Biotricity Inc. (BTCY) could be a solid addition to your portfolio given its recent upgrade to a Zacks Rank #2 (Buy). This upgrade primarily reflects an upward trend in earnings estimates, which is one of the most powerful forces impacting stock prices.The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked by the system.Si ...

As filed with the Securities and Exchange Commission on February 27, 2024 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 BIOTRICITY INC. (Exact Name of Registrant as Specified in Its Charter) (State or other jurisdiction of (Primary Standard Industrial (I.R.S. Employer incorporation or organization) Classification Code Number) Identification Number) Nevada 3845 30-0983531 203 Redwood Shores Parkwa ...

Biotricity, Inc. (NASDAQ:BTCY) Q3 2024 Earnings Call Transcript February 21, 2024 4:30 PM ET Company Participants Debra Chen - IR Waqaas Al-Siddiq - Founder and CEO John Ayanoglou - CFO Conference Call Participants Ben Haynor - Alliance Global Partners Michael Davin - H.C. Wainwright Operator Good afternoon, I welcome to Biotricity Third Quarter Fiscal 2024 Financial Results and Business Update Conference Call. Today's conference is being recorded. At this time, I would like to turn the conference over to ...

Biotricity Inc. (BTCY) came out with a quarterly loss of $0.34 per share versus the Zacks Consensus Estimate of a loss of $0.41. This compares to loss of $0.54 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 17.07%. A quarter ago, it was expected that this company would post a loss of $0.34 per share when it actually produced a loss of $0.44, delivering a surprise of -29.41%.Over the last four quarters, the company has surpass ...

● Fair value of derivative liabilities In determining the fair values of the derivative liabilities from the conversion and redemption features, the Company used MonteCarlo and lattice models with the following assumptions: dividend yields, volatility, risk-free rate and the remaining expected life. Changes in those assumptions and inputs could in turn impact the fair value of the derivative liabilities and can have a material impact on the reported loss and comprehensive loss for the applicable reporting p ...

Biotricity, Inc. (NASDAQ:BTCY) Q2 2024 Earnings Conference Call November 14, 2023 6:00 PM ET Company Participants Debra Chen - IR Waqaas Al-Siddiq - Founder and CEO John Ayanoglou - CFO Conference Call Participants Michael Davin - H.C. Wainwright Operator Good afternoon, and welcome to Biotricity's Second Quarter Fiscal 2024 Financial Results and Business Update Conference Call. Today's conference is being recorded. And at this time, I would like to turn the conference over to Debra Chen with Investor Relat ...

Part I – Financial Information [Condensed Consolidated Financial Statements](index=4&type=section&id=Item%201%20%E2%80%93%20Condensed%20Consolidated%20Financial%20Statements) The company's unaudited condensed consolidated financial statements for September 30, 2023, show increased revenue and gross profit, but continued net losses and a going concern uncertainty - The company has incurred recurring losses, resulting in an accumulated deficit of **$120.1 million** and a working capital deficiency of **$12.6 million** as of September 30, 2023. These conditions raise substantial doubt about its ability to continue as a going concern[27](index=27&type=chunk) Condensed Consolidated Balance Sheet Data (as of Sept 30, 2023 vs Mar 31, 2023) | Balance Sheet Item | September 30, 2023 ($) | March 31, 2023 ($) | | :--- | :--- | :--- | | **Total Current Assets** | 5,178,206 | 4,720,202 | | **Total Assets** | 6,823,837 | 6,510,544 | | **Total Current Liabilities** | 17,824,363 | 11,160,768 | | **Total Liabilities** | 32,295,289 | 26,355,929 | | **Total Stockholders' Deficiency** | (26,729,036) | (19,845,385) | Condensed Consolidated Statements of Operations Data (Six Months Ended Sept 30) | Metric | 2023 ($) | 2022 ($) | | :--- | :--- | :--- | | **Revenue** | 5,912,062 | 4,437,441 | | **Net Revenue (Gross Profit)** | 3,915,982 | 2,505,366 | | **Loss from Operations** | (4,502,159) | (8,117,648) | | **Net Loss** | (7,103,722) | (9,468,800) | | **Net Loss Attributable to Common Stockholders** | (7,482,861) | (9,928,756) | | **Loss Per Share (Basic and Diluted)** | (0.853) | (1.153) | Condensed Consolidated Statements of Cash Flows (Six Months Ended Sept 30) | Cash Flow Activity | 2023 ($) | 2022 ($) | | :--- | :--- | :--- | | **Net cash used in operating activities** | (4,222,154) | (8,490,203) | | **Net cash provided by (used in) financing activities** | 4,758,634 | (1,105,998) | | **Net increase (decrease) in cash** | 536,480 | (9,596,201) | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=34&type=section&id=Item%202%20%E2%80%93%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses significant revenue growth, improved gross margins, and reduced operating expenses, despite continued net losses and a going concern risk - The company is focused on a recurring revenue model, with technology fees from its Bioflux and Biotres products being the primary driver of growth. Sales have expanded to **32 U.S. states** as of September 30, 2023[197](index=197&type=chunk)[354](index=354&type=chunk) - In September 2023, the company issued **220 shares** of Series B Convertible Preferred Stock, raising gross proceeds of **$2.0 million** (**$1.9 million** net). This financing is intended to support operations and growth initiatives[154](index=154&type=chunk)[395](index=395&type=chunk) - Management emphasizes its commitment to financial discipline and leveraging AI to improve margins and drive revenue growth. The company has established relationships with Amazon and Google to enhance its proprietary cardiac AI model[173](index=173&type=chunk)[356](index=356&type=chunk) - A going concern risk exists due to recurring losses and a working capital deficit. The company plans to seek additional debt or equity capital to fund operations, product development, and expansion[158](index=158&type=chunk)[241](index=241&type=chunk) [Results of Operations](index=46&type=section&id=Results%20of%20Operations) For the three and six months ended September 30, 2023, revenue grew significantly with improved gross margins and reduced operating expenses, narrowing the net loss Three Months Ended September 30, 2023 vs 2022 | Metric | Q3 2023 ($) | Q3 2022 ($) | Change (%) | | :--- | :--- | :--- | :--- | | **Revenue** | 2,891,297 | 2,381,389 | +21.4% | | **Gross Profit** | 1,999,278 | 1,280,237 | +56.2% | | **Gross Margin** | 69.1% | 53.8% | +15.3 pts | | **Total Operating Expenses** | 4,174,951 | 5,309,224 | -21.4% | | **Loss from Operations** | (2,175,673) | (4,028,987) | +46.0% | | **Net Loss** | (3,690,840) | (4,692,548) | +21.3% | - Technology fees for Q3 2023 increased **30.3%** YoY to **$2.7 million**, comprising **94.5%** of total revenue. The gross margin improvement is attributed to higher-margin technology fees and AI-driven efficiencies in data processing[177](index=177&type=chunk) Six Months Ended September 30, 2023 vs 2022 | Metric | 2023 ($) | 2022 ($) | Change (%) | | :--- | :--- | :--- | :--- | | **Revenue** | 5,912,062 | 4,437,441 | +33.1% | | **Gross Profit** | 3,915,982 | 2,505,366 | +56.3% | | **Gross Margin** | 66.2% | 56.5% | +9.7 pts | | **Total Operating Expenses** | 8,418,141 | 10,623,014 | -20.7% | | **Loss from Operations** | (4,502,159) | (8,117,648) | +44.5% | | **Net Loss** | (7,103,722) | (9,468,800) | +25.0% | - For the six-month period, selling, general and administrative (SG&A) expenses decreased by **21.9%** or **$2.0 million** YoY, reflecting increased monitoring of spending efficiency[211](index=211&type=chunk) [Liquidity and Capital Resources](index=52&type=section&id=Liquidity%20and%20Capital%20Resources) As of September 30, 2023, the company had $1.2 million in cash, with improved operating cash flow and significant financing inflows, while acknowledging going concern doubts - The company had cash deposits of approximately **$1.2 million** as of September 30, 2023[393](index=393&type=chunk) - For the six months ended September 30, 2023, net cash from financing activities was **$4.8 million**, mainly from the issuance of Series B preferred stock (**$1.9M**), convertible notes (**$2.0M**), and short-term loans (**$0.8M**)[131](index=131&type=chunk)[415](index=415&type=chunk) - Management states that existing cash, access to funding, and anticipated near-term financings will be sufficient to meet needs for the next twelve months, despite the going concern warning[158](index=158&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=47&type=section&id=Item%203%20%E2%80%93%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not required for smaller reporting companies, and therefore no information is provided - The company is a smaller reporting company and is not required to provide this disclosure[249](index=249&type=chunk)[417](index=417&type=chunk) [Controls and Procedures](index=47&type=section&id=Item%204%20%E2%80%93%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2023, with no material changes to internal controls over financial reporting - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of September 30, 2023[159](index=159&type=chunk) - No material changes to internal controls over financial reporting occurred during the three-month period ended September 30, 2023[223](index=223&type=chunk) Part II – Other Information [Legal Proceedings](index=48&type=section&id=Item%201%20%E2%80%93%20Legal%20Proceedings) The company is not currently a party to any legal proceedings expected to have a material adverse effect on its business - The company reports that it is not currently involved in any legal proceedings that management believes would likely have a material adverse effect on the business[224](index=224&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=48&type=section&id=Item%202%20%E2%80%93%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities during the period - None reported[403](index=403&type=chunk) [Defaults Upon Senior Securities](index=48&type=section&id=Item%203%20%E2%80%93%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None reported[132](index=132&type=chunk) [Mine Safety Disclosures](index=48&type=section&id=Item%204%20%E2%80%93%20Mine%20Safety%20Disclosures) This section is not applicable to the company - Not applicable[346](index=346&type=chunk) [Other Information](index=48&type=section&id=Item%205%20%E2%80%93%20Other%20Information) The company reports no other information for this item - None reported[226](index=226&type=chunk) [Exhibits](index=48&type=section&id=Item%206%20%E2%80%93%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including Series B Preferred Stock documents and Sarbanes-Oxley certifications - Exhibits filed with the report include documents related to the Series B Preferred Stock financing and required certifications[184](index=184&type=chunk)

Financial Data and Key Metrics Changes - Revenue for Q1 2024 increased by 46.9% year-over-year to $3 million [7][57] - Gross profit rose to $1.9 million, up 56% from $1.2 million a year ago, with a gross profit margin of 63.5%, compared to 59.6% in the prior year [7][23][57] - Net loss decreased by 33% year-over-year to $3.6 million, or $0.069 per share, from a net loss of $5 million, or $0.098 per share [3][8] Business Line Data and Key Metrics Changes - Technology fees, which are recurring subscription service fees, rose by 47% to $2.77 million, comprising 92% of total revenue [36][37] - Device sales accounted for 8.3% of total revenue, reported at $252,000 [58] Market Data and Key Metrics Changes - The healthcare AI market is projected to grow to $208.2 billion by 2030, indicating a significant opportunity for the company [5] - The company has expanded its sales reach to over 35 states in the U.S., contributing to revenue growth [57] Company Strategy and Development Direction - The company aims to increase sales of remote cardiac monitoring devices, ramp up subscription-based services, and accelerate recurring revenue to achieve profitability [10][21] - Focus on enhancing AI technology to improve patient management and disease profiling, with ongoing R&D investments in automation and product enhancement [5][55] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving positive cash flow and highlighted the importance of maintaining financial discipline while driving margin and revenue growth [18][19] - The company is optimistic about the future, with expectations of continued improvement in gross margins as technology fees become a larger portion of revenue [36][48] Other Important Information - The company has monitored over 2 billion heartbeats for atrial fibrillation, resulting in significant cost savings for healthcare systems [4][20] - Management emphasized the importance of customer retention, with a retention rate of approximately 98% [37] Q&A Session Summary Question: Insights on device sales and service fee mix - Management indicated that Bioflux still dominates revenue, but Biotres is expected to grow as it becomes more established in the market [26][41] Question: R&D expenditure focus - The company is focusing R&D on automation and enhancing existing products to improve margins and reduce costs [42][43] Question: Future state coverage targets - Management aims for 50-state coverage and is building out its sales force to optimize distribution relationships [29][46] Question: Sustainability of reduced operating expenses - Management believes the current expense level is sustainable due to optimized operations and a focus on sales and account management [56] Question: Gross margin sustainability - Management anticipates that as revenue becomes predominantly SaaS-related, gross margins will stabilize around the SaaS rate [48][49]

[Part I – Financial Information](index=4&type=section&id=Part%20I%20%E2%80%93%20Financial%20Information) This section provides the company's unaudited condensed consolidated financial statements and management's discussion and analysis [Item 1 – Condensed Consolidated Financial Statements](index=4&type=section&id=Item%201%20%E2%80%93%20Condensed%20Consolidated%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for the three months ended June 30, 2023, including balance sheets, statements of operations, and cash flows, along with notes detailing accounting policies and financial condition [Condensed Consolidated Financial Statements (Unaudited)](index=5&type=section&id=Condensed%20Consolidated%20Financial%20Statements%20%28Unaudited%29) The unaudited financial statements for Q2 2023 show increased revenue, reduced net loss, a working capital deficiency, and positive cash from financing activities Condensed Consolidated Statements of Operations (Unaudited) | Metric | Three Months Ended June 30, 2023 ($) | Three Months Ended June 30, 2022 ($) | | :--- | :--- | :--- | | **Revenue** | 3,020,765 | 2,056,052 | | **Gross Profit** | 1,916,704 | 1,225,129 | | **Loss from Operations** | (2,316,486) | (4,088,662) | | **Net Loss Attributable to Common Stockholders** | (3,601,579) | (5,024,389) | | **Loss Per Share (Basic and Diluted)** | (0.069) | (0.098) | Condensed Consolidated Balance Sheets (Unaudited) | Metric | As at June 30, 2023 ($) | As at March 31, 2023 ($) | | :--- | :--- | :--- | | **Total Current Assets** | 4,400,678 | 4,720,202 | | **Total Assets** | 6,144,123 | 6,510,544 | | **Total Current Liabilities** | 15,097,543 | 11,160,768 | | **Total Liabilities** | 29,555,737 | 26,355,929 | | **Total Stockholders' Deficiency** | (23,411,614) | (19,845,385) | Condensed Consolidated Statements of Cash Flows (Unaudited) | Metric | Three Months Ended June 30, 2023 ($) | Three Months Ended June 30, 2022 ($) | | :--- | :--- | :--- | | **Net cash used in operating activities** | (1,832,118) | (4,039,394) | | **Net cash provided by (used in) financing activities** | 1,329,145 | (833,221) | | **Net decrease in cash** | (502,973) | (4,872,615) | | **Cash, end of period** | 51,433 | 7,207,974 | [Notes to the Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) These notes detail accounting policies, a going concern warning due to recurring losses and a working capital deficiency, significant debt, and a subsequent reverse stock split - The company has incurred recurring losses, with an accumulated deficit of **$116.2 million** and a working capital deficiency of **$10.7 million** as of June 30, 2023, raising substantial doubt about its ability to continue as a going concern[32](index=32&type=chunk) Revenue Breakdown (Q1 FY2024 vs Q1 FY2023) | Revenue Source | Q1 FY2024 (ended June 30, 2023) ($) | Q1 FY2023 (ended June 30, 2022) ($) | | :--- | :--- | :--- | | **Technology fees** | 2,768,918 | 1,889,982 | | **Device sales** | 251,847 | 166,070 | | **Total Revenue** | **3,020,765** | **2,056,052** | - During the quarter, the company raised additional funds through the issuance of **$1,017,700** in Series C Convertible Notes and net proceeds of **$479,656** from other short-term loans and promissory notes[164](index=164&type=chunk)[61](index=61&type=chunk) - As of June 30, 2023, the company was not in compliance with certain covenants of its term loan but received relief from the lender[137](index=137&type=chunk) - Subsequent to the quarter end, on July 3, 2023, the company effected a **1-for-6 reverse stock split** of its common stock[340](index=340&type=chunk) [Item 2 – Management's Discussion and Analysis of Financial Condition and Results of Operations](index=34&type=section&id=Item%202%20%E2%80%93%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial performance, highlighting revenue growth, improved gross margin, reduced operating expenses, and a lower net loss, while reiterating going concern doubts [Company Overview](index=34&type=section&id=Company%20Overview) Biotricity is a medical technology company providing biometric data monitoring solutions, focusing on recurring technology fees from its cardiac products and expanding AI for predictive monitoring - The company's strategy is to deliver remote monitoring solutions with a focus on an **insourcing business model** that generates recurring technology fee revenue[256](index=256&type=chunk)[341](index=341&type=chunk) - Key commercialized products include **Bioflux®**, **Biotres**, and the **Biocare Cardiac Disease Management Solution**, with sales launched in 31 U.S. states by December 31, 2022[231](index=231&type=chunk)[258](index=258&type=chunk)[234](index=234&type=chunk) - A strategic focus is the expansion of proprietary **AI technology** to create a suite of predictive monitoring tools for disease prevention and improved patient management[236](index=236&type=chunk)[351](index=351&type=chunk) [Results of Operations](index=36&type=section&id=Results%20of%20Operations) For the three months ended June 30, 2023, revenue increased, gross profit grew with improved margin, operating expenses decreased, and net loss significantly narrowed Key Operating Results (Q1 FY2024 vs Q1 FY2023) | Metric | Three Months Ended June 30, 2023 ($) | Three Months Ended June 30, 2022 ($) | Change | | :--- | :--- | :--- | :--- | | **Revenue** | 3,020,765 | 2,056,052 | +46.9% | | **Gross Profit** | 1,916,704 | 1,225,129 | +56.4% | | **Gross Margin** | 63.5% | 59.6% | +3.9 p.p. | | **Total Operating Expenses** | 4,233,190 | 5,313,791 | -20.3% | | **Net Loss Attributable to Common Stockholders** | (3,601,579) | (5,024,389) | -28.3% | - The increase in gross margin was primarily attributed to improved margins on technology fees, which comprised **92% of total revenue**[290](index=290&type=chunk) - Selling, general and administrative (SG&A) expenses decreased by **22%** or **$1.0 million** year-over-year, reflecting increased spending efficiency[352](index=352&type=chunk) [Liquidity and Capital Resources](index=41&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2023, the company had limited cash and a significant working capital deficit, raising going concern doubts and necessitating additional funding, despite improved operating cash flow - The company has a working capital deficit of **$10.7 million** and an accumulated deficit of **$116.2 million**, raising substantial doubt about its ability to continue as a going concern[299](index=299&type=chunk)[297](index=297&type=chunk) - Net cash used in operating activities decreased to **$1.8 million** for the quarter, compared to **$4.0 million** for the same period in 2022, reflecting cost containment efforts[302](index=302&type=chunk)[318](index=318&type=chunk) - Financing activities provided **$1.3 million** in cash, driven by **$0.9 million** from convertible notes and **$0.4 million** from other short-term loans[283](index=283&type=chunk)[303](index=303&type=chunk) [Item 3 – Quantitative and Qualitative Disclosures About Market Risk](index=44&type=section&id=Item%203%20%E2%80%93%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This disclosure is not required for a smaller reporting company - As a smaller reporting company, Biotricity Inc. is not required to provide this disclosure[306](index=306&type=chunk) [Item 4 – Controls and Procedures](index=44&type=section&id=Item%204%20%E2%80%93%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective, with no material changes to internal controls over financial reporting during the quarter - Based on an evaluation, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective[323](index=323&type=chunk) - No changes in internal controls over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, these controls[308](index=308&type=chunk) [Part II – Other Information](index=45&type=section&id=Part%20II%20%E2%80%93%20Other%20Information) This section covers legal proceedings, market risk disclosures, controls, and other required information [Item 1 – Legal Proceedings](index=45&type=section&id=Item%201%20%E2%80%93%20Legal%20Proceedings) The company is not currently a party to any legal proceedings expected to have a material adverse effect on its business - The company reports no material legal proceedings[326](index=326&type=chunk) [Other Items (1A, 2, 3, 4, 5, 6)](index=45&type=section&id=Other%20Items%20%281A%2C%202%2C%203%2C%204%2C%205%2C%206%29) This section covers other required disclosures, noting that risk factors are not required for smaller reporting companies, and no material unregistered sales, defaults, or mine safety issues were reported - Item 1A (Risk Factors): Not required for smaller reporting companies[327](index=327&type=chunk) - Item 2, 3, 5: No unregistered sales of equity, defaults upon senior securities, or other information were reported[328](index=328&type=chunk)[329](index=329&type=chunk)[331](index=331&type=chunk) - Item 4 (Mine Safety Disclosures): Not applicable[330](index=330&type=chunk)

PART I [Business](index=4&type=section&id=ITEM%201.%20BUSINESS) Biotricity provides biometric data monitoring solutions for cardiology, leveraging a TaaS model with FDA-cleared devices [Company Overview](index=4&type=section&id=Company%20Overview) - **Biotricity** is a medical technology company focused on biometric data monitoring, delivering **remote solutions** for diagnostic and post-diagnostic management of chronic illnesses[226](index=226&type=chunk)[229](index=229&type=chunk) - The company's business model is **technology-as-a-service (TaaS)**, focusing on earning utilization-based **recurring technology fee revenue**[230](index=230&type=chunk) - Key products include the **FDA-cleared Bioflux®** for mobile cardiac outpatient monitoring (COM), **Biotres** for Holter monitoring, and the direct-to-consumer **Bioheart** monitor[211](index=211&type=chunk)[215](index=215&type=chunk) [Market Opportunity and Strategy](index=6&type=section&id=Market%20Opportunity%20and%20Strategy) - The global ECG market is growing at a CAGR of **8.3%**, with the US accounting for about **25%**[217](index=217&type=chunk)[261](index=261&type=chunk) - The company targets approximately **23,018 physician offices**, **612 hospitals**, and **300 Independent Diagnostic Testing Facilities (IDTFs)** in the U.S[285](index=285&type=chunk) - Biotricity's **'insourcing' business model** allows physicians to bill for diagnostic services directly, creating a **new revenue stream** for them[269](index=269&type=chunk)[288](index=288&type=chunk) - The company is expanding into the **chronic care management (CCM)** and **remote patient monitoring (RPM)** markets with its **Biocare platform**[233](index=233&type=chunk)[271](index=271&type=chunk) [Product and Technology](index=10&type=section&id=Product%20and%20Technology) - **Bioflux** is a one-piece, **3-channel** mobile cardiac telemetry (COM) device, considered **clinically superior** to competitor two-piece, 2-channel solutions[252](index=252&type=chunk)[272](index=272&type=chunk)[290](index=290&type=chunk) - **Biotres** is a **3-channel**, connected, and rechargeable Holter patch solution, designed to provide **faster and higher quality data** than competing 1-channel, non-connected patches[254](index=254&type=chunk)[275](index=275&type=chunk)[292](index=292&type=chunk) - **Bioheart** and **Biocare** form a **cardiac-tailored disease management solution** for consumers and physicians respectively[250](index=250&type=chunk)[293](index=293&type=chunk)[295](index=295&type=chunk) [Competition](index=14&type=section&id=Competition) - **Primary competitors** in the Cardiac Outpatient Monitoring (COM) market include Biotelemetry (Philips), Preventice (Boston Scientific), ScottCare, and Infobionic[280](index=280&type=chunk)[300](index=300&type=chunk)[281](index=281&type=chunk) - In the Holter patch market, **key competitors** are iRhythm Technologies and BardyDx (Hillrom), who primarily operate as IDTFs with 1-channel, non-connected devices[319](index=319&type=chunk)[284](index=284&type=chunk) - **Competitors** in the cardiac disease management space include Alivecor for direct-to-consumer monitoring and Optimize Health for chronic care platforms[320](index=320&type=chunk)[303](index=303&type=chunk)[304](index=304&type=chunk) [Intellectual Property and R&D](index=17&type=section&id=Intellectual%20Property%20and%20R%26D) - The company primarily relies on **trade secret protection** for its proprietary information and uses non-disclosure and confidentiality agreements with employees and partners[307](index=307&type=chunk)[308](index=308&type=chunk) Research and Development Costs (Millions USD) | Expense | FY 2023 | FY 2022 | | :--- | :--- | :--- | | Research and Development Costs | $3.0 million | $2.7 million | [Government Regulation](index=17&type=section&id=Government%20Regulation) - The company's products are subject to regulation by the **U.S. FDA** and other federal, state, and foreign agencies, governing development, manufacturing, labeling, and marketing[324](index=324&type=chunk)[9](index=9&type=chunk) - The company's products, such as Bioflux and Biotres, are classified as **Class II medical devices** and have received **510(k) clearance** from the FDA[315](index=315&type=chunk)[332](index=332&type=chunk) - Post-clearance, the company must comply with **ongoing FDA requirements**, including the Quality System Regulation (QSR) and Medical Device Reporting (MDR)[344](index=344&type=chunk)[492](index=492&type=chunk) [Risk Factors](index=22&type=section&id=ITEM%201A.%20RISK%20FACTORS) The company faces significant risks including limited operating history, net losses, going concern doubt, regulatory compliance, and intense competition [Risks Related to Our Business](index=22&type=section&id=Risks%20Related%20to%20Our%20Business) - The company has a limited operating history and has not been profitable, with an accumulated deficit of **$112.6 million** as of March 31, 2023[338](index=338&type=chunk)[359](index=359&type=chunk)[22](index=22&type=chunk) - There is **substantial doubt** about the company's ability to continue as a going concern due to recurring losses, negative cash flow, and a cash balance of only **$0.6 million** at year-end[407](index=407&type=chunk)[522](index=522&type=chunk) - The business is **dependent on physicians** utilizing its solutions; failure to drive adoption could cause revenue to decrease[14](index=14&type=chunk)[363](index=363&type=chunk) - The company's assets, including intellectual property, are **secured as collateral** under a credit agreement, with default potentially leading to foreclosure[471](index=471&type=chunk)[362](index=362&type=chunk)[341](index=341&type=chunk) - Operations are subject to **extensive and changing government regulations** (FDA, Health Canada), and non-compliance could result in fines or suspension[343](index=343&type=chunk)[15](index=15&type=chunk)[366](index=366&type=chunk) [Risks Related to Our Industry](index=31&type=section&id=Risks%20Related%20to%20Our%20Industry) - The medical technology industry is **highly competitive** and subject to rapid technological change, with competitors potentially having greater resources[408](index=408&type=chunk)[425](index=425&type=chunk) - **Unfavorable clinical trial data**, from the company or competitors, could adversely affect regulatory approvals and market perception[429](index=429&type=chunk)[523](index=523&type=chunk) - **Changes in healthcare reimbursement policies** from government or private payers could reduce demand, create pricing pressure, and negatively impact revenue[369](index=369&type=chunk)[417](index=417&type=chunk) - The company may be subject to federal and state **healthcare fraud and abuse laws**, with violations leading to substantial penalties[415](index=415&type=chunk)[454](index=454&type=chunk)[455](index=455&type=chunk) [Risks Related to Intellectual Property](index=33&type=section&id=Risks%20Related%20to%20Intellectual%20Property) - The company has **no utility patent protection** and relies on trade secrets, copyrights, and limited design patents, which may not provide meaningful protection[465](index=465&type=chunk)[5](index=5&type=chunk) - The company may become involved in **costly intellectual property litigation**, either by asserting its rights or defending against claims from others[103](index=103&type=chunk)[430](index=430&type=chunk)[105](index=105&type=chunk) - **Failure to protect proprietary rights** could allow competitors to develop similar technologies, potentially damaging the company's competitive position[412](index=412&type=chunk)[6](index=6&type=chunk) [Risks Related to Our Securities](index=35&type=section&id=Risks%20Related%20to%20Our%20Securities) - The company is at risk of being **delisted from Nasdaq** for failing to maintain the minimum **$1.00 bid price requirement**[437](index=437&type=chunk)[456](index=456&type=chunk) - The company's common stock is classified as a **"penny stock"** under SEC rules, which could make it more difficult for broker-dealers to complete transactions[3](index=3&type=chunk)[485](index=485&type=chunk) - The company has **never paid cash dividends** on its common stock and does not anticipate doing so in the foreseeable future[4](index=4&type=chunk)[487](index=487&type=chunk) - **Anti-takeover provisions** in the company's charter and bylaws may prevent or frustrate attempts by stockholders to change the board or management[2](index=2&type=chunk)[448](index=448&type=chunk) [Unresolved Staff Comments](index=41&type=section&id=ITEM%201B.%20UNRESOLVED%20STAFF%20COMMENTS) The company reports that there are no unresolved staff comments - None identified[109](index=109&type=chunk)[84](index=84&type=chunk) [Properties](index=41&type=section&id=ITEM%202.%20PROPERTIES) The company leases its 8,300 square foot principal executive office in Redwood City, California, owning no real estate - The company's principal executive office is a leased space of approximately **8,300 square feet** at 203 Redwood Shores Parkway, Suite 600, Redwood City, California[109](index=109&type=chunk) - The company **does not own any real estate**[109](index=109&type=chunk) [Legal Proceedings](index=41&type=section&id=ITEM%203.%20LEGAL%20PROCEEDINGS) The company is not a party to any material legal or governmental regulatory proceedings - The company is **not currently a party** in any material legal or governmental regulatory proceeding[111](index=111&type=chunk) [Mine Safety Disclosures](index=41&type=section&id=ITEM%204.%20MINE%20SAFETY%20DISCLOSURES) This item is not applicable to the company - Not applicable[112](index=112&type=chunk)[143](index=143&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities](index=42&type=section&id=ITEM%205.%20MARKET%20FOR%20REGISTRANT%27S%20COMMON%20EQUITY%2C%20RELATED%20STOCKHOLDER%20MATTERS%2C%20AND%20ISSUER%20PURCHASES%20OF%20EQUITY%20SECURITIES) The company's common stock trades on NASDAQ, with 51 million shares outstanding, and no cash dividends are anticipated - The company's common stock has traded on **NASDAQ** under the symbol "BTCY" since August 26, 2021, with a closing price of **$0.47** per share on March 31, 2023[87](index=87&type=chunk) - As of June 29, 2023, there were **51,047,865 shares** of common stock issued and outstanding[88](index=88&type=chunk) - The company does not anticipate paying **no cash dividends** on common shares, while Series A preferred shares earn a **12% per annum dividend**[90](index=90&type=chunk) - In March 2023, the company adopted a new **2023 Equity Incentive Plan**, reserving **5,000,000 shares** plus shares remaining from the 2016 plan[95](index=95&type=chunk) [Selected Financial Data](index=45&type=section&id=ITEM%206.%20SELECTED%20FINANCIAL%20DATA) This item is not applicable as the company is a smaller reporting company - Not applicable to a smaller reporting company[17](index=17&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=45&type=section&id=ITEM%207.%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) Revenue grew 26% to $9.6 million, net loss narrowed, but liquidity challenges raise going concern doubt [Results of Operations](index=48&type=section&id=Results%20of%20Operations) Financial Performance Summary (USD) | Metric | FY 2023 (USD) | FY 2022 (USD) | Change (USD) | | :--- | :--- | :--- | :--- | | **Revenue** | **$9,639,057** | **$7,650,269** | **+$1,988,788** | | Gross Profit | $5,442,033 | $4,570,153 | +$871,880 | | Gross Margin | 56.5% | 59.7% | -3.2% | | Operating Expenses | $20,851,744 | $21,301,414 | -$455,212 | | **Loss from Operations** | **($15,409,711)** | **($16,731,261)** | **+$1,327,092** | | **Net Loss** | **($18,658,143)** | **($29,130,477)** | **+$10,472,334** | - Revenue growth of **26%** was primarily driven by an increase in technology fees, which rose to **$8.8 million** in FY2023 from **$5.9 million** in FY2022[529](index=529&type=chunk)[57](index=57&type=chunk) - The **slight decrease in gross margin** was due to discounts on device hardware sales intended to increase volumes and expand subscription billings[25](index=25&type=chunk) - Selling, general and administrative (SG&A) expenses **decreased by $0.9 million** to **$17.6 million**, primarily due to increased monitoring of spending efficiency[26](index=26&type=chunk) [Liquidity and Capital Resources](index=52&type=section&id=Liquidity%20and%20Capital%20Resources) - Management has noted **substantial doubt** about the company's ability to continue as a going concern, with only **$0.6 million** in cash deposits as of March 31, 2023[30](index=30&type=chunk) - The company will need to secure **additional funding** through equity or debt financing to fund operations for the next twelve months[30](index=30&type=chunk)[68](index=68&type=chunk) Cash Flow Summary (USD) | Cash Flow Activity | FY 2023 (USD) | FY 2022 (USD) | | :--- | :--- | :--- | | Net cash used in operating activities | ($13,547,935) | ($15,163,384) | | Net cash used in investing activities | $0 | ($29,767) | | Net cash provided by financing activities | $2,001,603 | $25,168,230 | - Net cash from financing activities **decreased significantly** from **$25.2 million** in FY2022 to **$2.0 million** in FY2023, as the prior year included Nasdaq uplisting proceeds[55](index=55&type=chunk)[70](index=70&type=chunk) [Critical Accounting Policies](index=56&type=section&id=Critical%20Accounting%20Policies) - Revenue is recognized in accordance with **ASC 606**, with technology fee revenue recognized upon study completion and device sales revenue upon delivery[71](index=71&type=chunk)[519](index=519&type=chunk) - **Significant accounting estimates** are required for share-based compensation, impairment analysis, fair value of warrants, convertible debt, derivative liabilities, and inventory obsolescence[75](index=75&type=chunk)[545](index=545&type=chunk) - **Derivative liabilities** related to convertible notes and preferred shares are measured at **fair value**, with changes recognized in the statement of operations using complex models[77](index=77&type=chunk)[667](index=667&type=chunk) - Inventories are stated at the **lower of cost or market value**, with write-downs for obsolete or excess inventory charged to cost of revenue[73](index=73&type=chunk)[60](index=60&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=63&type=section&id=ITEM%207A.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) This item is not applicable as the company is a smaller reporting company - Not applicable to a smaller reporting company[151](index=151&type=chunk) [Financial Statements and Supplementary Data](index=63&type=section&id=ITEM%208.%20FINANCIAL%20STATEMENTS%20AND%20SUPPLEMENTARY%20DATA) The company's financial statements and corresponding notes are included in the report, beginning on page F-1 - The company's financial statements and related notes can be found starting on page **F-1** of the Annual Report[152](index=152&type=chunk) [Changes in and Disagreements with Accountants on Accounting and Financial Disclosures](index=63&type=section&id=ITEM%209.%20CHANGES%20IN%20AND%20DISAGREEMENTS%20WITH%20ACCOUNTANTS%20ON%20ACCOUNTING%20AND%20FINANCIAL%20DISCLOSURES) The company reports no changes in or disagreements with its accountants on accounting and financial disclosures - None[153](index=153&type=chunk) [Controls and Procedures](index=63&type=section&id=ITEM%209A.%20CONTROLS%20AND%20PROCEDURES) Management evaluated disclosure controls and internal control over financial reporting, concluding both were effective with no material changes - Management concluded that the company's disclosure controls and procedures were **effective** as of the end of the reporting period[134](index=134&type=chunk)[172](index=172&type=chunk) - Based on an assessment using the COSO framework, management concluded that the company's internal control over financial reporting was **effective** as of March 31, 2023[155](index=155&type=chunk) - There were **no changes** in internal controls over financial reporting during the fiscal year that materially affected these controls[157](index=157&type=chunk) PART III [Directors and Executive Officers and Corporate Governance](index=65&type=section&id=ITEM%2010.%20DIRECTORS%20AND%20EXECUTIVE%20OFFICERS%20AND%20CORPORATE%20GOVERNANCE) This section identifies executive officers and directors, outlines corporate governance, and includes board diversity information - The company's executive officers include **Waqaas Al-Siddiq (President, CEO, Chairman)** and **John Ayanoglou (CFO)**[178](index=178&type=chunk)[180](index=180&type=chunk)[182](index=182&type=chunk) - The Board of Directors has **three standing committees**: Audit, Compensation, and Nominating and Corporate Governance[190](index=190&type=chunk) - The **Audit Committee** is responsible for overseeing the independent auditor, reviewing financial statements, and managing risk assessment policies[203](index=203&type=chunk)[191](index=191&type=chunk) Board Diversity (As of June 29, 2023) | Board Diversity (As of June 29, 2023) | | :--- | | **Total Directors: 4** | | **Gender Identity** | | Male: 4 | | **Demographic Background** | | African American or Black: 1 | | Asian: 1 | | White: 3 | | *Note: Some directors may identify with more than one demographic background.* | [Executive Compensation](index=68&type=section&id=ITEM%2011.%20EXECUTIVE%20COMPENSATION) This section details executive compensation for FY2023 and FY2022, including salary, bonus, and equity awards for key officers Executive Compensation Summary (USD) | Executive | Fiscal Year | Salary (USD) | Bonus (USD) | Option/Warrant Awards (USD) | Total Compensation (USD) | | :--- | :--- | :--- | :--- | :--- | :--- | | **Waqaas Al-Siddiq (CEO)** | **2023** | **$480,000** | **$240,000** | **$428,757** | **$1,160,757** | | | 2022 | $480,000 | $225,000 | $169,513 | $886,513 | | **John Ayanoglou (CFO)** | **2023** | **$293,750** | **$0** | **$232,537** | **$538,287** | | | 2022 | $300,000 | $75,000 | $504,910 | $891,910 | - CEO Waqaas Al-Siddiq's employment agreement provides for a salary of **$480,000** for FY2023 and eligibility for a cash/equity bonus of up to **50%** of his annual salary[196](index=196&type=chunk) - CFO John Ayanoglou's base salary for calendar year 2023 was set at **$300,000**, including annual grants of warrants to purchase **200,000 shares** of common stock[187](index=187&type=chunk) [Security Ownership of Certain Beneficial Owners and Management](index=73&type=section&id=ITEM%2012.%20SECURITY%20OWNERSHIP%20OF%20CERTAIN%20BENEFICIAL%20OWNERS%20AND%20MANAGEMENT) This section discloses beneficial ownership of common stock, with CEO Waqaas Al-Siddiq as the largest individual shareholder at 15.08% Beneficial Ownership as of June 29, 2023 | Name of Beneficial Owner | Shares Beneficially Owned | % of Shares Beneficially Owned | | :--- | :--- | :--- | | Waqaas Al-Siddiq (CEO) | 9,053,997 | 15.08% | | All directors and executive officers as a group | 11,925,924 | 19.86% | - Beneficial ownership is determined by **SEC rules** and includes voting and/or investment power, including shares subject to options and warrants exercisable within 60 days[590](index=590&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=74&type=section&id=ITEM%2013.%20CERTAIN%20RELATIONSHIPS%20AND%20RELATED%20TRANSACTIONS%2C%20AND%20DIRECTOR%20INDEPENDENCE) The company reports no certain relationships or related transactions that require disclosure - None[594](index=594&type=chunk) [Principal Accountant Fees and Services](index=75&type=section&id=ITEM%2014.%20PRINCIPAL%20ACCOUNTANT%20FEES%20AND%20SERVICES) This section presents fees paid to the principal accountant for professional services for FY2023 and FY2022 Principal Accountant Fees (USD) | Fee Category | FY 2023 (USD) | FY 2022 (USD) | | :--- | :--- | :--- | | Audit Fees | $145,733 | $169,250 | | **Total Fees** | **$145,733** | **$169,250** | - The Board **pre-approves** all audit and permitted non-audit services to be performed by the independent auditors[599](index=599&type=chunk) PART IV [Exhibits, Financial Statement Schedules](index=75&type=section&id=ITEM%2015.%20EXHIBITS%2C%20FINANCIAL%20STATEMENT%20SCHEDULES) This section lists exhibits filed as part of the Form 10-K report, including corporate governance documents and material contracts - Lists **key corporate documents** filed as exhibits, including Amended and Restated Articles of Incorporation (Exhibit 3.1) and By-Laws (Exhibit 3.2)[601](index=601&type=chunk) - Includes **material agreements** such as the 2016 Equity Incentive Plan (Exhibit 10.5) and various credit and employment agreements[602](index=602&type=chunk) - Contains **required certifications** from the Principal Executive Officer and Principal Financial Officer under Sections 302 and 906 of the Sarbanes-Oxley Act[603](index=603&type=chunk)