Anteris Technologies Ltd (ASX:AVR) (OTCMKTS:AMEUF) (FRA:DDF) has successfully completed a placement of shares to sophisticated investors to raise $1.1 million at $3.37 per share.
The raise provides additional working capital as Anteris continues to advance the development of DurAVR™, its 3D single-piece aortic valve for the treatment of aortic stenosis.
Transformation to a structural heart company
Since the company’s transformation to a structural heart company following the divestment of its patch business to LeMaitre Vascular Inc in October 2019, this year ended with its TAVR Early Feasibility Study (EFS) pre-submission lodged with the USA FDA.
The lodgement followed a presentation to FDA regulators during the previous quarter after a year of accomplishments including:
- Six patients with severe aortic stenosis successfully treated with the DurAVR™ prosthetic valve since the 15-patient study commenced on 27 March 2020. Final approval was granted on 20 March 2020 to start the study. The study is expected to conclude in 2021 with results thus far exceeding expectations;
- Testament to the year’s R&D effort, Anteris’ 3D single-piece aortic valve, DurAVR™, was selected as a “Best Innovation” at the PCR London Valves 2020 virtual conference, with data from the company’s first-in-human trial presented. PCR London Valves is the world’s largest educational meeting focused on transcatheter therapies for valvular heart disease;
- US FDA clearance granted on 27 March 2020 for ADAPT® treated tissue, paving the way for the TAVR and SAVR DurAVR™ valve US approval process;
- Interim results (published on 10 November 2020) from its anti-calcification study started in May 2020 showing superior results to competitor AOA™ tissue used in Medtronic’s TAVR and SAVR prosthetic valves. (Same trend shown on earlier study comparison with Edwards Life Sciences’ Thermafix tissue used in its prosthetic aortic valves);
- Started TAVR animal study in June 2020 with results due in Q1,2021; and
- Important to Anteris’ directional change to a structural heart company was the share consolidation members’ approval on 25 February 2020 and the change of company name on 22 May 2020.
Commercialisation strategy
Despite COVID-19’s catastrophic global impact, the company successfully navigated the year, driving its R&D programme, clinical, animal and technical studies impressively enough to attract new sophisticated investors to support its commercialisation strategy.
It was the first new capital raise in two years. Formerly AVR’S largest shareholder, the Star Bright Group (HK), sold the majority of its holding this year, putting a damp on the share price.
New York healthcare hedge fund, Sio Partners LP, is the largest shareholder with about 21% of issued shares post raise.