October 2018 News Briefs

Fresenius Awards $100,000 Grant to ANNA in Celebration of Nephrology Nurses Week


In recognition of the 50th anniversary year of the American Nephrology Nurses Association (ANNA) and in honor of Nephrology Nurses Week, September 9-15, Fresenius Medical Care North America has awarded ANNA a $100,000 grant. According to a press release from Fresenius Medical Care North America, the award will be used to “fund an ongoing scholarship program, help increase awareness of the profession, and strengthen engagement with nurses dedicated to caring for patients with chronic kidney disease.”


Franklin Maddux, MD, FACP, chief medical officer and executive vice president for clinical and scientific affairs at Fresenius Medical Care North America, said, “Nephrology nurses provide compassionate, individualized care every day to people living with kidney disease. Nephrology nurses forge deep connections with patients to help them thrive during their dialysis journey, and we are committed to providing the support nurses need to deliver superior patient care every day.”


Lynda Ball, MSN, RN, CNN, president of ANNA, said, “We appreciate this partnership and generous grant from Fresenius Medical Care North America to benefit nephrology nurses who want to continue their nursing education and to support our efforts to reach new nurses about the career opportunities available in nephrology.”


All members of ANNA are eligible for the scholarship. The deadline to apply for scholarships through this grant is March 15, 2019. Winners will be announced in April 2019. For more information, visit annanurse.org/fresenius-scholarships.


Frenova Renal Research Adds Fifth Practice to Site Management Organization

Frenova Renal Research, a division of Fresenius Medical Care North America, has announced the addition of a fifth clinical research site to its Site Management Organization (SMO). The new site is in Baton Rouge, Louisiana. According to a press release, Frenova Renal Research is the “world’s only contract clinical research services provider dedicated exclusively to renal research.”

The Baton Rouge site will bring 6000 patients with chronic kidney disease and 1500 patients with end-stage renal disease in the care of the practice. Three new principal investigators and 10 sub-investigators will be added to the SMO, increasing the ability to quickly enroll patients in renal clinical trials.

Michael W. Roppolo, MD, of Renal Associates of Baton Rouge, LLC, will head the new site. All operational trial activities will be overseen by Frenova, including training and management of Frenova clinical research staff working at the site. Research site protocol adherence, data quality site payment, regulatory obligations to the FDA and Institutional Review Board, drug accountability, and site performance will also be managed by Frenova.

“It is a privilege to be part of Frenova’s growing Site Management Organization, Dr. Roppolo said. “Frenova SMO and the F1RST Up® [Frenova Rapid Start Up] network are improving the health outcomes and quality of life for patients through important clinical research. By allowing Frenova to direct the clinical research staff and trial operations, we can enroll more patients into studies and ultimately help patients by introducing new advances and treatments to the market.”

Kurt Mussina, vice president and general manager, Frenova Renal Research, added, “This important collaboration will bring more patients into our network who are eligible for renal-specific clinical studies, enabling us to support the increasing number of clinical trials seeking to improve the lives of people with renal disease.”


RenalGuard® Reaches Patient Milestone in Europe

In a late-August press release, RenalGuard Solutions™, Inc., announced the treatment of 20,000 patients with RenalGuard® for the prevention of contrast-induced nephropathy, a form of acute kidney injury (AKI) affecting 10% to 20% of patients undergoing imaging procedures that utilize toxic contract dyes. RenalGuard Solutions is a medical device company that focuses on fluid management technologies for the cardiac and vascular markets.

RenalGuard is currently being used in Europe and in countries that recognize the CE mark. The device manages real-time fluid balance in conjunction with interventional procedures that involve contrast media in at-risk patients undergoing cardiovascular imaging procedures. Results of recent studies suggest that RenalGuard protects patients from AKI following catheterization procedures compared with standard of care.

Jim Dillon, chief executive officer at RenalGuard Solutions, said, “We are very pleased by the positive response in the medical community in Europe towards the use of RenalGuard in high-risk patients undergoing cardiovascular procedures. This is a huge milestone for the product, the company, and our patients.”

RenalGuard therapy was demonstrated at the Transcatheter Cardiovascular Therapeutics meeting in San Diego, California, in September.


Novel Kidney Assay May Guide Sepsis Treatment

In preliminary research, an assay from BioMérieux has been shown to detect acute kidney injury (AKI) due to sepsis earlier than the current standard of care. The assay combines the NephroCheck AKI test with a procalcitonin test that may enable physicians to alter treatment before irreparable kidney damage occurs.

The research, presented in a talk sponsored by BioMérieux at the American Association of Clinical Chemistry meeting in August, was conducted by Eric Gluck, MD, a critical care physician at Swedish Covenant Hospital in Chicago. In a press release, Dr. Gluck noted that the standard of care has been to use serum creatinine level as a marker of kidney injury. However, Dr. Gluck said that by the time that particular marker is evident, “the kidney is 50% destroyed. There was nothing you could do at that point in time, so you sort of waited through that storm and hoped that the kidney would regain function eventually if the patient survived.”

NephroCheck measures two proteins present in urine and can indicate whether a patient’s kidney is under stress. Dr. Gluck and colleagues identified 227 patients who had positive procalcitonin tests; of those patients, ~40% had severe sepsis and were further tested using NephroCheck. Of those, 85% had positive values, indicating impending renal failure.

The researchers saw a 30% decrease in the need for dialysis in the patients whose NephroCheck test led to kidney-sparing changes in sepsis treatment. In addition, there was an association between kidney stress in sepsis, indicated by positive procalcitonin and NephroCheck test results, and a 60% increase in mortality, from 25% with sepsis along to ~35% with sepsis and kidney damage.


Cricket Health Announces Series A Funding

In a press release in early September, Cricket Health announced that it closed a Series A funding round of $24 million. Cricket Health is a technology-enabled provider of integrated kidney care. New investors include Oak HC/FT as well as Cigna Corporation, LifeForce Capital, iSeed Ventures, Liquid 2 Ventures, Halle Tecco, and Sami Inkinen. Returning investors include First Round Capital, Box Group, Nexus Ventures, Seven Peaks Ventures, Aberdare Management, and LinkedIn CEO Jeff Weiner.

Arvind Rajan, Cricket Health CEO, said, “Our mission at Cricket is to reduce the burden of kidney disease and put patients back in control of their lives with care that is cost-effective, keeps them healthy, and gives them hope for the future. This funding will help us provide better care to millions of Americans facing kidney disease.”

The Series A funding will be used to help Cricket Health expand its programs and its clinical footprint, including the ongoing development of care management for patients with end-stage renal disease to delay the need for dialysis, and the creation of new home dialysis and in-center programs.

Nancy Brown, a partner at Oak HC/FT, said, “Cricket Health has the approach, technology, and leadership to transform [the kidney care] industry, improve the quality of care, and bring down costs. We are excited to support their innovation and growth.”


Outset Medical Announces Financing for Tablo® System

Outset Medical has announced it raised $132 million in a Series D equity financing. According to a press release from Outset Medical, the round was led by new investor Mubadala Investment Company, an investment company in Abu Dhabi. Also participating in the equity round were the venture capital arm of Baxter International, Fidelity Management and Research Company, Partner Fund Management LP, Perceptive Advisors, funds advised by T. Rowe Price Associates, Inc., and Warburg Pincus.

Outset Medical will use the financing to increase production capabilities and accelerate commercial expansion of its Tablo® Hemodialysis System in acute and chronic care markets in the United States. Tablo is designed to reduce the cost and complexity of dialysis, expanding how, when, and where dialysis can be provided.

Camilla Macapili Languille, senior vice president of Pharma & Medtech at Mubadala, said, “Our investment in Outset Medical represents an exciting opportunity for Mubadala, as it is aligned with our goal of improving people’s lives while meeting a major global market need. We selected Outset Medical as our first US private medtech investment because of Tablo’s ability to significantly improve global dialysis care and address one of the biggest areas of worldwide healthcare spend with very disruptive and innovative technology.”

Outset Medical designed Tablo to “transform [the] large, but stagnant, dialysis landscape,” the press release said. Tablo delivers real-time water purification and dialysis fluid production integrated in a single, compact system.

Leslie Trigg, chief executive officer at Outset Medical, said, “Tablo offers patients and healthcare providers a new option for more flexible and convenient dialysis treatment, improving the dialysis experience while at the same time reducing overall dialysis spend. We are grateful to our investors for the opportunity to significantly impact the future of dialysis care.”

The Tablo system is CE-marked and FDA-cleared for use in acute and chronic care settings. The company is currently conducting a clinical trial to expand the labeled indication of Tablo to include home use.