Aortic Vale publications form Berlin and Munich Hospitals, page-26

Without getting too granular, these studies areno more than histological analyses of anecdotal cases.

ADAPT® tissue has been used in more than 20,000patients for more than 10 years, according to the Company.

First study mentioned (Interactive CardioVascularand Thoracic Surgery, Volume 30, Issue 1, January2020, Pages 64–73, https://doi.org/10.1093/icvts/ivz234) totalled 60 patients where “Overall echocardiographic follow-up showed normal valve function in 50 out of 60 patients”. If the 60 patients were from one hospital or region, should the 17% of patients who exhibited poor outcomes not raise more questions about the standard of treatment or post-operative care than the CardioCell patch performance? The data apparently came from Department of Cardiovascular Surgery, German Heart Centre Munich. 17% is an alarming revision rate for any surgical category.

60/20,000 = 0.3% Insignificant statistically. The second study comprised 12 histologicalexaminations on explanted aortic valve leaflet tissue.

What the studies fail to include is the backstory.What may have caused the problems to occur on these cases but not in theoverwhelming majority of implants globally? All these surgeries were particularly complex with patients in acute disease states. They were not uniform and there is no mention of the standard of care or uniformity of surgical competency.

Were the calcification issues a result ofsurgical error, unintended patch or site contamination during the surgery? Whatrole did surgical technique (for instance, doing uninterrupted or running sutures of patches) and the length of time under surgery play in the eventualoutcome? How good were the surgeons who performed these procedures? What were theirhistorical revision rates for cardiac surgery involving and not involvingCardioCell patches?

As for the patients, there is no mention in eitherpapers about post-operative care, diet, exercise, medications and other factors which may havecontributed to the outcomes.