8-K - GlucoTrack, Inc. | StockGist

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Glucotrack, Inc. announced it is positioned to submit an Investigational Device Exemption (IDE) to the FDA for its novel continuous blood glucose monitoring (CBGM) technology in Q2 2026, following the successful completion of first-in-human trials in Brazil and Australia. This regulatory step is critical for initiating a planned U.S. clinical trial in the second half of 2026, subject to FDA approval.

Key Takeaways

1The company plans to submit an IDE to the FDA for its CBGM technology in Q2 2026.

2A first-in-human clinical trial in Brazil with ten participants was completed in Q1 2025, meeting all endpoints with a MARD of 7.7% and no serious adverse events.

3A feasibility clinical trial was initiated in Australia in July 2025, providing protocol and product learnings.

4The company expects to initiate a U.S. clinical trial in the second half of 2026, subject to FDA approval of the IDE.

5Three critical patents (US 12,453,494, US 12,458,257, US 12,458,258) were awarded in October and November 2025 for the CBGM platform.

6The company has secured a U.S. clinical trial site, engaged a CRO, and completed product design iterations for the planned U.S. study.

Current Report Details

Event Type

Regulation Fd

Exhibits Only

Disclosure

Voluntary

Variant

8-K

Items Reported

7.01

, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or oth

Regulation Fd

9.01

Financial Statements and Exhibits (d) Exhibits Exhibit No. Description 99.1 Press Release dated March 27, 2026 104 Cover Page Interactive Data File (embedded wi

Exhibits Only

Source Document

Exhibits (2)

8-K

99.1

EX-99.1