AngioDynamics and University College London Hospital Launch International Multi-Center Study to Assess Long Term Effects of Treatment with The NanoKnife® System

Rhea-AI Summary

AngioDynamics (NASDAQ: ANGO) has launched an international multi-center prospective registry study with University College London Hospital (UCLH) to evaluate the NanoKnife® System in treating unifocal intermediate-risk prostate cancer. The study aims to enroll 500+ patients worldwide to validate the system's safety and efficacy. The NanoKnife System offers a non-thermal alternative to conventional radical surgery or radiotherapy, designed to preserve vital structures and minimize impact on quality of life. In 2023, the UK's NICE upgraded the system's status from 'Research Only' to 'Special Arrangements', allowing broader hospital adoption while collecting additional data.

Positive

• NICE upgraded NanoKnife System status, enabling broader hospital adoption
• Partnership with UCLH, UK's largest center for robotic prostate surgery
• Addresses large market opportunity (40% of prostate cancer cases are intermediate risk)
• Non-thermal approach potentially offers better quality of life outcomes compared to conventional treatments

Negative

• System still requires additional data collection for full approval
• Study results and commercial success not guaranteed

Insights

Medical Research Analyst

This multi-center prospective registry study represents a significant development in prostate cancer treatment evaluation. The partnership between AngioDynamics and UCLH to assess the NanoKnife System's long-term efficacy addresses a important market need, targeting the 40% of prostate cancer cases classified as intermediate risk. The study's scope of 500 patients provides statistical relevance to validate previous single-center findings.

The NICE's upgrade from "Research Only" to "Special Arrangements" status signals increasing regulatory acceptance and potential market expansion. This study could significantly impact AngioDynamics' market position if it demonstrates superior outcomes compared to conventional treatments, particularly given the high dysfunction rates associated with current therapies (36% urinary leakage, 95% erectile dysfunction post-surgery).

The focus on quality-of-life metrics and long-term follow-up data could establish NanoKnife as a preferred treatment option, potentially driving adoption rates and market share growth in the prostate cancer treatment space.

Investigator initiated trial seeks to validate safety, efficacy of the NanoKnife System in treating targeted tumors while reducing or delaying need for radical intervention

LATHAM, N.Y.--(BUSINESS WIRE)-- AngioDynamics, Inc. (NASDAQ: ANGO), 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, today announced the launch of an international multi-center prospective registry study to assess the long term effects of treating men with unifocal intermediate-risk prostate cancer with the NanoKnife^® System in partnership with the University College London Hospital (UCLH).

Approximately 40% of all diagnosed prostate cancer cases are classified as intermediate risk.¹ In the first year after surgery, 36% of men report urinary leakage, and 95% are affected by erectile dysfunction (70% described as moderate/severe).²

The NanoKnife^® System delivers an innovative alternative to conventional radical surgery or radiotherapy, each of which often results in significant dysfunction in urinary continence and erectile potency. With its non-thermal approach, the NanoKnife system is engineered to preserve vital structures inside and outside the prostate, offering patients effective treatment of tumors, low complication rates, and minimal impact on quality of life.³

In 2023, the National Institute for Health and Care Excellence (NICE) in the U.K. upgraded the use of the NanoKnife^® System from “Research Only” to “Special Arrangements” allowing hospitals to start new services while collecting more data⁴ and signaling its growing acceptance in national urology guidelines.

AngioDynamics is conducting the international multi-center prospective registry study in partnership with UCLH. UCLH is the largest center for robotic prostate surgery in the U.K. and a leading provider of focal therapy, radiotherapy, robotic surgery, and active surveillance treatment options for men with prostate cancer. Additionally, UCLH was the first facility in the National Health Service to use the NanoKnife^® System to treat prostate cancer,⁵ and provide standardized patient selection, treatment, and long-term follow-up.

“Focal therapy has developed over the past ten years to identify patients with the most to gain from treatment effectively. We can now test a large cohort of patients to show benefit without adding long-term risk,” said Laura Piccinini, AngioDynamics Senior Vice President and General Manager of Endovascular Therapies and International. “We are proud of the partnership with UCLH in conducting this important study. This extensive prospective study will help support broader adoption, expanded treatment pathways, and increased patient access to improved treatment modalities for men in the U.K. with prostate cancer and help establish treatment with this technology as a standard of care. This collaboration demonstrates our steadfast commitment to supporting the physician community and their patients with innovative and effective products.”

“The international registry will allow us to track patients’ outcomes over time and allow us to quality control the dissemination of this novel technology across the world,” said Professor Mark Emberton, Interventional Oncology, Division of Surgery and Interventional Science at the University College Hospital London. “This will enable us to learn from every patient treated and, as a result, continue to refine this treatment that allows men to have their prostate cancer treated and maintain their quality of life.”

The study will enroll a minimum of 500 patients worldwide to confirm the multiple single-center published papers indicating that the NanoKnife^® System is safe and effective in the treatment of targeted tumors,³ and the prevention or delayed need for radical intervention in the preservation of patient quality of life.

Complementing the ongoing Randomized Controlled Trial studies evaluating NanoKnife versus radical treatment,^6,7 this investigator-initiated trial will closely monitor patients post-treatment, measuring critical quality of life metrics and tracking any necessary follow-up interventions. In addition to quality of life, the study will assess overall and prostate-specific mortality rates.

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. Visit nanoknife.com for full product information.

The NanoKnife System when used for the treatment of prostate cancer is an investigational device in the United States. The NanoKnife System has not received FDA clearance for the therapy or treatment of any specific disease or condition. In the European Union, the NanoKnife System is indicated for the ablation of prostate tissue in patients with intermediate risk prostate cancer. The use of this device in other organs for other disease states has not been fully evaluated.

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.

NanoKnife and the NanoKnife logo are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or subsidiary.

^{_________________________
1} https://www.npca.org.uk/wp-content/uploads/2021/01/NPCA-Annual-Report-2020_Final_140121.pdf (p.25)
² https://bjui-journals.onlinelibrary.wiley.com/doi/10.1111/bju.15739
³ https://doi.org/10.1016/j.urology.2023.01.024
⁴ https://www.nice.org.uk/guidance/ipg768
⁵ https://www.uclh.nhs.uk/news/uclh-first-nhs-use-nanoknife-prostate-cancer
⁶ https://fundingawards.nihr.ac.uk/award/17/150/01
⁷ https://clinicaltrials.gov/study/NCT05513443

View source version on businesswire.com: https://www.businesswire.com/news/home/20241023861610/en/

Investor Contact:

Stephen Trowbridge

Executive Vice President & CFO

518-795-1408

strowbridge@angiodynamics.com

Media Contact:

Saleem Cheeks

Vice President, Communications

518-795-1174

scheeks@angiodynamics.com

Source: AngioDynamics, Inc.

FAQ

What is the size of the ANGO NanoKnife System study with UCLH?

The study will enroll a minimum of 500 patients worldwide to evaluate the long-term effects of the NanoKnife System in treating unifocal intermediate-risk prostate cancer.

What was NICE's 2023 decision regarding ANGO's NanoKnife System?

In 2023, the UK's National Institute for Health and Care Excellence (NICE) upgraded the NanoKnife System from 'Research Only' to 'Special Arrangements' status, allowing hospitals to start new services while collecting more data.

What percentage of prostate cancer cases could potentially benefit from ANGO's NanoKnife System?

Approximately 40% of all diagnosed prostate cancer cases are classified as intermediate risk, which is the target population for the NanoKnife System study.