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Cala Health has developed a product to treat a massive unmet need in medicine
In the United States, it’s estimated that 2.2% of the population suffers from essential tremor (ET). This condition, much like Parkinson’s Disease, causes involuntary shaking, particularly in the hands, but ET is much more widespread. It affects around 7 million people, where Parkinson’s affects an estimated 0.5 to 1 million (NCBI).
Until recently, there were only two ways to treat ET: a beta blocker pill or deep brain stimulation, which requires a surgical implant. But California-based Cala Health is introducing a new treatment method with its electrotherapy-based nerve stimulating wristband, the Cala Trio.
Cala Health Founder and Chief Scientific Officer Kate Rosenbluth shared the story of how the company was conceived during Jumpstart’s conversation with her during the 2020 Collision conference in late June.
As a Biodesign Innovation Fellow at Stanford University, she was expected to shadow doctors and nurses and observe patients’ needs. When she came across patients with ET, she was immediately struck by how desperate many of the patients were for therapy, and how few options were available to them.
“I remember one gentleman in particular who […] had just learned that he was not a candidate for brainstem stimulation because of some other medical conditions that he had,” says Rosenbluth.
After hearing the man’s experience–he was desperate because no other therapies were working and the condition was severely affecting his quality of life–she realized that treatment for ET is vastly underprovided considering how widespread the condition is.
Using her background in neurosurgery, doctorate degree in bioengineering, and her biodesign fellowship, Rosenbluth conceptualized a new way of treating ET. It would use a wearable device and the natural circuitry of the nervous system to electrically stimulate the specific part of the brain that causes tremors.
“While having a physician-managed prescription therapy, we are able to give the patient an experience that’s actually much more like receiving a Fitbit or receiving an Apple Watch,” she explains.
Over six years, Rosenbluth’s team underwent a rigorous product development process. After mapping the body’s neural circuitry and developing its therapeutic approach, the company ran two clinical trials before receiving special FDA clearance through a backdoor for novel therapies called the De Novo classification. The end product, the Cala Trio, is now available commercially in the U.S. with a prescription, and the company wrapped one of the largest studies ever run on ET in September 2019.
Cala is unique in that it sits at the intersection of multiple industries, integrating medicine, pharmaceutics, wearables, and even AI. Having just run a study of 263 patients at 26 sites, the company has accumulated valuable datasets to better serve patients. The company’s appeal is also reflected in its investors, which include Novartis, Johnson & Johnson Development Corp, Google, and Qualcomm.
“I just think that sort of speaks to the sectors that we’re having to bring together in that sort of business model, and in that journey to deliver novel medical devices with a business model that actually feels a lot more like a pharmaceutical or tech wearables model,” she says.
While Cala Health is also working on developing therapies for other conditions, it continues fine-tune its approach for Trio, preparing for more clinical studies, and working to make it eligible for insurance coverage. Rosenbluth says the company has seen more prescriptions come in from May to June 2020 than in the history of the company, part of what she says is a meteoric acceleration in the healthtech space.
“Uniquely, I’d say healthcare has advanced 10 years in the past few months […] Some of the shining stars have been things like telemedicine,” she says. “It has actually moved tremendously fast, and that genie’s not going back in the bottle.”
Using needs-driven innovation, Cala Health is trying to make its therapy as accessible and functional as possible through its direct-to-consumer model and fresh approach to treating ET. It’s a hopeful indication that slowly but surely, other novel therapies will make strides into the mainstream, and be distributed to the people who need them.