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
You may also be interested in...
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.
Beauty Firms Using AI-Based Tools Could Be Subject To Health Privacy Laws In US States
Using AI-based programs to collect and store consumer information risks running afoul of new health privacy laws cropping up in US states. Lack of federal regulation or guidance on the issue is one of the biggest challenges for beauty firms deploying AI, according to Stacy Marcus, partner at Reed Smith LLP.
Mustang Bio Enters Race For CAR-T In Autoimmune Disease
The biotech company’s CEO talked to Scrip about plans to bring the CD20-targeting CAR-T MB-106 into an investigator-sponsored Phase I trial later this year.