Globe Newswire04.24.19
PAVmed Inc., a highly differentiated, multiproduct medical device company, announced that its PortIO Intraosseous Infusion System, which consists of an implantable intraosseous vascular access device and insertion kit, achieved 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.”
“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),” 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 completed a series of 7-day PortIO implants as part of a GLP animal study requested by the U.S. 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," Aklog said. "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 FDA de novo pathway as it seeks an initial seven-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.
The PortIO Intraosseous Infusion System consists of an implantable intraosseous vascular access device and insertion kit. Instead of a catheter located in a vein, it has a short extension from the device, which a physician inserts into a bone, leaving the device to reside completely beneath the skin. This allows direct access to the bone marrow, which is a well-established route for the delivery of medications, fluids and other substances. PortIO can be inserted and removed near-percutaneously without requiring a surgical pocket or significant dissection and does not require confirmation of the position of the tip by x-ray or other means. Once in place, the device can be accessed by the nurse through the skin using the same techniques as existing implantable ports. PortIO addresses known limitations of existing long-term vascular access devices which, in addition to the need for regular maintenance with flushes, include occlusion from blood clots, blood stream infections and difficult or impossible insertion in patients with poor veins. PortIO’s addressable market opportunity is estimated to be at least $700 million based on short-term patients with poor veins and medium or long-term patients who would benefit from its advantages over existing devices. This estimate does not include a separate, possibly larger, market opportunity in patients with renal failure whose veins must be carefully preserved for future hemodialysis.
PAVmed Inc. is a 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 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.
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.”
“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),” 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 completed a series of 7-day PortIO implants as part of a GLP animal study requested by the U.S. 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," Aklog said. "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 FDA de novo pathway as it seeks an initial seven-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.
The PortIO Intraosseous Infusion System consists of an implantable intraosseous vascular access device and insertion kit. Instead of a catheter located in a vein, it has a short extension from the device, which a physician inserts into a bone, leaving the device to reside completely beneath the skin. This allows direct access to the bone marrow, which is a well-established route for the delivery of medications, fluids and other substances. PortIO can be inserted and removed near-percutaneously without requiring a surgical pocket or significant dissection and does not require confirmation of the position of the tip by x-ray or other means. Once in place, the device can be accessed by the nurse through the skin using the same techniques as existing implantable ports. PortIO addresses known limitations of existing long-term vascular access devices which, in addition to the need for regular maintenance with flushes, include occlusion from blood clots, blood stream infections and difficult or impossible insertion in patients with poor veins. PortIO’s addressable market opportunity is estimated to be at least $700 million based on short-term patients with poor veins and medium or long-term patients who would benefit from its advantages over existing devices. This estimate does not include a separate, possibly larger, market opportunity in patients with renal failure whose veins must be carefully preserved for future hemodialysis.
PAVmed Inc. is a 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 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.
