Glucotrack Strenghtens Leadership Team with Addition of Industry Veteran as Vice President of Regulatory Affairs

Rhea-AI Summary

Glucotrack (Nasdaq: GCTK) has appointed Ted Williams as Vice President of Regulatory Affairs, effective immediately. Williams brings nearly 25 years of experience in regulatory affairs and quality assurance for Class III medical devices, including expertise in continuous glucose monitors (CGM) and drug/device combination products.

Williams previously served as Vice President of Regulatory Affairs/Quality Assurance at Glysens Inc, focusing on implantable CGM development. His experience spans roles at Therapeutics Inc. and Cardium Therapeutics, working with various medical technologies.

The appointment aims to advance Glucotrack's human clinical trials and regulatory program for their Continuous Blood Glucose Monitor (CBGM). According to CEO Paul V. Goode, Williams' expertise will be important in navigating FDA pathways as they develop their CBGM technology for diabetes patients.

Positive

• Appointment of experienced regulatory affairs executive with 25 years in medical devices
• Specific expertise in continuous glucose monitoring technology
• Strategic strengthening of leadership team during clinical trials phase

Negative

• CBGM product still in development phase, not yet commercialized
• Regulatory approval timeline uncertain

New hire set to drive clinical development and U.S. commercialization of the continuous blood glucose monitor for people with diabetes

RUTHERFORD, N.J., Jan. 15, 2025 (GLOBE NEWSWIRE) -- Glucotrack, Inc. (Nasdaq: GCTK) (“Glucotrack” or the “Company”), a medical technology company focused on the design, development, and commercialization of novel technologies for people with diabetes, announced today that Ted Williams has been named Vice President of Regulatory Affairs, effective immediately.

Mr. Williams has nearly 25 years of experience and a proven track record of successful management of Regulatory Affairs and Quality Assurance for highly complex Class III medical devices including active, long term implantable continuous glucose monitors (“CGM”), drug/device combination products, in-dwelling catheter based endovascular temperature control modules and cardiovascular biopharmaceutical drug development within the 510(k), De Novo, Premarket Approval and Biologics License Application Regulatory pathways. He served as Vice President, Regulatory Affairs/Quality Assurance for Glysens Inc, a technology innovator focused on development of an implantable CGM. Prior to that, his experience includes roles with Therapeutics Inc. and Cardium Therapeutics focusing on oral and injectable drugs, biologics, medical devices and gene therapy.

“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 Continuous Blood Glucose Monitor (CBGM),” said Mr. Williams.

Paul V. Goode, PhD, President and Chief Executive Officer of Glucotrack, said: “Mr. Williams brings extensive knowledge and experience in navigating regulatory pathways to Glucotrack, which will be instrumental as we progress development of our CBGM through the Food and Drug Administration and beyond. We are thrilled to welcome him to the team as we work to bring this technology closer to the millions of people living with diabetes.”

For more information about Glucotrack’s CBGM, visit glucotrack.com. Information on the Company’s website does not constitute a part of and is not incorporated by reference into this press release.

About Glucotrack, Inc.

Glucotrack, Inc. (NASDAQ: GCTK) is focused on the design, development, and commercialization of novel technologies for people with diabetes. The Company is currently developing a long-term implantable continuous blood glucose monitoring system for people living with diabetes.

Glucotrack’s CBGM is a long-term, implantable system that continually measures blood glucose levels with a sensor longevity of 3 years, no on-body wearable component and with minimal calibration. For more information, please visit http://www.glucotrack.com.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “believe”, “expect”, “plan” and “will” are intended to identify forward-looking statements. Such forward-looking statements are based on the beliefs of management, as well as assumptions made by, and information currently available to, management. These statements relate only to events as of the date on which the statements are made, and Glucotrack undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. All of the forward-looking statements made in this press release are qualified by these cautionary statements, and there can be no assurance that the actual results anticipated by Glucotrack will be realized or, even if substantially realized, that they will have the expected consequences to or effects on us or our business or operations. Readers are cautioned that certain important factors may affect Glucotrack’s actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release. Factors that may affect Glucotrack’s results include, but are not limited to, the ability of Glucotrack to raise additional capital to finance its operations (whether through public or private equity offerings, debt financings, strategic collaborations or otherwise); risks relating to the receipt (and timing) of regulatory approvals (including U.S. Food and Drug Administration approval); risks relating to enrollment of patients in, and the conduct of, clinical trials; risks relating to Glucotrack’s future distribution agreements; risks relating to its ability to hire and retain qualified personnel, including sales and distribution personnel; and the additional risk factors described in Glucotrack’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K for the year ended December 31, 2023 as filed with the SEC on March 28, 2024.

Contacts:

Investor Relations:
investors@glucotrack.com

Lisa Wilson
In-Site Communications
T: 917-543-9932
E: lwilson@insitecony.com

Media:
GlucotrackPR@icrinc.com

FAQ

What experience does Ted Williams bring to Glucotrack (GCTK) as new VP of Regulatory Affairs?

Ted Williams brings nearly 25 years of experience in regulatory affairs and quality assurance for Class III medical devices, including expertise in continuous glucose monitors, drug/device combination products, and various medical technologies.

What is the current development status of Glucotrack's (GCTK) Continuous Blood Glucose Monitor?

The CBGM is currently in the human clinical trials phase and pursuing regulatory approval through the FDA.

How will Ted Williams' appointment impact Glucotrack's (GCTK) regulatory strategy?

Williams will lead the strategic regulatory program for the CBGM and help navigate FDA pathways, leveraging his extensive experience with medical device approvals.

What are the key markets targeted by Glucotrack (GCTK) for their CBGM device?

The company is initially focusing on U.S. commercialization of their Continuous Blood Glucose Monitor for people with diabetes.