Cala Health

The first product developed by Cala Health was called Cala OneCala One. It was a wrist-worn device that acted as a stimulator and applied transcutaneous electrical stimulation in a non-invasive manner to the median and radial nerves of an individual using disposable hydrogel electrodes. The Cala One device achieved FDA clearance on the de novo pathway in April 2018 for transient relief of ET in adults.

In December 2018, Cala Health launched a clinical trial for the updated version of Cala OneCala One, called Cala TwoCala Two. The study had 500 patients in a single-arm ProspectPROSPECT trial, which evaluated the Cala Two device for symptom relief for three months, with treatments twice per day at 40 minutes each.The results forof this study were not published, but in the same year, the FDA cleared the proprietary electrode that was incorporated into the next version of the product.

Cala Trio is Cala Health's lead product as of 2019. Interim results from a clinical study called the PROSPECT trial, wherein which the Cala Trio device was usedtested, were reported in 2019 at the International Congress of Parkinson's Disease and Movement Disorders, in Nice, France. It was shown that the Cala Trio device, when used for 40 minutes, temporarily helps to reduce ET. The device stimulates the nerves responsible for ET and is calibrated to each patient’s hand tremor. 62%Sixty-two percent of trial participants had their tremors improve from severe to moderate or from mild to slight. Quality of life was also reported to be improved. 18%Eighteen percent of participants experienced transient device-related adverse events, which included wrist discomfort, skin irritation, and pain. The Cala Trio device has U.S. FDA clearance and is available by prescription in select U.S. markets.

Cala Health’s former CEO, Kate Rosenbluth, was replaced by Renee Ryan in September 2019. Ryan was previously VP of venture investments at Johnson & Johnson Innovation, where she led the firm’s investment in Cala’s Series A round and 15fifteen other investments.

The Cala One device achieved FDA clearance in April 2018 for transient relief of ET in adults. In December 2018, Cala Health launched a clinical trial for its wrist-worn neurostimulator that treats ET. The study had 500 patients in a single-arm Prospect trial, which evaluated the Cala Two device for symptom relief for three months, with treatments twice per day at 40 minutes each.

The first product developed by Cala Health was called Cala One. It was a wrist-worn device that acted as a stimulator and applied transcutaneous electrical stimulation in a non-invasive manner to the median and radial nerves of an individual using disposable hydrogel electrodes. The Cala One device achieved FDA clearance on the de novo pathway in April 2018 for transient relief of ET in adults.

In December 2018, Cala Health launched a clinical trial for the updated version of Cala One, called Cala Two. The study had 500 patients in a single-arm Prospect trial, which evaluated the Cala Two device for symptom relief for three months, with treatments twice per day at 40 minutes each.The results for this study were not published but in the same year the FDA cleared the proprietary electrode that was incorporated into the next version of the product.

Neuroperipheral therapy stimulates peripheral nerves with body-worn electronics and has the potential to treat chronic diseases non-invasively. Cala Health is working on a treatment for Essential Tremor (ET), a movement disorder that makes it difficult to perform daily activities like eating and writing. Cala Health supports the International Essential Tremor Foundation (IETF).

TheirThe Cala One device achieved FDA clearance in April 2018 for transient relief of ET in adults. In December 2018, Cala Health launched a clinical trailtrial for its wrist-worn neurostimulator in treatmentthat oftreats ET. The clinical trialstudy had 500 patients in a single-arm Prospect trial, which evaluated the Cala Two device atfor relievingsymptom symptomsrelief for three months, with treatments twice per day at 40 minutes each.

Cala Trio is Cala Health's lead product as of 2019.Interim2019. Interim results from a clinical study called the PROSPECT trial where the Cala Trio device was used were reported in 2019 at the International Congress of Parkinson's Disease and Movement Disorders, in Nice, France. It was shown that the Cala Trio device, when used for 40 minutes, temporarily helps to reduce ET. The device stimulates the nerves responsible for ET and is calibrated to each patient’s hand tremor. 62% of trial participants had their tremors improve from severe to moderate or from mild to slight. Quality of life was also reported to be improved. 18% of participants experienced transient device-related adverse events which included wrist discomfort, skin irritation and pain. The Cala Trio device has U.S. FDA clearance and is available by prescription in select U.S. markets.

Neuroperipheral therapy stimulates peripheral nerves with body-worn electronics and has the potential to treat chronic diseases non-invasively. Cala Health is working on a treatment for Essential TremorEssential Tremor (ET), a movement disorder that makes it difficult to perform daily activities like eating and writing. Cala Health supports the International Essential Tremor Foundation (IETF).

Their Cala One device achieved FDA clearance in April 2018 for transient relief of ET in adults of ET. In December 2018, Cala Health launched a clinical trail for its wrist-worn neurostimulator in treatment of ET. The clinical trial hashad 500 patients in a single-arm Prospect trial which will evaluateevaluated the Cala Two device at relieving symptoms for three months, with treatments twice per day at 40 minutes each.

Cala Trio is Cala Health's lead product as of 2019.Interim results from a clinical study called the PROSPECT trial where the Cala Trio device was used were reported in 2019 at the International Congress of Parkinson's Disease and Movement Disorders, in Nice, FranceFrance. It was shown that the Cala Trio device, when used for 40 minutes twice daily, effectivelytemporarily helpedhelps to reduce hand tremors within three monthsET. The device stimulates the nerves responsible for tremorET and is calibrated to each patient’s hand tremor. 62% of trial participants had their tremors improve from severe to moderate or from mild to slight. Quality of life was also reported to be improved. 18% of participants experienced transient device-related adverse events which included wrist discomfort, skin irritation and pain. The Cala Trio device has U.S. FDA clearance and is available by prescription in select U.S. markets.

Cala Health’s former CEO Kate Rosenbluth was replaced by Renee RyanRenee Ryan in September 2019. Ryan was previously VP of venture investments at Johnson & Johnson Innovation where she led the firm’s investment in Cala’s Series A round and 15 other investments.