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RUTHERFORD, N.J. - Glucotrack, Inc. (NASDAQ: GCTK), a medical technology company, announced the successful completion of its first in human clinical study for a novel continuous glucose monitoring system (CGM). The study, focusing on the safety and procedural aspects of the company’s new blood glucose monitor, met its primary endpoint with no serious adverse events related to the procedure or device.
The clinical trial involved six participants with diabetes mellitus, who underwent a four-day in-hospital evaluation of the CGM sensor lead placement, use, and removal. The sensor, placed in the subclavian vein, connects to a prototype sensor electronics component on the skin. According to the company, this approach offers direct blood glucose measurement, potentially overcoming limitations of traditional CGMs that measure glucose in interstitial fluid.
Paul V. Goode, PhD, President & Chief Executive Officer of Glucotrack, expressed satisfaction with the study’s outcome, stating that the system performed with similar accuracy to previous animal studies. Interventional cardiologists successfully conducted the placement and removal procedures.
David Klonoff, MD, a Clinical Professor of Medicine, commented on the study’s encouraging results, suggesting the technology could present a new alternative for continuous glucose monitoring in diabetes management.
Glucotrack’s CGM is designed as a long-term implantable device, intended for three years of continuous use without the need for an on-body external component, aiming to offer a less intrusive and more convenient solution for glucose monitoring.
The successful trial marks a step forward for Glucotrack, which specializes in developing technologies for diabetes care. The company’s stock has faced significant headwinds, with InvestingPro showing a -94.52% price return over the past year and an overall financial health score rated as "WEAK." The company emphasizes that the information shared in this press release is based on a press release statement and is not incorporated by reference into the press release. Glucotrack plans to advance this technology into long-term clinical trials, moving closer to potential FDA approval and commercial availability. Discover 13 additional key insights about GCTK’s financial position and market performance with an InvestingPro subscription.
In other recent news, Glucotrack, Inc. has embarked on several significant financial maneuvers. The medical device company announced a 1-for-20 reverse stock split, intending to comply with Nasdaq’s minimum bid price requirement. The company also appointed Ted Williams as Vice President of Regulatory Affairs to advance their continuous blood glucose monitoring system. Glucotrack issued 134.78 million shares of common stock following the exchange of Series B Warrants by certain holders.
Simultaneously, Glucotrack entered into a sales agreement with Dawson James Securities, Inc. to offer shares of common stock up to $8.23 million. The company initiated a public offering aiming to raise $10 million in gross proceeds by issuing approximately 7.2 million shares. Furthermore, Glucotrack closed its public and concurrent private offerings, resulting in the sale of over 2.4 million shares of common stock, nearly 4.8 million pre-funded warrants, and over 7.1 million each of Series A and Series B Warrants.
In addition to these financial developments, Glucotrack’s Continuous Blood Glucose Monitor (CBGM) technology demonstrated high accuracy in a preclinical study. The company also made strategic additions to its board and recruited a new Vice President of Clinical Operations. These are some of the recent developments in Glucotrack’s ongoing strategic efforts within the medical instruments and apparatus industry.
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