In August, Cala Health Inc. reported results from its pivotal PROSPECT study showing significant improvement in hand tremors with use of its Cala Trio wearable neuromodulation therapy. Now the company has real-world evidence affirming the benefit to patients with essential tremor (ET) who used Cala Trio at home over several months.

The multicenter PROspective study for SymPtomatic relief of Essential tremor with Cala Trio (PROSPECT) trial evaluated Cala Trio in 263 patients who used the wrist-worn device twice daily for three months. The therapy – which gently stimulates the nerves in the wrist to disrupt tremulous activity in the brain – met both its co-primary and secondary endpoints with 62% and 68% of “severe” or “moderate” patients seeing their tremor amplitude reduced to “mild” or “slight, measured using the validated physician-rated scale and validated patient-rated Bain & Findley Activities of Daily Living, respectively. The results were described in Tremor and Other Hyperkinetic Movements.

Real-world results

When used by 44 patients at home for three months, outside a controlled clinical environment, Cala Trio produced similar results, with 57% of patients achieving at least a two-fold improvement in their tremor. “Really importantly, when we cut the data to look at the times when patients were using therapy during their most severe tremors, nine out of 10 subjects improved at least two-fold,” Kate Rosenbluth, Cala Health’s founder and chief scientific officer, told BioWorld.

Additionally, of 18 patients who completed a survey after using Cala Trio for 90 days, 61% said their ability to eat, drink and write was improved and 56% reported better quality of life.

Patients with ET often face the choice of living with tremors that negatively affect their lives or risking unwanted side effects from drug therapy, Rosenbluth said. “As a bioelectronic alternative, Cala Trio offers a new approach for managing tremors without the systemic side effects of pharmacologic treatments or the brain surgery needed for implanted devices. The real-world evidence presented at MDS shows that excellent outcomes can be achieved with Cala Trio and that the device is easy for patients to use in their everyday lives.”

The Burlingame, Calif.-based bioelectronic medicine company reported the real-world evidence in a poster presentation at the International Parkinson and Movement Disorder Society’s MDS Virtual Congress 2020, being held Sept. 12-16.

Patient-centered feedback

The company is also seeing value from information collected on the device, which measures the physiology of patients’ tremors before and after use of the therapy.

“One of the really beautiful things about our product is that it’s a prescription device, it’s used by a patient on demand and we actually measure the efficacy of the device using motion sensors that are on board the device itself,” Rosenbluth said.

The PROSPECT study captured nearly 22,000 individual data points, depicting the efficacy of every session by every dose by every patient. Being able to capture and measure efficacy on a per patient basis enables patients and their caregivers to understand how the therapy works for them so that they can use it “in the best possible way,” she added.

The U.S. FDA granted de novo status for Cala One in April 2018 for transient relief of hand tremors in adults with ET. Later that year, the agency cleared the company’s electrode that was incorporated into Cala Trio.

Little COVID-19 impact

The company began a limited release of the device in the U.S. last summer, focusing on specific geographic markets with its sales and marketing resources, Rosenbluth said. It is now receiving prescriptions from doctors and patients nearly all 50 states.

Calla Health’s business strategy provides patients a prescription therapy with the convenience of consumer electronics by serving as a direct distributor. That model, and the loosening of restrictions on telehealth use, have served it well during current pandemic.

“We’re doing everything from receiving a prescription to drop shipping products to patients’ doorsteps and assisting them in the use of the therapy and supporting their journey,” Rosenbluth said. “When COVID-19 began, almost overnight we saw a shift in where prescriptions were coming from. While previously most of our prescriptions had been from an in-person appointment between a patient and their doctor, I was just so impressed with patients’ resilience in how fast some of those prescriptions started coming in by telemedicine.”

The company is currently working with Medicare and other payers to secure reimbursement for its neuromodulation therapy, Rosenbluth said.

Cala Health has raised a total of $71.3 million to advance its technology, most recently in a $50 million series C round that closed in May 2019. Those funds were earmarked for introducing Cala Trio for patients with essential tremor and growing the company’s therapeutic pipeline.

The company has its eye on additional targets in neurology, as well as other fields including psychiatry and cardiology, but has not revealed specific therapies that it’s working on.

In March 2019, the company licensed technology from Partners Healthcare innovation and its affiliate, Massachusetts General Hospital, to enhance its noninvasive neuromodulation platform. The partnership – which involves technology developed at MGH from research on transcutaneous vagus nerve stimulation and respiratory-gated vagal afferent nerve stimulation – is active and moving forward, Rosenbluth said.

“We’re making great progress. We’re continuing to collect clinical evidence and advance that technology as well.”

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