Marvao Medical Devices, based in Galway, Ireland, has developed a technology platform called NexSite that aims to reduce the risk of catheter related infections. We first spotted CEO Chris Davey at the MedTech Invest conference in London last September where he was presenting some impressive early performance data for their first commercial product, NexSite HD. Marvao has since received FDA clearance for NexSite HD and is conducting initial marketing trials at several clinical sites in the US. We caught up with Chris to learn a little bit more about Marvao and their plans for NexSite.
Gavin Corley, Medgadget: Can you tell me a little bit about the origins of Marvao and the NexSite technology?
Chris Davey: In the 1990s I worked in the central venous access space for one of the major multinational device companies and became very familiar with the state of this technology. Central venous catheters are routinely implanted for months at a time to deliver chemotherapy, systemic antibiotics, haemodialysis (HD), and a broad range of other therapies. The big problem associated with these devices is the inherent risk of acquiring a potentially fatal bloodstream infection. There have been significant improvements with almost all other aspects of central venous catheter design since the 1990’s, but the technology still hadn’t evolved in terms of providing infection reduction.
In 2006 Marvao was formed to develop new products that could address this clinical problem. Almost all research up to that date had focused on antimicrobial coating technology, but this approach had consistently proven to be ineffective when the catheter was implanted for more than a few weeks. A small number of researchers had evaluated whether or not management of the catheter exit site (the point where the devices exits the patient’s skin) could significantly reduce the risk of bloodstream infection. This approach seemed counter intuitive to many clinicians, who believed that these infections result primarily from pathogens entering the bloodstream through the catheter lumen, and that the exit site is not a significant contributing factor.This intuition seemed to be supported only by anecdotal data, but s clinical studies were starting to show that a >50% reduction in bloodstream infection could be achieved by careful management of the catheter exit site1.
Adoption of the exit site management technologies used in these studies was limited because they involved prophylactic use of antibiotics, were too costly or too difficult to implement in a busy hospital setting. We looked at this exit site management data closely and, stepping back a bit, recognized that the exit site is essentially an open wound that never heals. Starting from this point we began looking for ways to design catheters that enabled the skin at the exit site to heal into the device. We figured that ‘healed skin’ would reduce the potential for pathogens to enter the body, and possibly provide an alternative form of exit site management that could be more easily adopted.
Medgadget: What were some of the major challenges you faced in getting to market?
Chris Davey: Funding is always the major challenge with early stage medical device companies, and raising money in the post 2008 environment was very difficult. The next challenge was developing the technology platform and then translating it into a commercially viable product within these tight economic constraints. Fortunately, a small group of investors from both sides of the Atlantic hung in there with us as we moved through this process.
Medgadget: What are the key features of the NexSite technology?
Chris Davey: In a phrase, ‘Ease of use’. Marvao provides NexSite within a complete kit for the clinician, and has designed the product so that it fits neatly into their work flow. We recognized early on that any success we might achieve in mitigating the risk of infection wouldn’t be translated into clinical or commercial success if it raised new barriers to adoption. We purchase conventional catheter sub-assemblies from several suppliers on an OEM basis, add NexSite technology to the catheter on our production line, and then package NexSite with other devices the physician needs to use during placement. Keeping it simple was the key design feature we pursued.
Medgadget: How does NexSite work?
Chris Davey: The NexSite technology itself is a combination of a DISC component (which stands for Dermal Ingrowth Support Collar) and the completed catheter. The DISC and catheter are assembled together at the exit site by the physician during placement. The DISC and the catheter components are each equipped with tissue ingrowth scaffold material where they contact the skin at the exit site. The DISC sits in a pocket formed under the skin, the catheter then passes through the skin, through the DISC, and continues on into the patient’s bloodstream. When assembled, the two tissue ingrowth scaffolds align to form a single 3 dimensional surface below and through the skin exit site which facilitates skin healing into the device.
Medgadget: There is obviously a wide scope of applications for NexSite, what are the various clinical areas that you are targeting for the technology?
Chris Davey: NexSite technology can be added to any device that enters the body through the skin that needs to be stabilized there for thirty days or longer. Dialysis catheters are a good example. Catheters used for chemotherapy are another big opportunity, as are some types of drainage catheters and urology catheters. LVAD power leads are another important application. All of these medical devices are associated with an elevated risk of infectious complications and high healthcare cost. We focused initially on haemodialysis catheters because its infection rate is very well studied and it is well recognized as a significant unmet clinical need. The net effect of these two factors is that haemodialysis is a more accessible space within which to conduct the clinical studies needed to demonstrate NexSite’s potential to improve patient outcomes and reduce healthcare costs. It also helps that haemodialysis catheters are a large market opportunity.
Medgadget: Who are the primary clinical users and stakeholders for this technology?
Chris Davey: For NexSite HD the typical end user is an interventional radiologist, but vascular surgeons and interventional nephrologists also implant a significant number of these devices. The patient’s clinical team is always quite multi-disciplinary so speaking with the implanting physicians is just the starting point. Once you have them on board we’re able to speak with other key stakeholders such as the referring physician; in the case of haemodialysis this is the patient’s nephrologist. Nurses who use the device to deliver the patient’s therapy are also very important stakeholders whose input and support are needed.
As our clinical data accumulates we are starting to engage further upstream with the clinical microbiologists responsible for managing infections throughout the hospital, and this is leading to broader conversations with the hospital administration. It is already recognized by healthcare providers at the senior management level that catheter related infections exert a powerful drag on the hospital’s profitability, and they are also now under economic pressure from healthcare payers to reduce their occurrence.
Medgadget: How have clinicians responded to NexSite so far?
Chris Davey: Very positive! Many recognize NexSite’s potential to effect a paradigm shift for patients who need long term catheterization. We are fortunate to be working with several key opinion leaders who were willing to take the lead, and their initial clinical experience has been very positive. Results for our first 20 patients will be presented by Dr John Ross at the Vascular Access Society of the Americas (VASA) conference in Dallas TX next month – this is a big milestone for us! Several key opinion leaders in high volume medical centres are now teaming up to begin a multi-centre clinical registry study later this year.
Medgadget: What can we expect from Marvao in the next 12-18 months?
Chris Davey: Although we have operated somewhat in stealth mode, we’re now entering a phase where NexSite HD’s performance can be benchmarked against conventional catheters. Over the next 18 months we will engage with a broader range of clinicians interested in studying NexSite HD with regard to ease of use, clinical performance, and economic impact. Over time their findings will be presented at a series medical conferences and submitted for publication in peer reviewed clinical journals. These are the critical steps needed to support the commercialization phase we’ll be entering later this year.
Reference: 1. “A systematic review of antimicrobials for the prevention of HD catheter infections”: Rabindranath, et al; Nephrology Dialysis Transplantation (2009) 24(12): 3763-3774
Link: Marvao Medical…