Monogram Technologies Reports First Quarter 2025 Financial Results

Receives FDA Clearance for the mBôs$(TM)$ TKA System

Groundbreaking Trial Set to Deliver one of the World's First Autonomous Saw-Based Robotic TKA Surgeries on Live Patients

Management to Host Business Update Conference Call Today at 4:30 p.m. Eastern Time

AUSTIN, Texas, May 14, 2025 (GLOBE NEWSWIRE) -- Monogram Technologies Inc. $(MGRM)$ ("Monogram" or the "Company"), an AI-driven robotics company focused on improving human health with an initial focus on orthopedic surgery, has reported its financial and operational results for the first quarter ended March 31, 2025.

First Quarter 2025 and Subsequent Operational Highlights

   -- The U.S. Food and Drug Administration ("FDA") granted 510(k) clearance 
      for the Monogram mBôs(TM) Total Knee Arthroplasty ("TKA") System. 
      This determination means that Monogram may market the device, subject to 
      the general controls provisions of the Federal Food, Drug, and Cosmetic 
      Act. 
 
   -- Following the end of the quarter, Monogram received regulatory approval 
      from India's Central Drugs Standard Control Organization ("CDSCO") to 
      import the mBôs TKA System and initiate a 102-patient, multi-center 
      clinical investigation evaluating its safety and effectiveness in 
      collaboration with Shalby Limited ("Shalby"), one of India's leading 
      orthopedic hospital networks. 
 
          -- Patient enrollment for the trial is expected to begin shortly, 
             with the first live patient surgeries anticipated within 90 
             business days. 
 
          -- Clinical trial will be the first demonstration of fully autonomous, 
             hands-free, saw-based robotic total knee surgeries on live 
             patients, showcasing the potential of robotic precision and 
             setting a new standard for robotic surgery. 

Management Commentary

"The first quarter was transformational for Monogram. We received FDA clearance for the mBôs TKA System and subsequently obtained regulatory approval from India's CDSCO to initiate a multi-center clinical trial in collaboration with Shalby Hospitals," said Ben Sexson, Chief Executive Officer of Monogram Technologies. "These milestones validate the underlying technology and provide a clear path to commercial adoption in key markets.

"This study will be the first to evaluate autonomous saw-based robotic total knee surgeries on live patients. We believe this represents a historic step for the field of surgical robotics. It is our first opportunity to demonstrate that a fully active, hands-free, unconstrained robotic system can safely, precisely, and efficiently execute bone resections in a real-world clinical setting. The trial is expected to demonstrate the value proposition of autonomous robotics.

"We are now working to integrate recent system upgrades into the cleared mBôs platform and are preparing for initial placements with key opinion leader surgeons in select U.S. geographies. These early placements are designed to build real-world clinical evidence, deepen surgeon engagement, and establish a strong foundation for long-term growth. At the same time, we are advancing enrollment preparations in India, where the first live patient surgeries are expected to begin by late summer or early fall.

"Our recent milestone execution has demonstrated the strength of our team and the momentum behind our platform. We remain aggressively focused on enhancing system performance, including optimizing workflow efficiencies and reducing cut times, to strengthen long-term competitiveness further. We are also actively exploring additional domestic and international relationships as we move toward commercialization and executing our long-term roadmap. Collectively, these initiatives position us to create significant strategic value as we advance," concluded Sexson.

Upcoming Milestones

   -- Initiate patient enrollment for fully autonomous hands-free robotic 
      surgeries for the multi-center clinical trial. Begin first live patient 
      surgeries with the fully autonomous hands-free mBôs TKA System in 
      India. 
 
   -- Advance preparation for an international ("OUS") commercial launch of the 
      mBôs TKA System, leveraging strategic partnerships. 
 
   -- Launch initial seed placements with U.S.-based key opinion leader ("KOL") 
      surgeons in strategically selected geographies. Explore any new 
      opportunities for Monogram as we move toward commercialization that could 
      support broader adoption both internationally and domestically. 
 
   -- Continue to refine and enhance the mBôs system and support 
      next-generation product development. 
 
   -- Advance regulatory submissions for additional clinical applications to 
      expand system capabilities and establish a versatile multi-application 
      platform. 
 
   -- Evaluate strategic opportunities that could support domestic and 
      international growth. 

First Quarter 2025 Financial Results

Research and development expenses for the first quarter ended March 31, 2025, decreased 6% to $2.3 million, compared to $2.4 million in the prior-year quarter. The R&D decrease was primarily due to the completion of the verification and validation phase of the development of its Monogram mBôs(TM) TKA System robotic system, partially offset by a $250,000 performance-based compensation accrual during the first quarter of 2025 from the grant of FDA 510(k) clearance for its Monogram mBôs(TM) TKA System.

Marketing and advertising expenses for the first quarter ended March 31, 2025, decreased 63% to $44,000, compared to $120,000 in the prior-year quarter. During the first quarter of 2025, these expenses primarily related internal payroll-related expenses. During the first quarter of 2024, these expenses primarily related to external marketing efforts intended to increase market awareness of Monogram and its offerings for fund raising purposes.

General & administrative expenses for the first quarter ended March 31, 2025, were $1.0 million compared to $1.1 million in the prior-year quarter. In both periods, general and administrative expenses were composed primarily of payroll-related expenses and required public company expenses including insurance expenses, regulatory expenses, and professional services.

Net loss was $3.2 million for the quarter ended March 31, 2025, as compared to a net loss of $3.5 million for the prior-year quarter.

Cash and cash equivalents totaled $13.3 million as of March 31, 2025, compared to $15.7 million as of December 31, 2024. The company continues to direct its resources with a focus on commercializing the mBôs(TM) TKA System as capital efficiently as possible.

First Quarter 2025 Results Conference Call

Monogram Chief Executive Officer Ben Sexson and Chief Financial Officer Noel Knape will host the conference call, followed by a question-and-answer period.

To access the call, please use the following information:

 
Date:               Wednesday, May 14, 2025 
Time:               4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) 
Registration Link:  https://streamyard.com/watch/uKXmYngpKg5P 
 
 

The conference call webcast will be broadcast live and available for replay at the investor relations section of the Company's website here.

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.

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