Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

ATS Medical

This article was originally published in The Gray Sheet

Executive Summary

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
Advertisement
Advertisement
UsernamePublicRestriction

Register

MT012945

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel