Just some notes for thesis building.
In less than 15 years, transcatheter aortic valve replacement (TAVR) has progressed from a procedure of last resort in patients at prohibitively high perioperative risk for major morbidity and mortality from surgical valve replacement to a viable alternative option to surgery in most patients with native (non-bicuspid) aortic valve stenosis. The number of medical centers offering TAVR has rapidly proliferated.
Is there a market?
1. Is TAVR is a rapidly growing procedure with massive TAM
a. The Transcatheter Aortic Valve Implantation (TAVI) Market revenue was valued at $2,761 million in 2017 and is expected to reach $8,138 million by 2025, growing at a CAGR of 13.8% from 2018 to 2025. The volume market was valued at 107,011 units in 2017 and is expected to reach 337,778 units by 2025, growing at a CAGR of 14.8% from 2018 to 2025.
Is there a problem the company is solving?
2. Are TAVR patients are becoming younger so will need valves that last longer?
In 2019, the first year TAVR was FDA-approved for low-risk patients, this population made up 11.5% of all TAVR patients and had a median age of 75.
This was off the back of the PARTNER 3 trial which looked at TAVR for low risk patients. It found that TAVR was superior to surgery with regard to the primary composite end point of death, stroke, or rehospitalization at 1 year. - The most important limitation of this trial is the current results reflect only 1-year outcomes and do not address the problem of long-term structural valve deterioration. “This is a landmark study because it involves 80 percent of the people who are currently being treated with surgery for aortic stenosis. Our hope was that TAVR would be non-inferior or comparable to surgery, and we were surprised to find an almost 50 percent reduction in the primary endpoint, from 15.1 percent in the surgical group to 8.5 percent with TAVR,” said Martin B. Leon, M.D.
“There is a lot of long-term data on surgical valve durability, so in younger patients, which Valh said includes patients in their 60s and 70s, surgery might be the way to go. He explained a younger TAVR patient will almost certainly need to undergo a second valve replacement, which can be performed as a TAVR valve-in-valve procedure, but the patient's valve size then becomes important to guarantee there will be adequate room to place another TAVR device. "Unfortunately, not everybody is born with a valve annulus big enough where we can just do three to four TAVR procedures to carry them all the way to the end of their life span," he said.
3. Is Anteris’s technology unique? Are their claims believable?
a. I think this is the hardest question to answer but also the most important
i. The study the company sites as evidence was a study of The tissue-engineered ADAPT® bovine pericardial scaffold in 30 children who had repairs to congenital heart conditions they were followed up to 10 years and there was minimal calcification. (ADAPT is commercially available)
ii. They then use this material to make a single piece valve DurAVR and state that it should be more durable. A 2004 study is referenced which basically was just some mathematical modelling of stress distribution over a valve dependant on shape (Hardly convincing).
iii. Unfortunately valve degeneration is a complex process that goes far beyond mechanical stress if you are so inclined there is a good overview here.
And after reading through this material I think it’s plausible that they are on the right path (combination of mechanical design and minimising causes of calcification. However, I haven’t chased up what the competitors are up to.
