Article source: https://www.chinatimes.com/realtimenews/20181017004378-260410
Optimistic about the development potential of radiofrequency ablation (RFA) products, Haoyu and Huayu, which are subsidiaries of Jianya (4130), will join hands to enter. It is expected that Haoyu will carry out product optimization and production, and Huayu will be responsible for product design and channel layout and sales, and promote the “RFA Upgrade” to maximize synergy.
Chen Zheng, Chairman of Haoyu Biomedical, said that through the deep R&D energy and product regulatory verification experience established by ITRI in radiofrequency ablation (RFA), Haoyu will be assisted to obtain the FDA 510 (k) medical device license for RFA1.0 needles. At the same time, with the advantages of the surgical navigation focused ultrasound system that Haoyu has successfully developed, it will further develop the RAF2.0 generation that is unique to the world, establish its core competitiveness, and will join hands with Hoyu to jointly promote and commercialize RFA1.0/2.0.
Chen Zheng said that in the past, when doctors performed RFA treatment in clinical practice, because the needle could only be viewed on the two-dimensional screen of ultrasound scanning, and the three-dimensional position of the treatment site could only be confirmed by repeated needle insertion and comparison of images from different scanning angles during needle insertion, so the cautery position was easy to deviate and the procedure was time-consuming and laborious.
On the basis of RFA needles and hosts, Haoyu will improve the operability of the existing RFA system by integrating imaging and positioning and guidance related technologies, solve the dilemma of difficult treatment positioning, and upgrade it from the current RFA1.0 with empirical surgery to the 2.0 generation with visual guided surgery, so that doctors can more easily provide this minimally invasive RFA treatment and benefit more patients. In terms of product regulatory pathway planning, since the RFA1.0/2.0 system is classified as a Class II medical device in terms of risk level, it is expected to apply for US FDA 510 (k) at the end of 2019 and obtain certification and marketing in 2020.
Lin Qiwan, director of the Institute of Biomedical Sciences of the Industrial Technology Research Institute, pointed out that minimally invasive surgery has become a trend, but the RFA systems used by Taiwan’s medical centers are all from foreign manufacturers. In addition, we have also established a Rapid Prototyping Center (RPC) that complies with medical regulations, accumulating regulatory delivery experience and testing counseling energy for a long time, and conducting systematic marketing evaluation and counseling from the perspective of technology, regulations, quality, and clinical maturity (TRQC-RL).
Lin Liangguang, general manager of Huayu, said that through the energy and division of labor between industrial alliances and legal persons, the development of products and the construction of technology are no longer limited to the limited resources of a single company, whether it is from the perspective of the group’s operational vision or the oblique management of individual companies, the resources and opportunity costs invested can be greatly reduced for high-risk new medical ideas or product attempts, and the cooperation of Haoyu, Huayu and ITRI will be able to implement the commercialization of RFA1.0/2.0 more efficiently.
RFA is commonly used in the treatment of cancers, especially liver cancer and thyroid cancer, and is clinically effective in reducing complications, improving patient outcomes and reducing the need for hospitalization. Therefore, with the rise of the concept of minimally invasive medicine, it is also reflected in the sales of RFA devices, taking the tumor ablation of indications (such as liver cancer, thyroid cancer, etc.) used in RFA as an example, the global market is estimated to be US$400 million in 2016 and is estimated to reach US$1.5 billion in 2022, with a compound annual growth rate of about 13.2%.
After Haoyu’s product is planned to be licensed and launched in 2020, with Huayu’s layout and sales in the channel, it can catch up with this wave of growth and bring considerable licensing or stable sales revenue.
