Cala Health Enrolls First Patients in Landmark PROSPECT Study for Essential Tremor

Study will Evaluate Wearable Therapy Delivering Individualized Treatment for Hand Tremors

BURLINGAME, Calif., Dec. 17, 2018 (GLOBE NEWSWIRE) -- Cala Health, Inc, a neuromodulation platform company developing wearable therapies for chronic disease, today announced that the first patients have been enrolled in the PROspective study for SymPtomatic relief of Essential tremor with Cala Therapy (PROSPECT) at the University of South Florida Morsani College of Medicine, Tampa, Fla and the Keck School of Medicine of USC. The multi-center study will evaluate the effectiveness of Cala Health’s initial product, Cala TWO, in symptomatic relief of essential tremor (ET) in the hands.

PROSPECT is a prospective, multi-center, single-arm, study designed to evaluate the extended use of Cala TWO in symptomatic relief of essential tremors in the treated hand for a period of three months. The observational study will enroll hundreds of participants in 30 centers across the U.S. It will expand the evidence that enabled Cala Health’s therapy to become the first-ever non-invasive, targeted nerve stimulator for the treatment of ET to receive FDA marketing authorization in April 2018. During the study, patients will wear the compact device on their wrist like a smart watch and patterned electrical stimulation will be delivered to nerves through the skin twice per day. 

“People with essential tremor have their daily routine constantly disrupted and are looking for ways to control it,” said Mark Lew, MD, Professor of Clinical Neurology, and Director of the Division of Movement Disorders at the Keck School of Medicine of USC.  “Our study aims to explore electrical stimulation via wearable therapy in the hopes of providing relief for those experiencing essential tremor,” said Lew. 

“The PROSPECT study will expand our understanding of patient benefit of CALA TWO by studying its therapeutic effect over a three-month period,” said Theresa Zesiewicz, Professor of Neurology who leads the Ataxia and Frances Zesiewicz Foundation for Parkinson's Disease at the University of South Florida.  “This therapy holds the promise to increase accessibility of an effective, non-invasive treatment option for hand tremors.”

About Essential Tremor

ET affects over seven million Americans and millions more worldwide, making it one of the most common movement disorders and eight times more common than Parkinson’s disease. The condition is marked by hand tremors that make it difficult to perform daily activities like eating, drinking and writing.

People with ET have often given up on available medications due to harsh side effects and want an alternative to brain surgery and the associated risks.  The Cala Health therapy has already been used in an acute randomized controlled study that demonstrated benefit over sham in physician and patient-rated endpoints.

The PROSPECT study is expected to complete enrollment in 2019.

About Cala Health, Inc.

Cala Health is a neuromodulation platform company developing wearable therapies for chronic disease. The company is merging innovations in neuroscience and technology to deliver individualized, prescription wearable therapies. These therapies treat chronic disease non-invasively by stimulating peripheral nerves. The first indication for Cala’s wearable therapy will be Essential Tremor, a disease experienced by more than seven million people and characterized by severe hand tremors that impact daily quality of life.  Cala is further developing its technology for several other indications in neurology, cardiology and psychiatry.

The company is headquartered in the San Francisco Bay Area and backed by leading investors in both healthcare and technology.  For more information, please visit www.calahealth.com.  

For more information about Essential Tremor, visit the International Essential Tremor Foundation, www.essentialtremor.org.

Media Contact:

Terri Clevenger
terri.clevenger@icrinc.com
(203) 856-4326