With FDA 510(k) Approval Secured in May 2025, Brain Navi Launches Countdown to IPO – Taiwan’s First Publicly Listed High-End Surgical Robot Company
With the successful acquisition of the U.S. FDA 510(k) clearance for its neurosurgical navigation robot in May 2025, Taiwanese startup Brain Navi Biotechnology has officially kicked off its IPO countdown. The company is expected to list on the capital market in 2026, becoming the first Taiwanese firm to enter the high-end neurosurgical navigation robot sector with its own brand.
“This year marks Brain Navi’s 10th anniversary. Our pace has been steady, but each step has been purposeful and solid,” said Dr. Jerry Chen, founder and CEO. He noted that the company has not only passed the world’s most stringent regulatory system in the U.S., but has also completed more than 170 clinical cases to date.
Jerry Chen celebrates Brain Navi’s 10th anniversary. The company’s NaoTrac has been shipped to Spain, the Netherlands, Turkey, and several Eastern European countries, and is expanding into North America, Latin America, and Southeast Asia.
Regulatory Journey: From Europe to the U.S., Overcoming the Pandemic
Brain Navi’s neurosurgical navigation robotic system, NaoTrac, integrates machine vision, AI algorithms, and high-precision robotic arms. It features real-time navigation and positioning, enabling surgeons to precisely conduct craniotomies and remove intracerebral hemorrhages, significantly improving patient recovery time and reducing rehabilitation periods.
Looking back, the project began in 2014, with the company established in 2015, and entered the human clinical phase at the end of 2018. Originally aiming for rapid global market expansion, the plan was delayed due to the COVID-19 pandemic. Brain Navi filed for CE certification in 2019. After pandemic-related review delays, the company finally obtained the CE mark at the end of 2021, received TFDA approval in Taiwan in 2022, and ultimately completed U.S. FDA 510(k) certification in 2025—finally completing all key regulatory milestones.
Currently, NaoTrac has been shipped to Spain, the Netherlands, Turkey, and several Eastern European countries, with over 170 clinical applications performed. The company’s sales network is also expanding into North America, Latin America and Southeast Asia.
A Medical Startup Dream Born at Stanford
Dr. Jerry Chen, with a background as a physician and a Ph.D. in biomedical engineering from National Cheng Kung University, was one of the first recipients of Taiwan’s Stanford Taiwan Biomedical Program (STB) scholarship to pursue advanced studies in the U.S. After returning to Taiwan, he set out to bring Silicon Valley’s innovative spirit into Taiwan’s medtech startup scene.
“I come from a biomedical engineering background, but I deeply understand what tools clinical doctors truly need,” said Dr. Chen. “Over the past ten years, we have continuously optimized our system to create equipment that doctors truly trust and are willing to use long-term.”
In the early days, the company was launched with just USD 300,000, funded solely through personal credit and a few angel investors. Over the years, Brain Navi gradually gained the support of multiple seasoned investors in the medical and tech fields, establishing a strong financial and advisory network.
Pre-IPO Fundraising Accelerates Global Expansion
With the critical U.S. FDA approval secured and steady progress in European markets, Brain Navi launched a Pre-IPO fundraising round in 2025, targeting USD 10 million—nearly fully subscribed within a month.
In contrast to global giant Intuitive Surgical, the maker of the da Vinci robot with a market cap of USD 183 billion, Brain Navi’s current valuation remains under USD 100 million. Rather than becoming an OEM or competing on price, Brain Navi is determined to establish itself as an original brand owner, winning the market through quality and precision.
Regarding quality, Dr.Chen emphasized that the NaoTrac robot—from navigation software and robotic hardware to regulatory certification—was entirely developed in-house by Brain Navi, and its production line is fully based in Taiwan. The company insists on 100% inspection rather than sample testing, ensuring every unit undergoes a full quality control process and pressure testing before leaving the factory.
To expand its clinical applications, Brain Navi also developed the world’s first single-use brain endoscope, KrystoLens, which is expected to receive Taiwan certification by the end of the year and simultaneously enter the European and U.S. markets. The product integrates suction, navigation, and mechanical operation functions, reducing the risk of infection and offering doctors a new operating experience to further enhance surgical efficiency.
Children Without Umbrellas Run Faster — Stepping into the Global Arena with True Capability
“In the past decade, we have relied on neither conglomerates nor wasteful spending. With just NT$400 million in R&D, we became one of only five companies worldwide to have an FDA-approved brain surgical robot. That is an achievement I am truly proud of,” said Dr. Chen.
Despite ongoing challenges in Taiwan’s health insurance reimbursement and hospital procurement systems, Brain Navi has chosen to list on the Taiwan Stock Exchange first, taking a steady approach to build trust among physicians and establish a solid market foundation.
“We’re not here to chase short-term gains, and we have no interest in being a one-day wonder among startups,” Dr. Chen emphasized.
“We aim to become Taiwan’s first publicly listed company that truly represents medical robotics, proving to the world that Taiwan is not just a manufacturing hub, but also a place where branded, technology-driven medical products with core innovations can be built and taken to the global stage.”
