US-based bioelectronics company Cala has launched the Cala kIQ System, the first FDA-cleared wrist-worn device to deliver therapy for action hand tremor, which occurs when the patient undergoes intentional movement or posture, affecting people with essential tremors and Parkinson’s disease.
The Cala kIQ System senses each patient’s unique tremor signature and individualises stimulation via transcutaneous afferent patterned stimulation (TAPS). The stimulation non-invasively counteracts the tremor through the neurons on the wrist.
TAPS is validated by clinical studies and real-world evidence, which demonstrate clinically reduced tremor and improvement in activities of daily living.
The PROSPECT study is one of the largest clinical trials in essential tremor. It included 263 patients enrolled across 26 sites in the US and demonstrated improvement in 92% of patients. Further, 52% improved more than two-fold. Real-world evidence shows that TAPS reduces tremors in people using the therapy.
Millions of people across the US live with essential tremor or Parkinson’s disease, and diagnoses continue to rise. Historically, patients have been treated with medications or, in more severe cases, surgery.
Side effects from medications are often undesirable, and some patients are not able to use medications due to contraindications and comorbidity. One study showed that 35% of patients discontinue medication due to side effects or lack of benefit.
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Surgery options such as deep brain stimulation and ablation can be very effective but are invasive. Many patients do not wish to go down this path. The Cala kIQ System offers a non-invasive, non-pharmacologic solution with minimal side effects.
Accessed via prescription, Cala ships the product to the patient and supports them in its use. While administering the TAPS therapy on the wrist, the system offers online data insights through the MyCala.com patient portal. Patients can see their therapy session results over time and choose to share them with healthcare providers to adjust treatment plans.
The device is only available in the US so far, but Cala is hoping to expand globally in the future. According to GlobalData, the global wearable technology market is expected to register a compound annual growth rate of 19% from $22bn in 2018 to $54.4bn in 2023.
Cala founder and chief scientific officer Kate Rosenbluth spoke to Medical Device Network about the future for Cala: “While being focused mainly on action tremor, Cala is currently running exploratory studies in other areas of neurology, psychiatry and cardiology.
“Cala is a bioelectronic medicines company and the wearable neuromodulation therapy is more broadly merging innovations and neuroscience technology to deliver this new class of therapies. In the future, we believe these technologies as well as our service model, the direct-to-home digital durable medical equipment platform, will impact many patients with other diseases.”
In November 2021, Cala raised $77m in a funding round led by Ascension Ventures, which it planned to use to explore indications beyond essential tremor.