The Importance of Clinical Data in FDA Approval

In 2022 earlier this year, we submitted a de novo application to expand indications for use for the product. So that obviously required substantial clinical data. It's not just to satisfy the FDA to get our de novo, but there has to be other endpoints you're trying to collect for commercial success, marketing claims, reimbursement. The bar for adoption comes down to ultimately I'm practicing medicine and I'm making a clinical decision to send a patient home because of your test or to sent a patient to the cath lab because of yourtest. And so investing early in very definitive, robust clinical data well beyond what you would need for safety and efficacy is really the primary driver to invest aggressively in