Cala Presents Multiple Clinical Studies Demonstrating Impact of Transcutaneous Afferent Patterned Stimulation (TAPS) Therapy in Essential Tremor (ET) Patients at the American Academy of Neurology ...
SAN MATEO, Calif., April 7, 2025 /PRNewswire/ -- Cala, the bioelectronic medicine leader, who recently raised an oversubscribed growth financing round and was recognized on Fast Company's annual top 10 list of the Most Innovative Medical Device Companies in 2025, announced at the American Academy of Neurology (AAN) meeting in San Diego, CA, the results from multiple clinical studies further expanding the robust body of evidence for Cala TAPS™ Therapy. These studies demonstrate TAPS improves underlying tremor severity with consistent usage, supports TAPS mechanism of action acts on the same brain network as Deep Brain Stimulation (DBS), and shows reduced ET-related healthcare costs over a 12-month prospective study.
Analysis of data from the multi-center PROSPECT study (263 patients) indicated that consistent usage of Cala TAPS Therapy reduces underlying tremor severity. This effect was measured across eight key daily activities and indicated a substantial underlying improvement in functional capacity, with over 80% of participants demonstrating improvement after one- and three-months of TAPS use at home. These results showed that consistent use of TAPS leads to improvement in underlying tremor severity, expanding the evidence that TAPS offers a valuable therapeutic option for individuals seeking to manage their tremor and regain greater independence in their daily routines. https://index.mirasmart.com/AAN2025/PDFfiles/AAN2025-002253.html
A mechanism of action study used direct brain recordings to show TAPS modulated neural activity in the ventral intermediate (VIM) nucleus of the thalamus. VIM is the most broadly adopted site of DBS implantation for ET and a key area involved in tremor control. This study of eight patients receiving TAPS therapy demonstrated the degree of modulation in the VIM thalamus is correlated with tremor improvement, suggesting that TAPS reduces tremor by directly influencing neural activity in key tremor-related brain networks. The study also demonstrated significant tremor reduction in both the treated and untreated limbs, with greater improvement in the treated limb. https://index.mirasmart.com/AAN2025/PDFfiles/AAN2025-003933.html
A 12-month prospective study of Cala TAPS Therapy demonstrated significant tremor relief and reduced ET-related healthcare costs in patients. In the study comparing 153 patients using TAPS for a 12-month period to an external control arm of 306 matched patients from a national payor database, TAPS therapy was associated with a reduction in ET-related healthcare costs, alongside a marked improvement in tremor severity and daily functioning. These findings highlight TAPS therapy as a valuable treatment option for managing tremors and improving quality of life. https://index.mirasmart.com/AAN2025/PDFfiles/AAN2025-001549.html
"We are excited to see Cala TAPS therapy not only provides acute relief for tremor patients but also improves underlying tremor severity with consistent use," said Kate Rosenbluth, PhD, Founder, President and Chief Innovation Officer, Cala Health. "Cala continues to build clinical evidence to support TAPS outcomes improving the lives of ET patients and bringing value to healthcare, expanding our strong body of clinical evidence in over 2,000 patients, including randomized controlled trials, mechanism-of-action studies and real-world evidence analyses."
"We are thrilled that Cala is honored in Fast Company's 2025 Most Innovative Medical Device Companies List impacting health and culture," said Deanna Harshbarger, Chief Executive Officer, Cala Health. "Cala is committed to customer-centric innovation that transforms the standard of care for patients and clinicians. With the only FDA cleared wearable neuromodulation system commercially available for tremor relief in ET and PD patients, Cala continues to raise the bar with advancements in technology and clinical evidence."
The Cala System is available by the Veterans Affairs (VA) Health System at no cost to eligible VA beneficiaries and has Medicare coverage for those who meet Local Coverage Criteria. Cala will continue to advocate on behalf of patients with ET to secure additional coverage and reimbursement in Medicare Advantage and commercial payor plans.
About Cala®
Cala Health is a bioelectronic medicine company transforming the standard of care for chronic disease. The company's wearable neuromodulation therapies merge innovations in neuroscience and technology to deliver individualized peripheral nerve stimulation, and its direct-to-home digital durable medical equipment (DME) platform is reshaping the delivery of prescription therapies. Cala Health's products are the only FDA-cleared, clinically validated noninvasive devices for the relief of hand tremors, allowing patients with essential tremor to return to the moments that matter. New therapies are under development in neurology, cardiology, and psychiatry. Founded in 2014, the company is headquartered in the San Francisco Bay Area and backed by leading investors in both healthcare and technology.
The Cala™ kIQ device is indicated to aid in the temporary relief of hand tremors in the treated hand following stimulation in adults with essential tremor. The Cala kIQ device is indicated to aid in the temporary relief of postural and kinetic hand tremor symptoms that impact some activities of daily living in the treated hand following stimulation in adults with Parkinson's disease. The Cala kIQ device delivers Transcutaneous Afferent Patterned Stimulation (TAPS) therapy.
Caution: Federal law restricts this device to sale by or on the order of a physician. Prior to use, refer to the product labeling for complete product instructions for use, contraindications, warnings, and precautions at https://calahealth.com.
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