Major competitor Heartflow under investigation. Share price has been under pressure in the last few days.

“In October 2025, the Company and certain of its employees received civil investigative demands (the “CID”) from the U.S. Department of Justice, Civil Division, in connection with an investigation under the federal Anti-Kickback Statute and Civil False Claims Act (the “Investigation”). The CID requests information, documents, and testimony focused on the Company’s financial and contractual arrangements with providers and its sales and marketing activities. The Company is cooperating with the Investigation and is unable to express a view at this time regarding the likely duration, or ultimate outcome, of the Investigation or estimate the possibility of, or amount or range of, any possible financial impact. Depending on the outcome of the Investigation, there may be a material impact on the Company’s business, results of operations, financial condition, or cash flows.” SEC+1

You can access the full filing here: SEC-Filing PDF – Heartflow Form 10-Q Sept 30 2025

Saw your post@ Superfluous and agree this is an interesting one. At a high level, there is a large market for CCTA (Coronary Computed Tomography Angiogram) and its interpretation. In the US it’s a $US 4.4b market, and AYA has a relatively small market cap of around $170m.  

AYA have FDA approval for the “Coronary Anatomy Platform” software and have this month received FDA approval for the second Plaque Module. With the Coronary Flow module to be submitted to the FDA later in the year and approval expected in the first quarter of next CY.  

AYA's offering appears to be superior to the US competition, Heartflow and Cleerly.  AYA software providing an actionable report within 10 minutes and appears to integrate better with the patient workflow.

AYA have a foothold in the US (Cone Health, Tanner Health and N/E Georgia Health) and now a small revenue.   Appear to be doing the smart thing in nearly giving away the product in the first instance.

CEO John Konstantopoulos helped develop the software and has around 9% of the company.  Success almost wholly dependent on how they execute in the US.  Would be interested to know if any of the Straw-medicos have a view/experience in relation to AYA?  (Apparently the only current use in Australia has been at the Cardiac Center Wollongong). 

Found this interesting.

https://artrya.com/investor-calls-webcasts

Below are my skeletal journal notes for AYA.

DYOR - held in RL

Product

• Cloud-based AI analysis of CCTA scans in < 10 mins at point of care
• SOLIX Coronary Anatomy is the platform - every patient - USD50 revenue
• SOLIX Coronary Plaque = plaque report - 70% of patients - USD750 revenue
• SOLIX Coronary Flow = heart flow report - 35% of patients - USD 800 revenue

NOTE: This, imo, is an example of AI (machine learning actually - no such thing as artificial intelligence) migrating up the tech stack. This, imo, will be where investors will see the best returns over the cycle. Not GPUs or data centres...

FDA/CTP CAT codes

• Anatomy & Plaque FDA approved
• Flow in submission process
• CTP CAT 1 already in place: Platform USD325, Plaque - USD950, Flow USD1017

Current Adoption

• Tanner Health operational - SOLIX Plaque just FDA approved to revenue kicks on from here...
• Cone & NE Georgia in progress towards integration

Key differentiator

• Turns health providers' CCTA scans into profit centre (AYA charge less than reimbursement)
• PII stays locked in providers system
• Competitors require CCTA data to be sent to them for human analysis and charge more than reimbursement

TAM

• Current 3 commercial partners, Tanner, Cone & NE Georgia approx 14,000 scans pa
• SAPPHIRE study partners approx 400,000 scans pa
• 1.5 - 2m scans pa in USA - say 30% share = 500-700,000 tickets for AYA
• Platform (100% of patients): 500,000 x USD50 = USD 25m pa
• Plaque (70% of patients): 350,000 x USD750 = USD262.5m pa
• Flow (50% of patients): 175,000 x USD800 = USD140m pa
• Total USD427.5m pa = AUD650m pa (AUDUSD 0.6500)

M/ment skin in game

• Founder-led - Konstantopoulos 9%
• Barrington - 7.7%
• Other BOD - 3%
• Total: approx 20%

Earnings quality

• High when achieved - SaaS
• Should lead to high ROA which can be retained on the BS, reinvested to grow the footprint whilst increasing margins and ROA

Capital Structure

• SOI: 114m MC $200m Cash: $11m

Key Milestones

• FDA approval for flow - submission end CY2025 approval Mar 2025
• Firming up SAPPHIRE participants - each party will be announced when locked in
• Commercial go ahead for Cone & NE Georgia systems
• First sale of SOLIX Coronary Plaque
• Guidance for break-even beginning FY2027

Price Target

• AVG MC/revenue multiple for ASX listed SaaS stocks = 4-8 (say 6x)
• 6 x AUD650m = AUD3.9bn
• Allow 50% dilution = AUD3.9bn/150m = AUD26
• Time frame: 5+ years

Interested in fellow Straw people's thoughts on ARTRYA (ASX: AYA)

Company and Product

ARTRYA describe themselves as an AI-Driven Healthcare Tech Company - with a cloud based software solution that provides cardiovascular clinicians the ability to detect and diagnose patients with chest pain at the 'point of care'.

Their flagship product, the Salix Coronary Anatomy (SCA), is a breakthrough technology that can detect vulnerable plaque biomarkers from a CCTA (Coronary CT Angiography) scan within minutes.

Stage of Life-cycle

ARTRYA is a cash burning, pre-revenue micro-cap approaching key inflexion points, including the high likelihood of a capital raising either pre or post a 510(k) FDA regulatory clearance.

The Company has lodged a 2nd Q-submission recently (Jun 7th) to the FDA with an expected meeting within weeks, to gain final feedback prior to submitting for 510(k) regulatory clearance of their SCA product. FDA clearance is then expected sometime 2nd half 2024.

Notwithstanding this high risk status, if the product truly has a competitive advantage - and is accepted and integrated into large US Healthcare groups, then the scaleable nature of the software platform into a well established, and huge market looks interesting.

Target Market

ARTRYA are targeting the large US CCTA market (third of global market) where there is established medicare rebates of US$900 per CCTA scan. With a market of currently 4.4m scans pa. and growing with an ageing population.

Competitors and USP

There appears to be competitors with similar product offerings -> leading examples include Cleerly Health and Heartflow, however their solutions take between 24 - 48 hours (currently) to return a diagnosis to the clinician, with patient follow-up required.

Therefore the competitive advantage / point of difference for ARTRYA is the ability to provide analysis within 10-15 min, allowing the clinician to offer fast 'point of care' diagnosis and subsequent efficient triaging of patients.

This benefits patients through more immediate and informed care recommendations, and healthcare providers with improved productivity leading to increased revenue and reduced operating costs.

Market Status

ARTRYA has signed strategic agreements with three different US Hospital Healthcare groups who are integrating ARTRYA's software solution into their CCTA scanning systems, that will ultimately lead to commercial agreements with these groups once FDA clearance is achieved.

There has also been a 1 year commercial agreement reached in Australia with The Cardiac Centre NSW, who treat ~25,000 patients per year for heart disease - But from ARTRYA's ASX announcement under the commercial terms - "In this instance the revenue impact of this agreement is not considered material in value given the agreements short duration and size of the practice".

Business Model / Strategy Questions?

With the signing of 3 x major US Healthcare providers - there is clearly a recognised functional advantage for ARTRYA's software. These providers combined perform 30k CCTA scans pa. (< 1.0% of market)

However some important business model and strategic questions remain:

• Is the fast turnaround (10-15 mins) a genuine and sustainable point of difference in the med-long term vs. other players?

• If ARTRYA could capture say 5% of the US market (~220 K scans pa.) -> how much of the US$900 per scan rebate would they collect (what is their revenue model and potential revenue)?

• With a SAAS model, what margins could be expected on the revenues (60% - 80%)?

Perhaps a Strawman CEO meeting contender?



References (other than ASX announcements)

https://stockhead.com.au/health/fda-submission-looms-as-artryas-ai-platform-aims-to-capture-the-huge-cardio-diseases-market/

https://www.cbinsights.com/compare/artrya-vs-heartflow

https://www.cbinsights.com/compare/artrya-vs-cleerly

Disc: Not held in RL or SM

Risks

·      No Revenue, very recent IPO with very little business history (Artrya founded in 2018)

·      Competitive industry -Artrya could face competitors able to spend more on R&D and marketing etc.

·      Healthcare industry is highly regulated

Easy pass for us, until can prove it can earn revenue and scale.