Admedus, an Australia-based company, announced the sale of distribution rights to its CardioCel and VascuCel businesses to LeMaitre Vascular in October for up to A$36.2m (US$24.7m).
Admedus’ products are based around its proprietary ADAPT tissue technology, which consists of collagen bioscaffolds that are harvested from animal heart tissue and processed for safe use in humans.
The CardioCel is a Conformité Européenne (CE) marked bioscaffold used to repair congenital heart deformities, while the VascuCel (also CE marked) is a bio-patch used for vascular repair. Both devices are commercially available in the US, and the CardioCel is also sold outside the US.
While Admedus will continue to manufacture the CardioCel and VascuCel products for up to three years at its Western Australian facility, the company plans to shift its focus to the transcatheter aortic valve replacement (TAVR)/transcatheter aortic valve implantation (TAVI) market by using its ADAPT tissue technology to produce a TAVR implant device.
TAVR is a minimally invasive procedure that treats patients with severe aortic stenosis (hardening of the aortic valve) by implanting a new aortic valve through a minimally invasive access point (such as transfemoral or transapical).
The global TAVR market is currently dominated by devices from two companies: Edwards LifeSciences’ Sapien line of TAVR valves and Medtronic’s CoreValve Evolut brand. These devices are far ahead of any potential competition because they have been FDA-approved for use in severe aortic stenosis patients at high, intermediate, and low risk for the surgical alternative for aortic valve replacement, known as surgical aortic valve replacement (SAVR)/surgical aortic valve implantation (SAVI).
Most other devices in the market are only approved for the high-risk patient pool. However, a major drawback to these and other devices on the market is the lack of available long-term clinical trial data. As a result, it is not known how long these TAVR valves will last in the body, and therefore the procedure is generally not recommended for young patients (ages 65 years and younger) whose lifespans may surpass that of the device.
However, Admedus’ device may be the solution to this problem. Devices made with its ADAPT-treated tissue have been shown to last nine years without calcification or degradation, and Admedus states that a product lifespan without calcification will allow for device usage across a broader age span. The TAVR market is already large and growing quickly.
GlobalData estimates the global market value for TAVR devices in 2019 to be just under US$3.5bn and predicts a compound annual growth rate of just under 20% for TAVR devices in the US in the foreseeable future. If Admedus can successfully prove that its TAVR device lasts longer than other devices on the market, it may become the device of choice for a younger patient population, allowing the company to gain significant market share.