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 be led by Dr. Jorge H. Ulloa —a leading vascular surgeon who trained at the Walter Reed Army Medical Center Washington DC— and will be conducted at Cirulaser Andes (“Cirulaser”) in Bogota, Colombia — a specialized vascular center affiliated with Hospital Universitario de la Fundación Santa Fé de Bogotá ("FSFB").
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.
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.
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.
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