OM Outset Medical Inc

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, today announced two new research posters that demonstrate significant quality of life and mental health benefits for patients and their caregivers using its Tablo® Hemodialysis System for home hemodialysis (HHD).

“As physicians, we understand that a critical component of effective treatment includes not just providing physical relief, but also addressing the very real and challenging emotional aspects of managing end-stage kidney disease,” said Michael Aragon, MD, Chief Medical Officer of Outset Medical. “Our poster presentations at Kidney Week 2024 provide real-world evidence that Tablo is effective at helping both those in need of dialysis and their caregivers take back their life and build confidence in their treatment. Positive mental health and quality of life are essential factors in making this a reality.”

The following posters will be presented at Kidney Week 2024:

Improvement in Depression and Quality of Life in HHD Patients: Patients with end-stage renal disease (ESRD) commonly report depressive symptoms (e.g., feeling hopeless, suicidal thoughts), significantly impacting quality-of-life and feelings of self-worth (e.g., feeling like a failure, letting your family down). These symptoms can impact a patient’s overall sense of well-being as well as treatment recovery time. Patients on Tablo participating in the HOME Registry Study reported improvement in depression and faster recovery from dialysis treatments, over 12 months of observation. Importantly, at both 6 and 12 months, patients using Tablo at home reported that they were extremely likely to recommend home hemodialysis with Tablo to other patients. The mean Net Promoter Score (NPS) for likelihood of recommending HHD with Tablo to other ESRD patients on a 10-point scale from 1 “not likely” to 10 “extremely likely” was 9.2 at month 6 and 9.3 at month 12.

Caregiver Support for Tablo Home Hemodialysis: Care partners surveyed in this study reported confidence in their training and their ability to care for their loved one with little impact on their own quality of life. Care partner responses after completing training show 98% agree or strongly agree they are “confident in supporting my partner’s dialysis treatment with Tablo System”, and 100% of care partners agree or strongly agree with being "satisfied with what is being asked of them as a care partner.” Care partners of patients on Tablo at home were very likely to recommend Tablo HHD to others. The mean care partner NPS, reported on a 10-point scale from 1 “not at all likely” to 10 “extremely likely” was 8.9 at month 6 and 8.9 at month 12.

The posters will be showcased at the American Society of Nephrology’s (ASN) Kidney Week 2024 in San Diego, which runs October 23-27, 2024. More than 13,000 leading kidney health professionals gather at the annual conference to share the latest advances in kidney science and collaborate on kidney care innovation. Attendees are invited to meet the presenting authors in the Outset booth (#713) during the ASN meeting to ask questions or learn more about Tablo. The full posters can be viewed on the Outset Medical clinical evidence page following the conference.

New consensus recommendations published for catheter use in home hemodialysis

A recent study published in the October 14 issue of Kidney Medicine titled “Vascular Access for Home Hemodialysis: A Perspective on Tunneled Central Venous Catheters at Home” explores the issue of vascular access for HHD. While tunneled hemodialysis (HD) central venous catheters (CVC) have been used for decades, physicians still hesitate to send patients home without a mature, functional arteriovenous access.

The study convened an expert panel of clinicians to review available literature and provide consensus recommendations regarding the use of CVC for HHD. The research recommended that an end-stage kidney disease life plan should be created via shared decision-making for modality choices, with the corresponding dialysis access individualized for the patient, and for whom a CVC may represent the most appropriate vascular access to provide HHD.

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.

This device is not indicated for continuous renal replacement therapy (CRRT) and is cleared for use for up to 24 hours. The dialysate generated by this device is not sterile and should not be used for intravenous (IV) infusion.

Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include statements regarding Outset’s beliefs, projections and expectations concerning, among other things, the potential impact of the research results discussed in this press release. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, which could cause actual results and other events to differ materially from those expressed or implied in such statements. These risks and uncertainties include risks described in the Risk Factors section of Outset’s public filings with the U.S. Securities and Exchange Commission, including its latest annual and quarterly reports. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Outset disclaims any obligation to update these forward-looking statements.

For more information:

Investor ContactJim Mazzolajmazzola@outsetmedical.com

Media ContactJennifer Sipplemedia@outsetmedical.com

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