AngioDynamics Receives FDA Approval for NanoKnife Study
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 2 days ago
0mins
Source: NASDAQ.COM
- FDA Approval: AngioDynamics' NanoKnife system has received FDA investigational device exemption (IDE) approval for the RELIEF study, aimed at treating lower urinary tract symptoms in male patients with benign prostatic hyperplasia (BPH), potentially offering new treatment options for 15 million men in the U.S.
- Study Design: The RELIEF study plans to enroll 40 BPH patients for a six-month evaluation with up to five years of follow-up, utilizing transperineal electrode placement under transrectal ultrasound guidance to ensure the preservation of the urethra and neurovascular bundles during treatment.
- Technological Advantage: The NanoKnife employs irreversible electroporation (IRE) technology, which uses short high-voltage pulses to create permanent nanopores in cell membranes, inducing apoptotic cell death in targeted tissues, thus providing a minimally invasive and non-thermal ablation option that may reduce complications associated with traditional surgeries.
- Effectiveness Assessment: The primary effectiveness endpoint is the mean change in the International Prostate Symptom Score (IPSS) from baseline to six months post-procedure, while the primary safety endpoint focuses on the incidence and severity of device-related adverse events during this period, ensuring patient safety throughout the treatment process.
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Analyst Views on ANGO
Wall Street analysts forecast ANGO stock price to rise
3 Analyst Rating
3 Buy
0 Hold
0 Sell
Strong Buy
Current: 11.740
Low
16.00
Averages
19.33
High
24.00
Current: 11.740
Low
16.00
Averages
19.33
High
24.00
About ANGO
AngioDynamics, Inc. is a transformative medical technology company. The Company is focused on restoring healthy blood flow in the body's vascular system, expanding cancer treatment options and improving quality of life for patients. It designs, manufactures, and sells a range of medical, surgical and diagnostic devices used by professional healthcare providers for vascular access, for the treatment of peripheral vascular disease and for use in oncology and surgical settings. Its devices are generally used in minimally invasive, image-guided procedures. Its segments include Med Tech and Med Device. The Med Tech segment is comprised of its technology portfolio including Auryon, the thrombus management platform and NanoKnife. The Med Device segment includes its Core, Venous, Ports and other Oncology products. Its product types are Ablation, Catheters, Medical Balloons, and Ports. The Catheter products include Angiographic Catheters, Uni-Fuse Infusion Catheter and Drainage Catheters.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
AngioDynamics Receives FDA Approval for NanoKnife Study
- FDA Approval: AngioDynamics' NanoKnife system has received FDA investigational device exemption (IDE) approval for the RELIEF study, aimed at treating lower urinary tract symptoms in male patients with benign prostatic hyperplasia (BPH), potentially offering new treatment options for 15 million men in the U.S.
- Study Design: The RELIEF study plans to enroll 40 BPH patients for a six-month evaluation with up to five years of follow-up, utilizing transperineal electrode placement under transrectal ultrasound guidance to ensure the preservation of the urethra and neurovascular bundles during treatment.
- Technological Advantage: The NanoKnife employs irreversible electroporation (IRE) technology, which uses short high-voltage pulses to create permanent nanopores in cell membranes, inducing apoptotic cell death in targeted tissues, thus providing a minimally invasive and non-thermal ablation option that may reduce complications associated with traditional surgeries.
- Effectiveness Assessment: The primary effectiveness endpoint is the mean change in the International Prostate Symptom Score (IPSS) from baseline to six months post-procedure, while the primary safety endpoint focuses on the incidence and severity of device-related adverse events during this period, ensuring patient safety throughout the treatment process.
See More
AngioDynamics Receives FDA Approval for IRE Study
- Study Launch: AngioDynamics announced FDA approval to initiate the RELIEF study, evaluating irreversible electroporation (IRE) technology for benign prostatic hyperplasia (BPH)-related lower urinary tract symptoms, potentially offering new treatment options for over 300,000 surgeries performed annually.
- Clinical Trial Design: The study will enroll 40 patients to assess the impact of IRE on urinary symptoms, with the primary effectiveness endpoint being the change in the International Prostate Symptom Score (IPSS), aiming to provide initial safety and efficacy data for IRE as a tissue-sparing solution.
- Technological Advantage: The NanoKnife system delivers precise non-thermal ablation through short electrical pulses, improving urinary symptoms in BPH patients while preserving critical structures, highlighting the clinical potential of IRE technology.
- Long-term Follow-up: The RELIEF study will conduct follow-ups for up to five years to monitor treatment effects and safety, ensuring the effectiveness and sustainability of IRE technology in enhancing patient quality of life.
See More
Palmetto GBA Medicare Coverage Update for NanoKnife IRE
- Medicare Coverage Update: Palmetto GBA has issued a final Local Coverage Determination (LCD L40205) effective July 5, 2026, providing Medicare coverage for irreversible electroporation (IRE) technology, marking a significant advancement for AngioDynamics' NanoKnife system in treating prostate and liver cancers.
- CPT Code Activation: The American Medical Association activated Category I CPT codes for IRE procedures on January 1, 2026, indicating clinical effectiveness and widespread adoption, thereby supporting standardized billing across hospital outpatient departments and ambulatory surgical centers.
- Patient Selection Criteria: Under the LCD, IRE is covered for appropriately selected patients with favorable intermediate-risk prostate cancer and metastatic colorectal cancer to the liver, ensuring enhanced access to treatment options and improving patient care.
- Alignment with Clinical Guidelines: The LCD aligns with clinical practice guidelines from major specialty societies, reinforcing IRE's recognition as an effective treatment option and enhancing AngioDynamics' competitive position in the healthcare market.
See More
AngioDynamics Reports Strong Revenue Growth in Med Tech Segment
- Significant Revenue Growth: AngioDynamics reported an 8.9% increase in total revenue to $78.4 million, with the Med Tech segment achieving $37.3 million in revenue, reflecting a robust 19% growth that underscores the company's strong performance and rising market demand.
- Auryon Platform's Continued Strength: The Auryon platform achieved its 19th consecutive quarter of double-digit year-over-year growth, generating $16.3 million in revenue, indicating its competitive position and technological superiority, which are expected to further drive the company's future growth.
- Optimistic Financial Outlook: The company raised its full-year revenue guidance to $313.5 million to $315.5 million, while also increasing adjusted EBITDA guidance to $10 million to $12 million, reflecting management's confidence in future performance.
- Gross Margin Decline Challenges: Despite revenue growth, gross margin decreased by 110 basis points year-over-year, primarily due to tariffs and inflation, with tariff expenses expected to range between $4 million and $6 million for fiscal year 2026, potentially impacting the company's profitability.
See More
AngioDynamics Reports Strong Q3 FY2026 Earnings Growth
- Significant Revenue Growth: AngioDynamics reported Q3 revenue of $78.4 million, an 8.9% increase year-over-year, surpassing analyst estimates of $76.766 million, which enhances market confidence in the company's performance.
- Strong Med Tech Performance: The Med Tech segment generated $37.3 million in revenue, up 19% and accounting for 48% of total revenue, reflecting a continued shift in business mix that is expected to drive future profitability and market share growth.
- Auryon Momentum: Auryon achieved its 19th consecutive quarter of double-digit year-over-year growth, supported by expansion into the hospital market and CE Mark approval, indicating strengthening competitive positioning in the medical device sector.
- Optimistic Outlook: The company raised its FY2026 net sales guidance to $313.5 million to $315.5 million and adjusted EBITDA guidance to $10 million to $12 million, demonstrating management's confidence in future performance and positive market expectations.
See More
AngioDynamics Reports Wider Loss in Q3 Earnings
- Loss Report: AngioDynamics reported a GAAP net loss of $8.1 million in Q3, translating to a loss per share of $0.19, which is a significant increase from last year's loss of $4.4 million or $0.11 per share, indicating worsening financial health.
- Adjusted Financials: On a pro forma basis, the net loss was $13.1 million or $0.31 per share, compared to a loss of $9.9 million or $0.24 per share last year, reflecting ongoing operational challenges faced by the company.
- Sales Growth: The company achieved net sales of $78.4 million in Q3, an 8.9% increase year-over-year, with Med Tech sales rising to $37.3 million, a 19.0% increase from $31.3 million last year, demonstrating strong market demand.
- Revised Outlook: For fiscal 2026, the adjusted loss per share is now expected to be in the range of $0.30 to $0.23, revised from a previous guidance of $0.33 to $0.23, while adjusted EBITDA expectations have been raised to $10.0 to $12.0 million, indicating cautious optimism about future performance.
See More
AngioDynamics Receives FDA Approval for NanoKnife Study
- FDA Approval: AngioDynamics' NanoKnife system has received FDA investigational device exemption (IDE) approval for the RELIEF study, aimed at treating lower urinary tract symptoms in male patients with benign prostatic hyperplasia (BPH), potentially offering new treatment options for 15 million men in the U.S.
- Study Design: The RELIEF study plans to enroll 40 BPH patients for a six-month evaluation with up to five years of follow-up, utilizing transperineal electrode placement under transrectal ultrasound guidance to ensure the preservation of the urethra and neurovascular bundles during treatment.
- Technological Advantage: The NanoKnife employs irreversible electroporation (IRE) technology, which uses short high-voltage pulses to create permanent nanopores in cell membranes, inducing apoptotic cell death in targeted tissues, thus providing a minimally invasive and non-thermal ablation option that may reduce complications associated with traditional surgeries.
- Effectiveness Assessment: The primary effectiveness endpoint is the mean change in the International Prostate Symptom Score (IPSS) from baseline to six months post-procedure, while the primary safety endpoint focuses on the incidence and severity of device-related adverse events during this period, ensuring patient safety throughout the treatment process.
See More
AngioDynamics Receives FDA Approval for IRE Study
- Study Launch: AngioDynamics announced FDA approval to initiate the RELIEF study, evaluating irreversible electroporation (IRE) technology for benign prostatic hyperplasia (BPH)-related lower urinary tract symptoms, potentially offering new treatment options for over 300,000 surgeries performed annually.
- Clinical Trial Design: The study will enroll 40 patients to assess the impact of IRE on urinary symptoms, with the primary effectiveness endpoint being the change in the International Prostate Symptom Score (IPSS), aiming to provide initial safety and efficacy data for IRE as a tissue-sparing solution.
- Technological Advantage: The NanoKnife system delivers precise non-thermal ablation through short electrical pulses, improving urinary symptoms in BPH patients while preserving critical structures, highlighting the clinical potential of IRE technology.
- Long-term Follow-up: The RELIEF study will conduct follow-ups for up to five years to monitor treatment effects and safety, ensuring the effectiveness and sustainability of IRE technology in enhancing patient quality of life.
See More
Palmetto GBA Medicare Coverage Update for NanoKnife IRE
- Medicare Coverage Update: Palmetto GBA has issued a final Local Coverage Determination (LCD L40205) effective July 5, 2026, providing Medicare coverage for irreversible electroporation (IRE) technology, marking a significant advancement for AngioDynamics' NanoKnife system in treating prostate and liver cancers.
- CPT Code Activation: The American Medical Association activated Category I CPT codes for IRE procedures on January 1, 2026, indicating clinical effectiveness and widespread adoption, thereby supporting standardized billing across hospital outpatient departments and ambulatory surgical centers.
- Patient Selection Criteria: Under the LCD, IRE is covered for appropriately selected patients with favorable intermediate-risk prostate cancer and metastatic colorectal cancer to the liver, ensuring enhanced access to treatment options and improving patient care.
- Alignment with Clinical Guidelines: The LCD aligns with clinical practice guidelines from major specialty societies, reinforcing IRE's recognition as an effective treatment option and enhancing AngioDynamics' competitive position in the healthcare market.
See More
AngioDynamics Reports Strong Revenue Growth in Med Tech Segment
- Significant Revenue Growth: AngioDynamics reported an 8.9% increase in total revenue to $78.4 million, with the Med Tech segment achieving $37.3 million in revenue, reflecting a robust 19% growth that underscores the company's strong performance and rising market demand.
- Auryon Platform's Continued Strength: The Auryon platform achieved its 19th consecutive quarter of double-digit year-over-year growth, generating $16.3 million in revenue, indicating its competitive position and technological superiority, which are expected to further drive the company's future growth.
- Optimistic Financial Outlook: The company raised its full-year revenue guidance to $313.5 million to $315.5 million, while also increasing adjusted EBITDA guidance to $10 million to $12 million, reflecting management's confidence in future performance.
- Gross Margin Decline Challenges: Despite revenue growth, gross margin decreased by 110 basis points year-over-year, primarily due to tariffs and inflation, with tariff expenses expected to range between $4 million and $6 million for fiscal year 2026, potentially impacting the company's profitability.
See More
AngioDynamics Reports Strong Q3 FY2026 Earnings Growth
- Significant Revenue Growth: AngioDynamics reported Q3 revenue of $78.4 million, an 8.9% increase year-over-year, surpassing analyst estimates of $76.766 million, which enhances market confidence in the company's performance.
- Strong Med Tech Performance: The Med Tech segment generated $37.3 million in revenue, up 19% and accounting for 48% of total revenue, reflecting a continued shift in business mix that is expected to drive future profitability and market share growth.
- Auryon Momentum: Auryon achieved its 19th consecutive quarter of double-digit year-over-year growth, supported by expansion into the hospital market and CE Mark approval, indicating strengthening competitive positioning in the medical device sector.
- Optimistic Outlook: The company raised its FY2026 net sales guidance to $313.5 million to $315.5 million and adjusted EBITDA guidance to $10 million to $12 million, demonstrating management's confidence in future performance and positive market expectations.
See More
AngioDynamics Reports Wider Loss in Q3 Earnings
- Loss Report: AngioDynamics reported a GAAP net loss of $8.1 million in Q3, translating to a loss per share of $0.19, which is a significant increase from last year's loss of $4.4 million or $0.11 per share, indicating worsening financial health.
- Adjusted Financials: On a pro forma basis, the net loss was $13.1 million or $0.31 per share, compared to a loss of $9.9 million or $0.24 per share last year, reflecting ongoing operational challenges faced by the company.
- Sales Growth: The company achieved net sales of $78.4 million in Q3, an 8.9% increase year-over-year, with Med Tech sales rising to $37.3 million, a 19.0% increase from $31.3 million last year, demonstrating strong market demand.
- Revised Outlook: For fiscal 2026, the adjusted loss per share is now expected to be in the range of $0.30 to $0.23, revised from a previous guidance of $0.33 to $0.23, while adjusted EBITDA expectations have been raised to $10.0 to $12.0 million, indicating cautious optimism about future performance.
See More
