GlucoTrack, Inc. Provides Development Update on its Gen 2 Non-Invasive Glucose Monitor
GlucoTrack, Inc. (Nasdaq: GCTK) provided an update on its GlucoTrack 2.0 development, revealing successful lab testing of its clinical prototype. The company achieved better-than-expected accuracy and performance in bench tests and obtained Ethics Committee approvals for its first in-human clinical study at Rabin Medical Center, Israel, slated for Q3. The forthcoming U.S. study will follow, leading towards FDA clearance. The new design aims for improved user-friendliness and lower costs. CEO Paul Goode expressed optimism about the progress made.
- Completion of lab testing for GlucoTrack 2.0 clinical prototype.
- Achieved better-than-expected accuracy and performance in bench tests.
- Received Ethics Committee and clinical center approvals for in-human study.
- Plans for a multi-center U.S. study, leading towards FDA clearance.
- Potential for improved user experience and lower costs in the final design.
- None.
Rutherford, NJ and Or Yehuda, Israel, June 22, 2022 (GLOBE NEWSWIRE) -- GlucoTrack, Inc. (Nasdaq: GCTK) (“GlucoTrack” or the “Company”), a non-invasive device and digital health platform for measuring glucose levels in people with Type 2 diabetes and prediabetes, announced today that it has provided an update on the development of GlucoTrack 2.0 (or “Gen 2”).
In early Q2 the Company completed lab testing of its Gen 2 clinical prototype system. This process included testing of multiple iterations of electronics, ear clip, and mobile app with cloud-based software. In addition, human factors testing of the mobile app has been completed through simulated use in focus groups and by conducting a rigorous external design review for system architecture, stability, and cybersecurity.
The completion of bench testing and analyses of the Gen 2 clinical prototype system was followed by simulated use testing. During this in-house testing, the Company achieved better than expected accuracy and performance.
Initial data collected indicates that the Gen 2 system may achieve an accuracy comparable to invasive Continuous Glucose Monitors (CGM’s) currently available in the market when conducting the upcoming first in-human clinical study.
The Company has recently received Ethics Committee and clinical center approvals to conduct this study at the Rabin Medical Center in Israel. The initial results from this study will drive a follow-up multi-center study in the United States, led by Dr. Klonoff, Chair of the Company’s Scientific Advisory Board and Medical Director of the Diabetes Research Institute of Mills-Peninsula Medical Center. The U.S. study is intended to be a precursor to the eventual pivotal trial for FDA clearance. The Company aims to begin its first in-human study in Israel in Q3 and in U.S. centers in Q4. In addition, these positive results are driving a design re-assessment that the Company believes will lead to a more user-friendly system with a lower cost and faster measurement time than initially targeted.
“I am greatly encouraged by the promising early results of the testing of the Gen 2 clinical prototype system and by the opportunity that lays ahead of us” said Paul Goode, CEO and President. “We thank our shareholders for their encouragement and patience and look forward to providing further updates on our progress.”
About GlucoTrack, Inc.
GlucoTrack, Inc. (NASDAQ: GCTK), (formerly known as Integrity Applications, Inc.) is focused on the design, development, and commercialization of non-invasive glucose monitoring technologies for people with type 2 diabetes and prediabetes. The Company has developed GlucoTrack®, a proprietary non-invasive glucose monitoring device designed to obtain glucose level measurements without the pain, incremental cost, difficulty, or discomfort of conventional invasive finger stick devices. GlucoTrack, Inc. is a Delaware corporation, with headquarters in the United States and an R&D site in Or Yehuda, Israel. For more information, please visit http://www.integrity-app.com/ and http://www.glucotrack.com.
Investor Contact: investors@integrity-app.com
Media Contact: media@integrity-app.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 “expect”, “plan” and “will” are intended to identify forward-looking statements. 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 FDA approval); risks relating to enrollment of patients in, and the conduct of, clinical trials; risks relating to its current and 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, 2021 as filed with the SEC on March 31, 2022.
FAQ
What recent developments has GlucoTrack (GCTK) announced regarding GlucoTrack 2.0?
When is GlucoTrack's first in-human clinical study expected to start?
What is the significance of the clinical study at Rabin Medical Center for GlucoTrack (GCTK)?
How does GlucoTrack (GCTK) plan to improve its product based on recent testing?
