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ANGO Gains FDA IDE Approval for NanoKnife BPH Feasibility Study
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Key Takeaways
AngioDynamics received FDA IDE approval to begin the RELIEF study for NanoKnife IRE in BPH.
The RELIEF study will enroll 40 patients at up to five U.S. sites with six-month primary endpoints.
NanoKnife IRE uses electrical pulses for non-thermal prostate tissue ablation while sparing structures.
AngioDynamics (ANGO - Free Report) recently announced that the FDA has approved its IDE application to initiate the RELIEF study, which will evaluate the irreversible electroporation (IRE) technology delivered by the company's NanoKnife System. The IRE will be evaluated as a minimally invasive treatment for lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH).
BPH affects about 15 million men in the United States and leads to urinary symptoms that can significantly reduce quality of life. Existing treatment options range from medications to surgical procedures, highlighting demand for therapies that effectively relieve symptoms while preserving urinary and sexual function.
The NanoKnife IRE platform, already cleared for prostate tissue ablation, showed promising symptom improvement in prior studies, providing the rationale for the RELIEF study.
Per management, the NanoKnife System has an established role in the treatment of men with intermediate-risk prostate disease. Physicians have observed notable improvements in urinary symptoms following IRE treatment with the system. Based on these encouraging outcomes, AngioDynamics believes further clinical evaluation is justified. The RELIEF study is expected to generate the initial safety and efficacy data needed to advance IRE as a tissue-sparing solution for the millions of men living with BPH.
Likely Trend of ANGO Stock Following the News
Following the announcement, ANGO shares lost 3.4% at yesterday’s closing. In the year-to-date (YTD) period, shares of the company declined 8.6% compared with the industry’s 19% fall. However, the S&P 500 has risen 8.5% in the same timeframe.
ANGO stands to benefit from the FDA IDE approval of the RELIEF study, which expands the clinical development pathway for its NanoKnife System beyond oncology applications. Given the large prevalence of BPH and the growing demand for minimally invasive treatment options, positive study outcomes could broaden NanoKnife's addressable market. The development also strengthens the long-term growth potential of AngioDynamics’ IRE platform by supporting future physician adoption, procedure volume growth and revenue expansion.
ANGO currently has a market capitalization of $502.2 million.
Image Source: Zacks Investment Research
More on the RELIEF Study
The prospective, single-arm study will enroll 40 patients across up to five U.S. clinical sites to assess the safety and effectiveness. Participants will be evaluated at six months for primary endpoints, including changes in International Prostate Symptom Score (IPSS) and device-related adverse events, with follow-up continuing for five years.
The study is led by co-principal investigator Dr. Felix Cheung of Memorial Sloan Kettering Cancer Center. The procedure uses transperineally placed electrodes to deliver short electrical pulses that create permanent nanopores in targeted prostate cells, enabling precise, non-thermal tissue ablation while preserving surrounding critical structures.
The RELIEF study aims to generate preliminary clinical evidence supporting the use of IRE as a tissue-sparing treatment option for BPH and could pave the way for future clinical development of the NanoKnife platform.
Industry Prospects Favoring the Market
Going by the data provided by Grandview Research, the irreversible electroporation (IRE) market was valued at $78.3 million in 2025 and is estimated to grow at a CAGR of 10.1% from 2025 to 2033.
Factors like the rising incidence of cancer and cardiac disorders, IRE's non-thermal approach that preserves healthy tissues, continuous technological advancements with enhanced procedure safety and effectiveness and growing preference for minimally invasive treatments are boosting the IRE adoption.
Other News
In May, AngioDynamics announced Medicare coverage guidance for NanoKnife IRE in intermediate-risk prostate cancer and metastatic colorectal cancer to the liver, effective July 5, 2026. Combined with new Category I CPT codes, the decision strengthens reimbursement support and may accelerate broader payer adoption.
AngioDynamics announced two-year results from the PRESERVE pivotal trial showing durable cancer control and continued safety for its NanoKnife System in intermediate-risk prostate cancer. Among eligible patients, 94.4% completed 24-month follow-up, no new treatment failures or device-related adverse events were reported and 97% maintained PSA levels below baseline.
West Pharmaceutical, sporting a Zacks Rank #1 (Strong Buy) at present, reported first-quarter 2026 earnings per share (EPS) of $2.13, which beat the Zacks Consensus Estimate by 26.8%. Revenues of $844.9 million surpassed the Zacks Consensus Estimate by 8.5%. You can see the complete list of today’s Zacks #1 Rank stocks here.
West Pharmaceutical has an estimated long-term earnings growth rate of 13.9%. WST’s earnings surpassed estimates in the trailing four quarters, the average surprise being 19.4%.
Globus Medical, currently carrying a Zacks Rank #2 (Buy), reported first-quarter 2026 adjusted EPS of $1.12, which surpassed the Zacks Consensus Estimate by 22.1%. Revenues of $759.9 million beat the Zacks Consensus Estimate by 4.0%.
Globus Medical has an estimated long-term earnings growth rate of 10.2%. GMED’s earnings beat estimates in the trailing four quarters, the average surprise being 26.3%.
Biodesix, currently carrying a Zacks Rank of 2, reported a first-quarter 2026 adjusted loss per share of 81 cents, which was 35.71% narrower than the Zacks Consensus Estimate. Revenues of $26 million beat the Zacks Consensus Estimate by 12.3%.
BDSX has an estimated earnings growth rate of 36% for 2026. The company beat earnings estimates in three of the trailing four quarters and missed once, the average surprise being 25.6%.
View the Zacks #1 Rank List
Image: Bigstock
ANGO Gains FDA IDE Approval for NanoKnife BPH Feasibility Study
Key Takeaways
AngioDynamics (ANGO - Free Report) recently announced that the FDA has approved its IDE application to initiate the RELIEF study, which will evaluate the irreversible electroporation (IRE) technology delivered by the company's NanoKnife System. The IRE will be evaluated as a minimally invasive treatment for lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH).
BPH affects about 15 million men in the United States and leads to urinary symptoms that can significantly reduce quality of life. Existing treatment options range from medications to surgical procedures, highlighting demand for therapies that effectively relieve symptoms while preserving urinary and sexual function.
The NanoKnife IRE platform, already cleared for prostate tissue ablation, showed promising symptom improvement in prior studies, providing the rationale for the RELIEF study.
Per management, the NanoKnife System has an established role in the treatment of men with intermediate-risk prostate disease. Physicians have observed notable improvements in urinary symptoms following IRE treatment with the system. Based on these encouraging outcomes, AngioDynamics believes further clinical evaluation is justified. The RELIEF study is expected to generate the initial safety and efficacy data needed to advance IRE as a tissue-sparing solution for the millions of men living with BPH.
Likely Trend of ANGO Stock Following the News
Following the announcement, ANGO shares lost 3.4% at yesterday’s closing. In the year-to-date (YTD) period, shares of the company declined 8.6% compared with the industry’s 19% fall. However, the S&P 500 has risen 8.5% in the same timeframe.
ANGO stands to benefit from the FDA IDE approval of the RELIEF study, which expands the clinical development pathway for its NanoKnife System beyond oncology applications. Given the large prevalence of BPH and the growing demand for minimally invasive treatment options, positive study outcomes could broaden NanoKnife's addressable market. The development also strengthens the long-term growth potential of AngioDynamics’ IRE platform by supporting future physician adoption, procedure volume growth and revenue expansion.
ANGO currently has a market capitalization of $502.2 million.
Image Source: Zacks Investment Research
More on the RELIEF Study
The prospective, single-arm study will enroll 40 patients across up to five U.S. clinical sites to assess the safety and effectiveness. Participants will be evaluated at six months for primary endpoints, including changes in International Prostate Symptom Score (IPSS) and device-related adverse events, with follow-up continuing for five years.
The study is led by co-principal investigator Dr. Felix Cheung of Memorial Sloan Kettering Cancer Center. The procedure uses transperineally placed electrodes to deliver short electrical pulses that create permanent nanopores in targeted prostate cells, enabling precise, non-thermal tissue ablation while preserving surrounding critical structures.
The RELIEF study aims to generate preliminary clinical evidence supporting the use of IRE as a tissue-sparing treatment option for BPH and could pave the way for future clinical development of the NanoKnife platform.
Industry Prospects Favoring the Market
Going by the data provided by Grandview Research, the irreversible electroporation (IRE) market was valued at $78.3 million in 2025 and is estimated to grow at a CAGR of 10.1% from 2025 to 2033.
Factors like the rising incidence of cancer and cardiac disorders, IRE's non-thermal approach that preserves healthy tissues, continuous technological advancements with enhanced procedure safety and effectiveness and growing preference for minimally invasive treatments are boosting the IRE adoption.
Other News
In May, AngioDynamics announced Medicare coverage guidance for NanoKnife IRE in intermediate-risk prostate cancer and metastatic colorectal cancer to the liver, effective July 5, 2026. Combined with new Category I CPT codes, the decision strengthens reimbursement support and may accelerate broader payer adoption.
AngioDynamics announced two-year results from the PRESERVE pivotal trial showing durable cancer control and continued safety for its NanoKnife System in intermediate-risk prostate cancer. Among eligible patients, 94.4% completed 24-month follow-up, no new treatment failures or device-related adverse events were reported and 97% maintained PSA levels below baseline.
AngioDynamics, Inc. Price
AngioDynamics, Inc. price | AngioDynamics, Inc. Quote
ANGO’s Zacks Rank & Key Picks
Currently, ANGO has a Zacks Rank #3 (Hold).
Some better-ranked stocks from the broader medical space are West Pharmaceutical (WST - Free Report) , Globus Medical (GMED - Free Report) and Biodesix (BDSX - Free Report) .
West Pharmaceutical, sporting a Zacks Rank #1 (Strong Buy) at present, reported first-quarter 2026 earnings per share (EPS) of $2.13, which beat the Zacks Consensus Estimate by 26.8%. Revenues of $844.9 million surpassed the Zacks Consensus Estimate by 8.5%. You can see the complete list of today’s Zacks #1 Rank stocks here.
West Pharmaceutical has an estimated long-term earnings growth rate of 13.9%. WST’s earnings surpassed estimates in the trailing four quarters, the average surprise being 19.4%.
Globus Medical, currently carrying a Zacks Rank #2 (Buy), reported first-quarter 2026 adjusted EPS of $1.12, which surpassed the Zacks Consensus Estimate by 22.1%. Revenues of $759.9 million beat the Zacks Consensus Estimate by 4.0%.
Globus Medical has an estimated long-term earnings growth rate of 10.2%. GMED’s earnings beat estimates in the trailing four quarters, the average surprise being 26.3%.
Biodesix, currently carrying a Zacks Rank of 2, reported a first-quarter 2026 adjusted loss per share of 81 cents, which was 35.71% narrower than the Zacks Consensus Estimate. Revenues of $26 million beat the Zacks Consensus Estimate by 12.3%.
BDSX has an estimated earnings growth rate of 36% for 2026. The company beat earnings estimates in three of the trailing four quarters and missed once, the average surprise being 25.6%.