AspyreRx is the first FDA-authorized digital
behavioral therapeutic device delivering cognitive behavioral
therapy for the treatment of a cardiometabolic disease
As previously reported, adding AspyreRx to
standard of care resulted in significant and durable reductions in
A1c as well as improvements in a host of other health measures
Healthcare providers in the U.S. can now begin
prescribing AspyreRx
Better Therapeutics, Inc. (NASDAQ: BTTX), a pioneer in
developing prescription digital therapeutics (PDTs) to treat
cardiometabolic diseases, today announced the commercial launch of
AspyreRx, the first cognitive behavioral therapy (CBT) app to
receive U.S Food and Drug Administration (FDA) authorization as a
Class II device to treat adults with type 2 diabetes (T2D).
AspyreRx is a prescription-only therapy, backed by a randomized
controlled trial (RCT) that demonstrated statistically and
clinically significant durable reductions in A1c at 90 and 180 days
vs. the standard of care control group. The RCT also resulted in
statistically significant improvements in blood pressure, weight,
mood, and quality of life, as well as having lower medication
utilization and fewer adverse events vs. the control group.
Licensed healthcare providers are now able to prescribe AspyreRx,
and the app is available for download on the Apple App and Google
Play Stores.
AspyreRx delivers a novel form of CBT developed by Better
Therapeutics, specifically for the treatment of T2D. Rooted in the
fundamental belief that behaviors are learned and can be
transformed through systematic techniques and interventions,
AspyreRx provides a tailored experience to help patients make
meaningful and sustainable behavioral changes to improve their
diabetes management. AspyreRx is accessible through a smartphone
app and is prescribed for a 90-day treatment period.
“The impact of diabetes on 37 million people in the U.S.
underscores the pressing need to support healthcare providers and
patients in addressing the underlying factors contributing to the
disease,” said Diane Gomez-Thinnes, Chief Commercial Officer at
Better Therapeutics. “Our mission with AspyreRx is threefold: to
mitigate the growing burden of diabetes, to assist diabetes
patients in achieving meaningful behavior change, and to leverage
digital technologies to extend access, particularly in underserved
communities.”
A cost effectiveness analysis, which was part of a broader
Health Economics and Outcomes Research (HEOR) conducted by Better
Therapeutics, suggests that AspyreRx was cost-effective as compared
to standard of care, indicating the potential for AspyreRx to not
only yield better health outcomes than current standard of care
alone, but also to demonstrate cost savings for payers. The Company
continues to make progress towards obtaining commercial payer
coverage, while also advancing its efforts to get on the Federal
Supply Schedule. During the initial launch phase, as the Company
works on securing insurance coverage, eligible patients can access
AspyreRx on a cash-pay basis for a limited time.
“The need for novel, innovative and effective solutions for
people living with type 2 diabetes has never been more urgent,”
said David Kerr, MBChB, DM, FRCP, FRCPE, Director of Digital Health
at the Diabetes Technology Society. “AspyreRx has the potential to
overcome the limitations of traditional behavior change approaches,
offering infinite scalability as a digital solution for people who,
previously, have been excluded. By providing a structured approach
to behavior modification, AspyreRx can empower people with diabetes
in ways that healthcare providers, often constrained by time and
training, frequently find challenging to achieve. AspyreRx is a
compelling example of how technology can revolutionize traditional
healthcare, making treatments accessible to those who have until
now not had access, leading to clinically relevant improvements for
the many rather than the few.”
“With the launch of AspyreRx, providers now have a clinically
proven treatment delivered in an easily accessible, engaging and
affordable way. Behavior modification can be powerful medicine that
is valuable at any stage of the disease and since it is already
included in current treatment guidelines, we envision AspyreRx
becoming part of the standard of care for adults with T2D,” said
Frank Karbe, Chief Executive Officer of Better Therapeutics.
For more information and to help patients get started with
AspyreRx, visit www.aspyrerx.com.
About AspyreRx
AspyreRx (formerly BT-001) was granted marketing authorization
by the U.S. Food and Drug Administration (FDA) in July 2023 as the
first prescription-only digital therapeutic to treat adults with
type 2 diabetes (T2D). AspyreRx is backed by robust data
demonstrating clinically meaningful and sustained reduction in A1c
as well as improvements in other markers of cardiometabolic health
when used up to 180 days. Using proven techniques that target the
underlying psychological, behavioral, and cognitive factors that
sustain or worsen T2D, AspyreRx is a self-paced, engaging
experience that patients can access from their smartphone. It is
prescribed by a healthcare provider in 90-day increments, with
proprietary CBT delivered digitally in a weekly step-by-step
process. Through interactive therapy lessons, skill-building
modules, weekly goal setting and tracking, patients connect changes
in behavior to improvements in blood sugar and other biometrics.
Each step in the experience builds on the prior to enable and
reinforce cognitive restructuring, building the emotional
resilience and acceptance needed to make enduring changes.
Indications for Use
AspyreRx is a prescription-only digital therapeutic device
intended to provide cognitive behavioral therapy to patients 18
years or older with type 2 diabetes. The device targets behavior to
aid in the management of type 2 diabetes in patients who are under
the care of a healthcare provider. AspyreRx provides cognitive
behavioral therapy as a treatment that should be used adjunctively
with standard of care.
About Better Therapeutics
Better Therapeutics is a prescription digital therapeutics
company developing a novel form of cognitive behavioral therapy to
address underlying factors that sustain or worsen cardiometabolic
diseases. The Company has developed a proprietary platform for the
development of FDA-regulated, software-based solutions for T2D,
heart disease and other conditions. The CBT delivered by Better
Therapeutics’ PDT is designed to enable changes in neural pathways
of the brain so lasting changes in behavior become possible.
Addressing the underlying causes of these diseases has the
potential to dramatically improve patient health while lowering
healthcare costs. Better Therapeutics’ clinically validated mobile
applications are intended to be prescribed by physicians and
reimbursed like traditional medicines.
For more information visit: bettertx.com
Forward-Looking Statements
Certain statements made in this press release are
“forward-looking statements” within the meaning of the safe harbor
provisions under the United States Private Securities Litigation
Reform Act of 1995. Forward-looking statements are typically
identified by words such as “plan,” “believe,” “expect,”
“anticipate,” “intend,” “outlook,” “estimate,” “forecast,”
“project,” “continue,” “could,” “may,” “might,” “possible,”
“potential,” “predict,” “should,” “would” and other similar words
and expressions, but the absence of these words does not mean that
a statement is not forward-looking. The forward-looking statements
in this press release include, but are not limited to, statements
regarding Better Therapeutics’ expectations related to the efficacy
and potential benefits of PDTs, including AspyreRx and CBT, and
their potential treatment applications and their ability to improve
clinical outcomes, beliefs regarding the importance and potential
of behavior modification in diabetes treatment and statements
related to the needs of people living with T2D, among others. These
forward-looking statements are based on the current expectations of
the management of Better Therapeutics and are inherently subject to
uncertainties and changes in circumstances and their potential
effects and speak only as of the date of such statement. There can
be no assurance that future developments will be those that have
been anticipated. These forward-looking statements involve a number
of risks, uncertainties or other assumptions that may cause actual
results or performance to be materially different from those
expressed or implied by these forward-looking statements including:
risks related to Better Therapeutics’ business, such as the
willingness of the FDA to authorize PDTs, for commercial
distribution and insurance companies to reimburse their use, market
acceptance of PDTs, including AspyreRx, the risk that the results
of previously conducted studies will not be interpreted favorably
by the FDA or repeated or observed in ongoing or future studies
involving Better Therapeutics’ product candidates and other risks
and uncertainties included under the header “Risk Factors” in
Better Therapeutics’ quarterly report on Form 10-Q for the quarter
ended June 30, 2023 filed with the Securities and Exchange
Commission (SEC) on August 9, 2023, and those that are included in
any of Better Therapeutics’ subsequent filings with the SEC.
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version on businesswire.com: https://www.businesswire.com/news/home/20231016559397/en/
Investor Relations: Mark Heinen IR@bettertx.com
Media Enquiries: Emma Williams info@bettertx.com
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