Autonomix Completes Licensing Transaction for FDA-Cleared Ablation Technology
Autonomix Medical (NASDAQ: AMIX) has completed a licensing transaction with RF Innovations for the FDA-cleared Apex 6 Radiofrequency Generator. This transaction, involving 250,000 shares of common stock, grants Autonomix a perpetual non-exclusive worldwide and royalty-free license for the Apex 6 Generator intellectual property. The Apex 6 Generator will be a component of Autonomix's sensing and ablation system for FDA clearance.
The deal aligns with Autonomix's specifications for their ablation system and enhances their supply chain with RF Innovations' experienced manufacturing partner. Autonomix plans to utilize this technology in its strategic therapeutic areas, initially focusing on pancreatic cancer-related pain, with potential for follow-on indications.
Autonomix Medical (NASDAQ: AMIX) ha completato una transazione di licensing con RF Innovations per il Generatore di Radiofrequenza Apex 6, approvato dalla FDA. Questa transazione, che coinvolge 250.000 azioni ordinarie, concede ad Autonomix una licenza perpetua non esclusiva mondiale e senza diritti d'autore per la proprietà intellettuale del Generatore Apex 6. Il Generatore Apex 6 sarà un componente del sistema di rilevamento e ablazione di Autonomix per l'approvazione della FDA.
Accordo è in linea con le specifiche di Autonomix per il loro sistema di ablazione e migliora la loro catena di approvvigionamento grazie al partner manifatturiero esperto di RF Innovations. Autonomix prevede di utilizzare questa tecnologia nelle sue aree terapeutiche strategiche, concentrandosi inizialmente sul dolore correlato al cancro al pancreas, con potenziale per indicazioni successive.
Autonomix Medical (NASDAQ: AMIX) ha completado una transacción de licencia con RF Innovations para el Generador de Radiofrecuencia Apex 6 aprobado por la FDA. Esta transacción, que involucra 250,000 acciones comunes, otorga a Autonomix una licencia mundial perpetua no exclusiva y libre de regalías para la propiedad intelectual del Generador Apex 6. El Generador Apex 6 será un componente del sistema de detección y ablación de Autonomix para la aprobación de la FDA.
El acuerdo se alinea con las especificaciones de Autonomix para su sistema de ablación y mejora su cadena de suministro con el socio de fabricación experimentado de RF Innovations. Autonomix planea utilizar esta tecnología en sus áreas terapéuticas estratégicas, enfocándose inicialmente en el dolor relacionado con el cáncer de páncreas, con potencial para indicaciones posteriores.
오토노믹스 의료(NASDAQ: AMIX)가 FDA 승인된 Apex 6 고주파 생성기에 대해 RF 혁신과 라이선스 거래를 완료했습니다. 이 거래는 250,000주의 보통주를 포함하며, 오토노믹스에 대해 비독점적이며 전 세계적으로 사용 가능한 영구적 라이선스를 부여합니다. Apex 6 생성기는 오토노믹스의 FDA 승인 감지 및 제거 시스템의 구성 요소가 될 것입니다.
이 거래는 오토노믹스의 제거 시스템 사양에 부합하며, RF 혁신의 경험이 풍부한 제조 파트너와 함께 공급망을 강화합니다. 오토노믹스는 이 기술을 전략적 치료 분야에서 활용할 계획이며, 처음에는 췌장암 관련 통증에 집중하고, 이후의 적응증 가능성도 염두에 두고 있습니다.
Autonomix Medical (NASDAQ: AMIX) a conclu une transaction de licence avec RF Innovations pour le Générateur de Radiofréquence Apex 6, approuvé par la FDA. Cette transaction, impliquant 250 000 actions ordinaires, accorde à Autonomix une licence mondiale perpétuelle non exclusive et sans redevance pour la propriété intellectuelle du Générateur Apex 6. Le Générateur Apex 6 sera un composant du système de détection et d'ablation d'Autonomix pour l'approbation de la FDA.
Cet accord est en accord avec les spécifications d'Autonomix pour leur système d'ablation et renforce leur chaîne d'approvisionnement avec le partenaire de fabrication expérimenté de RF Innovations. Autonomix prévoit d'utiliser cette technologie dans ses domaines thérapeutiques stratégiques, en se concentrant initialement sur la douleur liée au cancer du pancréas, avec un potentiel pour des indications ultérieures.
Autonomix Medical (NASDAQ: AMIX) hat eine Lizenztransaktion mit RF Innovations für den von der FDA zugelassenen Apex 6-Radiofrequenzgenerator abgeschlossen. Diese Transaktion, die 250.000 Stammaktien umfasst, gewährt Autonomix eine weltweite, nicht exklusive, unbefristete Lizenz ohne Lizenzgebühren für das geistige Eigentum des Apex 6 Generators. Der Apex 6 Generator wird ein Bestandteil des Sensierungs- und Ablationssystems von Autonomix für die FDA-Zulassung sein.
Das Abkommen stimmt mit Autonomix' Spezifikationen für ihr Ablationssystem überein und stärkt ihre Lieferkette durch den erfahrenen Fertigungspartner von RF Innovations. Autonomix plant, diese Technologie in seinen strategischen therapeutischen Bereichen zu nutzen, wobei der Fokus zunächst auf Schmerzen im Zusammenhang mit Bauchspeicheldrüsenkrebs liegt und potenzielle Folgediagnosen möglich sind.
- Acquisition of FDA-cleared ablation technology aligning with Autonomix's system specifications
- Perpetual non-exclusive worldwide and royalty-free license obtained
- Enhanced supply chain with experienced manufacturing partner
- Potential acceleration of FDA clearance process for Autonomix's technology
- Addressing unmet need in pancreatic cancer-related pain management
- Dilution of existing shareholders due to issuance of 250,000 shares of common stock for the license
Insights
Autonomix's licensing transaction for the Apex 6 Generator presents a substantial opportunity for the company to enhance its product offerings and expedite its regulatory journey. The acquisition of a royalty-free and perpetual license for FDA-cleared technology mitigates significant financial risks associated with ongoing product development. By securing a known and approved technology, Autonomix can potentially save millions in R&D and reduce the time to market. Additionally, the integration of RF Innovations' experienced manufacturing partner strengthens the supply chain, which is critical for scaling up production and ensuring quality control. For investors, this translates into a potentially lower cost base, faster revenue generation and improved margins. The commitment to address pancreatic cancer-related pain, an area with high unmet needs, also positions the company for significant market penetration and revenue growth. Overall, this strategic move could bolster investor confidence and positively impact Autonomix's stock performance in the medium to long term.
The integration of the Apex 6 Generator into Autonomix's product pipeline is a noteworthy advancement in the medical field, especially for patients suffering from chronic pain due to pancreatic cancer. The technology's FDA clearance for lesioning neural tissue offers a promising therapeutic alternative to opioids and invasive treatments, which have significant limitations and side effects. The focus on non-opioid pain management aligns with current healthcare trends aiming to reduce opioid dependence. Moreover, the use of RF ablation technology could provide longer-lasting pain relief with fewer complications, making it a game-changer in pain management. The immediate initiation of development activities with RF Innovations' manufacturing partner indicates a committed timeline towards clinical application, which could lead to accelerated patient benefits and clinical adoption. From a research perspective, this transaction underpins a critical step towards innovative and effective patient care solutions.
The licensing of the Apex 6 Generator represents a significant technological enhancement for Autonomix. The generator's compatibility with Autonomix's ablation system not only de-risks the development process but also accelerates the integration of advanced technologies in their products. A key aspect of this transaction is the collaboration with RF Innovations' manufacturing partner, which likely brings in advanced manufacturing techniques and quality assurance processes. This partnership could result in higher reliability and efficiency of the ablation systems, critical factors for gaining and maintaining FDA clearance. Additionally, the perpetual non-exclusive license ensures that Autonomix retains the flexibility to innovate and optimize their products without the constraint of ongoing royalty payments. For the tech-savvy investor, this indicates a robust foundation for future technological advancements and a competitive edge in the medical device market.
RF Innovations’ Apex 6 Generator aligns with specifications required for Autonomix’s ablation system and facilitates ongoing development
Transaction further reinforces Autonomix’s FDA regulatory pathway
THE WOODLANDS, TX, July 24, 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 it has completed its previously announced transaction with RF Innovations, Inc., a privately held medical technology company, to license the intellectual property to its Apex 6 Radiofrequency Generator. The transaction, for 250,000 shares of common stock, grants Autonomix a perpetual non-exclusive worldwide and royalty-free license of the Apex 6 Generator intellectual property, as well as enhances the Autonomix supply chain with RF Innovations’ experienced manufacturing partner.
The Apex 6 Generator is an FDA-cleared ablation technology designed to lesion neural tissue for pain management in the peripheral nervous system and will be a component of the sensing and ablation system submitted to gain FDA clearance for Autonomix’s technology. Autonomix plans to utilize the technology in its strategic therapeutic areas to drive value across its pipeline.
“The Apex 6 Generator’s compatibility with the specifics for our radiofrequency generator ablation system de-risks incremental product development and further accelerates our journey towards FDA clearance. We are pleased to successfully execute this transaction and advance the development and commercialization of our innovative technology platform, which we believe has the potential to fill an important unmet need for patients. With this transaction now complete, we are focused on working with RF Innovations’ manufacturing partner and integrating them into our supply chain as quickly and efficiently as possible,” commented Brad Hauser, President and Chief Executive Officer of Autonomix.
To facilitate equipment development, activities will begin immediately with RF Innovations’ manufacturing partner who will be incorporated into Autonomix’s manufacturing supply chain.
Autonomix is initially developing its technology to address pancreatic cancer-related pain, with plans for follow-on indications pending the results of the initial data. Current approaches, primarily relying on opioids or invasive ethanol injections, can provide only limited relief and may lead to risky side effects. For more information about the Company’s technology, please visit autonomix.com.
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 technology platform includes a catheter-based microchip sensing array that has 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 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 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 ability of Autonomix to adapt the licensed technology for its specific use case. 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,” “can,” 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
833-475-8247
autonomix@jtcir.com
FAQ
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