Since the 1960s, dialysis access technology has remained largely unchanged; though a number of incremental improvements to the equipment used in these procedures have since been introduced, the underlying technology and concepts involved in the procedure have remained stagnant until 2018. Below, we provide an outline of the most substantial recent developments in the dialysis access space and illustrate the potential downstream market impact this may have in the coming years.
Endovascular AVFs: A Formidable Alternative to Surgical AVFs
In June 2018, the FDA cleared two new minimally invasive devices to create endovascular arteriovenous fistulas (AVFs) through the de novo premarket review pathway, marking a rare radical innovation in dialysis access technology. Traditionally, AVFs—artificial connections created between veins and arteries to enable hemodialysis—were created surgically, using sedation, incisions, and ligatures, which resulted in a considerable level of trauma and bruising in patients.
The two devices, the Ellipsys from Avenu Medical and the WaveLinQ (previously known as everlinQ) from TVA Medical (which was acquired by BD in July 2018), allow for the creation of AVFs through the use of needles and catheters, leaving behind only the needle entry points and no visible scars or bruising.
In addition to the aesthetic benefits, the AVFs created with these devices mature (i.e. become ready for use in dialysis) much faster and more reliably than those created through invasive surgical techniques, which often require up to 4 months to mature and in many cases fail to do so. Studies have thus far shown that AVFs created with the Ellipsys and WaveLinQ begin maturing in as little as a single month, allowing patients to undergo dialysis several months earlier than they would have with surgical techniques
Moreover, early clinical data show that these endovascular AVFs are more robust than surgical ones, incurring less damage from repeated needle insertion for dialysis treatment sessions. Also, considering that 40-60% of dialysis patients currently have to rely on dialysis catheters to receive dialysis (due to the long maturation period associated with surgical AVFs), the use of these new devices would mitigate the heightened mortality and morbidity risks associated with dialysis catheters.
Human Acellular Vessels: A Lab-Grown Solution
Surprisingly, however, it appears that minimally invasive endovascular AVFs are not the biggest story in the dialysis access space this year; in April 2019, Humacyte—a regenerative medicine company—published encouraging results on creating an AV graft (which is an indirect connection between an artery and a vein that performs the same function as a fistula) with its HUMACYL human acellular vessels (HAV), known in lay terms as bioengineered, or lab-grown, vessels. This product had received the FDA’s Fast Track designation in 2014, as well as the RMAT designation in 2017, which demonstrates the great deal of confidence and excitement surrounding its development and future potential.
Early results have not only shown that these HAVs can function like AV grafts, but have also demonstrated that the human body ultimately transforms them into an organic vascular tissue that has regenerative and self-healing properties, much like actual human tissue. Currently, phase 3 trials are being conducted to compare HAVs against AVFs, and positive results from that trial may lead to more widespread acceptance of this technology.
Dialysis Access in 2019—A Major Inflection Point
Though the dialysis access space has been historically stagnant, our research suggests that 2019 will represent a major inflection point in this space, due largely to the aforementioned innovations and the following associated developments.
- M&A: Firstly, in July 2018, BD acquired TVA Medical and its WaveLinQ system, which will allow the company to provide a broad portfolio of ESRD solutions and rapidly deploy the WaveLinQ to its existing large customer network; moreover, this will support confidence in the WaveLinQ among patients and physicians, given BD’s strong reputation for high-quality products.
- Reimbursement: Secondly, beginning January 1, 2019, both percutaneous AVF catheters began receiving reimbursement in the hospital outpatient, and ASC setting; this will encourage patient demand for this device and will ameliorate concerns surrounding the device’s cost, thereby bolstering procedure volumes significantly and providing patients with a painless, rapid-recovery, and effective alternative to surgical AVFs.
- Strategic Partnership: Finally, Humacyte announced that it is establishing a partnership with Fresenius Medical Care, which is the largest dialysis product provider globally. Through this partnership, Fresenius received a 19% stake in Humacyte and exclusive global commercialization rights for HUMACYL, while Humacyte received a $150 million equity investment. Going forward, it is likely that Fresenius will fully acquire Humacyte once ongoing clinical trials fully establish the efficacy and safety of HUMACYL.
Considering the immense population of dialysis patients—over 2 million worldwide—and projections for this population to continue expanding, the ramifications of these developments cannot be overstated. Dialysis patients have to endure scars, bruising, and potential infections. Therefore, Avenu Medical, BD, and Humacyte are all well positioned to provide these patients with more effective alternative solutions, which—in addition to affording these companies the opportunity to substantially strengthen their presence in the dialysis access space—may potentially improve the quality of life for millions of patients globally.
Looking forward, medtech companies should track the following questions as the market develops:
- How can payers, providers and manufacturers best prepare for the change in care for patients with an endoAVF?
- What products in the dialysis access market will be most affected by the introduction of endoAVFs?
- How will referral patterns change for patients receiving endoAVFs?
- How will innovations such in HAVs impact the graft market?
DRG released a new, comprehensive analysis of the US dialysis access treatment device market, including market forecasts and competitive insights, in May. In June, DRG will be releasing similar analyses for Europe, Japan, and the Asia Pacific region.
Interested in more data and expert perspectives around dialysis access treatments?
DRG experts are staying on top of the latest updates and market impact.
- Fernando Amador: Principal Analyst, Medtech Insights - Follow him on Linkedin
- Zaid Al-Nassir: Senior Analyst, Product Support - Follow him on LinkedIn