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PRCT Stock Rises on FDA's Nod to Initiate Study on Prostate Cancer

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PROCEPT BioRobotics Corporation (PRCT - Free Report) recently announced that it has received the FDA’s approval to commence a pivotal Investigational Device Exemption clinical trial comparing Aquablation therapy to radical prostatectomy. The study will evaluate the efficacy of Aquablation therapy for patients with prostate cancer.

This approval marks a critical step in the company's objective to revolutionize treatment options for patients suffering from prostate cancer. The company also recently received Breakthrough Device Designation to investigate the use of Aquablation therapy for prostate cancer.

Likely Trend of PRCT Stock Following the News

Following the announcement, shares of the company moved north 4.9% in the after-market session on Monday.

PRCT’s innovative solutions, particularly Aquablation therapy, have positioned the company as a major player in the medical robotics space. With this FDA approval, the company is expected to gain traction among investors looking for growth opportunities in the healthcare sector.

For the year-to-date period, PRCT shares have lost 41.6% against the industry’s rise of 10.7%. The S&P 500 increased 19.6% in the same time frame.

Meanwhile, PRCT currently has a market capitalization of $3.77 billion. In the last reported quarter, PRCT delivered an earnings surprise of 3.9%.

Find the latest earnings estimates and surprises on the Zacks Earnings Calendar.

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More on Aquablation Therapy

Aquablation therapy is the first and only ultrasound-guided, robotic-assisted, heat-free waterjet for the treatment of benign prostatic hyperplasia (BPH). The system’s real-time ultrasound imaging provides the surgeon with a multi-dimensional view of the prostate enabling personalized treatment planning tailored to each patient’s unique anatomy.

The surgeon can specify which areas of the prostate to remove while preserving the anatomy that controls erectile function, ejaculatory function and continence. Once the treatment plan is mapped by the surgeon, the predictable robotic-assisted execution enables prostate tissue to be removed in a precise, targeted, and controlled fashion.

More on PRCT’s Initial Study

The WATER IV PCa trial is a prospective, randomized, multicenter, worldwide clinical study that evaluates the safety and effectiveness of Aquablation therapy in comparison to radical prostatectomy for men with Grade Group 1 to 3 localized prostate cancer. Up to 280 individuals will be enrolled in the trial at up to 50 centers, and they will be followed for 10 years.

There is a co-primary endpoint based on morbidity evaluated at the six-month follow-up. Oncologic events and treatment-related damage reduction are the main goals of longer-term follow-up.

Industry Prospects in Favor of PRCT

Per a report by Grand View Research, the global surgical robotics market was estimated at $3.92 billion in 2023 and is expected to witness a CAGR of 9.5% from 2024 to 2030.

With the growing need for minimally invasive therapies, particularly in cancer care, PROCEPT BioRobotics stands to benefit from expanding its Aquablation technology into this new area. If successful, the company could tap into a highly lucrative segment of the healthcare market, further boosting its revenues and overall growth.

Notable Developments for PRCT

In August, PRCT announced FDA 510(k) clearance of its next-generation platform, the HYDROS Robotic System. The HYDROS Robotic System represents the next evolution in the delivery of Aquablation therapy, combining cutting-edge technology with user-friendly features designed to deliver better clinical outcomes for patients and healthcare providers.

In June, the company announced that the American Medical Association had established a new Current Procedural Terminology Category I code for transurethral waterjet resection of prostate tissue (Aquablation therapy) to treat BPH.

PRCT’s Zacks Rank & Other Stocks to Consider

PRCT carries a Zacks Rank #2 (Buy) at present.

Some other top-ranked stocks in the broader medical space are Inspire Medical (INSP - Free Report) , TransMedics Group (TMDX - Free Report) and Boston Scientific (BSX - Free Report) . While Intuitive Surgical and TransMedics currently sport a Zacks Rank #1 (Strong Buy), Quest Diagnostics carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.

Inspire Medical’s shares have surged 60.5% in the past year. Estimates for the company’s earnings have moved 5.1% north to $1.65 per share for 2024 in the past 30 days.

ISRG’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 436.2%. In the last reported quarter, it posted an earnings surprise of 328.6%.

Estimates for TransMedics’ 2024 EPS have moved up 125% to 27 cents in the past 30 days. Shares of the company have soared 135.2% in the past year compared with the industry’s 14.9% growth.

TMDX’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 287.50%. In the last reported quarter, it delivered an earnings surprise of 66.67%.

Estimates for Boston Scientific’s 2024 EPS have increased 1.7% to $2.40 in the past 30 days. In the past year, shares of BSX have risen 55.5% compared with the industry’s 17.9% growth.

In the last reported quarter, BSX delivered an earnings surprise of 6.90%. Its earnings surpassed estimates in each of the trailing four quarters, the average surprise being 7.18%.

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