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Haemonetics gains CE Mark for SavvyWire TAVI guidewire

EditorEmilio Ghigini
Published 07/30/2024, 06:24 AM
HAE
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BOSTON - Haemonetics Corporation (NYSE: NYSE:HAE), a company specializing in medical technology, has received CE Mark certification for its SavvyWire® Pre-Shaped Pressure Guidewire (NYSE:GWRE).

This certification marks a significant milestone, allowing the company to introduce the product to the European Union and other regions recognizing the CE Mark. The first commercial use of the SavvyWire guidewire in Europe occurred this month at facilities in France and The Netherlands.

The SavvyWire is a pioneering medical device in the field of Transcatheter Aortic Valve Implantation (TAVI). It combines three functionalities into a single solution: wire performance, hemodynamic measurement, and left-ventricular pacing capability.

This integration is intended to streamline the TAVI procedure by reducing the number of device exchanges, providing stable aortic valve delivery, and enabling continuous cardiac monitoring.

Medical professionals at Hôpital Haut-Lévêque du Centre Hospitalier Universitaire (CHU) de Bordeaux and Catharina Ziekenhuis Eindhoven, where the initial procedures were performed, have recognized the guidewire's potential to improve procedural efficiency and patient monitoring.

Dr. Lionel Leroux and Professor Thomas Modine (NYSE:MOD) of CHU Bordeaux highlighted the guidewire's ability to minimize manipulations and continuously monitor hemodynamics.

Similarly, Professor Pim Tonino from Catharina Ziekenhuis Eindhoven noted the device's enhanced standard for hemodynamic measurements, which facilitates immediate decision-making during TAVI procedures.

Stewart Strong, President of Global Hospital at Haemonetics, stated that the CE Mark certification is a key component of the company's strategic international expansion. He expressed the company's intention to leverage its global commercial infrastructure to bring the SavvyWire's fiber optic sensor technology to a broader market, including Europe, the Middle East, and Africa.

Haemonetics is a global healthcare provider that offers a variety of medical products and solutions aimed at improving patient care and reducing healthcare costs. Its portfolio includes technologies for blood and plasma component collection, surgical suite solutions, and hospital transfusion services.

This report is based on a press release statement, and it should be noted that forward-looking statements regarding the potential benefits and commercialization of the SavvyWire guidewire involve risks and uncertainties that could affect actual results.

In other recent news, Haemonetics Corporation has been in the spotlight with several significant developments. The company reported a 10% organic revenue increase in Q4 and a 12% rise for the fiscal year, projecting growth across its core plasma and hospital business units, with a decline in its blood center business for fiscal year 2025.

Haemonetics also upsized its private offering to $600 million in convertible senior notes, an increase from the initially proposed $525 million. The notes, due in 2029, are targeted towards qualified institutional buyers.

In addition, Haemonetics stock was upgraded from Hold to Buy by Needham, with a price target of $112. This positive revision is based on the company's projected ability to achieve a "high-20%" operating margin target for fiscal year 2026, driven by a decrease in lower-margin Plasma sales and an increase in higher-margin Interventional Technologies sales.

In their annual meeting, Haemonetics shareholders approved several key proposals, including the re-election of the board of directors and executive compensation. The appointment of Ernst & Young LLP as the company's independent registered public accounting firm for the fiscal year ending March 30, 2024, was also ratified by the shareholders. These are part of the recent developments shaping the future of the company.

InvestingPro Insights

As Haemonetics Corporation (NYSE: HAE) celebrates its recent CE Mark certification for the SavvyWire® Pre-Shaped Pressure Guidewire, investors are closely watching the company's financial health and market performance. With a market capitalization of $4.57 billion and a price-to-earnings (P/E) ratio of 38.36, Haemonetics is trading at a high earnings multiple, which is an important consideration for those looking to invest. This is particularly relevant given the company's P/E ratio is high relative to its near-term earnings growth. Despite this, Haemonetics has demonstrated a solid financial footing, with revenue growth over the last twelve months as of Q4 2024 at 12.01% and a gross profit margin standing strong at 54.38%.

One of the InvestingPro Tips indicates that Haemonetics' stock generally trades with low price volatility, which could be appealing to investors seeking stability in their portfolio. Moreover, the company has shown the ability to cover its interest payments with its cash flows, suggesting a degree of financial resilience. Additionally, analysts predict the company will be profitable this year, a sentiment backed by its profitability over the last twelve months.

For investors interested in further insights, there are additional InvestingPro Tips available at: https://www.investing.com/pro/HAE. These tips provide deeper analysis and can help inform investment decisions. To access these insights, consider using the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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