Recently, ShiraTronics, an innovative medical device company for migraine, announced the completion of a $66 million (approximately RMB 460 million) Series B financing to support its innovative migraine treatment system. This round of financing was led by new investor Norwest Venture Partners, and other new investors included Seroba, OSF Ventures, Global BioAccess Fund, and an undisclosed strategic investor. In addition, some existing investors such as U.S. Venture Partners, Amzak Health, Treo Ventures, and Aperture Venture Partners also participated in this round of financing.

ShiraTronics, located in Minneapolis, Minnesota, is a clinical-stage medical device company focused on developing neurostimulation therapies for chronic migraine patients. It is committed to improving the lives of chronic migraine patients and received the FDA breakthrough device designation in 2021. The name of the disease migraine is not unfamiliar, and it is often heard in life, so the migraine market is also quite extensive worldwide. According to global and Chinese epidemiological studies, the global prevalence of migraine is about 15%, and the prevalence of migraine in China is about 10%. Based on this, the number of potential migraine patients in the world and China is as high as 1.2 billion and 140 million respectively. What is more worrying is that the number of patients is already very large, but on this base, the number of patients is still growing, with a patient growth rate of 16% in 30 years, and the prevalence rate of migraine in the future may continue to rise.

In this context, how to effectively treat migraine has become one of the urgent problems to be solved, and ShiraTronics is at the forefront of the migraine treatment industry. ShiraTronics' neuromodulation treatment system is designed for migraine patients who are ineffective with drug treatment and have severe headaches at least 15 days a month. ShiraTronics has launched the first fully implantable head neuromodulation system ever using a minimally invasive method. The device can be implanted under the skin of the head to deliver narrow pulses of current to the occipital nerve and supraorbital nerve to help interrupt migraine signals. In addition, the device has a matching APP, and patients can adjust the treatment program on the mobile terminal, which can provide uninterrupted treatment 24 hours a day, 7 days a week.

Currently, ShiraTronics is conducting a key RELIEV-CM2 clinical study. In July this year, the clinical results of RELIEV-CM from a pilot study of about 10 patients in Australia were presented at the American Academy of Pain and Neuroscience Conference: After 12 weeks of treatment, participants reported that the number of migraine days per month was significantly reduced, from an average of 19 days at the beginning of the study to about 7 days, and the quality of life was also improved. Patients are currently being recruited for the randomized, sham-controlled RELIEV-CM2 trial at centers in the United States and Australia. For this round of $66 million investment, ShiraTronics said that the latest funds will support its recently launched, FDA-approved key trial RELIEV-CM2 clinical study. As ShiraTronics obtains FDA pre-market approval and its first commercial launch, the funds can also support it.

When it comes to innovative medical devices for migraines, we have to mention Cefaly Technology, a device company that pioneered the era of electrotherapy for migraines. Cefaly Technology launched a blockbuster product in 2014 - Cefaly, the world's first neurostimulator for treating migraine (entered China in 2016, Chinese name: Shifanli), and it is also the first FDA-approved neurostimulator for migraine. Previously, migraines have been treated with drugs, and the emergence of Cefaly also provides a new option for migraine patients who are relatively ineffective with drug treatment.

Cefaly targets the first branch of the trigeminal nerve and has three functional modes: treating migraines, preventing migraines, and relieving stress. The treatment mode is used for acute attacks of migraines, and the recommended use time is 60 minutes; the prevention mode is used for daily use, once a day, 20 minutes each time, and regular use can reduce the frequency of migraine attacks; the stress relief mode is used when you are under stress, anxious and insomnia. A retrospective study published in the Journal of Neurological Sciences in May 2020 found that after using Cefaly, patients had fewer migraine attacks and migraine days per month, and the number of migraine prescription drugs they needed to take was also reduced by more than half.

There are also various devices for treating migraines. In order to benefit the vast number of migraine patients, there are also handheld devices and upper arm armband devices. The representative product of handheld devices is electroCore's GammaCore Sapphire, which is a very delicate and compact handheld device that can be carried around. The device treats cluster headaches and migraines (acute treatment and preventive treatment) by applying mild electrical stimulation to the vagus nerve in the neck. GammaCore requires a doctor's prescription and costs $600 per month in the United States. The representative product of upper arm armband devices is Theranica's Nerivio, which is a remote neuromodulation (REN) device. Remote neuromodulation (REN) may be particularly suitable for migraine patients because some patients are worried that using devices that apply electrical stimulation to the head area may aggravate the pain, and this method stimulates the peripheral nerves in the upper arm, reducing patients' concerns. Usually, patients wear it on their arms when a migraine attack occurs, and control the treatment time and intensity through a mobile phone program.

With the rapid progress of the times, more and more innovative products dedicated to improving the current situation of patients have emerged, from drug treatment to device-assisted treatment, from electrical treatment to minimally invasive treatment by complete brain implantation, all of which reflect the active innovation and development of devices. Although there is no good way to cure migraine today, I believe that with the continuous development of modern medical technology, the dawn of a cure is not far away.

https://mp.weixin.qq.com/