One regenerative platform spanning the full heart-failure spectrum — led by the fastest, most capital-efficient product in our portfolio.
Validated across the four levers that matter most: market, speed to clinic, capital intensity, and regulatory path. Lami-Pro™ wins on all four — and funds everything behind it.
| Decision criterion | Lami-Pro™ · HFpEF | Ventri-Pro™ · HFrEF | Your-Heart™ · End-stage HF |
|---|---|---|---|
| Unmet need / competition | Zero approved biologics: first mover | Crowded device & GDMT space | No competition, but distant |
| Time to first-in-human | ~3 years (IND Year 2) | Longer — surgical patch | 5+ years |
| Capital to clinic | Low cost: ~$8.6MM preclinical | Moderate | $300–500MM (public estimate) |
| Regulatory path | BLA pathway; accelerated approval to be discussed with FDA | Combination product, complex | Unprecedented |
| Platform leverage | Validates IP; funds the rest | Strong follow-on | Ultimate payoff |
A bioengineered cardiac-derived patch designed to slow dilated heart-failure progression by stabilizing the heart, promoting vascularization, and supporting an environment for regeneration. With demonstrated activity in preclinical models, Ventri-Pro™ is being developed as a scalable, near-term candidate for the more than 500,000 patients who develop dilated heart failure each year — before irreversible damage occurs.
How Ventri-Pro™ works →A fully bioengineered, patient-specific heart for transplant in end-stage heart failure — created from a patient's own cells. Your-Heart™ is designed to reduce or eliminate the need for lifelong immunosuppression and to address the donor-availability ceiling. It is the long-term aspiration our sequential strategy is built to fund.
How Your-Heart™ works →All Organamet Bio product candidates are investigational, have not been approved by FDA or any regulatory authority, and their safety and effectiveness have not been established.
A BLA-directed plan, with an accelerated-approval pathway to be discussed with FDA based on trial data. Timelines below are targets and assumptions, contingent on data and FDA interaction.
GLP Ossabaw-swine program (3 protocols, 21 CFR Part 58), five FDA pre-submission meetings, and CMC/GMP development. ~$8.6MM. IND targeted Year 2 Q4.
IND activation; Fast Track Designation filed; DSMB established and academic catheterization sites contracted.
HFpEF patients (n ≤ 40); primary endpoint E/e′ change at 6 months (~$7.8MM); End-of-Phase-2 FDA meeting
If agreed with FDA, a surrogate-endpoint pathway could support U.S. approval around Year 5 — subject to data and FDA interaction.
Phase 3 pivotal (HF-hospitalization endpoint); Rolling Review + Priority Review; EMEA and LATAM revenue ramps.
Regulatory pathways and designations we intend to pursue (not yet granted or agreed with FDA):