Aug 13, 2026 earnings call — Heart attack detection and commercial launch
Company submitted a pre-sub to the FDA for heart attack detection; the FDA has 75 days to respond.
Revenue $0.0B (est $0.0B) · EPS $-0.10 (est $-0.09)
Key quotes
"We completed enrollment of the ALIGN-ACS pilot study in less than four months."
"The first orders have shipped, and initial patients are being onboarded as we speak."
"All in all, we are trending to come in below $14 million for operating cash outflows for the full year for 2026."
Analyst Q&A 7
licensing, international focus, concierge market
Q (Jeremy Pearlman · Maxim Group): Analyst asked what partners, applications, and structure the licensing or data partnerships will take. He also asked which international markets are being prioritized and how big the concierge practice opportunity is, including patients, rollout speed, breakeven, and manufacturing capacity.
A: Management said "licensing" is more partnership embedding their technology into integrated systems rather than pure licensing, though Indonesia could become a license depending on trial results. They are only prioritizing the Ministry of Health in Indonesia internationally; otherwise the focus is the U.S. Management said concierge practices include 1.9 million patients, maybe about 20% cardiac, representing hundreds of thousands of potential patients, and manufacturing can support a ramp through 2027.
"I think licensing may have been a bit of an overstatement because it's embedded into basically the concept and the initiative of working with the integrated systems to incorporate our technology into their workflow." — Richard Ferrari (CHAIR)
endometriosis revenue impact
Q (Josh Jennings · TD Cowen): Analyst asked how material the first endometriosis program in Europe will be to revenue in the next few quarters and whether more systems will be placed directly.
A: Management did not provide a substantive answer in this turn; there was only a brief greeting. The analyst then attempted a follow-up before the call briefly lost connection.
call interruption and follow-up
Q (Josh Jennings · TD Cowen): Operator/analyst noted the analyst may have been disconnected and whether the questioner could return.
A: Management said the analyst may have switched to another call and offered to come back to him. They paused that thread to move on.
"He may have had to switch over to another call." — Tim Cruickshank (CFO)
FDA pathway and pivotal timing
Q (Katie · H.C. Wainwright): Analyst asked which indication and regulatory pathway were proposed to the FDA, whether a 75-day review applies, when a pivotal could begin, and likely patient numbers.
A: Management said they filed via the 510(k) pathway and provided extensive backup information to the FDA. They cannot yet say what size the clinical trial will be, but they would not expect an exorbitant number and feel cautiously optimistic they could start the trial before year-end.
"So I cannot tell you yet what size of a clinical trial that might be required." — Richard Ferrari (CHAIR)
covered lives and break-even
Q (Kyle Bowser · Titan Partners): Analyst asked how many covered lives the signed agreements across four U.S. geographies capture and sought a sense of the initial opportunity relative to the $1.5 million concierge market.
A: Management said the four geographies cover the majority of the target pool and that contracts signed to date are still in the thousands. They reiterated a historical breakeven point of about 30,000 patients (now likely less based on costs) and believe the four geographies contain enough patients to reach that goal as they sign more agreements and see momentum.
"we've told the market historically it's about 30,000 patients to get to break even or it's cash flow positive" — Tim Cruickshank (CFO)
pilot learnings and onboarding workflow
Q (Branislav Vajdic · Titan Partners): Analyst asked what learnings from pilot studies affected the pivotal submission and what learnings exist for commercial onboarding and first orders.
A: Management said the pilot in Belgrade showed strong performance versus 12-lead ECG and helped them debug execution issues, giving confidence to start a pivotal potentially by year-end; the Jakarta HEADSTART-ACS study will supplement that experience. For commercial onboarding, they learned to streamline workflow by making baseline 12-lead ECGs part of intake and only deploying the HeartBeam AIMIGo when the patient has cardiac concerns, which eases adoption.
closing remarks
Q (Kyle Bowser · Titan Partners): Analyst closed with thanks and ended his questions.
A: Management thanked him and closed the exchange briefly. No new information was provided.