Executive Summary

Q4 FY2024 (fiscal year ended April 30, 2024) had no significant revenues; liquidity remained adequate with $5.8M cash and $7.3M shareholders’ equity as the company prioritized regulatory and platform development ahead of commercialization .
The FDA pathway shifted to 510(k) for MyoVista wavECG; after resolving hardware/software issues and updating age-adjusted algorithms, HSCS targeted submission in Q1 calendar 2025, a modest delay versus prior “around calendar year end 2024” expectations .
MyoVista Insights cloud platform progressed to Phase 1 completion target in calendar Q4 2024, with regulatory strategy focused on a low ejection fraction (LVEF ≤40) AI-ECG algorithm licensed from Mount Sinai and aiming for mid/2H 2025 submission for software-based medical device .
Subsequent catalysts strengthen the medium-term setup: CMS OPPS 2025 final rule recognized HSCS’s AI-ECG algorithms for reimbursement effective January 2025, and the company demonstrated MyoVista at the UN General Assembly Digital Health Symposium, enhancing thought-leadership and adoption narratives .

What Went Well and What Went Wrong

What Went Well

Progress toward dual-delivery strategy: device-based MyoVista wavECG and device-agnostic MyoVista Insights cloud, enabling AI-ECG in multiple care settings; management emphasized this as a unique competitive position .
- “We believe we are now uniquely positioned to bring forward both cloud-based and device-based AI-ECG solutions…” .
MyoVista Insights Phase 1 remained on track for calendar Q4 2024 completion; algorithm validation planned with retrospective data to reduce cost/timeline .
Ecosystem validation and visibility: UNGA Digital Health Symposium selection and IVI analysis suggesting material pathway efficiency gains for LV function queries (“49.5% of queries could potentially be eliminated from the waitlist”) .

What Went Wrong

Timeline shift for device submission: from “around calendar year end 2024” to “first calendar quarter 2025,” reflecting required algorithm updates and final system testing; delay likely to prolong commercialization and revenue ramp .
No revenues across Q2 FY2024–Q4 FY2024; the business remains pre-commercial, reliant on financing and equity to fund development and regulatory activities .
Liquidity trend down from Q3 FY2024 ($7.1M cash) to FY2024 year-end ($5.8M), necessitating subsequent non-dilutive financing and loan extensions to extend runway .

Financial Results

Core Financials vs Prior Periods (USD Millions unless noted)

Metric	Q2 FY2024 (Oct 31, 2023)	Q3 FY2024 (Jan 31, 2024)	Q4 FY2024 (Apr 30, 2024)
Revenue	None	No significant revenues	No significant revenues
Diluted EPS	Not disclosed	Not disclosed	Not disclosed
Cash & Equivalents	$0.1	$7.1	$5.8
Shareholders’ Equity	$(1.6)	$8.6	$7.3

Notes:

HSCS did not disclose quarterly EPS in press releases; complete results referenced as available in 10-Q/10-K filings .

Post-Q4 Momentum Indicators

Metric	Q1 FY2025 (Jul 31, 2024)	Q2 FY2025 (Oct 31, 2024)
Revenue	None	None
Cash & Equivalents	$4.3	$4.1
Shareholders’ Equity	$5.9	$4.0
Financing Actions	$1.9 non-dilutive loan; 12-month extension of $0.5 loan	Not disclosed

Segment breakdown: Not applicable (pre-commercial, no segment reporting in press releases) .

KPIs:

Regulatory timeline: MyoVista device submission targeted Q1 CY2025 ; MyoVista Insights software submission targeted mid/2H CY2025 .
Reimbursement: CMS OPPS recognition effective Jan 2025 for AI-ECG algorithms, enabling reimbursement at launch .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
MyoVista wavECG FDA submission	Device, 510(k)	Around calendar year end 2024	First calendar quarter 2025	Lowered/delayed (timeline pushed)
MyoVista Insights Phase 1 completion	Cloud platform	Working beta; Phase 1 expected calendar Q4 2024	Phase 1 completion by end of calendar 2024	Maintained
MyoVista Insights + LVEF algorithm FDA submission	Cloud sBMD	Target mid-2025	Aiming for second half of 2025	Maintained/slightly clarified
CMS OPPS reimbursement	AI-ECG algorithms	Not previously specified	Included in CMS 2025 OPPS final rule, effective Jan 2025	New positive inclusion
Capital runway	Liquidity	N/A	$1.9M non-dilutive loan; $0.5M extension (to Sep 2025)	Extended runway

Earnings Call Themes & Trends

No Q4 FY2024 earnings call transcript was available in the document catalog (none found) [ListDocuments]. Trends below reflect press releases across Q-2 (Q2 FY2024), Q-1 (Q3 FY2024), and current period (Q4 FY2024).

Topic	Previous Mentions (Q2 FY2024)	Previous Mentions (Q3 FY2024)	Current Period (Q4 FY2024)	Trend
AI/technology initiatives	Shift to broad AI-ECG portfolio; Mount Sinai licenses; platform/device strategy	Reinforced portfolio, team expansion; beta platform work underway	Dual strategy emphasized; platform agnostic marketplace; beta testing continues	Consistent build-out
Regulatory	FDA confirmation of 510(k) pathway for device	Target clearance around CY end 2024; validation completed; algorithm threshold updates	Submission expected Q1 CY2025; final pre-sub meeting planned	Timeline slip; path clarifies
Reimbursement/macro	N/A	Health economic studies referenced for LVEF algorithm	Later recognized in CMS 2025 OPPS (post-Q4)	Improving
Product performance	Garda screening program; distribution expansion	Clinical validation publications; international feedback positive	Continued ecosystem validation (UNGA, IVI analysis)	Strengthening visibility
R&D execution	Algorithm threshold updates; core-lab work progressing	Algorithm update nearing completion; ensemble work	Hardware/software issues resolved; final system testing	Converging toward submission
Liquidity	Deficit repaired post-raise; cash $0.1 at Q2	Cash $7.1; equity $8.6	Cash $5.8; equity $7.3 at FY-end; financing followed later	Normalizing with financing

Management Commentary

“We believe we are now uniquely positioned to bring forward both cloud-based and device-based AI-ECG solutions for the resting ECG…” .
“We are in the process of final system testing… hardware and software issues… now resolved… expecting FDA submission… first calendar quarter of 2025” .
“Feedback on our MyoVista Insights platform has been positive… first of the Mount Sinai licensed algorithms is well underway… avoids many of the most time-consuming development and regulatory requirements associated with a hardware-based device” .
On ecosystem adoption: UNGA and IVI selection underscore potential to “radically transform healthcare” and “improve cardiovascular pathway efficiency” .

Q&A Highlights

No Q4 FY2024 earnings call transcript was available; therefore, no management Q&A to summarize [ListDocuments].

Estimates Context

Wall Street consensus EPS and revenue estimates via S&P Global for Q4 FY2024 were unavailable in our data pull today. Given HSCS’s pre-commercial status and lack of reported revenues in Q2–Q4 FY2024, near-term estimate coverage may be limited; we recommend monitoring for initiation or updates following regulatory milestones .

Key Takeaways for Investors

HSCS’s thesis is execution-dependent: finalizing device validation and achieving 510(k) submission in Q1 CY2025 could be a pivotal inflection toward commercialization .
Cloud strategy widens TAM and reduces R&D/validation burden via retrospective data and an algorithm marketplace; Phase 1 completion supports 2H CY2025 submission alongside LVEF algorithm .
Reimbursement recognition (CMS OPPS 2025) is a major de-risking step for monetization at launch; monitor payer adoption and coding utilization in early deployments .
Liquidity management remains crucial; financing extended runway, but continued non-dilutive funding or partnerships could accelerate market entry without shareholder dilution .
Near-term revenue visibility is minimal until regulatory clearance; stock drivers are milestone-based (FDA submissions, validation readouts, early site deployments, payer adoption).
External validation and KOL engagement (UNGA, IVI analysis) strengthen adoption narrative; expect continued thought-leadership to support early market traction .
Risk: any additional FDA delays or validation issues could push timelines; conversely, on-time submissions and reimbursement readiness could catalyze estimate initiation and rerating .

Heart Test Laboratories, Inc. (HSCS)·Q4 2024 Earnings Summary