PAVmed Selects Colombia for a First-in-Human Study on its PortIO™ Medical Device

[ORLANDO, FL., November 21, 2019] — PAVmed Inc. (Nasdaq:PAVM) recently reported its third-quarter 2019 financial results and provided a business update. In its business update, PAVmed announced that it will Launch a long-term PortIO clinical study in Colombia, South America to demonstrate up to 60-day maintenance-free implant durations in humans, in Q1 2020. With the help of bioaccess™, PAVmed will activate five clinical research sites in Colombia including two in Barranquilla, one in Cali, and two in Bogota.

Long-term vascular access devices, including implanted ports, are used to deliver various fluids, medications, and other substances to patients with a wide variety of clinical conditions over a period of weeks to months. Short-term, non-implantable intraosseous devices, which are inserted into the bone marrow instead of a vein, are commonly used in military trauma, pediatric emergencies, and other situations where rapid vascular access is required. The annual addressable markets for implantable vascular access ports and non-implantable intraosseous devices are estimated to be $500 million and $150 million respectively.

PAVmed’s PortIO™ is an implantable intraosseous vascular access device that allows direct access to the bone marrow, a well-established route for the delivery of medications, fluids, and other substances, addressing an estimated $700 million market opportunity based on patients with poor veins and those with renal failure whose veins must be carefully preserved for current or future hemodialysis. PAVmed was recently granted two patents with broad independent claims covering the device technology and methods underlying PortIO.

The intraosseous route provides a means for infusing fluids, medications, and other substances directly into the bone marrow cavity which communicates with the central venous circulation via nutrient and emissary veins. This route, which has been used for decades, is well established and has been shown to be bioequivalent to the intravenous route. PortIO is a novel, implantable, intraosseous vascular access device, which, unlike existing long-term vascular access devices, does not have a component residing in a vein. It is designed to be highly resistant to occlusion and, we believe, may not require regular flushes or radiologic confirmation. It can be inserted and removed without the need for surgical dissection and provides a limitless number of potential access sites in chronically ill patients who have poor or no central venous access. We believe PortIO will have the potential to decrease costs by shifting the procedure to a less expensive office or bedside setting.

The core technologies underlying currently available long-term vascular access devices have several limitations directly related to the presence of a catheter in a vein. Up to 10% become infected, which can lead to costly and severe complications and even death. They require regular flushes to clear stagnant blood and prevent clot formation and occlusion. Nonetheless, up to one third become occluded at some point requiring treatment with clot-dissolving agents or removal and implantation of a new device. Most devices also require surgical insertion and removal, as well as radiologic confirmation of proper placement. In addition, many chronically ill patients have poor or no central venous access as a result of repeated instrumentation of the veins or the presence of pacemaker or defibrillator leads. A limitation of non-implantable intraosseous devices is that the device exits the skin and can be difficult to protect and susceptible to dislodgement. 

“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 (Heparin Induced Thrombocytopenia or HIT),” Dr. Murphy added. “If this maintenance-free implant duration is preserved or exceeded through regulatory clearance and clinical launch, PortIO will provide significant benefits to a multitude of patients and the healthcare system as a whole – particularly those patients with poor venous access, those on, or expected to need, kidney dialysis and those with known adverse reactions to Heparin.”

A long-term animal study of PortIO has demonstrated unprecedented six-month maintenance-free implant duration. These unprecedented results stand in stark contrast to all other commercially available vascular access devices which require regular flushes to prevent occlusions and device failure. In Q1 2020, PAVmed will launch a 60-day implant duration PortIO clinical study in dialysis patients and those with poor venous access in Colombia, South America, to demonstrate this long-term maintenance-free implant duration in humans.

Former President of the Society of Interventional Radiology (SIR), Timothy P. Murphy, M.D., said this about the results of PAVmed's recent animal study: “A truly groundbreaking accomplishment in the field of vascular access which, if replicated in clinical practice, would represent one of the most important advances in long-term vascular access that I have seen during my career. All other vascular access devices, whether short, medium or long-term are limited by the need for regular maintenance with flushes which are labor-intensive, costly and interfere with a patient’s activity.”

PAVmed recently completed a long-term pilot clinical study in New Zealand to assess PortIO function and patency for up to 60 days. PortIO devices were used to infuse antibiotics, saline, albumin, and blood at various intervals and over various implant durations. The device with the longest implant duration was simply left in place, untouched, with no infusions or flushes for a period of 62 days following implantation. Prior to removal, its function and patency were confirmed by injecting intravenous contrast material and visualizing brisk flow into the bone marrow and central veins. There was no evidence of clots, bony ingrowth, or infection in any device or implant site.

“The results of this pilot study are truly unprecedented,” said Lishan Aklog M.D., PAVmed’s Chairman, and CEO. “Although, for many decades, physicians have used the intraosseous route to infuse fluids, medications, and other substances into patients through the bone marrow instead of through a vein, existing intraosseous devices protrude through the skin and can only be used for 24 hours or less.

“PortIO is the first implantable intraosseous device designed for long-term use and to eliminate many of the shortcomings of existing vascular access devices, including the need for regular maintenance. 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.

“We are gratified that these results validate our initial thesis that the fundamental biologic differences between bone marrow and the blood in veins would allow an innovatively designed implantable intraosseous port to remain patent and functioning over the long-term, without the need for flushes or other maintenance. We are confident, based on the underlying biologic processes, that these pilot results will be replicated over longer implant durations and in upcoming human clinical studies. The over 60-day maintenance-free implant duration achieved already covers one of the most common indications for long-term vascular access – long-term intravenous antibiotics courses, which typically last four to eight weeks.”

About PAVmed

PAVmed Inc. is a highly differentiated, multiproduct medical device company employing a unique business model designed to advance innovative products 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 addresses unmet clinical needs encompassing a broad spectrum of clinical areas with attractive regulatory pathways and market opportunities. Its five lead products provide groundbreaking approaches to carpal tunnel syndrome (CarpX™), precancerous conditions of the esophagus (EsoCheck™), vascular access (PortIO™), pediatric ear infections (DisappEAR™) and medical infusions (NextFlo™). The company is also developing innovative products in other areas, such as catheters and tissue ablation while seeking to further expand its pipeline through engagements with clinician innovators and leading academic medical centers. For more information, please visit www.pavmed.com, 

About bioaccess.™

bioaccess™ is a Florida-based clinical research organization (CRO) and market access consulting company which mission is to help innovative medical device companies conduct clinical research and commercialize their innovations in Colombia and the rest of Latin America. The company provides its clinical research clients with support services to ensure their first-in-human trials are a success in Colombia (e.g., regulatory submission, logistical support, project management, and study monitoring; among others). For more information, please visit www.bioaccessla.com.

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bioaccess™ Press Contact:

Julio G. Martinez-Clark, CEO
Tel: +1 (954) 903-7210
Email: jmclark@bioaccessla.com