Following the successful attainment of U.S. FDA 510(k) clearance for its brain surgery robot in May 2025, Taiwanese startup Brain Navi officially launches its countdown to IPO, aiming to list on the capital market in 2026. This will mark Brain Navi as Taiwan’s first company to enter the advanced surgical robot field with an independent brand.

“2025 marks Brain Navi’s 10th anniversary. Though our pace has been steady rather than fast, each step has been solid,” said Dr. Chieh-Hsiao Chen, founder and CEO. Brain Navi has not only passed the world’s strictest U.S. regulatory approval process but has also completed over 170 clinical cases.

Caption: Dr. Chieh-Hsiao Chen celebrates Brain Navi’s 10th anniversary. The company’s NaoTrac system has been shipped to Spain, the Netherlands, Turkey, and several Eastern European countries, with market expansion ongoing in Latin America and Southeast Asia.

Approval Journey: Launching from Europe, Overcoming Pandemic Challenges, Achieving U.S. Certification

Brain Navi’s brain surgery robot system, NaoTrac, integrates machine vision, AI algorithms, and a high-precision robotic arm. Featuring real-time navigation and positioning, it assists surgeons in performing craniotomies and removing brain hemorrhages with precision—significantly improving patient recovery speed and reducing hospitalization and rehabilitation time.

The project started in 2014, with the company founded in 2015. By the end of 2018, it entered clinical trials. Although originally planning a rapid international rollout, COVID-19 caused delays. The company submitted its EU CE certification application in 2019, which was postponed in 2020 but ultimately granted at the end of 2021. Taiwan’s TFDA approval followed in 2022, and U.S. FDA 510(k) clearance was finalized in 2025, completing the certification puzzle.

NaoTrac units have been shipped to Spain, the Netherlands, Turkey, and multiple Eastern European countries, with clinical applications exceeding 170 cases. Sales networks are expanding into Latin America and Southeast Asia.

From Stanford to Medical Innovation Entrepreneurship

Dr. Chen, a physician with a PhD in biomedical engineering from National Cheng Kung University, was among the first Taiwanese government-supported scholars through the Stanford Taiwan Biomedical Program (STB) to study in the U.S. Upon returning to Taiwan, he resolved to bring Silicon Valley’s innovative spirit into Taiwan’s medical startup ecosystem.

“I come from a medical engineering background, so I deeply understand what tools clinicians truly need. Over the past decade, we have continuously optimized the system to develop equipment that doctors trust and are willing to use long term,” he said.

Starting with personal credit and a few angel investors, Brain Navi raised NT$10 million to initiate the project. Over subsequent years, the company steadily gained backing from medical and tech investors, building a solid capital and advisory network.

Accelerated Pre-IPO Fundraising and Global Expansion

With the key U.S. certification secured and steady growth in Europe, Brain Navi launched a pre-IPO fundraising round in 2025 targeting US$10 million, nearly reaching the goal within a month. Compared to international giants like Intuitive Surgical with a market value of US$183 billion, Brain Navi’s valuation remains under US$100 million. Brain Navi aims to be an original equipment manufacturer with its own brand, eschewing contract manufacturing and price wars, striving instead to win the market through quality and precision.

On quality, Dr. Chen said the entire NaoTrac system—from navigation software and robot hardware to regulatory certification—is independently developed in-house, with all production lines based in Taiwan. The company enforces a “100% inspection” policy replacing random checks to ensure every machine undergoes complete process and pressure tests before leaving the factory.

To broaden clinical applications, Brain Navi has also developed the world’s first single-use intracranial endoscope, KrystoLens, expected to receive Taiwan certification by year-end and simultaneously enter the European and U.S. markets. The device integrates suction, navigation, and mechanical operation, reducing infection risk and offering surgeons a new operating experience, further enhancing surgical efficiency.

A Small Player Without a Backer, Winning on Strength and Innovation

“We have neither financial conglomerates backing us nor have we squandered resources. With just NT$400 million in R&D investment, we have become one of only five brain surgery robot manufacturers worldwide to receive FDA approval. I believe this is an achievement to be proud of,” Dr. Chen said candidly.

Despite ongoing challenges in Taiwan’s healthcare reimbursement and hospital procurement systems, Brain Navi has chosen to list first on Taiwan’s capital market to steadily build trust among clinicians and a solid market foundation. “We have no capital for short-term speculation and don’t want to be a one-day hype stock,” he emphasized.

“We aspire to be Taiwan’s first listed company truly representing medical robot technology, showing the world that Taiwan is not just a manufacturing hub but can also develop medical products with proprietary brands and core technologies that stand on the global stage.”

Resource: 【專訪鈦隼生物科技】取得美國510(k)許可 啟動IPO倒數