PAVmed Reports Second Quarter 2017 Financial Results
Business Wire: August 14, 2017 – NEW YORK, NY, U.S.A. – PAVmed Inc. (Nasdaq: PAVM, PAVMW), a highly differentiated, multiproduct medical device company, today announced financial results for the three and six months ended June 30, 2017, and provided a business update.
“During this past quarter and in recent weeks PAVmed has continued to grow stronger as a company, moving steadily towards major developmental, regulatory, and commercialization milestones, while exploring all opportunities to enhance shareholder value,” said Lishan Aklog, M.D., PAVmed’s chairman and chief executive officer.
“We significantly strengthened our balance sheet, raising $5.5 million in gross proceeds from seasoned and well-known healthcare investors,” Dr. Aklog noted. “These funds provide us with sufficient capital to reach our key milestones well into 2018.”
“Our development and commercialization strategy has been to focus our resources on three products in our pipeline with the greatest and nearest-term commercial opportunities—PortIO™, CarpX™, and DisappEAR™,” Dr. Aklog stated.
PortIO is PAVmed’s implantable intraosseous vascular access device, which is designed to provide short- or long-term access to the bone marrow cavity for the delivery of medications, fluids, or other substances, eliminating many of the shortcomings of existing devices, especially in patients with poor veins. “PortIO was submitted to the U.S. Food and Drug Administration (FDA) for 510(k) clearance for short-term use, and we continue to work with the FDA to demonstrate substantial equivalence to our selected predicate, with the de novo 510(k) pathway available to us as an alternative,” said Brian deGuzman, M.D., PAVmed’s chief medical officer. CarpX is PAVmed’s percutaneous device to treat carpal tunnel syndrome, which is designed to eliminate the need for invasive carpal surgery, performed in 600,000 patients annually, resulting in decreased costs, reduced pain, accelerated recovery, and a lower the threshold for intervention. “CarpX is undergoing verification and validation testing, and we are on schedule for FDA 510(k) submission by the end of this quarter,” Dr. deGuzman added. DisappEAR is PAVmed’s reabsorbable, antibiotic-eluting pediatric ear tube device, which is designed to eliminate many of the shortcomings of currently available plastic ear tubes inserted in over one million children annually. The device utilizes a propriety aqueous silk technology licensed from Tufts University. “DisappEAR’s development is progressing well and on schedule as we target FDA submission in 2018,” Dr. deGuzman noted.
“These are exciting times for PAVmed,” Dr. Aklog concluded. “Our recent financings have put us in a sound capital position, our lead products are advancing towards important milestones, and we remain nimble, creative, and resourceful as opportunities to enhance shareholder value present themselves. We greatly appreciate the strong commitment of our long-term shareholders and remain laserfocused on enhancing the value of the company for the benefit of all of our shareholders.”
PAVmed Inc. is a highly differentiated, multiproduct medical device company employing a unique business model designed to advance products from concept to commercialization much more rapidly and with significantly less capital than the typical medical device company. This proprietary model enables PAVmed to pursue an expanding pipeline strategy with a view to enhancing and accelerating value creation. PAVmed’s diversified pipeline of products address unmet clinical needs, have attractive regulatory pathways, and market opportunities and encompass a broad spectrum of clinical areas including carpal tunnel syndrome (CarpX™), medical infusions (NextFlo™ and NextCath™), interventional radiology (PortIO™ and NextCath™), tissue ablation and cardiovascular intervention (Caldus™), and pediatric ear infections (DisappEAR™). The company intends to further expand its pipeline through engagements with clinician innovators and leading academic medical centers. For further information, please visit www.pavmed.com.
