AVR News & Events

Anteris Technologies announced that it is offering to sell, subject to market and other conditions, $200M of shares of its common stock through a proposed underwritten public offering. In addition, pursuant to a stock purchase agreement, dated January 20, Anteris has agreed to sell to Medtronic plc in a private placement up to $90M of shares of common stock. Anteris intends to use the net proceeds from the offering, together with its existing cash and cash equivalents and the net proceeds from the private placement, to support the next stage of growth and advance execution of the company's clinical strategy. This includes ongoing recruitment and study execution of the DurAVR Transcatheter Heart Valve global pivotal trial for patients with severe aortic stenosis and expansion of manufacturing capabilities. In addition, a portion of the proceeds is expected to fund ongoing research and development for v2vmedtech, with the balance allocated to working capital and other general corporate purposes determined from time to time. Barclays, Wells Fargo Securities and Cantor are acting as joint book-running managers for the offering.

Anteris Technologies files $500M mixed securities shelf

Anteris Technologies released 30-day clinical outcomes for the DurAVR THV in one hundred severe aortic stenosis patients with small aortic annuli - aortic annulus area 404 +/- 37mm2 -. The DurAVR THV demonstrated single digit mean gradients, large effective orifice areas, no moderate or severe paravalvular leaks and no valve related mortality, with 97% freedom from moderate or severe prosthesis-patient mismatch in a cohort of small annuli patients similar to the one reported in the SMART Trial. DurAVR THV delivered a favorable hemodynamic profile with a large EOA of 2.2 +/- 0.3 cm2 and a single digit mean pressure gradient of 8.2 +/- 3.1 mmHg. At 30-days, clinical safety outcomes were positive with no valve related mortality and no moderate or severe paravalvular leak. Prosthesis-patient mismatch was 3.0% compared with 11.2% to 35.3%1 for current commercial devices. A technical success rate of 100% was achieved in the last 50 consecutive patient implants. The global PARADIGM Trial will evaluate the safety and effectiveness of the DurAVR THV compared to commercially available transcatheter aortic valve replacements in the treatment of severe aortic stenosis.

Anteris announced it has received U.S. Food and Drug Administration, FDA, approval to initiate PARADIGM, its global Investigational Device Exemption, IDE, clinical trial which is designed to evaluate the DurAVR Transcatheter Heart Valve, THV, in patients with severe calcific aortic stenosis and to support a future PMA submission. "We are extremely pleased to receive FDA approval for the PARADIGM Trial, which allows us to commence patient recruitment in the United States**. This milestone, together with the recent launch of the trial and first patients treated in Denmark, represents a significant achievement and a key step forward in advancing this life-saving technology worldwide for patients living with aortic stenosis, a debilitating and progressive condition," commented Vice Chairman and CEO, Wayne Paterson.