CORRECTION FROM SOURCE: Monogram Technologies Receives Regulatory Approval to Start Clinical Trials in India
Monogram Technologies has received regulatory approval from India's CDSCO to begin clinical trials of its mBȏs TKA System for knee replacement surgery. The company will conduct a 102-patient, multi-center study in partnership with Shalby Hospitals, one of the world's largest orthopedic hospital groups.
The trial will evaluate the safety and effectiveness of the Monogram TKA System with the Consensus CKS implant. Patient enrollment is expected to begin shortly, with first surgeries anticipated within 90 business days. The company has already delivered training systems and hosted investigator meetings in Ahmedabad, India.
The clinical investigation is supported by Reliance Life Sciences, which manages regulatory submissions in India. Dr. Vikram I. Shah, Shalby Hospitals' Founder and Chairman, recently featured in TIME Magazine Asia Edition, endorsed the mBȏs System as the most advanced robotic technology in orthopedic medicine.
Monogram Technologies ha ottenuto l'approvazione regolatoria dalla CDSCO indiana per avviare gli studi clinici del suo sistema mBȏs TKA per la chirurgia di sostituzione del ginocchio. L'azienda condurrà uno studio multicentrico su 102 pazienti in collaborazione con Shalby Hospitals, uno dei più grandi gruppi ospedalieri ortopedici al mondo.
La sperimentazione valuterà la sicurezza e l'efficacia del sistema Monogram TKA con l'impianto Consensus CKS. L'arruolamento dei pazienti è previsto a breve, con le prime operazioni attese entro 90 giorni lavorativi. L'azienda ha già fornito sistemi di formazione e organizzato incontri con gli sperimentatori ad Ahmedabad, India.
Lo studio clinico è supportato da Reliance Life Sciences, che gestisce le pratiche regolatorie in India. Il Dr. Vikram I. Shah, fondatore e presidente di Shalby Hospitals, recentemente apparso sulla rivista TIME Asia, ha definito il sistema mBȏs la tecnologia robotica più avanzata nella medicina ortopedica.
Monogram Technologies ha recibido la aprobación regulatoria de la CDSCO de India para iniciar ensayos clínicos de su sistema mBȏs TKA para cirugía de reemplazo de rodilla. La empresa llevará a cabo un estudio multicéntrico con 102 pacientes en asociación con Shalby Hospitals, uno de los grupos hospitalarios ortopédicos más grandes del mundo.
El ensayo evaluará la seguridad y eficacia del sistema Monogram TKA con el implante Consensus CKS. Se espera que el reclutamiento de pacientes comience pronto, con las primeras cirugías previstas dentro de 90 días hábiles. La empresa ya ha entregado sistemas de entrenamiento y organizado reuniones con investigadores en Ahmedabad, India.
La investigación clínica cuenta con el apoyo de Reliance Life Sciences, que gestiona las presentaciones regulatorias en India. El Dr. Vikram I. Shah, fundador y presidente de Shalby Hospitals, recientemente destacado en la edición asiática de TIME Magazine, respaldó el sistema mBȏs como la tecnología robótica más avanzada en medicina ortopédica.
모노그램 테크놀로지스가 인도 CDSCO로부터 무릎 교체 수술용 mBȏs TKA 시스템 임상시험 시작 승인을 받았습니다. 회사는 세계 최대 정형외과 병원 그룹 중 하나인 샬비 병원과 협력하여 102명의 환자를 대상으로 다기관 연구를 진행할 예정입니다.
이번 임상시험은 Consensus CKS 임플란트와 함께하는 모노그램 TKA 시스템의 안전성과 효과를 평가합니다. 환자 등록은 곧 시작될 예정이며, 첫 수술은 90영업일 이내에 이루어질 것으로 예상됩니다. 회사는 이미 아메다바드에서 교육 시스템을 제공하고 연구자 회의를 개최했습니다.
임상 조사는 인도 내 규제 제출을 관리하는 Reliance Life Sciences의 지원을 받고 있습니다. 샬비 병원의 창립자 겸 회장인 Dr. Vikram I. Shah는 최근 TIME 아시아판에 소개되었으며, mBȏs 시스템을 정형외과 의학에서 가장 진보된 로봇 기술로 평가했습니다.
Monogram Technologies a obtenu l'approbation réglementaire de la CDSCO en Inde pour commencer les essais cliniques de son système mBȏs TKA pour la chirurgie de remplacement du genou. L'entreprise mènera une étude multicentrique portant sur 102 patients en partenariat avec Shalby Hospitals, l'un des plus grands groupes hospitaliers orthopédiques au monde.
L'essai évaluera la sécurité et l'efficacité du système Monogram TKA avec l'implant Consensus CKS. Le recrutement des patients devrait commencer prochainement, avec les premières opérations prévues dans les 90 jours ouvrables. L'entreprise a déjà fourni des systèmes de formation et organisé des réunions avec les investigateurs à Ahmedabad, en Inde.
L'investigation clinique est soutenue par Reliance Life Sciences, qui gère les soumissions réglementaires en Inde. Le Dr Vikram I. Shah, fondateur et président de Shalby Hospitals, récemment présenté dans l'édition asiatique du magazine TIME, a salué le système mBȏs comme la technologie robotique la plus avancée en médecine orthopédique.
Monogram Technologies hat von der indischen CDSCO die behördliche Genehmigung erhalten, klinische Studien mit seinem mBȏs TKA System für Kniegelenkersatzoperationen zu beginnen. Das Unternehmen wird eine multizentrische Studie mit 102 Patienten in Zusammenarbeit mit Shalby Hospitals, einer der weltweit größten orthopädischen Krankenhausgruppen, durchführen.
Die Studie wird die Sicherheit und Wirksamkeit des Monogram TKA Systems mit dem Consensus CKS Implantat bewerten. Die Patientenaufnahme soll bald beginnen, wobei die ersten Operationen innerhalb von 90 Werktagen erwartet werden. Das Unternehmen hat bereits Trainingssysteme geliefert und Untersuchungstreffen in Ahmedabad, Indien, abgehalten.
Die klinische Untersuchung wird von Reliance Life Sciences unterstützt, die die behördlichen Einreichungen in Indien verwalten. Dr. Vikram I. Shah, Gründer und Vorsitzender von Shalby Hospitals, der kürzlich in der TIME Magazin Asien-Ausgabe vorgestellt wurde, bezeichnete das mBȏs System als die fortschrittlichste Robotik-Technologie in der orthopädischen Medizin.
- Received regulatory approval from India's CDSCO to begin 102-patient clinical trial
- Strategic partnership with Shalby, one of world's largest orthopedic hospital groups
- First live patient surgeries expected within 90 business days
- Full-time employees will be deployed to India to support trial execution
- Validation from Reliance Life Sciences, part of one of India's largest private sector companies
- Company still in clinical trial phase, no commercial revenue yet
- Will incur additional expenses from deploying full-time staff to India
- Three-month follow-up period required before data analysis
Insights
Monogram's regulatory approval in India advances clinical validation for its robotic knee system, marking crucial progress toward commercialization milestones.
The regulatory approval from India's CDSCO represents a significant advancement in Monogram's clinical development strategy, specifically permitting importation of the mBȏs TKA system for a substantial 102-patient clinical investigation. This clearance enables the company to generate critical safety and effectiveness data with the Consensus CKS implant across multiple surgical centers.
The partnership with Shalby Limited, a major orthopedic hospital group, provides both specialized clinical expertise and access to a relevant patient population—essential factors for successful orthopedic technology validation. The three-month clinical follow-up suggests a focus on immediate procedural outcomes and safety parameters, standard for initial validation studies in surgical robotics.
Notably, Monogram has already delivered training systems and completed investigator meetings, indicating efficient execution. The 90-business-day timeline to first surgeries reflects reasonable operational momentum in clinical trial implementation. The deployment of full-time employees for surgeon training addresses the critical learning curve challenges inherent in surgical robotics adoption.
This clinical investigation will provide essential real-world performance data in what the company describes as "technically demanding cases"—precisely the validation needed to build clinical confidence in AI-driven robotic surgical platforms before broader commercial deployment.
Regulatory milestone unlocks clinical validation pathway for Monogram's orthopedic technology, de-risking the product's value proposition through real-world surgical data.
The CDSCO approval represents meaningful progress in Monogram's clinical development roadmap, enabling the company to advance toward generating critical validation data for its mBȏs TKA System. CEO Benjamin Sexson explicitly frames this as "a major milestone" that will "de-risk the value proposition" of their technology—acknowledging the importance of clinical evidence in the commercialization strategy for advanced surgical systems.
Strategically, the partnership with Shalby Hospitals, described as "one of the world's largest orthopedic hospital groups," provides specialized clinical infrastructure specifically aligned with Monogram's orthopedic technology focus. This collaboration offers both immediate trial execution capabilities and potential demonstration of the system's performance in a high-volume orthopedic setting.
The company's operational readiness is evidenced by the completed training deployment and established investigator meetings, with patient enrollment expected to begin shortly. The defined 90-business-day timeline to first surgeries demonstrates concrete progression toward data generation.
While immediate financial impact remains limited to clinical development expenses, this represents a clearly defined advancement toward potential commercialization, as referenced in the company's "ongoing efforts toward commercial launch." The multi-center trial design will generate evidence across multiple clinical environments, addressing a critical validation requirement for robotic surgical systems before market entry.
Monogram Granted Regulatory Approval to Import mBôs TKA System for Clinical Investigation
Patient Enrollment will Begin Shortly; First Live Patient Surgeries are Anticipated within 90 Business Days
Critical Milestone Achieved for Multi-Center Clinical Trial in India with Strategic Partner Shalby Hospitals for the mBȏs TKA System
AUSTIN, TX / ACCESS Newswire / April 29, 2025 / Monogram Technologies Inc. (NASDAQ:MGRM) ("Monogram" or the "Company"), an AI-driven robotics company revolutionizing orthopedic surgery, today announced it has obtained regulatory approval from India's Central Drugs Standard Control Organization ("CDSCO") to import its mBôs TKA system to conduct a 102-patient, multi-center clinical investigation evaluating the safety and effectiveness of the Monogram TKA System. The study will be conducted in collaboration with Shalby Limited (NSE: SHALBY) ("Shalby"), one of the world's largest orthopedic hospital groups.
As previously announced, Monogram and Shalby are partnering to evaluate the safety and effectiveness of the mBôs TKA System with the Consensus CKS implant, which is substantially equivalent to the Monogram mPress implants for regulatory purposes. The clinical trial will include 102 total knee replacement procedures, with a three-month clinical follow-up, conducted across multiple sites in India.
In January, Monogram successfully delivered a training version of the Monogram TKA System, and from January 31 to February 1, the Company hosted an Investigator Meeting in Ahmedabad, India. The Company expects to continue training surgeons and hospital personnel in preparation for trial initiation. Monogram will deploy full-time employees to India to support surgeon training and clinical trial execution and anticipates that patient enrollment will start shortly, with the first surgeries within 90 business days.
"The approval to begin clinical trial activities marks a major milestone for Monogram, further advancing our efforts to de-risk the value proposition of our technology," said Benjamin Sexson, Chief Executive Officer of Monogram Technologies. "This trial will allow us to demonstrate performance in real surgical settings, including what will likely include technically demanding cases. Initiating this trial is an important step in building clinical confidence and proving our value proposition. As we continue our ongoing efforts toward commercial launch, we remain focused on creating long-term value and will continue to thoughtfully evaluate opportunities that align with the best interests of our shareholders. I am incredibly proud of our team-their dedication, resilience, and belief in what we are building have made this moment possible. Special thanks to Ani Nayak, Senior Manager of Clinical R&D, for his support with this application."
"The approval to enable the clinical investigation in India is not only a major step for Monogram but also a meaningful milestone for the advancement of orthopedic innovation globally," said Dr. Ajaykumar Yadav, Associate Vice President and Head of Clinical Research at Reliance Life Sciences. Reliance Life Sciences, a Reliance Group company-one of India's largest private sector companies-is responsible for managing the regulatory submission and communications for the clinical trial in India. "At Reliance, we understand the unique dynamics of the Indian healthcare market, especially in the medical device space and the transformative potential of MedTech solutions. Monogram's robotic system is, in our view, one of the most advanced in orthopedic medicine today and we are proud to support its clinical validation. This collaboration represents a powerful opportunity to bring cutting-edge surgical technology to patients in India and beyond. We believe India is at the forefront of global medical innovation and we are honored to play a role in moving the standard of care forward."
"With decades of clinical experience and a deep commitment to advancing orthopedic care, I believe the Monogram mBôs System is the most advanced robotic technology available in our field today," said Dr. Vikram I. Shah, Founder and Chairman of Shalby Hospitals. "Obtaining regulatory approval to initiate the clinical trial in India is a proud moment-not just for Shalby and Monogram, but for the future of orthopedic medicine. We are excited to help lead this effort and demonstrate the clinical value of this transformative system. Robotic medicine has a bright future and India is uniquely positioned to be at the forefront of this evolution. At Shalby, we are committed to bringing innovative technologies like mBôs to our patients and are honored to contribute to a study that could redefine standards of care around the world."
Dr. Shah was recently featured in TIME Magazine, Asia Edition, for his exceptional contributions to healthcare and his role in revolutionizing orthopedic care globally.
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 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
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MZ North America
Direct: 949-491-8235
MGRM@mzgroup.us
SOURCE: Monogram Technologies Inc.
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