ASX Health Stocks: FDA greenlights Anteris study, Respiri selected in Arkansas
Health & Biotech
Health & Biotech
Heart specialist Anteris Technologies (ASX: AVR) rallied as high as 5% after reporting some US FDA related news this morning.
Anteris says the FDA has conditionally approved its DurAVR Transcatheter Heart Valve (THV) System for an investigational device exemption (IDE) application to commence an Early Feasibility Study (EFS).
The FDA concluded that Anteris has provided adequate data to support the initiation of this clinical study in the United States.
The EFS will enrol 15 subjects at seven Heart Valve Centers of Excellence in the US, and will commence in early 2023.
The FDA has categorised DurAVR as a CMS Category B device, which permits the device to potentially be sold during the study.
The FDA approval is a critical milestone for Anteris achieving a pre-market approval in the US.
The DurAV THV System is a novel balloon-expandable single-piece 3D transcatheter aortic valve for the treatment of aortic stenosis.
It is said to be the world’s first and only 3D single piece aortic valve.
A leading US cardiac centre, the Arkansas Heart Hospital (AHH), has selected Respiri (ASX:RSH)’s wheezo and Access Telehealth’s cloud-based RPM solution, Remotli, to help better manage its cardiovascular (CVD) patients.
The wheezo RPM (Remote Patient Monitoring) program was selected as part of a standard of care for CVD patients who are also suffering from Chronic Obstructive Pulmonary Disease (COPD).
The program was secured with Respiri’s RPM partner Access Telehealth, and will provide a full RPM solution that includes the patient engagement Remotli platform.
The program is not a pilot and will commence immediately, and is expected to not only improve patient outcomes but also reduce hospital readmissions costs.
The Arkansas Heart Hospital holds a five-star, Center for Medicare & Medicaid Services (CMS) rating and is one of the country’s largest private providers of CVD care.
Emyria (ASX:EMD) has been accepted into the NIH HEAL Initiative, a program focused on improving prevention and treatment strategies for opioid misuse and addiction.
The PSPP program, part of the NIH HEAL Initiative, evaluates non-opioid drugs in established preclinical models.
The PSPP program accepts small molecules, biologics, devices, or natural products for evaluation, from researchers in academia and industry worldwide.
Specifically, PSPP will evaluate Emyria’s proprietary formulations of ultra-pure cannabinoids for suitability as treatments for pain.
Emyria is currently focusing its EMD-RX7 cannabinoid program on US-FDA registration pathways.
“Our compelling real world data has demonstrated that cannabinoids may be useful amongst sufferers of chronic, non-cancer pain and we saw a need to develop reliable, ultra-pure dose forms, suitable for registration with major regulators,” says CEO, Dr Michael Winlo.