Market Need

Heart Failure: A Global
Health Crisis

Globally, heart failure is the leading cause of death 1. There are approximately 64 million people worldwide with heart failure (expected to be 70 million by 2030)2 . Heart failure significantly reduces the heart’s ability to pump blood effectively.

Current estimates are that nearly 6.5 million Americans over the age of 20 have heart failure. One major US study estimates there are 960,000 new heart failure cases annually.3

Heart failure is a significant public health concern in India, with an estimated annual incidence ranging from 491,600 to 1.8 million cases. The prevalence is also substantial, estimated at 1.3 to 4.6 million.4

In Australia almost 144,000 people (0.6% of the population) live with heart failure.5

Advanced heart failure is often linked to significant functional decline and challenging symptoms, including severe shortness of breath, chest pain, fatigue, anorexia, and oedema, which can often lead to death.

Pharmacotherapeutics play a critical component in the initial medical management of heart failure. However, as the heart’s blood-pumping function continues to decline, patients might need to be evaluated for surgical options such as heart transplantation and/or the implantation of an active implantable cardiac assist device, like a ventricular assist device (VAD).

Heart Transplant Complications

Heart transplantation therapy is complicated by factors such as the substantial shortage of donor hearts (less than 6000 annually worldwide) 6, difficulties in matching donor hearts with patients, the intricacy of the transplantation procedure, and the capacity of end-stage heart failure patients to endure major surgery.
On the other hand, while VADs have been in production for several years, their design and manufacture present considerable engineering challenges and lead to extremely high costs for the devices.

Left ventricular assist devices (LVADs) currently cost around USD$ 100k. Total implantable artificial hearts (TAH) have a very small market share due to their size, complexity, and requirement for completely removing the native heart. They are expensive, costing USD$ 200k. 7

The largest market is the Left Ventricle Assist Device (LVAD), since it is usually the left side of the heart that fails.

Addressing the Critical Need in Heart Failure Treatment

Only a small percentage of patients with end-stage heart failure who need a heart transplant actually receive one. The lives of such patients could be significantly improved and prolonged by receiving a ventricular assist device (VAD) implant. The need in developing economies is even greater.

There is a significant ongoing need for advancements in this sector, particularly in creating new VAD products that simplify implantation and usage while reducing the overall cost associated with device manufacture and implantation.

1Di Cesare M, Perel P, Taylor S, Kabudula C, Bixby H, Gaziano TA, McGhie DV, Mwangi J, Pervan B, Narula J, Pineiro D, Pinto FJ. The Heart of the World. Glob Heart. 2024 Jan 25;19(1):11. doi: 10.5334/gh.1288. PMID: 38273998; PMCID: PMC10809869.
2Shahim B, Kapelios CJ, Savarese G, Lund LH. Global Public Health Burden of Heart Failure: An Updated Review. Card Fail Rev. Jul 27;9:e11. doi: 10.15420/cfr.2023.05. PMID: 37547123; PMCID: PMC10398425. 2023
3According to Heart Failure Society of America (HFSA), How common is heart failure? Accessed on 13 April 2025 https://hfsa.org/patient-hub/heart-failure-facts-information
4Feng, J, Zhang, Y, Zhang, J. Epidemiology and Burden of Heart Failure in Asia.
5Australian Bureau of Statistics 2023, National Health Survey 2022. JACC: Asia. 2024 Apr, 4 (4) 249–264. https://doi.org/10.1016/j.jacasi.2024.01.013
6Victor Chang Cardiac Research Institute. (n.d.). Artificial hearts. Retrieved March 28, 2025, from https://www.victorchang.edu.au/artificial-hearts
7Whittthaker, 2024, Forbes Australia, Decades in the making: BiVACOR implants first in-human artificial heart, 26 july 2024, accessed on 14 April 2025, https://www.forbes.com.au/news/innovation/bivacor-implants-first-in-human-artificial-heart/