SAN JOSE, Calif. - Outset Medical, Inc. (NASDAQ:OM), a company focused on innovative medical technology, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its TabloCart™ with prefiltration, an accessory to the Tablo® Hemodialysis System. The company has announced that distribution of this product has resumed and is now available to customers throughout the United States.
TabloCart is designed to enhance the hemodialysis process within healthcare facilities, offering two versions to cater to different clinical requirements. One model provides additional storage, while the other includes water prefiltration capabilities. The prefiltration feature is customizable, allowing adaptation to various water conditions, and includes a booster pump to enhance incoming water pressure.
The Tablo Hemodialysis System, which can be used in hospitals or home settings, is a significant step in dialysis technology. It simplifies the dialysis experience for patients and streamlines operations for providers. Tablo operates with just tap water and a standard electrical outlet, positioning it as a versatile solution for different care environments. It also integrates water purification and on-demand dialysate production, effectively acting as a mobile dialysis clinic.
Leslie Trigg, Chair and CEO of Outset Medical, emphasized the company's commitment to innovation and the improvement of dialysis treatment, stating that the FDA clearance of TabloCart with prefiltration will increase flexibility for healthcare providers to serve patients in various settings.
The Tablo Hemodialysis System and TabloCart™ are indicated for use in patients with acute or chronic renal failure, in both acute and chronic care facilities, as well as for home use. The treatments, which include Intermittent Hemodialysis (IHD), Sustained Low Efficiency Dialysis (SLED/SLEDD), Prolonged Intermittent Renal Replacement Therapy (PIRRT), and Isolated Ultrafiltration, must be prescribed by a physician and supervised by a trained individual.
This announcement is based on a press release statement from Outset Medical, Inc.
InvestingPro Insights
Outset Medical, Inc. (NASDAQ:OM) has recently made headlines with its FDA clearance for TabloCart™, signaling a positive stride in its operational achievements. As the company continues to navigate the healthcare technology market, it's important to consider its financial health and market performance to understand the broader context of its operational news.
According to InvestingPro data, Outset Medical holds a market capitalization of $162.34 million. This valuation is reflective of the company's potential in the eyes of investors, despite the fact that it is not currently profitable, with a negative P/E ratio of -0.94 for the last twelve months as of Q4 2023. This could indicate that investors are expecting future growth or that the company is investing heavily in its technology and market expansion.
The company's revenue growth stands at 13.0% for the same period, suggesting a growing interest in its products and services. However, this growth is juxtaposed with a quarterly revenue decline of -4.69% in Q4 2023, which may be worth monitoring for future trends.
InvestingPro Tips highlight that Outset Medical is quickly burning through cash, which is a crucial consideration for investors. The company's ability to manage its cash flow efficiently is paramount to sustaining its innovative endeavors and market presence. Additionally, the stock has experienced significant volatility, as evidenced by a strong return of 53.17% over the last month, yet a substantial decline of -84.94% over the past year. This volatility could present both opportunities and risks for investors.
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Investors and interested parties are encouraged to visit https://www.investing.com/pro/OM for further insights, where they can find a total of 11 InvestingPro Tips that provide a comprehensive analysis of Outset Medical's financial health and stock performance.
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