- ImpediMed Limited (ASX:IPD) produces CE-Marked as well as FDA-cleared medical devices.
- Recently, its HF-Dex™ abstract was published online; it has also been accepted for a poster presentation at the American College of Cardiology.
- The Company also received the United States Food and Drug Administration (FDA) 510(k) clearance for a heart failure index (HF-DexTM).
- A manuscript demonstrating the clinical utility of SOZO® device in monitoring heart failure patients was published in Frontiers in Cardiovascular Medicine.
ImpediMed Limited (ASX:IPD), a medtech corporation is based in Brisbane. The Company makes use of bioimpedance spectroscopy (BIS) technology. Through this breakthrough technology, powerful data to maximise patients’ health is produced.
The Company is building a strong and resilient business and accelerating innovation to drive growth. Record results of Q3 FY’21 in a challenging environment prove that ImpediMed is on the right path to achieve growth across its focus areas - three large and growing markets of oncology, heart failure, and renal failure.
Q3 FY’21 Overall Business Results, Source: Company presentation, April 2021
Notably, renowned organisations recently have been acknowledging ImpediMed’s lucrative stance. Let us skim through three such cases-
American College of Cardiology (ACC)
An abstract, evaluating the use of the Company’s SOZO® BIS technology in identifying heart failure patients at the risk of hospital readmission during discharge, was accepted for poster presentation at the ACC. The institute’s 70th Annual Scientific Session was due on 15-17 May 2021 in Atlanta, Georgia, USA.
Presenting data at the prestigious forum lends important credibility to ImpediMed’s technology. It could also support the Company’s commercialisation effort in heart failure.
Earlier in May, the Company announced the online publication of the HF-Dex™ abstract. It was published in the Journal of the American College of Cardiology Abstract Supplement.
The analysis shows that SOZO® with HF-DexTM can identify patients with fluid overload, who are at higher risk of readmission at the time of hospital discharge and would benefit from closer follow up.
The United States Food and Drug Administration (FDA)
The FDA is perhaps the most significant federal agency of the Department of Health and Human Services. It has the mission to safeguard and stimulate public health, while meeting the various tests of innovation across industries. It is the oldest consumer protection agency in the American federal government.
In April 2021, the FDA granted a 510(k) clearance to the Company’s SOZO® device to include a heart failure index (HF-DexTM) as a monitoring tool for patients living with heart failure. To this, Managing Director and the CEO Richard Carreon commented-
FETCH DETAILS HERE: ImpediMed stock jumps on FDA nod for SOZO® heart failure index
Frontiers in Cardiovascular Medicine
Frontiers in Cardiovascular Medicine is a multidisciplinary open access journal. It diligently publishes peer-reviewed research articles that revolve around cardiovascular medicine.
In early April 2021, the full peer-reviewed manuscript demonstrating the clinical utility of the Company’s SOZO® device in monitoring heart failure patients was published in this journal. The publication was titled - “Clinical Utility of Fluid Volume Assessment in Heart Failure Patients Using Bioimpedance Spectroscopy.”
With multiple milestones being achieved, ImpediMed’s stock has also caught the market eye. On 21 May 2021, IPD traded up 2.08% at A$0.12. The market capitalisation stood at A$179 million. The stock quoted A$0.12 on 24 May 2021 after market close.