Autonomix Medical, Inc. Drives Towards U.S. Pivotal Trial with Appointment of Vice President, Regulatory Affairs and Quality
Autonomix Medical (NASDAQ: AMIX) has appointed Julie Manchester as Vice President of Regulatory Affairs and Quality, strengthening its team ahead of planned FDA approval initiatives. The company, which recently completed animal testing and design lock for its RF technology, remains on track to submit an Investigational Device Exemption (IDE) and commence a pivotal clinical trial in 2025 to support a De Novo FDA application.
Manchester brings over 15 years of quality and regulatory experience in medical devices and related industries. The company granted her an inducement stock option to purchase 19,500 shares, vesting over four years. Autonomix continues to make progress in its proof-of-concept clinical trial for treating pancreatic cancer pain, reporting positive patient outcomes.
Autonomix Medical (NASDAQ: AMIX) ha nominato Julie Manchester come Vice Presidente degli Affari Regolatori e della Qualità, rafforzando il suo team in vista delle iniziative di approvazione programmate dalla FDA. L'azienda, che ha recentemente completato i test su animali e il design finale per la sua tecnologia RF, è sulla buona strada per presentare un'Esenzione per Dispositivo Investigativo (IDE) e avviare uno studio clinico fondamentale nel 2025 a supporto di una domanda De Novo alla FDA.
Manchester porta con sé oltre 15 anni di esperienza nella qualità e nella regolamentazione nel settore dei dispositivi medici e delle industrie correlate. L'azienda le ha concesso un'opzione su azioni pe motivi di incentivo per l'acquisto di 19.500 azioni, che matureranno nell'arco di quattro anni. Autonomix continua a fare progressi nel suo studio clinico di prova di concetto per il trattamento del dolore da cancro pancreatico, riportando risultati positivi per i pazienti.
Autonomix Medical (NASDAQ: AMIX) ha nombrado a Julie Manchester como Vicepresidenta de Asuntos Regulatorios y Calidad, fortaleciendo su equipo antes de las iniciativas de aprobación previstas por la FDA. La empresa, que recientemente completó pruebas en animales y el diseño final de su tecnología de RF, se mantiene en camino para presentar una Exención de Dispositivo Investigacional (IDE) y comenzar un ensayo clínico pivotal en 2025 para apoyar una aplicación De Novo a la FDA.
Manchester aporta más de 15 años de experiencia en calidad y regulación en dispositivos médicos y industrias relacionadas. La empresa le otorgó una opción de acciones por incentivo para comprar 19,500 acciones, que se liberarán en un período de cuatro años. Autonomix sigue avanzando en su ensayo clínico de prueba de concepto para el tratamiento del dolor por cáncer pancreático, reportando resultados positivos entre los pacientes.
Autonomix Medical (NASDAQ: AMIX)는 Julie Manchester를 규제 업무 및 품질 부사장으로 임명하여 FDA 승인 추진 계획에 앞서 팀을 강화했습니다. 최근 동물 실험과 RF 기술에 대한 설계가 완료된 이 회사는 2025년 Investigational Device Exemption (IDE)을 제출하고 주요 임상 시험을 시작할 예정입니다. 이는 De Novo FDA 신청을 뒷받침할 것입니다.
Manchester는 의료 기기 및 관련 산업에서 15년 이상의 품질 및 규제 경험을 가져옵니다. 회사는 그녀에게 19,500주를 구매할 수 있는 유인 주식 옵션을 부여하였으며, 이 옵션은 4년 동안 단계적으로 제공됩니다. Autonomix는 췌장암 통증 치료를 위한 개념 증명 임상 시험에서 긍정적인 환자 결과를 보고하며 계속해서 진행 중입니다.
Autonomix Medical (NASDAQ: AMIX) a nommé Julie Manchester au poste de Vice-Présidente des Affaires Réglementaires et de la Qualité, renforçant ainsi son équipe avant les initiatives d'approbation prévues par la FDA. L'entreprise, qui a récemment achevé des tests sur animaux et le verrouillage de conception de sa technologie RF, est sur la bonne voie pour soumettre une Demande d'Exemption pour Dispositif Investigatif (IDE) et commencer un essai clinique majeur en 2025 pour soutenir une demande De Novo auprès de la FDA.
Manchester apporte plus de 15 ans d'expérience en matière de qualité et de réglementation dans le domaine des dispositifs médicaux et des industries connexes. L'entreprise lui a accordé une option d'achat d'actions pour acquérir 19 500 actions, qui seront acquises sur une période de quatre ans. Autonomix continue de progresser dans son essai clinique de preuve de concept pour le traitement de la douleur liée au cancer du pancréas, rapportant des résultats positifs chez les patients.
Autonomix Medical (NASDAQ: AMIX) hat Julie Manchester zur Vizepräsidentin für Regulierungsangelegenheiten und Qualität ernannt und damit sein Team im Hinblick auf geplante FDA-Zulassungsinitiativen gestärkt. Das Unternehmen, das kürzlich Tierversuche und das Design für seine RF-Technologie abgeschlossen hat, ist auf dem richtigen Weg, einen Antrag auf Investigational Device Exemption (IDE) einzureichen und 2025 eine entscheidende klinische Studie zu beginnen, um einen De Novo-Antrag bei der FDA zu unterstützen.
Manchester bringt über 15 Jahre Erfahrung in Qualität und Regulierung im Bereich der medizinischen Geräte und verwandten Branchen mit. Das Unternehmen gewährte ihr eine Anreiz-Aktienoption zum Kauf von 19.500 Aktien, die über vier Jahre aufgeschlüsselt wird. Autonomix macht weiterhin Fortschritte in seiner Machbarkeitsstudie zur Behandlung von Schmerzen bei Bauchspeicheldrüsenkrebs und berichtet von positiven Ergebnissen bei den Patienten.
- Successfully completed animal testing and design lock for RF technology
- On track for IDE submission and pivotal clinical trial in 2025
- Reporting positive outcomes in ongoing proof-of-concept trial for pancreatic cancer pain
- None.
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
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
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.
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.
“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.”
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.”
Inducement Grant
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.
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.
About 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.
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.
For more information, visit autonomix.com and connect with the Company on X, LinkedIn, Instagram and Facebook.
Forward Looking Statements
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.”
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.
Investor and Media Contact
JTC Team, LLC
Jenene Thomas
908.824.0775
autonomix@jtcir.com
Attachment
FAQ
When will Autonomix Medical (AMIX) begin its pivotal clinical trial for its nerve sensing technology?
What is the status of Autonomix Medical's (AMIX) RF technology development?
What are the terms of Julie Manchester's stock option grant at Autonomix Medical (AMIX)?
What progress has Autonomix Medical (AMIX) made in its pancreatic cancer pain treatment trials?
