Advancing Cardiac Care with Innovative Australian Heart Assist Technology

CardioBionic Pty. Ltd. comprises a diverse team of professionals with expertise in cardiology, engineering, medical research, computational design, high precision manufacturing and other areas. Together, the members of our core team and advisory board have decades of experience with ventricular and other cardiac assist technologies.

Heart Failure: A Global Health Crisis

Heart failure is where the heart is impaired in its ability to pump blood and is the result of (often interacting) factors such as ischaemic heart disease. Ultimately, heart failure is an end-point of cardiovascular disease and the epidemiological scale of cardiovascular disease is serious, being the cause-of-mortality for approximately 18 million individuals globally each year. Heart failure itself is estimated to affect about 25 million individuals globally. Although heart failure is a common cause of death it is by no means always fatal, but even so, it is often associated with a significant functional decline for individuals, one that is inextricable from what can be particularly challenging symptoms for patients including (severe) shortness of breath, chest pain, fatigue, anorexia and oedema, to say nothing of the conditions patients with heart failure have an increased risk of.

Pharmacotherapeutics are a cornerstone of the medical management of heart failure. However, in advanced cases or 'end-stage' disease (e.g., intractable symptoms despite optimised medical management), patients may need to be considered for surgical interventions such as transplantation and/or implantation of an active implantable cardiac assist device such as a ventricular assist device (VAD).

One issue for patients with advanced heart failure is that heart transplantation is complicated by factors including donor heart shortages, difficulties matching, procedural complexity and the ability of the patient to tolerate the surgery. On the other hand, while VADs are available and have been for some time, the design and development of these devices comes with significant engineering and manufacturing challenges. As a result, there is arguably still an unmet need not only for further advances in this area, but for simply even an increased availability of such devices.

In response to this, CardioBionic has designed and has been developing a ventricular assist system (VAS), i.e., a VAD control system. In parallel with the VAS we have been developing an LVAD, and are currently testing the VAS as an LVAD control system in animals.

Below is an overview of our VAS (Ventrii™ VAS) and the implantable devices we are developing for it.

Our Technology: Ventrii™ Ventricular Assist System (VAS) and Devices

Features of Our Technology

Ventrii™ Ventricular Assist System (VAS)

Ventrii™ VAS is our ventricular assist device control system. Our VAS is being designed and developed to have the flexibility of supporting a biventricular or single ventricular assist device configuration, as well as being able to serve as a controller for our Ventrii™ Cath (in early stages of development). Ventrii™ VAS is being realized through a meticulous research and development process as well as rigorous verification and validation. Clinical monitoring of Ventrii™ VAS is facilitated by our clinical monitoring interface.

Ventrii™ Ventricular Assist Device (VAD)

Our VADs are our left- and right-ventricular assist devices (VADs). They are active implantable centrifugal pumps controlled by the VAS and are intended to be used for the management of certain types of heart failure, such as when there is a need for bridge-to-transplant. In addition to an LVAD and RVAD, Ventrii™ VAS will also be capable of controlling our paediatric LVAD. Ventrii™ VAS will also run in a bi-ventricular configuration or 'BiVAD'. Our VADs are designed with a magnetically driven, hydrodynamically levitating impeller. The animation below demonstrates (i) one of our propotype LVAD locking mechanisms and (ii) the dynamics of the impeller in situ.

Ventrii™ Cath

Ventrii™ Cath is our cardiac catheter, which is in an early development stage. It is being developed with a view to integration with our VAS for use in acute heart failure.

Team

CardioBionic began with engineer Dr. Pete Ayre and cardiothoracic surgeon Dr. KR Balakrishnan meeting in Chennai, India, and sharing together a vison of doing their bit to help make progress in the global space of medical devices for heart failure. After the establishing of CardioBionic Pty. Ltd. in Australia, the company has expanded to include highly experienced core and advisory teams bringing together experts from across the globe and from a broad range of areas including engineering, precision-manufacturing, medicine and biomedical science. The collective experience of the individuals at CardioBionic is, we believe, an invaluable asset, and has been key to our currently being in animal testing stages for our Ventrii™ VAS and Ventrii™ VAD (LVAD).

Directors, Founders and Advisors

Dr. KR Balakrishnan

Chief Medical Officer Co-Founder Medical Advisory Board

Dr. KR Balakrishnan is a distinguished academic cardiothoracic surgeon who continues to have a profound impact on the field of heart and lung transplantation and mechanical circulatory support. His pioneering work, extensive experience, and ongoing research efforts continue to shape the landscape of cardiac care in India.

Established a first of its kind heart transplant program in India and has completed over 600 heart and lung transplants, the highest not only in the country but also in South Asia.
Pioneered and oversaw the implantation of over 100 continuous-flow LVADs in India, including the first as destination therapy in 2012.
Introduced India's first use of venoarterial ECMO (extracorporeal membrnae oxygenation) as a bridge to heart transplant in 2012.
Successfully performed India's first four of eight paediatric heart transplants, including in a two-year-old child in 2014, and has conducted over 130 paediatric heart transplants.

Clinical Advisory Board

Professor Chris Hayward

MBBS (Hons) MD BMedSc FRACP FSANZ

Medical Advisory Board Australia

Professor Hayward is a heart failure and transplant cardiologist at St Vincent’s Hospital in Sydney, Australia. His areas of interest in cardiology include not only heart failure and heart transplantation but also echocardiography and hypertension.

Director of the Mechanical and Circulatory Support Research Program at St. Vincent's Private Hospital.
Professor of Medicine at the University of New South Wales and Adjunct Professor at the University of Technology, Sydney.
Former Chairman of the Heart Failure Working Group of the Cardiac Society of Australia and New Zealand.