PAVmed Inc. (NSDQ:PAVMU) said today it raised $1.5 million through a private placement of Series A convertible preferred stock and Series A warrants, with funds slated to support FDA clearance of its 1st product, the PortIO intraosseous infusion system.
The New York-based company said it is hopeful for for FDA 510(k) clearance for the PortIO by the end of the 2nd quarter of 2017. PAVmed said it also plans to file a 510(k) premarket notification submission for its 2nd product, the CarpX percutaneous system for the treatment of Carpal Tunnel Syndrome, during the 2nd quarter.
“The strong investor interest in our company has been extremely gratifying. Furthermore, we continue to be delighted with investors’ growing receptivity and endorsement of our business model. We are excited about the near-term milestones for PortIO and CarpX. The combined addressable market opportunities for these products are in excess of $1 billion. We believe that the commercialization of these products has the potential to generate significant value for our shareholders. Our time and capital efficient business model enables our multi-product pipeline strategy.” CEO Dr. Lishan Aklog said in a press release.
The company said it estimates the cost to gain clearance and initiate commercialization for both products will be approximately $1 million.
Preferred stock sold in the round is convertible into PAVmed common shares at $6 per share, while each Series A warrant is exercisable for 1 share of common stock at $8 per share.
PAVmed said it will continue to evaluate potential exchange offers involving outstanding securities.
“We look forward to making further announcements about the forward momentum of other products in our pipeline. The alternatives currently being evaluated are intended to reward holders of our outstanding securities, provide additional incentives for long-term ownership of such securities and attract additional investors to our company,” Aklog said in a prepared statement.
Last November, PAVmed said it inked an exclusive licensing agreement with academic institutions to develop and commercialize antibiotic-eluting resorbable ear tubes based on an aqueous silk technology designed by the institutions.
The licensing deal includes agreements with Tufts University, Massachusetts Eye & Ear Infirmary and Massachusetts General Hospital, who developed the aqueous silk technology.