Admedus Limited (ASX:AHZ) is making a smooth transition to its new sales model, according to chief executive officer Wayne Paterson, with this process including receipt of the company's first major manufacturing order.
An upcoming major milestone is set to be the first animal study of Admedus' transcatheter aortic valve replacement device (TAVR) system as discussions with potential strategic partners progress.
The company’s singular focus on developing novel ADAPT®-based products for global markets is driven by its highly differentiated program within the surgical (SAVR) and transcatheter aortic valve replacement devices (TAVR) space.
Paterson said, “We are now moving towards important milestones with the commencement of our first-inhuman trial for SAVR and animal study for the TAVR device while continuing discussions with potential strategic partners."
CEO Wayne Paterson:
“The balance sheet is greatly improved due to the transformational deal with LeMaitre."
Admedus' innovation suite debuted at the world’s largest structural heart valve congress, PCR London Valves in the UK in November 2019, generating a positive response amongst an audience of global key opinion leaders, primarily interventional cardiologists and cardiac surgeons.
The company's Advisory Board of TAVR physicians and engineers participated in presentations highlighting the key features and benefits its devices could bring to heart teams and their patients.
Results from the recently completed sheep study of the ADAPT® single-piece 3D aortic valve presented at PCR London Valves showed normal valve function postoperatively with no surgical or material failure, a low gradient across the valve and overall positive clinical status of the animals.
First milestone payment
Following the sale of the CardioCel® and VascuCel® distribution rights to LeMaitre Vascular Inc on October 14, 2019, the company completed the integration process including the required reporting procedures by the due date, resulting in AHZ’s first milestone payment.
At the end of the integration process, the company’s fulltime equivalent staff decreased by 28% to 16%.
On December 9, 2019, the company also announced LeMaitre’s first order for approximately 12,500 units of CardioCel® and VascuCel® product.
The quantity exceeded Admedus’ unit sales for the previous 12 months and the company retains manufacturing rights for up to three years, with a 20% margin over cost.
First-in-human SAVR trial
In January 2020, the company received approval to conduct its first-in-human SAVR trial of its proprietary ADAPT® single-piece 3D aortic valve.
Professor Bart Meuris MD, PhD, a renowned cardiac surgeon, will conduct the clinical trial at the Leuven University Hospitals in Belgium.
The trial is on track to begin this quarter, enrolling 15 patients who will each be followed for six months after implantation.
Results are expected between the first and third quarters of 2021.
Revenue was $2.3 million for the quarter with the Infusion business contributing $0.9 million following the division’s divestment in May 2019.
ADAPT® sales were $1.4 million reflecting the CardioCel® and VascuCel® patch business sold to LeMaitre.
Going forward, revenues from ADAPT® will relate to manufacturing as well as sales forming part of the 4C Technology Partnership Agreement.