SAN JOSE, Calif. - PROCEPT BioRobotics Corporation (NASDAQ:PRCT), a company specializing in surgical robotics, announced today the FDA 510(k) clearance of its HYDROS™ Robotic System. The system, which incorporates FirstAssist AI™ for treatment planning and advanced image guidance, aims to enhance the precision and efficiency of urological procedures.
The HYDROS Robotic System is designed to provide a more accurate and consistent treatment plan, improving clinical outcomes. CEO Reza Zadno expressed optimism about the system's potential to facilitate the growth of Aquablation therapy, which has seen over 400 installations in the U.S. to date.
The system's AI-powered treatment planning utilizes a library of Aquablation therapy procedures to identify critical anatomy on ultrasound images. Advanced image guidance, robotic resection, and a streamlined workflow are among the key features that aim to improve the experience for surgeons and staff.
Dr. Steven Kaplan from the Icahn School of Medicine at Mount Sinai highlighted the system's ability to interpret ultrasound for surgical planning with the help of AI, which could be beneficial for patients with BPH (Benign Prostatic Hyperplasia).
PROCEPT has reaffirmed its 2024 financial guidance in conjunction with the announcement of the HYDROS Robotic System's clearance. The company will discuss the system's features, benefits, and commercial launch plans in a conference call today.
The HYDROS Robotic System is the only AI-powered platform delivering Aquablation therapy for BPH, a condition affecting approximately 40 million men in the U.S. The therapy has been backed by clinical trials demonstrating its effectiveness and safety.
This news article is based on a press release statement. It should be noted that forward-looking statements involve risks and uncertainties, and actual results may differ materially from those anticipated. For a list of potential side effects, interested parties can visit the Aquablation website.
In other recent news, PROCEPT BioRobotics Corporation has reported robust growth in its second quarter of 2024, with a significant 61% increase in total earnings to $53.4 million. This surge is credited to strong U.S. system sales, an expanded U.S. install base, and record international revenues. The company also welcomed Larry Wood and Tom Prescott to its Board of Directors, aiming to fortify its leadership team.
The firm's Q2 net loss was reported at $25.6 million, despite the strong sales. However, the company's outlook remains optimistic, with an anticipated gross margin of approximately 59% and operating expenses expected to be around $231.5 million.
PROCEPT's international growth is predominantly driven by the UK market, with a focus on building a robust sales team and onboarding new accounts. The company sold 47 AquaBeam Robotic Systems in the second quarter, generating $17.8 million in system revenue.
The firm's strategic initiatives include expanding its capital sales team, increasing surgeon activity, and exploring international opportunities, all of which are expected to support its ambitious growth trajectory. These recent developments indicate a positive outlook for PROCEPT BioRobotics Corporation.
InvestingPro Insights
PROCEPT BioRobotics Corporation's recent FDA clearance of its HYDROS™ Robotic System marks a significant step forward in the field of surgical robotics, particularly in the treatment of urological conditions. With the company's stock reacting to the news, let's delve into some key metrics and insights from InvestingPro that could help investors better understand PROCEPT's financial landscape.
The company's market capitalization stands at approximately $3.38 billion, reflecting the market's valuation of the company's potential growth and innovation in surgical robotics. Despite the optimism surrounding its technology, analysts have noted that PROCEPT is not expected to be profitable this year, pointing to a current Price/Earnings (P/E) ratio of -27.89 and an adjusted P/E ratio for the last twelve months as of Q2 2024 at -32.55. This suggests that investors are pricing in future growth, as current earnings do not justify the market cap.
However, PROCEPT's strong revenue growth of 73.74% over the last twelve months as of Q2 2024 indicates a rapid expansion in sales, a positive sign for the company's scale-up in operations. The company also operates with a moderate level of debt and has liquid assets that exceed its short-term obligations, which could provide financial stability and flexibility for further investments into research and development or market expansion.
InvestingPro Tips reveal that two analysts have revised their earnings upwards for the upcoming period, reflecting a positive sentiment about the company's future financial performance. Additionally, the company has experienced a high return over the last year, with a year-to-date price total return of 55.11% and a one-year price total return of 111.26%, signaling strong investor confidence in the stock.
For those looking to delve deeper into PROCEPT's financials and future prospects, InvestingPro offers additional tips and insights. Currently, there are 9 more InvestingPro Tips available for PROCEPT at https://www.investing.com/pro/PRCT, which could provide investors with a more comprehensive analysis of the company's financial health and market position.
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