Annoviant is advancing patient outcomes in heart disease by delivering innovative, regenerative cardiovascular devices built on its proprietary TxGuard™ soft-tissue technology.
The platform enables durable, off-the-shelf solutions that address critical unmet needs in heart valve disease and coronary artery bypass grafting—helping patients live healthier lives while reducing long-term healthcare costs.
About Annoviant
Founded in 2018, Annoviant is a cardiovascular device company developing next-generation regenerative implants that improve durability, reduce complications, and promote natural tissue remodeling.
The company is backed by leading healthcare institutions, research organizations, established vendors, incubator programs, FDA-funded consortia, NIH grants, and private capital.
The Clinical Challenge
Heart disease affects nearly 50% of U.S. adults and is projected to impact 184 million people by 2050. As the leading cause of death, it drives over 550,000 cardiovascular surgeries annually.
Current bioprosthetic valves suffer from calcification, thrombosis, and degeneration. Small-diameter vascular grafts for coronary artery bypass grafting (CABG) remain unavailable off-the-shelf, forcing surgeons to harvest patient vessels—a practice that often leads to complications and repeat procedures.
These limitations create an urgent need for durable, regenerative solutions that integrate seamlessly with existing surgical techniques.
Leadership & Expertise
Annoviant’s team combines over 250 years of collective experience across technical development, regulatory affairs, preclinical research, business development, finance, clinical practice, and cardiovascular science.
- Dr. Ajay Houde – Co-Founder & CEO
Over 25 years successfully commercializing breakthrough medical technologies. Proven track record of driving innovation that improves patient outcomes while creating value for stakeholders. - Dr. Naren Vyavahare – Co-Founder & CTO
Hunter Endowed Chair at Clemson University. Renowned expert in cardiovascular tissue engineering and regenerative therapies. Long-standing collaboration with Dr. Houde spanning over 35 years. - Broader Team
Seasoned healthcare professionals, leading clinicians from top hospitals, and academic specialists—all united by deep domain expertise and a shared mission to transform cardiovascular care.
Annoviant’s lead product, the TxGuard™ Pulmonary Valved Graft (PVG), is a Class III device with established reimbursement codes (306 & 307), enabling clear market access.
Commercial Strategy
- Manufacturing
Partnered with an ISO 13485-certified facility to ensure global quality compliance and scalable production. - Initial Launch Focus
Top pediatric hospitals, leveraging strong relationships with leading institutions and the Pediatric Device Consortia. - Distribution & Adoption
Strategic partnerships with established distributors and hospital networks to accelerate market penetration. - Pricing
Aligned with predicate devices for competitive positioning and rapid uptake.
This focused, partnership-driven approach positions Annoviant for efficient commercialization and early revenue generation.
Market Opportunity
Annoviant is targeting two high-growth cardiovascular markets driven by rising disease prevalence, aging demographics, improved diagnostics, and demand for minimally invasive solutions.
- U.S. Prosthetic Heart Valve Market
Projected to reach $5.86 billion by 2032. - CABG Market
Valued at $4.9 billion in 2022, growing at a 9.6% CAGR through 2030.
TxGuard™’s clinical advantages—superior durability, reduced complications, and regenerative properties—position Annoviant to capture significant share in these expanding segments.
Investment Ask
Annoviant is seeking $10 million to advance its TxGuard™ platform toward clinical and commercial milestones.
Use of Proceeds
| Purpose | Amount | Key Activities |
|---|---|---|
| First-in-Human Studies (TxGuard™ PVG) | $3.5 million | Execute clinical studies for initial pulmonary valved graft indication. |
| Pipeline Acceleration | $6.5 million | Advance additional cardiovascular devices in development. |
This capital will enable pivotal clinical progress, regulatory milestones, and expanded product portfolio—driving toward sustainable revenue and broad patient impact.
TxGuard™ Platform
Annoviant’s proprietary TxGuard™ technology integrates three patented/core processes that preserve natural tissue architecture while addressing key failure modes—without changing established surgical techniques.
- Advanced Decellularization
Removes immunogenic cells while retaining the native extracellular matrix scaffold. - Patented Stabilization
Strengthens collagen and elastin to prevent degradation and calcification. - Novel Sterilization
Eliminates bacteria and viruses for maximum safety.
Preclinical Validation
In robust lamb models, TxGuard™ pulmonary valved grafts demonstrated no calcification, thrombosis, or infection, with excellent host tissue remodeling.
The platform has been validated across multiple tissue types (bovine/porcine) and forms (valves, patches, vessels).
Product Pipeline
- Pulmonary Valved Graft (PVG) – lead product, preparing for first-in-human studies and FDA Humanitarian Device Exemption (HDE) pathway
- Aortic Valve
- Leaflet Patch
- Vascular Patch
- Vascular Grafts
TxGuard™ is positioned to set a new standard in regenerative cardiovascular implants.
Annoviant has raised a total of $7.5 million to date.
| Source | Amount |
|---|---|
| Grants (including NIH) | $5.7 million |
| Angel Investment | $1.6 million |
| Bank Loan | $0.2 million |
