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Fresenius Medical's (FMS) New HHD Device to Increase Portability

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Fresenius Medical Care (FMS - Free Report) announced that the FDA has granted 510(k) clearance for Versi HD with GuideMe Software. VersiHD is the company’s chronic home hemodialysis (HHD) system that was first introduced in 2017. The GuideMe Software is a completely reinvented self-guided interface for VersiHD.

FMS believes that VersiHD with GuideMe Software will likely transform the experience of HHD for patients and nurses. This device has a graphical interface that gives you step-by-step instructions on how to use it, which can help patients and nurses feel more confident and comfortable about the device. VersiHD with GuideMe Software can facilitate smooth and safe switch from hospital to home with easier training experiences.

Price Performance

Shares of Fresenius Medical have risen 48% year to date against the industry’s 3.7% decline. The S&P 500 has witnessed 15.5% growth in the said time frame.

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Significance of VersiHD Clearance

The VersiHD with GuideMe Software aligns with the company’s goal to help dialysis patients live better and healthier lives by providing an innovative product that challenges the status quo of home dialysis. It is one of FMS’ latest products that makes home hemodialysis easier and more convenient for patients. Its graphical interface will guide through each step of the process, both during training and at home. This way, patient and care partner can feel more secure and confident about the therapy at home. VersiHD with GuideMe Software is part of FMS’ vision to make home therapies more accessible and appealing to more patients.

Fresenius Medical stated that there are more than 13,000 HHD patients in the United States alone, reflecting a significant potential. The VersiHD with GuideMe Software boosts the company’s portable HHD portfolio that includes NxStage System One and PureFlow DI Water Purification System. The company also has a connected health platform for HHD, named Nx2me Connected Health. FMS stated that more than 95% of HHD patients in the United States use its NxStage HHD system that is likely to sustain with the addition of VersiHD with GuideMe Software.

The company has planned to launch VersiHD with GuideMe Software in selected markets in 2023. Moreover, existing users of VersiHD are also eligible for an upgrade to GuideMe Software.

Industry Prospects

Per a report by Markets and Markets, the global hemodialysis market was valued at $76.9 billion in 2021 and is anticipated to reach $105.1 billion by 2026, at a CAGR of 6.4%. Factors like the rise in the number of chronic kidney diseases globally, introduction of advanced products and services by industry-leaders, and technological advancements are expected to drive the market.

Given the market potential, the launch of easy-to-use GuideMe software for VersiHD is likely to provide a boost to Fresenius Medical’s portable HHD business.

Recent Developments

This month, Fresenius Medical reported its second-quarter 2023 results, which reflected improving treatment volumes as well as a stabilizing labor environment in the United States. A potential continuation of improvement in these two key factors will be beneficial for the company in the rest of 2023. Overall price improvements also supported growth in the Care Enablement segment. While U.S. revenues continued to be hurt by the FX impact, international sales improved. The bottom line was hurt by inflationary cost increases in energy, material and personnel. However, these headwinds are likely to improve over the rest of 2023.

Zacks Rank & Stocks to Consider

Currently, Fresenius Medical carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the broader medical space are Patterson Companies, Inc. (PDCO - Free Report) , HealthEquity, Inc. (HQY - Free Report) and McKesson Corporation (MCK - Free Report) .

Patterson Companies, carrying a Zacks Rank #2 (Buy) at present, has an estimated long-term growth rate of 9.2%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

PDCO’s earnings surpassed estimates in three of the trailing four quarters and missed once, delivering an average surprise of 4.5%. The company’s shares have risen 21% year to date compared with the industry’s 13.7% growth.

HealthEquity, carrying a Zacks Rank #2 at present, has an estimated long-term growth rate of 22%. HQY’s earnings surpassed estimates in three of the trailing four quarters and missed once, delivering an average surprise of 9.1%.

The company’s shares have rallied 8.9% year to date against the industry’s 8.6% decline.

McKesson, carrying a Zacks Rank #2 at present, has an estimated long-term growth rate of 10.7%. MCK’s earnings surpassed estimates in three of the trailing four quarters and missed once, delivering an average surprise of 8.1%.

The stock has gained 12.3% year to date compared with the industry’s 13.6% growth.


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