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).
1
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.
2
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.
3
There is a clear need for more effective acute treatment options for patients with
ADHF and potential for longer term therapy to reduce re-admissions, improve quality
of life and reduce the unacceptable early mortality rate.
4
Over 1M patients per year in the US are estimated to be indicated for the QHeart
Medical TARR™ device during acute in-hospital use, representing a significant
revenue opportunity for the TARR™ device.
1
QHeart Medical TARR™ device objective is to reduce congestion and improve heart output for short term use.
2
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.
3
The extensive TARR ™ research shows increased cardiac output of 34% and stroke volume of 22%.
4
TARR™ represents a significant ADHF treatment
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
1
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.
2
QHeart Medical is preparing to execute a Capital Raise to fund clinical trials through to FDA clearance for the QHeart Medical TARR™ device.
3
QHeart has a strong investment proposition:
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