Full Press Release Details
Monogram Technologies
Reports Full Year 2024 Financial Results
Supplemental Testing and has Submitted its Formal Response to the FDA's Additional Information Request (AIR)
Host Business Update Conference Call on Wednesday, March 12, 2025, at 4:30 p.m. Eastern Time
TX - March 12, 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,
has reported its financial and operational results for the fourth quarter and year ended December 31, 2024.
Fourth Quarter 2024 and Subsequent Operational
Management Commentary
"The fourth quarter was marked by continued
progress toward the commercialization of our mB s Total Knee Arthroplasty (TKA) System, and a strengthened balance sheet
to provide the cash runway to meet near-term commercialization milestones," said Ben Sexson, Chief Executive Officer of Monogram.
"Early in the quarter, we closed an upsized and oversubscribed $13 million public offering to support key strategic initiatives,
including clinical trials and new technology development.
"We remain diligently focused on FDA clearance
for our mB s TKA System 510(k) submission. The Application was submitted on July 19, 2024, and passed the initial
FDA Administrative Review. On September 30, 2024, we received an Additional Information Request ("AIR") from the FDA regarding
the submission, placing the application on hold pending a complete response to the AIR within 180 days. On October 16, 2024, we held
a teleconference with the FDA to address clarification questions, which we found constructive. On December 17, 2024, we conducted
a positive Submission Issue Request (SIR) meeting with the FDA.
"We have now completed all supplemental
testing and submitted our formal response to the FDA regarding the AIR, and do not currently anticipate further requests for information.
Assuming a favorable decision by the FDA following receipt of the AIR, the next communication from them is anticipated to be a clearance
decision for the mB s TKA System. If granted, clearance would enable commercialization and sales of the TKA system in the
"We are also moving forward with our application
to run an Outside the United States ("OUS") clinical trial on the fully autonomous version of the system in collaboration
with Shalby Limited, a global multi-specialty hospital chain and one of India's leading orthopedic hospital groups. This would prepare
the groundwork for the international launch of the mB s TKA System. Under the collaboration, Shalby will enroll patients at various
sites in India for surgeons to evaluate the safety and effectiveness of the mB s TKA System with the Consensus CKS implant, which
is substantially equivalent to the Monogram mPress implants for regulatory purposes.
"In January, we successfully shipped a robot
to support clinical trial training to India, and an Investigator Meeting was conducted at a Shalby Hospital in Ahmedabad, India.
The meeting was attended by principal investigators, multiple surgeons, and staff to review study protocols, regulatory requirements,
and operational procedures. Bringing together key stakeholders, the meeting provided an opportunity for in-depth discussions on study
protocols and a demonstration of the mB s technology, reinforcing the collaborative approach to this clinical trial. The meeting
was organized by Reliance Life Sciences, a Reliance Group company and one of India's largest private sector companies, which is responsible
for managing the regulatory submission and communications for the clinical trial. While regulatory timelines can be variable, we remain
confident in our submission and the strength of our strategic partnerships with Reliance Life Sciences and Shalby to support the process.
"During the quarter, we continued to hold
cadaveric system demos, receiving surgeon and market interest for our hands-free, fully active system. With this support, we continue
to believe in our thesis for orthopedic robotics and the value proposition of our proposed active robotic system and are confident such
a system could be a game-changing advancement for the industry. Validating this thesis, we were recently named Orthopedic Joint
Replacement Company of the Year 2024' by Medical Tech Outlook from an expert panel of C-level executives, industry thought leaders,
and the editorial board.
"Looking ahead, we are awaiting response
from the FDA for a clearance decision for the mB s TKA System, which would enable commercialization and sales in the U.S.
We continue to work with regulators, our Contract Research Organization (CRO) and the team at Shalby to obtain clearance and
plan logistics for our anticipated multicenter clinical trial. At the same time, we remain aggressively focused on enhancing
our system's performance, including optimizing workflow efficiencies and reducing cut times, to further improve future system competitiveness.
We are also exploring further domestic and international relationships as we move toward commercialization and execution of our long-term
road map. Strengthened by the cash runway needed to meet all near-term commercialization milestones, we are incredibly optimistic for
2025 and our mission to advance the standard of care in orthopedic medicine." concluded Sexson.
Full Year 2024 Financial Results
Research and development expenses for the year
ended December 31, 2024, were $8.8 million, compared to $10.6 million the prior year (17%). The R&D decrease year over year was
driven by the company having largely completed the verification and validation phases in the first half of 2024, resulting in overall
reduction of R&D expenses in 2024 compared to 2023.
Marketing and advertising expenses for the year
ended December 31, 2024, were $2.1 million, compared to $3.0 million in the prior year (30%). The decrease in marketing and advertising
expenses was driven largely by market conditions that influenced the effectiveness of fundraising efforts impacting both the cost of investor
acquisition and the overall success of a crowdfunded capital raise.
General & administrative expenses for
the year ended December 31, 2024, increased to $4.4 million, from $4.1 million in 2023 (9%). The increase was primarily due to a
full year of public company expenses primarily composed of insurance expenses, regulatory compliance expenses, and professional expenses
offset by reductions in payroll and related expenses.
Net loss was $16.3 million for the year ended
December 31, 2024, compared to a net loss of $13.7 million for the year ended December 31, 2023.
The net loss in 2023 was positively impacted by
the change in fair value of a warrant liability of $3M that did not re-occur in 2024, as the warrant was exercised.
Cash and cash equivalents totaled $15.7 million
as of December 31, 2024, compared to $13.6 million as of December 31, 2023. The company continues to direct its resources with
a focus on commercializing the mB s TKA System as capital efficiently as possible.
Fourth Quarter and Full Year 2024 Results Conference
Chief Executive Officer Ben Sexson and Chief Financial Officer Noel Knape will host the conference call, followed by a question-and-answer
To access the call, please use the following information:
| Date: | Wednesday, March 12, 2025 |
| Time: | 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) |
| Registration Link: | https://streamyard.com/watch/MHCyeqvkPqzK |
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
Monograms mB s 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 mB s 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 mB s 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 mB s precision robot and mVision navigation.
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