PAVmed completed a pre-clinical animal study documenting a maintenance-free implant duration over six months, an important clinical threshold in long-term infusion applications
PAVmed, a highly differentiated, multiproduct medical device company, today announced that its groundbreaking PortIO Intraosseous Infusion System has achieved multiple important development, regulatory and intellectual property (IP) milestones towards establishing the first commercially available implantable intraosseous vascular access device.
PAVmed completed a pre-clinical animal study documenting a maintenance-free implant duration over six months, an important clinical threshold in long-term infusion applications. The Company also secured a pre-submission meeting with the U.S. Food and Drug Administration (FDA) scheduled for January 8, 2020 during which it will review the clinical protocol for a small upcoming first-in-human (FIH) clinical safety study – the final step in its de novo application. Finally, the U.S. Patent and Trademark Office (USPTO) has granted U.S. Patents 10,426,940 and 10,434,296, entitled “Intraosseous Infusion Ports” which include broad independent claims covering the device technology and methods underlying PortIO. The patents, assigned to PAVmed at its founding, lists Lishan Aklog, M.D., PAVmed’s Chairman & CEO, and Brian J. deGuzman, M.D., its Chief Medical Officer, as inventors. They further expand PAVmed and its subsidiaries growing IP portfolio that now includes over 100 patents and patent applications across 17 families.
“PortIO is a very important, and I believe underappreciated, value driver in our lead product portfolio,” said Lishan Aklog, M.D., PAVmed’s Chairman and Chief Executive Officer. “PortIO promises to provide dialysis patients and those with poor venous access a superior alternative to traditional vascular access devices, representing an immediately addressable market opportunity of over $700 million. These important milestones put us in an excellent position to complete a small clinical safety study, secure regulatory clearance and commercialize a highly differentiated maintenance-free device with strong IP protection addressing a significant unmet clinical need.”
All long-term vascular access devices, including peripherally inserted central catheters (PICC), tunneled central venous catheters and implantable venous ports, require regular flushes by a skilled healthcare professional to prevent them from clotting. These maintenance requirements are labor intensive, costly and interfere with a patient’s activity. Improper flushing techniques and other factors can result in serious or even deadly complications, including bloodstream infections, air embolism and life-threatening blood clotting reactions to the drug Heparin used in flushes.
“PAVmed has now extended the maintenance-free implant duration in pre-clinical testing beyond the requirements of nearly all long-term infusion applications in clinical practice,” said Timothy P. Murphy, M.D., former President of the Society of Interventional Radiology (SIR). “I continue to believe that if these results are replicated in clinical practice, PortIO could represent one of the most important advances in long-term vascular access that I have seen during my career, providing significant benefit to a multitude of patients and the healthcare system as a whole – particularly patients with poor venous access, those on, or expected to need, hemodialysis and those with known adverse reactions to the blood thinner Heparin.”
The FDA pre-submission filing incorporated data from extensive pre-clinical testing performed in close consultation with the FDA, including a GLP animal study along with supplemental cadaver and animal studies. It includes a detailed protocol for an FIH small clinical safety study to support an initial indication for a seven-day implant duration through the de novo pathway. The Company is proposing a single-center prospective study to be performed in New Zealand with up to 25 patients who require infusions of fluids or medications for up to seven days undergoing PortIO implantation. The proposed primary effectiveness endpoint is successful PortIO implantation and infusion. The proposed primary safety endpoint is freedom from serious device-related adverse events through a 30-day post-explant follow-up period. In anticipation of FDA sign-off on the protocol following the January 8th meeting, the Company has already initiated the study logistics in New Zealand with the goal of launching the study immediately following the FDA meeting and completing enrollment soon thereafter. The clinical data will then be submitted to the FDA as part of a final de novo application package.
Source: Company Press Release