Anteris Technologies (AVR: $23.20) is developing an aortic heart valve, called DurAVR THV. The device is implanted via a catheter rather than through open chest surgery and has delivered some impressive results compared to other valves implanted through the same process or through surgery.
Last month the company announced that it had reached agreement with the FDA on an early feasibility study to follow on from its first feasibility study in 13 patients. The early feasibility study will recruit 15 patients who will be implanted across seven implant centres in the US. It is only expected to take a few weeks to fully recruit.
The primary difference between the two studies is that the first feasibility study was conducted at the one site. In the forthcoming study the company will also be able to receive payment for the devices implanted from CMS in the US (around US$25,000 per implant). This study will be a precursor to a pivotal US study that will need to be conducted to gain regulatory approval. The pivotal IDE study will involve up to 400 patients and take around two years to complete.
Last month the company also presented data from its first feasibility study at PCR London Valves. There was 100% procedural success with no device-related complications.
Cardiologist Bernard Prendergast said that the question is now whether all implants can be conducted via the minimally invasive procedure through a catheter. The company's CMO Dr Chris Meduri said that DurAVR THV is able to replicate native-like blood flow through the valve as well as facilitating an easy delivery (balloon expandable) with a short frame height that allows correct alignment (commissure alignment).
The other benefit with the device is that it uses bovine pericardium tissue which has been treated using the company's ADAPT technology. This has been used in over 30,000 tissue implants with a 'remarkable lack of calcification' across those patients according to Meduri. Meduri said that another differentiating feature is that the DurAVR THV valve is made from a single piece of tissue; whereas every other valve implanted is made from three tissue sections joined together.
Meduri said that most of the first 13 patients treated had very difficult anatomies with the last patient implanted in just 27 mins. The results from that study also mirrored the results of the valve hemodynamics obtained in the laboratory. Dr Joao Cavalcante said that the DurAVR THV restored laminar flow to that of a normal, native valve unlike competing devices (Edwards Sapien 3 and the Medtronic Evolut R), which could be important.
Prendergast stressed that durability of the Anteris valve will be very crucial to whether the DurAVR THV can be implanted into younger patients using a minimally invasive (by catheter) procedure. Cavalcante said that the company now has 30 day and one year data from patients with no concerning signals.
Anteris is capitalised at $322 million. Its cash balance at September 30 was $22.8 million.
Bioshares recommendation: Speculative Buy Class A
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