A medical technology company specializing in diabetes care, has announced the appointment of Ted Williams as Vice President of Regulatory Affairs. Williams, who brings nearly 25 years of experience in regulatory affairs for complex medical devices, is expected to play a pivotal role in advancing the company’s continuous blood glucose monitoring system (CBGM) through the regulatory process and into the U.S. market.
Williams has held significant regulatory roles at companies like Glysens Inc., where he managed regulatory affairs for an implantable continuous glucose monitor (CGM), and has also contributed to organizations like Therapeutics Inc. and Cardium Therapeutics, focusing on medical devices, biologics, and gene therapy. His expertise spans a range of regulatory pathways, including 510(k), De Novo, Premarket Approval, and Biologics License Application processes.
“I am honored to join the company at this pivotal time as we advance our human clinical trials and create a strategic regulatory program for the CBGM,” said Williams. His addition comes at a critical time, as Glucotrack faces significant financial challenges, with its stock down over 90% in the past year, currently trading at just $0.12.
Paul V. Goode, PhD, President and CEO of Glucotrack, expressed his enthusiasm for Williams’ appointment, emphasizing the value of his regulatory experience as the company moves forward with the development of its CBGM technology. The CBGM system is designed for long-term, implantable blood glucose monitoring, with a sensor lifespan of three years, no on-body wearable component, and minimal calibration, aiming to improve the lives of millions living with diabetes.
However, the company is grappling with financial difficulties, including negative EBITDA of $13.1 million and a concerning current ratio of 0.14, as reported by InvestingPro. Additionally, Glucotrack has issued a significant number of new shares and entered into sales agreements to raise capital, signaling an ongoing effort to address its financial issues.
Despite these financial hurdles, Glucotrack’s CBGM technology has demonstrated high accuracy in preclinical studies, and the company has made strategic additions to its leadership, including a new Vice President of Clinical Operations, to further its progress in the medical devices industry.
Related topics:
Understanding the Complexities of Diabetes: Beyond Sugar Intake
Experts Discuss the Causes and Treatments of Prediabetes and Type 2 Diabetes in Young People.
