Frequently Asked Questions

CardioLife's pump architecture and engineering team derive directly from the VentrAssist LVAD programme. VentrAssist was TGA- and CE Mark-approved and implanted in more than 420 patients worldwide, with a longest tracked patient survival of 13 years — generating substantial real-world evidence on the safety and durability of continuous-flow LVAD technology. CardioLife's Founder and Chief Scientific Officer, Dr. Peter Ayre, co-founded Ventracor and led its research and development for 13 years, taking VentrAssist from concept through to clinical use. CardioLife is iterating on a clinically validated technology lineage rather than starting from a blank sheet.

The Andhra Pradesh MedTech Zone (AMTZ) in Visakhapatnam is one of the world's largest medical-device manufacturing clusters, with ISO 13485-certified facilities and an established components and quality-systems ecosystem. AMTZ is CardioLife's Indian manufacturing base, which allows the company to reach production readiness far faster than building a facility from scratch and to manufacture at an Indian cost base. AMTZ is also a strategic shareholder in CardioLife's Indian entity, Cardio Life India Pvt Ltd, aligning the manufacturing relationship with a long-term equity partnership.

CardioLife's Indian clinical programme is led by Dr Sandeep Attawar, Chair of Cardiac Surgery and Thoracic Organ Transplants at KIMS Hospital Group. The company is also guided by a clinical advisory network of cardiologists, cardiac surgeons and mechanical-circulatory-support specialists across India and Australia, including advisors affiliated with St Vincent's Hospital, Sydney.

The UCA is CardioLife's integrated control, monitoring and data platform. Rather than a separate system for each therapy, the UCA underpins CardioLife's full range of cardiac support devices — so a hospital that adopts one CardioLife product is already equipped and trained for the next. It is the foundation that lets a single platform span acute, bridge, and long-term cardiac support.

The internal LVAD is being developed with a non-contact bearing design derived from the VentrAssist continuous-flow architecture. In conventional pumps, contact between rotating parts causes wear and can contribute to blood-handling complications such as haemolysis and thrombosis. A non-contact approach is designed to reduce those risks. The Internal and External LVADs also integrate an onboard sensor array intended to provide continuous pump and haemodynamic data, laying the groundwork for remote monitoring and future decision-support tools. These are design goals; performance will be established through CardioLife's own pre-clinical and clinical programme.

Three devices on the shared UCA platform, each designed for a different stage of care: • Internal LVAD — an implantable left ventricular assist device for long-term circulatory support. • External LVAD — an extracorporeal device for short- to mid-term ventricular support and bridge therapy. • ECMO — an acute extracorporeal life-support system for severe heart or lung conditions. All three are in development at various stages and share the UCA platform, so engineering, clinical and regulatory work compounds across the portfolio rather than starting over for each product.

India is the lead market. CardioLife's devices fall under CDSCO's risk-based framework (Classes A–D), with the implantable LVAD in the highest risk class. Clinical and engineering data are being generated to international standards so they can support subsequent submissions in additional markets — including TGA (Australia), CE Mark (Europe) and the US FDA — over time. CardioLife is not publishing specific approval dates publicly; regulatory timelines depend on clinical progress and agency review and are discussed directly with partners and qualified investors.

More than 56 million people live with heart failure worldwide (GBD 2021), yet fewer than 25,000 receive durable mechanical circulatory support each year — under 0.1% of those who could benefit. Three barriers drive this gap: advanced devices are priced for the wealthiest health systems; care is fragmented across multiple separate systems; and existing devices do not fit the full range of patient anatomies. CardioLife exists to close that gap by making advanced cardiac support both more capable and more affordable.

CardioLife brings together deep engineering, clinical and commercial experience: • Dr Peter Ayre — Founder & Chief Scientific Officer; co-founded Ventracor and led VentrAssist R&D for 13 years; 30+ years in implantable device engineering. • Prof. Stephen Moss — Executive Chair; decades of experience across professional services and MedTech. • Scott Roantree — Chief Executive Officer & Founder; 20+ years in cross-border growth and execution. • Dr Sandeep Attawar — Clinical lead (KIMS Hospital Group); cardiac surgeon and principal investigator. • Board & advisors — including directors Ross Harricks and Andrew Seaton, and a medical advisory network spanning India and Australia.

India combines a very large underserved patient population — several million people living with heart failure, most with little or no access to mechanical circulatory support — with a clear regulatory pathway through the Central Drugs Standard Control Organization (CDSCO) and a strong medical-device manufacturing base. Building first in India lets CardioLife develop affordable, high-quality devices close to one of the largest groups of patients who currently have no option, while generating clinical and engineering data to international standards that can support entry into other markets over time.

We work with clinicians, hospitals, suppliers and partners who share our goal of widening access to advanced cardiac care. For clinical collaboration, partnership or supplier enquiries, or to explore careers, please get in touch via our Contact page or LinkedIn.

Please contact us directly. Investment information is shared with qualified investors through confidential materials rather than being published here.