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Monogram Orthopaedics Reports Full Year 2023 Financial Results 510(k) Submission with FDA On Track for Second Half of 2024 Shipped mB s Surgical Robot System to First International Customer Introduced mVision Technologie

Key Takeaway: Monogram Orthopaedics Reports Full Year 2023 510(k) Submission with FDA On Track for Second Shipped mB s Surgical Robot System to First International Customer Introduced mVision Technologies, a Novel Approach to Registration and Tracking Management to Host Business Update C

Full Press Release Details

Monogram Orthopaedics Reports Full Year 2023
510(k) Submission with FDA On Track for Second
Shipped mB s Surgical Robot System to
First International Customer
Introduced mVision Technologies, a Novel Approach
to Registration and Tracking
Management to Host Business Update Conference
Call on Thursday, March 21 at 5:00 p.m. Eastern Time
AUSTIN, TX - March 15, 2024 - Monogram
Orthopaedics Inc. (NASDAQ:MGRM) ("Monogram" or the "Company"), a medical technology company focused on reconstructive
joint procedures and surgical robotics, has reported its financial and operational results for the fourth quarter and full year ended
Fourth Quarter 2023 and Subsequent Operational
The Company's plan to aggressively accelerate 510(k) submission with design modifications that management believes reduce the risk of a clinical trial is on track. The Company anticipates Verification and Validation completion on the upgraded design as early as the first half of 2024. The Company is fully funded to anticipated 510(k) submission in the second half of 2024.
Delivered mB s surgical robot to one of the world's largest global robotics distributors in a first sale, representing a key revenue milestone and paving the way for broader commercialization.
The Company is moving forward with an OUS clinical trial that will support US and OUS post-launch marketing or US 510(k) submission, depending on FDA feedback.
Introduced mVision technology, a novel approach to registration and tracking that the company is now working on as a standalone product or for integration into the mB s surgical robotic system in the future.
Presented a product discussion featuring Monogram's mB s and mVision technologies with a surgeon panel during AAOS Annual Meeting
Presented at the Canaccord Genuity 2024 Musculoskeletal Conference
Management Commentary
"2023 was transformative for Monogram
as our first year as a public company, with a focus on advancing our product launch for mB s and the continued development of
our next-gen product pipeline," said Ben Sexson, Chief Executive Officer of Monogram. "The fourth quarter was highlighted
by the delivery of our first mB s surgical robot to one of the world's largest global robotics distributors and the
introduction of mVision technology.
"Throughout 2023, we were highly focused
on executing our commercialization roadmap. We have employed a dynamic regulatory strategy as new facts and opportunities emerge, which
supports our intention to obtain FDA clearance as expeditiously and economically as possible. We are currently in the Verification phase,
with the team actively executing extensive, highly rigorous internal and external testing. We think it could be possible to complete all
Verification and Validation testing as early as the first half of 2024 with a 510(k) submission without clinical data in the second half
"We have had several formal communications
with the FDA, and we believe they understand the technical areas of concern that could necessitate a clinical study. The team has preemptively
made design changes related primarily to foot pedal control of the system that we believe could address the FDA's cited technical equivalence
concerns and potentially obviate the need for a clinical trial. We believe the modified system has very strong equivalence arguments and
a potentially favorable safety profile compared to other cleared products on the market, and the design modifications could even favorably
improve the system's performance.
"This approach could potentially be quite
favorable to our commercialization timeline, and based on our progress with the FDA, we believe we have sufficient funding through the
510(k) submission. We remain on target to largely complete verification and validation testing in H1 2024, a requirement for FDA submission
and clearance. At the same time, we are aggressively preparing to launch OUS clinical trials with our international partners. We plan
to leverage OUS clinical data to supplement our US submission should the agency require a clinical trial despite our improved equivalence
profile, or for post-launch marketing in the US and international approval should the FDA clear mB s without clinical data. We like
the optionality that comes with this strategy.
"We recently announced mVision, our next-generation
navigation solution designed to eliminate cart-based tracking and streamline registration and tracking to eliminate point sampling and
tracking with large arrays. Our engineers plan to configure the mB s robot to be upgradable to mVision navigation. With mVision,
the goal is to minimize the risks associated with pin site fracture and infection and significantly reduce the surgical time associated
with placing the arrays and registration. In addition, the goal is to minimize the surgical footprint in the OR. We are confident that
mVision will advance the standard of care in orthopedic robotics.
"During the quarter, we delivered our first
mB s robot. We believe the international market for orthopedic robotics is attractive, large, and growing. The ability to scale
OUS in a capital-efficient manner without the implant or significant increases to SG&A costs is also attractive. In the US, we want
to own the total economics of the sale that would accrete from selling the implant, mB s robot, and related consumables.
"Monogram's technology and its
intrinsic value continue to gain recognition with surgeons in the joint reconstruction market, in which higher barriers to entry for
new participants have historically reduced innovation in our view. We see an opportunity to unlock new growth within this extremely
attractive market by providing a solution to the vulnerabilities in the existing economic model for robotics - namely,
increased surgical time and increased consumables cost. We are confident that this fundamental value proposition will continue to
garner recognition from the market and industry participants, including from potential strategic partners, as we continue to execute
to generate long-term value for our shareholders.
"Looking ahead into 2024, our next milestones
on the commercialization path include completing our verification and validation testing, submitting mB s to the FDA for clearance,
and obtaining approvals to run our OUS clinical trial. We will also further develop our mVision navigation technology, which could become
a standalone product and/or be integrated into mB s. Taken together, we are incredibly enthusiastic about the future for Monogram,
the pace of our product timeline, and our team's ability to scale the commercialization path of our advanced, next-generation active
surgical robotics." concluded Sexson.
Upcoming 2024 Milestones
Largely complete mB s system verification and validation - H1 2024
Submit semi-active modality 510(k) application to FDA - H2 2024
Commence OUS live-patient surgery trials - H2 2024
Anticipated FDA response & expand international relationships - H2 2024
Full Year 2023 Financial Results
Research and development expenses for the year
ended December 31, 2023, were $10.6 million, compared to $5.4 million the prior year. The R&D increase year over year was driven by
increased efforts in the development of the Company's sagittal cutting systems and related platform software required to operate
its active navigated robotic system, as well as the Company moving into the verification phase of the development of its robot prototype.
For the year ended December 31, 2023, General
& Administrative expense increased to $4.0 million compared to $2.5 million in 2022. The increase was primarily due to increases in
compensation expenses, including bonus and stock - option compensation, insurance and regulatory compliance expenses, facilities
expenses, and consulting and professional fees.
Net loss was $13.74 million for the year ended
December 31, 2023 compared to a net loss of $13.69 million for the year ended December 31, 2022. The net loss in 2023 was positively impacted
by $3.1 million due to the change in fair market value of existing warrant obligations, while the 2022 results were negatively impacted
by $3.4 million due to the change in fair market value in that period.
Cash and cash equivalents totaled $13.6 million as of December 31,
2023, compared to $10.4 million as of December 31, 2022.
Business Update Conference Call
Monogram Chief Executive Officer Ben Sexson, Chief
Medical Officer Doug Unis, MD, Chief Technology Officer Kamran Shamaei, 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 : Thursday, March 21, 2024
Time: 5:00 p.m. Eastern time (2:00 p.m. Pacific time)
Registration Link : https://streamyard.com/watch/Cqvuk6Z3nsUg
A replay will be available after the call and
will be available in the Company's investor relations section here.
About Monogram Orthopaedics
Monogram Orthopaedics (NASDAQ: MGRM) is working
to develop a product solution architecture with the long-term goal of enabling patient-optimized orthopedic implants at scale by linking
3D printing and robotics with advanced pre-operative imaging. The Company has a robotic system that can autonomously execute optimized
paths for high-precision insertion of implants in synthetic bone specimens. Monogram 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. The Company has not yet made 510(k) premarket notification submissions or obtained 510(k)
clearances for its robotic products. FDA approval is required to market these products, and the Company has not obtained FDA approval
for any of its robotic products, and it cannot estimate the timing or assure the ability, to obtain such clearances.
Monogram Orthopaedics is working to advance the
way orthopedic surgery is done. Our system is being developed to combine personalized knee implants with precision robotic surgical assistants
to hopefully give patients a better-fitting knee replacement with minimally invasive surgery. One hundred thousand knee replacements failing
each year in a $19.4B market represents an enormous opportunity for us.
To learn more, visit www.monogramorthopedics.com.
Forward-Looking Statements
Last updated: Mar 15, 2024