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, /PRNewswire/ -- Haemonetics Corporation (NYSE: HAE), a global medical technology company focused on delivering innovative solutions designed to improve patient outcomes, today announced U.S. Food and Drug Administration (FDA) approval of the PerQseal® Elite vascular closure system for large-bore arterial procedures. The approval expands Haemonetics' portfolio of clinically-differentiated large-bore closure devices for structural heart and endovascular procedures in the U.S., following the company's acquisition of Vivasure Medical Limited in January 2026.

The PerQseal Elite system provides sutureless, large-bore vascular closure following structural heart and endovascular procedures performed with 14 – 22F sheaths. Its fully bioabsorbable patch seals arteriotomies up to 26F from within the vessel, enabling near-instantaneous hemostasis and leaving nothing permanent behind. Physicians can confirm hemostasis while maintaining guidewire access, with the flexibility to reposition or recover the system until implant release. Results from the prospective, single-arm, multicenter ELITE arterial study demonstrated 0% major complications per VARC-3 and a mean time to hemostasis of less than one minute.1 In 2025, PerQseal Elite received CE Mark approval in Europe for both arterial and venous indications.

"FDA approval represents an important milestone in our strategy to bolster our presence and growth in advanced vascular closure, with new and meaningful innovation to meet evolving procedural needs," said Jan Hartmann, M.D., Senior Vice President and Chief Medical Officer at Haemonetics. "PerQseal Elite has the potential to further simplify minimally invasive procedures such as TAVR, while supporting patient comfort and experience. We are pleased to offer physicians and their patients in the U.S. this novel, patch-based approach to large-bore vascular closure."

Professor Nicolas van Mieghem, MD, co-investigator of the ELITE study clinical trials and interventional cardiologist at ZOL Hospital in Genk, Belgium, said, "I have found PerQseal Elite to be easy to adopt and intuitive to use, with rapid hemostasis being a particularly notable feature. In both the ELITE study and our early clinical experience, it has integrated well into procedural workflows for large-bore arterial interventions."

Clinical data related to PerQseal Elite will be presented and discussed by Haemonetics at the Transcatheter Cardiovascular Therapeutics® (TCT) Conference at the end of October.

VARC-3 major device-related vascular access site complications through 30 days. See PerQseal® Elite Instructions for Use.

About Haemonetics

Haemonetics is a global medical technology company dedicated to improving the quality, effectiveness and efficiency of health care. Our Apheresis business features proprietary technologies designed to enhance safety, yield, donor satisfaction and operational efficiency for plasma and blood collectors around the world. Our MedSurg business offers Blood Management Technologies designed to help inform treatment decisions and optimize the management of blood products, and Interventional Technologies, including advanced vascular closure systems and sensor-guided technologies, designed to drive procedural effectiveness and elevate the patient experience. To learn more about Haemonetics, visit www.haemonetics.com.

Cautionary Statement Regarding Forward-Looking Information

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Forward-looking statements in this press release may include, without limitation, statements regarding plans and objectives of management for the operation of Haemonetics, including statements regarding potential benefits associated with the PerQseal Elite vascular closure system and Haemonetics' plans or objectives related to the commercialization of such product. Such forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based upon Haemonetics' current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of risks and uncertainties and other influences. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, product quality; market acceptance; the effect of economic and political conditions; and the impact of competitive products and pricing. These and other factors are identified and described in more detail in Haemonetics' periodic reports and other filings with the U.S. Securities and Exchange Commission. Haemonetics does not undertake to update these forward-looking statements.

Investor Contacts:

Olga Guyette, Vice President-Investor Relations & Treasury     

David Trenk, Sr. Manager-Investor Relations

(781) 356-9763                                                                                         

(203) 733-4987

[email protected]                                   

[email protected]

Media Contact:

Josh Gitelson, Sr. Director-Global Communications

(781) 356-9776

[email protected]

SOURCE Haemonetics Corporation

Key Takeaways HAE shares jumped 149.3% in a year, outperforming the industry's 26.8% decline and S&P 500's 18% gain.
HAE's Plasma and MedSurg revenues grew 7.2% and 6%, respectively, in the first quarter of fiscal 2027.
HAE raised fiscal 2027 revenue growth guidance to 5-8%, though high debt and competition remain concerns.

Haemonetics (HAE - Free Report) has witnessed strong momentum over the past year. Shares of the company have risen 149.3%, outperforming the industry’s 26.8% decline. The S&P 500 composite has increased 18% during the same time frame.

With healthy fundamentals and strong growth opportunities, this Zacks Rank #3 (Hold) company appears to be a solid wealth creator for its investors at the moment.

Haemonetics provides blood management solutions to customers encompassing blood and plasma collectors, hospitals and health care providers globally.  The company operates through two global reportable segments — Apheresis and MedSurg. Apheresis comprises Plasma and Other. 

Plasma includes plasma collection devices and disposables, donor management software, anticoagulants and saline sold to plasma customers. Other includes blood collection and processing devices and disposables. MedSurg comprises Interventional Technologies and Blood Management Technologies. Interventional Technologies includes Vascular Closure, Sensor Guided Technologies and Esophageal Protection, while Blood Management Technologies includes Hemostasis Management, Cell Salvage and Transfusion Management.

Factors Favoring HAE’s Share Price GrowthHaemonetic’s share price is trending upward, prompted by strong demand for its Plasma franchise.  In the first quarter of fiscal 2027, Plasma revenues increased 7.2% on a reported basis and 8.2% organically to $155.5 million. This growth reflected double-digit disposable rise globally, including mid-20% growth in North American disposables and double-digit growth in Europe, supported by prior U.S. share gains, new international share gains and higher collection volumes. Persona PLUS is extending the NexSys PCS platform through a firmware upgrade that increases plasma yield and center productivity. 

Investors are also impressed with the growth of MedSurg business. In the fiscal first quarter, MedSurg revenues increased 6.0% on a reported basis and 5.9% organically to $148.1 million. Blood Management Technologies grew 8.1% organically, with double-digit growth in Hemostasis and Transfusion Management partly offset by slower Cell Salvage capital upgrades. 

Image Source: Zacks Investment Research

Transfusion Management continued to benefit from software implementations and faster customer activations, expanding the recurring revenue base. Meanwhile, Interventional Technologies returned to growth, increasing 2.8% organically as Vascular Closure grew in the low double digits. VASCADE MVP and MVP XL benefited from renewed U.S. momentum, broader utilization and the expanded MVP XL indication for sheaths up to 17F outer diameter. 

Hemostasis Management remains a principal product line within Blood Management Technologies. The portfolio includes TEG 5000, TEG 6s and related hemostasis analyzers. In the first quarter of fiscal 2027, Hemostasis delivered double-digit growth, supported by mid-teens disposable growth, higher utilization across the installed base and continued share gains. The HN cartridge is expanding clinical applications and extending the company’s reach in international markets. Continued adoption of TEG 6s and broader cartridge use should sustain the franchise’s contribution to Blood Management Technologies growth.

Against this backdrop, Haemonetics raised fiscal 2027 reported revenue growth guidance to 5-8% from 4-7%. Organic revenue growth is now projected to be 4-7%, up from the prior 3-6% guidance, while the expected impact from the 53rd week remains roughly 2%.

Factors That May Offset HAE’s GainsFrom a solvency viewpoint, Haemonetics ended the fiscal first quarter with $223.4 million in cash and cash equivalents and $5 million in short-term debt. The long-term debt at the end of the quarter was $1.17 billion, indicating a highly leveraged balance sheet. Net leverage was 2.69x EBITDA. The company repaid $50 million of revolver borrowings during the quarter and another $50 million after the quarter ended. Despite progress on deleveraging, the debt load remains sizable and may constrain capital allocation flexibility.

Additionally, HAE operates in a competitive environment, both for manual and automated systems. Slower-than-expected product adoption by customers, especially the American Red Cross, might reduce the company’s revenues and profit.

A Look at HAE’s EstimatesThe Zacks Consensus Estimate for 2026 earnings per share has remained unchanged at $5.29 in the past 30 days.

The company has an estimated long-term EPS growth rate of 9.4%, in line with the industry. 

Stocks to ConsiderSome better-ranked stocks in the broader medical space are Phibro Animal Health (PAHC - Free Report) , Abbott (ABT - Free Report) and Globus Medical (GMED - Free Report) .

Phibro Animal Health has an earnings yield of 9.3% compared with the industry’s 2.7% yield. Shares of the company have risen 2.6% against the industry’s 27.9% decline over the past year. PAHC’s earnings outpaced estimates in each of the trailing four quarters, the average surprise being 18.4%. 

PAHC sports a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Abbott, carrying a Zacks Rank #2 (Buy) at present, has an earnings yield of 5.6% compared with the industry’s 2.6% yield. Its earnings beat estimates in each of the trailing four quarters, the average surprise being 0.8%. ABT shares have plunged 22.5% compared with the industry’s 27.9% decline over the past year.

Globus Medical, currently carrying a Zacks Rank #2, has an earnings yield of 6.8% against the industry’s negative 1.7% yield. Its earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 27.9%. GMED shares have rallied 32.6% compared with the industry’s 7.3% growth over the past year.

Haemonetics (NYSE:HAE) shares jumped over 13% to $115.20 on Thursday after CSL set out a timetable for moving its US plasma collection centers onto the company's devices.

CSL Limited (ASX:CSL), the Australian biotechnology company, expects to finish rolling out Haemonetics' NexSys PCS devices with Persona PLUS technology and related disposables by the end of 2027.

Plasma is the liquid portion of blood that donors give at collection centers and manufacturers use to make treatments for rare and chronic diseases.

CSL told Haemonetics it anticipates the transition will cover all of its plasma collection centers currently operating in the US.

The companies signed a non-exclusive supply agreement in August, which allows CSL to use Haemonetics' devices and buy related disposables in the US while keeping other suppliers available.

The scope and timing of the rollout remain subject to change under the terms of the supply agreement, and implementation details have yet to be determined.

Haemonetics is not updating its previously issued financial year 2027 guidance, so its forecast remains unchanged for now.

The company expects to update investors on the agreement's anticipated effect on its financial year 2027 results during its second-quarter earnings call in November 2026.

Disposables are single-use items that are replaced for each donor and generate recurring revenue for device makers beyond the initial equipment sale.

Haemonetics (HAE - Free Report) came out with quarterly earnings of $1.14 per share, beating the Zacks Consensus Estimate of $1.07 per share. This compares to earnings of $1.1 per share a year ago. These figures are adjusted for non-recurring items.

This quarterly report represents an earnings surprise of +6.54%. A quarter ago, it was expected that this provider blood management systems for health care providers and blood collectors would post earnings of $1.28 per share when it actually produced earnings of $1.29, delivering a surprise of +0.78%.

Over the last four quarters, the company has surpassed consensus EPS estimates four times.

Haemonetics, which belongs to the Zacks Medical - Products industry, posted revenues of $339.38 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 3.49%. This compares to year-ago revenues of $321.39 million. The company has topped consensus revenue estimates four times over the last four quarters.

The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call.

Haemonetics shares have added about 4.3% since the beginning of the year versus the S&P 500's gain of 12.8%.

What's Next for Haemonetics?While Haemonetics has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock?

There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately.

Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions.

Ahead of this earnings release, the estimate revisions trend for Haemonetics was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #4 (Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.

It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $1.30 on $343.02 million in revenues for the coming quarter and $5.21 on $1.4 billion in revenues for the current fiscal year.

Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Products is currently in the bottom 37% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.

One other stock from the same industry, Phibro Animal Health (PAHC - Free Report) , is yet to report results for the quarter ended June 2026.

This maker of animal health products and nutritional supplements is expected to post quarterly earnings of $0.72 per share in its upcoming report, which represents a year-over-year change of +26.3%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days.

Phibro Animal Health's revenues are expected to be $366.14 million, down 3.3% from the year-ago quarter.