SAN MATEO, Calif.--(BUSINESS WIRE)--Cala Health, the bioelectronic medicine leader setting a new standard of patient care for chronic disease, announces two research studies to be presented at the American Academy of Neurology’s (AAN) Annual Meeting on April 2-7, 2022, in Seattle.
The retrospective real-world analysis, titled “Increased Healthcare Cost and Mental Health Burden Among Patients with Essential Tremor: A Retrospective Observational Study in a Large U.S. Commercially Insured and Medicare Advantage Population,” sought to compare changes to comorbidities, psychiatric disorders, healthcare resource utilization (HCRU) and healthcare costs (HCCs) in patients with and without essential tremor (ET). Key findings include (for ET vs. non-ET patients):
- A higher mean of total healthcare costs ($17,560 vs. $13,237)
- A higher mean number of comorbidities (5.3 vs. 4.0)
- A higher prevalence of depression (25.6% vs. 15.3%), anxiety (27.7% vs. 15.5%) and total psychiatric disorders (45.9% vs 31.1%)
While ET has traditionally been regarded as a benign condition, this retrospective, observational study clearly demonstrated that ET is associated with a significant burden to patients and the healthcare system. Multiple comorbid conditions and psychiatric disorders are highly prevalent among patients with ET compared with non-ET patients. Additionally, ET patients use significantly greater HCRU and demonstrate increased HCCs compared to matched non-ET patients suggesting additional therapies are needed to address the unmet needs in this population of patients.
“Essential tremor patients – in addition to having to manage a debilitating condition – are shown to pay higher healthcare costs, have more chronic conditions, and suffer from more mental health challenges than patients without ET,” said Ali Samiian, senior director of reimbursement at Cala and one of the researchers of the study. “This latest research further demonstrates the need for better therapeutic offerings for this population. We are dedicated to improving patients’ quality of life and expanding access to our clinically proven treatment for ET, Cala TAPS therapy.”
Another study presented at AAN, titled “Transcutaneous Afferent Patterned Stimulation Provides Upper Limb Motor Symptom Relief in Parkinson’s Disease Patients,” was designed to investigate the efficacy and safety of non-invasive transcutaneous afferent patterned stimulation (TAPS) to reduce postural and kinetic tremors in PD patients. TAPS is a neuromodulation therapy that uses surface electrodes for calibrating and delivering stimulation to peripheral nerves in the wrist resulting in tremor reduction. This investigational research in patients with PD found that:
- TAPS reduced postural tremor power by 66% from pre- to post-stimulation
- Bain and Findley Activities of Daily Living scores – which measure functions such as holding a cup or writing – improved by 0.5±0.5 and 0.3±0.4
- At study exit, clinicians observed symptom improvement in 83% of patients, and 81% of patients reported perceived symptom improvement
- Objective, clinician, and patient-rated outcomes demonstrate that TAPS improved upper limb action tremor symptoms in patients with PD
Cala TAPS therapy is not currently indicated for treating hand tremor in Parkinson’s Disease patients. Cala was granted breakthrough device designation for TAPS therapy in Parkinson’s disease patients, and these data will be submitted for U.S. FDA review.
About Cala Health
Cala 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 vertically integrated commercial model is reshaping the delivery of prescription therapies. Cala’s lead product, Cala Trio™ therapy, is the only non-invasive prescription therapy for essential tremor. New therapies are under development in Parkinson’s disease and other indications in neurology, as well as targets in psychiatry, cardiology, and autoimmune disorders. The company is headquartered in the San Francisco Bay Area and backed by leading investors in both healthcare and technology.
Indication: Cala Trio therapy is indicated to aid in the temporary relief of hand tremors in the treated hand following stimulation in adults with essential tremor.
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://calatrio.com/Safety.