8-K: Know Labs Unveils Wearable Non-Invasive Glucose Monitor, KnowU

Know Labs has announced the KnowU, a wearable non-invasive continuous glucose monitor, incorporating a sensor intended for FDA submission.

Summary

• Know Labs has announced the development of the KnowU, a wearable non-invasive continuous glucose monitor (CGM).
• The KnowU incorporates a sensor that the company plans to submit to the FDA for clearance.
• This sensor has been tested and proven stable and accurate in a lab setting and is now miniaturized and wearable.
• The device is designed to be significantly smaller and lighter than previous prototypes, and includes on-board computing power and machine learning capabilities.
• The KnowU is designed for long-term use, eliminating the need for costly disposables, and features a rechargeable battery and a companion mobile app.
• The device will be used for accelerated data collection in preparation for FDA clinical trials, including testing performance across different body locations, glycemic ranges, and diverse populations.
• Know Labs holds over 270 patents related to non-invasive blood glucose monitoring.
• The company plans to deploy the KnowU in large-scale external clinical trials during 2024 while continuing to refine the device and its algorithms.

Sentiment

Score: 8

Explanation: The announcement of the KnowU is a positive development for the company, indicating progress in their technology and a step closer to commercialization. The device has the potential to disrupt the market, and the company has a strong IP portfolio. However, the device still needs to undergo clinical trials and obtain FDA clearance, which introduces some uncertainty.

Positives

• The KnowU is a wearable, non-invasive continuous glucose monitor, which could be a significant improvement over current invasive methods.
• The device incorporates a sensor that has been tested for stability and accuracy in the lab.
• The KnowU is designed to be user-friendly with a rechargeable battery and a companion mobile app.
• The device is significantly smaller and lighter than previous prototypes.
• The company has a strong intellectual property portfolio with over 270 patents related to non-invasive blood glucose monitoring.

Negatives

• The device is still in development and requires FDA clearance before it can be marketed.
• The device needs to undergo large-scale external clinical trials to validate its performance.

Risks

• The company's ability to obtain FDA clearance for the KnowU is not guaranteed.
• The device's performance in real-world settings may differ from lab results.
• The company may face competition from other companies developing similar technologies.
• The company's ability to successfully commercialize the KnowU depends on its ability to scale production and distribution.

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. The company aims to bring the world's first non-invasive blood glucose monitor to the global marketplace.

Management Comments

• Ron Erickson, CEO and Chairman at Know Labs, stated that the company is committed to delivering an accessible, affordable, and accurate solution that improves the current standard of care for those living with diabetes.
• Ron Erickson also mentioned that the KnowU brings the company closer to a future where equitable care in diabetes management will become a reality.

Industry Context

The announcement comes amid a growing global prevalence of diabetes and a need for more accessible and affordable glucose monitoring solutions. The development of a non-invasive CGM could disrupt the market currently dominated by invasive methods.

Comparison to Industry Standards

• Current continuous glucose monitors on the market, such as those from Dexcom and Abbott, require the insertion of a sensor under the skin.
• The KnowU aims to differentiate itself by being non-invasive, potentially offering a more convenient and less painful alternative.
• The company's claim of having over 270 patents suggests a strong intellectual property position compared to competitors.
• The device's miniaturization and integration of machine learning capabilities are also key differentiators.

Stakeholder Impact

• Shareholders may view the announcement positively, as it represents progress in the company's product development.
• Potential customers, particularly those with diabetes, may be interested in the non-invasive nature of the device.
• Employees may be motivated by the progress and potential impact of the technology.
• The company's suppliers may see increased demand as the device moves closer to commercialization.

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.

Key Dates

Keywords

non-invasive glucose monitor, continuous glucose monitor, CGM, wearable technology, FDA clearance, diabetes management, medical device, KnowU, dielectric spectroscopy, radiofrequency sensor