Know Labs(KNW)2022-12-20 21:06Technology Development - Know Labs, Inc. is focused on the development and commercialization of proprietary sensor technologies, specifically the Bio-RFID and ChromaID platforms, which utilize electromagnetic energy for material identification and measurement [27]. - The Bio-RFID technology has successfully demonstrated the ability to non-invasively measure blood glucose levels, addressing limitations of existing optical technologies [33]. - The company plans to market two versions of its non-invasive glucose monitoring device: the KnowU (desktop version) and the UBand (wearable version), both requiring FDA clearance [35]. - Internal laboratory testing has shown a high degree of correlation between Bio-RFID technology and leading continuous glucose monitors from Abbott Labs and DexCom [36]. - The company is also exploring additional analytes for monitoring through its devices, which will require separate FDA approvals [38]. - The ChromaID technology generates unique signatures from materials using light, enabling applications in authentication and verification [39]. - Bio-RFID technology enables real-time identification of a wide range of materials and analytes, enhancing clinical diagnostics and health monitoring [50]. - The Bio-RFID platform is expected to enter the continuous glucose monitoring market, with plans to expand into other clinical monitoring markets [59]. Regulatory and Compliance - The FDA regulates the company's medical diagnostic products, including KnowU and UBand, ensuring compliance with safety and effectiveness standards [63]. - The company believes its initial product is suitable for a de novo classification request with the FDA [79]. - Regulatory approvals are necessary for some products, and there is no assurance that such approvals will be granted, which could hinder revenue generation [130]. - International regulatory clearances are required for product sales outside the U.S., and failure to obtain these could harm business operations [131]. - The company is subject to increasingly stringent foreign governmental regulations for the manufacture and sale of medical devices, which may impact international sales [132]. Financial Performance - The company reported an accumulated deficit of $101,397,738 as of September 30, 2022, with net losses of $20,071,244 and $25,360,213 for the years ended September 30, 2022 and 2021, respectively [105]. - The company completed a public offering on September 20, 2022, selling 4,140,000 shares at $2.00 per share, generating total gross proceeds of $8,280,000 [102]. - The company anticipates needing additional financing to support technology development and ongoing operations, as it is currently operating at a loss [99]. - The potential proceeds from outstanding warrants could amount to up to $15,694,288, although there is no assurance these will be exercised [103]. - The company has limited insurance coverage, which may not cover significant claims, potentially impacting financial condition [115]. Intellectual Property - The company has been granted 27 patents and 19 design patents, with additional patents pending, supporting its intellectual property strategy [54]. - The company faces challenges in protecting its intellectual property, which could affect its competitive position and revenue [116]. Market Strategy - Know Labs, Inc. is building an internal sales and marketing team to prepare for the launch of its products and explore various market entry strategies [48]. - The competitive landscape includes large global technology companies, legacy providers, and new entrants, with Know Labs, Inc. believing its Bio-RFID technology offers a unique advantage in the market [49]. - The company aims to monetize its AI deep learning platform, exploring new applications to generate revenue for further development of its diagnostic technology [53]. Operational Challenges - The company is actively monitoring the impact of COVID-19 on its operations, which has caused supply chain delays and increased costs due to inflation [96]. - The company relies on external resources for engineering and product development, which could impact its ability to commercialize technology successfully [107]. - The company relies on key personnel, including its Chairman and CEO, and failure to retain them could adversely affect business operations [114]. - The company may face significant costs related to compliance with corporate governance and internal control requirements, which are expected to remain substantial [138]. - Cybersecurity risks pose a threat to the integrity and availability of sensitive information, necessitating ongoing investment in security measures [137]. Employee and Corporate Structure - The company has 16 full-time employees as of September 30, 2022, supplemented by consulting firms and contractors [62]. - The company has anti-takeover provisions in its bylaws designed to delay or prevent unsolicited acquisition attempts [212][215]. - The company has elected not to be governed by certain Nevada statutes that could limit third-party acquisitions of its stock [213][214]. Stock and Shareholder Information - As of September 30, 2022, the company had 48,156,062 shares of common stock issued and outstanding, with options and warrants potentially diluting future earnings per share [144]. - The company is authorized to issue up to 200,000,000 shares of common stock, which could lead to substantial dilution of existing stockholders' ownership [146]. - The market price of the company's common stock has been volatile, influenced by various market and industry factors, which may adversely affect stockholder investments [143]. - The company has never declared or paid cash dividends on its common stock and intends to retain all available funds for business operations [168].