HeartSciences Inc.
For the period ended Jul 31, 2025. Filed Sep 11, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jul 31, 2025 · Filed Sep 11, 2025
HSCS$2.83+6.0%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-01-31; filed 2025-03-13.
0000950170-25-038699
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-07-31; filed 2025-09-11.
0001468492-25-000010
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 75 previous paragraphs and 81 current paragraphs.
28 unchanged; 22 reworded; 31 added; 23 removed; 2 previous and 0 current paragraphs rearranged.
Tables are not compared: 2 previous and 2 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (31)
Current report
Phase 1 of the MyoVista Insights Cloud Platform has been launched, and we expect revenues will come from a combination of install fees and SaaS based usage fees. We expect to adopt a recurring subscription revenues model for AI-ECG algorithms hosted on either the platform or device based on algorithm or device usage including proprietary device based consumable revenue. Our MyoVista Insights Cloud Platform has been designed to provide an algorithm marketplace and host third party AI-ECG algorithms, which increases its clinical value and our speed to market as well as reducing Research and Development ("R&D") costs associated with internal algorithm development.
Current report
Our first AI-ECG algorithm expected to be hosted on the MyoVistawav ECG device has been designed by the Company and applies AI-machine learning to the signal processed ECG signal to develop a proprietary algorithm designed to detect the echocardiographic measure for impaired cardiac relaxation (e’) (i.e. cardiac dysfunction). In July 2025, the American Society of Echocardiography (“ASE”) released updated guidelines for evaluating Left Ventricular Diastolic Dysfunction (“LVDD”), placing increased emphasis on cardiac relaxation (e’) and now requiring specific age-based threshold adjustments. Although we incorporated age-based measures, previously agreed with the FDA, we expect to update the algorithm to the new ASE published age-based measures prior to FDA submission and also make it available on both the MyoVista Insights Cloud Platform and MyoVistawav ECG device.
Current report
Previously, we intended to combine, in a single FDA submission, the MyoVistawav ECG and the impaired cardiac relaxation algorithm under two separate two product codes. We now intend to make separate submissions to the FDA for the device and software algorithm which we believe would simplify and speed up the FDA submission and clearance process and allow us to make the algorithm available on both the device and MyoVista Insights Cloud Platform.
Current report
Amendment to the Bylaws
Current report
On June 27, 2025, in connection with certain recent changes to the Texas Business Organizations Code (“TBOC”) and in light of Texas law, the Board adopted certain amendments to the Company’s Bylaws (the “Bylaw Amendments”) in order to: (i) add a new section to provide for a jury trial waiver for “internal entity claims” as defined in the TBOC; (ii) add a new section to adopt an ownership threshold requiring any shareholder or group of shareholders to hold shares of common stock sufficient to meet an ownership threshold of at least 3% of the Company’s issued and outstanding shares in order to institute or maintain a derivative proceeding; and (iii) make technical revisions to clarify the scope of the exclusive forum provision. The Bylaw Amendments, adopted in accordance with Texas law, became effective on June 27, 2025.
Current report
Going Concern
Current report
On July 24, 2025, our independent registered public accounting firm issued an opinion on our audited financial statements, included in our Annual Report on Form 10-K for the year ended April 30, 2025, that contained an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern because we have experienced recurring losses, negative cash flows from operations, and limited capital resources.
Current report
On March 19, 2025, we received a letter from Nasdaq stating that we were not in compliance with the minimum stockholders’ equity requirement for continued listing on the Nasdaq Capital Market, under Listing Rule 5550(b)(1)(the “Minimum Stockholders’ Equity Requirement”), because our stockholders’ equity of $1,786,689 as reported in our Quarterly Report on Form 10-Q for the period ending January 31, 2025, was below the required minimum of $2.5 million, and because, as of January 31, 2025, we did not meet the alternative compliance standards, relating to the market value of listed securities of $25 million or net income from continuing operations of $500,000 in the most recently completed fiscal year or two of the last three most recently completed fiscal years.
Current report
On May 5, 2025, we submitted to Nasdaq a plan to regain compliance with the Minimum Stockholders’ Equity Requirement. On May 14, 2025, Nasdaq notified us that they granted us an extension of up to 180 calendar days from March 19, 2025, or through September 15, 2025, to regain compliance. The Company intends to take all reasonable measures available to regain compliance under the Nasdaq Listing Rules and remain listed on Nasdaq. While there can be no assurance that the Company will be able to regain compliance with all applicable Nasdaq continued listing requirements, the Company continues to implement various steps taken to date, and is evaluating its available options, to resolve the deficiency and regain compliance with the Minimum Stockholders’ Equity Requirement as soon as possible by the above referenced deadline.
Current report
In June 2025, we were granted a foundational patent from the USPTO covering the estimation of echocardiography parameters indicative of heart function using an ECG.
Current report
FDA Breakthrough Device Designation
Current report
In June 2025, we were granted “Breakthrough Device” designation by the FDA for our aortic stenosis ECG algorithm.
Current report
Series D Preferred Stock Offering and Certificate of Designations of Series D Preferred Stock
Current report
Pursuant to the Placement Agent Agreement, the Placement Agent will be entitled to receive from each closing of the Offering (i) a cash fee of 7% of the gross proceeds received by the Company from such closing, (ii) warrants (the "Agent Unit Warrants") to purchase 3% of the total number of Units sold by the Company at such closing (the "Agent Units") at an exercise price of $4.375 per Agent Unit Warrant, with each Agent Unit consisting of one share of Series D Preferred Stock (the "Agent Preferred Shares") and one Warrant (the "Agent Warrants" and the shares of Common Stock underlying such Agent Warrants, the "Agent Warrant Shares"), and (iii) reimbursement of certain of its out-of-pocket expenses. Digital Offering is acting on a “reasonable best efforts” basis, in connection with the Offering and is under no obligation to purchase any of the Units or arrange for the sale of any specific number or dollar amount of shares of the Units.
Current report
As of the date of this Quarterly Report, we have issued 1,556,409 Units consisting of shares of Series D Preferred Stock and Warrants to purchase shares of Common Stock for gross proceeds of approximately $5.4 million. As of the date of this Quarterly Report, no Agent Units have been issued and 1,054,549 shares of Series D Preferred Stock have been converted into 1,054,549 shares of Common Stock.
Current report
Amendment No. 3 to the Equity Distribution Agreement
Current report
On August 3, 2025, the Company entered into Amendment No. 3 to the Original EDA (the “Third Amended EDA” and, collectively with the Amendments to the EDA, the “EDA”) with Maxim Group pursuant to which the Company may offer and sell, from time to time, up to $25,000,000 of shares of Common Stock and the parties further agreed that Maxim will be entitled to compensation at a commission rate equal to 4.0% of the gross sales price per share sold pursuant to the EDA up to a maximum of $11,036,310 in gross proceeds to the Company, and 3.0% of the gross sales price per share sold pursuant to the EDA from any gross proceeds to the Company in excess of such amount; provided, however, that in no event will the Company issue or sell through the Sales Agent such number of shares of Common Stock that would cause the Company or the offering of its shares of Common Stock to not satisfy the eligibility and transaction requirements for use of Form S-3 (including General Instruction I.B.6 of Form S-3). As of July 31, 2025, the aggregate market value of the Company’s outstanding shares of Common Stock held by non-affiliates was $14,737,609, which was calculated based on 2,276,253 outstanding shares of Common Stock held by non-affiliates on July 31, 2025 and a price per share of $5.73, which was the closing price of the Common Stock on July 10, 2025 and is the highest closing sale price of Common Stock on the Nasdaq Capital Market within the prior 60 days. Pursuant to General Instruction I.B.6 of Form S-3, in no event will the Company sell the shelf securities in a public primary offering with a value exceeding more than one-third of the aggregate market value of the Company’s voting and non-voting ordinary shares held by non-affiliates in any 12-month period as long as the aggregate market value of the
Current report
Company’s outstanding ordinary shares held by non-affiliates is less than $75 million. During the 12 calendar months prior to, the Company has not sold any shares of Common Stock pursuant to General Instruction I.B.6 of Form S-3.
Current report
Results of Operations
Current report
Revenues
Current report
Revenues, which have been minimal to date, consist mainly of sales of devices, electrodes and other supplies in the establishment of distributor relationships outside the U.S. during the approval, development and improvement of the MyoVistawav ECG.
Current report
Cost of Sales
Current report
Cost of sales consists primarily of costs related to materials, components and subassemblies. Cost of sales also includes certain direct costs such as those incurred for shipping and freight.
Current report
Other Income (Expense), Net
Current report
Other income (expense), net primarily consists of interest earned on cash balances.
Current report
Research and development expenses were $997,000 for the three months ended July 31, 2025, representing a decrease of $228,000, or 19% when compared to the same periods in 2024. The decrease is primarily due to reduced cloud consulting costs as we have completed phase 1 of our MyoVista Insights Cloud Platform providing an initial functioning platform as a basis for FDA submission and clearance contemporaneous with our first cloud-based AI-ECG algorithm.
Current report
Selling, general, and administrative expenses were approximately $878,000 for the three months ended July 31, 2025, representing an increase of $27,000, or 3% when compared to the same periods in 2024. The increase is primarily due to approximately $100,000 increase in stock compensation expense during the quarter ended July 31, 2025, offset by reductions in marketing costs, professional fees related to the Reverse Stock Split, and patent costs in an aggregate amount of approximately $81,000.
Current report
On March 10, 2025, the Company commenced an offering on a "best efforts" basis for a maximum of up to 4,285,714 Units. Each Unit (each a "Unit" and collectively the “Units”) consists of one (1) share of Series D Convertible Preferred Stock, par value $0.001 per share (the “Series D Preferred Stock”), and one (1) warrant the (“Warrants”), each to purchase one (1) share of the Company's Common
Current report
Stock. The Units will be sold at an offering price of $3.50 per Unit, for a maximum offering amount of $15.0 million worth of units. During the three months ended July 31, 2025, the Company issued 1,317,689 Units for gross proceeds of approximately $4.6 million. Subsequent to July 31, 2025, the Company issued 238,720 Units for gross proceeds of approximately $0.8 million, and there was approximately $9.6 million available for issuance as of the financial statement issuance date. We expect any proceeds received from the offering will be used for working capital and general corporate purposes.
Current report
In September 2023, the Company entered into an Equity Distribution Agreement (“EDA”) with an institutional investor, pursuant to which the Company may offer and sell an aggregate of up to $3.25 million of its shares of Common Stock in At-the-Market offerings (“ATM Facility”). In November 2023, the EDA was further amended increasing the aggregate amount of Common Stock that may be sold under the ATM Facility to up to $15.0 million, and further amended again in August 2025, increasing the aggregate amount of Common Stock that may be sold under the ATM Facility from to up to $25.0 million. The Company is eligible to sell up to $14.7 million worth of shares of Common Stock as the aggregate market value of the Company's shares of Common Stock eligible for sale under the EDA is subject to limitations of General Instruction I.B.6 of Form S-3 until such time that the Company's public float equals or exceeds $75.0 million. In the event the aggregate market value of the Company’s outstanding Common Stock held by non-affiliates equals or exceeds $75.0 million, then the one-third limitation on sales set forth in General Instruction I.B.6 of Form S-3 shall not apply to additional sales made pursuant to the EDA. There were no shares issued under the ATM during the three months ended July 31, 2025, and there was approximately $4.3 million available for issuance as of the financial statement issuance date. We expect any proceeds received from the ATM Facility will be used for working capital and general corporate purposes.
Current report
In March 2023, the Company entered into a purchase agreement with Lincoln Park Capital Fund, LLC (“Lincoln Park”) providing for the purchase, from time to time at the Company’s discretion, of up to $15.0 million of the Company’s Common Stock, over the thirty-six (36) month term of the purchase agreement (“Equity Line”). There were no shares issued under the equity line during the three months ended July 31, 2025. As of the date of this Quarterly Report, the Company has issued and sold an aggregate 253,617 shares of Common Stock, including 1,625 commitment shares, under the Equity Line receiving gross proceeds of approximately $2.2 million and there was approximately $12.8 million available for issuance under the Equity Line. We expect any proceeds received from the Equity Line will be used for working capital and general corporate purposes.
Removed paragraphs (23)
Previous report
Our first AI-ECG algorithm to be incorporated into the MyoVistawav ECG device has been designed by the Company and applies AI-machine learning to the signal processed ECG signal to develop a proprietary algorithm designed to detect impaired cardiac relaxation, or cardiac dysfunction caused by heart disease and/or age-related cardiac dysfunction. We have been adjusting the algorithm to reflect updated echo measurement thresholds in respect of ≥60-year-old patients. The change was made, and agreed with the FDA, to reflect recent clinical findings which we believe will further increase the clinical value of this algorithm.
Previous report
Corporate Name Change
Previous report
On October 17, 2024, the Company filed a Certificate of Amendment to its Amended and Restated Certificate of Formation with the Secretary of State of Texas to change the Company's corporate name to “HeartSciences Inc.”, with an effective date of October 17, 2024. The Name Change was approved by the Company's shareholders at the Company's Annual Meeting of Shareholders held on January 17, 2024. The Name Change became effective at the open of market on October 23, 2024, and does not affect the Company’s ticker symbols or the applicable CUSIP number for the Company’s outstanding shares of Common Stock and public warrants.
Previous report
On August 2, 2023, we received a letter from the Staff indicating that, based upon the closing bid price of the Company’s Common Stock for the last 30 consecutive business days, the Company no longer met the Minimum Bid Price Requirement. In accordance with Nasdaq listing rules, we had until January 29, 2024 to regain compliance with the Minimum Bid Price Requirement. In the event we did not regain compliance during this period, we were eligible to seek an additional 180 calendar day compliance period if we met the Nasdaq continued listing requirement for market value of publicly held shares and all other initial listing standards, with the exception of the Minimum Bid Price Requirement, and provide written notice to Nasdaq of our intent to cure the deficiency during this second compliance period.
Previous report
We attended an August 17, 2023 hearing before the Nasdaq Hearing Panel(the “Panel”), and requested the continued listing of its securities on the Nasdaq Capital Market pending our return to compliance with the Minimum Bid Price Requirement.
Previous report
On January 30, 2024, we received a letter from the Panel advising that we have been granted an additional 180-day extension to July 29, 2024, to regain compliance with the Minimum Bid Price Requirement.
Previous report
On May 9, 2024, the Company received a Staff Determination from Nasdaq to delist the Company’s securities from the Nasdaq Capital Market. The Staff Determination was issued because, as of May 8, 2024, the Company’s Common Stock had a closing bid price of $0.10 or less for at least ten consecutive trading days. Accordingly, the Company is subject to the provisions contemplated under Nasdaq Listing Rule 5810(c)(3)(A)(iii) (the “Low Priced Stocks Rule”).
Previous report
On May 17, 2024, the Company effected the Reverse Stock Split, such that as a result of the Reverse Stock Split, every 100 shares of the Company's issued and outstanding pre-reverse split Common Stock were combined into one share of Common Stock.
Previous report
On June 3, 2024, the Company received a letter from Nasdaq informing the Company that the Nasdaq Listing Qualifications staff has confirmed that the Company has regained compliance with the $1.00 per share minimum bid price requirement pursuant to the Minimum Bid Price Requirement, and that the Company is therefore in compliance with Nasdaq’s listing requirements. The Company's Common Stock and public warrants continue to be listed on Nasdaq.
Previous report
Reverse Stock Split
Previous report
On May 6, 2024, the Company filed a Certificate of Amendment to the Amended and Restated Certificate of Formation with the Secretary of the State of Texas to effect the Reverse Stock Split of its outstanding shares of Common Stock, with an effective date of May 17, 2024. As a result of the Reverse Stock Split, equitable adjustments corresponding to the Reverse Stock Split ratio were made to the Company’s outstanding warrants and its other convertible instruments and upon the exercise or vesting of all stock options such that every 100 shares of Common Stock that may be issued upon the exercise of the Company’s warrants and stock options and conversion of its other convertible instruments held immediately prior to the Reverse Stock Split represent one share of Common Stock that may be issued upon exercise of such warrants and stock options and conversion of the other convertible instruments immediately following the Reverse Stock Split. Correspondingly, the exercise price per share of Common Stock attributable to the Company’s warrants and stock options and the conversion price of its other convertible instruments immediately prior to the Reverse Stock Split was proportionately increased by a multiple of 100 following the Reverse Stock Split.
Previous report
In May 2024, we were granted a patent from the Indian Patent Office covering MyoVista wavelet technology.
Previous report
In July 2024, we were granted a patent allowance from the United States Patent and Trademark Office for the detection of left ventricular and/or right ventricular dysfunction using deep learning.
Previous report
Debt Extension
Previous report
On August 19, 2024, the Company and FRV entered into Amendment No. 6 to the Loan and Security Agreement to further extend the maturity date of the FRV Note to September 30, 2025 and pay the outstanding accrued interest as follows: (i) a payment of all accrued interest outstanding within five (5) business days of execution of the agreement; (ii) a payment of accrued interest on September 30, 2024 and (iii) thereafter all accrued interest due shall be payable at maturity. In August and September 2024, the Company paid approximately $305,000 in accrued interest to FRV.
Previous report
Series D Preferred Stock Offering
Previous report
Digital Offering will act as the lead selling agent for the offering pursuant to the terms of the Selling Agency Agreement. Under the Selling Agency Agreement, the Company has agreed to pay Digital Offering a commission of 7% of the gross proceeds received in the offering and the Company will reimburse Digital Offering for its reasonable and documented legal costs up to a maximum of $85,000, of which $25,000 has been paid to date. Digital Offering is acting on a “reasonable best efforts” basis, in connection with the offering. Digital Offering is under no obligation to purchase any of the units or arrange for the sale of any specific number or dollar amount of shares of the units.
Previous report
As of the date of this Quarterly Report on Form 10-Q, the Company has not received any proceeds from the offering.
Previous report
Research and development expenses were $1.0 million and $3.5 million for the three and nine months ended January 31, 2025, representing an increase of $524,000, or 103% , and an increase of $1.6 million, or 89%, when compared to the same periods in 2024. The increase is primarily due to consulting costs incurred for development of our MyoVista Insights Cloud Platform and increase in headcount and professional services supporting the FDA submission process.
Previous report
Selling, general, and administrative expenses were approximately $1.3 million and $3.0 million for the three and nine months ended January 31, 2025, representing an increase of $312,000, or 30%, and an increase of $369,000, or 14%, when compared to the same periods in 2024. The increase is primarily related to legal, accounting, and other professional fee expenses amounting to approximately $611,000 resulting from the withdrawal of the Company's S-1/A registration statement in December 2024, offset by a decrease in investor relation related expenditures of approximately $150,000, a reduction in stock-based compensation of approximately $89,000, and reduced D&O premiums of approximately $25,000.
Previous report
On March 10, 2023, we entered into the Lincoln Park Purchase Agreement providing for the purchase, from time to time at our discretion, of up to $15.0 million of our Common Stock, over the 36-month term of the agreement. Actual sales of shares of Common Stock will depend on a variety of factors to be determined by us from time to time. The net proceeds received from these purchases will depend on the frequency and prices at which we sell shares of our Common Stock to Lincoln Park. As of the date of this Quarterly Report, we have received approximately $2.1 million from the sale of Common Stock pursuant to the Lincoln Park Purchase Agreement. We expect that any proceeds received from such sales to Lincoln Park will be used for working capital and general corporate purposes.
Previous report
On September 18, 2023, we entered into an EDA with Maxim Group LLC as sales agent pursuant to which we may offer and sell up to $3.25 million of our shares of Common Stock in at-the-market offerings. The EDA was further amended on November 9, 2023 and again on November 17, 2023, to increase the amount of shares of Common Stock we may sell to up to $15.0 million. The shares of Common Stock may be issued and sold from time to time through or to the placement agent acting as sales agent or principal pursuant to our shelf registration statement on the Shelf S-3, as filed with the SEC on September 18, 2023. As of the date of this Quarterly Report, we have received approximately $9.8 million in net proceeds, after Maxim fees, legal fees and other costs, from the sale of Common Stock pursuant to the amended EDA. We expect that any proceeds received from such sales under the ATM Facility will be used for working capital and general corporate purposes
Previous report
In September 2024, the Company entered into a Note Purchase Agreement with Streeterville pursuant to which Streeterville issued the Company an unsecured promissory note in the amount of $2,510,000 which included an original issuance discount of $500,000 and reimbursement of Streeterville's transaction expenses of $10,000. The Company incurred placement agent fees equal to 7% of the gross proceeds received from the sale of the Streeterville Note. The Company received approximately $1.9 million in net cash proceeds from the sale of the Streeterville Note.
Reworded paragraphs (22)
Previous wording
We are a medical technology company focused on applying innovative AI-based technology to an ECG, also known as an “EKG,” to expand and improve an ECG’s clinical usefulness. Our objective is to make an ECG a far more valuable cardiac screening tool by expanding its clinical capability to detect a broader range of heart disease conditions through the development of AI-ECG. We are seeking to provide AI-ECG solutions in any care setting worldwide in a manner that best suits different providers, either via our cloud-based application that can receive an upload from one of the millions of ECG devices currently in clinical use or via our proprietary MyoVistawav ECG device. The MyoVistawav ECG, is a resting 12-lead ECG that will incorporate HeartSciences’ proprietary AI-ECG algorithm designed to provide diagnostic information related to cardiac dysfunction as well as conventional ECG information in the same test. We are also developing a cloud-based platform to host AI-ECG algorithms on an ECG hardware agnostic basis (the “MyoVista Insights Cloud Platform”). In the future, we intend to offer a range of AI-ECG algorithms, via each product. Neither the MyoVistawav ECG device, MyoVista Insights Cloud Platform nor any of our AI-ECG algorithms are yet cleared for marketing by the FDA.
Current wording
We are a medical technology company focused on applying AI and innovative software technology to expand and improve ECG’s (also known as an EKG) clinical usefulness. Our objective is to provide modernized ECG software and hardware platforms that will allow ECGs to be far more valuable cardiac screening tools by expanding clinical capabilities to detect a broader range of heart disease using Artificial Intelligence. We are seeking to provide both hardware and software solutions that can be used in almost any care setting worldwide, either via our MyoVista Insights cloud-based ECG management and AI-ECG algorithm hosting platform using one of the millions of ECG devices currently in clinical use or via our proprietary MyoVistawav ECG device. We have been developing a cloud-based platform to modernize ECG management systems that can also host state-of-the-art AI-ECG algorithms on an ECG hardware agnostic basis (the “MyoVista Insights Cloud Platform”). The MyoVistawav ECG, is a resting 12-lead ECG has been developed to host AI-ECG software algorithm(s) designed to make available on-device AI-ECG algorithms as well as conventional ECG information in the same test. We intend to offer a range of software-based AI-ECG algorithms, via each product. The MyoVista Insights Cloud Platform does not require FDA clearance. AI-ECG algorithms to be delivered on MyoVista Insights Cloud Platform or the MyoVistawav ECG device would each require FDA clearance and, as yet, those are not available.
Previous wording
The AI-ECG algorithms are intended to provide diagnostic information which has traditionally required cardiac imaging. We believe, the combination of a device agnostic cloud platform and MyoVistawav ECG device would allow us to offer AI-ECG solutions across a wide range of healthcare settings from large heath systems to frontline or point of care environments such as primary care. The initial revenue model for the MyoVistawav ECG device, which involves the use of the MyoVista hardware, associated software and consumables for each test, is expected to be “razor-razorblade” as the cable connection to the electrodes used with the MyoVistawav ECG are proprietary to HeartSciences, and new electrodes are used for every test performed. As further algorithms are made commercially available via the MyoVistawav ECG or the MyoVista Insights Cloud Platform, we would expect to adopt revenue models based on algorithm usage and/or recurring subscriptions. Our MyoVista Insights Cloud Platform is being designed to fit simply into existing clinical workflows and be available to host third party AI-ECG algorithms, which increases its clinical value and our speed to market as well as reducing R&D costs associated with internal algorithm development.
Current wording
The AI-ECG algorithms are intended to provide diagnostic information which has traditionally required cardiac imaging. We believe the combination of a device agnostic cloud platform and MyoVistawav ECG device would allow us to offer AI-ECG s algorithms developed by us or other third parties across a wide range of healthcare settings from large heath systems to frontline or point of care environments such as primary care.
Previous wording
On September 20, 2023, we entered into the License Agreements with Mount Sinai to commercialize a range of AI-ECG algorithms covering a range of cardiovascular conditions developed by Mount Sinai as well as a memorandum of understanding for ongoing cooperation encompassing de-identified data access, on-going research, and the evaluation of the MyoVistawav ECG device.
Current wording
On September 20, 2023, we entered into multiple definitive license agreements (each a “License Agreement” and collectively, the “License Agreements”) with Mount Sinai to commercialize a range of AI-ECG algorithms covering a range of cardiovascular conditions developed by Mount Sinai as well as a memorandum of understanding for ongoing cooperation encompassing de-identified data access, on-going research, and the evaluation of the MyoVistawav ECG device.
Previous wording
We expect the first AI-ECG algorithm to be submitted as part of the MyoVista Insights Cloud Platform will be for detection of low ejection fraction, or systolic dysfunction, and based on one of those licensed from Mount Sinai.
Current wording
The Company has designed or licensed algorithms designed to help address these limitations and extend the clinical capability of an ECG to detect cardiac dysfunction and other heart disease types. We expect the first AI-ECG algorithm to be submitted for use on the MyoVista Insights Cloud Platform would be for detection of low ejection fraction, or systolic dysfunction, and based on one of those licensed from Mount Sinai.
Previous wording
New Class II devices, such as our products, require FDA premarket review. The MyoVistawav ECG device along with its proprietary software and hardware is classified as a Class II medical device by the FDA. Premarket review and clearance by the FDA for these devices is generally accomplished through the 510(k) premarket notification process or De Novo classification request, or petition process. We previously submitted an FDA De Novo classification request in December 2019 and, following feedback and communications with the FDA during and since that submission, we have been making modifications to our device, including our proprietary algorithm. We have finished the patient recruitment and core lab work for our FDA validation study and have been undertaking device and algorithm development testing for a revised FDA submission. We had been planning a revised submission under the De Novo pathway, however, in December 2023 the FDA confirmed that we could submit the MyoVistawav ECG device for clearance under the 510(k) pathway following the grant by the FDA in August 2023 of an industry-first De Novo clearance which created a new Class II product code for cardiovascular machine learning-based notification software. This was in respect of a hypertrophic cardiomyopathy algorithm and in late September 2023, the FDA cleared an algorithm for low ejection fraction (less than 40%) under the 510(k) pathway using this new product code. Accordingly, we are now preparing for a 510(k) FDA submission and are aiming for a submission in the first half of 2025. If successful, FDA clearance would provide us the ability to market and sell the MyoVistawav ECG device in the U.S. and additional funding would be required to support the sales launch of the MyoVistawav ECG device in the U.S., provide working capital and support further R&D.
Current wording
New Class II devices, such as our products, require FDA premarket review. The MyoVistawav ECG device along with its proprietary software and hardware is classified as a Class II medical device by the FDA. Premarket review and clearance by the FDA for these devices is generally accomplished through the 510(k) premarket notification process or De Novo classification request, or petition process. We previously submitted an FDA De Novo classification request in December 2019 for the MyoVistawav ECG and, following feedback and communications with the FDA during and since that submission, we have been making modifications to our device, including its proprietary algorithm. We were previously planning a revised submission under the De Novo pathway, however, in December 2023 the FDA confirmed that we could submit the MyoVistawav ECG device for clearance under the 510(k) pathway following the grant by the FDA in August 2023 of an industry-first De Novo clearance which created a new Class II product code for cardiovascular machine learning-based notification software. This was in respect of a hypertrophic cardiomyopathy algorithm and in late September 2023, the FDA cleared an algorithm for low ejection fraction (less than 40%) under the 510(k) pathway using this new product code. We finished the patient recruitment and core lab work for our FDA validation study and had been undertaking device and algorithm development testing for a revised FDA submission. Following the release by the American Society of Echocardiography of updated guidelines for evaluating LVDD in July 2025, and new age-based threshold adjustments we now intend to make separate submissions to the FDA for the device and software algorithm. FDA submission of the MyoVistawav ECG device is expected in the calendar 2025.
Previous wording
To date we have not yet entered into a discussion with the FDA regarding the MyoVista Insights Cloud Platform or Mount Sinai licensed AI-ECG algorithms but we expect these products to fall under the 510(k) pathway and are aiming for an FDA submission of our MyoVista Insights Cloud Platform and low ejection fraction algorithm in the second half of 2025.
Current wording
To date we have not yet entered into a discussion with the FDA regarding the first self-developed AI-ECG algorithm for the MyoVista Insights Cloud Platform. We expect that to fall under the 510(k) pathway and are aiming for an FDA submission of a low-ejection fraction algorithm during the first half of calendar 2026.
Previous wording
In September 2024, the Company entered into a Note Purchase Agreement with Streeterville, pursuant to which the Company issued to Streeterville the unsecured Streeterville Note in the original principal amount of $2,510,000. The Streeterville Note carried an OID of $500,000 and $10,000 was withheld from the Streeterville Note for reimbursement of Streeterville's transaction expenses. Additionally, the Company incurred debt financing costs of $159,700. As a result, the Company received aggregate net proceeds of approximately $1.9 million in connection with the issuance of the Streeterville Note.
Current wording
In September 2024, the Company entered into a Note Purchase Agreement (the “Note Purchase Agreement”), with Streeterville Capital, LLC, an accredited investor (“Streeterville”), pursuant to which the Company issued to Streeterville an unsecured note in the original principal amount of $2,510,000 (the “Streeterville Note”). The Streeterville Note carried an OID of $500,000, and $10,000 was reimbursement for Streeterville's transaction expenses. Additionally, the Company incurred debt financing costs of $159,700. As a result, the Company received aggregate net proceeds of approximately $1.9 million in connection with the issuance of the Streeterville Note. As of the date of this Quarterly Report, the Company and Streeterville has exchanged $1,805,000 in aggregate principal for 506,348 shares of the Company's Common Stock and the Company has repaid in cash $450,000 of principal. The issuance of the shares were made pursuant to the exemption from the registration requirements afforded by Section 3(a)(9) of the Securities Act.
Previous wording
On March 10, 2025, the Company entered into a selling agency agreement (the“Selling Agency Agreement”) with Digital offering LLC (the“Digital Offering”), in connection with the Company's best efforts offering of up to 4,285,714 Units, with each Unit consisting of (a) one share of our Series D Convertible Preferred Stock (the“Series D Preferred Stock”) and (b) one warrant to purchase one share of our Common Stock, $0.001 par value, for a total of 4,285,714 shares of our Series D Preferred Stock and warrants to purchase up to an aggregate of 4,285,714 shares of our Common Stock. The Units will be sold at an offering price of $3.50 per Unit, for a maximum offering amount of $15.0 million worth of Units. Each warrant is exercisable at any time from the date of issuance through the third anniversary from the date of issuance, unless earlier redeemed and is exercisable to purchase one share of Common Stock at $5.00 per share, subject to customary adjustment.
Current wording
On March 10, 2025, the Company entered into a selling agency agreement (the “Placement Agent Agreement”) with Digital Offering LLC (“Digital Offering”) to act as sole placement agent (the “Placement Agent”) on a "best efforts" offering of up to 4,285,714 Units, with each Unit consisting of (a) one share of our Series D Convertible Preferred Stock (the “Series D Preferred Stock”) and (b) one warrant to purchase one share of our Common Stock, $0.001 par value, for a total of 4,285,714 shares of our Series D Preferred Stock and warrants to purchase up to an aggregate of 4,285,714 shares of our Common Stock (collectively, the "Offering"), pursuant to certain subscription agreements with certain investors, upon which each investor must complete a Subscription Agreement and submit the applicable subscription price as set forth therein. The offering price is $3.50 per Unit, for a maximum offering amount of $15.0 million worth of Units. Each warrant is exercisable at any time from the date of issuance through the third anniversary from the date of issuance, unless earlier redeemed, and is exercisable to purchase one share of Common Stock at $5.00 per share, subject to customary adjustment.
Previous wording
The Company refers to the offering therein as the “Series D Preferred Stock Offering”. On February 10, 2025, in connection with the Series D Preferred Stock Offering, the Company’s board of directors adopted a Certificate of Designations to be filed with the Secretary of State of the State of Texas (the “TX Secretary”) to create, out of the Company’s authorized but unissued preferred stock, the Series D Preferred Stock (the “Certificates of Designations”). The Company intends to file the Certificate of Designations with the TX Secretary.
Current wording
The Company refers to the offering therein as the “Series D Preferred Stock Offering”. On February 10, 2025, in connection with the Series D Preferred Stock Offering, the Company’s board of directors adopted a Certificate of Designations of Series D Preferred Stock to be filed with the Secretary of State of the State of Texas (the “TX Secretary”) to create, out of the Company’s authorized but unissued preferred stock, the Series D Preferred Stock. The Company filed the Certificate of Designations of Series D Preferred Stock with the TX Secretary on May 21, 2025.
Previous wording
Our operating expenses have consisted solely of research and development expenses and selling, general and administrative expenses.
Current wording
Our operating expenses have consisted solely of R&D expenses and selling, general and administrative expenses.
Previous wording
Our research and development activities primarily consist of clinical, regulatory, engineering and research work associated with our MyoVista wavECG device and Myo Vista Insights Cloud Platform. Research and development expenses include payroll and personnel-related costs for our research and development, clinical and regulatory personnel, including expenses related to stock-based compensation for such employees, consulting services, clinical trial expenses, regulatory expenses, prototyping and testing. Research and development expenses also include costs attributable to clinical trial expenses including clinical trial design, site development and study costs, data, related travel expenses, the cost of products used for clinical activities, internal and external costs associated with regulatory compliance and patent costs. We have expensed research and development costs as they have been incurred.
Current wording
Our R&D activities primarily consist of clinical, regulatory, engineering and research work associated with our MyoVista wavECG device and MyoVista Insights Cloud Platform. R&D expenses include payroll and personnel-related costs for our R&D, clinical and regulatory personnel, including expenses related to stock-based compensation for such employees, consulting services, clinical trial expenses, regulatory expenses, prototyping and testing. R&D expenses also include costs attributable to clinical trial expenses including clinical trial design, site development and study costs, data, related travel expenses, the cost of products used for clinical activities, internal and external costs associated with regulatory compliance and patent costs. We have expensed R&D costs as they have been incurred.
Previous wording
Interest expense relates to our loan facilities.
Current wording
Interest expense relates to our outstanding debt and related amortization of debt discount and deferred offering costs.
Previous wording
Summary of Statements of Operations for the three and nine months ended January 31, 2025 compared with the three and nine months ended January 31, 2024:
Current wording
Summary of Statements of Operations for the three months ended July 31, 2025 compared with the three months ended July 31, 2024:
Previous wording
There were no revenues for the three and nine months ended January 31, 2025. Revenues were $15,000 and cost of sales were $5,000 for the three and nine months ended January 31, 2024. Our revenues to date have been mainly generated in the establishment of distributor relationships outside the United States as part of obtaining feedback during product development and improvement of the MyoVistawav ECG.
Current wording
Revenues were $2,000 and cost of sales were $1,000 for the three months ended July 31, 2025. Our revenues in the fiscal years have been mainly generated from suppliers in the establishment of distributor relationships outside the United States as part of obtaining feedback during product development and improvement of the MyoVistawav ECG.
Previous wording
Interest expense was $179,000 and $320,000 for the three and nine months ended January 31, 2025, representing an increase of $61,000, or 52%, and a decrease of $14,000, or 4%, when compared to the same periods in 2024. Interest expense in Fiscal 2025 is related to interest on the FRV Note and interest and debt service amortization on the Streeterville Note. The JQA Note and related accrued interest converted to equity in November 2023.
Current wording
Interest expense was $184,000 for the three months ended July 31, 2025, representing an increase of $161,000 or 715% when compared to the same periods in 2024. Interest expense in Fiscal 2025 is related to interest on the FRV Note and interest and debt service amortization on the Streeterville Note.
Previous wording
Other income of $15,000 and $81,000 during the three and nine months ended January 31, 2025 is related to interest earned on our cash balances.
Current wording
Other income of $3,000 during the three months ended July 31, 2025 is related to interest earned on our cash balances.
Previous wording
We have incurred losses each year since inception and have experienced negative cash flows from operations in each year since inception. We incurred a net loss of $6.7 million for the period ended January 31, 2025. As of January 31, 2025, we had an accumulated deficit of $74.0 million and stockholder's equity of $1.8 million and working capital of $64,000.
Current wording
We have incurred losses each year since inception and have experienced negative cash flows from operations in each year since inception. We incurred a net loss of $2.1 million for the period ended July 31, 2025. As of July 31, 2025, we had an accumulated deficit of $78.2 million and stockholder's equity of $3.1 million and working capital of $1.4 million.
Previous wording
Since our inception, we have raised capital through the public and private sale of debt and equity. As of January 31, 2025, we had cash and cash equivalents balance of approximately $2.6 million, a decrease of $3.2 million from $5.8 million as of April 30, 2024.
Current wording
Since our inception, we have raised capital through the public and private sale of debt and equity. As of July 31, 2025, we had cash and cash equivalents balance of approximately $2.8 million, an increase of $1.7 million from $1.1 million as of April 30, 2025.
Previous wording
Net cash used by our operating activities of $4.5 million during the nine months ended January 31, 2024 is primarily due to our net loss of $4.8 million plus $831,000 in non-cash expenses less $565,000 of net changes in operating assets and liabilities.
Current wording
Net cash used by our operating activities of $1.9 million during the three months ended July 31, 2025 is primarily due to our net loss of $2.1 million, plus $316,000 in non-cash expenses less $215,000 of net changes in operating assets and liabilities.
Previous wording
Net cash used by our operating activities of $5.8 million during the nine months ended January 31, 2025 is primarily due to our net loss of $6.7 million, plus $437,000 in non-cash expenses plus $405,000 of net changes in operating assets and liabilities.
Current wording
Net cash used by our operating activities of $2.0 million during the three months ended July 31, 2024 is primarily due to our net loss of $2.1 million, plus $98,000 in non-cash expenses less $65,000 of net changes in operating assets and liabilities.
Previous wording
Net cash provided by financing activities of $2.6 million during the nine months ended January 31, 2025 is primarily from the issuance of Common Stock under the Equity Line, the ATM Facility, and net proceeds from the Streeterville Note.
Current wording
Net cash provided by financing activities of $3.6 million during the three months ended July 31, 2025 is primarily from the issuance of Series D Preferred Stock and warrants.
Previous wording
Net cash provided by financing activities of $10.0 million during the nine months ended January 31, 2024 is primarily from the issuance of Common Stock under the Equity Line, ATM Facility, and net proceeds from the MSW Note.
Current wording
Net cash provided by financing activities of $0.6 million during the three months ended July 31, 2024 is primarily from the issuance of Common Stock under the Equity Line and the ATM Facility.
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
HeartSciences has designed or licensed algorithms designed to help address these limitations and extend the clinical capability of an ECG to detect cardiac dysfunction and other heart disease types.
Previous report — wording carried elsewhere
In connection with the offering, the Company will enter into a subscription agreement (the “Subscription Agreement”), pursuant to which the Company agrees to sell to certain investors up to 4,285,714 Units. Each investor must complete a Subscription Agreement and submit the applicable subscription price as set forth therein.