When Kate Rosenbluth was a Stanford Biodesign Fellow, she was captivated by the challenging unmet need to treat hand tremors. For the seven million Americans living with a condition called essential tremor, the only options were partially effective pharmacotherapies or brain surgery. She discovered that the site of deep brain stimulation was accessible through the peripheral nerves in the wrist and teamed up with Scott Delp, Director of the Stanford Neuromuscular Biomechanics Laboratory. They wondered – might it be possible to reverse engineer the circuit and treat movement disorders outside the brain?
Kate and Scott raised Series A funding in 2014 to support proof-of-concept studies and early product development on peripheral stimulation. Serena Wong joined the founding team to lead Research and Development. Their studies showed the therapeutic potential for using stimulation on the surface of the wrist to interrupt the tremulous signal driving the tremor in the brain.
In 2016, the team raised Series B to pursue regulatory clearance for a therapeutic device for essential tremor. They assembled a team of experts at the intersection of the medical devices, pharmaceuticals and technology. Cala ONE, an individualized wrist-worn therapy, was cleared by the FDA on the de novo pathway in 2018 for the transient relief of hand tremors in the treated hands of adults with essential tremor. Later that year, the FDA cleared Cala Health’s proprietary electrode that was incorporated into Cala Trio™, the company’s third generation device. Cala Trio will be commercially available by prescription in select US markets in 2019.
Cala Health’s investigational pipeline includes additional targets in neurology and expansion into other fields including psychiatry and cardiology. The team is motivated by the belief that wearable neuromodulation therapies will soon transform the standard of care for patients living with many chronic diseases.