In August last year, 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 to support its 510(k) re-submission. On August 15, Pavmed reported that all 20 patients underwent successful procedures. They will undergo a post-operative clinical follow-up at 90 days, with repeat electrodiagnostic testing during the follow-up period to document the protocol’s safety endpoint, the company has said.
According to the SEC document filed on Friday, Pavmed received a notice from the NASDAQ on Oct. 10, stating that, for the prior 30 consecutive business days, the closing bid price of the company’s common stock had been below the minimum of $1 per share required for continued listing. The last time PAVM exceeded a $1 closing price was Aug. 27, when it reached $1.01.
The notification letter said Pavmed has 180 calendar days — until April 7, 2020 — to regain compliance.
A Pavmed spokesman did not immediately respond to a request for comment. PAVM was trading at $0.88 late this morning.