Pilots were described as low-friction deployments where clinics quickly move from evaluation to pricing discussions, often with lower early pricing until regulatory clearance enables broader reimbursement-aligned commercialization. Monetization may be seat-based, per-ECG, or hybrid depending on clinic volume and structure.
Key clarification: the company expects to fit into existing billing/reimbursement codes rather than create new ones. The primary economic driver discussed was throughput/capacity gains, which can increase clinic revenue opportunity in pay-for-performance environments. The US may include both reimbursement and cash-pay pathways depending on clinic model.
The unregulated market was positioned as flexible for pricing and structure, often centered on licensing MaxYield into devices/app ecosystems and tiering based on the depth of insights produced (contrasted with limitations of PPG-only approaches).
The AMA emphasized ongoing conversations with major players and reiterated the thesis that ECG is becoming the next competitive battleground in wearables. A roadmap for PPG-related neural net work was also discussed as part of multi-signal expansion.
To avoid slow clinic-by-clinic adoption in the US, the strategy discussed was to sell “up the pyramid” into clinic aggregators / roll-ups that can deploy across many clinics at once.
Management reiterated openness to embedding/licensing the technology into incumbents (ECG devices, implantables, new form factors) as a distribution accelerator.
The AMA included a high-level discussion of prior exits, team quality, capital efficiency, and the idea that larger licensing deals could materially change financial trajectory.
Public demos were described as limited due to confidentiality, but there was mention of shareholders potentially trialing Insight360 under controlled access as pilots expand.
Expected themes for upcoming quarters included: more pilots, wearables licensing progress, selective team announcements, measured IP disclosures, and regulatory updates.
The year-end shareholder update was delivered by Paul Duffy, CEO & Chairman of AI/ML Innovations Inc.
The purpose of the presentation was to:
• Provide context on the global cardiovascular disease problem
• Explain AIML’s technology and product strategy
• Review operational, regulatory, and commercial milestones achieved in 2025
• Outline strategic priorities and expectations for 2026
• Transition into a live Ask Me Anything (AMA) session with shareholders
The agenda followed a clear structure:
Markets → 2025 Milestones → 2026 Outlook
Cardiovascular disease (CVD) was framed as the largest single health challenge facing humanity.
It is the leading cause of death globally, with projections indicating that more than one billion
people will be living with cardiovascular disease by 2050, accounting for roughly one-third of
all global deaths.
Electrocardiograms (ECGs) are positioned as one of the most critical diagnostic tools in this fight.
ECGs are non-invasive, widely deployed, and foundational to early detection, risk stratification,
and clinical decision-making across cardiology and electrophysiology.
The scale is significant:
• Hundreds of millions of medical ECGs are recorded annually worldwide
• ECGs are central to nearly every cardiac diagnostic pathway
• Demand for ECG interpretation continues to grow faster than clinical capacity
AIML’s core thesis is that the greatest leverage in cardiac diagnostics exists between:
• Signal capture (ECG devices)
• Signal exploitation (interpretation, reporting, decision-making)
Rather than building new hardware, AIML inserts intelligence at the signal-processing layer.
The company focuses on transforming noisy, raw ECG recordings into clean, structured,
machine-readable data that maximizes diagnostic yield downstream.
This philosophy is referred to internally as “maximum diagnostic yield.”
The approach is deliberately device-agnostic, allowing AIML’s software to work across:
• Clinical ECG devices
• Holters and patches
• Consumer and wellness wearables
• Research and non-human ECG applications
MaxYield™ is the core neural engine underpinning the platform.
It processes raw ECG signals by:
• Penetrating noise rather than discarding data
• Identifying true cardiac activity within noisy recordings
• Labeling each heartbeat with high granularity
MaxYield produces three standardized outputs:
1. Beat-level label matrix
- Detailed identification of P-wave, QRS complex, and T-wave structure
- Designed to scale from thousands to millions of heartbeats per recording
2. Time-series interval streams
- Enables rhythm analysis, trends, and longitudinal monitoring
3. Event and anomaly detection tables
- Identifies arrhythmias, artifacts, and irregular cardiac events
Together, these outputs form a structured “data packet” that can be reused across
multiple products, workflows, and markets.
A) MaxYield™
• Neuralized ECG signal processing engine
• Six-point beat-level labeling within each heartbeat
• Benchmarked against trained cardiology technologists
• Designed to continuously improve through AI learning
B) Insight360™
• Visualization and analytics layer built on top of MaxYield data
• Enables interrogation of large ECG datasets
• Targets:
- Research and academic use
- Wellness and quantified-self users
- Sports performance and recovery monitoring
• Strong emphasis on single-lead ECG as an emerging high-volume market
C) CardioYield™
• Clinic and hospital-facing diagnostic workflow platform
• Purpose-built to modernize Holter reporting
• Key benefits:
- Reduced manual review and cleanup
- Standardized, auto-populated reports
- Improved consistency and quality
• Claimed outcome:
- 2–3× throughput per technician
- Shorter turnaround times
- Better utilization of trained clinical staff
2025 marked a major expansion phase for the organization.
Highlights include:
• Growth from a small core team to 50+ contributors
• Mix of full-time employees and specialized consultants
• Engineering footprint spanning:
- Toronto
- Edmonton
- Barcelona
- Ukraine
• Dedicated clinical operators and cardiology advisors
• Formal internalization of regulatory and quality management functions
The leadership emphasized disciplined hiring, capital efficiency,
and building institutional readiness for regulated markets.
AIML announced the granting of its first patent, described as:
• Broad in scope
• With minimal prior art
• Foundational to its neural network ECG processing approach
In addition, the company has:
• Expanded patent depth and specificity
• Secured trademarks including:
- MaxYield™
- CardioYield™
- BodyOS™
The longer-term vision includes multi-signal fusion, with ECG positioned as
the ground-truth signal combined with others such as PPG and EEG.
Regulatory readiness was a central theme of the presentation.
Key points:
• FDA and Health Canada clearance pathways for MaxYield™, followed by CardioYield™
• Jamaica positioned as both:
- A regulatory jurisdiction
- A proof point for expanding access in underserved populations
• Implementation of a formal Quality Management System (QMS)
• Target expectation for initial clearances: First half of 2026
(subject to regulator timelines)
Commercial progress was described as steady and deliberate.
Highlights:
• 3–4 pilot or partnership announcements per month
• Clinical pilots across Canada and Jamaica
• Research collaborations, including SickKids
• Wearables and consumer technology engagements
• Entry into veterinary and equine ECG markets
Management described the strategy as “singles and doubles” —
early validation-focused deals intended to scale into larger licensing agreements.
Looking ahead, the company outlined several priorities:
• Convert pilots into recurring, long-term licensing revenue
• Execute regulatory clearances
• Expand platform capabilities:
- Multi-lead ECG
- PPG integration
- Multi-signal analysis
• Continue strengthening the team
• Increase capital markets visibility and engagement
Management concluded that the company now has:
• A complete platform
• Early commercial traction
• Regulatory momentum
The focus for 2026 is execution, scale, and value realization.
Learn more about the technology & team driving AIML. Watch a quick video on the product suite & company vision, plus backgrounds the key drivers leading the company, our legal counsel, & world-class Medical Advisors guiding product development.
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