Undisclosed to investors, and as Defendants have now admitted, Outset Medical “continuously” made significant changes to Tablo for use in the home setting. While performing further regulatory studies during the Class Period, the Company assured investors that it was conducting the studies “in accordance with the FDA approved protocol,” which required an appropriate demonstration of “real-world” human testing given that the device would be used at home by non-professionals. Thus, though cleared by the FDA for sale, Tablo was subject to additional studies for use in the home setting, the results of which could require additional applications for clearance and approvals.
However, devices like Tablo that are used by non-professionals outside of a clinical setting and can present serious health consequences are subject to heightened scrutiny by the FDA, including post-market surveillance studies. Throughout the Class Period, Outset Medical touted that Tablo can “serve as a dialysis clinic on wheels” and had been “cleared by the Food and Drug Administration for use in the hospital, clinic or home setting.” Outset Medical contended it was “well-positioned” to “help accelerate th shift to home-based hemodialysis therapy” prompted by the COVID-19 pandemic, patient preferences, government initiatives, and reimbursement changes. Tablo is a dialysis machine that purifies tap water and then artificially purifies and removes toxins from the blood of patients suffering from kidney failure. The Company’s flagship product is the Tablo Hemodialysis System (“Tablo”). Outset Medical is a medical technology company focused on kidney dialysis, the primary treatment for acute and chronic kidney failure. The lawsuit was filed in the United States District Court for the Northern District of California and alleges violations of the Securities Exchange Act of 1934. (“Outset Medical” or the “Company”) ( OM) between September 15, 2020, and June 13, 2022, inclusive (the “Class Period”). NEW YORK, J(GLOBE NEWSWIRE) - Bernstein Liebhard LLP, a nationally acclaimed investor rights law firm, reminds investors of the deadline to file a lead plaintiff motion in a securities class action lawsuit that has been filed on behalf of investors who purchased or acquired the common stock of Outset Medical, Inc. Shareholder Class Action Lawsuit or contact Peter Allocco at (212) 951-2030 or to discuss your rights. The KidneyX competition is a partnership between ASN and the US Department of Health and Human Services to support innovative strategies for tackling kidney diseases.Did you lose money on investments in Outset Medical? If so, please visit Outset Medical, Inc. Outset Medical was a winner of the 2019 KidneyX Redesign Dialysis competition. “If the company can see the same adoption in the home care market, it might be a $200–$300 million business in a year or two.” “Basically, in a time period of just 1 to 2 years, Outset Medical has grasped a $50 million run rate in a market segment pegged at $2.2 billion, as home sales were cleared just a quarter ago,” Seeking Alpha’s Value Investor column states. The future remains to be written, but Seeking Alpha, an investment website, says Outset Medical’s Tablo could spread widely into homes, which would quadruple its market presence. The system contrasts with other systems that require separate equipment for purifying water and generating dialysate. It requires an electrical outlet and tap water to make the dialysate and includes a wireless cloud connection for monitoring data.
The portable, four-wheel dialyzer Tablo unit is simple to operate. The first patient was trained and used the system at home on July 13 in New Jersey. On March 31, the company received US Food and Drug Administration approval to use the system in patients’ homes. The company raised $125 million earlier in 2020 to make its product commercially viable, FierceBiotech reports.
In a year in which hospitals have been battered by the COVID-19 pandemic, Outset Medical was ready with a product not only needed in healthcare settings, but also in homes. Nasdaq tweeted: “OM has the highest raise in 2020 of healthcare equipment and technology companies.” The IPO made quite a splash on the market. 17, 2020, with a $241.7 million initial public offering (IPO). Outset Medical, based in San Jose, CA, went public on the Nasdaq exchange on Sept.
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