Angel Valve Project, a spin off from the Medical University Vienna is developing what it says is the first transvascular catheter-deployed mitral valve implant for the heart. The present grant money will be used to further develop the device and to back preclinical development of its stented chordal repair system that consists of a PTFE matrix that is mounted on a nitinol stent and deployed via femoral artery or femoral vein and transseptal approach inside the atrioventricular valve. Once deployed, its self-expanding wings spread along the mitral annulus and covers the diseased part of the mitral leaflet containing the prolapsing segment.
The device, Mitral Butterfly is named for the wings spreading above and below the prolapsing segment and is intended to be used instead of a standard surgical “conventional” chordal repair which requires major surgery. There is an unmet need of mitral valve therapy since about 98% of patients requiring repair or replacement of the valve remain untreated. Mitral butterfly and its intended use is the correction of the mitral prolapse of the posterior leaflet
The startup Angel Valve Project AVP situated in Vienna expects its device could enable not only non-option patients, but also younger and relatively healthier patients to receive treatment, because of the minimal invasive and expected ease of the implantation procedure.
Transcatheter mitral valve concepts have attracted a lot of attention with currently more than 40 concepts in the pipeline. The proprietary concept of the Mitral Butterfly is the only transvascular chordal repair concept to date.
The PreSeed financing by Austria Wirtschaftsservice (aws), the Austrian Government Promotional Bank, is expected to get the company into the first preclinical testing in a passive perfused heart model to visualize the device in action and proof of concept in acute and chronic animals. First-in-human trials will be performed after the initial financing round next year with a clinical pilot study to follow in 2019. Angel valve Project is a cooperation of established experts in the field of nitinol, catheter and textile research and production.
The startup is a spinoff of the Medical University Vienna where the inventor Prof. Mohl an academic surgeon worked for 40 years in research, patient care and medical education. He is a serial entrepreneur who started Miracormedicalsystems in 2008, a company treating acute and chronic myocardial jeopardy. He has a longstanding experience in surgical repair of the mitral valve. The development was started by the inventor W. Mohl with the PRIZE program, a prototype developing program of AWS. During this conceptualizing phase of the early development, the primary concept was completely reengineered and adapted to medical needs.
A consortium from different companies as the Grabher group, BMT, Endosmart, Lenzing plastics and additional experts in the field of medical technology, were invited among others to cooperate in the present development.
Presently the startup AVP is hiring people in the field of medical technology, project management and business administration to further develop the mitral butterfly concept and other concepts for mitral repair and replacement currently in the development pipeline.
According to the consortium total financing up to € 13 million will be needed to reach FIM. „The additional commitment and interest from the AWS program investing in the Seed Phase of the Angel Valve Project will attract new investors and validates our technology and the need for less invasive options to treat mitral valve disease, said AVP consortial leader W. Mohl in a statement. We are confident that we will be able to further develop our concept and bring our concept “Mitral Butterfly” to market. Like many early-stage medical device startups, AVP will use longstanding experience of medical technology partners to reduce the risk of the development and timeline of the project until clinical use.
Longstanding clinical experience with surgical mitral valve repair and an unique concept together with continuing innovation in the field of medical technology will allow rapid and robust project management attracting risk capital to get to the clinical stage, and we are proud of our role in advancing Dr. Mohl´s concept, summed up G.Grabher who also sits on Consortium Board of AVP. „Recent in vitro tests have been very encouraging, and we are quite confident that this technology has the potential to dramatically impact the treatment options for a large number of patients suffering from mitral insufficiency.“