Anteris Technologies Ltd (ASX:AVR, OTC:AMEUF) has partnered with IQVIA Inc and the Cardiovascular Research Foundation (CRF) to help it conduct an FDA early feasibility study (EFS).
This is an important milestone, as it places AVR with vastly experienced partners who have led hundreds of cardiovascular clinical trials, including many landmark studies in the Transcatheter aortic valve replacement (TAVR) space.
TAVR is a procedure that replaces a diseased aortic valve with a man-made valve.
IQVIA and CRF have vast experience in this space and complement AVR’s development of next-generation technologies including the Anteris DurAVR™ aortic replacement valve, which addresses the acute need in terms of superior hemodynamic profile as well as chronic needs in its ability to sustain that profile longer over the lifetime of the patient.
"Best in their space"
“These appointments mark a significant milestone,” Anteris CEO Wayne Paterson said.
“Not only are the companies we have partnered with the best in their space but they also validate the company’s viability by them agreeing to work with us.
"Having these important partnerships in place as we head towards our human TAVR study ensures Anteris is well prepared to optimise the future.”
Why an EFS is important
Paired with its ADAPT® tissue technology, AVR has the potential to deliver a functional cure to aortic stenosis patients and provide a much-needed solution to the challenges heart surgeons currently face.
The partnership with IQVIA and CRF puts AVR on a surefooted path, while the EFS will help AVR increase the efficiency of its device development.
An EFS is a limited clinical investigation of a device early in development. It typically:
- Enrols a small number of subjects;
- Is used to evaluate the device design concept with respect to initial clinical safety and device functionality; and
- May guide device modifications.
How partnership will work
IQVIA, one of the world largest clinical research organisations, will take responsibility for clinical data monitoring, project and site management, data management and safety. The organisation has completed hundreds of studies in the cardiovascular medical device space in different phases of research from EFS with novel products under the FDA Breakthrough Program to large post-market studies/registries.
CRF, a non-profit research and education organisation founded 25-years-ago by Dr Martin Leon MD (Professor of Medicine at Columbia University), will provide core lab services for the study (echo CT) and the independent Clinical Events Committee.
The CRF’s Clinical Trials Center (CTC) plans and executes clinical investigations from first-in-man studies to large, multicentre, international trials and provides expert, independent qualitative and quantitative analyses of clinical and imaging data.
The study being undertaken by AVR and its partners is a single-arm, multi-centre clinical trial designed to test the safety and feasibility of AVR’s DurAVR™ THV System on patients with severe aortic stenosis.
Its focus is on durability and calcification at 30 days post-implant procedure as a primary end point. It will also include a durability study over 10 years as part of the long-term follow-up.
This study represents an important milestone in the DurAVR™ clinical development program as it will provide valuable clinical data to support AVR’s pursuit of regulatory approvals in multiple geographies.
M&A advisor appointed
As it looks to position itself as a leading player in cardiovascular management, AVR has sought an M&A advisor to guide it through the highly competitive med-tech space.
US investment bank Piper Sandler & Co. will now act as AVR’s M&A adviser.
Piper Sandler ranks number one in Med-Tech M&A advisories by number of sell-side deals, cross border deals and buy-side deals.