Submitted FDA 510(k) Application and Passed FDA Administrative Review for the mBôs TKA System

Secured Initial Strategic Multicenter Clinical Trial Collaboration with Shalby Limited

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

AUSTIN, TX / ACCESSWIRE / August 14, 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, has reported its financial and operational results for the second quarter ended June 30, 2024.

Second Quarter 2024 and Subsequent Operational Highlights

• Submitted a 510(k) premarket filing to the U.S. Food and Drug Administration (FDA) for the Company's mBôs TKA System and passed the FDA Administrative Review.

• Secured initial strategic collaboration with Shalby Limited ("Shalby"), a global multi-specialty hospital chain and one of India's leading orthopedic hospital groups, to conduct a multicenter clinical trial to demonstrate the safety and effectiveness of the mBȏs TKA System.

• Completed corporate name change to Monogram Technologies reflecting its continued evolution as an AI-driven robotics company with a strong IP position.

• Hosted an Investor and Analyst Tour at its headquarters in Austin, Texas, showcasing a product demonstration of mBôs Precision Robotic Surgical System and mVision Technologies

• Launched a continuous offering of 8.00% convertible preferred stock and warrants.

Management Commentary

"In the second quarter we made significant progress on key milestones with a 510(k) premarket filing to the FDA for our mBôs TKA System, and a new partnership to begin clinical trials in India," said Ben Sexson, Chief Executive Officer of Monogram. "The application passed the FDA Administrative Review, and a decision is expected within 90 days of the initial submission, although the process may take longer if additional information is requested. We believe this is a very strong application at over 28,000-pages, and 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.

"Our clinical trial collaboration with Shalby Limited, a global multi-specialty hospital chain and one of India's leading orthopedic hospital groups follows this 510(k) submission, setting the stage for the international launch of the mBȏs TKA System. Shalby is the largest (ranked #1 in arthroplasty by volume) orthopedic hospital chain in the world employing over 4,000 people at 14 hospitals in 13 cities and more than 3 million patients treated. Under the collaboration, Shalby will enroll patients at various sites in India for surgeons to evaluate the safety and effectiveness of the mBȏs TKA System with the Consensus CKS implant, which is substantially equivalent to the Monogram mPress implants for regulatory purposes.

"Operationally during the second quarter, we took the opportunity to update our corporate name to better reflect our continued evolution as an AI-driven robotics company and the broadening applications for our technology long term. We were also excited to offer our loyal followers and shareholders the opportunity to participate in a Unit offering typically reserved for institutional investors. Finally, a successful Investor and Analyst Day at our headquarters demonstrated our work to develop a product solution architecture to enable patient-optimized orthopedic implants at scale by combining 3D printing, advanced machine vision, AI, and next-generation robotics.

"Looking ahead, we are focused on the successful FDA clearance of our 510(k) submission in the expected 90-day timeframe. Based on the FDA's previous feedback, we believe our proposed testing plan is sufficient for evaluating the safety and effectiveness of our robotic system, supporting this strong 510(k) submission. We are now working with the team at Shalby to begin enrollment of patients in our multicenter clinical trial. Taken together, we continue to execute on our milestones toward commercialization and look forward to additional updates as we work to provide long-term value for our shareholders," concluded Sexson.

Upcoming 2024 Milestones

• Obtain clearance for the mBôs™ TKA System following FDA decision

• Progress towards OUS live-patient surgery trials

• Expanded international relationships

Second Quarter 2024 Financial Results

Research and development expenses for the second quarter ended June 30, 2024, were $2.4 million, compared to $3.0 million in the prior-year quarter. The R&D decrease was primarily a result of the Company moving more into the validation phase of the verification and validation phase, which the Company largely completed in the first half of 2024. The move into the validation phase, which consisted largely of testing and documenting the system components and protocols led to significant decreases in prototype material and contractor services spend which were primarily incurred in connection with the verification phase.

Marketing and advertising expenses decreased from $1.7 million to $92,000 for the second quarter ended June 30, 2024 compared to the prior year quarter. Marketing and advertising expenses incurred during the three months ended June 30, 2023 were primarily related Company's marketing campaign for its Regulation A - Tier 2 offering of its Common Stock (the "Reg A Common Stock Offering") that began during the three months ended March 31, 2023 and successfully culminated with a round closing in May of 2023. The marketing expenses in 2024 related primarily to advertising to drive awareness of the company's NASDAQ listing and increase the volume of trading activity.

General & administrative expenses for the second quarter ended June 30, 2024, were $1.1 million compared to $1.1 million in the prior-year quarter.

Net loss of $3.5 million for the second quarter ended June 30, 2024, was an improvement compared to a net loss of $5.2 million for the prior-year quarter, driven primarily by the decrease in marketing and advertising spend and the reduction in R&D spend noted above.

Cash and cash equivalents totaled $7.3 million as of June 30, 2024, compared to $13.6 million as of December 31, 2023. The company continues to marshall its resources with a focus on commercializing the mBôs™ TKA System as capital efficiently as possible.

Second Quarter 2024 Business Update 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:

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. 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

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SOURCE: Monogram Technologies Inc.