Breakthrough in Device Therapy for Patients with Late-Stage Heart Disease

SWANSEA, Wales and TEL AVIV, Israel, Jan. 10, 2022 /PRNewswire/ -- Severe heart failure is the most life-threatening medical condition in all age groups across the globe. Implantable heart pumps, known as Ventricular Assist Devices (or VADs), have proven to sustainably increase long term survival. However, due to the need for tethering to an external power source using a cable exiting the body through the abdomen, these devices have not yet been fully accepted as mainstream therapy.

Now, for the first time globally, a compact, fully implantable VAD (FiVAD) has been successfully implemented by combining the Calon Cardio MiniVAD™ with the versatile, fully implantable wireless energy recharging system of Leviticus Cardio. Completion of a 60-day in-vivo pre-clinical study of this FiVAD has successfully validated the integration of these two innovative technologies.

This new disruptive technology, FiVAD, will allow a patient a full day without a cable or connection to any external equipment whatsoever. The recharging process itself only requires a light belt around the patient's chest during the night. The successful elimination of the electric power cable is a major step forward leading to a near-normal quality of life for these severely ill patients. It will convince physicians around the world that VAD therapy has reached the point of routine use and will lead to widespread application of this life saving therapy.

The trial was conducted at the internationally recognised Centre of Excellence at the Catholic University of Leuven, in Belgium. The success of this ground-breaking study marks a further step in the integration of the two companies who are committed to taking this life changing innovation in partnership to patients across the globe.

Stuart McConchie, CEO of Calon Cardio-Technology Ltd: "The combination of our MiniVAD, designed to optimize blood handling, and the Leviticus wireless technology provides a safe and usable truly wireless VAD system, representing major progress in blood pump technology. Together this FiVAD will significantly improve the lives of vast numbers of late-stage heart failure patients."

Michael Zilbershlag, CEO of Leviticus Cardio Ltd: "Our study has demonstrated that the combination of the very effective Calon MiniVAD™ and the Leviticus FiVAD offers for the first time a fully functioning heart pump without the need to be recharged for more than 10 hours allowing freedom from any external equipment for a whole working day."

Marc Clement, Chairman of Calon Cardio-Technology Ltd: "I am sure I speak for both companies when I say how delighted we are with the outcome of the integration of our respective ground-breaking technologies. We are committed to a long-term relationship that will improve the quality of life of thousands of patients across the world."

"The successful 60-days preclinical milestone of the MiniVAD and FiVAD platform poses an encouraging accomplishment in further integration of these two innovative technologies," states Professor Ivan Netuka, Cardiac Surgeon, a Chairman in the Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic.

Professor Stephen Westaby, renowned heart surgeon (now retired) and a founder of Calon Cardio impresses that "The critical importance of the integration of the Calon Cardio and Leviticus Cardio technologies is the elimination of driveline infection. Infection destroys quality of life, promotes thrombosis and stroke, and too often results in substantial early mortality. The integrated FiVAD is a system that has the potential to supersede cardiac transplant as the preferred intervention in advanced heart failure, without needing someone else to die first."

"A system like this will give patients the freedom to do what they like for more than a whole working day without any external cable connections. When in clinical practice, this is more than we as physicians could have ever dreamed for VAD patient quality of life," adds Professor Stephan Schueler, Head of Department of Cardiothoracic Surgery at The Newcastle Upon Tyne Hospitals NHS Foundation Trust, United Kingdom.

About Calon Cardio-Technology Ltd

Calon Cardio was founded by Professor Stephen Westaby, Cardiac Surgeon, and Professor Marc Clement, Physicist, to optimise the heart failure therapy provided by early ventricular assist devices. The focus of this work was on reducing damage caused by shear forces during the passage of blood components through a pump. By achieving this objective, the clinical value of VAD therapy is increased, and at the same time, the overall cost is reduced. The Company has been supported financially by the Development Bank of Wales, by UK Government Grants, Longbow Capital, and more recently by the UK Future Fund program. Calon has drawn significant support from UK, US, and EU equity investors.

About Leviticus-Cardio Ltd.

Leviticus Cardio is a medical device company dedicated to improving the clinical outcome for patients with an implanted left ventricular assist device (LVAD) for the treatment of impaired cardiac function. The Leviticus FiVAD received several innovation awards, was implanted in humans in 2018/9 and received Breakthrough Device Designation from the FDA in 2019. The Company has received funding from The Trendlines Group (SGX:42T) (OTCQX: TRNLY), a consortium of acclaimed cardiovascular physicians, private investors, and Israel's Innovation Authority.

Contacts:

Stuart McConchie
CEO, Calon Cardio-Technology Ltd
+1 (212) 444-2346 • Mobile
[email protected]

Michael Zilbershlag
CEO, Leviticus -Cardio Ltd.
+972-50-8807135 • Mobile
[email protected]

SOURCE Calon Cardio-Technology Ltd.; Leviticus-Cardio Ltd.