PROCEPT BioRobotics Announces FDA Clearance of the HYDROS™ Robotic System, the Next-Generation, AI-Powered Platform for Aquablation® Therapy
PROCEPT BioRobotics (Nasdaq: PRCT) has announced FDA 510(k) clearance for its HYDROS™ Robotic System, a next-generation platform for Aquablation® therapy. This AI-powered system is designed to improve efficiency, enhance surgeon experience, and deliver more accurate treatment plans for better clinical outcomes in urology.
Key features of HYDROS include:
- FirstAssist AI™ for treatment planning
- Advanced image guidance with integrated ultrasound and cystoscopy
- Robotic resection using a heat-free waterjet
- Streamlined workflow with a single-footprint integrated tower
The company expects HYDROS to be fully available in the current quarter across U.S. hospitals. PROCEPT BioRobotics has reaffirmed its 2024 financial guidance following this announcement.
PROCEPT BioRobotics (Nasdaq: PRCT) ha annunciato l'approvazione FDA 510(k) per il suo HYDROS™ Robotic System, una piattaforma di nuova generazione per la terapia di Aquablation®. Questo sistema alimentato dall'IA è progettato per migliorare l'efficienza, arricchire l'esperienza del chirurgo e fornire piani di trattamento più accurati per migliori risultati clinici in urologia.
Le caratteristiche principali di HYDROS includono:
- FirstAssist AI™ per la pianificazione del trattamento
- Guida all'immagine avanzata con ultrasuoni e cistoscopia integrati
- Asportazione robotica utilizzando un getto d'acqua a temperatura ambiente
- Flusso di lavoro semplificato con una torre integrata a ingombro ridotto
L'azienda prevede che HYDROS sarà pienamente disponibile nel trimestre attuale negli ospedali statunitensi. PROCEPT BioRobotics ha confermato le sue previsioni finanziarie per il 2024 a seguito di questo annuncio.
PROCEPT BioRobotics (Nasdaq: PRCT) ha anunciado la aprobación FDA 510(k) para su Sistema Robótico HYDROS™, una plataforma de próxima generación para la terapia Aquablation®. Este sistema impulsado por IA está diseñado para mejorar la eficiencia, enriquecer la experiencia del cirujano y ofrecer planes de tratamiento más precisos para mejores resultados clínicos en urología.
Las características clave de HYDROS incluyen:
- FirstAssist AI™ para la planificación del tratamiento
- Guía de imagen avanzada con ultrasonido y cistoscopia integrados
- Resección robótica usando un chorro de agua sin calor
- Flujo de trabajo optimizado con una torre integrada de huella única
La empresa espera que HYDROS esté completamente disponible en el trimestre actual en los hospitales de EE. UU. PROCEPT BioRobotics ha reafirmado su guía financiera para 2024 tras este anuncio.
PROCEPT BioRobotics (Nasdaq: PRCT)는 HYDROS™ 로봇 시스템의 FDA 510(k) 승인을 발표했습니다. 이는 Aquablation® 치료를 위한 차세대 플랫폼입니다. 이 AI 기반 시스템은 효율성을 개선하고, 외과 의사의 경험을 향상시키며, 보다 정확한 치료 계획을 제공하여 비뇨기학에서 더 나은 임상 결과를 제공합니다.
HYDROS의 주요 기능은 다음과 같습니다:
- 치료 계획을 위한 FirstAssist AI™
- 통합 초음파 및 방광경을 갖춘 고급 이미지 안내
- 무열수젯을 이용한 로봇 절제
- 단일 발자국 통합 타워를 통한 간소화된 작업 흐름
회사는 HYDROS가 현재 분기 내에 미국 병원에서 완전히 이용 가능할 것으로 예상하고 있습니다. PROCEPT BioRobotics는 이번 발표에 따라 2024년 재무 가이드를 재확인했습니다.
PROCEPT BioRobotics (Nasdaq: PRCT) a annoncé l'approbation FDA 510(k) de son Système Robotique HYDROS™, une plateforme de nouvelle génération pour la thérapie Aquablation®. Ce système alimenté par l'IA est conçu pour améliorer l'efficacité, enrichir l'expérience du chirurgien et fournir des plans de traitement plus précis pour de meilleurs résultats cliniques en urologie.
Les caractéristiques clés de HYDROS incluent :
- FirstAssist AI™ pour la planification du traitement
- Guidage d'image avancé avec échographie et cystoscopie intégrées
- Resection robotique à l'aide d'un jet d'eau sans chaleur
- Flux de travail rationalisé avec une tour intégrée à empreinte unique
L'entreprise prévoit que HYDROS sera entièrement disponible au cours du trimestre actuel dans les hôpitaux américains. PROCEPT BioRobotics a confirmé ses prévisions financières pour 2024 à la suite de cette annonce.
PROCEPT BioRobotics (Nasdaq: PRCT) hat die FDA 510(k)-Zulassung für ihr HYDROS™ Robotic System bekannt gegeben, eine Plattform der nächsten Generation für die Aquablation®-Therapie. Dieses KI-gestützte System ist darauf ausgelegt, die Effizienz zu verbessern, das Chirurgenerlebnis zu optimieren und genauere Behandlungspläne für bessere klinische Ergebnisse in der Urologie zu liefern.
Die Hauptmerkmale von HYDROS sind:
- FirstAssist AI™ für die Behandlungsplanung
- Erweiterte Bildführung mit integriertem Ultraschall und Cystoskopie
- Robotische Resektion mit einem kältefreien Wasserstrahl
- Optimierter Arbeitsablauf mit einem integrierten Turm in kompakter Bauweise
Das Unternehmen erwartet, dass HYDROS im laufenden Quartal in den US-Krankenhäusern vollständig verfügbar sein wird. PROCEPT BioRobotics hat nach dieser Bekanntgabe seine Finanzprognose für 2024 bekräftigt.
- FDA 510(k) clearance received for the HYDROS™ Robotic System
- AI-powered treatment planning with FirstAssist AI™
- Advanced image guidance with integrated ultrasound and cystoscopy
- Streamlined workflow expected to improve efficiency and user experience
- Full market release planned within the current quarter
- Reaffirmation of 2024 financial guidance
- None.
Insights
The FDA clearance of PROCEPT BioRobotics' HYDROS™ Robotic System marks a significant advancement in BPH treatment. The integration of AI-powered planning and advanced imaging could potentially improve surgical precision and outcomes. This next-generation platform addresses key aspects of procedural efficiency and standardization, which may accelerate adoption among urologists.
The system's ability to suggest optimal treatment plans using FirstAssist AI™ could be a game-changer for less experienced surgeons, potentially reducing the learning curve and improving consistency across procedures. The streamlined workflow and ergonomic design may also enhance operating room efficiency, a important factor for hospitals considering new technology investments.
While the clinical benefits are promising, the market response and adoption rate will be critical to watch. The company's ability to effectively train surgeons and demonstrate clear advantages over existing methods will be key to its commercial success.
PROCEPT BioRobotics' launch of the HYDROS™ system could be a significant catalyst for growth. With over 400 systems already installed in the U.S., this upgrade path may drive both new system sales and potential upgrades from existing customers. The reaffirmation of 2024 financial guidance suggests management's confidence in the commercial rollout.
Investors should note the potential for increased recurring revenue if the new system leads to higher procedure volumes or consumable usage. The AI and advanced imaging features may also command premium pricing, potentially improving margins.
However, it's important to monitor the adoption rate and any associated costs for marketing and training. The company's ability to manage the transition from existing systems to HYDROS without disrupting current revenue streams will be key. Long-term success will depend on clinical data supporting improved outcomes and cost-effectiveness to justify the investment for healthcare providers.
The HYDROS™ Robotic System represents a significant leap in BPH treatment technology. The integration of AI for treatment planning addresses a critical challenge in prostate surgery: accurately identifying and preserving critical structures. This could potentially reduce complications and improve functional outcomes for patients.
The system's ability to standardize the Aquablation procedure across various prostate sizes and shapes is particularly noteworthy. This could expand the eligible patient population and make the treatment more accessible to a broader range of urologists.
However, the true clinical impact will need to be validated through real-world data and comparative studies. Urologists will be keen to see evidence of improved outcomes, reduced operative times and potential cost savings before widely adopting this new technology. The learning curve and training requirements for existing Aquablation users transitioning to HYDROS will also be a factor to consider in its initial rollout and adoption.
Designed to improve efficiency, enhance surgeon and staff experience and deliver a more accurate and consistent treatment plan for better clinical outcomes
SAN JOSE, Calif., Aug. 21, 2024 (GLOBE NEWSWIRE) -- PROCEPT BioRobotics® Corporation (Nasdaq: 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:
Dial-in registration for sell-side research analysts:
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.
Forward Looking Statements
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
m.bacso@procept-biorobotics.com
Media Contact:
Lauren Cohen
Senior Director, Integrated Marketing Communications
l.cohen@procept-biorobotics.com
FAQ
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