Leading the Evolution of Pumpless Heart Assist Devices
QHeart Medical Pty Ltd is an Australian privately owned, clinical stage MedTech company exploring the clinical utility of a novel “pumpless” heart assist device to address unresolved clinical consequences of heart failure, focused initially on the treatment of acute decompensated heart failure (ADHF).
QHeart Medical recently achieved proof of concept for its Transcatheter Aortic Recoil Repair (TARR™) implant, an endovascular intra-aortic balloon device, achieving significant improvement in blood flow from the heart.
The next step is to execute a pilot first-in-man study, before progressing to a clinical trial aiming to secure FDA clearance for the device.
To date, the project has been financed by a competitive grant (CRC Project Grant) and founders to a total of AU$10M.
To facilitate next steps, QHeart Medical is progressing a Capital Raise to fund an FDA clinical trial of the TARR™ device for use in the treatment of Acute Decompensated Heart Failure (ADHF).
The Need – Acute Decompensated Heart Failure (ADHF)
Heart failure is when the heart fails to pump sufficient oxygenated blood necessary
for the functioning of bodily tissues and organs, including the heart’s own needs.
Acute Decompensated Heart Failure (ADHF) is a life-threatening acute presentation of heart failure, and is the cause of up to 2 million US emergency hospital admissions annually. Patients present with congestion & fluid retention, shortness of breath and lower limb swelling. For many patients, emergency hospital admission is required. Poor treatment outcomes are common with 60% of hospitalized patients discharged with persistent congestion, leading to short-term re-hospitalization, poor quality of life, and high mortality.
The QHeart Medical TARR™ Solution
QHeart Medical TARR™ device objective is to reduce congestion and improve heart output for short term use.
The TARR™ is an endovascular intra-aortic balloon device that supports the heart to pump more effectively. All other mechanical devices indicated for heart failure pump on behalf of the failing heart.
The extensive TARR ™ research shows increased cardiac output of 34% and stroke volume of 22%.
- TARR™ demonstrates excellent performance and use features
- TARR™ has potential as a fast-acting therapy for ADHF
- 1,000,000 patients per year indicated for TARR™ for short term in hospital use in the USA alone
Commercialising the QHeart TARR™
The next step is to execute a pilot first-in-man study, before progressing to a clinical trial aiming to secure FDA clearance for the device.
QHeart Medical is preparing to execute a Capital Raise to fund clinical trials through to FDA clearance for the QHeart Medical TARR™ device.
- Project significantly de-risked
- Excellent validation data
- Fifteen issued & pending patents
- Represents a revenue opportunity of >US$1B per year
- An experienced team with a strong track record
- Clear pathway defined to commercialization and exit
