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First patients have been enrolled in the clinical trial for next
generation dialysis technology
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Innovative system designed to improve home dialysis experience and
simplify therapy management
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New technology made possible by Baxter’s leadership in dialysis,
drug delivery technology and water filtration systems
DEERFIELD, Ill.--(BUSINESS WIRE)--
Baxter International Inc. (NYSE:BAX), a global innovator in renal care,
announced today that the first patients have been enrolled in a U.S.
clinical trial for the company’s on-demand peritoneal dialysis (PD)
solution generation system. The innovative system is designed to improve
the patient experience by making PD solutions in small batches in the
patient’s home. The Food and Drug Administration (FDA) has indicated
that the company may proceed with the prospective, multi-center clinical
trial.
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“We are on a journey to transform how kidney disease is identified,
managed and treated, with a focus on improving outcomes for patients,”
said Laura Angelini, general manager of Baxter’s Renal Care business.
“Our on-demand technology is the cornerstone of our innovation pipeline,
as we believe the technology will open up new possibilities for therapy
delivery while improving the experience for patients today.”
The system brings together Baxter’s pioneering innovations in home
dialysis, industry-leading drug delivery technology and expertise in
water filtration systems. The on-demand technology uses a small water
filtration device, concentrates and Baxter’s Amia automated
peritoneal dialysis system to turn patient’s tap water into dialysis
solution, as it is needed to complete each therapy session.
Today, patients receive up to 40 boxes of pre-made dialysis solution
every four weeks, weighing in at more than 900 pounds on average. These
boxes take up a lot of space in a patient’s home, often filling a closet
or spare bedroom. Making solution on demand allows Baxter to improve the
PD experience by eliminating heavy, six-liter bags that patients must
carry around their homes while setting up therapy. On-demand solutions
may also drastically reduce the storage space patients need. Because the
concentrate bags are smaller and can be used for several dialysis
sessions, patients may also be able to reduce the amount of plastic and
cardboard they recycle and dispose of daily.
The innovative system is designed to be more flexible to meet individual
patient needs, while simplifying how clinicians manage therapy for their
patients. PD solutions are available in different concentrations of
glucose, with higher concentrations removing more fluid and waste than
lower concentrations. Making solutions on demand means that a physician
could add or change the concentrations being used in therapy in near
real-time, through Baxter’s Sharesource remote patient management
system. The flexibility to adapt therapy would be a significant
improvement from current practice, where a clinician manually creates a
new prescription, places an order for pre-made solutions and waits for
delivery, or keeps even more boxes of solutions on-hand in patients’
homes.
The clinical trial assesses the efficacy and safety of the system, with
each participant using the new system for 12 weeks. Following conclusion
of the trial and study reporting process, Baxter expects to submit a New
Drug Application (NDA) for the concentrates and 510(k) for the device to
the FDA.
Baxter’s on-demand solution technology is an investigative product
and not approved for use. Amia with Sharesource is by Rx
Only. For safe and proper use of the devices mentioned herein, refer to
the complete instructions in the Operator's Manual.
About Peritoneal Dialysis
Patients with end-stage renal disease need dialysis to replace their
lost kidney function. PD therapy is done by the patient at home,
offering flexibility to choose when therapy is done. Many patients
choose PD to have more time for family and work commitments. The therapy
works inside the body, using the abdominal lining (peritoneal membrane)
as a natural filter to remove toxins from the bloodstream. PD solution
dwells in the cavity with toxins being pulled into the solution before
draining. The process then repeats itself three to four times during
each therapy session.
About Baxter
Every day, millions of patients and caregivers rely on Baxter’s leading
portfolio of critical care, nutrition, renal, hospital and surgical
products. For more than 85 years, we’ve been operating at the critical
intersection where innovations that save and sustain lives meet the
healthcare providers that make it happen. With products, technologies
and therapies available in more than 100 countries, Baxter’s employees
worldwide are now building upon the company’s rich heritage of medical
breakthroughs to advance the next generation of transformative
healthcare innovations. To learn more, visit www.baxter.com
and follow us on Twitter, LinkedIn and Facebook.
This release includes forward-looking statements concerning Baxter's
AMIA APD system, on-demand solutions technology and the SHARESOURCE
remote patient management platform, including anticipated benefits
associated with its use and anticipated timing associated with the
proposed NDA and 501(k) submissions. The statements are based on
assumptions about many important factors, including the following, which
could cause actual results to differ materially from those in the
forward-looking statements: satisfaction of regulatory and other
requirements; actions of regulatory bodies and other governmental
authorities; product quality, manufacturing or supply issues; patient
safety issues; changes in law and regulations; breaches or failures of
the company’s information technology systems; and other risks identified
in Baxter's most recent filing on Form 10-K and other SEC filings, all
of which are available on Baxter's website. Baxter does not undertake to
update its forward-looking statements.
Baxter, Amia and Sharesource are registered trademarks of
Baxter International Inc.
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Media Contact
Lauren Russ, (224) 948-5353
media@baxter.com
Investor Contact
Clare Trachtman, (224) 948-3085
Source: Baxter International Inc.