PAVmed Selects bioaccess.™ as CRO in Colombia for the First-in-Human Study of its PortIO Medical Device
[ORLANDO, FL., January 24, 2019] — PAVmed Inc. (Nasdaq:PAVM), is a highly-differentiated, multi-product medical device company employing a unique and proven business model designed to advance products from concept to commercialization much more rapidly and with significantly less capital than the typical medical device company. PAVmed has selected bioaccess.™ as its contract research organization (CRO) for the first-in-human (FIH) clinical trial of its PortIO medical device. The clinical trial will likely be conducted at a leading hospital in Barranquilla, Colombia.
bioaccess.™ will assist PAVmed to obtain Cirulaser’s research and ethics committee approval for its planned PortIO’s first-in-human trial. bioaccess.™ will also handle the regulatory submission to help PAVmed obtain Ministry of Health (INVIMA) approval in Colombia; along with the importation of the investigational devices, project management, study monitoring, and other necessary activities to ensure a successful trial. No specific time frame is being announced for the approvals, however, the companies expect to have all necessary approvals and paperwork in place to begin recruiting patients by the first quarter of 2019.
PAVmed develops and commercializes innovative medical device products that the company believes address unmet clinical needs, have attractive regulatory pathways, and encompass a broad spectrum of clinical areas. PAVmed focuses on high-margin, single-use, interventional products which provide less invasive, safer, and more cost effective solutions for clinicians and their patients. The company seeks to expand its pipeline through creative engagements with clinicians, innovators, and leading medical centers.
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.
PortIO continues to advance along the FDA’s de novo pathway. The FDA-requested GLP animal study implants have been completed. Device explants will be completed this month followed by pathologic analysis of the implant sites. PAVmed is planning a FIH series in Colombia and will explore the possibility of fulfilling the likely FDA request for human clinical data with this outside-the-US (OUS) study. The PortIO's CE Mark submission is scheduled for Q2-2019.
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 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.”
PAVmed recently announced that PortIO was able to achieve a maintenance-free implant duration of over 60 days in pre-clinical animal testing. Former President of the Society of Interventional Radiology (SIR), Timothy P. Murphy, M.D., described this announcement as “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 series of 7-day PortIO implants as part of a GLP animal study requested by the Food and Drug Administration (FDA). In parallel with this GLP study, it also performed a long-term pilot study 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, it’s function and patency was 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.”
PortIO continues to advance through the U.S. Food and Drug Administration (FDA) de novopathway as it seeks an initial 7-day implant duration indication for use. The data from the recently completed GLP animal study will be submitted to the FDA once pathologic analysis of the implant sites is completed in the coming weeks. Based on this encouraging long-term preclinical data, PAVmed is planning to initiate a long-term (90-day implant duration) first-in-human series in Colombia, South America in Q2-2019. It also intends to fulfill the likely FDA request for human clinical data to support its de novo application with a small short-term clinical safety study in New Zealand. Both studies will target the same patient population, namely patients with poor veins or the need to preserve veins for future dialysis. CE Mark submission is scheduled for Q2-2019 and the company continues to explore potential strategic partnerships, including acquisition of PortIO.
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 address 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,
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.
bioaccess™ Press Contact:
Julio G. Martinez-Clark, CEO
Tel: +1 (954) 903-7210