Summary |
Pulsed Ultrahigh Frequency Spinal Cord Stimulation (pUHF SCS) is based on our research which was intended to treat low back pain, lower limb pain, and neuropathic pain. It is a novel therapeutic modality. The innovation was initiated from a National Science Council project, which aimed to access the effectiveness of pulsed radiofrequency (PRF) on nerve injury-induced neuropathic pain in animals and to explore the possible mechanisms. After the animal study results published, the Gimer Medical company was founded and the team started to design the system of chip (SOC), and implanted it in large animals (beagles, sheep, and pigs) for the bioavailability and biocompatibility test. Two pilot human trials were conducted to obtain the FIH results. According to the clinical trial results, the pUHF SCS has characteristics of excellent analgesic effect, long-term analgesia without continuous stimulation, paresthesia-free, safe, and low-cost without battery. |
Scientific Breakthrough |
We modified some PRF parameters to adapt the spinal space. Stimulation at 500 kHz with 2 Hz pulse rate can induce “long-term depression”. During 2017-2019, two pilot human trials of 20 chronic pain patients showed the first-in-human result that patients had long-term analgesia (3 days to > 1 week) and greater than 80% patients showed excellent pain relief (i.e. > 50% pain reduction). A new proposal has been submitted to US FDA to initiate an international pivotal human study in USA and Taiwan in 2021. Comparing with traditional SCS, of which effectiveness is present while electrical stimulation continues, pUHF SCS has long-term effect by single 10-min stimulation. Since no built-in battery in IPG, pUHF SCS has advantages in cost and safety and may have a higher acceptability by patients. |
Industrial Applicability |
International neuromodulation market is evaluated to cost US$ 20 billion in 2019, and SCS shares US$ 5 billion in it. Because the price of each SCS system is as high as NT$ 80-90 dollars (including surgery) and the complex high-end technique is a big barrier for most countries, production of SCS is a promising medical industry suitable for Taiwan to fully dedicate and develop in the next decade. Our research product, pUHF SCS, is a domestic-oriented novel invention and over 90% of the entire system can be produced by ourselves. We hold all details and knowledge of the key technology and own the international patent protections for the major items. We believe, the advantages of the product, after been commercialized, will become a new Taiwan miracle in pain medicine and medical industry. |