Business plan optimisation and preparation for scaling of a transcatheter heart...
Business plan optimisation and preparation for scaling of a transcatheter heart valve replacement manufactured using automation
Lifelet Medical is on a mission to deliver one valve for life for patients suffering from heart valve disease. Lifelet is developing a disruptive polymeric heart valve replacement to transcend the limitations of mechanical and ani...
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Descripción del proyecto
Lifelet Medical is on a mission to deliver one valve for life for patients suffering from heart valve disease. Lifelet is developing a disruptive polymeric heart valve replacement to transcend the limitations of mechanical and animal tissue-based devices available to patients today. Combining the durability of mechanical valves with the blood compatibility and minimally invasive delivery of animal tissue valves, Lifelet’s fully synthetic device aims to enable improved patient outcomes and reduced complications with easier deliverability, enhanced durability, and cost savings for healthcare systems through automated manufacturing and processing.
There are 1.2 million patients in the U.S. with severe aortic valve stenosis, and over half of these patients are symptomatic, requiring a heart valve replacement. The transcatheter aortic valve replacement (TAVR) market size is €4B, expected to growth to €7B+ by 2024, with a double-digit CAGR. Thanks to recent clinical trials, indications are being expanded for younger patients, asymptomatic patients, and those at low and intermediate risk for surgery, driving growth of the market. Cardiologists will Lifelet's device with existing reimbursement in place. As a platform technology, the Lifelet polymer may also offer clinical benefits in the treatment of obesity, gastrointestinal diseases, and incontinence.
Elle Sander, female CEO and co-founder, is a biomedical engineer who has led the company to a proof-of-principle in chronic sheep studies and is a lead inventor of the material technology, with one patent granted in the EU already. Co-founder and CMO Dr. Faisal Sharif, consultant interventional cardiologist, has a track-record of implanting new devices and a extensive experience of clinical trial development and operations. The team have a passion to commercialise this deep tech, and have the vision to execute on what is required from technical, clinical, regulatory, and commercial perspectives.
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