PAVmed (PAVM) is a medical device company with a fast-moving business model. The company intends to speed up the time it takes to get medical devices on the market through a proven pipeline.

(All images via PAVmed – http://ir.pavm.com/events-presentations)

This model enables PAVmed to pursue an increasing multi-product pipeline with foresight to enhancing and accelerating value creation. According to company materials, 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 casts a wide net of products in the intent of finding unmet needs in the medical marketplace. This is key to the company’s business model: finding an attractive and high margin product that can be accelerated into production. PAVM claims to be able to bring a product to market in half the time.

First, the company achieves regulatory clearance and then moves it into their independent distribution network. A corporate partner will sell the product and afterwards the company will look to license.

In December 2015, PAVM announced that it filed a 510(k) premarket notification submission with the U.S. Food and Drug Administration (FDA) for its first product, the PortIO™ Intraosseous Infusion System. Lishan Aklog, M.D., Chairman and CEO of PAVmed, said “We are excited to have achieved this important corporate milestone, the submission of our first product for regulatory clearance, on schedule and under budget. Our growth strategy is built on a capital and time efficient business model which enables us to pursue an expanding multi-product pipeline. PortIO is the first FDA submission from our pipeline and we look forward to additional regulatory submissions and product commercializations in 2017 and beyond.”

PAVmed’s Chief Medical Officer, Brian J. deGuzman M.D., explained “PortIO was designed to eliminate many of the shortcomings of existing implantable vascular access devices and intraosseous infusion systems. We expect PortIO to provide physicians with a rapid and efficient system to establish an intraosseous route for delivery of medications, fluids and other substances. We look forward to receiving FDA clearance and beginning commercialization of this exciting product in 2017.”

Timothy P. Murphy, M.D., a member of PAVmed’s medical advisory board, Professor and Director of the Vascular Disease Research Center at the Brown University’s Warren Alpert Medical School and the former President of the Society of Interventional Radiology, stated “We eagerly anticipate PortIO’s regulatory clearance and introduction into clinical practice. We expect PortIO to have significant advantages relative to traditional ports and intraosseous devices, which gives it the potential to be game-changing with respect to improved outcomes and reduced costs.”