> 6 Mio Euro capitalized from 2016
Shareholder Structure: 81% founders, 15% business angels, 4% private investors
Funding structure: 60% grants/ public funding, 40% equity/ investors
Lean team set-up consisting of highly skilled experts with <10 employees
Our Heart System, which utilizes shock wave therapy for the treatment of ischemic heart failure, is undergoing a rigorous regulatory process. Specifically, it is currently going through the CB scheme process, which is followed by the conformity assessment procedure. This process ensures that our device meets all necessary safety and performance standards required for market approval.
Additionally, our shock wave applicator is being evaluated in a recruiting approval study called the Cardiac Shockwave Therapy in Heart Failure (CAST-HF) trial. This trial is being conducted by the Department of Cardiac Surgery at the Medical University Innsbruck and aims to assess the safety and efficacy of direct cardiac shock wave therapy in combination with coronary artery bypass grafting surgery in patients with ischemic heart failure.
By undergoing these regulatory processes and clinical trials, we aim to demonstrate the safety and efficacy of our Heart System for the treatment of ischemic heart failure and pave the way for its use in clinical practice.
The company is currently undergoing the conformity assessment procedure with a Notified Body to obtain CE approval for their medical device. The certification process involves two stages of audits, including a review of the technical documentation and quality management system, clinical evaluation, and an on-site audit to verify implementation of the QM system. Due to significant delays caused by the implementation of the new Medical Device Regulation, the company has decided to work with a consulting company specializing in CE-marking and MDR.
The Stage I audit is expected to start in May/June 2023. The company is also in discussions with the FDA for market approval in the US, and they are working on the Investigational Device Exemption application with the Head of their Advisory Board. The FDA has proposed to include the company in its Breakthrough Device Program, and the company is continuously working on pre-proposals with their partner to assess their non-clinical data.
