The funds will go towards a pivotal study with its device, DurAVR THV, which is expected to involve 1,000-1,200 patients. The company anticipates submitting an IDE to the FDA by the end of March next year, which once approved, will allow the company to start its pivotal study in Q3 next year.
The pivotal study will involve a 12 month follow-up of patients. Anteris expects to raise 'significant additional funding' over the course of the pivotal study period.
So far 73 patients have been implanted with the company's device in clinical studies over the last three years, which has been rapid progress in the commercialization of this product.
The core technology emanates from the tissue re-engineering techniques developed by William Neethling and his team in Perth using what's called the ADAPT process. The starting material is bovine pericardium tissue. The first product using this technology is CardioCel, which has now been implanted in over 55,000 patients. The second product, in development, is DurAVR THV.
The global market for the company's lead product – aortic valves delivered via catheter – is expected to reach US$9.9 billion in 2028. In studies conducted to date, the DurAVR THV has shown to have significant advantages over leading, incumbent products from Medtronic and Edward Lifesciences.
Bioshares recommendation: Speculative Buy Class A
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