Aegis has developed a surgically implanted device that reduces the risk of stroke in patients suffering from irregular heartbeat by preventing the flow of blood between the heart and left atrial appendage on the left side of the heart.
The surgically implanted device, called Sierra, has been in development for 11+ years with over $15 million invested. The FDA empanelled a group of experts, who after detailed study advised they did not find a single opportunity for improvement. Aegis wishes to undertake a 50-60 patient trial - take 12-18 months, cost $3.5mm, with objective to earn a CE Mark approval for commercial sale of Sierra in Europe.
There is a natural pool of buyers for Aegis/Sierra on grant of CE Mark. The precedent transaction is Boston Scientific's purchase of Atritech and its Watchman device, for an up front payment of $100mm and milestone payments of $275mm, 12+ years ago. Their 2022 revenue from their Watchman franchise has eclipsed $1 Billion.. Abbott Laboratories acquired their Amulet device as part of their St. Jude Medical purchase in 2017, with FDA approval granted in 2021. Johnson and Johnson acquired their Wavecrest device in 2015 and Atricure Inc. purchased their Lariat device in 2019. All were first CE Mark approved, prior to initial commercial market entry.
Besides being a better, cheaper, faster, safer device, Sierra has two distinct advantages. due to Sierra's epicardial deployment (as opposed to endocardial deployment.) . In about 15% of the patients Sierra, also cures A-Fib and can potentially be a very effective treatment for hypertension. Sierra, atrial fibrillation ("SierraAF") and hypertension ("SierraHT") present the potential opportunity to, at some point, split Aegis into two companies.
Low risk is i) the conclusions reached in the FDA review, ii) same doctor that ran Aegis successful
7 patient trial 3 years ago will run our planned 50-60 person triaI iii) Aegis is navigating familiar waters, iv) Boston Scientific and other majors have proven the efficacy, demand, profitability, market, and the procedure is now health insurance supported in many cases.
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