Years ago, Kate Rosenbluth, PhD, watched as a neurosurgeon delivered the news to one of his patients that a pre-existing blood condition made him ineligible for deep brain stimulation surgery. The man had suffered from hand tremors for years, and drug therapies didn’t help. His condition caused constant challenges in his daily life, had forced his early retirement, and even made him embarrassed to meet with his friends, so this latest blow devastated him.
Witnessing the man’s disconsolate reaction to the news made Rosenbluth, a neuroscientist and engineer, wonder why the well-understood sort of brain stimulation that could offer the suffering patient the relief he sought couldn’t be administered without brain surgery. She decided then and there to find a solution. She teamed up with Scott Delp, PhD, Director of the Neuromuscular Biomechanics Laboratory at Stanford University, where she was a Biodesign Innovation Fellow, and founded Cala Health, Inc., based in the San Francisco Bay area, to do just that.
Electricity as medicine, or bioelectronics, is still a fairly new notion, but it has already been shown to be effective in certain applications. Now, for the seven to ten million Americans who, like the patient whose devastation Rosenbluth witnessed, suffer from essential tremor–a disorder of the nervous system that causes rhythmic shaking, most often in the hands–the solution that Cala Health innovated, a wearable bioelectronics device, may be their answer.
The company has represented the quintessential startup story along the way. “We were founded in 2014,” said Renee Ryan, Cala Health’s CEO. “The technology was developed while our founder was working at Stanford. We raised over $100 million in funding over four rounds, the most recent in November 2021. We started in only three test markets, and now we’re pushing national.”
The product itself is a wrist-worn device, the Cala Trio, that provides individualized treatment for essential tremor. It’s FDA-cleared and non-invasive. “It has three key components,” explained Ryan. “There’s a proprietary wristband. Then there’s a stimulator, which is an oval-shaped puck. Finally, there’s the base station that transmits data from the device to the cloud.” The Cala Trio device is available by prescription only, and is calibrated to each patient’s individual brain signal patterns, addressing the root cause of essential tremor through electrical stimulation known as neuromodulation. “We use a proprietary components and software algorithms, and added an off-the-shelf motion sensor. The frequency of the tremors at the hand match the oscillations in the brain.”
The device’s non-invasive nature offers huge benefits. “Previously, there have only been two treatment options,” Ryan said. “There’s drugs, which can have significant side-effects. And there’s surgery, which has a high risk of infection, along with serious side-effects and high costs.
The benefits have product demand surging, and Cala Health has been racing to keep up on the production side. “We expanded from a 2,000 square foot manufacturing floor to a 56,000 square foot space,” said Ryan. “We also signed up with a contract manufacturer so we can keep up as numbers get even bigger next year. We have the advantages that we don’t need clean rooms to produce them, we don’t use harsh chemicals, and we don’t use heavy equipment.”
The company is focused on two other critical objectives. “For the future, two things are important for us,” Ryan said. “The first is to expand patient access. The second is to expand the device’s labeling to include Parkinson’s disease. That’s mission-critical for us. The doctors we work with all see a few essential tremor patients a week, but they see many more with Parkinson’s.”
They have other work going on as well. “We’ve launched a partnership with Massachusetts General Hospital on vagus nerve stimulation,” added Ryan. “We’re looking at other collaborations as well, to continue to fuel innovations.”
In all that work, Cala Health has kept its focus on the most important people. “We have a direct relationship with our patients,” Ryan said. “We decided early on to put our patients at the center of our business. The interesting thing about this condition is that it’s the single most prevalent one in the world. We had a patient come to us and pick his device up at our office–he couldn’t wait for it. The drugs were knocking him out, and he’d had his surgery delayed. We believe in that kind of direct engagement.”