Bioelectronic company Cala Health released positive data from its ongoing PROSPECT trial demonstrating that a majority of patients using its FDA-cleared Cala Trio device reported a reduction in hand tremors.
The study — published in Tremor and Other Hyperkinetic Movements — enrolled 263 patients with essential tremor across 26 sites. Patients wore the Trio on their wrist and used the therapy twice daily, initiating more than 21,000 stimulation sessions. According to Cala, the study met both its co-primary and secondary endpoints with 62% and 68% of severe or moderate patients seeing improvements in their tremors.
“The PROSPECT study publication confirms that Cala Trio therapy is a safe and effective treatment option and, most importantly, shows the improved quality of life for these ET patients,” said Cala Health CEO Renee Ryan in a news release. “These findings, consistent with those demonstrated in previous trials against sham, will be leveraged to support our reimbursement initiatives, leading to improved access for patients living with essential tremor.”
The Burlingame, Calif.-based company also announced additions to its executive team. Ali Samiian joined the company as head of market access and reimbursement, and Bobby Thomas as vice president, digital.
Samiian joined Cala after spending 15 years at holding commercial and reimbursement roles at Novartis and Abbott Diabetes Care. He most recently served as director of marketing, U.S. market access for Freesytle Libre, where he helped secure reimbursement.
Thomas brings more than 25 years of experience as CTO at Navigating Cancer, VP of digital architecture and engineering at Intuitive Surgical, and chief architect/director of applications architecture at Blue Shield of California.
In an interview to be broadcast in this Friday’s DeviceTalks Weekly podcast, Ryan says the company has had a successful commercial rollout. Early on, Cala anticipated 2% penetration into neurologists’ offices, Ryan said, but actually built inroads into twice that amount.
“Doctors are seeing these patients and they are willing to prescribe a new therapy for these patients,” she said.
Ryan said Cala will move ahead with the commercial launch and additional studies. The company could be ready to raise a new round of capital later next year, she added.