Outset Medical's TabloCart with Prefiltration Receives FDA 510(k) Clearance

Rhea-AI Summary

Outset Medical, Inc. (Nasdaq: OM) received FDA 510(k) clearance for TabloCart with prefiltration, an accessory for the Tablo Hemodialysis System, improving flexibility for healthcare providers. This innovative technology enhances user experience with versatile prefiltration options and enhanced maneuverability, simplifying dialysis treatment. TabloCart complements Tablo as a single enterprise solution, revolutionizing the dialysis experience for patients and providers.

Positive

• Outset Medical (OM) received FDA clearance for TabloCart with prefiltration, enhancing the Tablo Hemodialysis System's capabilities and increasing flexibility for healthcare providers.

• TabloCart offers versatile prefiltration options and enhanced maneuverability, improving the user experience within healthcare facilities.

• Tablo, along with TabloCart, simplifies dialysis treatment by serving as a single enterprise solution that can be utilized across the continuum of care, transforming the dialysis experience for patients and providers.

Negative

• No negative aspects reported in the press release.

Insights

Medical Technology Analyst

The FDA 510(k) clearance of Outset Medical's TabloCart with prefiltration notable for investors as it potentially broadens the capabilities and appeal of the Tablo Hemodialysis System. This optional accessory, which can adapt to different water conditions and improve maneuverability, may enhance the overall utility of the Tablo system in various clinical settings. From a business perspective, the clearance allows for resumption of distribution in the U.S market, which could positively affect Outset Medical's sales and market penetration. However, investors should consider the additional costs of production and distribution and whether the market demand will justify these expenses. Further, they should monitor how this product is adopted by healthcare facilities and whether it leads to an increase in sales of the base Tablo system, as the accessory's success is tied to the main product's market presence.

Healthcare Industry Analyst

The enhancement of the Tablo Hemodialysis System with the TabloCart could signify a strategic move by Outset Medical to differentiate itself from competitors in the dialysis market. Improved prefiltration and maneuverability are features that could streamline the dialysis process and improve the experience of healthcare providers. However, for investors, the impact on Outset's stock will likely depend on the adoption rate within hospitals and clinics. It is vital to assess whether these enhancements will lead to an increase in contracts or partnerships with healthcare providers. Additionally, there could be implications for the home dialysis market, as ease-of-use and system efficiency are valuable propositions for patients and providers. Observing competitors' responses and any shifts in market dynamics will be key for understanding the long-term significance of this FDA clearance.

SAN JOSE, Calif.--(BUSINESS WIRE)-- Outset Medical, Inc. (Nasdaq: OM) (“Outset”), a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis, announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance of TabloCart^TM with prefiltration, an innovative optional accessory for the Tablo® Hemodialysis System.

Outset has resumed distribution of TabloCart with prefiltration and has product available to ship to customers in the United States.

"With the FDA's clearance of TabloCart with prefiltration, we have delivered features to the Tablo Hemodialysis System that increase the flexibility for nurses and health systems to serve patients from the ICU to the bedside,” said Leslie Trigg, Chair and CEO of Outset Medical. “Today’s announcement underscores Outset Medical's commitment to innovation and our ongoing dedication to transforming the landscape of dialysis treatment.”

TabloCart is designed to enhance the user experience within healthcare facilities. It comes in two versions: one with added storage and another featuring water prefiltration capabilities, meeting diverse clinical needs. Key features of TabloCart include:

• Versatile prefiltration: With its three customizable prefiltration options, TabloCart is designed to adapt to varying water conditions and also features a booster pump to increase incoming water pressure.
  
• Enhanced maneuverability: Equipped with 360-degree rotating wheels and directional locking rear wheels, it facilitates seamless movement through various clinical environments.

TabloCart is an innovative optional accessory that complements the Tablo Hemodialysis System. Tablo, which is used from the hospital to the home, represents a significant technological advancement that transforms the dialysis experience for patients, and operationally simplifies it for providers. Requiring only access to tap water and a standard electrical outlet, Tablo serves as a single enterprise solution that can be utilized across the continuum of care, allowing dialysis to be delivered anytime, anywhere and by virtually anyone.

About Outset Medical, Inc.

Outset is a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis. The Tablo Hemodialysis System, FDA cleared for use from the hospital to the home, represents a significant technological advancement that transforms the dialysis experience for patients and operationally simplifies it for providers. Tablo serves as a single enterprise solution that can be utilized across the continuum of care, allowing dialysis to be delivered anytime, anywhere and by anyone. The integration of water purification and on-demand dialysate production enables Tablo to serve as a dialysis clinic on wheels, with 2-way wireless data transmission and a proprietary data analytics platform powering a new holistic approach to dialysis care. Tablo is a registered trademark of Outset Medical, Inc.

Indications for Use

The Tablo® Hemodialysis System and TabloCart™ is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility. Treatments must be administered under physician's prescription and observed by a trained individual who is considered competent in the use of the device. The Tablo Hemodialysis System is also indicated for use in the home. Treatment types available include Intermittent Hemodialysis (IHD), Sustained Low Efficiency Dialysis (SLED/ SLEDD), Prolonged Intermittent Renal Replacement Therapy (PIRRT), and Isolated Ultrafiltration.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240506578203/en/

Investor Contact

Jim Mazzola

858-342-8272

jmazzola@outsetmedical.com

Media Contact

Jennifer Sipple

media@outsetmedical.com

Source: Outset Medical, Inc.

FAQ

What is the FDA clearance received by Outset Medical (OM)?

Outset Medical received FDA 510(k) clearance for TabloCart with prefiltration, an optional accessory for the Tablo Hemodialysis System.

What are the key features of TabloCart?

TabloCart offers versatile prefiltration options and enhanced maneuverability with rotating wheels, boosting the user experience within healthcare facilities.

How does TabloCart complement the Tablo Hemodialysis System?

TabloCart complements Tablo as an innovative optional accessory, enhancing the flexibility and capabilities of the system to serve patients across various clinical environments.