Know Labs(KNW)2024-08-14 20:00Product Development and Technology - Know Labs is focused on developing a non-invasive continuous glucose monitor, with a working prototype currently undergoing internal and external testing[85]. - The internal clinical study showed a Mean Absolute Relative Difference (MARD) of 11.1% in measuring blood glucose levels compared to venous blood[96]. - The next iteration of the KnowU device aims for FDA clearance, with ongoing internal development and clinical research to enhance accuracy[105]. - The sensor technology has gathered billions of data points to refine machine learning algorithms for improved glucose monitoring accuracy[93]. - Preliminary tests indicate the potential for the platform to measure other analytes, such as blood alcohol and blood oxygen levels[97]. - The technology aims to provide real-time, non-invasive monitoring, differentiating it from existing continuous glucose monitors[91]. - The wearable KnowU device is designed for continuous data collection, which is essential for improving machine learning algorithm accuracy[105]. - Know Labs has developed a proprietary radio frequency and microwave spectroscopy platform with over 300 active patent assets, focusing on non-invasive continuous glucose monitoring[87][90]. - The algorithm refinement study demonstrated an improved MARD of 12.9% using a light gradient-boosting machine model, indicating competitive accuracy with FDA-cleared devices[101]. - The company plans to expand its testing with larger and more diverse populations to evaluate technology performance in real-world environments[103]. Market Strategy and Opportunities - The company is engaging strategic partners for product design, data science, and regulatory affairs to facilitate market entry[105]. - The company is exploring various market entry strategies, including direct-to-consumer and partnerships with biopharma and medical device companies[108]. - Know Labs aims to position its technology as a screening device in high diabetes incidence populations, differentiating itself from legacy continuous glucose monitor manufacturers[106]. - Each new application of the sensor technology may require its own subsequent FDA clearance, providing new monetization opportunities[118]. - The company plans to enter other clinical monitoring markets following its entry into the diabetes glucose monitoring market[117]. Financial Performance and Expenses - The company incurred approximately $5,011,000 and $6,186,000 in research and development expenses for the nine months ended June 30, 2024, and 2023, respectively[119]. - Selling, general and administrative expenses increased by $1,128,000 to $2,487,000 for the three months ended June 30, 2024, primarily due to increases in salaries, legal expenses, and stock-based compensation[133]. - Net loss for the three months ended June 30, 2024 was $4,103,000, compared to a net loss of $3,600,000 for the same period in 2023, reflecting an increase of $503,000[135]. - For the nine months ended June 30, 2024, research and development expenses decreased by $1,175,000 to $5,011,000 compared to $6,186,000 for the same period in 2023[137]. - Selling, general and administrative expenses for the nine months ended June 30, 2024 increased by $1,517,000 to $7,025,000 compared to $5,508,000 for the same period in 2023[138]. - Net loss for the nine months ended June 30, 2024 was $12,948,000, compared to a net loss of $12,354,000 for the same period in 2023, an increase of $594,000[140]. - The company anticipates recording losses from operations for the foreseeable future and believes it has enough cash to operate until October 31, 2024[143]. - The company reported a net working capital deficit of $3,987,763 as of June 30, 2024, indicating liquidity challenges[18]. - The company expects to raise additional funds through the issuance of preferred stock, convertible debentures, or equity during the remainder of 2024[144]. Patent Portfolio and Intellectual Property - The company has over 300 active patent assets and is exploring revenue generation through patent licensing opportunities[87]. - The company's patent portfolio increased from 159 to 336 year over year, reflecting a 109% growth compared to the market's 35% growth[110]. - The company has been granted 50 patents and has a total of 325 patents issued and pending, positioning it as the top worldwide IP holder in non-invasive blood glucose monitoring[120]. - The company has a strategy to expand its patent portfolio and maintain trade secrets related to its AI and ML-driven algorithms[121]. Market Context and Demographics - The global population suffering from diabetes is estimated at 579 million, projected to reach 643 million by 2030 and 784 million by 2040[113]. - Leading continuous glucose monitor (CGM) providers, Dexcom, Abbott, and Medtronic, hold 100% market share but have penetrated less than 1% of the global addressable market[113].