- Glucotrack stated that the company completed its first‑in‑human study in Brazil in 2025 and initiated a follow-up of its study in Australia.
- The company stated that it has built a dual-source U.S. manufacturing strategy with two qualified contract manufacturing partners.
- Glucotrack stated that its first in-human trial met all its primary and secondary endpoints, with a 99% data capture rate.
Glucotrack Inc. (GCTK) shares soared more than 26% in Friday’s opening trade after the company announced that it is in a position to file an Investigational Device Exemption (IDE) for its glucose monitoring technology in the second quarter (Q2) with the U.S. Food and Drug Administration.
Glucotrack cited critical operational milestones achieved by the company in developing its continuous blood glucose monitoring (CBGM) technology.
Retail sentiment on Stocktwits around Glucotrack trended in the ‘bullish’ territory at the time of writing.
Glucotrack Lists 2025 Milestones
Glucotrack stated that the company completed its first‑in‑human study in Brazil in 2025 and initiated a follow-up of its study in Australia. It said that these updates allow the company to advance toward its clinical program in the U.S.
“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 Glucotrack CEO Paul V Goode.
Goode added that Glucotrack has also completed extensive U.S. market research across patients and multiple healthcare provider segments. He noted that CBGM is among the fastest-growing segments in the global diabetes market, which remains among the largest in the healthcare industry.
The company stated that it has built a dual-source U.S. manufacturing strategy with two qualified contract manufacturing partners, while also identifying a pathway with a compelling economic profile.
In-Human Study Shows Consistent Testing Performance, Says Glucotrack
Glucotrack said that its first in-human study, which was completed in the first quarter (Q1), showed consistent testing performance. The company stated that the trial met all its primary and secondary endpoints, with a 99% data capture rate and a Mean Absolute Relative Difference (MARD) of 7.7% across 122 matched pairs.
Glucotrack’s implantable CBGM measures glucose from blood rather than interstitial fluid, thereby eliminating the lag time associated with traditional continuous glucose monitoring systems.
GCTK stock is down 64% year-to-date and 90% over the past 12 months.
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