Pier 88 Health and Theranica Announce China NMPA Approval of the Nerivio® REN wearable for Acute Treatment of Migraine

First and Only REN-Based Migraine Treatment Approved in China

BEIJING and NETANYA, Israel, Sept. 29, 2025 /PRNewswire/ -- Pier 88 Health, a digital health company dedicated to reshaping chronic pain management and bringing breakthrough global medical innovations to Greater China, and Theranica, a prescribed digital therapeutics company, today announced that the Nerivio® REN wearable, a novel treatment of migraine, has received regulatory approval from China's National Medical Products Administration (NMPA).

The registration certificate (国械注进20252090343), issued on August 11, 2025, marks the first and only approval in China of a wearable migraine device using the Remote Electrical Neuromodulation (REN) technology. This drug-free, smartphone-controlled prescribed therapy provides a clinically validated, self-administered solution for people living with migraine. By offering an earlier, non-pharmacological intervention, the REN wearable may help prevent disease progression and reduce the risk of migraine chronification, a key driver of long-term disability. 

Migraine is a significant public health concern in China, with an estimated 130 million people affected, yet limited access to specialized care and heavy reliance on oral medications present substantial barriers for patients and healthcare providers. If left undertreated, episodic migraine often progresses to chronic migraine, further increasing disability and healthcare costs. The demand for drug-free, non-invasive therapies is growing, particularly among younger and working-age populations. The REN wearable's entry into the market is well-aligned with China's shift toward digital health innovation and patient-empowered solutions.

Pier 88 Health has built a comprehensive, migraine-focused digital ecosystem in China that integrates patients, physicians, and advanced technologies. This 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.

Leveraging AI, these platforms deliver personalized migraine tracking, treatment recommendations, teleconsultations, cognitive behavioral therapy (CBT) guidance, lifestyle management, and patient education. Already connected to thousands of headache specialists, neurologists, and pain physicians across China, Pier 88 Health is laying the groundwork for rapid education, adoption, and impact of the REN wearable nationwide and is leading the charge in modernizing migraine care with this non-drug, digital-first option.

"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.

Dr. Xiang Qian, Clinical Professor of Pain Medicine at Stanford University, Co-Director of Stanford's Wearable Electronics Initiative 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."

"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 initial approval covers acute treatment of migraine in adults, with future plans to expand to additional indications and patient populations.

About Nerivio®

The Nerivio® REN wearable is an acute and preventive (dual-use) prescription migraine treatment that works without drugs, needles, or invasive procedures. FDA-cleared for patients 8 and above, it 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. Controlled by a smartphone app, the Nerivio REN wearable offers a safe, effective, and easy-to-use way to manage migraine—without the risk of systemic side effects or drug interactions.

About Theranica

Theranica is a neuromodulation therapeutics company pioneering drug-free treatments for idiopathic pain conditions. Its FDA-cleared flagship product, Nerivio®, is the first-and-only prescribed REN wearable for both acute and preventive migraine care. Used in more than one million treatments across the U.S., Nerivio provides a much-needed option for migraine patient populations with unique qualities, including children, veterans, individuals managing comorbidities, and women of childbearing age. Dedicated to modernizing pain management without drugs or needles, Theranica continues to develop cutting-edge neuromodulation therapies that reshape the way pain is treated.

About Pier 88 Health

Pier 88 Health is a digital health company committed to transforming chronic pain management and accelerating the adoption of breakthrough medical technologies across Greater China. By combining regulatory expertise, clinical collaboration, and innovative digital platforms, Pier 88 Health is building a future-ready ecosystem where patients gain access to cutting-edge, drug-free solutions and physicians are empowered to deliver more personalized, effective care.

Learn more: https://www.pier88health.com 

Media Contacts:
Pier 88 Health: Min Luo – [email protected] 
Theranica: Ronen Jashek – [email protected] 
Grey Matter Marketing: [email protected] 

SOURCE Theranica