Pavmed (NSDQ:PAVM) filed an SEC Form D to confirm the sale of more than $4 million in debt, options, warrants and other rights to acquire securities. The medical device company completed its total offering of approximately $4.1 million, having made its first sale on April 30, according to the filing. It took just one investor to […]
Pavmed to resubmit carpal tunnel device 510(k) application
Pavmed (NSDQ:PAVM) said today that it has reapplied for FDA 510(k) clearance for its CarpX device designed to treat carpal tunnel syndrome. In August 2018, the FDA group reviewing the application for CarpX requested that the company resubmit the application because the group hadn’t reached a consensus within the designated review period. The resubmission incorporates data […]
Pavmed’s Lucid Diagnostics enters clinical trial with U of Penn
Pavmed (NSDQ:PAVM) announced today that its majority-owned subsidiary Lucid Diagnostics entered into a clinical trial research agreement with the University of Pennsylvania to observe its EsoCheck esophageal cell collection device. EsoCheck with “collect & protect technology” is designed to offer a less invasive, more efficient and cost-effective alternative to endoscopic biopsies when managing patients with eosinophilic […]
Pavmed gains FDA breakthrough nod for esophageal pre-cancer test
Pavmed (NSDQ:PAVM) recently announced that its Lucid Diagnostics subsidiary has received FDA breakthrough device designation for its EsoGuard esophageal DNA test. The test uses esophageal samples collected using Lucid’s 510(k)-cleared EsoCheck cell collection device from certain patients at elevated risk for esophageal dysplasia due to chronic gastroesophageal reflux disease (GERD). EsoGuard and EsoCheck are designed to […]
Pavmed back in NASDAQ compliance
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 […]
Pavmed threatened with stock exchange delisting
Pavmed (NSDQ:PAVM) is in danger of losing its listing on the NASDAQ exchange, according to a report filed with the Securities & Exchange Commission. 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 […]
Pavmed touts FIH CarpX study launch in pursuit of FDA 510(k) resubmission
Pavmed (NSDQ:PAVM) said yesterday that it launched a first-in-human safety study of its CarpX device to support a planned FDA 510(k) resubmission. The 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 […]
ConvaTec taps Bitar as CEO | Personnel Moves – March 26, 2019
ConvaTec (LON:CTEC) said today it tapped Karim Bitar as its new CEO, set to take the position on September 30. Prior to joining the U.K.-based medtech company, Bitar served as CEO of agricultural biotech company Genus, holding the corner office position for approximately eight years. Before his time with Genus, Bitar spent 15 years in various […]
Pavmed plans safety study for CarpX following FDA meeting
After a meeting with the FDA, Pavmed (NSDQ:PAVM) said that the agency wants to see more clinical testing for the CarpX device before it can make a decision on whether or not to approve the product. In August last year, the FDA group reviewing Pavmed’s 510(k) application for CarpX requested that the company resubmit the application […]
Pavmed raises $7m in private placement
Pavmed (NSDQ:PAVM) said this week that it inked a deal to sell a senior secured convertible note of $7.8 million to an institutional investor. The note was sold with an issue discount of $725,000, for gross proceeds to Pavmed of $7 million. Maxim Group, which acted as the placement agent for the transaction, received a 6.5% […]
FDA wants Pavmed to re-submit for CarpX carpal tunnel device
The FDA group reviewing the 510(k) application for Pavmed‘s (NSDQ:PAVM) CarpX device wants the company to resubmit the application. The FDA told the company that it had not reached a consensus within the review period set by the agency’s rules. To extend the review process, the FDA recommended that Pavmed resubmit the application. In a […]
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