Encora Therapeutics Announces Leadership Change as FDA Review Continues

Encora Therapeutics, a Cambridge, Massachusetts-based medical device company specializing in wearable technology for movement disorders, has announced a significant leadership transition. The company, known for its innovative approach to treating essential tremors and Parkinson's disease, is positioning itself for potential FDA approval and commercial growth.

Nadim Yared Takes the Helm as New CEO

Encora Therapeutics has named Nadim Yared as its new chairman and CEO, replacing co-founder Daniel Carballo. Yared brings extensive experience in the medical device industry, having previously served as president and chief executive of CVRx. During his tenure at CVRx, Yared oversaw clinical development, commercial strategies, and successful fundraising efforts, including taking the company public in 2021.

Yared expressed enthusiasm for his new role, stating, "The team (at Encora) has developed a compelling, patient-centered platform with the potential to meaningfully improve daily function for people with movement disorders. I'm committed to advancing rigorous clinical evidence, building scalable commercial pathways, and partnering with clinicians and patients to deliver measurable impact."

Strategic Shift for Co-Founder Carballo

As part of this leadership transition, Daniel Carballo, who co-founded Encora Therapeutics in 2018, will assume the role of vice president of strategy. Carballo commented on the change, saying, "Nadim brings a systems-driven approach to scaling medtech companies and a track record of combining product development with evidence generation and commercialization plans to the table for Encora." He added, "I'm excited to remain deeply involved as VP of Strategy, partnering with Nadim to accelerate our therapy to patients."

Encora Pulse: Awaiting FDA Decision

The leadership change comes at a crucial time for Encora Therapeutics as the company awaits the FDA's decision on its 510(k) review of the Encora Pulse device. This wearable technology is designed to sense and counteract motor symptoms in real-time by applying customized vibratory stimulation to the wrist, primarily targeting patients with Parkinson's disease and essential tremors.

The Encora Pulse received FDA breakthrough device designation in 2021, highlighting its potential to address unmet needs in movement disorder treatment. The company recently completed its 47-patient ULTRE (Upper Limb Tremor Reduction in Essential Tremor) clinical trial, which garnered recognition as an "Abstract of Distinction" by the American Academy of Neurology and the Science Committee earlier this year.

As Encora Therapeutics navigates this period of transition and anticipation, the pharmaceutical industry watches closely to see how the company's innovative approach to movement disorders will fare in the regulatory process and potential market entry.