BOSTON - Haemonetics Corporation (NYSE:HAE), a prominent medical technology company, announced today that it has secured 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its TEG® 6s hemostasis analyzer system Global Hemostasis-HN assay cartridge.
The new cartridge is designed to enhance the TEG 6s system's viscoelastic testing capabilities, catering to fully heparinized patients undergoing adult cardiovascular surgeries or liver transplants, applicable in both lab and point-of-care settings.
The Global Hemostasis-HN assay cartridge is intended to provide critical information for physicians to manage hemostasis more effectively during complex medical procedures. According to Jan Hartmann, MD, Senior Vice President and Chief Medical Officer at Haemonetics, the new cartridge will have a significant impact on clinical outcomes and the utilization of blood products.
The TEG 6s system, equipped with the new cartridge, is expected to offer faster and more detailed coagulation profiles than traditional coagulation tests. It is supported by TEG Manager® software, which allows for remote real-time monitoring of results across hospital networks.
The FDA's clearance was based on data from a multi-center trial involving 335 patients and a study with 164 healthy volunteers to establish normal reference ranges. The clinical trial amassed over 5,500 data points to confirm the safety and effectiveness of the Global Hemostasis-HN assays.
Stewart Strong, President of Global Hospital at Haemonetics, emphasized the company's commitment to expanding the impact of its Blood Management Technologies through the TEG 6s platform. The new cartridge is anticipated to be released in the upcoming months.
This announcement is based on a press release statement.
InvestingPro Insights
As Haemonetics Corporation (NYSE:HAE) gears up for the release of its FDA-approved Global Hemostasis-HN assay cartridge, the company's financial health and market performance remain key areas of interest for investors. With a market capitalization of $4.26 billion and a price-to-earnings (P/E) ratio of 33.46, Haemonetics trades at a high earnings multiple, indicating that investors may expect higher earnings growth in the future compared to the overall market.
InvestingPro data shows that Haemonetics has experienced a revenue growth of 12.48% over the last twelve months as of Q3 2024. This growth is complemented by a robust gross profit margin of 54.1%, demonstrating the company's ability to maintain profitability amidst expanding operations. Furthermore, the company's operating income margin stands at 15.72%, reflecting efficient management and a strong competitive position within the medical technology industry.
An InvestingPro Tip suggests that Haemonetics' stock generally trades with low price volatility, which could be an attractive feature for investors seeking stable investment opportunities in the healthcare sector. Additionally, the company has been profitable over the last twelve months and analysts predict it will remain profitable this year. However, it is worth noting that Haemonetics does not pay a dividend, which may influence the investment decisions of income-focused shareholders.
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