Australia is a leader in the development of heart pumps to treat cardiovascular disease. Venstra Medical is a Newcastle headquartered company with operating personnel in the USA. It is developing an innovative new percutaneous Ventricular Assist Device (pVAD) to treat the 10% of heart attack patients that suffer cardiogenic shock and have the highest mortality rate. The pVAD is a mechanical catheter-based device that has an expandable and collapsible impellor which is designed to supplement or replace the mechanical functioning of the heart at the point of presentation in a clinic. pVADS are temporary devices that can typically remain in place for 4 days. They come in a large or small size.
A large diameter catheter offers the pumping power (5l/min at 60mmHg) needed to unload the heart fully while it recovers. The larger diameter device needs surgical implantation which often limits access to patients who present in regional/remote hospitals that do not offer quaternary coronary treatment. Unless patients and surgeons can link up quickly, a patient’s chance of survival is reduced. Large diameter devices are also often not feasible for patient’s with diseased/narrow arteries or (typically) female patient’s with healthy but smaller arteries. Small diameter pVAD’s are designed to be accessible to all patients and do not need surgical implantation. They can be implanted by a trained interventional cardiologist in a catheter laboratory at point of presentation. However, smaller devices have less pumping power and cannot fully unload the heart. There are a range of risks and complications with both sizes of device. The clinical need is for a small diameter device that can deliver the pumping power of a large diameter device and because of its smaller diameter greatly reduces the risk of complications.
Venstra Medical has developed the world’s smallest diameter highest powered pump (7l/min at 60mmHg) calling on specialist Australian-based development and US-based MedTech commercialisation expertise. This type of device is a Class III device and therefore needs to undergo clinical trials initially in Australia and then in the USA to secure FDA Regulatory Approval. This is a long and expensive pathway.
Venstra Medical has 4 key capabilities that lay a platform for success:
A. An excellent clinical team and clinical outreach to key influencers (as a Medical Advisory Board) that have come on the journey, understand the science and the device and are prepared to support human clinical trials and advocate its use.
B. A MedTech experienced Management Team that have successfully commercialised MedTech devices before, know what it takes, know how to manage contractors to time and budget (because they know what has to be done) and have credibility with Investors. This team includes biomedical engineers and clinical specialists.
C. A great product which is heavily patented. Whilst this is an incremental device in many ways it has solved a problem in a unique and compelling way opening opportunities for an exit to large pharma who are looking for new patented technologies that address a recognised clinical need and (ideally) provides a protected runway for commercial exploitation.
D. An organisation that has its Board, Management, and Clinicians aligned to support fund-raising effort and commercial success.
Triple Innovation has been assisted Venstra Medical during 2024 in its fund-raising endeavours to support device development, pre-clinical and early clinical activity in Australia..