October 16, 2024 Source: drugdu 63
Recently, migraine innovative equipment company ShiraTronics announced the completion of a Series B financing of $66 million (approximately RMB 460 million) to support its innovative migraine treatment system.
This round of financing is led by new investor Norwest Venture Partners, with other new investors including 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.
The world's first medical device to treat migraine
ShiraTronics, located in Minneapolis, Minnesota, is a clinical stage medical device company dedicated to developing neurostimulation therapies for chronic migraine patients. It is committed to improving the lives of chronic migraine patients and was awarded the FDA Breakthrough Device designation in 2021.
The name migraine is not unfamiliar and is often heard in daily 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%, while the prevalence of migraine in China is about 10%. Based on this, it is estimated that the potential number of migraine patients worldwide and in China is as high as 1.2 billion and 140 million, respectively.
Moreover, what is even more worrying is that the number of patients with migraine is already very large, but the number of patients is still increasing, with a growth rate of 16% over the past 30 years. Moreover, the incidence rate of migraine in the population may continue to rise in the future.
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 therapy system is designed specifically for migraine patients who have experienced severe headaches for at least 15 days per month despite ineffective drug treatment.
ShiraTronics has launched the first-ever fully implantable head nerve regulation system using minimally invasive methods. The device can be implanted under the skin of the head, delivering narrow pulses of current to the occipital and orbital nerves to help interrupt migraine signals. Moreover, the device comes with a matching APP, allowing patients to adjust their treatment program on their mobile devices and provide uninterrupted treatment 24 hours a day, 7 days a week.
Currently, ShiraTronics is conducting critical RELIEV-CM2 clinical studies. And in July of this year, the RELIEV-CM clinical results of a pilot study on about 10 patients in Australia were presented at the American Society for Pain and Neuroscience conference: after 12 weeks of treatment, participants reported a significant reduction in the number of migraine days per month, from an average of 19 days at the beginning of the study to about 7 days, and their quality of life also improved. We are currently recruiting patients for randomized, sham controlled RELIEV-CM2 trials at centers in the United States and Australia.
For this round of $66 million investment, ShiraTronics stated that the latest funding will support its recently launched and FDA approved critical trial RELIEV-CM2 clinical trial. With ShiraTronics receiving pre-market approval from the FDA and its first commercial launch, funding can also provide support for it.
Embark on the era of electrotherapy
When it comes to innovative medical devices for migraines, one cannot help but mention Cefaly Technology, a device company that pioneered the era of migraine electrotherapy. Cefaly Technology launched a heavyweight product in 2014- the world's first neural electrical stimulation instrument for treating migraines, Cefaly (entered China in 2016, Chinese name: Shi Fanli), and was also the earliest approved migraine neural electrical stimulation instrument by the FDA. Previously, migraine has been treated with medication, and the emergence of Cefaly has provided a new option for migraine patients who have relatively ineffective medication 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 migraine attacks, with a recommended duration of 60 minutes; Prevention mode is used for daily use, once a day for 20 minutes each time. Regular use can reduce the frequency of migraine attacks; The stress relief mode is used when experiencing high levels of stress, anxiety, and insomnia.
A retrospective study published in the Journal of Neurological Sciences in May 2020 found that after using Cefaly, patients' monthly migraine attacks and migraine days decreased, and they also needed to take more than half of their migraine prescription medication.
There are also various instruments for treating migraines, including handheld devices and upper arm band devices, in order to benefit the convenience of migraine patients.
The representative product of handheld devices is the GammaCore Sapphire from electroCore, which is a rather delicate and compact handheld device that can be carried around. This device treats cluster headaches and migraines (acute and preventive treatments) 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 the upper arm strap device is Theranica's Nervio, which is a remote neuromodulation (REN) device. Remote Neuromodulation (REN) may be particularly suitable for migraine patients, as some patients are concerned that using devices that apply electrical stimulation to the head area may exacerbate pain, while this method stimulates the peripheral nerves in the upper arm, reducing patients' concerns. Usually, patients wear it on their arms during migraine attacks and control the treatment time and intensity through a mobile app.
Epilogue
With the rapid progress of the times, more and more innovative products dedicated to improving the current situation of patients have emerged. From drug therapy to instrument assisted therapy, from electrical therapy to fully implanted brain therapy using minimally invasive methods, all reflect the active innovation and development of instruments. Although there is currently no good way to cure migraine, I believe that with the continuous development of modern medical technology, the dawn of cure is not far ahead.
Source: https://news.yaozh.com/archive/44354.html
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