AngioDynamics, Inc. ANGO, yesterday, announced the receipt of the FDA’s 510(k) clearance for the NanoKnife System for prostate tissue ablation. The clearance for the NanoKnife System for prostate tissue ablation follows the completion of the pivotal PRESERVE clinical study and submission of results to the FDA in September.

It is worthwhile to note that the PRESERVE clinical study assessed the safety and effectiveness of the NanoKnife System for ablating prostate tissue in patients with intermediate-risk prostate cancer (PCa).

The latest regulatory clearance is a significant stepping stone for AngioDynamics to strengthen its foothold in the prostate tumor treatment space.

Likely Trend of ANGO Stock Following the News

Following the announcement on Dec. 9, shares of the company gained nearly 23.3% till yesterday’s trading.

Historically, the company has gained a high level of synergies from its various positive study outcomes and regulatory clearances. We expect market sentiment on the stock to continue to remain positive around this announcement, too.

AngioDynamics currently has a market capitalization of $350.7 million. Its P/S ratio of 1.20 is lower than the industry’s 3.14. In the last reported quarter, ANGO delivered an earnings surprise of 26.7%.

Significance of AngioDynamics’ FDA Approval

Per ANGO’s estimates, PCa is the second most common cancer in men worldwide, with approximately 1.5 million new cases diagnosed annually. Many of these patients seek alternatives to radical procedures that can lead to significant, long-term urological side effects.

According to AngioDynamics’ management, the NanoKnife System is currently the first and only non-thermal, radiation-free, ablation technology designed to treat prostate tissue using Irreversible Electroporation (IRE) technology. This will likely offer patients a minimally-invasive option for prostate treatment.

Per management, as the NanoKnife System delivers an alternative to conventional radical surgery or radiotherapy (which often results in significant dysfunction in urinary continence and erectile potency), the system is expected to preserve vital structures inside and outside the prostate. This, in turn, will likely offer patients improved outcomes, reduced recovery times and enhanced quality of life.

Industry Prospects in Favor of ANGO

Per a report by MarketsandMarkets, the global ablation technology market is expected to grow from $6.11 billion in 2024 to $9.62 billion by 2029, witnessing a CAGR of 9.5%. Factors like expanding access to healthcare services, an increasing preference for minimally-invasive treatments and the use of ablation procedures in expanded application fields are likely to drive the market.

Given the market potential, the latest FDA clearance is expected to provide a significant boost to AngioDynamics’ business.

AngioDynamics’ Notable Developments

In October, AngioDynamics announced the launch of an international multi-center prospective registry study to assess the long-term effects of treating men with unifocal intermediate-risk PCa with the NanoKnife System in partnership with the University College London Hospital.

The same month, AngioDynamics announced that IRE had received CPT Category I codes for the treatment of lesions in the prostate and liver.

ANGO’s Share Price Performance

Shares of the company have gained 24.9% in the past year compared with the industry’s 14.2% rise and the S&P 500's 31.4% growth.

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AngioDynamics’ Zacks Rank & Key Picks

Currently, ANGO carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the broader medical space are Cardinal Health, Inc. CAH, Merit Medical Systems, Inc. MMSI and Globus Medical, Inc. GMED.

Cardinal Health, carrying a Zacks Rank #2 (Buy) at present, has an estimated long-term growth rate of 10.2%. CAH’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 11.2%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Cardinal Health’s shares have gained 13.7% compared with the industry’s 7.7% rise in the past year.

Merit Medical, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 12%. MMSI’s earnings surpassed estimates in each of the trailing four quarters, with the average being 6.4%.

Merit Medical has gained 48.4% compared with the industry’s 7.7% rise in the past year.

Globus Medical, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 14.1%. GMED’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 17.7%.

Globus Medical’s shares have rallied 75.4% compared with the industry’s 14.2% rise in the past year.

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