Novel heart valve development company Anteris Technologies (AVR: $20.00) has secured commitments to raise $40 million at $20 per share through a private placement.
Anteris is commercialising an aortic heart valve that is delivered via catheter and to date has been implanted in 39 patients in what the company says are outstanding results.
There was just one mild side effect in one of the implant recipients in the most recent study, that being a 'paravalvular leak' which can be caused by incorrect implantation of the valve and is generally not considered significant. There were no moderate or severe leaks between the aorta tissue and the implant.
The outcome for patients who have received the implant is an improved result over not just completing valves on the market that are also delivered via catheter, but also an improved result over valves implanted through open chest surgery.
One of the main measures of performance is the pressure gradient across the valve, with lower being better. In the 15 patient feasibility study recently completed, a mean pressure gradient of 7.8 mmHg was achieved, with a value to lower than 10 mmHg considered normal/healthy.
This is an improvement over the first 13 patients (Cohorts 1 and 2) implanted in the first study with a mean pressure gradient of 9.0 mmHg achieved at 30 days following implant. In Cohort 3 in the first study in seven patients, the mean pressure gradient was reduced from 53 mmHg to 8.7 mmHg post implant.
The Sapien 3 transaortic valve from Edwards Lifesciences is considered one of the gold standards in these valves. In the September quarter just ended, TAVR product sales for Edwards were US$961 million, up 11% on the previous year.
In a similar patient population and implant, Edwards Sapien 3 achieved a mean pressure gradient of 11.7 mmHg compared to 8.8 mmHg for the Anteris valve. With respect to mean effective orifice area (the larger the better) the EOA for the Sapien 3 was 1.9 cm2 compared to 2.26 cm2 for the Anteris DurAVR device.
The Anteris valve is expected to provide not just better hemodynamic outcomes, but also improved durability due to its single tissue design with tissue that has been used in over 50,000 patients in tissue repair with sustained anti-calcification properties over 10 years.
Anteris remains an acquisition target with one of the two majors in the sector, Edwards or Medtronic being likely suitors.
Anteris is capitalised at $312 million. The company held cash of $7 million at September 30 and is raising an additional $40 million.
Bioshares recommendation: Speculative Buy Class A
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