HeartSciences Reports Fiscal Second Quarter 2026 Financial Results and Provides Business Update

Rhea-AI Summary

HeartSciences (Nasdaq: HSCS) reported fiscal Q2 2026 results and a business update on Dec 15, 2025. The company launched its MyoVista Insights MDDS healthcare IT platform (released May 2025; Version 1.1 live) and is in commercial discussions with multiple healthcare institutions with expected near-term customer announcements. HeartSciences submitted the MyoVista wavECG device to the FDA for 510(k) clearance and separated device and AI-algorithm submissions after updated ASE LVDD guidance.

Financially, HeartSciences reported no meaningful revenue for FQ2 2026 and held approximately $2.0 million cash and $4.2 million shareholders' equity as of Oct 31, 2025.

Positive

• Submitted MyoVista wavECG device to FDA for 510(k) clearance
• MyoVista Insights classified as MDDS, lowering regulatory burden
• MyoVista Insights launched (May 2025) with Version 1.1 validation
• Platform designed to host FDA-cleared AI-ECG algorithms marketplace

Negative

• Reported no meaningful revenue for FQ2 2026
• Cash and equivalents approximately $2.0 million as of Oct 31, 2025
• Shareholders' equity approximately $4.2 million as of Oct 31, 2025

Key Figures

Cash & equivalents $2.0 million As of October 31, 2025 (FQ2 2026)

Shareholders’ equity $4.2 million As of October 31, 2025 (FQ2 2026)

Cash balance prior $2.8 million As of July 31, 2025 (Q1 2026 earnings)

CMS reimbursement rate $128 per test AI-ECG algorithm reimbursement (fiscal 2025 results)

Cash FY2025 $1.1 million As of April 30, 2025 (fiscal 2025 results)

Equity FY2025 $4.0 million As of October 31, 2024 (Q2 FY2025 results)

Cash Q3 FY2025 $2.6 million As of January 31, 2025 (Q3 FY2025 results)

Shareholders’ equity Q3 FY2025 $1.8 million As of January 31, 2025 (Q3 FY2025 results)

Market Reality Check

$2.47 Last Close

Volume Volume 18,244 vs 20-day average 36,927, indicating below-normal trading activity before this release. low

Technical Price $2.55 is trading below the 200-day MA ($3.37) and well under the 52-week high ($6.47).

Peers on Argus

Pre-news, HSCS was down 2.67% while peers showed mixed moves: BMRA up 1.98%, RSLS up 29.8%, and PAVM/SSKN down. This points to stock-specific, not sector-driven, dynamics.

Historical Context

Date	Event	Sentiment	Move	Catalyst
2025-12-11	Product update	Positive	+0.0%	Launch of MyoVista Insights version 1.1 with expanded usability features.
2025-09-11	Earnings update	Positive	-10.0%	Q1 FY2026 results with tech progress but no meaningful revenue and low cash.
2025-08-15	Investor outreach	Positive	-3.4%	Announcement of investor webinar and conference participation in August 2025.
2025-07-24	Annual results	Positive	+0.3%	Fiscal 2025 results with CMS reimbursement and financing to support development.

Pattern Detected

Earnings and business updates have often been operationally positive but produced mixed price reactions, with some notable selloffs on otherwise constructive news.

Recent Company History

Over the last year, HeartSciences has repeatedly highlighted progress in its AI-enabled ECG strategy. Earnings updates on 2025-07-24 and 2025-09-11 emphasized MyoVista Insights, FDA designations, and reimbursement positioning, while reporting no meaningful revenue and modest cash levels. Interim news in August and December 2025 focused on platform launches and outreach. Today’s FQ2 2026 update continues this pattern of operational milestones alongside a still-early commercial and financial profile.

Market Pulse Summary

The stock is up +5.7% following this news. A strong positive reaction aligns with HeartSciences’ pattern of announcing meaningful regulatory and platform milestones while still reporting no meaningful revenue. Investors have previously seen mixed moves around earnings, with an average change of 3.47% for similar events. Sustained gains could depend on converting MyoVista Insights deployments and the submitted wavECG device into revenue while managing a modest cash balance of $2.0 million.

Key Terms

ecg medical

"advancing electrocardiography (“ECG” or “EKG”) through the integration of"

An ECG (electrocardiogram) records the heart’s electrical activity through small sensors on the skin and produces a waveform that shows heart rate, rhythm and signs of stress or damage—think of it as a seismograph for the heart’s electrical signals. Investors care because ECGs are central to diagnosing and monitoring cardiac safety in clinical trials, required for regulatory approval of many drugs and devices, and drive demand for related medical equipment and services.

ekg medical

"advancing electrocardiography (“ECG” or “EKG”) through the integration of"

An EKG is a short test that records the heart’s electrical activity using sensors on the skin, producing a simple tracing like a road map of each heartbeat. Investors care because EKG results are used to spot heart-related side effects or safety signals in drug trials and medical devices, and clear or abnormal EKG findings can affect regulatory approval, trial continuation, product liability, and market value.

left ventricular diastolic dysfunction medical

"guidelines ... for the assessment of Left Ventricular Diastolic Dysfunction (“LVDD”)"

A condition in which the heart’s left pumping chamber becomes stiff and cannot relax fully between beats, so it fills with less blood and delivers reduced output. Investors should care because it drives demand for drugs, medical devices, diagnostics and long‑term care, affects healthcare costs and insurance payouts, and can influence company revenues and valuations—think of a pump that won’t refill properly, reducing flow and increasing strain on the system.

AI-generated analysis. Not financial advice.

Southlake, TX, Dec. 15, 2025 (GLOBE NEWSWIRE) -- HeartSciences Inc. (Nasdaq: HSCS) (“HeartSciences” or the “Company”), a healthcare information technology (“HIT”) company focused on advancing electrocardiography (“ECG” or “EKG”) through the integration of artificial intelligence (“AI”), today reported financial results for its fiscal second quarter ended October 31, 2025 (“FQ2 2026”) and provided a business update.

Second Quarter and Recent Highlights

During the second quarter and subsequent period, the Company made significant progress in the commercialization and advancement of its MyoVista Insights™ healthcare IT platform and submitted its MyoVista® wavECG™ device to the U.S. Food and Drug Administration (“FDA”) for 510(k) premarket clearance.

MyoVista Insights™ Healthcare IT Software

• MyoVista Insights is classified as a Medical Device Data System (“MDDS”), which carries significantly lower regulatory requirements and is exempt from 510(k) clearance. As a result, the organizational costs and speed of commercial rollout are expected to be substantially lower and faster than those associated with regulated medical devices.
• Since its launch in May 2025, and following the recent release of Version 1.1, MyoVista Insights has received strong validation from early adopters. The Company is currently engaged in commercial discussions with several healthcare institutions for deployment and expects to announce multiple key customer wins in the near term.
• In addition to generating per-test, SaaS-based revenues as an ECG reporting and management system, MyoVista Insights is designed as a platform capable of hosting third-party AI-ECG algorithms through an AI-ECG marketplace. The Company is in discussions with several partners to host FDA-cleared algorithms. Management believes this platform uniquely positions HeartSciences to capture a multibillion-dollar market opportunity while significantly reducing the cost and time required for algorithm development and regulatory clearance.
• The Company plans to host an investor call early in the new year, during which it will demonstrate the MyoVista Insights software and provide additional details regarding its commercialization strategy and market opportunity.

MyoVista® wavECG™ Device

• The Company has submitted its MyoVista® wavECG™ device to the FDA for 510(k) premarket clearance.
• HeartSciences elected to separate the FDA submissions for the MyoVista wavECG device and its impaired cardiac relaxation AI-ECG software algorithm following the publication of updated guidelines by the American Society of Echocardiography (“ASE”) for the assessment of Left Ventricular Diastolic Dysfunction (“LVDD”), including revised age-based thresholds for cardiac relaxation (e’).

Management Commentary

“MyoVista Insights is a state-of-the-art ECG reporting and management platform that delivers meaningful clinical, operational, and data security benefits for healthcare systems,” said Andrew Simpson, Chief Executive Officer of HeartSciences. “In a short period of time, we have received strong validation from early adopters and are actively engaged in commercial discussions with several healthcare institutions. We expect to announce key customer wins in the near term.”

Mr. Simpson continued, “The submission of the MyoVista wavECG device to the FDA represents an important regulatory milestone for the Company and advances our broader strategy to modernize ECG through artificial intelligence.”

Second Quarter Fiscal 2026 Financial Results

HeartSciences reported no meaningful revenue for FQ2 2026. As of October 31, 2025, the Company had approximately $2.0 million in cash and cash equivalents and $4.2 million in shareholders’ equity.

Complete financial results are included in the Company’s Quarterly Report on Form 10-Q for the fiscal quarter ended October 31, 2025, which has been filed with the U.S. Securities and Exchange Commission and is available on the Company’s website at www.heartsciences.com.

About HeartSciences

HeartSciences is a healthcare information technology (“HIT”) company advancing the use of ECG/EKGs through the integration of artificial intelligence (“AI”). The Company’s MyoVista Insights platform is a device-agnostic, next-generation ECG management system designed to improve clinical efficiency and decision-making. Its MyoVista wavECG device is designed to deliver conventional ECG functionality while supporting on-device AI-enabled solutions

For more information, please visit: https://www.heartsciences.com. X: @HeartSciences

Safe Harbor Statement
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are made under the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and are relating to the Company's future financial and operating performance. All statements, other than statements of historical facts, included herein are "forward-looking statements" including, among other things, statements about HeartSciences' beliefs and expectations. These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company's control. The expectations reflected in these forward-looking statements involve significant assumptions, risks and uncertainties, and these expectations may prove to be incorrect. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Potential risks and uncertainties include, but are not limited to, risks discussed in HeartSciences' Annual Report on Form 10-K for the fiscal year ended April 30, 2025, filed with the U.S. Securities and Exchange Commission (the "SEC") on July 24, 2025, HeartSciences’ Quarterly Report on Form 10-Q for the fiscal quarter ended July 31, 2025 filed with the SEC on September 11, 2025, HeartSciences’ Quarterly Report on Form 10-Q for the fiscal quarter ended October 31, 2025 filed with the SEC on December 15, 2025  and in HeartSciences' other filings with the SEC at www.sec.gov. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.

Investor Relations:
Integrous Communications
Mark Komonoski, Partner
Phone: 877 255 8483
Email: mkomonoski@integcom.us

Media Contact:
HeartSciences
Gene Gephart
Phone: +1 682 244 2578 Ext. 2024
Email: info@heartsciences.com

FAQ

What did HeartSciences (HSCS) announce on Dec 15, 2025 about MyoVista Insights?

The company said MyoVista Insights (an MDDS) launched in May 2025, has Version 1.1, and is in commercial talks with multiple healthcare institutions.

Has HeartSciences (HSCS) submitted the MyoVista wavECG device to the FDA?

Yes. HeartSciences submitted the MyoVista wavECG device to the FDA for 510(k) premarket clearance.

What were HeartSciences' (HSCS) FQ2 2026 revenue and cash figures?

The company reported no meaningful revenue for FQ2 2026 and had about $2.0 million in cash and equivalents on Oct 31, 2025.

Why did HeartSciences separate FDA submissions for device and AI algorithm?

The company separated submissions after updated ASE guidelines for assessing left ventricular diastolic dysfunction, including revised age-based thresholds.

Will HeartSciences (HSCS) provide a product demonstration to investors?

Yes. The company plans an investor call early in the new year to demonstrate MyoVista Insights and discuss commercialization strategy.

How does HeartSciences plan to monetize MyoVista Insights (HSCS)?

MyoVista Insights is designed to generate per-test SaaS revenues as an ECG reporting and management system and host third-party AI-ECG algorithms via a marketplace.