Founded by the Chairman John Hsuan 8 years ago, HKBio has spent years honing the expertise in regulatory consultation, product registration services, and contract design and development services for medical device products. HKBio has announced this month that it has partnered with Brain Navi Biotechnology to co-develop a robot-assisted brain endoscope, helping surgeons safely, swiftly and accurately to place endoscopes into the brain prior to surgery.
Brain Navi Biotechnology, a Taiwan-based high-end medical device company received the CE Mark for their NaoTrac, a robotic-assisted surgical robot, in April 2021. Earlier this year, Brain Navi passed the medical device quality management system(QMS), and it is currently seeking regulatory approval from the Taiwan Food and Drug Administration (TFDA).
“Brain Navi has accumulated 7 years of R&D in the surgical robot space and it is now actively developing periphery accessories. In addition to capital investment, emerging companies also require capable talents in the team. The partnership with HKBio solves our current talent shortage and speeds up the R&D.” – Dr. Jerry Chen, CEO of Brain Navi Biotechnology.
HKBio is the first Taiwan-based full service medical device contract design and manufacturing organization (CDMO) with offices in the US and China. In 2021, Taiwan enterprise COVID-19 rapid test services and fruitful business development in China have fueled the rapid growth at HKBio, resulting in an YoY growth of 600%, a record-breaking revenue achievement in the past 3 years. In addition, HKBio has begun business development activities for its CDMO services in the US and Europe. At the same time, the company has started the next round of fundraising efforts and is seeking acquisition targets to accelerate business and R&D growth.
“HKBio has been in the medical device contract manufacturing business for many years. The partnership with Brain Navi Biotechnology is synergistic with respect to each party’s expertise. We are setting an example for future medical device co-development in Taiwan.” – John Hsuan, Chairman of HKBio.
HKBio completed a US $5.5M Series C fundraising in early 2021. With this funding, the company began hiring talents to serve the US and European markets. Key products include COVID-19 rapid test kits, wound care dressing, and AI-powered long-term care products. Additionally, HKBio is exploring single-use medical electronics and hand-held imaging devices, with specific use cases in the fields of sleep diagnosis, at-home health monitoring, and minimally invasive surgical tools.
“It is HKBio’s principle to nurture long term synergy in our partnerships. As a result, HKBio has partnered with early stage startups as well as more established medical device companies. We hope to replicate the successful contract manufacturing model in the electronics industry and open the door to alternative growth drivers in the medical device industry in Taiwan.” – Michael Kuo, CEO of HKBio.
Moving forward, business growth via capital means will be a key strategy for Taiwanese medical device companies that seek global business expansion. Both HKBio and Brain Navi Biotechnology are currently planning the next round of financing, targeting strategic investors in the US and Europe as well as venture capital funds. By joining forces, HKBio and Bran Navi Biotechnology can better serve our clients around the globe.
HKBio is a medical device CDMO with a VC mindset. For more information, please contact [email protected]
