Innovation & Business Idea
Angel Valve Vienna (AVVie GmbH) has created an innovative technology for cardiac mitral valve prolapse repair. AVVie has an experienced leadership team whose objective is to establish the Mitral Butterfly device as the standard of care for patients with mitral regurgitation (MR). The advanced technology is based on product implantation via a transvascular catheter onto the compromised mitral valve. The implant can be placed directly on the malfunctioning valve's leaflet in a one-step procedure.
- shorter, low-risk, minimally invasive intervention
- significant burden reduction for the patients
- shorter recovery and hospitalization time
- expected cost reductions
The Mitral Butterfly device offers a treatment option for patients with severe MR, for whom surgery is not an option, as well as for everyone affected.
Customers / Target Market
Around 8.2 million patients in Europe and the US suffer from moderate to severe mitral regurgitation. Incidence rate is around 250.000 new patients per year. Many patients are declined open-heart surgery due to advanced age or comorbidities. AVVie is addressing this unmet clinical need for mitral valve repair in the cardiology market. Clinicians performing transcatheter mitral valve repair include interventional cardiologists and cardiac surgeons. Furthermore, purchasing departments of hospitals and healthcare systems, being a key part of clinical decision-making processes, are also customers.
The product has been designed to compete within the market trend of moving from maxium cardiac surgical exposure to a minimally invasive exposure. The only clinically well-established transcatheter mitral valve repair device is MitraClip from Abbott. There are 5 direct competitors to the Mitral Butterfly device (NeoChord, Harpoon, ChordArt, CardioMech, Pipeline). All competitive devices require multiple steps to sequentially introduce individual yarns and attach them to muscular tissue. The AVVie product has clear advantages over its competitors: a one-stage delivery, device attachment via a single clasp, and significantly reduced intervention time.
Intellectual Property Status
AVVie's IP portfolio is strongly positioned, including 15 patent applications and 4 granted patents.
Development Status & Future Steps
Several prototype iterations have been developed and successfully tested. A preclinical (90 day chronic animal) study has been completed. ISO 13485 certification and further development of the transcatheter device are planned for 2021, before entering the clinical phase in 2023.
The initial business objective is an acquisition by a strategic corporate partner (such as Medtronic, Abbott, Edwards Lifesciences).
- Werner Mohl, MD, PhD – Founder, CMO 30+ years of experience in surgical mitral valve repair
- Patrick Maguire, MD, PhD, MBA – CEO AV US 21+ years of experience, primarily in strategic senior management, equity financing; previously CEO of medical device companies (e.g. CyberHeart Inc); substantial clinical, regulatory and strategic knowledge in the cardiovascular field
- Johanna Ticar, MMSc – R&D Project Manager Profound knowledge of cardiovascular devices, 6+ years of experience in the cardiovascular medical device industry
AVVie is raising € 10 Mio in a series A round - anticipated closing date is Q2 2021. The investment will be utilized for product development and initial clinical experience (First-in-Human study).
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