BARCELONA - Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS), the global healthcare company known for its plasma-derived medicines, has received U.S. FDA approval for its Fibrin Sealant (FS) for use in pediatric surgery. The product, aimed at controlling surgical bleeding, is already available for children and adolescents in Europe and is now extended to the same age group in the United States.
The FDA's endorsement follows a successful phase 3b clinical trial that demonstrated over 95% efficacy in achieving hemostasis within four minutes of application in pediatric patients. The trial involved 178 patients across 18 centers worldwide, comparing the FS to an active control.
Grifols' FS, marketed as VISTASEAL™ in the U.S. and Canada and VERASEAL™ in Europe, is a biosurgery treatment combining fibrinogen and thrombin. It is distributed by Johnson & Johnson MedTech as part of a strategic collaboration. The product is now available in 18 countries and is applied using an airless spray technology to rapidly form clots, which is crucial for surgeries where bleeding is a concern.
VISTASEAL™ is indicated as an adjunct to hemostasis for mild to moderate bleeding during surgery when traditional methods are ineffective or impractical. It is also effective in heparinized patients. However, it should not be injected directly into the circulatory system or used for severe arterial bleeding.
The most common adverse reactions reported were procedural pain and nausea. As with any human blood product, there is a risk of transmitting infectious agents.
Grifols, headquartered in Barcelona, continues to expand its portfolio, focusing on innovative healthcare solutions. The company operates the world's largest network of plasma donation centers and is a key player in transfusion medicine, offering a range of products and services designed to ensure safety from donation to transfusion.
The information in this article is based on a press release statement from Grifols.
InvestingPro Insights
Grifols' recent FDA approval for its Fibrin Sealant in pediatric surgery aligns well with the company's financial performance and market position. According to InvestingPro data, Grifols has demonstrated strong revenue growth, with a 28.67% increase in quarterly revenue as of Q2 2024. This growth trajectory is likely to be further supported by the expanded market access for its VISTASEAL™ product in the United States.
InvestingPro Tips highlight that Grifols has maintained dividend payments for 34 consecutive years, showcasing the company's financial stability and commitment to shareholder returns. This is particularly noteworthy in the context of the company's ongoing investment in product development and market expansion, as evidenced by the successful clinical trials and regulatory approvals mentioned in the article.
Additionally, InvestingPro data reveals that Grifols has a gross profit margin of 100% for the last twelve months as of Q2 2024, indicating highly efficient operations and strong pricing power for its specialized healthcare products. This impressive margin aligns with the company's position as a global leader in plasma-derived medicines and its strategic collaborations, such as the one with Johnson & Johnson MedTech for product distribution.
For investors seeking a deeper understanding of Grifols' financial health and market potential, InvestingPro offers 3 additional tips and a wealth of real-time metrics to inform investment decisions.
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