In early June 2018, Fresenius Medical Care announced a global partnership and $150 million equity investment in Humacyte, to make their human acellular vessel, HUMACYL®, available to more hemodialysis patients worldwide upon approval by appropriate regulatory authorities. This bioengineered blood vessel is currently in a Phase III pivotal trial in the U.S. and Europe.
Dr. Frank Maddux, chief medical officer and executive vice president for clinical and scientific affairs for Fresenius Medical Care North America, recently sat down with Humacyte Executive Chairman Carrie Coxto discuss this partnership and its potential for a significantly improved option for vascular access and better overall health outcomes for patients with End Stage Renal Disease (ESRD) requiring dialysis.
FM: How would you slot these human acellular vessels into both the regenerative medicine space and the biologic space?
CC: HUMACYL is a biologic because we start with donated human cells. But once the product is grown in our laboratories and then decellularized, HUMACYL is available as a universal donor tissue that can be implanted in just about any patient. As the patient’s own cells begin to move into the new tissue, the patient’s own body remodels that tissue to become their own. That is really why HUMACYL is a regenerative medicine product. We think we’re actually going to be the first regenerative medicine product out there that will be available for broad use. It’s been truly ground-breaking and exciting for us.
FM: Walk us through some of what’s been recognized in the science of this that’s different than typical manufacturing?
CC: We were given the fast track status early on by FDA because they recognized this had the potential to be different than anything else that’s out there and potentially better than traditional standards of care for human dialysis access. As we developed early clinical data, the results were so astounding and so durable that FDA then gave us an additional RMAT (Regenerative Medicine Advanced Therapy) designation which we’re very proud of. We are the first product to obtain the equivalent of a breakthrough designation in the regenerative medicine space.
FM: We’ve been interested in looking for ground-breaking scientific innovations, because of our company’s inherent science and engineering DNA. We know from our patient care businesses what a difficult problem vascular access has been for years, and this looks like an opportunity to create an environment where we can reduce catheter contact time. These access vessels also seem much more biocompatible, which has really been very attractive to us as a company.
CC: And we think that’s also going to result in long-term durability of the vessel so that patients can use that same access consistently, hopefully for years, which would be a major benefit as well.
FM: What is your sense of how patients who have had the opportunity to have a vessel implanted perceive this innovation? Have you had a chance to speak to any of them or hear from any of them on what their experience has been?
CC: We get extremely good feedback from the patients who’ve had a chance to use the vessel, and one of the most important things is, in fact, this durability. They love not having to undergo repeat access procedures, and potentially avoid the long maturation times associated with a fistula procedure. They very much appreciate the fact that HUMACYL functions a bit more like a fistula, so they have perhaps the benefits of that and, at the same time, having a vessel that can remodel and potentially look and act like their own tissue.
FM: From the standpoint of how you perceive the value of these vessels from a health economics standpoint to large payers—whether it’s the federal government or a private insurer—describe how you see this vessel. It’s obviously much more complicated to produce than an arteriovenus (AV) fistula, so how do you see the health economics of this playing out?
CC: We started collecting health economic data immediately in Phase II, because we knew this was going to be a more expensive product to manufacture than a piece of Teflon or other synthetic would be. But what we found in the first two years of our Phase II research was how using this vessel may have the potential to result in significant cost savings. Very early evidence suggests that HUMACYL may last longer, might require fewer procedures and show lower rates of infection, and so the overall cost to the patient and to the healthcare system is dramatically reduced. You mentioned catheter contact time. That’s the most expensive driver in the whole dialysis care equation. If you can limit the number of days on a catheter, not only do you limit all the comorbidities and the bad health outcomes, you dramatically drop the healthcare costs too.