The N.Y.-based company posted a net loss of -$5.37 million, or -40¢ per share, for the 3 months ended Sept. 30, for bottom-line loss of -178.5% compared with the same period last year.
Adjusted to exclude 1-time items, earnings per share were -13¢, two cents ahead of consensus on The Street.
“During this quarter and in recent weeks, Pavmed has continued its inexorable march towards important developmental, regulatory and commercialization milestones,” chairman & CEO Dr. Lishan Aklog said in prepared remarks.
The chief executive highlighted Pavmed’s decision last month to seek a de novo classification for its PortIO intraosseous infusion system, rather than a 510(k) clearance. The company has requested an in-person meeting with the FDA next month, Aklog said.
Pavmed is also preparing to finish testing and submit its CarpX device for review by the FDA at the end of this month, according to the CEO.
The company added that its DisappEar anti-microbial pediatric ear tube will be ready for FDA submission in the second half of next year.
“Finally, we strengthened our balance sheet during the third quarter, raising $5.5 million from the sale of senior secured notes, warrants, and convertible preferred stock, providing us with the resources to advance our lead products towards commercialization.”
PAVM shares were trading at $4.16 apiece today in afternoon activity, up 6.7%.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.