Vincent Capponi

“As Makis mentioned, the de novo timeline – we're in the final stages of assembling the technical file that will be submitted through the eSTAR program. I'm happy to say we're 75% complete with that file.”

“Health Canada is not dependent upon U.S. approval. We'll use the same data, but we will structure the submissions slightly differently as required by Health Canada than what the U.S. FDA requires.”

“So there's a couple of areas that we've already started preparation, and one is in the manufacturing facility. So we're preparing that facility to meet all the requirements within FDA.”

“In the U.S., we plan to use a blended approach of direct sales and distributors. We've developed some strong distributors during the COVID period when we were selling CytoSorbents or CytoSorbents under EUA.”

“As we prepare for commercialization in the U.S. and Canada, our core sales and marketing team has established a go-to-market launch plan, identifying key personnel and sales operations to facilitate rapid entry into the market.”