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Here are 1-3 brief analogies to describe Outset Medical (OM):

• Peloton for home dialysis: Outset Medical is making hemodialysis simpler and more accessible for use at home, similar to how Peloton brought high-tech fitness equipment and guided workouts into people's living rooms.
• Apple for dialysis machines: Outset Medical is modernizing and simplifying the traditionally complex dialysis machine with a user-friendly interface and integrated technology, much like Apple revolutionized personal computing and smartphones with intuitive design.

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• Tablo Hemodialysis System: A portable, enterprise-wide hemodialysis system designed for use by healthcare professionals in hospitals and clinics, and by patients for home use.
• Consumables and Services: Provides the necessary supplies and ongoing support for the operation and maintenance of the Tablo Hemodialysis System.

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Outset Medical (OM) primarily sells its Tablo Hemodialysis System to other companies and healthcare institutions, rather than directly to individual patients. While specific names of their major customers (e.g., individual hospital systems or dialysis chains) are typically not publicly disclosed by Outset Medical due to competitive and confidentiality reasons, their customer base primarily consists of the following categories of organizations:

• Hospitals and Integrated Delivery Networks (IDNs): These institutions purchase the Tablo System for use in acute care settings (e.g., intensive care units, emergency departments, general medical floors) for in-patient dialysis. Many also acquire Tablo for their home dialysis programs, leveraging their existing infrastructure to support patients who choose to dialyze at home.
• Dialysis Service Providers and Outpatient Dialysis Clinics: These organizations acquire Tablo systems to equip their outpatient clinics, offering an alternative to traditional in-center hemodialysis. A significant focus is also on enabling and expanding home hemodialysis programs for their patient populations, with Tablo being a key technology for this model.

Examples of such customers would include large national and regional hospital systems, academic medical centers, and various independent and large corporate dialysis chains that provide both in-center and home dialysis services. Specific public company names are not typically identified by Outset Medical as major customers in their public filings or statements, as their sales are distributed across numerous healthcare providers within these categories.

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Leslie Trigg, Chair and CEO

Leslie Trigg has served as Chief Executive Officer of Outset Medical since November 2014 and was elected Chair in 2022. She joined Outset Medical from Warburg Pincus, a private equity firm, where she was an Executive in Residence from March 2012 to March 2014. Prior to that, Ms. Trigg held executive leadership positions at several medical device companies, including Executive Vice President at Lutonix (acquired by CR Bard), Chief Business Officer of AccessClosure (acquired by Cardinal Health), and senior roles at FoxHollow Technologies (acquired by ev3/Covidien). Her career also includes positions at Cytyc Corporation, Pro-Duct Health (acquired by Cytyc), and Guidant Corporation.

Renee Gaeta, Chief Financial Officer

Renee Gaeta was appointed Chief Financial Officer of Outset Medical in June 2025. She most recently served as CFO of Shockwave Medical until its $13.1 billion acquisition by Johnson & Johnson in May 2024. Ms. Gaeta's prior experience also includes CFO roles at Eko Health and Establishment Labs, where she played a key role in the latter's initial public offering and global business growth. She has also served as a Board Director at Candel Therapeutics.

Michael Aragon, Chief Medical Officer

Michael Aragon serves as Chief Medical Officer, a role he has held since September 2018, guiding the company's clinical strategy. He is board certified in Internal Medicine and Nephrology and completed his medical training at UT Health Sciences Center in Houston. Previously, Dr. Aragon was the founding partner and President of North Texas Kidney Consultants-DFW for 14 years.

Marc Nash, Senior Vice President, Operations and Research and Development

Marc Nash has overseen Outset Medical's operations and R&D since 2023. His previous roles at Outset Medical include General Manager of Outset Mexico, Vice President of Manufacturing, and Senior Director of Operations. He has also held other manufacturing leadership positions within the medical device sector.

John Brottem, General Counsel and Secretary

John Brottem serves as the General Counsel and Secretary for Outset Medical.

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The key risks to Outset Medical's business include regulatory challenges, intense competition in the dialysis market, and a heavy reliance on its single flagship product, the Tablo Hemodialysis System.

1. Regulatory Challenges: Outset Medical has faced significant regulatory hurdles with the U.S. Food and Drug Administration (FDA). The company received a warning letter in July 2023 concerning the promotion of its Tablo system for indications not approved by the FDA (continuous renal replacement therapy) and for marketing the TabloCart accessory without the necessary 510(k) clearance. These regulatory issues led to pauses in shipments of the TabloCart and negatively impacted the company's financial performance and revenue growth. While Outset Medical announced the resolution of the FDA warning letter issues in February 2025, demonstrating its commitment to regulatory compliance, ongoing adherence to complex medical device regulations and securing future approvals remain critical for market access and expansion.
2. Intense Competition: Outset Medical operates in a highly competitive global dialysis market. The company faces significant competition from established industry leaders such as Fresenius Medical Care, Baxter International, and DaVita, which possess extensive resources, comprehensive product portfolios, and strong market presence. The competitive landscape also includes specialized companies and emerging players. This intense competition necessitates continuous innovation and effective strategies to capture and maintain market share, particularly in the expanding home dialysis segment, and to navigate complex reimbursement policies.
3. Heavy Reliance on a Single Product: Outset Medical's business model is largely centered on its innovative Tablo Hemodialysis System. This heavy reliance on a single flagship device introduces risks to the company's revenue and margin stability. Any unforeseen technical issues with the Tablo system, increased competition specifically targeting this technology, or future regulatory challenges related to the device could disproportionately impact Outset Medical's financial condition and operational results.

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1. Growth in Recurring Revenue (Consumables and Services): Outset Medical operates on a "razor and razor blade" model, generating a high-margin recurring revenue stream from Tablo cartridges and associated services after console sales. The company reported a 14% year-over-year growth in treatment revenue and a 22% increase in service revenue in Q3 2024. Recurring revenue is consistently performing well, with the company expecting to exit Q4 2025 at an annual recurring revenue run rate of over $100 million. This sustained utilization of its installed base is a cornerstone of its financial strength and gross margin expansion.
2. Expansion of Tablo Console Sales and Installed Base: While there have been fluctuations, recent quarters indicate a positive trend in Tablo console sales. The company saw a 25% increase in Tablo console revenue in Q2 2025, contributing to overall revenue growth. Outset Medical is actively working to expand its footprint across acute, subacute, and home dialysis settings, with the Tablo system already trusted by over 1,000 U.S. healthcare facilities. Increased console placements are crucial as they directly lead to higher recurring revenue from consumables and services.
3. Penetration of the Home Dialysis Market: The Tablo Hemodialysis System is FDA-cleared for use in both hospital and home settings, positioning Outset Medical to capitalize on the substantial home dialysis market, estimated at $8.9 billion. The company has demonstrated high patient satisfaction and retention rates (over 90% at 90 days) for its Tablo home dialysis program, indicating strong potential for continued expansion in this segment.
4. Insourcing Dialysis Services by Healthcare Providers: Outset Medical is focused on opportunities to help healthcare providers, particularly hospitals, insource their dialysis services. This strategy leverages the Tablo system to offer significant cost savings (over 50%) and operational efficiencies, with a payback period under 12 months for facilities. The company has undergone a commercial transformation to enhance its sales process and engage with "enterprise adopters," securing significant agreements to deploy Tablo systems across numerous facilities.
5. Improved Average Selling Prices (ASPs) for Consoles: Outset Medical has shown an ability to increase the average selling prices of its Tablo consoles. In Q3 2024, the company achieved an 18% improvement in average selling prices for consoles, which is a direct contributor to revenue growth and gross margin expansion. This indicates strong demand and perceived value for the Tablo system.

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Share Issuance

• In April 2021, Outset Medical closed an underwritten public offering, generating approximately $149.7 million in net proceeds for the company from the sale of 2,945,864 shares of its common stock at $53.50 per share.
• Outset Medical executed a one-for-fifteen reverse stock split effective March 20, 2025, reducing the number of outstanding shares from approximately 265 million to about 17 million.

Inbound Investments

• Outset Medical has primarily financed its operations and capital expenditures through sales of redeemable convertible preferred stock and common stock, revenue from sales, and debt financing.
• The company's total cash, cash equivalents, restricted cash, and short-term investments were $187.4 million as of June 30, 2025, and $179.0 million as of September 30, 2024.

Capital Expenditures

• Purchases of property and equipment were $869 thousand for the nine months ended September 30, 2024, a decrease from $2.387 million for the same period in 2023.
• Capital expenditures included in accounts payable and accrued expenses were $8 thousand for the nine months ended September 30, 2024, down from $207 thousand in the prior year period.
• Outset Medical anticipates using less than $50 million of cash in 2025, a significant reduction from over $100 million used in 2024, with capital expenditures being a component of this cash usage.