BURLINGAME, Calif.--(BUSINESS WIRE)--Cala Health, Inc., a bioelectronic medicine company developing wearable therapies for chronic disease, today announced that data from its landmark PROspective study for SymPtomatic relief of Essential tremor with Cala Therapy (PROSPECT), was published in Tremor and Other Hyperkinetic Movements. This important study demonstrated that the company's FDA cleared, neuromodulation therapy, Cala Trio™, repeatedly used at home over three months resulted in safe and effective hand tremor reduction and improved quality-of-life for adults with essential tremor (ET). Additionally, Cala Health added to its strong management team with the appointment of industry veterans Ali Samiian, Head of Market Access and Reimbursement, and Bobby Thomas, Vice President, Digital.
As the largest therapeutic clinical trial in ET, the PROSPECT study (NCT03597100) enrolled 263 patients across 26 sites. Study patients used the therapy twice daily for three months – overall, collecting more than 21,000 stimulation sessions. The unique study met both its co-primary and secondary endpoints with 62% and 68% of 'severe' or 'moderate' patients improving their tremor amplitude to 'mild' or 'slight,' measured using the validated physician-rated scale (TETRAS) and validated patient-rated Bain & Findley Activities of Daily Living (BF-ADL), respectively. Clinical and Patient Global Impression scores showed 68% of clinicians and 60% of patients reported improvement in the severity of their tremors. In Quality of Life in Essential Tremor (QUEST) surveys conducted after three months of use, patients indicated their quality of life improved (p=0.0019). This manuscript includes all data previously presented at recent clinical meetings.
"ET is one of the most common movement disorders among adults. It can be physically and psychologically draining while reducing the quality of life for these patients," said Renee Ryan, Chief Executive Officer of Cala Health. "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. 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."
In the last few months, Cala has expanded the experience and talent of the management team, adding Ali Samiian as Head of Market Access and Reimbursement and Bobby Thomas as Vice President, Digital. In these newly created positions, Ali and Bobby will contribute to the company's mission to deliver breakthrough bioelectronic therapies to people living with chronic disease and build on Cala's vertically integrated commercial model.
Before joining the Cala team, Ali spent over 15 years at Novartis and Abbott Diabetes Care in commercial and reimbursement roles of increasing responsibility, most recently, serving as Director of Marketing, US Market Access for Freestyle Libre. In this role, as part of the Global Market Access team, Ali was integral in securing reimbursement for this novel diabetes monitoring system, which has revolutionized the glucose monitoring market.
Bobby has more than 25 years of experience transforming payor, healthcare business processing, surgical robotics, and consumer healthcare journeys. His previous roles include 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.
"The recent hiring of Ali and Bobby adds tremendous depth to the team to pursue US reimbursement and expand our digital solutions. We have been able to further our business goals, grow the team all while working during a very tumultuous time," added Ryan.
About Essential Tremor (ET)
Essential Tremor (ET) is the most prevalent tremor disorder and one of the most common neurological disorders, affecting an estimated seven million people in the United States. It is a chronic condition that causes involuntary and rhythmic shaking and typically worsens over time. ET can affect almost any part of the body, but the trembling most often occurs in the hands, making everyday activities such as eating, writing, or getting dressed extremely difficult. ET is often confused with Parkinson's disease, although it is eight times more common. A key difference is that hand tremors caused by ET happen with goal-directed movement (with intention), whereas Parkinson's disease tremors occur mostly at rest. Current ET treatments include mostly off-label use of medications or brain surgery.
About Cala Trio™
Cala Trio™ is the first non-invasive targeted therapy that reduces hand tremors for adults living with Essential Tremor (ET). Prescription therapy is a simple, wrist-worn device that is calibrated to treat a patient's unique tremor symptoms. When activated, Cala Trio gently stimulates the nerves in the wrist to disrupt the tremulous activity in the brain, without the need for invasive brain surgery or medication. The easy-to-use and effective Cala Trio can be prescribed through an in-person consultation or telemedicine appointment. Therapy is conveniently delivered to the patient's home, and Cala Health educates patients based on how they learn—phone, video, user portal.
About Cala Health, Inc.
Cala Health, an award-winning bioelectronic medicine company, is transforming the standard of care for chronic disease while putting patients first. 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 Health's lead product, Cala Trio™, is the only non-invasive, wrist-worn prescription therapy for essential tremor. New therapies are under development in neurology, cardiology, and psychiatry. Cala Health is headquartered in the San Francisco Bay Area and backed by leading investors in both healthcare and technology. For more information, visit CalaHealth.com.