New Research Highlights Improvements in Quality of Life and Caregiver Experience for Home Hemodialysis Patients Using Tablo
2024年10月24日 - 5:05AM
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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