AngioDynamics Receives FDA Clearance for The NanoKnife® System for Prostate Tissue Ablation
AngioDynamics (NASDAQ: ANGO) has received FDA 510(k) clearance for its NanoKnife System for prostate tissue ablation following the successful completion of the PRESERVE clinical study. The pivotal study, which enrolled 121 patients across 17 clinical sites, demonstrated significant effectiveness with 84% of men being free from clinically significant disease at 12 months post-procedure.
The study showed impressive quality of life outcomes, with urinary continence preservation at 95.4% after 12 months and only a 9% decrease in erectile function. The NanoKnife System is the first non-thermal, radiation-free ablation technology for prostate tissue using IRE technology, offering a minimally invasive alternative to conventional treatments.
This clearance represents a significant milestone for treating prostate cancer, which affects approximately 1.5 million new patients annually worldwide.
AngioDynamics (NASDAQ: ANGO) ha ricevuto l'autorizzazione 510(k) dalla FDA per il suo NanoKnife System per l'ablazione dei tessuti prostatici dopo il completamento con successo dello studio clinico PRESERVE. Lo studio cruciale, che ha arruolato 121 pazienti in 17 siti clinici, ha dimostrato una significativa efficacia, con l'84% degli uomini che risultano liberi da malattie clinicamente significative 12 mesi dopo la procedura.
Lo studio ha mostrato risultati impressionanti per la qualità della vita, con la preservazione della continenza urinaria al 95,4% dopo 12 mesi e solo un 9% di diminuzione della funzione erettile. Il NanoKnife System è la prima tecnologia di ablazione non termica e priva di radiazioni per il tessuto prostatico che utilizza la tecnologia IRE, offrendo un'alternativa minimamente invasiva ai trattamenti convenzionali.
Questa autorizzazione rappresenta un traguardo significativo per il trattamento del cancro alla prostata, che colpisce circa 1,5 milioni di nuovi pazienti all'anno in tutto il mondo.
AngioDynamics (NASDAQ: ANGO) ha recibido la aprobación 510(k) de la FDA para su NanoKnife System para la ablación de tejidos prostáticos tras la finalización exitosa del estudio clínico PRESERVE. El estudio clave, que incluyó a 121 pacientes en 17 sitios clínicos, demostró una efectividad significativa con un 84% de los hombres libres de enfermedad clínicamente significativa a los 12 meses después del procedimiento.
El estudio mostró resultados impresionantes en cuanto a la calidad de vida, con una preservación de la continencia urinaria del 95,4% después de 12 meses y solo un 9% de disminución en la función eréctil. El NanoKnife System es la primera tecnología de ablación no térmica y libre de radiación para el tejido prostático que utiliza la tecnología IRE, ofreciendo una alternativa mínimamente invasiva a los tratamientos convencionales.
Esta aprobación representa un hito significativo para el tratamiento del cáncer de próstata, que afecta a aproximadamente 1,5 millones de nuevos pacientes anualmente en todo el mundo.
AngioDynamics (NASDAQ: ANGO)는 PRESERVE 임상 연구의 성공적인 완료 이후 전립선 조직 절제를 위한 NanoKnife System에 대해 FDA 510(k) 승인을 받았습니다. 17개 임상 사이트에서 121명의 환자를 모집한 이 주요 연구는 시술 후 12개월 동안 84%의 남성이 임상적으로 중요한 질병이 없는 것으로 나타나는 등 상당한 효과를 입증했습니다.
이 연구는 12개월 후에 95.4%의 비뇨기 continence 유지를 보여주었고, 발기 기능의 감소는 단 9%에 불과했습니다. NanoKnife System은 IRE 기술을 사용하는 전립선 조직을 위한 최초의 비열 치료법 및 방사선 없는 절제 기술로, 전통적인 치료법에 대한 최소한의 침습적인 대안을 제공합니다.
이번 승인은 매년 전 세계적으로 약 150만 명의 신규 환자가 영향을 받는 전립선암 치료에 있어 중요한 이정표를 나타냅니다.
AngioDynamics (NASDAQ: ANGO) a reçu l'autorisation 510(k) de la FDA pour son NanoKnife System pour l'ablation des tissus prostatiques après l'achèvement réussi de l'étude clinique PRESERVE. L'étude clé, qui a inclus 121 patients à travers 17 sites cliniques, a montré une efficacité significative avec 84% des hommes libres de maladie cliniquement significative 12 mois après la procédure.
L'étude a montré des résultats impressionnants en matière de qualité de vie, avec une préservation de la continence urinaire de 95,4% après 12 mois et seulement une diminution de 9% de la fonction érectile. Le NanoKnife System est la première technologie d'ablation non thermique et sans radiation pour les tissus prostatiques utilisant la technologie IRE, offrant une alternative minimement invasive aux traitements conventionnels.
Cette autorisation représente une étape importante dans le traitement du cancer de la prostate, qui touche environ 1,5 million de nouveaux patients chaque année dans le monde.
AngioDynamics (NASDAQ: ANGO) hat die FDA 510(k)-Zulassung für ihr NanoKnife System zur Ablation von Prostatagewebe nach dem erfolgreichen Abschluss der PRESERVE-Studie erhalten. Die wegweisende Studie, an der 121 Patienten an 17 klinischen Standorten teilnahmen, zeigte eine signifikante Wirksamkeit, wobei 84 % der Männer 12 Monate nach dem Eingriff frei von klinisch signifikanten Krankheiten waren.
Die Studie zeigte beeindruckende Ergebnisse zur Lebensqualität, mit einem Erhalt der Harninkontinenz von 95,4 % nach 12 Monaten und nur einem Rückgang der erektilen Funktion von 9 %. Das NanoKnife System ist die erste nicht-thermische, strahlungsfreie Ablationstechnologie für Prostatagewebe, die die IRE-Technologie verwendet und eine minimal-invasive Alternative zu herkömmlichen Behandlungen bietet.
Diese Zulassung stellt einen bedeutenden Meilenstein für die Behandlung von Prostatakrebs dar, der weltweit etwa 1,5 Millionen neue Patienten jährlich betrifft.
- FDA 510(k) clearance received for NanoKnife System
- 84% of patients were disease-free at 12-months post-procedure
- High preservation rate of urinary continence (95.4%) at 12 months
- Minimal impact on erectile function (only 9% decrease)
- First-to-market non-thermal, radiation-free ablation technology for prostate tissue
- None.
Insights
The Company received clearance for the NanoKnife System for prostate tissue ablation following the completion of the pivotal PRESERVE clinical study and submission of results to the FDA in September. The study evaluated the safety and effectiveness of the system for ablating prostate tissue in patients with intermediate-risk prostate cancer (PCa). Conducted in collaboration with the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC), PRESERVE enrolled 121 patients across 17 clinical sites.
“We are incredibly proud to receive FDA clearance for the NanoKnife System’s use in prostate tissue,” said Jim Clemmer, President and Chief Executive Officer of AngioDynamics. “This milestone is the first step in recognizing our vision to become the standard, function-preserving treatment for men with prostate tumors. The NanoKnife System minimizes the life-altering complications often associated with traditional treatments by selectively targeting prostate tissue while preserving critical functions. As we expand our global footprint and increase access to our technology, we are launching comprehensive education and awareness campaigns to empower physicians with hands-on training and clinical support while engaging patients through innovative outreach initiatives.”
Mr. Clemmer added, “These efforts are designed to accelerate the adoption of the NanoKnife System, redefine the standard of care for prostate health, and deliver treatment outcomes that patients and physicians need. AngioDynamics is committed to driving meaningful impact through this revolutionary technology, providing new hope to patients and improved quality of life.”
The PRESERVE clinical study met its primary effectiveness endpoint demonstrating the performance of the NanoKnife System for the ablation of prostate tissue in patients with intermediate-risk PCa. At 12-months post-procedure,
The study’s results validated the robust safety and clinical efficacy profile of the NanoKnife System, reinforcing findings from more than 32 clinical studies performed around the world involving over 2,600 patients.1
Prostate cancer is the second most common cancer in men worldwide, with approximately 1.5 million new cases diagnosed annually.2 Many of these patients seek alternatives to radical procedures that can lead to significant, long-term urological side effects.3 The NanoKnife System is the first and only non-thermal, radiation-free, ablation technology designed to treat prostate tissue by using IRE technology, offering patients a minimally invasive option for prostate treatment.
The NanoKnife System delivers an innovative alternative to conventional radical surgery or radiotherapy, which often results in significant dysfunction in urinary continence and erectile potency.4 With its non-thermal approach, the system is engineered to preserve vital structures inside and outside the prostate, offering patients improved outcomes, reduced recovery times, and enhanced quality of life.5
For important risk information, visit https://www.angiodynamics.com/about-us/risk-information/#inano
About the NanoKnife System
The NanoKnife System utilizes Irreversible Electroporation (IRE) technology to effectively destroy targeted cells without the use of thermal energy by delivering high-voltage pulses, creating permanent nanopores within the cell membrane. This stimulus induces an apoptotic-like cellular death in the targeted tissue, resulting in a complete ablation of the targeted tissue.6 Visit nanoknife.com for full product information.
European Union: The NanoKnife System is indicated for the ablation of prostate tissue in patients with intermediate risk prostate cancer.
About AngioDynamics, Inc.
AngioDynamics is a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving patient quality of life.
The Company’s innovative technologies and devices are chosen by talented physicians in fast-growing healthcare markets to treat unmet patient needs. For more information, visit www.angiodynamics.com.
Safe Harbor
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements regarding AngioDynamics’ expected future financial position, results of operations, cash flows, business strategy, budgets, projected costs, capital expenditures, products, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include the words such as “expects,” “reaffirms,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “projects,” “optimistic,” or variations of such words and similar expressions, are forward-looking statements. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties. Investors are cautioned that actual events or results may differ materially from AngioDynamics’ expectations, expressed or implied. Factors that may affect the actual results achieved by AngioDynamics include, without limitation, the scale and scope of the COVID-19 global pandemic, the ability of AngioDynamics to develop its existing and new products, technological advances and patents attained by competitors, infringement of AngioDynamics’ technology or assertions that AngioDynamics’ technology infringes the technology of third parties, the ability of AngioDynamics to effectively compete against competitors that have substantially greater resources, future actions by the FDA or other regulatory agencies, domestic and foreign healthcare reforms and government regulations, results of pending or future clinical trials, overall economic conditions (including inflation, labor shortages and supply chain challenges including the cost and availability of raw materials), the results of on-going litigation, challenges with respect to third-party distributors or joint venture partners or collaborators, the results of sales efforts, the effects of product recalls and product liability claims, changes in key personnel, the ability of AngioDynamics to execute on strategic initiatives, the effects of economic, credit and capital market conditions, general market conditions, market acceptance, foreign currency exchange rate fluctuations, the effects on pricing from group purchasing organizations and competition, the ability of AngioDynamics to obtain regulatory clearances or approval of its products, or to integrate acquired businesses, as well as the risk factors listed from time to time in AngioDynamics’ SEC filings, including but not limited to its Annual Report on Form 10-K for the year ended May 31, 2024. AngioDynamics does not assume any obligation to publicly update or revise any forward-looking statements for any reason.
AngioDynamics, the AngioDynamics logo, and NanoKnife are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or subsidiary. All other trademarks are the property of their respective owners. ©2024 AngioDynamics, Inc
1 Data on file.
2 https://www.wcrf.org/cancer-trends/prostate-cancer-statistics/
3 Cheng JY. The Prostate Cancer Intervention Versus Observation Trial (PIVOT) in Perspective. J Clin Med Res. 2013;5(4):266-268. doi:10.4021/jocmr1395w
Lomas DJ, Ziegelmann MJ, Elliott DS. How informed is our consent? Patient awareness of radiation and radical prostatectomy complications. Turk J Urol. 2018;45(3):191-195. Published 2018 Dec 20. doi:10.5152/tud.2018.81522
4 Faiella E, Santucci D, D'Amone G, et al. Focal minimally invasive treatment in localized prostate cancer: comprehensive review of different possible strategies. Cancers (
Donovan JL, Hamdy FC, Lane JA, et al. Patient-reported outcomes 12 years after localized prostate cancer treatment. NEJM Evid. 2023;2(4):EVIDoa2300018. doi:10.1056/EVIDoa2300018
5 Faiella E, Santucci D, D'Amone G, et al. Focal minimally invasive treatment in localized prostate cancer: comprehensive review of different possible strategies. Cancers (
Scheltema MJ, Geboers B, Blazevski A, et al. Median 5-year outcomes of primary focal irreversible electroporation for localised prostate cancer. BJU Int. 2023;131 Suppl 4:6-13. doi:10.1111/bju.15946
Resnick MJ, Koyama T, Fan KH, et al. Long-term functional outcomes after treatment for localized prostate cancer. N Engl J Med. 2013;368(5):436-445. doi:10.1056/NEJMoa1209978
Golberg A, Yarmush ML. Nonthermal irreversible electroporation: fundamentals, applications, and challenges. IEEE Trans Biomed Eng. 2013;60(3):707-714. doi:10.1109/TBME.2013.2238672
6 Lee EW, Thai S, Kee ST. Irreversible electroporation: a novel image-guided cancer therapy. Gut Liver. 2010;4 Suppl 1(Suppl 1):S99-S104. doi:10.5009/gnl.2010.4.S1.S99
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Investor:
Stephen Trowbridge
Executive Vice President & CFO
518-795-1408
strowbridge@angiodynamics.com
Media:
Saleem Cheeks
Vice President, Communications
518-795-1174
scheeks@angiodynamics.com
Source: AngioDynamics, Inc.
FAQ
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