Specificity
90%
n=595 · NSTE-ACS
PPV
84%
positive predictive value
FDA Pivotal Trial · In progress
Rule-in for cath lab activation, in 3 minutes at the bedside.
Infrasensor™ is a non-invasive wearable, currently in FDA Pivotal Trial, designed to identify patients with high-grade obstructive coronary artery disease at first touch — without a blood draw or a lab.
Watch full product demonstration video0+
patients in clinical studies to date
0%spec.
84% PPV for high-grade obstructive NSTE-ACSstudy population, n=595
6+4
issued + pending US patents
FDA
Pivotal Trial in progressde novo clearance pathway
02The problem
Chest-pain triage in the ED relies on a multi-hour pathway.
Today’s standard of care combines serial troponin, ECG, and risk scoring — a process that can take 4–6 hours to identify patients who require cath lab activation.
Standard of care
Serial troponin · ECG · risk score
4–6 hours
RCE With Infrasensor
Bedside test · binary rule-in result
3 minutes
Time recovered~99% reduction · hours of ED throughput per patient
03The solution
Infrasensor™ — a point-of-care wearable designed to optimize and accelerate crucial decision-making.
A point-of-care platform that delivers a binary cath-lab rule-in result in 3 minutes, at the bedside.
/01Simple
Used at triage. No specialized training, no consumables to manage, no calibration before each test.
/02Non-invasive
No blood, no lab. Mid-infrared spectroscopy reads transdermal signals directly from the skin surface at the wrist.
/03Rapid
A 3-minute test produces a binary rule-in result for high-grade obstructive NSTE-ACS at the point of care.
Mechanism
Mid-infrared spectroscopy reads transdermal signals from the skin surface; an AI model trained on 1,500+ patient cases produces a binary rule-in result for high-grade obstructive NSTE-ACS.
How Infrasensor works →04The evidence
Peer-reviewed evidence across 1,500+ patients and 10 US hospitals.
Five peer-reviewed publications and a clinical advisory board drawn from leading academic medical centers.
Cohort
0+
patients enrolled across pivotal and feasibility studies to date.
10 US hospital sites · 2019–present
Performance
0% spec.
84% PPV — high-grade obstructive NSTE-ACS
n=595, suspected ACS patients
Publications
5
peer-reviewed publications across leading clinical and digital-health journals.
Nature Communications MedicineEuropean Heart Journal–Digital HealthDiagnostics
Medical advisory board
Allan Jaffe
Mayo Clinic
Jim Januzzi
Mass General
Gregg Stone
Mount Sinai
Frank Peacock
Baylor
Partho Sengupta
Robert Wood Johnson
05The opportunity
A beachhead in the ED — with a platform path.
Infrasensor’s first indication targets the 6,000 US emergency departments. Subsequent indications expand into urgent care, private cardiology, and home monitoring.
Total addressable market · expanding platform
$4.5B Phase 1
US emergency depts
$10.8B Phase 2
Urgent care + cardiology
$25B+ Phase 3
Home monitoring + licensing
Regulatory roadmap
2026
FDA Pivotal Trial in progress. Enrollment ongoing across 10 US sites.
2027
De novo clearance target. Cath lab rule-in indication.
2028+
Indication expansion. Urgent care, cardiology, home monitoring.
06The team
A team built for the regulatory and commercial path ahead.
Founder-led, with a former FDA Senior Medical Officer guiding the regulatory side and a clinical advisory board drawn from Mayo, Mass General, and Mount Sinai.
ex-FDA
07Investor CTA