CorAssist Proves Efficacy in Animals and Shows 3 Months Safety in Humans
CorAssist, a developer of novel therapeutic devices for Diastolic Heart Failure (DHF), announced today its flagship product, the ImCardia(TM), significantly improved DHF parameters in a first-of-its-kind preclinical study and has shown preliminary safety in two humans after three months follow up.
After working closely for four years with researchers at the Technion – Israel Institute of Technology in Haifa, Israel, CorAssist successfully adapted an acute diastolic dysfunction canine model developed by Dr. Margaret Redfield of the Mayo Clinic into the first chronic diastolic dysfunction mini-pig model.
Mini-pigs implanted with the ImCardia(TM) device showed a significant improvement in diastolic performance, as compared to a mini-pig control group.
“It was amazing to see the echo parameters nearly return to a healthy baseline in the ImCardia(TM) group while the control group continued to show a decline in diastolic performance,” says Dr. Lea Lak, Medical Director of CorAssist. “This gives us great encouragement as we prepare for our efficacy study in humans planned for early next year.”
In Q2 2008, CorAssist began enrolling patients for a first-in-man safety study in select medical centers in Latin America and Europe. To-date, two patients have been implanted with the ImCardia(TM). Preliminary clinical, echo and quality of life assessments have shown the ImCardia(TM) to be safe after three months follow-up. CorAssist aims to implant the device in an additional thirteen patients with enrollment to be completed in Q2 2009.
“Diastolic Heart Failure is a very serious and unresolved problem in cardiology. The CorAssist device is absolutely innovative and could potentially be the first therapeutic device for this disease. It is built on basic mechanical principles – energy from systole is harnessed and transferred to assist in diastole. When I saw the device for the first time, I understood at once that it has great potential,” says Dr. Peteris Stradins, Chief of Department of Cardiac Surgery, Pauls Stradins Clinical University in Riga Latvia and a principal investigator in CorAssist’s first-in-man safety study.
In parallel to its ImCardia(TM) efforts, CorAssist has advanced a minimally invasive product, the CORolla, into animal studies. The company’s achievements will receive special mention at this week’s European Association of Cardio-Thoracic Surgery (EACTS) Techno-College Innovation Award ceremony in Lisbon, Portugal.
“We are very excited about the progress being made at CorAssist. We are now raising a $15 million financing with new and current investors to bring to market a pipeline of devices that can really make a difference to the quality of life of DHF patients,” says Amir Loshakove, CEO of CorAssist.
CorAssist is a medical device company developing novel therapeutic devices for Diastolic Heart Failure (DHF). DHF is a condition in which the heart becomes stiff and/or fails to relax, and fills inadequately. Today, there are no evidence based therapeutic options for the estimated two million DHF patients in the United States.
The company’s “spring-like” devices harness elastic energy produced by the left ventricle during systole (contraction) and release the energy during diastole (relaxation). The released energy assists the left ventricle to overcome its stiffness by “springing back” an appropriate amount to improve relaxation and blood filling.