Pavmed (NSDQ:PAVM) said today that it has received formal notice from NASDAQ that it has returned to compliance with the stock exchange’s listing rule after 10 consecutive days with a closing bid price of at least $1 per share.
NASDAQ warned the company in November that it was in danger of delisting due to poor stock performance.
In August 2018, the FDA group reviewing Pavmed’s 510(k) application for its CarpX minimally invasive carpal tunnel release device asked the company to resubmit the application because the group hadn’t reached a consensus within the designated review period.
CarpX is a percutaneous device designed to allow the operating physician to relieve compression of the median nerve without a surgical incision. The system combines a balloon catheter with bipolar radio-frequency cutting electrodes and is positioned through guidance with ultrasound, the company said.
The New York-based company launched a first-in-human safety study of CarpX in May 2019 to support its 510(k) re-submission. On August 15, Pavmed reported that all 20 patients underwent successful procedures. Nineteen of 20 had completed the 90-day clinical follow-up as of Dec. 13, 2019, with no adverse events, the company said on its website.
Pavmed beat the deadline for regaining NASDAQ compliance. The exchange had given the company until April 7, 2020 to do so.
“We are pleased to have regained full compliance with Nasdaq’s continued listing requirements,” said Pavmed CEO Dr. Lishan Aklog in today’s news release. “The New Year is off to a great start. Additionally, we recently participated in a successful PortIO FDA pre-submission meeting and are already seeing a surge of interest in our EsoGuard LDT esophageal DNA test following its commercial launch last month. We look forward to updating investors as we continue to execute on the significant upcoming milestones outlined in our most recent business update.”
Shares of PAV were trading at $1.60 this morning, up 3.88% .