Monogram Technologies Submits 510(k) Application for mBôs TKA System Clearance
Monogram Technologies (NASDAQ:MGRM) has submitted a 510(k) premarket filing to the FDA for its mBôs TKA System, an AI-driven robotic system for orthopedic surgery. The 28,214-page application, submitted on July 19, 2024, has passed the FDA Administrative Review. An FDA decision is expected within 90 days, though the process may be paused if additional information is requested.
The submission represents a significant milestone for Monogram and is expected to be a catalyst for institutional engagement. The company believes the application is strong, with thorough testing based on FDA feedback. Several orthopedic surgeons have expressed support for the mBôs system, praising its focus on patient safety, accuracy, and efficiency. Monogram anticipates that this submission will open up funding opportunities and increase traction with institutional players.
Monogram Technologies (NASDAQ:MGRM) ha presentato una domanda di premarket 510(k) alla FDA per il suo mBôs TKA System, un sistema robotico guidato dall'IA per la chirurgia ortopedica. La richiesta di 28.214 pagine, inviata il 19 luglio 2024, ha superato la revisione amministrativa della FDA. Una decisione da parte della FDA è prevista entro 90 giorni, anche se il processo potrebbe essere sospeso se vengono richieste ulteriori informazioni.
Questa presentazione rappresenta una pietra miliare significativa per Monogram ed è attesa come un catalizzatore per il coinvolgimento istituzionale. L'azienda è convinta che la domanda sia solida, con test approfonditi basati sul feedback della FDA. Diversi chirurghi ortopedici hanno espresso sostegno per il sistema mBôs, lodandone l'attenzione alla sicurezza dei pazienti, all'accuratezza e all'efficienza. Monogram prevede che questa richiesta aprirà opportunità di finanziamento e aumenterà la trazione con gli operatori istituzionali.
Monogram Technologies (NASDAQ:MGRM) ha presentado una solicitud de premercado 510(k) a la FDA para su sistema mBôs TKA, un sistema robótico impulsado por IA para la cirugía ortopédica. La solicitud de 28,214 páginas, presentada el 19 de julio de 2024, ha pasado la revisión administrativa de la FDA. Se espera una decisión de la FDA dentro de los 90 días, aunque el proceso puede ser pausado si se solicita información adicional.
La presentación representa un hito significativo para Monogram y se espera que sea un catalizador para el compromiso institucional. La empresa cree que la solicitud es sólida, con pruebas exhaustivas basadas en los comentarios de la FDA. Varios cirujanos ortopédicos han expresado su apoyo al sistema mBôs, elogiando su enfoque en la seguridad del paciente, la precisión y la eficiencia. Monogram anticipa que esta presentación abrirá oportunidades de financiamiento y aumentará el interés de los actores institucionales.
모노그램 테크놀로지스 (NASDAQ:MGRM)는 FDA에 mBôs TKA 시스템에 대한 510(k) 사전 시장 제출을 했습니다. 이는 정형 외과 수술을 위한 AI 기반 로봇 시스템입니다. 28,214페이지에 이르는 신청서는 2024년 7월 19일에 제출되었으며 FDA 관리 검토를 통과했습니다. FDA의 결정은 90일 이내에 예상되지만 추가 정보 요청 시 절차가 중단될 수 있습니다.
이번 제출은 모노그램에게 중요한 이정표가 되며, 기관의 참여를 촉진할 것으로 기대됩니다. 회사는 이 신청이 매우 견고하다고 믿고 있으며, FDA의 피드백을 바탕으로 철저한 테스트를 거쳤습니다. 여러 정형 외과 의사들은 mBôs 시스템에 대한 지지를 표명하며, 환자 안전, 정확성 및 효율성에 대한 초점을 칭찬했습니다. 모노그램은 이번 제출이 자금 조달 기회를 열고 기관 투자자들과의 관계를 강화할 것이라고 예상하고 있습니다.
Monogram Technologies (NASDAQ:MGRM) a soumis un dossier 510(k) au FDA pour son système mBôs TKA, un système robotique piloté par IA pour la chirurgie orthopédique. La demande de 28 214 pages, soumise le 19 juillet 2024, a passé l'examen administratif de la FDA. Une décision de la FDA est attendue dans les 90 jours, bien que le processus puisse être suspendu si des informations supplémentaires sont demandées.
Cette soumission représente une étape importante pour Monogram et est attendue comme un catalyseur pour l'engagement institutionnel. L'entreprise estime que le dossier est solide, avec des tests approfondis basés sur les retours de la FDA. Plusieurs chirurgiens orthopédiques ont exprimé leur soutien au système mBôs, louant son attention à la sécurité des patients, à la précision et à l'efficacité. Monogram anticipe que cette soumission ouvrira des opportunités de financement et augmentera l'attrait auprès des acteurs institutionnels.
Monogram Technologies (NASDAQ:MGRM) hat einen 510(k) Vorantrag bei der FDA für sein mBôs TKA System, ein KI-gesteuertes robotisches System für die Orthopädie, eingereicht. Der 28.214 Seiten umfassende Antrag wurde am 19. Juli 2024 eingereicht und hat die administrative Prüfung der FDA bestanden. Eine Entscheidung der FDA wird innerhalb von 90 Tagen erwartet, wobei der Prozess pausiert werden kann, wenn zusätzliche Informationen angefordert werden.
Die Einreichung stellt einen bedeutenden Meilenstein für Monogram dar und wird als Katalysator für institutionelles Engagement angesehen. Das Unternehmen ist überzeugt, dass der Antrag stark ist und auf umfassenden Tests basiert, die auf dem Feedback der FDA beruhen. Mehrere orthopädische Chirurgen haben ihre Unterstützung für das mBôs System bekundet und dessen Fokus auf Patientensicherheit, Präzision und Effizienz gelobt. Monogram erwartet, dass diese Einreichung Finanzierungsmöglichkeiten eröffnet und die Bindung zu institutionellen Akteuren verstärkt.
- Successful submission of 510(k) premarket filing to FDA for mBôs TKA System
- Application passed FDA Administrative Review
- Strong support from experienced orthopedic surgeons
- Potential for increased institutional engagement and funding opportunities
- Comprehensive 28,214-page submission based on rigorous testing and FDA feedback
- FDA decision process may be paused if additional information is requested
- Commercialization timeline uncertain pending FDA clearance
Insights
The submission of Monogram's 510(k) application for the mBôs TKA System is a significant milestone in the regulatory process. The 28,214-page submission demonstrates the depth of data provided, which is important for FDA review. The company's engagement with the FDA through pre-submission feedback and teleconference meetings is a positive sign, potentially streamlining the review process.
However, investors should note that while an FDA decision is expected within 90 days, this timeline may be extended if additional information is requested. The
The mBôs TKA System appears to be a significant advancement in robotic-assisted orthopedic surgery. The endorsements from high-volume surgeons like Dr. Fabio Orozco and Dr. Robert Jamieson, who perform 1,000 and "thousands" of knee replacements annually, respectively, lend credibility to the system's potential impact.
The system's focus on patient safety, accuracy and efficiency addresses key concerns in orthopedic surgery. The comparison to the "most recent iPhone" suggests a substantial leap in technology. However, the true clinical impact and adoption rate will only be determined post-market and investors should be cautious about overly optimistic projections without real-world data.
Monogram's mBôs TKA System represents a potential leap forward in AI-driven robotics for orthopedic surgery. The system's reported ability to scale to other applications sets it apart from current market offerings, which could be a significant competitive advantage.
The emphasis on AI-driven computer vision and high-efficiency surgeon-assisted robotics aligns with broader trends in medical technology. However, the lack of specific technical details or comparative performance metrics makes it challenging to fully assess the system's capabilities. Investors should seek more concrete data on the AI's decision-making processes and the extent of its autonomy to better understand its market potential and any associated risks.
Application was Submitted on July 19, 2024, Passed the FDA Administrative Review, and is Now Under Substantive Review
FDA Decision is Expected Within 90 Days of Initial Submission; However, the Process May be Paused if Additional Information is Requested
AUSTIN, TX / ACCESSWIRE / August 8, 2024 / Monogram Technologies Inc. (NASDAQ:MGRM) ("Monogram" or the "Company"), an AI-driven robotics company focused on improving human health with an initial focus on orthopedic surgery, today announced that it has submitted a 510(k) premarket filing to the U.S. Food and Drug Administration (FDA) for the Company's mBôs TKA System. The application was submitted on July 19, 2024, and passed the FDA Administrative Review. An FDA decision is expected within 90 days of the initial submission; however, the process may be paused if additional information is requested.
"The 28,214-page submission is the culmination of over eight years and thousands of hours, comprising verification and validation from numerous, extremely rigorous tests including simulated cadaveric surgeries by fifteen surgeons," said Ben Sexson, CEO of Monogram Technologies. "This FDA submission for the mBôs TKA System represents a significant milestone for Monogram in our journey to improve human health with our precision robotic surgical system and should be an essential catalyst for institutional engagement.
"I would like to thank our entire team for their incredible hard work and dedication, including Kamran Shamaei and engineering leadership, Muhammad Afnan, Pedro Alfonso, Gerardo Gonzalez, Daniel Grunden, Ani Nayak, and Nisha Patel. I would also like to thank our founder and Chief Medical Officer, Dr. Doug Unis, for starting this vision many years ago. The work undertaken by such a small group is a true testament to our incredible teamwork. No task was too small, and the team worked extremely hard to get this done in a timely manner, driven by our mission to advance the standard of care for orthopedic patients," concluded Sexson.
Dave McGurl, Vice President of Regulatory Affairs at MCRA, said, "We believe that this is a very strong application. The team did a thorough job, with strong support for their arguments and thorough testing based on FDA feedback. The quality of the documentation is high, and I'm confident it will be evident to the FDA how much work went into developing this system."
The submission follows recent FDA written feedback regarding Monogram's pre-submission request and a teleconference meeting to discuss further the Monogram mBôs™ TKA System verification test plan, including a proposed clinical trial protocol on an outside the U.S. (OUS) target population. Management believes the feedback was comprehensive and will be advantageous for a successful 510(k) submission to obtain clearance, commercialization, and marketing for the mBôs™ TKA System.
Kamran Shamaei, Chief Technology Officer at Monogram, added, "We are more committed than ever to see this vision materialize. The team is already pushing the next-gen technology and other clinical applications. We believe our system will fit a unique market opportunity we intend to exploit. Robots on the market today have limitations, including the inability to scale to other applications. We believe AI-driven computer vision and high-efficiency surgeon-assisted robotics with an uncompromised focus on safety and accuracy will become the de facto choice in the future."
"I do approximately 1,000 knees per year, and all robotically," said Dr. Fabio Orozco. "The Monogram mBôs prioritizes patient safety and accuracy with uncompromised efficiency and ease of use. I demand only the best for my patients and feel the mBôs is a significant step forward for the orthopedic market. After having done robotic surgery for ten years, I genuinely believe that Monogram's will be the most advanced technology and will have the biggest impact on orthopedic surgery once it is released. After clearance, I plan to support Monogram's commercial launch. Dr. Orozco is the president of Orozco Orthopaedics in South Jersey and is the Director of orthopedic surgery and robotics at AtlantiCare Regional Medical Center. Dr. Orozco did his residency and fellowship at Thomas Jefferson University Hospital, where he serves as an associate professor.
"I have done thousands of Total Knee Replacements and used many of the most advanced technologies on the market," said Dr. Robert Jamieson. "I have helped support Monogram's development of the mBôs and also participated in the Verification and Validation testing for the FDA. In my opinion, Monogram's mBôs is like the most recent iPhone, and the competition is still the first-generation iPhone. What excites me the most about Monogram and the mBôs is its potential for the future. A high-efficiency robot with high autonomy has the potential to be transformative for the orthopedic market. Monogram's leadership is dedicated to advancing the state of the art in orthopedic medicine. Management is highly dedicated to patient safety in all aspects of their product design, and it shows. After clearance, I plan to support Monogram's commercial launch. Dr. Robert Jamieson recently left private practice in Northern California and is now joining Intermountain Health in St. George, UT. Dr. Jamieson completed his fellowship at the Joint Replacement Institute in Los Angeles.
"My team performs approximately 300 total knee replacement surgeries annually, and
"Our 510(k) submission marks another major milestone on the road to building the next generation of orthopedic robotics," said Dr. Doug Unis, founder and Chief Medical Officer. "Thanks to the tireless work of our incredible team, the day I can use the mBôs in my operating room continues to grow closer."
Monogram's Chief Financial Officer Noel Knape said, "We anticipate this submission will open up funding opportunities, and we are seeing continued traction with institutional players as we execute our milestones."
About Monogram Technologies Inc.
Monogram Technologies (NASDAQ:MGRM) is an AI-driven robotics company focused on improving human health, with an initial focus on orthopedic surgery. The Company is developing a product solution architecture to enable patient-optimized orthopedic implants at scale by combining 3D printing, advanced machine vision, AI and next-generation robotics.
Monograms mBôs precision robotic surgical system is designed to autonomously execute optimized paths for high-precision insertion of its FDA-cleared mPress press-fit implants. The goal is well balanced better-fitting bone sparing knee replacements. The Company initially intends to produce and market robotic surgical equipment and related software, orthopedic implants, tissue ablation tools, navigation consumables, and other miscellaneous instrumentation necessary for reconstructive joint replacement procedures. Other clinical and commercial applications for the mBôs with mVision navigation are also being explored.
Monogram has obtained FDA clearance for mPress implants and applied for 510(k) clearance for its robotic products. The Company is required to obtain FDA clearance before it can market its products. Monogram cannot estimate the timing or assure the ability to obtain such clearances.
The Company believes that its mBôs precision robotic surgical assistants, which combine AI and novel navigation methods (mVision), will enable more personalized knee implants for patients, resulting in well balanced better-fitting knee replacements with bone sparing implants. Monogram anticipates that there may be other clinical and commercial applications for its navigated mBôs precision robot and mVision navigation.
To learn more, visit monogramtechnologies.com.
Forward-Looking Statements
This press release may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Statements other than statements of historical facts included in this press release may constitute forward-looking statements and are not guarantees of future performance or results and involve a number of risks and uncertainties. For example, the Company's statement regarding the Company's proposed use of net proceeds is a forward-looking statement. Forward-looking statements, other than statements of historical fact, are highly likely to be affected by other unknowable future events and conditions, including elements of the future that are or are not under our control, and that the Company may or may not have considered; accordingly, such statements cannot be guarantees or assurances of any aspect of future performance. Actual developments and results are highly likely to vary materially from any forward-looking statements as a result of a number of factors, including those described in the prospectus and the Company's other filings with the SEC. The Company undertakes no duty to update any forward-looking statement made herein. All forward-looking statements speak only as of the date of this press release.
Investor Relations
Chris Tyson
Executive Vice President
MZ North America
Direct: 949-491-8235
MGRM@mzgroup.us
SOURCE: Monogram Technologies Inc.
View the original press release on accesswire.com
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