Cala Heath, Inc. is a bioelectronic medicine company that develops non-invasive neuromodulation therapies for chronic diseases through wearable devices. Their lead product, Cala Trio™ is FDA approved to treat essential tremor (ET), a neurological disorder that causes patients to experience involuntary rhythmic shaking in their hands, legs, head, trunk, or voice.
ET is a progressive disease. Symptoms typically begin to appear when a person is in their 40s, and worsen with age. ET is a non-fatal diagnosis, however, symptoms can drastically hinder a person’s quality of life. The cause of ET is unknown, but it is believed that it may be the result of miscommunication between the cerebellum (which controls motor function) and other parts of the brain. There is a clear hereditary component to ET; patients who have a parent with ET have a genetic predisposition, increasing their risk of developing the disease to 50%.
Cala Trio is calibrated specifically to each individual patient’s unique brain signaling pattern. The device is worn on the wrist, and delivers surface stimulation to the radial and median nerves. The stimulation is believed to target and disrupt the central tremor network in the ventral intermediate nucleus of the thalamus in the brain.
Prior to the development of Cala Trio, ET could either be treated with pharmaceuticals such as propranolol and primidone, or surgically with deep brain stimulation (DBS). However, both of these options come with the risk of negative side effects. ET medications may cause insomnia, fatigue, general weakness, erectile dysfunction, depression, chronic heart failure, bronchospastic pulmonary disease, constipation, dizziness, nausea, and vomiting. Risks following DBS surgery include mood changes, infection, sensations of numbness or tingling, speech, balance, and gait problems, and increased likelihood of having a stroke. Additionally, complications could occur during the surgery, leading to a stroke or stroke-like symptoms. In contrast to these options, Cala Trio offers patients relief from tremors without the negative side effects and risks.
In order to test the effectiveness of Cala Trio therapy, Cala Health sponsored the largest therapeutic clinical trial ever conducted for ET—the prospective study for SymPtomatic relief of Essential tremor with Cala Therapy (PROSPECT). The study measured per-patient tremor power—a calculation of motion amplitude and frequency—and found that 92% of patients had a reduction in tremor power upon home-use therapy sessions. 54% of these patients had a 50% reduction of tremor power, which is comparable to results seen from drug treatment, but without the negative side-effects. Additionally, some patients experienced 55-90% tremor reduction, similar to results seen in patients who underwent DBS, but without the risks of surgical complications or side-effects. None of the patients who used Cala Trio had any device-related serious adverse events. Some mild adverse events were reported, such as skin irritation and discomfort, but the risk for these reactions was minor and easily treatable. Furthermore, 68% of patients that had previously described their ET symptoms as either ‘severe’ or ‘moderate’ reported their symptoms as being ‘mild’ after treatment with Cala Trio. Even after a single 40-minute therapy session, 75% of patients experienced meaningful improvement.
Cala Trio is the first, and currently the only, non-invasive neuromodulation therapy that directly targets the source of patients’ tremors. As of November 2021, Cala Health received $77 million in new financing, led by Ascension Ventures, with the plan to explore indications beyond ET. Potential future indications for Cala Trio include Parkinson’s disease, a neurological condition that also involves involuntary tremor symptoms. Clinical trials for Cala Trio and Parkinson’s disease are being held virtually, and incorporate telehealth visits with a neurologist, which increases accessibility and allows volunteer participants to remain at home. In addition to Parkinson’s disease, Cala Health plans to explore indication targets in psychiatry, cardiology, and autoimmune disorders. Clinical trials of Cala Trio for Parkinson’s disease began in 2020, and are still underway.
Cala Health was founded by Kate Rosenbluth, an engineer and neuroscientist with extensive experience in developing breakthrough neurotherapies. Rosenbluth currently works as a Member of the Board of Directors and as Chief Scientific Officer of Cala Health, and previously worked as Chief Executive officer. Rosenbluth assembled a team of scientific experts, with expertise in medical devices, pharmaceuticals and technology.
Author
Lauren Elder 