Medtronic will invest up to US$90m in Anteris Technologies to help fund the next stage of growth and the DurAVR transcatheter heart valve programme.
The Australia-founded company said the funding will support execution of its clinical strategy for DurAVR, designed to mimic a healthy human aortic valve and replicate normal aortic blood flow.
Transcatheter heart valves are replacement valves delivered to the heart through a catheter, a thin flexible tube inserted through a blood vessel rather than open heart surgery.
The private placement requires Medtronic to acquire a 16.0 to 19.99 per cent stake in Anteris.
Anteris is also proposing a US$200m underwritten public offering, with underwriters given a 30-day option to spend US$30m to buy additional shares at the offering price, minus underwriting discounts and commissions.
Recruitment is ongoing for the DurAVR transcatheter heart valve global pivotal trial for patients with severe aortic stenosis, known as the Paradigm trial. Aortic stenosis occurs when the aortic valve, which controls blood flow from the heart to the body, becomes narrowed.
The company said it is expanding its manufacturing capabilities.
Jorie Soskin is vice president and general manager of the structural heart business in Medtronic’s cardiovascular portfolio.
Soskin said: “Medtronic is a pioneer in TAVR innovation and evidence.
“Our investment in differentiated innovation like DurAVR THV technology, which has the potential to offer improved valve performance in a balloon-expandable platform, is core to our commitment to define and drive the future of TAVR, meeting the needs of more aortic stenosis patients and heart teams with a comprehensive portfolio.”
Officials said part of the proceeds may also fund research and development for v2vmedtech, Anteris’ partner company, which is developing a next-generation transcatheter edge-to-edge repair system for mitral and tricuspid valve regurgitation. This refers to leaky valves that allow blood to flow backwards.
Any remaining funds could be used for working capital and other general corporate purposes.
The fundraising came nearly three months after Anteris announced positive one-year clinical outcomes for DurAVR. The balloon-expandable, biomimetic DurAVR THV is made from a single piece of moulded Adapt tissue, described as the company’s patented anti-calcification bovine tissue technology.
Wayne Paterson, chief executive of Anteris Technologies, said the deal followed 2.5 years of negotiations.
Paterson said Medtronic wanted to acquire the company outright because Anteris’ technology could make it more competitive against TAVR rival Edwards Lifesciences, but it ultimately agreed to an investment that could enable a co-commercialisation partnership and manufacturing collaborations around Minneapolis.
TAVR stands for transcatheter aortic valve replacement, a minimally invasive procedure to replace a diseased aortic valve.
According to a regulatory filing linked to the offering, Medtronic will also have the right to a non-voting board observer and certain negotiation rights in connection with future third-party acquisition proposals.
The investment in Anteris comes after Medtronic’s TAVR competitor Edwards Lifesciences failed to acquire JenaValve due to antitrust concerns from the Federal Trade Commission.
