Cuspa Medical will provide a first-of-its-kind heart valve repair device that will save over 10 million patients with heart valve insufficiency that don’t have a good alternative today, the company announced.
Cuspa’s state-of-the-art implant seals heart valves in a minimally invasive procedure, avoiding an invasive open heart surgery and providing immediate symptom relief to the patient.
Heart valve insufficiency causes the leakage of blood through a malfunctioning heart valve. Specifically, aortic regurgitation (AR) is a condition where the aortic valve fails, allowing backflow of blood from the aorta to the left ventricle of the heart. Structural changes to the structures around the aortic valve can cause the leaflets to not close properly, leaving a central jet of backflow during the diastole phase of the heart cycle.
If left untreated, AR can lead to life-debilitating symptoms including heart palpitations, chest pain, fatigue, or shortness of breath, and ultimately leads to heart failure. The 5-year survival rate of untreated patients suffering from severe symptomatic AR and classified as NYHA class 3-4 stands at 28±12%, representing a high risk for this patient population, specifically those with prohibited or high operative risk. These patients are longing for a solution that increases survival rate, and minimizes side effects and risks.
Cusper will bring a first-of-its-kind innovative approach to the medical world, providing a highly valued treatment to the AR condition. With Cusper, there is no need for invasive open heart surgeries, which are extremely dangerous to the patient, require a long recovery period, and are costly procedures. Cusper is an artificial cusp, attached to the native aortic valve cusp using a Nitinol grasper. Cusper's unique design secures the implant to the native valve using an atraumatic grasper, allowing normal cusp motion and preserving the native anatomy. With Cusper, a huge patient population suffering from AR, including patients who are not surgical candidates, can finally have their aortic valve repaired in a minimally invasive, safe, effective, and easy-to-use procedure.
The Cusper technology was invented by Dr. Yair Feld, MD and PhD and founder of Cuspa. The idea came to him after seeing a patient with AR that was referred to TAVI, but the procedure failed and the patient was rushed to emergency surgery. Dr Feld has conducted intense research and multiple tests before founding Cuspa and working the process of bringing this life-changing innovation to a complete and authorized medical approved product. The company is run by Co-founder and CEO, Ariel Weigler, Ms.c. Mr. Weigler is an experienced R&D engineer with a proven track record leading multidisciplinary teams. He has led the development from concept to clinical trials of a novel non-invasive blood testing system as well as projects at Philips Healthcare as a process engineer.
Aortic regurgitation (AR) is the third most common valvular heart disease, with higher prevalence as age increases: 3.4% of the European population suffer from AR, out of which 11.56% suffer from moderate to severe AR, representing more than 2.6M people. The burden of valvular heart disease is expected to rise due to underestimation and it is often underdiagnosed. The expected rise in the age of the population will also contribute to a higher prevalence of valvular heart diseases in general and of AR specifically.
Cuspa is expected to do to AR what transcatheter solutions did to aortic stenosis: By providing a simple, clever solution to the AR treatment problem, Cuspa will create its own AR transcatheter devices market segment within the rapidly-growing heart valve market. And, in light of the rise in population age, the need for solutions that fit the elderly population (non-operable patients) will grow even further.
The Cusper is currently being tested in large animals to test device safety and efficacy. The company has two international patents pending approval in the US, Europe, China, Israel, Japan, Korea, and Canada. World-renowned interventional cardiologists have joined Cuspa’s Scientific Advisory Board, including Prof. Giora Weisz from Columbia University hospital and Prof. Felix Mahfoud from Homburg university hospital, Germany.