Glucotrack's Implantable Continuous Glucose Monitor Clears Initial Human Safety Trial

Glucotrack, a pioneering company in diabetes management technology, has successfully completed the first human clinical study of its long-term continuous glucose monitoring (CGM) implant. This groundbreaking device, designed to remain under the skin for up to three years, represents a significant leap forward in diabetes care and monitoring.

Innovative Implant Design and Placement

The Glucotrack CGM system utilizes a novel approach to glucose monitoring. Unlike traditional CGM devices that measure glucose levels in the interstitial fluid, Glucotrack's implant is placed within the subclavian vein, located beneath the collarbone. This strategic positioning allows the sensor to collect sugar levels directly from the bloodstream, potentially eliminating the lag times associated with interstitial fluid readings.

The implant's design aims to provide a seamless user experience, with no external components worn on the skin. This feature could significantly improve quality of life for individuals with diabetes by reducing the visibility and maintenance requirements typically associated with CGM devices.

Clinical Trial Results and Safety Profile

The prospective, single-arm study included six participants with Type 1 or Type 2 diabetes. Conducted in a hospital setting over a minimum of four days, the trial was designed to evaluate both the safety of the sensor placement procedure and its subsequent removal by an interventional cardiologist.

Key findings from the study include:

• The trial met its primary endpoint, with no procedure- or device-related serious complications reported in the week following the removal of the sensor lead.
• The implant successfully demonstrated its ability to take glucose readings from within the vein.
• While not specifically designed to evaluate sensor accuracy, the system performed as expected, with accuracy results similar to those observed in previous animal studies.

Paul Goode, President and CEO of Glucotrack, expressed optimism about the results, stating, "With these positive results, the promise of continuous blood glucose monitoring is one step closer to reality."

Future Developments and Financial Outlook

Following the success of this initial human trial, Glucotrack is poised to continue development and refinement of its implantable CGM technology. The company's ultimate goal is to deliver a fully implantable device that provides continuous, accurate glucose monitoring without the need for external components.

In conjunction with the announcement of the trial results, Glucotrack has launched a public share offering to raise $3 million. The offering consists of approximately 2.6 million shares of common stock, priced at $1.15 per share. This capital raise is likely intended to support further research and development efforts as the company moves towards larger clinical trials and potential commercialization of its innovative CGM system.