Sam Brusco, Associate Editor03.31.21
Encora Therapeutics, a clinical-stage medical device developer, received the U.S. Food and Drug Administration’s (FDA) Breakthrough Device Designation for its patent-pending tremor reduction wearable. The device stimulates the wrist with vibrations. It is indicated to aid in the transient relief of hand tremors in adult essential tremor or Parkinson's patients.
Encora’s device senses and counteracts motor symptoms in real time by applying customized vibratory stimulation to the wrist.
The Breakthrough Device Program will fast-track development, assessment, and review by establishing prioritized communication and interaction channels between new tech developers and the FDA’s experts.
The Centers for Medicare and Medicaid Services (CMS) also recently finalized the Medicare Coverage of Innovative Technology (MCIT) program, a new coverage pathway specifically for Breakthrough Devices. The MCIT coverage policy provides up to four years of Medicare coverage beginning the date FDA clears or approves a Breakthrough Device. The MCIT program is planned to go into effect on May 15.
“Current pharmacological therapies for tremor are suboptimal and most treatments with powerful effects are invasive and require brain surgery e.g. (DBS) or brain lesions (using focused ultrasound). If proven, the Encora technology could represent an exciting non-invasive improvement in the standard of care,” Dr. Jeffrey Kordower, founding member of the Michael J. Fox Foundation Scientific Advisory Board and member of the Encora Scientific Advisory Board, said in a press release.
“Our number one priority is, and always has been, getting life changing technology into the hands of patients,” said Daniel Carballo, co-founder and CEO of Encora. “We are thrilled to have the support of the FDA as we race to bring that vision to life.”
Encora expects to begin clinical trials this year.
Encora’s device senses and counteracts motor symptoms in real time by applying customized vibratory stimulation to the wrist.
The Breakthrough Device Program will fast-track development, assessment, and review by establishing prioritized communication and interaction channels between new tech developers and the FDA’s experts.
The Centers for Medicare and Medicaid Services (CMS) also recently finalized the Medicare Coverage of Innovative Technology (MCIT) program, a new coverage pathway specifically for Breakthrough Devices. The MCIT coverage policy provides up to four years of Medicare coverage beginning the date FDA clears or approves a Breakthrough Device. The MCIT program is planned to go into effect on May 15.
“Current pharmacological therapies for tremor are suboptimal and most treatments with powerful effects are invasive and require brain surgery e.g. (DBS) or brain lesions (using focused ultrasound). If proven, the Encora technology could represent an exciting non-invasive improvement in the standard of care,” Dr. Jeffrey Kordower, founding member of the Michael J. Fox Foundation Scientific Advisory Board and member of the Encora Scientific Advisory Board, said in a press release.
“Our number one priority is, and always has been, getting life changing technology into the hands of patients,” said Daniel Carballo, co-founder and CEO of Encora. “We are thrilled to have the support of the FDA as we race to bring that vision to life.”
Encora expects to begin clinical trials this year.
