Monogram Technologies Announces FDA 510(k) Clearance for the Monogram mBôsTM TKA System
Monogram Technologies (NASDAQ:MGRM) has received FDA 510(k) clearance for its Monogram mBôs TKA System, a robotic-assisted technology for total knee arthroplasty. The system is designed to deliver enhanced safety, efficiency, and accuracy in knee replacement procedures.
The clearance allows Monogram to market the device under the Federal Food, Drug, and Cosmetic Act's provisions. The company plans to integrate recent upgrades to the cutting system and other enhancements to strengthen its market competitiveness.
Monogram's commercialization strategy includes:
- Initial placements with key surgeon KOLs in strategic locations
- System demonstrations in real-world surgical settings
- Potential international expansion, including clinical trials in India with Shalby
- Development of additional clinical applications to establish it as a multi-application platform
Monogram Technologies (NASDAQ:MGRM) ha ricevuto l'approvazione FDA 510(k) per il suo Monogram mBôs TKA System, una tecnologia assistita da robot per l'artroplastica totale del ginocchio. Il sistema è progettato per offrire maggiore sicurezza, efficienza e precisione nelle procedure di sostituzione del ginocchio.
L'approvazione consente a Monogram di commercializzare il dispositivo secondo le disposizioni del Federal Food, Drug, and Cosmetic Act. L'azienda prevede di integrare recenti aggiornamenti al sistema di taglio e altre migliorie per rafforzare la sua competitività sul mercato.
La strategia di commercializzazione di Monogram include:
- Posizionamenti iniziali con chirurghi KOL chiave in località strategiche
- Dimostrazioni del sistema in contesti chirurgici reali
- Possibile espansione internazionale, inclusi studi clinici in India con Shalby
- Sviluppo di ulteriori applicazioni cliniche per stabilirlo come piattaforma multi-applicazione
Monogram Technologies (NASDAQ:MGRM) ha recibido la autorización FDA 510(k) para su Monogram mBôs TKA System, una tecnología asistida por robot para la artroplastia total de rodilla. El sistema está diseñado para ofrecer mayor seguridad, eficiencia y precisión en los procedimientos de reemplazo de rodilla.
La autorización permite a Monogram comercializar el dispositivo bajo las disposiciones de la Ley Federal de Alimentos, Medicamentos y Cosméticos. La empresa planea integrar actualizaciones recientes al sistema de corte y otras mejoras para fortalecer su competitividad en el mercado.
La estrategia de comercialización de Monogram incluye:
- Colocaciones iniciales con cirujanos KOL clave en ubicaciones estratégicas
- Demostraciones del sistema en entornos quirúrgicos del mundo real
- Posible expansión internacional, incluidos ensayos clínicos en India con Shalby
- Desarrollo de aplicaciones clínicas adicionales para establecerlo como una plataforma de múltiples aplicaciones
모노그램 테크놀로지스 (NASDAQ:MGRM)는 모노그램 mBôs TKA 시스템에 대해 FDA 510(k) 승인을 받았습니다. 이 로봇 보조 기술은 무릎 전체 치환술을 위한 것입니다. 이 시스템은 무릎 교체 절차에서 향상된 안전성, 효율성 및 정확성을 제공하도록 설계되었습니다.
이 승인은 모노그램이 연방 식품, 의약품 및 화장품 법의 조항에 따라 장치를 상업화할 수 있도록 합니다. 회사는 절단 시스템에 대한 최근 업그레이드와 기타 개선 사항을 통합하여 시장 경쟁력을 강화할 계획입니다.
모노그램의 상업화 전략은 다음과 같습니다:
- 전략적 위치에 있는 주요 외과 의사 KOL과의 초기 배치
- 실제 외과 환경에서 시스템 시연
- Shalby와 함께 인도에서의 임상 시험을 포함한 잠재적인 국제 확장
- 다중 응용 플랫폼으로 자리 잡기 위한 추가 임상 응용 프로그램 개발
Monogram Technologies (NASDAQ:MGRM) a reçu l'approbation FDA 510(k) pour son Monogram mBôs TKA System, une technologie assistée par robot pour l'arthroplastie totale du genou. Le système est conçu pour offrir une sécurité, une efficacité et une précision accrues lors des procédures de remplacement du genou.
Cette approbation permet à Monogram de commercialiser le dispositif conformément aux dispositions de la loi fédérale sur les aliments, les médicaments et les cosmétiques. L'entreprise prévoit d'intégrer des mises à jour récentes du système de coupe et d'autres améliorations pour renforcer sa compétitivité sur le marché.
La stratégie de commercialisation de Monogram comprend :
- Des placements initiaux avec des chirurgiens KOL clés dans des emplacements stratégiques
- Des démonstrations du système dans des environnements chirurgicaux réels
- Une expansion internationale potentielle, y compris des essais cliniques en Inde avec Shalby
- Le développement d'applications cliniques supplémentaires pour l'établir comme une plateforme multi-applications
Monogram Technologies (NASDAQ:MGRM) hat die FDA 510(k)-Zulassung für sein Monogram mBôs TKA System erhalten, eine roboterassistierte Technologie für die totale Kniearthroplastik. Das System ist darauf ausgelegt, in Knieersatzverfahren verbesserte Sicherheit, Effizienz und Genauigkeit zu bieten.
Die Zulassung ermöglicht es Monogram, das Gerät gemäß den Bestimmungen des Federal Food, Drug, and Cosmetic Act zu vermarkten. Das Unternehmen plant, kürzlich durchgeführte Upgrades des Schneidsystems und andere Verbesserungen zu integrieren, um seine Wettbewerbsfähigkeit auf dem Markt zu stärken.
Die Kommerzialisierungsstrategie von Monogram umfasst:
- Erstplatzierungen mit wichtigen Chirurgen KOLs an strategischen Standorten
- Systemdemonstrationen in realen chirurgischen Umgebungen
- Potenzielle internationale Expansion, einschließlich klinischer Studien in Indien mit Shalby
- Entwicklung zusätzlicher klinischer Anwendungen, um es als Multi-Anwendungsplattform zu etablieren
- FDA 510(k) clearance achieved for mBôs TKA System
- System designed for multiple orthopedic applications beyond knee replacement
- Strategic partnership with Shalby for Indian market expansion
- Market opportunity in underpenetrated robotic surgery segment
- Long sales cycle in orthopedic robotics market
- Highly consolidated market with established competitors
- Additional regulatory approvals needed for international expansion
Insights
The FDA 510(k) clearance for Monogram's mBôs TKA System represents a pivotal regulatory milestone that significantly transforms MGRM's commercial prospects. This clearance essentially converts MGRM from a pre-revenue R&D operation to a company with immediate commercialization potential in the $5+ billion orthopedic robotics market.
This development dramatically reduces regulatory risk and validates the company's core technology platform. With a market cap of just
The company's strategic approach to commercialization appears measured and realistic, acknowledging the long sales cycles typical in medical robotics. Their focus on key opinion leader (KOL) adoption and strategic placements demonstrates a disciplined go-to-market strategy that optimizes resources.
The potential for platform expansion beyond knee arthroplasty to additional orthopedic applications represents significant optionality value, as each new indication could multiply the addressable market. The international strategy, particularly the Shalby partnership targeting India, offers access to high-growth markets with less competition.
While revenue impact will take time to materialize given typical medical device adoption curves, this clearance fundamentally changes MGRM's risk profile and opens doors to potential strategic partnerships, licensing deals, or acquisition interest from larger players seeking innovative robotics technology.
The FDA 510(k) clearance for the mBôs TKA System represents a technically significant achievement in the orthopedic robotics space. The system's architecture appears designed with uncommon versatility, potentially positioning it as a platform technology rather than a single-application device.
What distinguishes this clearance is the complexity of robotic systems requiring 510(k) approval. Unlike simpler medical devices, robotic surgical platforms must demonstrate substantial equivalence while managing complex software, hardware integration, and safety protocols. Particularly noteworthy is the acknowledgment from Dr. Unis, who claims experience with all market competitors, suggesting potentially meaningful differentiation.
The system's CT-based imaging approach for personalized procedures aligns with leading-edge practices in precision orthopedics. The mention of recent cutting system upgrades indicates ongoing refinement even post-clearance, suggesting the company continues technical innovation while pursuing commercialization.
From a technical adoption perspective, securing KOL support is critical in this market, where surgeon preference heavily influences institutional purchasing decisions. The extended sales cycles in orthopedic robotics require developer patience, but early adopter feedback will prove important to gaining momentum.
The planned expansion to other orthopedic applications would leverage the core technology while expanding market potential. However, each new indication will require additional regulatory clearances and clinical validation. The international strategy targeting emerging markets like India could provide valuable real-world data while establishing presence in high-growth regions where competitors may have less established footprints.
The FDA 510(k) clearance for Monogram's mBôs TKA System represents a pivotal regulatory milestone that significantly transforms MGRM's commercial prospects. This clearance essentially converts MGRM from a pre-revenue R&D operation to a company with immediate commercialization potential in the $5+ billion orthopedic robotics market.
This development dramatically reduces regulatory risk and validates the company's core technology platform. With a market cap of just
The company's strategic approach to commercialization appears measured and realistic, acknowledging the long sales cycles typical in medical robotics. Their focus on key opinion leader (KOL) adoption and strategic placements demonstrates a disciplined go-to-market strategy that optimizes resources.
The potential for platform expansion beyond knee arthroplasty to additional orthopedic applications represents significant optionality value, as each new indication could multiply the addressable market. The international strategy, particularly the Shalby partnership targeting India, offers access to high-growth markets with less competition.
While revenue impact will take time to materialize given typical medical device adoption curves, this clearance fundamentally changes MGRM's risk profile and opens doors to potential strategic partnerships, licensing deals, or acquisition interest from larger players seeking innovative robotics technology.
The FDA 510(k) clearance for the mBôs TKA System represents a technically significant achievement in the orthopedic robotics space. The system's architecture appears designed with uncommon versatility, potentially positioning it as a platform technology rather than a single-application device.
What distinguishes this clearance is the complexity of robotic systems requiring 510(k) approval. Unlike simpler medical devices, robotic surgical platforms must demonstrate substantial equivalence while managing complex software, hardware integration, and safety protocols. Particularly noteworthy is the acknowledgment from Dr. Unis, who claims experience with all market competitors, suggesting potentially meaningful differentiation.
The system's CT-based imaging approach for personalized procedures aligns with leading-edge practices in precision orthopedics. The mention of recent cutting system upgrades indicates ongoing refinement even post-clearance, suggesting the company continues technical innovation while pursuing commercialization.
From a technical adoption perspective, securing KOL support is critical in this market, where surgeon preference heavily influences institutional purchasing decisions. The extended sales cycles in orthopedic robotics require developer patience, but early adopter feedback will prove important to gaining momentum.
The planned expansion to other orthopedic applications would leverage the core technology while expanding market potential. However, each new indication will require additional regulatory clearances and clinical validation. The international strategy targeting emerging markets like India could provide valuable real-world data while establishing presence in high-growth regions where competitors may have less established footprints.
Monogram May Market the Monogram mBôs™ TKA System, Subject to the Requirements of the Federal Food, Drug, and Cosmetic Act (the Act).
The Company is Preparing for Commercialization and Evaluating Strategies to Support the Adoption of its Robotic-Assisted Technology
AUSTIN, TX / ACCESS Newswire / March 17, 2025 / 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 the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Monogram mBôs™ TKA System. This determination means that Monogram may market the device, subject to the general controls provisions of the Act.
Ben Sexson, Monogram Chief Executive Officer, commented, "This FDA 510(k) clearance is a defining moment for Monogram. It marks the culmination of years of relentless effort, innovation, and teamwork. Bringing a new technology to market in the medical field is an immense challenge, and this milestone is a testament to the dedication and resilience of our entire team. We have navigated obstacles, refined our technology, and remained steadfast in our mission to advance orthopedic robotics. Today, we take a significant step forward.
"Securing clearance for the Monogram mBôs TKA System was a rigorous process due to the complexity and sophistication of the technology. We are particularly excited about the system's performance and its potential to advance robotics in orthopedic medicine. We believe we will have strong product-market fit and are well-positioned to make a meaningful impact.
"I want to personally thank Kamran Shamaei and Dr. Douglas Unis for their vision, dedication, and contributions to this achievement. Their expertise and commitment have been invaluable in bringing this technology to life. Advancing a system like this from concept to clearance requires perseverance and collaboration, and I'm incredibly proud of what we've accomplished together. We appreciate the FDA's engagement throughout this process.
"We anticipate this clearance will open new opportunities for Monogram. As we move toward commercialization, we will continue refining our strategy and engaging in discussions to support broader adoption. The journey has been long, but this is just the beginning."
The Monogram mBôs TKA System is designed to deliver uncompromised safety, efficiency, and accuracy in robotic-assisted total knee arthroplasty. Engineered with scalability in mind, the system is architected to eventually support multiple orthopedic applications beyond knee replacement, positioning it as a platform for future expansion. Despite the increasing role of robotics in joint reconstruction, the market remains underpenetrated and highly consolidated, leaving significant room for innovation and growth.
Monogram believes in the benefits of personalized robotic surgery, enabled by patient-specific imaging (CT-based) and accurate predictive navigation tools. We see an opportunity to be part of the ongoing adoption of robotic-assisted procedures.
"I've used nearly every robotic system on the market, and I truly believe the Monogram mBôs has the potential to be the best. It's slick. The precision, efficiency, versatility, and safety considerations set it apart from anything I've seen. I'm incredibly impressed and confident that surgeons will recognize the impact of this system," said Dr. Douglas Unis, Founder and Chief Medical Officer of Monogram.
"Navigating a regulatory submission of this complexity is no small feat, and I'm extremely impressed by our management team's strategic approach and execution. Bringing a system of this sophistication through clearance requires immense effort and careful planning. Monogram has achieved this with such a small, highly focused, and motivated team. The dedication and commitment to the mission that our leadership has fostered is inspiring. Now that we're cleared, I'm confident that when surgeons experience the mBôs TKA System firsthand-especially given the responses I've seen in multiple live demos-they will want to use it."
Now that the Monogram mBôs TKA System has received FDA clearance, it opens significant opportunities for the Company both domestically and internationally. Over the coming months, Monogram will integrate recent upgrades to the cutting system and other system enhancements into the cleared mBôs TKA System to further strengthen its competitiveness. The Company is focused on initial placements with key surgeon KOLs in strategic geographies to establish clinical experience and demonstrate the system's advantages in real-world surgical settings.
Monogram remains committed to a disciplined, long-term commercialization strategy and will take a measured and strategic approach to market adoption. While the orthopedic robotics market operates on a long sales cycle, this milestone significantly de-risks the platform and validates the Company's technology, positioning Monogram for new strategic opportunities as it executes its growth strategy.
"At Monogram, we've built a small but incredibly dedicated and highly technical team. It has been an incredible experience working alongside such talented and motivated individuals. We run lean, but I believe our commitment is second to none. Every day, we push ourselves to develop what we hope will be the safest, fastest, and most accurate robotic system on the market," commented Kamran Shamaei, Chief Technology Officer of Monogram.
"This work is deeply personal to us. We imagine this system being used on our loved ones, and that drives us to hold ourselves to the highest standards of performance and excellence. We work hard together because we believe in what we're building and the impact it can have on patient care.
"This achievement is dedicated to my beloved sister, Ladan."
Upcoming Milestones
Upgrade cleared system cutting system and other improvements to enhance competitiveness.
Launch with key KOL surgeons in critical geographies to continue demonstrating the system's advantages.
Explore any new opportunities for Monogram as we move toward commercialization that could support broader adoption both internationally and domestically.
Continues to refine and enhance its next-generation technology in parallel with regulatory and clinical trial preparations to improve future competitiveness and expand to new applications.
The Company is working to obtain regulatory clearance to initiate clinical trials in India in collaboration with its strategic partner, Shalby Limited ("Shalby"), a leading global multi-specialty hospital chain. The recent FDA clearance may further support these efforts.
The Company is working to advance the submission of additional clinical applications to expand the robotic system's capabilities and establish it as a versatile, multi-application platform.
The Company continues to enhance the robotic system with ongoing improvements designed to optimize surgical workflows, increase accuracy, improve speed, and ensure greater reliability in clinical use.
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 510(k) clearance for its mBôs TKA System and FDA clearance for its mPress implants. The Company is required to obtain FDA clearance before it can market its products.
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 www.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. 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 Company's 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 ACCESS Newswire
FAQ
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