairs

  • Jan 04, 2019 AEDT
  • Team Kalkine
GI Dynamics Appointed New Vice President of Clinical and Regulatory Affairs

Medical device company, GI Dynamics Inc (ASX:GID) has appointment highly experienced Mr. Stephen Linhares as the new Vice President of clinical and regulatory affairs.

As Vice President of clinical and regulatory affairs at GI Dynamics, Mr. Linhares will lead GID’s efforts with its notified body i.e., Intertek, for seeking a CE mark for its medical device EndoBarrier. The company has also announced that he will be focusing on the pivotal trial of its medical device EndoBarrier in the U.S (GID 18-1). He will also focus on the clinical trial of the safety and efficacy of EndoBarrier in India which will be conducted by Apollo Sugar.

In his thirty years of experience in the medical healthcare industry, Mr. Stephen Linhares has led ten clinical trials, various CE mark approvals, and multiple 510(k) clearances. Before joining GI Dynamics, he held various leadership roles in several companies like Neograft Technologies Inc, Insulet Corporation, Boston Scientific Corporation Inc and PLC Medical Systems.

Mr. Stephen Linhares is having an in-depth knowledge of the diabetes disease space, and he holds nearly 20 U.S and international patents. Further, he also co-authored two peer-reviewed publications.

Recently on 2 January 2019, the company announced that it had reached an agreement with Crystal Amber Fund Ltd for the extension of the maturity date of its 2017 Senior Secured Convertible Promissory Note from 31 December 2018 to 31 March 2019.

In June 2017, GI Dynamics had issued Convertible Promissory Note to its largest shareholder Crystal Amber for an aggregate principal amount of US$5 million. Currently, the company does not have enough cash reserves to repay the total amount, which is why they have extended the maturity date from 31 December 2018 to 31 March 2019.

In December 2018, the company appointed highly experienced Mr. Charles Carter as the new chief financial officer (CFO) of the company. He will serve as the Company’s treasurer and he will perform various finance, accounting, and administrative functions for the company.

Recently, the company entered into an agreement with Apollo Sugar to jointly study the safety and efficacy of EndoBarrier in India through a clinical trial. Only after carefully reviewing the safety and efficiency of EndoBarrier in India, the company can supply EndoBarrier to suitable patients within India.

As at 30 September 2018, the company was having total current assets of $3,393 and total current liabilities of 7,261. In the September quarter, the company reported a loss from operations of $1,999 and a net loss of $2,183. Basic and diluted net loss per common share in the September quarter was $0.17.

In the last six months, the share price of GID decreased by 44.12 percent as on 2 January 2019 and is trading at a PE ratio of 0.080x. GID’s shares traded at $0.019 with a market capitalization of circa $18.22 million as on 4 January 2019 (AEST 4:00 PM).


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