Cala TAPS Therapy is Now Covered by Medicare for Essential Tremor Patients, And Company Appoints CEO and President

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Jun 10, 2024, 09:00 ET

SAN MATEO, Calif., June 10, 2024 /PRNewswire/ -- Cala, the bioelectronic medicine leader, reached a major milestone: a positive Medicare Local Coverage Determination for the Cala TAPS (Transcutaneous Afferent Patterned Stimulation) Therapy for essential tremor (ET) from the Centers for Medicare & Medicaid Services (CMS): External Upper Limb Tremor Stimulator Therapy L39591. Medicare beneficiaries who qualify under the new coverage guidelines now have access to Cala TAPS therapy to treat their hand tremor.

Cala Appoints CEO and President

Cala announced the appointment of Deanna Harshbarger as Chief Executive Officer (CEO) and as a member of the Company's Board of Directors, effective immediately. Concurrently, Cala has appointed Founder Kate Rosenbluth as President and Chief Innovation Officer (CIO). Kate continues to serve on the Board of Directors. Both were instrumental in leading Cala to the current reimbursement milestone for positive Medicare coverage.

Deanna brings over 20 years of experience and leadership in the global medical device space, having the ideal blend of expertise across the entire business continuum, from early product development to successful commercialization in movement disorders, neuromodulation and durable medical equipment. Prior to her most recent role as Chief Product Officer at Cala, Deanna served in leadership positions at Medtronic Diabetes, Boston Scientific Neuromodulation, and Johnson & Johnson. She is known for building businesses, developing winning technology portfolios, and guiding strategic acquisitions.

"Deanna's extensive commercial leadership in the movement disorders space, strategic view on the care continuum, and her ability to foster a winning team culture are ideal. I am confident she is the right CEO to lead Cala in this next chapter of accelerated growth and market adoption" said Stacy Enxing Seng, Board Chair, Cala Health. "Additionally, we are pleased Kate, as President and CIO, will continue to bring her vision and scientific prowess to trailblaze the next phase of development for Cala's disease state and technology pipeline."

"I have worked with Kate and the Cala team for the past three years. We are passionately committed to improving our therapy and developing new products that transform care for patients," said Deanna Harshbarger, CEO, Cala. "I am excited to be serving as the CEO for Cala as we significantly expand access of Cala TAPS Therapy to Medicare patients who represent approximately 75% of the ET population."

"It is exciting to see how the strong and broad clinical evidence for TAPS Therapy has opened doors for patients to treat their tremor. TAPS Therapy makes essential daily activities such as eating, drinking, writing, and self-care feasible," said Kate Rosenbluth, President and CIO, Cala. "Cala is committed to innovation that improves patients' lives and looks forward to continuing on that journey."

ET impacts over 7 million people in the United States and is characterized by uncontrollable movement that can make critical daily activities very difficult.

Drugs are most used to treat ET, but they can cause a range of unwanted side effects such as fatigue, nausea and depression and may not provide desired outcomes. Surgical options like Deep Brain Stimulation or Focused Ultrasound ablation can be effective but are invasive procedures that carry the risk of potentially irreversible side effects.

The Cala kIQ System with TAPS (Transcutaneous Afferent Patterned Stimulation) Therapy is the only non-invasive, FDA-cleared, wearable device that delivers effective therapy for action hand tremor relief in people with essential tremor and Parkinson's disease. The TAPS device is physician-prescribed and clinically proven to safely and effectively reduce action hand tremors. The Cala kIQ device treats tremor by sensing each patient's unique tremor signature and delivering individualized stimulation to the nerves on the wrist that then reach the brain to counteract tremor.

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.

SOURCE Cala Health