Back to top

Image: Bigstock

Fresenius Medical (FMS) Gets FDA Nod for New Hemodialysis System

Read MoreHide Full Article

Fresenius Medical Care (FMS - Free Report) recently announced the receipt of FDA 510(k) clearance for the company’s 5008X Hemodialysis System.

The new system is aimed at providing an improved standard of care in dialysis therapy to patients suffering from kidney diseases in the United States. The FDA clearance will allow the company to start clinical evaluations and user studies in the United States.

Price Performance

For the past six months, FMS’s shares have declined 24.0% against the industry’s growth of 6.0%. The S&P 500 increased 11.4% in the same time frame.

Zacks Investment Research
Image Source: Zacks Investment Research

More on the News

For patients whose kidneys are failing and are unable to naturally filter their blood to eliminate excess water, solutes, and toxins from the body, dialysis is a life-saving procedure. The 5008X Hemodialysis System will enable the company to offer high-volume hemodiafiltration dialysis therapy for patients living with kidney diseases in the United States.

High-volume hemodiafiltration uses both diffusion and convection techniques to remove larger molecules and efficiently manage fluid replacement through convection, in contrast to conventional high-flux hemodialysis, which primarily uses diffusion to remove small molecules and fluid from the blood.

According to the recently released ground-breaking CONVINCE* trial data, patients receiving high-volume hemodiafiltration had a surprising 23% lower death rate than those receiving the more popular high-flux hemodialysis. Throughout Europe, Latin America, and Asia Pacific, the company’s hemodialysis system series has demonstrated success, and this latest innovation builds on that success.

The 5008X Hemodialysis System combines the most recent advancements in device engineering and cutting-edge membrane technology necessary to enable high-volume hemodiafiltration, along with the registered companion, FX CorAL dialyzer.

The 510(k) clearance allows the start of clinical evaluations and user studies in the United States, with a planned broad commercial launch of the 5008X Hemodialysis System in 2025.

Approximately 160,000 in-center hemodialysis machines are currently installed in the United States across all service providers, and these machines might be replaced to meet this new standard of care. This new system demonstrates the company’s ability to innovate at scale and is likely to boost the company’s care enablement segment.

Industry Prospects

Per a report by Strategic Market Research, the global hemodialysis market size was estimated to be $85.5 million in 2021 and is expected to grow at 5.1% to reach $130.3 million by 2030.

The market is being driven by rising cases of renal hypertension, diabetes, end-stage renal disorder and kidney shortages.

Zacks Rank & Stocks to Consider

FMS carries a Zacks Rank #3 (Hold) at present.

Some better-ranked stocks in the broader medical space are Universal Health Services (UHS - Free Report) , Integer Holdings Corporation (ITGR - Free Report) and Elevance Health, Inc (ELV - Free Report) .

Universal Health Services, carrying a Zacks Rank #2 (Buy) at present, has an estimated growth rate of 4.4% for 2024. UHS’s earnings surpassed estimates in all the trailing four quarters, delivering an average surprise of 5.47%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

UHS’s shares have gained 1.9% in the past six months against the industry’s 5% decline.

Integer Holdings, presently carrying a Zacks Rank of 2, has an estimated long-term growth rate of 15.8%. ITGR’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 11.9%.

Integer Holdings’ shares have rallied 43.5% in the past year against the industry’s 3.7% decline.

Elevance Health, carrying a Zacks Rank of 2, reported fourth-quarter 2023 adjusted EPS of $5.62, beating the Zacks Consensus Estimate by 1.3%. Revenues of $42.45 billion outpaced the consensus mark by 1.5%.

Elevance Health has a long-term estimated growth rate of 12%. ELV’s earnings surpassed estimates in all the trailing four quarters, the average surprise being 3.1%

Published in