Needle-Free safe and efficient access to the pericardial space
CardioVia is a medical device company in the field of cardiology. Established in 2018 in Nazareth, Israel, the company is developing a novel minimal invasive, safe and efficient needle-free access to the pericardial space (the membrane that surrounds the heart). The access to the outer surface of the heart through the pericardium is needed in order to treat the most prevalent Cardiovascular Diseases and arrhythmias without using a needle.
By using CardioVia’s system, physicians will be able to perform procedures on one of the most delicate and complicated instrument that the human body has with full confidence and a sense of safeness for them and their patients.
The pericardium is a highly sensitive double walled sac that surrounds the heart and protects it by preventing friction of the muscle with other organs during contractions.
Penetration to the pericardial space carries a great risk of harming the heart as current procedures use a sharp needle that is directed towards the beating heart and fail to generate a secure workspace. The pericardium tissue is very thin and is in average only 1-3 mm thick while current techniques lack sufficient monitoring and control and don’t address the fact that during the penetration process the heart is in constant motion.
An example for how the procedure of reaching the pericardial space for liquid drainage is done today:
Penetrating the pericardial space requires agility, experience and great precision and most physicians would prefer a better solution that will minimize the risk for their patients.
CardioVia's system is an access device that allows safe passage to the pericardial space and does that by performing an accurate cut between the pericardium layers thanks to a tangential scalpel with special angles while changing the way we think about the access to the delicate cavities in the human body.
NO needle is pointed towards the heart and the system has several safety mechanisms such as the A-Traumatic distal surface point that is flexible and soft.
Furthermore, the threads of the tangential scalpel are not sharp (only the distal tip) and form as an anchoring surface of the system within the pericardial space as the pericardial tissue clinches over them.
While synchronizing with the patient’s heartbeats, the procedure is performed in a controlled and measured manner, and the device includes special sensors that indicate the system’s location enabling the physician to halt the system after the penetration to the epicardial space.
Once inserted, the device anchors to the pericardium and serves as a pathway that allows through it an easy and secure continuous access.
The systems key elements:
CardioVia is targeting three main segments of patients that need a safer and a more efficient access to the pericardial space:
- Mapping and Ablation procedures for arrhythmias (A-fib, VT)
- Pericardium conditions (Cardiac Tamponade, Pericardial Effusion)
- Further applications (drugs, stem cells, gene therapy delivery and pacemaker implementation)
The combined prevalence of these segments is more than 50 million patients with an incidence rate of more than 3 million procedures in the US & EU creating a market that is estimated to be more than $0.5 billion annually.
A-Fib is the most common serious abnormal heart arrhythmia. Billions of dollars are spent annually on its diagnosis and treatment (more than $6 Billion in the USA alone each year). With more than 750,000 hospitalizations that occur each year. A-Fib contributes to an estimated130,000 deaths each year .
The study on the left shows that in some cases the focus of the arrhythmia (marked in red) is presented on the heart surface (The right column). In this case, it is shown that there is a high relevance in accessing the pericardial space in order to perform ablation procedures for a more efficient treatment.
Ventricular tachycardia (VT) is a fast heart rhythm disorder arises from improper electrical activity in the ventricles of the heart. When that happens, the heart may not be able to pump enough blood to the body and lungs because the ventricles are beating so fast that they don't have time to fill properly.
VT is responsible for most of the sudden cardiac deaths in the United States, at an estimated rate of 300,000 deaths per year.
Those patients can highly benefit from mapping & ablation procedures performed directly on the surface of the heart.
There are various conditions that the pericardial space is known for such as Pericardial Effusion and Tamponade. Approximately, over 1M people across the US and EU are treated for those conditions with a needle that is directed and pushed towards the heart in an unsafe manner.
In up to 25% of the cases the heart is being punctured, this can cause in ~10-17% of the cases further complications of the procedure such as an occurrence of an arrhythmia and in 1-2% of the cases even death.
There are promising indications for improvements of existing drugs by delivery of agents directly to the pericardial space which is a unique and region-specific target to give effective cardio active drug therapy without many of the side effects of conventional drug delivery methods.
This field aims to enhance outcomes of existing therapies by broadening their therapeutic window and to utilize new agents that otherwise could not be implemented systemically, such as gene and stem cells therapy. CardioVia’s system will allow a minimal invasive, safe and efficient agents delivery to the epicardial space.
Approximately 750K pacemakers are being implanted each year in the US and EU, having an easy and safe access to the outer surface of the heart will encourage the market to shift from endocardial pacemakers and lead placement to an epicardial application.
Ziv Menshes - Co-Founder, CEO
Ziv has experience in managerial and economic activities with a demonstrated history in consulting for government offices and in the machinery industry.
Ziv Holds a B.Sc. in economics and agriculture and an MBA specializing in Strategy & Entrepreneurship and Urban, Community and Regional Planning, both degrees from The Hebrew University of Jerusalem.
Or Hazan, Co-Founder, Director & VP Product Development
Or brings managerial experience and project management skills in the medical device industries. He also gained experience in vast legal aspects of Hi-tech companies as he specialized at APM&Co.
Or holds an LLB. and a Masters in Business Law with specialization in Finance, both degrees accomplished with distinctions from the Hebrew University, Jerusalem. Or also has a Diplomacy in Biomed Development from the Technion, Israel Institute of Technology.
Maor Rosenberg – CTO
Maor has vast R&D, mechanical design, project management and team leadership experience in the medical-device industry and in the past few years has been focused on medical implants and electro mechanical disposables. Prior to joining CardioVia, Maor served as an R&D mechanical Engineer in the field of medical infusion systems.
Maor holds a B.Sc. in mechanical engineering and is completing his M.Sc. in Bio-medical engineering from the Technion, Israel Institute of Technology, Haifa.
Nizar Mishael – CFO
Nizar has hands-on financial management experience at all levels: from seed investment through early and late financial rounds. He serves as managing partner and CFO of NGT3vc early stage fund. Nizar is a certified CPA and holds an MBA from Tel Aviv University’s Recanati program.
Ran Eliaz – MD, Co-Founder & Medical advisor
Dr. Ran Eliaz is an attending physician at Hadassah Hebrew university medical center, currently working at the Heart Institute in Hadassah Medical Center gaining expertise in the field of Coronary and structural interventions as well as basic science and research, and preparing for his fellowship in interventional cardiology in 2019.
Yonatan Avraham Demma – MD, Co-Founder & Medical advisor
Dr. Demma is a Senior Surgeon at Hadassah Medical Center. He had his residency in Hadassah’s Medical Center and is about to perform a fellowship in surgery of the esophagus in Paris, France. Dr Demma is currently studying for a Master of Health Administration and furthermore serves as an instructor and physician in the medical corps of the Israel Defense Force (IDF).
Zohar Gendler – Director
Managing Partner & CEO of NGT3VC. Former CEO & director of Beta-O2 Technologies (developed proprietary implantable bio-artificial pancreas). Served as CEO of the Technion Technological Incubator for 11 years. Led the establishment and investment in 53 companies, such as Prolor Biotech (sold to OPKO, NYSE: OPK, for $480M), Mazor (NASDAQ: MZOR), ReWalk (NASDAQ: RWLK), Corindus (NASDAQ: CVRS), Regentis, and many others.
Ziv Menshes, B.SC, MBA
Co-Founder & CEO, NGT3 VC Technological Incubator
P.O. Box 1252, Nazareth Illit 17111, Israel
Or Hazan, LLB, LLM
Co-Founder & VP PD and Director, NGT3 VC Technological Incubator
P.O. Box 1252, Nazareth Illit 17111, Israel