PRESS RELEASE. Groundbreaking system for patients with failing heart successfully implanted in human

PRESS RELEASE

Groundbreaking system for patients with failing heart successfully implanted in human

The team of heart surgeons in Kazakhstan, under the leadership of Dr. Yuriy Pya, MD, PhD, in collaboration with partners from the Czech Republic, Israel, Italy and the U.S.A., performed the first in a human of a fully implantable heart assist device.The Fully ImplantedVentricular Assist Device (FIVAD)is the world’s first wirelesscontinuous flow left ventricular assist device which allows patients to carry on with daily activities,free from beingphysically connected to an external power source for over 6 hours. The fully implantable heart assist device ensures the patient’s safety with the addition of an integrated external connector behind the ear which can be activated in case of wireless operation abnormality.

Heart failure is the leading cause of death worldwide. Patients with end-stage heart disease are often kept alive using heart assist devices, which support blood circulation. They are used as a bridge therapy while the patient awaits a heart transplant. Whereas the pumps are implanted in the heart itself, they must be hooked up to a power supply via drivelines which physically run out across the skin of the chest cavity or abdomen. As a consequence, this often results in complications such as an infection leading to frequent rehospitalization and in some instances these medical issues may even prove fatal.

FIVAD’s new technology for heart assist device eliminates many of these risks, since the heart pump does not have an external driveline. Instead, power is supplied via wireless system of external belt and internally implanted coil ring. Moreover, due to the implanted battery this technology allows patients to spend their days without this belt for 6-8 hours a day, enabling them to engage in daily activities without being limited by drivelines or other external batteries.

The implantation of FIVADwas performed by the team of cardiac surgeon led by Dr. YuriyPya at the National Research Center for Cardiac Surgery, Astana, Kazakhstan. The patient suffered from dilated cardiomyopathy with worsening symptoms of heart failure, and the implantation of heart assist device was indicated as a lifesavingsurgical procedure. The patient is almost 2 months since implantation and has already been discharged from hospital. He isliving almost normal life style including swimming,while being closely monitored by Dr. Pya and the center’s staff.

With regard to this collaborative technology, Dr. Yuriy Pya, CEO of the National Research Center for Cardiac Surgery, commented: “FIVAD has a tremendous promise not only in the treatment of end-stage heart failure, but also in the evolution of medical devices in terms of delivery of healthcare as effective and safe as possible. We are delighted to provide this auspicious technological achievement to patients with a vision of successful treatment of heart failure and their high quality of life after surgical interventions”.

LeviticusCardio Ltd., inventor of the FIVAD wireless powering technology, plans to expand its clinical adoption tomitigate the risks and increase the quality of end-stage heart failure treatment. Moreover, this innovation has a potential to scale up the therapy and provide technological alternative practically equivalent to heart transplantation which is limited by a scarcity of donors.

International team members:

Professor Ivan Netuka, MD, Ph.D., FICS, Chairman of the Department of Cardiovascular Surgery of the Institute for Clinical and Experimental Medicine, Prague, Czech Republic; He practices as Consultant cardiac surgeon. He serves as a Surgical Programme Director of VAD and Heart Transplantation. In 2014 he has been elected as a member of Executive Board of Euromacs, a Committee of EACTS

Jiri Maly, MD, Ph.D. Consultant cardiac surgeon , Prague, Czech Republic; Deputy Head of Dept. of Cardiac Surgery, Institute for Clinical and Experimental Medicine, Prague; Deputy Head of MCS Programme.

Professor Massimo Massetti, MD, Cardiac Surgery, Catholic University of Sacred Heart, Gemelli Hospital, Rome, Italy.

Yuriy Pya, M.D. CEO of JSC "National Scientific Cardiac Surgery Center", at Astana, Kazakhstan. Doctor of Medical Science, 27^TH President of the World Society of Cardio Thoracic Surgeons (WSCTS). Chief cardiac surgeon of the Ministry of Health of the Republic of Kazakhstan.

About Leviticus Cardio Ltd.: Founded in 2008, Leviticus Cardio (Leviticus-cardio.com) 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 Company has received funding from The Trendlines Group, Israel’s foremost seed- and early-stage investment group, a consortium of acclaimed cardiovascular physicians, private investors and Israel’s Innovation Authority (previously, the Office of the Chief Scientist of the Ministry of Economy).

About the National Research Center for Cardiac Surgery, Astana, Kazakhstan

The National Research Center for Cardiac Surgery is the leading center in the Central Asia because of its remarkable pioneering and successful activities in cardiac surgery and cardiology in the region and the larger world. Its core missions are improvement of health of patients with cardiovascular diseases and subsequent increase in life expectancy of citizens of Kazakhstan. The Center aims to enhance the quality and efficiency of medical services, implement innovative technologies, and develop research activities. During 7 years since its establishment, the Center is the first one to introduce the heart and lung transplantation in the Central Asian region and the first to implement left ventricular assist devices among Commonwealth of Independent States (former Soviet Republics). Currently, the Center is the place for numerous international clinical trials including CARMAT and Heartmate 3. The Center carried out more than 9000 operations in 2018 including 42 heart assist device implantations and 8 heart transplants.