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SAN JOSE, Calif. - PROCEPT BioRobotics Corporation (NASDAQ:PRCT), a surgical robotics company, announced today that the U.S. Food and Drug Administration (FDA) has approved a pivotal clinical trial for Aquablation therapy as a potential treatment for localized prostate cancer. The therapy, which has received Breakthrough Device Designation, will be compared to radical prostatectomy in the forthcoming WATER IV PCa study.
Aquablation therapy is a robotic-assisted, heat-free waterjet treatment currently used for benign prostatic hyperplasia (BPH). This technology utilizes real-time ultrasound imaging to allow surgeons to personalize treatment plans, preserving critical anatomy for erectile and ejaculatory function and continence. The WATER IV PCa study aims to enroll up to 280 patients across up to 50 centers globally, tracking outcomes over a 10-year period, with a co-primary endpoint based on morbidity at six months.
Dr. Inderbir Gill, founding executive director of USC Urology, expressed optimism about the trial's potential to shift the standard treatment for millions of men with localized prostate cancer. The trial's design focuses on minimizing treatment-related harm while assessing long-term oncological outcomes.
PROCEPT BioRobotics believes that Aquablation therapy could become a first-line treatment for localized prostate cancer, a step that no other energy-based treatment has achieved to date. The company's AQUABEAM and HYDROS Robotic Systems deliver Aquablation therapy, which has been supported by over 150 peer-reviewed publications.
The announcement also addresses the company's broader mission of advancing patient care through innovative solutions in urology and its commitment to developing safe and effective treatments for prostate conditions.
The information in this article is based on a press release statement from PROCEPT BioRobotics. The FDA's approval of the IDE clinical trial marks a significant milestone in the evaluation of Aquablation therapy for the treatment of localized prostate cancer.
In other recent news, Procept BioRobotics has seen a significant increase in its share target prices by several analyst firms. TD Cowen, Truist Securities, and BofA Securities have all raised their target prices for Procept BioRobotics, reflecting confidence in the company's growth trajectory. This optimism is largely fueled by the recent FDA clearance of the Hydros robotic system, a product anticipated to enhance efficiency and clinical outcomes.
The Hydros system, which integrates AI-driven treatment planning and advanced image guidance, is expected to drive the company's growth. The system's potential has led to raised target prices from $75 to $99 by TD Cowen, $74 to $95 by Truist Securities, and $80 to $94 by BofA Securities, each maintaining a Buy rating on the stock.
In addition to the Hydros system, Procept BioRobotics has made significant strides in the prostate cancer space, with the completion of the 002 trial enrollment marking a key milestone in the company's efforts. This development is seen as a potential driver for the company's growth, second only to the Hydros system.
The company also reported a substantial 61% increase in total earnings for its second quarter of 2024, reaching $53.4 million, despite a reported net loss of $25.6 million. These financial developments are attributed to strong U.S. system sales, an expanded U.S. install base, and record international revenues.
These are the recent developments for Procept BioRobotics, a company that continues to make significant strides in product advancements and robust financial growth.
InvestingPro Insights
PROCEPT BioRobotics Corporation's (NASDAQ:PRCT) recent FDA approval for a pivotal clinical trial of Aquablation therapy in prostate cancer treatment aligns with the company's strong growth trajectory. According to InvestingPro data, PRCT has demonstrated impressive revenue growth of 73.74% over the last twelve months as of Q2 2024, with quarterly revenue growth of 61.17% in Q2 2024. This robust growth reflects the increasing adoption of the company's innovative technology in urology.
Despite the positive news and growth figures, it's important to note that PRCT is currently not profitable, with an operating income margin of -62.09% over the last twelve months. This is consistent with the InvestingPro Tip that analysts do not anticipate the company will be profitable this year. However, this is not uncommon for high-growth medical technology companies investing heavily in research and development.
The market appears to be optimistic about PRCT's future prospects, as evidenced by the stock's significant price appreciation. InvestingPro data shows a remarkable 132.21% price total return over the past year, with a 54.46% increase in the last six months alone. This performance aligns with the InvestingPro Tip highlighting the stock's high return over the last year.
For investors seeking a more comprehensive analysis, InvestingPro offers 11 additional tips for PROCEPT BioRobotics, providing deeper insights into the company's financial health and market position.
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