PROCEPT BioRobotics Receives FDA Clearance for Advanced Urology System, Analysts Maintain Buy Rating

Truist maintains a buy rating on Procept BioRobotics shares By Investing.com

On Wednesday, Procept BioRobotics Corp (NASDAQ:PRCT) received a reaffirmed Buy rating and a $74.00 price target from Truist Securities. The firm's endorsement follows Procept's announcement of its next-generation HYDROS robotic platform, which is designed to deliver aquablation therapy for benign prostate hyperplasia (BPH). The new HYDROS system is seen as a significant development as it could lead to quicker adoption in the existing market for BPH and cancer treatments. It addresses certain operational issues, such as reducing setup and teardown time and integrating a scope, which may facilitate broader use beyond the initial customer base. Truist Securities believes that this advanced platform marks a critical step in sustaining long-term growth for Procept BioRobotics. The introduction of this technology is also timely, offering a new product cycle that could attract investors looking for companies with potential growth catalysts as they position for the 2025-2026 period and beyond. The analyst from Truist Securities emphasized the importance of the HYDROS robotic platform in potentially expanding the total addressable market (TAM) for Procept. This next-generation system is expected to advance the company's reach within an already underpenetrated market. In summary, the reiteration of the Buy rating and the $74.00 price target reflects confidence in Procept BioRobotics' growth trajectory, underpinned by the launch of its new HYDROS robotic platform for BPH treatment. The company's strategic innovation is anticipated to catalyze adoption and broaden its market presence in the coming years. PROCEPT BioRobotics Corporation made significant strides with both product advancements and robust financial growth. The FDA granted 510(k) clearance to the company's HYDROS Robotic System, which incorporates FirstAssist AI for treatment planning and advanced image guidance. The system aims to enhance the precision and efficiency of urological procedures, with a focus on Aquablation therapy, which has seen over 400 installations in the U.S. PROCEPT reported a substantial 61% increase in total earnings for its second quarter of 2024, reaching $53.4 million. This growth was attributed to strong U.S. system sales, an expanded U.S. install base, and record international revenues. Despite a reported net loss of $25.6 million, the company's financial outlook remains positive, with an anticipated gross margin of approximately 59% and projected operating expenses around $231.5 million. Finally, the company announced the addition of Larry Wood and Tom Prescott to its Board of Directors, strengthening its leadership team. As Procept BioRobotics Corp (NASDAQ:PRCT) continues to innovate with its HYDROS robotic platform, investors are closely monitoring its financial health and market performance. According to real-time data from InvestingPro, Procept has a market capitalization of $3.38 billion, suggesting a robust market presence. Despite not being profitable over the last twelve months, the company has seen a remarkable revenue growth of 73.74% in the same period, indicating significant market traction for its products. InvestingPro Tips also highlight that analysts have recently revised their earnings upwards for the upcoming period, which could signal growing confidence in Procept's financial outlook. However, they do not expect the company to be profitable this year. With a high Price / Book multiple of 13.41, Procept is trading at a premium, which may reflect its growth potential and innovative edge in the medical device sector. Furthermore, the company's liquid assets exceed its short-term obligations, providing financial flexibility to support ongoing operations and research and development efforts. Investors may find additional insights and tips on Procept BioRobotics by visiting InvestingPro, which includes a total of 11 InvestingPro Tips for a more comprehensive analysis. These tips could provide valuable context for evaluating the company's future prospects, especially as it embarks on new product cycles that could shape its growth trajectory in the years ahead.

FDA clears PROCEPT BioRobotics' advanced urology system By Investing.com

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. 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.

PROCEPT BioRobotics Announces FDA Clearance of the HYDROS™ Robotic System, the Next-Generation, AI-Powered Platform for Aquablation® Therapy - PROCEPT BioRobotics (NASDAQ:PRCT)

SAN JOSE, Calif., Aug. 21, 2024 (GLOBE NEWSWIRE) -- PROCEPT BioRobotics® Corporation PRCT (the "Company"), a surgical robotics company focused on advancing patient care by developing transformative solutions in urology, today announced FDA 510(k) clearance of its next-generation platform, the HYDROS™ Robotic System. Leveraging insights from over 50,000 procedures, HYDROS features FirstAssist AI™ treatment planning, advanced image guidance, robotic resection, and a streamlined workflow. HYDROS is designed to improve efficiency, enhance surgeon and staff experience and deliver a more accurate and consistent treatment plan for better clinical outcomes. "We are pleased to bring the HYDROS Robotic System to the U.S. market," said Reza Zadno, CEO of PROCEPT BioRobotics. "This milestone marks a pivotal moment for PROCEPT as Aquablation therapy continues its rapid adoption, with over 400 robotic systems now installed across the United States. After years of research and development, HYDROS introduces significant technological advancements designed for mass-market adoption, and we believe will power the next phase of our growth." "As a urologist, my goal is to treat my patients' symptoms while preserving their quality of life. Aquablation therapy has been instrumental in helping me achieve this for patients struggling with BPH," said Dr. Steven Kaplan, Icahn School of Medicine at Mount Sinai. "The HYDROS Robotic System advances this further by utilizing the power of AI to better read and interpret ultrasound for optimal surgical planning." 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. Key Features of the Fully Integrated HYDROS Robotic System Include: AI-Powered Treatment Planning: FirstAssist AI, built from a library of real-world Aquablation therapy procedures, uses advanced image recognition software to accurately identify critical anatomy on ultrasound and suggest an optimal treatment plan for each patient.Advanced Image Guidance: The system integrates next-generation ultrasound imaging, digital cystoscopy, and dual high-definition touchscreens providing enhanced visualization of the anatomy and simultaneous viewing of ultrasound and cystoscopy images.Robotic Resection: Utilizing a heat-free waterjet, the robot executes the surgeon-defined treatment plan to resect obstructive tissue while protecting critical anatomy. This enables efficient and predictable waterjet execution, standardizing the operative experience across a wide range of prostate sizes and shapes.Streamlined Workflow: Designed to improve the surgeon and staff experience at every stage of the Aquablation therapy procedure. With a single-footprint, the integrated tower facilitates efficient operating room setup and turnover. The adjustable touchscreen improves surgeon ergonomics with midline placement, and the instinctive software interface simplifies procedural workflow. "The HYDROS Robotic System is a game-changer for new surgeons. I believe the streamlined system along with the system's intraoperative AI capabilities provide a tool to suggest an optimal treatment, helping surgeons learn the procedure faster and with greater precision," said Dr. Brian Helfand, NorthShore's Chief of Urology and Clinical Professor at the University of Chicago. "The HYDROS Robotic System is a testament to our commitment to innovation. By integrating AI and advanced imaging into the robotic platform, we are providing surgeons with the tools they need to deliver precise, efficient, and high-quality care," said Sham Shiblaq, Chief Commercial Officer. "HYDROS will move to full market release within the current quarter and be available immediately to hospitals across the United States." 2024 Financial Guidance Update: In conjunction with today's announcement, the Company is reaffirming its 2024 financial guidance, which was initially provided on the most recent second quarter 2024 earnings conference call on August 1, 2024. Webcast and Conference Call Information PROCEPT BioRobotics will host a conference call on Wednesday, August 21, 2024, at 8:00 a.m. Eastern Time to discuss the HYDROS Robotic System key features, benefits, and commercial launch plans. Investors interested in listening to the conference call may do so by following one of the below links: Webcast link for interested listeners: https://edge.media-server.com/mmc/p/q3dbybx5/ Dial-in registration for sell-side research analysts: https://register.vevent.com/register/BI4959cac15c6540aa97a4d156af947d55 For more information on the HYDROS Robotic System, visit www.procept-biorobotics.com/hydros About Aquablation Therapy and the HYDROS Robotic System The HYDROS Robotic System is the only AI-powered platform that delivers Aquablation therapy for BPH. The clinically proven procedure uses real-time ultrasound imaging combined with cystoscopy to provide the surgeon with a multi-dimensional, detailed view of the entire prostate, enabling personalized treatment planning tailored to each patient's unique anatomy. With the HYDROS Robotic System, the surgeon can now use AI to specify which areas of the prostate to resect while avoiding the anatomy that controls erectile function, ejaculatory function, and continence. Once the treatment plan is mapped by the surgeon, the predictable robotic-assisted waterjet execution enables prostate tissue to be resected in a precise, targeted, and controlled fashion. Aquablation therapy is backed by two 5-year clinical trials demonstrating significant durable symptom relief while preserving sexual function and continence across prostates of all shapes and sizes. About PROCEPT BioRobotics Corporation PROCEPT BioRobotics is a surgical robotics company focused on advancing patient care by developing transformative solutions in urology. The HYDROS Robotic System is the only AI-Powered, robotic technology that delivers Aquablation therapy. PROCEPT BioRobotics designed Aquablation therapy to deliver effective, safe, and durable outcomes for males suffering from lower urinary tract symptoms or LUTS, due to BPH that are independent of prostate size and shape or surgeon experience. BPH is the most common prostate disease and impacts approximately 40 million men in the United States. The Company has developed a significant and growing body of clinical evidence with over 150 peer-reviewed publications, supporting the benefits and clinical advantages of Aquablation therapy. This release contains forward‐looking statements within the meaning of federal securities laws, including with respect to the Company's projected financial performance for full year 2024 and statements regarding the potential utilities, values, benefits and advantages of Aquablation® therapy performed using PROCEPT BioRobotics' products, including HYDROS™ Robotic System, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements. Forward-looking statements are only predictions based on our current expectations, estimates, and assumptions, valid only as of the date they are made, and subject to risks and uncertainties, some of which we are not currently aware. Forward-looking statements may include statements regarding financial guidance, market opportunity and penetration, the Company's possible or assumed future results of operations, including descriptions of the Company's revenues, gross margin, profitability, operating expenses, installed base growth, commercial momentum, reimbursement coverage, overall business strategy, or information regarding the impact of other global events on the Company and its operations. Forward‐looking statements should not be read as a guarantee of future performance or results and may not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. These forward‐looking statements are based on the Company's current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward‐looking statements as a result of these risks and uncertainties. These risks and uncertainties are described more fully in the section titled "Risk Factors" in the Company's filings with the Securities and Exchange Commission (the "SEC"), including the Company's annual report on Form 10-K filed with the SEC on February 28, 2024. PROCEPT BioRobotics does not undertake any obligation to update forward‐looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward‐looking statements contained herein. These forward-looking statements should not be relied upon as representing PROCEPT BioRobotics' views as of any date subsequent to the date of this press release. Important Safety Information All surgical treatments have inherent and associated side effects. For a list of potential side effects visit https://aquablation.com/safety-information/. Investor Contact: Matt Bacso VP, Investor Relations and Business Operations [email protected] Lauren Cohen Senior Director, Integrated Marketing Communications [email protected] Market News and Data brought to you by Benzinga APIs