Pier 88 Health and Theranica announced that China's National Medical Products Administration (NMPA) has approved the Nerivio® REN wearable device for acute migraine treatment, representing the first regulatory approval of Remote Electrical Neuromodulation (REN) technology in the country. The registration certificate (国械注进20252090343) was issued on August 11, 2025.
Addressing China's Migraine Burden
The approval comes at a critical time for China's healthcare system, where an estimated 130 million people are affected by migraine. According to the companies, limited access to specialized care and heavy reliance on oral medications present substantial barriers for patients and healthcare providers. The condition often progresses from episodic to chronic migraine when left undertreated, further increasing disability and healthcare costs.
"This approval not only reflects strong collaboration between our teams but also sets a new standard for patient-centered migraine care in China—empowering patients with earlier, drug-free intervention that reduces long-term disease burden," said Min Luo, CEO and cofounder of Pier 88 Health.
Technology and Clinical Application
The Nerivio® REN wearable is a drug-free, smartphone-controlled prescribed therapy that provides a clinically validated, self-administered solution for migraine management. The device uses gentle electrical pulses on the arm to activate the brain's natural pain regulation system, relieving migraine symptoms during an attack and reducing the frequency and burden of future episodes when used preventively.
Dr. Xiang Qian, Clinical Professor of Pain Medicine at Stanford University and Chief Medical advisor for Pier 88 Health, commented: "REN therapy represents an important innovation in neuromodulation therapy. It's exciting to see a wearable, drug-free solution gaining clearance in China—it aligns with growing evidence in pain medicine that certain neuromodulation technologies are both effective and scalable."
Digital Health Infrastructure
Pier 88 Health has developed a comprehensive, migraine-focused digital ecosystem in China that integrates patients, physicians, and advanced technologies. The ecosystem includes TengAI Health, a WeChat-based tool that empowers patients to track symptoms and engage in self-management, and MedLinc, a dedicated mobile app that enables physicians to monitor and support chronic pain patients.
These AI-powered platforms deliver personalized migraine tracking, treatment recommendations, teleconsultations, cognitive behavioral therapy guidance, lifestyle management, and patient education. The company reports being already connected to thousands of headache specialists, neurologists, and pain physicians across China.
Global Market Expansion
The Chinese approval represents a significant milestone in Theranica's international expansion strategy. "China now joins the U.S., Europe, India and South Africa as a key pillar of our global rollout. With extensive real-world use worldwide, Nerivio's approval underscores its clinical credibility, international scalability and paradigm-shifting potential to free patients from dependency on pills or injections," said Ronen Jashek, COO and cofounder of Theranica.
The device has been used in more than one million treatments across the U.S. and is FDA-cleared for patients 8 and above. The initial Chinese approval covers acute treatment of migraine in adults, with future plans to expand to additional indications and patient populations.
Market Positioning
The approval aligns with China's shift toward digital health innovation and patient-empowered solutions, particularly among younger and working-age populations where demand for drug-free, non-invasive therapies is growing. By offering an earlier, non-pharmacological intervention, the REN wearable may help prevent disease progression and reduce the risk of migraine chronification, addressing a key driver of long-term disability.
