Pavmed (NSDQ:PAVMU) said today that it’s planning to submit an application for FDA clearance for its 1st product, the PortIO long-term implantable vascular access device, during the 4th quarter.
New York City-based Pavmed said the PortIO device is in the verification and validation testing phase, the final stage of pre-submission testing. The company has 4 other devices in development: The Caldus line disposable tissue ablation devices, including renal denervation for hypertension; the CarpX percutaneous device to treat carpal tunnel syndrome; the NextCath self-anchoring short-term catheter; and the NextFlo disposable infusion pump.
Pavmed raised $5.3 million in an initial public offering earlier this year.
“We are excited about our timeline for submitting PortIO to the FDA in 2016 and the prospects for product commercialization in 2017. Since obtaining our IPO funding in April, we have accelerated the pace of advancing the products in our pipeline towards FDA submission and commercialization. Our capital and time efficient business model enables Pavmed to pursue a multi-product pipeline strategy and PortIO will be the first FDA submission from this pipeline. We look forward to following this up with additional product submissions and commercialization in 2017 and beyond,” chairman & CEO Dr. Lishan Aklog said in prepared remarks.
“PortIO was designed to eliminate many of the shortcomings of existing implantable vascular access devices which result from the presence of a catheter in the bloodstream. These include clotting, which occurs in up to 30% of patients1, necessitating repeat procedures to clear clots or replace the device. Furthermore, many patients have scarred or otherwise inaccessible veins which can make insertion of existing devices difficult or impossible,” added chief medical officer Dr. Brian deGuzman.
Pavmed said the PortIO device is designed to be inserted into bone to deliver medication directly to bone marrow, unlike conventional vascular access devices that are inserted into veins.
Pavmed’s founders – Aklog, deGuzman and Michael Glennon – were also behind Pavilion Medical Innovations, a medical device incubator built around a faster, low-cost development plan. Pavilion spun out Vortex Medical, acquired for $55 million in 2012 by AngioDynamics (NSDQ:ANGO), and Saphena Medical, which in March raised a $1.3 million round for its device to harvest veins for coronary artery bypass grafting.
Pavilion also created Kaleidoscope Medical, which is developing a reversible inferior vena cava filter, and Cruzar Medsystems and its Houdini peripheral chronic total occlusion device. All 4 companies raised just $1.5 million to $3.5 million and “rapidly advance[d] their products,” according to Pavmed’s original IPO filing last year. In the case of Vortex Medical, the AngioVac system won 510(k) clearance from the FDA 16 months after its founding. Saphena won 510(k) clearance for VenaPax in 18 months and has had it on the market since last October, according to the filing.
Aklog, deGuzman and Glennon are betting that their formula for commercializing single-product companies can be applied to a company making multiple devices, dramatically slashing the estimated $30 million and 5 years it typically takes to get to market.
PAVMU shares closed up 2.4% at $14.05 apiece yesterday.
