Keep pulling the thread on Deanna Harshbarger.
Cala Health has developed a bioelectronic medicine that non-invasively treats tremor in patients.
Cala Health successfully established new reimbursement codes for its novel non-invasive tremor treatment.
Cala Health has secured a local coverage determination with Medicare for its tremor therapy device.
In March, Cala Health announced the upcoming launch of its next-generation system, the CalaKick Plus.
A significant treatment gap exists for tremor patients, as almost half are unable to tolerate the increasing doses of pharmaceutical medications required as their neurodegenerative disease progresses.
Beyond pharmaceuticals, the only other treatment options available for tremor are invasive procedures such as ablative surgery or deep brain stimulation.
Cala Health's CalaTherapy device treats tremor non-invasively by delivering personalized stimulation through the peripheral nervous system at the wrist.
The stimulation from the CalaTherapy device interrupts signals in the VIM (ventral intermediate nucleus) area of the brain, the same region targeted by deep brain stimulation for tremor.
The CalaTherapy system personalizes treatment for each patient by first measuring their unique tremor and then using that data to calibrate the stimulation parameters.
Cala Health's first device obtained regulatory clearance through the FDA's de novo pathway.
Cala Health is a commercial-stage company currently providing its tremor therapy to Medicare patients and veterans through the VA system.
Cala Health plans to bring its next-generation CalaKick Plus system to market later this year.