Cala Health Receives FDA Breakthrough Device Designation for Cala Trio™ Therapy to Treat Action Tremors in Parkinson's Dise...
22 Oktober 2020 - 2:34PM
Business Wire
-- Subsequent clinical trials expected to
commence in 2020 --
Cala Health, Inc., a bioelectronic medicine company developing
wearable therapies for chronic disease, announced that the U.S.
Food and Drug Administration (FDA) has granted Breakthrough Device
Designation to Cala Trio™ for the treatment of action tremors in
the hands of adults with Parkinson's disease. Cala Trio is
currently FDA-cleared to relieve hand tremors from essential tremor
(ET). The Company expects to initiate the next clinical trials
evaluating the therapy in the treatment of action hand tremors in
patients with Parkinson's disease by the end of 2020.
Breakthrough Device Designation is granted to specific medical
devices that have the potential to provide a more effective
treatment for life-threatening or irreversibly debilitating
diseases. The goal of the Breakthrough Devices Program is to
provide patients and health care providers with timely access to
these medical devices by speeding up their development, assessment,
and review while preserving the statutory standards for premarket
approval, 510(k) clearance, and De Novo marketing
authorization.
"While hand tremor in patients living with Parkinson's disease
typically occurs when the arm is at rest while sitting or walking,
it is also estimated that more than half of patients also
experience action tremor, which occurs when the arm is being used
to perform an activity or task," said Stuart Isaacson, MD, Director
of the Parkinson's Disease and Movement Disorders Center of Boca
Raton in Florida. "Furthermore, published data suggest that
levodopa, the primary treatment for motor symptoms of Parkinson's
disease, is not usually effective in treating this type of tremor,
which can negatively affect performing daily tasks like eating and
writing. For this reason, treatment for action tremor in patients
with Parkinson's disease remains a significant unmet medical need
that impacts their daily activities and overall quality of
life."
Cala Trio, a non-invasive targeted therapy, is currently
available in the U.S. by prescription. Cala Health sought
Breakthrough Device Designation for Cala Trio because many patients
with Parkinson's disease experience the same action tremor as
patients with essential tremor.
The Company expects to initiate the next clinical trials of Cala
Trio virtually in patients with Parkinson's disease in 2020.
Physicians and their patients with Parkinson's disease-related
action hand tremors interested in participating in research are
encouraged to visit https://calahealth.com/research/. Virtual
clinical trials will allow participants to volunteer from home,
using the therapy as indicated in the study design and having
telemedicine visits with a neurologist throughout the study.
"Cala Health is committed to pursuing rigorous scientific and
clinical research to demonstrate the mechanism, benefits,
useability, and safety of our technologies," said Kate Rosenbluth,
Ph.D., Founder and Chief Scientific Officer of Cala Health. "We are
pleased to have the FDA recognize the novelty and potential for our
wrist-worn neuromodulation therapy."
About Action Tremor
Action tremor occurs with the voluntary movement of a muscle.
Most types of tremor are considered action tremor. There are
several sub-classifications of action tremor, many of which
overlap.1 Patients with both Essential Tremor (ET) and Parkinson's
disease (PD) often present with tremors during muscle contractions,
including during intentional activities such as while hands are
outstretched from the body ('postural tremors') and when hands are
in motion during tasks ('kinetic tremors').
About Essential Tremor (ET)
Essential Tremor (ET) is the most prevalent tremor disorder and
one of the most common neurological disorders, affecting an
estimated seven million people in the United States. It is a
chronic condition that causes involuntary and rhythmic shaking and
typically worsens over time. ET can affect almost any part of the
body, but the trembling most often occurs in the hands, making
everyday activities such as eating, writing, or getting dressed
extremely difficult. ET is often confused with Parkinson's disease,
although it is eight times more common. Current ET treatments
include mostly off-label use of medications or brain surgery.
About Cala Trio™
Cala Trio is the first non-invasive targeted therapy that
reduces hand tremors for adults living with Essential Tremor (ET).
Prescription therapy is a simple, wrist-worn device that is
calibrated to treat a patient's unique tremor symptoms. When
activated, Cala Trio gently stimulates the nerves in the wrist to
disrupt the tremulous activity in the brain, without the need for
invasive brain surgery or medication. The easy-to-use and effective
Cala Trio can be prescribed through an in-person consultation or
telemedicine appointment. Therapy is conveniently delivered to the
patient's home, and Cala Health educates patients based on how they
learn—phone, video, user portal.
About Cala Health, Inc.
Cala Health, an award-winning bioelectronic medicine company, is
transforming the standard of care for chronic disease while putting
patients first. The Company's wearable neuromodulation therapies
merge innovations in neuroscience and technology to deliver
individualized peripheral nerve stimulation, and its vertically
integrated commercial model is reshaping the delivery of
prescription therapies. Cala Health's lead product, Cala Trio, is
the only non-invasive, wrist-worn prescription therapy for
essential tremor. New therapies are under development in neurology,
cardiology, and psychiatry. Cala Health is headquartered in the San
Francisco Bay Area and backed by leading investors in both
healthcare and technology. For more information, visit
CalaHealth.com.
1Crawford P, Zimmerman EE. Differentiation and diagnosis of
tremor. Am Fam Physician. 2011 Mar 15;83(6):697-702. PMID:
21404980.
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Erich Sandoval Erich.Sandoval@FinnPartners.com