Cala Health Receives FDA Breakthrough Device Designation for Cala Trio™ Therapy to Treat Action Tremors in Parkinson's Disease
Retrieved on:
Thursday, October 22, 2020
Venture capital, Biotechnology, Pharmaceutical, Health, FDA, Medical devices, Professional services, Clinical trials, Branches of biology, Clinical medicine, Nervous system, Essential tremor, Tremor, Parkinson's disease, CALA, Transcutaneous electrical nerve stimulation, Venture capital, Biotechnology, Pharmaceutical, Health, FDA, Medical devices, Professional services, Clinical trials, Branches of biology, Clinical medicine, Nervous system, Essential tremor, Tremor, Parkinson's disease, CALA, Transcutaneous electrical nerve stimulation, Action Tremor, Essential Tremor (ET), Cala Trio™, Cala Health, Inc.
Cala Health, Inc., a bioelectronic medicine company developing wearable therapies for chronic disease, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Cala Trio for the treatment of action tremors in the hands of adults with Parkinson's disease.
Key Points:
- Cala Health, Inc., a bioelectronic medicine company developing wearable therapies for chronic disease, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Cala Trio for the treatment of action tremors in the hands of adults with Parkinson's disease.
- Cala Health sought Breakthrough Device Designation for Cala Trio because many patients with Parkinson's disease experience the same action tremor as patients with essential tremor.
- The Company expects to initiate the next clinical trials of Cala Trio virtually in patients with Parkinson's disease in 2020.
- Cala Trio is the first non-invasive targeted therapy that reduces hand tremors for adults living with Essential Tremor (ET).