Cala Health - Most Innovative Company of the Year

Company: Cala Health, Burlingame, CA
Company Description: Cala Health Inc., an award-winning bioelectronic medicine company, is transforming the standard of care for chronic disease. Cala’s wearable neuromodulation therapies utilize electricity as medicine, merging innovations in neuroscience and technology to deliver individualized peripheral nerve stimulation, while its vertically integrated commercial model is transforming prescription therapies.
Nomination Category: Company/Organization Awards Categories
Nomination Sub Category: Most Innovative Company of the Year – More Than 10 Employees

Nomination Title: Cala Health

Cala Health is the first to use electricity as medicine to harness the power of the body's nervous system via a wearable, data-driven, individualized treatment that positively impacts the lives of those with chronic movement disorders. Cala Trio™, the company's flagship product, is the only FDA-cleared, non-invasive neuromodulation treatment to deliver customized therapy for essential tremor. A chronic nervous system disorder causing involuntary rhythmic shaking primarily in the hands, essential tremor affect 25 million people globally. Until now, the only treatment options were partially effective pharmacotherapies or brain surgery. By combining advanced scientific research with transformative technologies to solve this challenging healthcare need, Cala empowers those living with chronic movement disorders to take control of their lives by providing a tailored treatment plan in a device that fits seamlessly into the patient's lifestyle. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8035980/#:~:text=The%20total%20number%20of%20people,our%20prevalence%20estimate%20of%200.32%25.

Cala Health was established in 2014 by Kate Rosenbluth. As a Stanford Biodesign Fellow, she was captivated by the large unmet need to treat hand tremors and began researching this complex neurological disorder. Kate and her team introduced Cala Trio to the US market in 2019 and are committed to expanding the applications of wearable neuromodulation therapies for patients living with common chronic diseases.

Cala Trio was awarded the 2019 North American Technology Innovation Award, presented by Frost & Sullivan, in January 2020. The award was granted to Cala Trio for its innovative design enabling users to effectively treat essential tremor with minimal side effects. Cala Trio delivers precise electrical pulses to the peripheral nerves in the wrist, which in turn target the brain's central tremor network to address the underlying cause of the disorder. The award is presented annually to a company that has developed a product with innovative features and functionality that is gaining rapid acceptance in the market.

In October 2020, the FDA granted Breakthrough Device Designation to Cala Trio to treat action tremors in the hands of adults with Parkinson's disease. Breakthrough Device Designation is granted to specific medical devices with the potential to provide a more effective treatment for life-threatening or irreversibly debilitating diseases. The program aims to give patients and HCPs timely access to medical devices by speeding up their development, assessment, and review while preserving the standards for premarket approval.

In June 2021, Cala Health announced a partnership with the University of California, San Francisco (UCSF) to develop non-invasive, individualized, peripheral nerve stimulation therapies that leverage Cala Health's neuromodulation and data science platform technology. The partnership intends to advance non-invasive treatments for serious neurological conditions; it also broadens Cala Health's research on novel individualized therapies and the integration of data to advance a software-enabled future that delivers tailored treatment to patients.

The achievements listed above demonstrate Cala Health's leading position in the world of wearable neuromodulation devices for movement disorders. Described as "a pioneer in treating essential tremor" by an industry analyst at Frost & Sullivan, Cala Health has set itself apart from the competition. Being both non-pharmaceutical and non-invasive, Cala Trio leverages its digitally connected ecosystem to treat essential tremor effectively, safely, and with minimal side effects and no recovery time.

The 2019 Innovation Award granted to the Cala Trio demonstrates the quality of the device and the value it brings to those living with chronic movement disorders. The therapy is a more convenient method of managing the condition without systemic side effects, as compared to pharmacological treatments. Cala Trio is cost-effective compared to surgical procedures, involves no post-op recovery, and allows patients to control the pulse intensity based on their comfort level.

The award was granted following the PROSPECT study, in which physicians, patients, and objective motion sensors reported statistically significant improvement in tremor after three months of daily use.

The Breakthrough Device Designation demonstrates Cala's advancements in the significant unmet medical need that is Parkinson's treatment. The disease remains challenging to treat and impacts the daily activities and overall quality of life of patients. The FDA recognized Cala Trio as a novel and effective treatment for Parkinson's.

The partnership with UCSF demonstrates Cala's commitment to improving and expanding non-invasive treatments for serious neurological conditions.

Cala Health has extensive clinical evidence supporting Cala Trio’s efficacy and safety (reference 1). Cala Health conducted the largest therapeutic clinical trial in ET, the PROSPECT study, using the Cala Trio, which showed that the Cala Trio has similar efficacy to traditional ET treatment options while avoiding common side effects and risks associated with prescription medication. In the study, Cala Trio delivered significant tremor reduction in clinician-rated, patient-rated, and objective accelerometer measurements.

Cala Trio delivers non-invasive peripheral nerve stimulation, also referred to as transcutaneous afferent patterned stimulation (TAPS) that lasts beyond the immediate stimulation, due to changes in metabolic brain activity (reference 2). Insights from core research drive therapy and product development every step of the way.

Kate Rosenbluth (reference 3), founder and Chief Scientific Officer of Cala Health, is an engineer and neuroscientist who previously worked on cutting-edge neuro therapies at Stanford Biodesign, UCSF Neurosurgery, Brainlab, Autonomic Technologies, and Genentech, which eventually led to the development of Cala Trio.

Renee Ryan (reference 4), Cala Health's CEO, has over 25 years of building category-creating healthcare companies. She led the medical technology investments for Johnson & Johnson Innovation (JJDC) on the West Coast and Asia Pacific for eight years, investing $800 million in 16 companies, including the Series A funding for Cala Health. Previously, she was a healthcare investment banker at RW Baird, Jefferies, and Goldman Sachs.

https://tremorjournal.org/articles/10.5334/tohm.59/

https://tremorjournal.org/article/10.5334/tohm.565/

https://calahealth.com/team/kate-rosenbluth/

https://calahealth.com/team/renee-ryan/

https://www.prnewswire.com/news-releases/cala-health-applauded-by-frost--sullivan-for-revolutionizing-the-essential-tremor-market-with-its-body-worn-neuromodulation-therapy-cala-trio-300983998.html

https://www.businesswire.com/news/home/20201022005276/en/Cala-Health-Receives-FDA-Breakthrough-Device-Designation-for-Cala-Trio%E2%84%A2-Therapy-to-Treat-Action-Tremors-in-Parkinsons-Disease

https://www.businesswire.com/news/home/20210617005048/en/Cala-Health-and-University-of-California-San-Francisco-Announce-Partnership-to-Develop-Next-Generation-Smart-Neuromodulation-Therapies