About

Kardiatec, S.A. is a new, innovative medical device manufacturer based in Athens, Greece. Our device, the PULVAD, is a dramatic solution to the growing worldwide problem of heart-failure.

Solution & Product

-The PULVAD is a unique Pressure Unloading Left Ventricular Assist Device that reduces the heart’s workload and allows it to recover normal function over an implant period of up to 6 months. This curative therapy is elegantly simple: the PULVAD reduces the pressure that the heart pumps against. Unlike left ventricular assist devices (LVADs) in current use, the PULVAD does not completely usurp the heart’s pumping function, causing it to atrophy and eliminating all potential for recovery. Existing LVADs save lives, but to do so they must literally sacrifice the patient’s heart. Like existing devices, the PULVAD can also be used as a bridge to other treatments, such as cardiac transplantation or permanent LVAD implantation. Unlike existing LVADs, our device is inexpensive to manufacture and its simple implant procedure does not require a cardiothoracic surgeon or a hospital with sophisticated cardiac surgery capabilities.

Innovation & Scalability

-The PULVAD, as a device aiming at myocardial recovery, presents significant advantages over the other currently available LVADs Our Solution PULVAD has1. Impressive pressure unloading leading to effective support of the left ventricle and intrinsic cardiac muscle function by increasing its pulse volume (other currently used LVADs suppress the functionality of the left ventricle by reducing its pulse volume). 2. Relatively simple implantation and explantation surgery or deactivation (without explantation). The surgical implantation/explantation of the PULVAD is performed via partial clamping of the ascending aorta, unlike other similar LVADs which require cardiopulmonary bypass. 3. The surgical implantation, explantation or deactivation of the PULVAD leaves the heart intact since it is implanted on the ascending aorta and does not involve destruction or removal of part of the myocardium, which is required for insertion of other LVADs 4. Pulsatile flow which is associated with higher rates of myocardial recovery. 5. Low cost, wide availability and easy operation. The PULVAD has a relatively simple design (no complex electromechanical parts) and low production cost ($1,7K), much lower in comparison of the currently available devices (short-term support devices $10K-25K, long-term support devices > $200K). The PULVAD’s operation does not required specialized technical personnel. Anyone with ΙΑΒP console training (even the patient) could handle it. 6. Low rate of complications

Traction & achievements

Completion of PULVAD’s prototype USPTO and international PCT patent filing in 2019 Completion of 14 pre-clinical trials, animal safety and validation experiments, and durability testing. Authorization from EOF for 3 clinical trials (“Odysseus” and “Admetus” and "Prometheus") Initiation of the first clinical trial

Team & Why Us

Dr. John Nanas is Emeritus Professor of Cardiology at the Medical School of the University of Athens. He studied at the University of Utah in the Department of artificial organs under Pr. William Kolff. There, he acquired great experience in the operation of the artificial heart developing important experimental work In the '90s, he implanted a pressure unloading assist device of the circulation in 3 patients. Since then, he’s been working towards the development of PULVAD, a device of his own invention following the same rational aiming at the treatment of patients with end-stage heart failure. Dr. Mason is Professor of Cardiology at the University of Utah, Chief Medical Officer at Spaulding Clinical Research, and an independent consultant in cardiac safety. Chris Mortis has led the engineering effort for the PULVAD device. He has over 20 years of experience in medical device product development and commercialization.

Funding Needs

Finalized product design 60000€ Clinical Trials 1260000€ Lab results 4000€ Evaluation 15680€ Sterilationt15800€ Chemical tests 18500€ Mechanical test 20000€ File preparation 8000€ CE Mark audit application and audit 300000€