
Financial Performance - Revenue for the fiscal year ended March 31, 2024, was $12,063,345, representing a 25.2% increase from $9,639,057 in the previous year[310]. - Gross profit for the fiscal year 2024 was $8,356,281, compared to $5,442,033 in fiscal year 2023, indicating a significant improvement in profitability[310]. - The net loss attributable to common stockholders decreased to $14,928,960 in fiscal year 2024 from $19,533,683 in fiscal year 2023, reflecting a reduction of approximately 23.3%[310]. - The total operating expenses for fiscal year 2024 were $17,184,550, down from $20,851,744 in fiscal year 2023, showing a reduction of approximately 17.8%[310]. - Net loss before dividends for the year ended March 31, 2024, was $14,094,283, an improvement from a loss of $18,658,143 in the previous year, representing a reduction of approximately 24%[315]. - The company reported a net cash used in operating activities of $6,693,912 for the year ended March 31, 2024, compared to $13,547,935 in 2023, indicating a significant decrease of approximately 51%[315]. - Net cash provided by financing activities increased to $6,741,685 in 2024 from $2,001,603 in 2023, marking an increase of about 237%[315]. Regulatory and Compliance - The company is subject to extensive governmental regulations, which could increase regulatory costs and affect the marketing of its products[151]. - The company’s manufacturing operations must comply with FDA regulations, which may increase production costs and affect market supply[154]. - Regulatory compliance is critical; failure to maintain approval for manufacturing facilities could limit growth and harm the business[199]. - The Company is subject to various federal and state health care fraud and abuse laws, which could result in substantial penalties if compliance is not maintained[239]. - The company’s ability to raise equity financing may be negatively impacted if it fails to maintain compliance with Nasdaq listing standards[246]. Market and Competition - The company faces intense competition in the medical technology industry, which is characterized by rapid technological change and significant competition from larger firms with greater resources[210]. - The company’s ability to compete effectively depends on achieving regulatory clearance and market acceptance for its products[211]. - Changes in the healthcare industry aimed at controlling costs could reduce demand for the company’s arrhythmia monitoring solutions, leading to pricing pressure[230]. Operational Challenges - The company has a limited operating history, making it difficult to accurately forecast future revenues and profitability[124]. - The company may experience shortages of monitors, sensors, or bases due to manufacturing difficulties, which could disrupt operations[126]. - The company has limited experience in commercial manufacturing, which poses risks to meeting production and delivery requirements[198]. - The company may face difficulties in recruiting and retaining qualified personnel, which could hinder its growth strategy[203]. - The company is dependent on physicians utilizing its cardiac monitoring solutions; failure to convince physicians could lead to stagnant or decreasing revenue[176]. Growth and Development - The company plans to hire 10 to 15 additional full-time employees within the next 12 months to support growth in sales, marketing, research and development, and clinical development activities[143]. - The company plans to continue developing and commercializing its existing and proposed products to generate significant revenues[125]. - The company plans to use an additional $10 million in capital to fund operations and sales efforts for the commercialization of Bioflux and Biocore in broader US markets[167]. - The company plans to expand its sales force to enhance market penetration and address new markets, focusing on utilization-based recurring technology fee revenue[289]. - The company has expanded its sales efforts to 35 states and aims to compete in the broader US market using an insourcing business model[288]. - The company is focused on building and commercializing a technology ecosystem within the remote monitoring segment of preventative care, indicating a strategic emphasis on healthcare innovation[317]. - The company is actively engaged in research and development activities to enhance its market position and commercialization pathways in healthcare[317]. Financial Position - As of March 31, 2024, the company had an accumulated deficit of $127,499,785[125]. - The company had aggregate outstanding indebtedness of $22.5 million as of March 31, 2024, compared to $17.8 million for the year ended March 31, 2023[214]. - The company may need to seek additional funding to support business growth, which could be dilutive to current stockholders[195]. - The company may require additional equity or debt financings to fund working capital needs and further expansion, which could lead to substantial dilution of stockholders[202]. - The concentration of voting power held by the CEO, who owns approximately 7.21% of outstanding shares, may influence corporate decisions and affect stock price perception[258]. Stock and Market Conditions - Nasdaq notified the Company on August 1, 2023, that its Market Value of Listed Securities (MVLS) was below the $35 million minimum requirement for continued inclusion, granting 180 days to regain compliance[241]. - As of January 30, 2024, the Company did not regain compliance with the MVLS Requirement, leading to a delisting determination from Nasdaq[242]. - The Company received a letter from Nasdaq on May 1, 2024, indicating additional grounds for delisting, which will be considered in the decision regarding continued listing[245]. - The Company’s common stock is classified as "penny stock" under SEC rules, which may affect trading activity and investor interest[254]. - The Company has the authority to issue additional shares of common or preferred stock, which could lead to a decline in the market price of existing shares[260]. Product Development - The company has received 510(k) clearance for both the software and hardware components of its Bioflux and Biocore products, which typically takes three to 12 months from submission[137]. - The company developed the FDA-cleared Bioflux® COM technology and launched the Biocore Cardiac Monitoring Device, targeting a broader market segment[288]. - The company ordered device inventory from its FDA-approved manufacturer to support the commercialization of its products[320]. - The company has filed for one industrial design patent in Canada and the U.S. and may seek further patent protection for its proprietary technology[222]. Risk Factors - The company faces significant risks related to product liability claims and recalls, which could adversely affect financial condition[193]. - The reimbursement rates from commercial payors may decline due to consolidation, potentially impacting revenue growth[162]. - Changes in reimbursement policies from Medicare and commercial payors could negatively impact revenue and operational results[187]. - The company’s operations in international markets are subject to various uncontrollable risks, including macroeconomic conditions and political instability[207]. - The company anticipates needing additional research and development expenditures for existing and new products, with uncertain technological success[168]. Miscellaneous - The company has not encountered significant cybersecurity challenges that have materially impaired operations or financial standing[299]. - The effect of foreign currency translation resulted in an increase of $167,827 in cash during the year ended March 31, 2024[315]. - The company experienced a change in fair value of derivative liabilities, resulting in a loss of $9,777 in 2024, compared to a gain of $483,873 in 2023[315]. - Audit fees for fiscal year 2024 were $155,377, an increase from $145,733 in fiscal year 2023[298]. - Stock-based compensation increased to $1,025,930 in 2024 from $647,631 in 2023, reflecting a rise of about 58%[315]. - The weighted average number of common shares outstanding increased to 8,991,766 in fiscal year 2024 from 8,659,718 in fiscal year 2023[310].