We are building a deep and expanding pipeline of innovative products with near-term value creation opportunities across a broad spectrum of clinical conditions, without limiting ourselves to a particular medical specialty or call point. PAVmed’s current pipeline consists of six lead products with a collective annual market opportunity of more than $4 billion, focused on medical infusion, hand surgery, pediatric ear infections, and tissue ablation.
We choose projects to develop and commercialize based on a variety of characteristics which contribute to a strong commercial opportunity. We place a heavy emphasis on single-use, interventional medical device products with the potential for high margins and high impact in attractive markets, and, most importantly, streamlined pathways to initial regulatory clearance.
To expand our multi-product pipeline, we continue to explore promising ideas and opportunities that fulfill our project selection criteria, sourced internally and from innovative clinicians and academic medical centers. Our pipeline is dynamic, and we make adjustments to our development and commercialization based on real-time progress, changes in market conditions, commercial opportunities, and availability of resources.
Over one million patients receive some type of infusion each day, and 90% of hospitalized patients receive an intravenous infusion at some point during their hospital stay. In an example of technologic overkill, nearly all inpatient infusions, including routine ones, are delivered by complex and expensive electric pumps instead of simple gravity. An increasing number of patients are also receiving infusions outside of the hospital in ambulatory facilities and in the home. Disposable infusion pumps have many attractive features that favor their use in these settings over outpatient electric pumps, and are used to deliver medications, including antibiotics, local anesthesia, and opioids. Inpatient infusion sets and disposable infusion pumps account for nearly 20% and 10%, respectively, of the estimated $5 billion annual global infusion market.
Infusion pump errors are a serious ongoing problem and represent a large share of the overall human and economic burden of medical errors. Electronic infusion pumps have become expensive and high maintenance devices, which have been plagued in recent years by recalls due to serious software and hardware problems. These pumps are designed for fine adjustments of infusions in complex patients, such as those in a critical care setting, and their use for routine infusions is technologic overkill. In terms of outpatient infusions, disposable infusion pumps can be highly inaccurate and are therefore unsuitable for use with medications where flow accuracy is critical, such as chemotherapeutics. The FDA’s MAUDE database includes numerous reports of complications and even deaths resulting from disposable infusion pump flow inaccuracies.
We are developing highly-accurate infusion systems using variable flow resistors, building on principles underlying two issued patents, which we have acquired. Our variable flow resistors adjusts its resistance to match the input pressure, maintaining a constant predetermined flow rate. The device’s design ensures that it can only flow at the designated flow rate, preventing complications associated with infusions running too slow or too fast. The variable flow resistor device will be incorporated into intravenous infusion sets and disposable infusion pumps for routine inpatient and outpatients infusions respectively. We believe our infusion sets will permit hospitals to return to gravity and eliminate expensive electric infusion pumps for most inpatient infusions. We also believe the accuracy of our device incorporated into disposable infusion pumps will allow outpatient administration of a broader range of drugs, thereby significantly expanding the addressable market.
Tissue ablation involves targeted destruction of tumors or benign tissues with pathologic impact using one of a variety of ablation devices based on a specific energy source, such as radiofrequency, microwave, laser, ultrasound, and cryoablation. With the exception of cryoablation, all these devices act through a common pathway of cellular hyperthermia. The overall tissue ablation market targeting numerous anatomic sites is estimated to generate $4-5 billion in annual revenue. One target which has not been successfully treated with ablation is fistula tracts. The renal nerves have also been identified as a therapeutic target for ablation in patients with poorly controlled hypertension. Endovenous ablation of varicose veins is a common and well established procedure. The estimated annual addressable markets for fistula ablation, renal denervation, and varicose veins are $300 million, $1 billion, and $240 million respectively.
All commercially available devices rely on some form of console to generate the ablation energy. These consoles, whether sold or leased as capital equipment or incorporated to the disposable cost, represent a significant proportion of the cost of the technology and the procedure, dramatically impacting procedural margins. These consoles require ongoing maintenance and monitoring by the manufacturer and local facility technical staff to assure they remain safe for use in patients. This can be particularly burdensome when commercializing such devices in emerging markets where access to qualified biomedical personnel may be limited.
We are developing completely disposable tissue ablation devices based on direct thermal ablation using heated fluid. We take advantage of the fact that all currently available energy sources, except cryoablation, act through the same common pathway of cellular hyperthermia. Caldus uses a proprietary disposable infusion device to continuously deliver heated fluid to a specially designed balloon catheter, which heats the target tissue above its cytotoxic threshold according to a specific pattern. Although, we believe this technology is applicable to over a dozen ablation targets, we have decided to initially focus on developing devices to treat fistula tracts, perform renal denervation and endovenous ablation of varicose veins. Once these products are commercialized, we believe that our completely disposable system will have lower procedural costs and higher margins than existing technologies. We anticipate applying the technology to other target tissues as resources permit.
A wide variety of short-term catheters are used in clinical practice to infuse fluids, medications, or other substances, monitor physiologic parameters, and drain organs or other cavities. Interventional radiology catheters, in particular, are widely used to drain various structures and cavities, including the chest cavity, obstructed kidneys, and abscesses, accounting for approximately $200 million in annual revenue. There is an increasing appreciation, however, in the importance of catheter securement. A variety of catheter securement devices are now on the market accounting for about $4 billion in annual revenue.
Currently marketed short-term catheters are not self anchoring, they have been traditionally anchored to the skin with simple tape or other adhesive incorporated into a sterile dressing. Catheter dislodgement leads to increased pain and costs, as well as potentially more serious complications, including the interruption of critical treatments, bleeding, and the influx of air, adversely impacting quality of care. Dislodgement of interventional radiology catheters, in particular, are a major concern and may require another visit to the procedural suite to replace or reposition the catheter. Monitoring catheter patency and reinserting dislodged catheters is labor intensive. Currently marketed short-term catheters are not self anchoring and separate securement devices add complexity and cost to patient care.
NextCath catheters are self-anchoring and do not require suturing, traditional anchoring techniques or costly add-on catheter securement devices. We are initially focusing on interventional radiology catheters which are less commoditized and result in significantly greater risk when dislodged. A proximal helical section of the catheter is advanced through the skin creating a retaining structure just under the skin. This self-anchoring mechanism is applicable to most, if not all, short-term catheters, allowing insertion with standard techniques and the use of simple, clear sterile dressings. It allows the hub of the catheter to be flat and the tubing to emerge parallel to the skin, improving patient comfort and catheter management.