EXECUTIVE
SUMMARY

Structural cardiac interventions represent one of the biggest challenges in health care. The intended addressable market in the U.S. alone is well over 5 million people and growing. Many of these patients are never treated and die of their conditions. A cost-effective, minimally invasive approach can reach many of these people.

Valvublator Vision – Address valvular insufficiency due to the calcification of heart valves and related structures thus restoring heart function to affected patients.

Mission – Provide an effective and minimally invasive alternative to surgical and transcatheter valve replacement. This is envisioned to be a minimally invasive, percutaneous de-calcification system for (a)symptomatic patients with valvular regurgitation or other insufficiencies.

Valvublator was formed to exploit this opportunity. We intend to raise sufficient capital in stages to study and create a commercial solution. Currently, a Series A round of US$2m is under consideration.

Thesis – It is typically preferred to rehabilitate existing valve tissue as opposed to a prosthetic solution. A method of transcatheter ablation can be developed to achieve this. This might include different methods such as mechanical, ultrasound, RF or chemical. It might include a combination of these.

Applications for such a system may include valve rehabilitation, pre-TVR preparation and other cardiac calcification issues.

Challenges include developing a method for working on a functioning heart. This may prove to be more difficult than placing a TAVR which has a minimal interruption of blood flow. Challenges also include the actual ablation method and embolic protection.

Domain expertise – We must recruit expertise to cover many areas. To attract sufficient development funds and ensure commercial success, we must demonstrate expertise in related heart functions, calcification, interventional procedures, etc.

Recruitment of KOL’s is critical to advise the company, champion the system, publish and present.

Next steps – A proof of concept prototype will be built, tested and entered into the Bench to Bedside competition. This will incorporate current concepts being considered and allow the team to gain valuable knowledge and experience. In parallel, alternative technical approaches must be evaluated.

At the same time, we will begin recruiting potential clinical and technical advisors to serve on a SAB. Areas of expertise might include interventional cardiologists, cardiac surgeons, regulatory specialists and reimbursement specialists.