PAVmed Inc. (PAVM)

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“I am very pleased with the excellent progress we are making in both phases of our EsoCheck regulatory and commercialization strategy,” Dr. Aklog stated. “We expect to submit EsoCheck CCD for 510(k) clearance next week and, given the excellent predicate and low risk profile, I am optimistic that it will be cleared expeditiously. EsoCheck DX continues to undergo a battery of tests to secure CLIA certification and is on schedule to achieve LDT designation in late Q1-2019. We are working with a leading consulting firm to apply for EsoCheck Dx reimbursement codes through the AMA’s Proprietary Laboratory Analysis (PLA) process. Phase II is also off to an excellent start. The ongoing multi-center National Institutes of Health funded clinical trial comparing EsoCheck with endoscopy has enrolled well over 100 patients. In addition, we have retained a leading regulatory firm, whose many ex-FDA partners include the former director of the FDA’s Office of In Vitro Diagnostics, to help us move toward an FDA pre-submission meeting in early 2019.”