Shares in diabetes-focused medical technology group Glucotrack (GCTK) zoomed higher today after it said it was going to apply for a U.S. trial for its new glucose monitoring technology.
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FDA Trial Hopes
The company said it planned to file an application for a study for its novel continuous blood glucose monitoring technology with the U.S. Food and Drug Administration during the second quarter this year.
“In 2025 we made meaningful progress in advancing the development of our fully implantable continuous blood glucose monitoring technology and strengthening Glucotrack’s foundation,” said Paul V. Goode, PhD, President and Chief Executive Officer of Glucotrack. “The completion of our first-in-human study in Brazil and initiation of our follow-up study in Australia enables us to advance toward our U.S. clinical program. With trial infrastructure in place and product enhancements completed, we are prepared to initiate the study, pending FDA approval.”
A U.S. clinical trial site has been secured, and a Clinical Research Organization (CRO) experienced with diabetes Medtech has been engaged to manage and conduct the study. Glucotrack is currently in talks with the FDA regarding its planned U.S. clinical trial program and expects the study to start in the second half of 2026, subject to FDA approval.
Extensive U.S. Research
Goode said the company had also completed extensive U.S. market research across patients and healthcare providers which “indicated an unmet need for a fully implantable CBGM solution.” Over 40 million Americans have diabetes.
It said that it has also built a “dual source U.S. manufacturing strategy with two qualified contract manufacturing partners, and assembled a seasoned management team with deep experience in diabetes and implantable medical technologies.”
The company said that its first-in-human study in Brazil, involving ten people with either Type 1 or Type 2 diabetes, had met all primary and secondary endpoints. In July 2025, it also carried out a feasibility clinical trial at the Diabetes Technology Research Group of St Vincent’s Hospital in Melbourne, Australia.
Is GCTK a Good Stock to Buy Now?
Given its lack of analyst coverage on Wall Street, let’s look at how GCTK’s shares have performed over the last three months. As can be seen below, it is down over 70% over that period.
