Pavmed eyes Q4 FDA submission for PortIO vascular access device

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 resul...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Vascular Pavmed Source Type: news