8-K: Know Labs Achieves 11.1% MARD in Non-Invasive Glucose Monitoring Study

Know Labs announced interim results from a clinical study showing its non-invasive glucose monitor achieved an 11.1% Mean Absolute Relative Difference (MARD) using venous blood as a reference.

Summary

• Know Labs has released interim results from a clinical study evaluating their non-invasive glucose monitoring technology.
• The study used venous blood samples as a reference and included participants with prediabetes and Type 2 diabetes.
• The results showed a Mean Absolute Relative Difference (MARD) of 11.1% overall.
• The study used a proprietary radiofrequency (RF) dielectric sensor to measure glucose levels.
• The sensor scanned participants' forearms during 21 three-hour sessions involving a 75g Oral Glucose Tolerance Test.
• Venous blood samples were collected every five minutes and analyzed using an FDA-cleared blood glucose hospital meter.
• The data was preprocessed and split into training and test datasets, with a Light Gradient Boosting Machine model used for analysis.
• The study included 520 paired RF and reference blood glucose values for training and 130 for testing.
• Similar accuracy was observed in normoglycemic and hyperglycemic ranges.
• The company plans to conduct large-scale external clinical trials in 2024 to further refine the device and algorithms.

Sentiment

Score: 8

Explanation: The document presents very positive interim results from a clinical study, indicating significant progress in the development of a non-invasive glucose monitor. The use of venous blood as a reference and the consistent accuracy across different glucose ranges are strong positives. The company is also actively moving towards FDA clearance, which is a key milestone.

Positives

• The 11.1% MARD is a significant achievement for a non-invasive glucose monitoring technology.
• The study's use of venous blood as a reference is a rigorous approach.
• The sensor's consistent accuracy across normoglycemic and hyperglycemic ranges is promising.
• The company is actively moving towards FDA clearance with the KnowU device.
• The technology has the potential to provide accessible and affordable real-time glucose monitoring.

Risks

• The technology still requires FDA clearance before it can be marketed.
• Further large-scale clinical trials are needed to validate the technology's performance in real-world conditions.
• The device's performance in the hypoglycemic range needs to be evaluated.
• The company's success depends on the continued refinement of the device and its algorithms.

Future Outlook

Know Labs plans to deploy the KnowU in large-scale, external clinical trials during 2024 while making refinements to the device and its algorithms. These studies will assess the technology's performance during continuous wear, in real-world environments, and across a wider range of glycemic levels, including hypoglycemia.

Management Comments

• Larry Ellingson, former Chair of the Board of the American Diabetes Association, stated that achieving this level of accuracy in the first study using a blood reference device is truly remarkable.
• Management believes the results reflect the impressive and continued stability of Know Labs' novel sensor technology and algorithms.

Industry Context

The announcement is significant in the context of the ongoing efforts to develop non-invasive glucose monitoring solutions. The company is aiming to deliver a highly accurate, economical, FDA-cleared non-invasive continuous glucose monitor (CGM), which is a major goal in the diabetes technology space.

Comparison to Industry Standards

• The 11.1% MARD achieved by Know Labs is a promising result compared to existing non-invasive glucose monitoring technologies, which often struggle with accuracy.
• Most current non-invasive devices underperform outside the normoglycemic range, while Know Labs' sensor showed similar accuracy in both normoglycemic and hyperglycemic ranges.
• The use of venous blood as a reference is a more rigorous approach than using other CGM devices as a reference, which is common in other studies.
• The company is competing with established players in the CGM market, such as Dexcom and Abbott, but is focusing on a non-invasive approach.

Stakeholder Impact

• Shareholders will likely view the positive clinical results favorably.
• The technology has the potential to improve the lives of people with diabetes by providing a non-invasive monitoring option.
• The company's employees are working on a potentially groundbreaking technology.
• The company's success could lead to new partnerships and collaborations.

Next Steps

• Know Labs will deploy the KnowU in large-scale, external clinical trials during 2024.
• The company will continue to refine the device and its algorithms.
• Know Labs plans to submit the KnowU device to the FDA for clearance.

Key Dates

Keywords

non-invasive glucose monitoring, MARD, radiofrequency sensor, dielectric spectroscopy, clinical study, diabetes, FDA clearance, KnowU, venous blood, hyperglycemia, hypoglycemia, machine learning