Cala Health - Global Leader in Wearable Neuromodulation for Tremor Management

📢 Key Milestones (2024–2026):
   In January 2024, Cala TAPS™ Therapy received Medicare coverage and Deanna Harshbarger was appointed CEO. In August 2024, the company secured $50 million in growth capital from Trinity Capital. In March 2025, Cala closed a $50 million Series C financing. In April 2026, the FDA cleared the next-generation Cala kIQ® Plus system (K253587) with new therapy modes and adaptive calibration for both essential tremor and Parkinson's disease. In February 2026, a published PROSPECT trial analysis demonstrated underlying tremor improvement with consistent TAPS use, with over 80% of patients meeting responder criteria.

Company Profile (Updated April 2026)

Cala Health is a bioelectronic medicine company headquartered in San Mateo, California, USA. Founded in 2013 as a Stanford Biodesign spinout by neuroscientist Kate Rosenbluth, the company is dedicated to transforming the standard of care for chronic diseases through wearAble Neuromodulation therapies that merge innovations in neuroScience and technology to deliver individualized peripheral nerve stimulation.

The company's flagship Cala kIQ® System is the only FDA-cleared wearable device that delivers effective therapy for action hand tremor in people with essential tremor (ET) and Parkinson's disease (PD). The device uses proprietary Transcutaneous Afferent Patterned Stimulation (TAPS™) technology to stimulate the median and radial nerves at the wrist, interrupting the tremulous circuit in the brain and reducing hand tremors. EACH 40-minute stimulation session provides tremor relief lasting on average over 90 minutes, with effects persisting beyond the stimulation period in many patients.

Development History:

- 2013: Founded as a Stanford Biodesign spinout by Kate Rosenbluth in San Mateo, California

- 2014: Completed Series A financing

- 2016: Completed Series B financing

- 2018: Published first sham-controlled pilot trial in Movement Disorders, demonstrating significant tremor improvement with noninvasive neuromodulation

- 2019: Completed Series C financing

- 2020: Published data in Frontiers in Neuroscience showing 80% of essential tremor patients demonstrated tremor improvement lasting at least 60 minutes after therapy

- 2021: Completed Series D financing

- 2023: Received FDA De Novo clearance for the Cala kIQ System; launched next-generation system and accelerated leadership in bioelectronic medicine

- 2024.01: Cala TAPS Therapy received Medicare Local Coverage Determination; appointed Deanna Harshbarger as Chief Executive Officer and President

- 2024.08: Secured $50 million in growth capital from Trinity Capital Inc. to support commercial expansion

- 2025.03: Closed $50 million Series C financing

- 2025.10: Published landmark PROSPECT trial results — the largest trial ever conducted for essential tremor (263 patients, 26 sites) — showing 68% of patients achieved significant improvement in hand tremor after three months of therapy

- 2025.11: Expanded leadership team to support growing adoption of Cala TAPS Therapy

- 2026.02: Published PROSPECT trial retrospective analysis demonstrating underlying tremor improvement with consistent TAPS use; BF-ADL scores improved by 2.0 points at one month and 2.7 points at three months; over 80% of patients met responder criteria

- 2026.04: FDA cleared Cala kIQ® Plus (K253587), the next-generation wearable neurostimulation device with new therapy modes and adaptive calibration designed to optimize tremor relief and personalize treatment

Core Mission: To transform the standard of care for chronic disease by delivering individualized, noninvasive wearable neuromodulation therapies that enable patients to reduce tremors and regain independence in daily activities.

Core Product Portfolio

Cala kIQ® System (Commercial)

- Indications: Temporary relief of action hand tremors in adults with essential tremor; temporary relief of postural and kinetic hand tremor symptoms impacting activities of daily living in adults with Parkinson's disease

- Technology: Transcutaneous Afferent Patterned Stimulation (TAPS™) targeting median and radial nerves at the wrist

- Session Duration: 40 minutes, twice daily

- Tremor Relief: On average, tremor relief lasts over 90 minutes after a session (SD 138 min; median 60 min)

- Personalization: Device calibrated to each patient's dominant tremor frequency (typically 4–12 Hz) via wrist-worn accelerometer

- FDA Status: De Novo cleared (2023); 510(k) cleared for kIQ Plus (K253587, April 2026)

Cala kIQ® Plus (Next Generation — 2026)

- New Features: Adaptive calibration, new therapy modes, enhanced personalization

- Clinical Data: Improved efficacy with therapy modes; increased responder rates and bilateral tremor improvement demonstrated in clinical studies

- Presentation: Data presented at American Academy of Neurology (AAN) 2026 in Chicago (April 18–22)

Digital DME Platform

- Direct-to-Home Delivery: Prescription therapy delivered through a digital durable medical equipment (DME) platform

- MyCala Patient Portal: Secure online portal for patients to view therapy data, track results over time, and share reports with clinicians

- Telehealth Integration: Companion dashboard for remote clinical monitoring

Clinical Evidence

PROSPECT Trial (Landmark Study)

- Design: Largest trial ever conducted for essential tremor; 263 patients at 26 sites; single-arm prospective study

- Duration: 3 months of repeated home use

- Primary Outcomes: 68% of patients showed significant improvement in hand tremor on ADL assessment scale; post-stimulation tremor ratings significantly better than baseline (P < .0001)

- Underlying Tremor Improvement: Retrospective analysis (February 2026) showed BF-ADL underlying scores improved by 2.0 points at one month and 2.7 points at three months (P < 0.001); over 80% of patients met responder criteria on both ADL and TETRAS scales

Sham-Controlled Pilot Trial

- Publication: Movement Disorders, 2018

- Results: Noninvasive neuromodulation resulted in significant improvement in tremor severity as assessed by blinded spiral-drawing tasks

Home-Use Study

- Publication: Frontiers in Neuroscience, 2020; Tremor and Other Hyperkinetic Movements, 2020

- Results: 80% of essential tremor patients demonstrated improvement in tremor severity lasting at least 60 minutes after therapy; more than 70% showed sustained reductions in tremor power across motor tasks

Real-World Evidence

- Data: Published March 2026 affirming benefit to essential tremor patients who used Cala kIQ at home over several months

- Outcomes: Consistent with pivotal PROSPECT study findings

Regulatory & Reimbursement

- FDA De Novo (2023): Cala kIQ System for essential tremor and Parkinson's disease hand tremor

- FDA 510(k) (April 2026): Cala kIQ Plus (K253587) — next-generation system with adaptive calibration and new therapy modes

- Medicare: Local Coverage Determination (LCD) approved; covered for qualifying beneficiaries who meet Local Coverage Criteria

- Veterans Affairs (VA): Available at no cost to eligible VA beneficiaries

- Commercial Payors: Ongoing advocacy to secure additional coverage and reimbursement in Medicare Advantage and commercial insurance plans

Financial Performance & Funding

Funding History

- Grant (2013): $35K

- Series A (2014): Completed

- Series B (2016): Completed

- Series C (2019): Completed

- Series D (2021): Completed

- Series BB: Completed

- Growth Capital (August 2024): $50 million from Trinity Capital Inc.

- Series C (March 2025): $50 million

- Total Funding Raised: Approximately $263 million

Key Investors

- GV (Google Ventures): Venture capital investor

- Lightspeed Venture Partners: Venture capital investor

- Johnson & Johnson Innovation: Corporate venture capital

- Trinity Capital Inc.: Growth capital provider (2024)

- Alumni Ventures: Venture capital investor

- Kirin Health Innovation Fund: Corporate venture capital

- Nexus NeuroTech Ventures: Venture capital investor

- Octant Ventures: Venture capital investor

- Pegasus Tech Ventures: Venture capital investor

- Total Investors: 36 investors

Company Overview

Corporate Information

Legal Name: Cala Health, Inc.

Founded: 2013

Headquarters: San Mateo, California, USA

Company Type: Privately held

Industry: Bioelectronic Medicine / Wearable Neuromodulation / Therapeutic Devices

Employees: 102 (as of 2026)

Estimated Annual Revenue: $5.0–25 million

Website: calahealth.com

Leadership Team

Chief Executive Officer & President: Deanna Harshbarger (appointed January 2024)

- Leads corporate strategy, commercial expansion, and investor relations

Founder: Kate Rosenbluth, PhD

- Neuroscientist; Stanford Biodesign spinout founder

Competitive Landscape

Key Competitors

- Fasikl: University of Minnesota spinout; FDA-cleared tremor-targeted neuromodulation wrist device using closed-loop AI-guided stimulation

- Medtronic: Implanted DBS for movement disorders (not wearable)

- Boston Scientific: Implanted DBS for movement disorders (not wearable)

- Neuspera: Neuromodulation competitor

- Allevion Therapeutics: Neuromodulation competitor

- Neuromonics: Neuromodulation competitor

- ShiraTronics: Neuromodulation competitor

- MicroTransponder: Neuromodulation competitor

- GYROGEAR: Tremor-canceling gloves

- Trequant: Wearable tremor therapy competitor

Competitive Advantages

- First-Mover: Only FDA-cleared wearable neurostimulation device for both essential tremor and Parkinson's disease hand tremor

- Noninvasive Alternative: Drug-free, surgery-free option positioned between pharmacologic therapy and invasive DBS surgery

- Strong Clinical Evidence: Largest ET trial ever conducted (PROSPECT, 263 patients); published in peer-reviewed journals; real-world evidence supporting efficacy

- Reimbursement Progress: Medicare coverage and VA availability remove major financial barriers for core patient demographic

- Platform Expandability: TAPS technology applicable to other peripheral nerve indications including dystonia, chronic pain, anxiety, and cardiology

- Digital DME Model: Direct-to-home prescription delivery platform with patient portal and telehealth integration

2026 Strategic Outlook

- kIQ Plus Launch: Commercialize the next-generation Cala kIQ Plus system with enhanced therapy modes and adaptive calibration

- Clinical Evidence: Present latest kIQ Plus data at AAN 2026 and continue publishing peer-reviewed evidence to support reimbursement expansion

- Reimbursement Expansion: Secure additional coverage in Medicare Advantage and commercial payor plans

- Platform Expansion: Explore TAPS technology applications beyond tremor, including peripheral neuropathy pain, anxiety, and cardiology indications

- Market Penetration: Target the 7+ million essential tremor patients and 1+ million Parkinson's tremor patients in the U.S.

Contact Information

Global Headquarters

Address: San Mateo, California, USA

Website: calahealth.com

LinkedIn: Cala Health on LinkedIn

Investor Relations

Contact: Trinity Capital Inc. (growth capital partner)

Website: www.trinitycap.com

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