Corvivo Cardiovascular is a commercial-stage regenerative medical device company focused on cardiovascular repair and regeneration products.
Its flagship Natev™ Tricuspid Valve is a regenerative valve for surgical management of tricuspid valve disease, damage, and dysfunction in adult and pediatric patients—now in final stages of FDA review.
Tricuspid regurgitation (TR) is the most common valvular heart disease, affecting more than 20 million people in the US, including 1.8 million with severe dysfunction.
TR occurs when the tricuspid valve fails to close properly, allowing blood to flow backward from the right ventricle to the right atrium. As severity increases, the heart works harder, leading to reduced quality of life, end-organ dysfunction, and higher mortality.
Current options are limited: no FDA-approved implantable device exists for surgical tricuspid valve replacement (TVR). Off-label bioprosthetic or mechanical valves are not optimized for the right-side heart’s unique morphology and dynamics.
Clinicians seek regenerative tricuspid valve replacement (RTVR) that restores durable function while preserving native anatomy, natural characteristics, and growth potential—without calcification, immune rejection, or anticoagulation.
Corvivo’s Natev™ Tricuspid Valve delivers exactly that: a regenerative extracellular matrix device designed to facilitate natural tissue integration and long-term performance.
Early results demonstrate the potential to restore durable valve function, maintain normal flow characteristics, preserve anatomy, and support growth—positioning Natev™ as a transformative solution in a market with significant unmet need.
Leadership Team
- John Engels – CEO & Co-Founder
Investor and operator with a proven track record in regenerative medicine. Co-founded AxoGen (NASDAQ: AXGN), which grew into a Russell 2000 company. - Dr. Robert Matheny – CSO & Co-Founder
Renowned cardiovascular surgeon with decades of expertise in regenerative therapies. Led development and clinical oversight for six novel cardiovascular products, including the ongoing FDA-authorized IDE/HDE study for Natev™. - Dawn Heimer – Head of Clinical
Over 30 years of academic and industry-sponsored research experience. Held senior clinical research roles at Bayer, J&J, Bard, BD, and Olympus. Oversees the current FDA clinical trial for Natev™.
The team combines deep domain expertise, successful commercialization experience, and clinical trial leadership—ideally positioned to drive Corvivo to regulatory approval and market success.
Leveraging proven experience from building AxoGen (now >$250M in annual sales), Corvivo is prepared to rapidly commercialize upon regulatory clearance.
Commercial Strategy
- Commercial Team Development
Build in-house sales capability or partner with established regenerative surgical teams. - Launch Preparations
Develop educational materials, establish distribution/logistics for U.S. and international markets, and hire key representatives to engage hospitals and healthcare systems. - Market Positioning
Target growing cardiovascular market driven by aging populations and rising heart disease prevalence.
Leadership has extensive experience pursuing diverse exits, including commercialization/IPO and M&A. The cardiovascular space has seen scores of transactions averaging >$400M, with current comparables valued between $250M–$1B.
Corvivo provides regenerative medical devices directly to surgeons in healthcare organizations.
Products are expected to be reimbursed under established DRGs and existing codes—a pathway already confirmed by CMS and payors upon approval.
Scalable Business Model
- Regional Sales Structure
Each region covers a defined number of healthcare organizations. - Profitability Focus
Drive productivity through targeted marketing, clinical training, and ongoing support.
This proven model supports efficient scaling and sustainable revenue growth in the cardiovascular device market.
Investment Opportunity
Corvivo is seeking the final $2M to complete its Series A offering (post-money valuation $27M).
Funds will finalize the Natev™ pivotal trial, secure FDA approval, and lay groundwork for commercial launch of Natev™ and CorPatch™ products.
Use of Proceeds
| Purpose | Focus |
|---|---|
| FDA Clinical Study & Regulatory Submissions | Complete pivotal study for Natev™ Tricuspid Valve and file for approval. |
| Reimbursement Initiatives | Strengthen reimbursement profile to drive market adoption. |
| Product Launch & Commercialization Planning | Prepare marketing, sales, and distribution infrastructure. |
This investment positions Corvivo to lead the regenerative cardiovascular market and deliver transformative solutions for patients with tricuspid valve disease and myocardial recovery.
The Natev™ Tricuspid Valve has undergone years of rigorous development and is now in the final stages of FDA review.
Accepted into an FDA human pivotal study in 2022, Corvivo is completing patient enrollment and preparing final submission—commercial availability anticipated within 18 months of Series A close.
Clinical data to date demonstrate regenerative performance: natural tissue integration, favorable safety profile, and potential to transform tricuspid valve replacement.
Total Raised to Date: $17.5M
Current Raise: Final $2M to complete Priced Series A Round (with Lead Investor)
Post-Money Valuation: $27M
