Artificial Intelligence
NeuroOne® Submits 510(k) Application to FDA for OneRF™ Ablation System
Potential for transformative improvement in neurosurgery as first known sEEG-guided RF system that records and ablates nervous tissue with the added benefit of temperature control
EDEN PRAIRIE, Minn., June 12, 2023 (GLOBE NEWSWIRE) — NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) (“NeuroOne” or the “Company”), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, announced today its submission of a 510(k) application to the U.S. Food and Drug Administration (FDA) for its OneRF™ Ablation System. This technology uses the already implanted sEEG electrodes to record brain activity and allow for ablation of nervous tissue when connected to a proprietary radio frequency (RF) generator. If cleared by the FDA, NeuroOne’s OneRF 510(k) submission represents the first step in bringing to market an innovative RF ablation system in the field of neurology and neurosurgery.
As the Company’s first therapeutic device, OneRF is a combination system that includes both diagnostic and therapeutic capabilities. The system utilizes a customized RF generator with real-time temperature monitoring capabilities, allowing clinicians to have greater control over temperature management during the ablation. Designed to both record brain activity and ablate nervous tissue using the same electrode, the system is designed to offer the potential for a safer clinical option for patients as well as lower costs by reducing the number of invasive procedures and hospital stays for patients. NeuroOne estimates the current brain ablation market to be at least $100M worldwide and growing rapidly, with the potential to grow multiple fold based on large addressable patient populations with unmet clinical needs.
Dave Rosa, CEO of NeuroOne, commented, “This is a monumental day for NeuroOne as it represents the first known FDA 510(k) submission of an sEEG electrode intended to record brain activity and also be used as an RF probe to ablate nervous tissue. In addition, it marks the Company’s first complete system combining hardware, software, and our novel electrode technology. Over the past few years, we have been excited with the feedback we have received from our advisory board as well as the performance of the system in animal feasibility studies. We also believe this system has applications beyond ablation of nervous tissue in the brain, offering a larger opportunity than we initially envisioned. I am proud of our entire team and their efforts which allowed us to complete this before the end of June as planned.”
NeuroOne anticipates receiving initial feedback from the FDA no later than August 7th, 2023.
About NeuroOne
NeuroOne Medical Technologies Corporation is a developmental stage company committed to providing minimally invasive and hi-definition solutions for EEG recording, brain stimulation and ablation solutions for patients suffering from epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries, and other related neurological disorders that may improve patient outcomes and reduce procedural costs. The Company may also pursue applications for other areas such as depression, mood disorders, pain, incontinence, high blood pressure, and artificial intelligence. For more information, visit nmtc1.com.
Forward Looking Statements
This press release may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Except for statements of historical fact, any information contained in this presentation may be a forward–looking statement that reflects NeuroOne’s current views about future events and are subject to known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. In some cases, you can identify forward–looking statements by the words or phrases “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “target,” “seek,” “contemplate,” “continue, “focused on,” “committed to” and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward–looking statements may include statements regarding the development of the Company’s electrode technology program, applications for, or receipt of, regulatory clearance, the receipt and/or timing of any feedback from the FDA relating to the Company’s OneRF ablation system, the ability of the OneRF ablation system to offer a safer option for patients, the timing and extent of product launch and commercialization of our technology, clinical and pre-clinical testing, what the future may hold for electrical stimulation and NeuroOne’s potential role, business strategy, market size, potential growth opportunities, future operations, future efficiencies, and other financial and operating information. Although NeuroOne believes that we have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. Our actual future results may be materially different from what we expect due to factors largely outside our control, including risks that the partnership with Zimmer Biomet may not facilitate the commercialization or market acceptance of our technology; whether due to supply chain disruptions, labor shortages, the impact of COVID-19 or otherwise; risks that our technology will not perform as expected based on results of our pre-clinical and clinical trials; risks related to uncertainties associated with the Company’s capital requirements to achieve its business objectives and ability to raise additional funds: the risk that we may not be able to secure or retain coverage or adequate reimbursement for our technology; uncertainties inherent in the development process of our technology; risks related to changes in regulatory requirements or decisions of regulatory authorities; that we may not have accurately estimated the size and growth potential of the markets for our technology; risks relate to clinical trial patient enrollment and the results of clinical trials; that we may be unable to protect our intellectual property rights; and other risks, uncertainties and assumptions, including those described under the heading “Risk Factors” in our filings with the Securities and Exchange Commission. These forward–looking statements speak only as of the date of this press release and NeuroOne undertakes no obligation to revise or update any forward–looking statements for any reason, even if new information becomes available in the future.
Caution: Federal law restricts this device to sale by or on the order of a physician.
Contact:
800-631-4030
[email protected]
Artificial Intelligence
Xinhua Silk Road: E China’s Changzhou City unveils investment opportunities in sectors of new productive forces for global investors
BEIJING, Sept. 29, 2024 /PRNewswire/ — Changzhou City, an leading international smart manufacturing base located in east China’s Jiangsu Province, has released a bunch of investment investment opportunities to global investors in various sectors of new productive forces at the the 2024 New Energy Industry Development Conference & Invest in Changzhou Conference held in the city on September 19.
The investment opportunities covers nine areas including synthetic biology, low-altitude economy, intelligent connected new energy vehicles, solid-state batteries, hydrogen energy, third-generation semiconductors, and artificial intelligence, manifesting the confidence of Changzhou in further opening development.
Changzhou, seated in the axis of the Yangtze River Delta, has become an important base for advanced manufacturing in China.
In recent years, thanks to intensified efforts in developing new energy industry and fostering new quality productive forces, Changzhou has expanded the added value of its industrial sector to more than two trillion yuan, with manufacturing added value accounting for about 43 percent, both ranking among the top three in Jiangsu Province.
In the Hurun China New Energy Cities 2024, a list released by the Hurun Research Institute at the conference, Changzhou ranked first among other cities in the country for three consecutive years in terms of investment attractiveness and concentration.
Changzhou has accumulated a total of 10.59 billion US dollars (nearly 74.25 billion yuan) in terms of actually utilized foreign capital since 2020. Major projects such as soft magnetism of ArcelorMittal and medical device of BIOS, a Hong Kong-based company, have been launched during the conference.
In addition, Changzhou has released a multilingual guide for foreign nationals in Changzhou at the conference, which includes practical service items in stay and residence, work, convenient payment options, among others, turning the city into a more open and international place.
Original link: https://en.imsilkroad.com/p/342380.html
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Artificial Intelligence
CGTN: China honors individuals with highest awards in celebration of 75th National Day
BEIJING, Sept. 29, 2024 /PRNewswire/ — Huang Zongde enlisted in the Chinese People’s Liberation Army at the age of 17, beginning a nearly four-decade-long military career where his bravery, valor and devotion earned him countless awards and honors.
The heavily decorated 93-year-old received the highest state honor on Sunday when Chinese President Xi Jinping conferred him with the Medal of the Republic at a ceremony in the Great Hall of the People in Beijing.
China awarded national medals and national honorary titles to 15 individuals, including Huang, in recognition of their contribution and achievement as it celebrates the 75th anniversary of the founding of the People’s Republic of China, which falls on October 1.
Chinese heroes and role models
In addition to Huang, three others were awarded the Medal of the Republic. Wang Yongzhi, a missile and rocket expert and a pioneer of China’s manned space program, was honored posthumously. Wang Zhenyi, a medical scientist known for breakthroughs in leukemia treatment, and Li Zhensheng, an expert in wheat breeding, are also among the honorees.
The national honorary titles went to 10 people, including scientists, a border patrolman, an artist, a craftsman, educators, a health worker, an economist and an athlete.
Addressing Sunday’s awarding ceremony, President Xi, also general secretary of the Communist Party of China Central Committee and chairman of the Central Military Commission, called on the Chinese people to learn from heroes and role models to form a mighty force to build a strong China.
China is in a crucial period for building a great modern socialist country in all respects and achieving national rejuvenation through Chinese modernization, he said.
Encouraging the Chinese people to strive for extraordinary achievements at ordinary job posts, Xi urged them to contribute to resolving challenges to development and reform and safeguarding social harmony and stability.
China’s old friends and good friends
As its highest state honor for foreigners, China awarded the Friendship Medal to Dilma Rousseff, president of the New Development Bank and former Brazilian president, for her commitment to the friendship between China and Brazil, and development of relationship between China and the Community of Latin American and Caribbean States, and cooperation among BRICS countries, a group of major emerging economies.
Accepting the honor at the ceremony, Rousseff said the medal symbolizes the strong bonds between Brazil and China and pledged to continue her unremitting efforts to promote the friendship.
China’s achievements over the decades, including economic transformation, technological innovation and remarkable social development, have made it a beacon and a source of inspiration for the world, she said.
Xi lauded Rousseff as an outstanding representative of China’s old friends and good friends who have shared the same aspirations and stood together with the Chinese people over the past 75 years and vowed that China will never forget such international friends.
The Chinese people are ready to join hands with people from all over the world to safeguard world peace, promote common development and advance the building of a community with a shared future for mankind to create a better future for humanity, he said.
https://news.cgtn.com/news/2024-09-29/China-honors-individuals-with-highest-awards-ahead-of-National-Day-1xhS1SaZeZa/p.html
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HANGZHOU, China, Sept. 29, 2024 /PRNewswire/ — On September 26, a delegation from the Ministry of Digital Development, Innovations and Aerospace Industry of the Republic of Kazakhstan, led by Minister Madiyev Zhaslan, visited SUPCON. SUPCON’s Chairman and President, Mr.Cui Shan, warmly welcomed the delegation.
The Kazakhstan government representatives expressed their appreciation and recognition of SUPCON’s expertise and innovation in intelligent manufacturing, digital transformation, and industrial AI.
Madiyev Zhaslan expressed a strong interest in industrial AI technologies of SUPCON, particularly their applications in intelligent and low-carbon facilities. He looks forward to exploring extensive collaboration with SUPCON across various sectors in Kazakhstan.
Cui Shan emphasized that as a leading industrial AI company with a global presence, SUPCON will leverage its technological advantages to meet Kazakhstan’s industry development requirements and trends, injecting new momentum into the country’s industrial digitalization.
In 2023, SUPCON established a subsidiary in Kazakhstan as its Central Asia regional headquarters and set up a localized operational system. SUPCON will continue to invest in the long-term development of the Central Asia region, contributing further wisdom and strength to the industrial digital transformation in Kazakhstan and beyond.
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View original content:https://www.prnewswire.co.uk/news-releases/kazakhstan-government-delegation-visited-supcon-302261857.html
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