Cala Health Study Shows Sustained Tremor Reduction With Consistent TAPS Therapy Use

New updates have been reported about Cala Health.

Cala Health has strengthened the clinical and commercial case for its wearable neuromodulation platform with a newly published retrospective analysis of the multicenter PROSPECT trial in the journal Tremor and Other Hyperkinetic Movements. The analysis indicates that consistent, twice-daily use of Cala’s TAPS therapy for essential tremor not only delivers immediate relief but also reduces underlying tremor severity over one and three months of use.

In the PROSPECT study, 263 essential tremor patients were enrolled and 192 with complete data were analyzed, with pre-stimulation tremor severity at baseline compared to one- and three-month follow-up visits. Outcomes were measured using the Bain & Findley Activities of Daily Living scale and the Tremor Research Group’s Essential Tremor Rating Assessment Scale, both showing statistically significant pre-stimulation improvement at each time point.

Patients experienced a 2.0-point improvement in BF-ADL scores at one month and 2.7 points at three months versus baseline, with p-values below 0.001, while pre-stimulation TETRAS scores also improved significantly, suggesting that tremor control extends beyond each stimulation session. More than 80% of patients met responder criteria for underlying tremor improvement on both scales at both follow-up visits, reinforcing the potential for TAPS therapy to alter day-to-day functional performance rather than offering only episodic benefit.

These findings deepen the evidence base behind the Cala kIQ System, the only FDA-cleared wearable delivering TAPS therapy for action hand tremor in adults with essential tremor and Parkinson’s disease, and support Cala Health’s positioning as a leader in wearable neurostimulation. CEO Deanna Harshbarger framed the analysis as further validation of the company’s strategy to build a data-driven, at-home digital DME platform for chronic neurological conditions.

From a market access perspective, the Cala system is already available at no cost to eligible beneficiaries through the U.S. Veterans Affairs health system and is covered by Medicare for patients meeting local coverage criteria, providing a foundation for recurring, reimbursed device utilization. Cala Health is actively pursuing expanded reimbursement from Medicare Advantage and commercial payers, and the demonstration of sustained, underlying tremor improvement could strengthen health-economic arguments around functional gains in activities of daily living.

For executives and investors, the study underscores multiple levers of strategic value: differentiated long-term efficacy in a large, underserved essential tremor population, an established regulatory and reimbursement beachhead, and a scalable, direct-to-home delivery model. As clinical data accumulate around both acute and sustained benefit, Cala Health is positioned to deepen adoption among neurologists and integrated health systems, while potential incremental coverage decisions could translate into higher utilization, improved patient retention, and a clearer path to revenue growth in the neuromodulation and digital therapeutics market.