Among the new features introduced at Kidney Week 2012 in San Diego was Innovators Place: a dedicated space to exhibit medical technologies not yet approved by the U.S. Food and Drug Administration (FDA). Inaugural exhibitors were selected by an ASN committee based on a set of criteria including the technology’s relevance to curing kidney disease and the exhibit’s educational value for Kidney Week attendees.
The exhibitors—mostly U.S. and European start-up companies, as well as nonprofit academic labs—presented innovations ranging from a benchtop instrument for early detection of severe acute kidney injury (AKI) to a compression device to reduce postdialysis clotting time. For most participants, Innovators Place provided an opportunity to secure potential partners and investors.
One exception was Semprus Biosciences, which was acquired 5 months before Kidney Week 2012 by Teleflex, Inc., and whose vascular access catheter received 501(k) clearance from the FDA 2 weeks after the meeting. Designed to reduce thrombus accumulation inside and outside the device, the catheter was exhibited at Innovators Place to generate awareness of the new technology, according to a Semprus Biosciences representative. Based on biomaterial discoveries by Robert Langer, ScD, of the Massachusetts Institute of Technology, the catheter received European market clearance in July 2012.
Other exhibitors presented innovations that are in the early stages of development. Joris Rotmans, MD, PhD, from the Leiden University Medical Center (LUMC) in the Netherlands said that he and his colleagues are searching for a commercial partner for the joint preclinical and clinical development of the Dutch group’s new technique for generating in vivo tissue–engineered blood vessels for hemodialysis vascular access. He noted the technique was developed at LUMC labs as part of the DialysisXS consortium, a research collaboration with the University of Twente in the Netherlands, the Dutch Kidney Foundation, and the Swiss biotech firm Xeltis.
Also searching for partners is the French nephrologist Mokhtar Chawki, MD, founder of the Nephrokit compressive device named IRIS, which is designed to reduce the postdialysis time to clot by securing dialysis needle vascular access puncture sites. The device speeds up coagulation time from 10.5 minutes, the average duration for conventional techniques, to 2 to 3 minutes, said Chawki. Nephrokit already has a nonexclusive agreement for IRIS distribution with Bellco in France and Belgium and Gambro in France, and the device is also sold in dialysis kits by Mölnylcke Health Care in Europe, he said.
At an adjacent Innovators Place booth, several nephrologists from the Henry Ford Health System in Detroit presented their universal regional citrate anticoagulation (RCA). Balazs Szamosfalvi, MD, said that he and his fellow nephrologists designed the sustained low-efficiency dialysis (SLED)-RCA technology to provide 100 percent–effective RCA with automated delivery using integrated intravenous pumps and optical blood and dialyzer effluent sensing. It can be adapted to most commercial renal replacement therapy devices with a customized RCA protocol and dialysis machine data interface program, Szamosfalvi said. In over 50,000 hours of clinical use, the technology prevented systematic citrate accumulation in patients with severe liver failure, and predictive-calcium infusion dosing maintains normal systematic ionized calcium levels, according to the display material.
Another Innovators Place participant was FAST BioMedical, whose co-founders include ASN President Bruce A. Molitoris, MD, FASN, of Indiana University. The Indianapolis medical device company has developed a small, durable bedside device to accurately measure GFR in approximately 40 minutes, based on technology licensed from Indiana University, said co-founder and president James Strickland. Over 30 clinical trials of FAST (Filtration Assessment and Surveillance Technology) have been conducted in Europe, Strickland said.
Argutus Medical of Dublin, Ireland, likely demonstrated the most professional marketing display at Innovators Place, where visitors learned about RenaStat, a new point of care test benchtop device for early detection of AKI in critical care requiring 100 µL of patient urine. Argutus Medical also provided scientific information about the development and use of biomarkers for AKI detection.
