Autonomix Medical, Inc. Drives Towards U.S. Pivotal Trial With Appointment of Vice President, Regulatory Affairs and Quality
Autonomix Medical, Inc. Drives Towards U.S. Pivotal Trial With Appointment of Vice President, Regulatory Affairs and Quality
Autonomix Medical, Inc.
Autonomix Medical, Inc。
Continued efforts to build team and infrastructure required to support clinical and regulatory initiatives in anticipation of the FDA approval process for first-in-class catheter-based sensing technology
繼續努力建立支持臨床和監管工作所需的團隊和控件，以期待首次類導管基礎傳感技術的FDA批准過程。
Company remains on track to submit an Investigational Device Exemption ("IDE"), and if approved, will commence a pivotal clinical trial in 2025 to support a De Novo application for FDA approval
公司按計劃提交調查設備豁免（"IDE"），如果獲得批准，將於2025年開始關鍵臨床試驗，以支持FDA的De Novo申請。
THE WOODLANDS, TX , Dec. 19, 2024 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (NASDAQ: AMIX) ("Autonomix" or the "Company"), a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated, today announced the appointment of Julie Manchester as Vice President, Regulatory Affairs and Quality. As recently announced, the Company successfully completed its animal testing and design lock for its RF technology and is executing on its efforts of building the required team and infrastructure to support its clinical and regulatory initiatives in anticipation of the FDA approval process. The Company remains on track with its projected timelines and expects to submit an IDE and commence its pivotal clinical trial in 2025 to support a De Novo application for FDA approval.
德克薩斯州伍德蘭，2024年12月19日（環球新聞通訊）-- Autonomix Medical, Inc。 (納斯達克: AMIX) ("Autonomix"或"公司"), 一家專注於推動創新科技以徹底改變神經系統相關疾病的診斷和治療的醫療器械公司，今天宣佈任命朱莉·曼徹斯特爲副總裁，監管事務和質量。在最近的公告中，公司成功完成了其射頻技術的動物測試和設計鎖定，並正在執行建立所需團隊和製造行業以支持其臨床和監管計劃的工作，以期待FDA的批准流程。公司在預計的時間表上並保持在軌，預計將在2025年提交IDE並開始其關鍵臨床試驗，以支持FDA的De Novo申請。
Ms. Manchester is a Biotech/Med Device executive with over 15 years of quality and regulatory experience within the medical device, cosmetics, pharmaceutical, and product testing industries. Over the course of her career, she has built, led, and executed quality management and regulatory programs, product launches, and new product development. She has managed operations across ten different locations including other countries, ensuring consistent adherence to quality standards and regulatory compliance including building and leading teams from the ground up.
曼徹斯特女士是一位生物科技/器械高管，在醫療器械、化妝品、藥品和產品測試行業擁有超過15年的質量和監管經驗。在她的職業生涯中，她建立、領導並執行了質量管理和監管程序、產品發佈和新產品開發。她管理過十個不同地點的運營，包括其他國家，確保一致遵守質量標準和監管合規，並從零開始建立和領導團隊。
"Over this past year, we have continued to make steady progress in our ongoing proof-of-concept clinical trial for treating pancreatic cancer pain with extraordinary outcomes for our patients. We are pleased with the progress made and believe the year ahead holds catalytic milestones that we believe have the potential to truly transform the Company. As we prepare for upcoming milestones and position ourselves for success, key hires remain a focus. With that, we are pleased to welcome Julie to our team and believe her leadership and expertise will be incredibly valuable as we work to meet the regulatory needs to advance our technology forward," commented Brad Hauser, CEO of Autonomix. "We look forward to leveraging Julie's impressive experience and continue taking the necessary steps toward commencing a pivotal clinical trial, planned in 2025, and beyond to potential De Novo clearance."
"在過去一年中，我們在治療胰腺癌疼痛的概念驗證臨床試驗中繼續取得穩定進展，爲我們的患者帶來了非凡的結果。我們對取得的進展感到滿意，並相信未來一年將有催化性的里程碑，我們認爲這些里程碑有潛力真正改變公司。爲了準備即將到來的里程碑併爲成功做好定位，關鍵招聘仍然是我們的重點。因此，我們很高興歡迎朱莉加入我們的團隊，我們相信她的領導力和專業知識在滿足監管需求、推動我們的科技進步方面將極具價值，" Autonomix的首席執行官布拉德·豪澤評論道。"我們期待着利用朱莉的令人印象深刻的經驗，並繼續採取必要的步驟，以啓動計劃在2025年進行的關鍵臨床試驗，以及潛在的De Novo批准。"
Ms. Manchester added, "I am pleased to join the Autonomix organization and work closely with the team to bring this innovative technology to patients in need. Based on the preclinical and initial proof of concept data seen to date, I believe Autonomix has the potential to provide a much-needed breakthrough technology for the treatment of a number of high value indications where there remains unmet need. I believe we are poised for an exciting 2025, and I look forward to playing a key role on the regulatory front."
曼徹斯特女士補充道，"我很高興加入Autonomix組織，並與團隊緊密合作，將這項創新科技帶給有需要的患者。根據迄今爲止看到的臨床前和初步概念驗證數據，我相信Autonomix有潛力爲治療許多仍然存在未滿足需求的高價值適應症提供急需的突破性科技。我相信我們正在爲2025年的激動人心的一年做準備，我期待在監管方面發揮關鍵作用。"
Inducement Grant
誘導補助
In connection with Ms. Manchester joining Autonomix, the Compensation Committee of Autonomix's Board of Directors approved the grant of an inducement stock option on December 17, 2024 to purchase 19,500 shares of the Company's common stock. The option award was granted pursuant to the Nasdaq Rule 5635(c)(4) inducement grant exception as a component of the individual's employment compensation and was granted as an inducement material to her acceptance of employment with Autonomix.
與曼徹斯特女士加入Autonomix相關，Autonomix董事會的薪酬委員會於2024年12月17日批准授予一項誘導期權，以購買19,500股公司的普通股。根據納斯達克規則5635(c)(4)的誘導授予例外，該期權獎項作爲個人就業薪酬的組成部分授予，並作爲她接受在Autonomix工作的誘因。
The option has an exercise price equal to the closing price of Autonomix's common stock as reported by the Nasdaq Capital Market on December 17, 2024. The options have a ten-year term and vest in four equal annual installments, subject to Ms. Manchester's continued service with Autonomix through the applicable vesting dates.
該期權的行使價格等於2024年12月17日納斯達克資本市場報告的Autonomix普通股的收盤價格。期權期限爲十年，並在四個相等的年度分期內歸屬，前提是曼徹斯特女士在適用的歸屬日期繼續爲Autonomix服務。
About Autonomix Medical, Inc.
關於Autonomix Medical, Inc。
Autonomix is a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated. The Company's first-in-class platform system technology includes a catheter-based microchip sensing array that may have the ability to detect and differentiate neural signals with approximately 3,000 times greater sensitivity than currently available technologies. We believe this will enable, for the first time ever, transvascular diagnosis and treatment of diseases involving the peripheral nervous system virtually anywhere in the body.
Autonomix是一家醫療器械公司，專注於推進創新技術，徹底改變涉及神經系統疾病的診斷和治療。該公司的首創平台系統技術包括基於導管的微芯片傳感陣列，能夠以大約3000倍於當前可用技術的靈敏度檢測和區分神經信號。我們相信，這將首次實現幾乎在身體任何地方的外周神經系統疾病的經血管診斷和治療。
We are initially developing this technology for the treatment of pain, with initial trials focused on pancreatic cancer, a condition that causes debilitating pain and is without a reliable solution. Our technology constitutes a platform to address dozens of potential indications, including cardiology, hypertension and chronic pain management, across a wide disease spectrum. Our technology is investigational and has not yet been cleared for marketing in the United States.
我們最初正在開發這項技術用於治療疼痛，初步試驗集中在胰腺癌上，這是一種導致嚴重疼痛且沒有可靠解決方案的控件。我們的技術構成了一個平台，可以解決幾十種潛在的應用，包括心臟病、高血壓和慢性疼痛管理，涵蓋廣泛的疾病譜。我們的技術仍處於研究階段，目前尚未獲得美國市場的批准。
For more information, visit autonomix.com and connect with the Company on X, LinkedIn, Instagram and Facebook.
如需更多信息，請訪問 autonomix.com 並與公司聯繫 X, LinkedIn, Instagram 和 臉書.
Forward Looking Statements
前瞻性聲明
Some of the statements in this release are "forward-looking statements," which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the potential of the technology to treat cancerous tumors and the pain associated with pancreatic cancer, to submit and receive approval of an IDE, and to file a De Novo application. Such forward-looking statements can be identified by the use of words such as "should," "might," "may," "intends," "anticipates," "believes," "estimates," "projects," "forecasts," "expects," "plans," and "proposes."
本公告中的一些陳述爲「前瞻性陳述」，涉及風險和不確定性。此新聞稿中的前瞻性陳述包括但不限於，治療癌性腫瘤及與胰腺癌相關的疼痛的技術潛力，提交併獲得IDE的批准，以及提交De Novo申請。此類前瞻性陳述可以通過使用如下詞語識別："應該"，"可能"，"會"，"打算"，"預期"，"相信"，"估計"，"項目"，"預測"，"期望"，"計劃"，和"建議"。
Although Autonomix believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. You are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading "Risk Factors" and elsewhere in the Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on May 31, 2024. Forward-looking statements speak only as of the date of the document in which they are contained and Autonomix does not undertake any duty to update any forward-looking statements except as may be required by law.
儘管Autonomix認爲這些前瞻性陳述中所反映的期望是基於合理的假設，但仍存在多種風險和不確定性，可能導致實際結果與這些前瞻性陳述出現重大差異。我們敦促您仔細審查和考慮任何警告性陳述和其他披露，包括在《風險因素》標題下和在2024年5月31日向美國證券交易委員會（SEC）提交的10-K年報中所作的陳述。前瞻性陳述僅在所包含文件的日期內有效，Autonomix並未承擔更新任何前瞻性陳述的義務，除非法律要求。
Investor and Media Contact
投資者和媒體聯繫方式
JTC Team, LLC
Jenene Thomas
908.824.0775
autonomix@jtcir.com
JTC團隊，有限責任公司
珍妮·托馬斯
908.824.0775
autonomix@jtcir.com
Attachment
附件
- Autonomix Medical, Inc.
- Autonomix Medical, Inc。
譯文內容由第三人軟體翻譯。
