This article was originally published in The Gray Sheet
Firm expects to submit additional PMA data in the next four to eight weeks for its open pivot, bileaflet, pyrolytic carbon heart valve in response to a request by FDA, the company reports Feb. 9. Agency review could take an additional 180 days, ATS notes. "Until our valve is approved for general use in the U.S., it will be challenging for us to dramatically increase revenue," CEO Manny Villafana states in a same-day release announcing fourth quarter results. Sales for the three months ended Dec. 31 fell 14% to $4.3 mil. year-over-year. Net income declined almost 20% to $514,665 versus $637,529 one year ago
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