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Ed. note: News about Leviticus Cardio’s successful study appeared here and on many other websites.
The Company will be available at the “EUMS2015” meeting in Paris, December 3-5 to discuss the results of this pre-clinical chronic animal study.
Petah Tikva, Israel, November 16, 2015 — Leviticus Cardio announces positive achievement of a preclinical study evaluating their transcutaneous Coplanar Energy Transfer (CET) system in a chronic animal model. In the study, conducted at the Catholic University of Leuven, Belgium under the supervision of Professor Bart Meyns, MD, Ph.D., the device was well tolerated in animals for 28 days. Additionally, the experience indicates stable and consistent energy transfer, suggesting the capability for discharge and re-charge cycles of its implanted battery-powered control unit to be examined in further studies.
“This encouraging data builds on prior preclinical data presented at ISHLT 2015 demonstrating the CET system, states Assoc. Professor Ivan Netuka, MD, Ph.D., Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic. The successful implant of the wireless Coplanar Energy Transfer (CET) system developed by Leviticus Cardio in a chronic ovine model [70Kg] providing power to the implanted HVAD® system [Heartware International Inc. Framingham, Mass.] has achieved its target endpoint of 28 days, demonstrating that the CET system is an efficient tool delivering both stable and consistent energy transfer.
We implanted the system to power the HVAD® on the 14th October 2015 to determine the long-term stability in a chronic animal model. The results of the study indicate:
“Importantly, the data reinforces our belief that the CET system has the potential to provide substantial Quality of Life improvement and infection reduction for patients treated with a ventricular assist device,” comments MUDr. Jiří Malý, MD, Ph.D, of IKEM, Prague.
Michael Zilbershlag, BSc, MBA, CEO of Leviticus Cardio, comments, “This is a very important step towards the feasibility study and a significant milestone for the technology. We are pleased with these results, which will enable us to move forward.” Also announced today, is the achievement of ISO13485 certification, “a critical step in our ability to manufacture our product, enabling us to progress towards our feasibility and CE Mark study” states Mr. Zilbershlag.