Full Press Release Details
Monogram Provides Regulatory Update Following
510(k) Submission with FDA Accelerated for
Early Second Half of 2024
May 1, 2024 - Monogram Orthopaedics Inc. (NASDAQ: MGRM) ("Monogram" or the "Company"), an AI-driven
robotics company focused on improving human health with an initial focus on orthopedic surgery, today provided an update related to the
regulatory and commercialization path for its mB s surgical system following its meeting with the U.S. Food and Drug Administration
On April 19, 2024, Monogram received written
feedback from the FDA regarding the Company's Q1 2023 pre-submission request. Subsequently, Monogram conducted a teleconference meeting
with the FDA on April 24, 2024, to discuss the written feedback further and obtain feedback on the Monogram mB s TKA
System verification test plan, including a proposed clinical trial protocol on an outside the U.S. (OUS) target population. Management
believes the feedback was comprehensive and will be advantageous for preparing a successful 510(k) submission to obtain clearance.
The Company shared with the FDA various test protocols
essential for establishing the safety and effectiveness of the Monogram mB s TKA System and a synopsis of its proposed OUS
clinical investigation plan.
on the feedback, management assesses that: 1) the proposed testing plan generally appears acceptable to address the technical differences
identified with the proposed predicate device, and 2) for the active (also autonomous) embodiment of its product, a clinical testing plan
that includes approximately 100 knee surgeries conducted on an OUS population at three sites with three months of follow-up should generally
be sufficient for evaluating the safety and effectiveness of the Monogram mB s TKA System. Notably, on March 21st,
the Company announced that it had modified the Monogram mB s TKA System to reduce the likelihood of an FDA clinical data
request with its submission.
response the FDA indicated they support a least burdensome approach to acquiring clinical data. Management anticipates running an OUS
clinical trial could save the Company significant cost and time. Currently, management estimates the cost to run an OUS clinical trial
as proposed to be approximately $1.5M. The Company plans to run a clinical trial to support post-launch marketing irrespective
of whether it will be needed for obtaining regulatory clearance with the FDA.
Updated Key Objectives
to aggressively accelerate 510(k) submission for its mB s surgical system with design modifications that management believes
reduce the risk of a clinical trial request is on track. The Verification and Validation testing is underway, and the Company has
largely completed various mandated packaging, biocompatibility, sterilization, and cleaning validations. Except for ongoing IEC testing,
most tests that rely on outside vendors are on track or largely complete. For IEC testing, the Company has largely completed
various mandated radiated emissions and immunity testing. The paperwork reviews are largely complete, and various electromechanical and
safety tests are starting soon. The Company believes the system will perform favorably in outstanding IEC testing based on completed internal
testing and various design considerations. One of the most demanding test protocols is the Human Factors Evaluation and Design Validation,
which requires at least 15 surgeons to use the system in a simulated surgery. The Company is using much of the data from these labs to
test other aspects of the system, such as system accuracy. The Company has completed six simulated surgeries, with a significant remaining
portion planned in May 2024.
Monogram has engaged MCRA, a US-based Contract
Research Organization (CRO), to support its regulatory strategy for submission.
"Our team has been actively executing extensive,
highly rigorous internal and external testing while diligently incorporating feedback from the FDA," said Ben Sexson, Chief Executive
Officer of Monogram. "We continue to expect verification and validation to be largely complete in H1 2024, with a planned FDA 510(k) submission
in H2 2024. We believe an OUS clinical data strategy could become valuable for ongoing research, development, and commercialization efforts."
Dave McGurl, Vice President, Regulatory Affairs
at MCRA, commented: "Monogram's engagements with the FDA have been highly constructive, with the Company having incorporated the
FDA's feedback into the mB s TKA System design. After numerous communications with the FDA and extensive clarity provided
by the Monogram team, the Company should be set up for success with the 510(k) submission to the FDA for clearance. The Company has
taken patient safety extremely seriously, which is apparent in numerous aspects of the design. The Company's verification and validation
plan appears to satisfy all the FDA's stated concerns, and the FDA has been supportive of Monogram following a least burdensome approach
to clinical data procurement. We look forward to continuing to support Monogram through its submission and clearance."
Upcoming 2024 Milestones
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
This press release may include "forward-looking
statements.'' To the extent that the information presented in this presentation discusses financial projections, information, or expectations
about Monogram Orthopaedics Inc.'s business plans, results of operations, products or markets, or otherwise makes statements about future
events, such statements are forward-looking. Such forward-looking statements can be identified by the use of words such as "should,"
"may," "intends," "anticipates," "believes," "estimates," "projects," "forecasts,"
"expects," "plans," and "proposes."
Although Monogram Orthopaedics Inc. believes that
the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties
that could cause actual results to differ materially from such forward-looking statements. You are urged to carefully review and consider
any cautionary statements and other disclosures, including the statements made under the heading "Risk Factors" and elsewhere
in the offering statement filed with the SEC. Forward-looking statements speak only as of the date of the document in which they are contained,
and Monogram Orthopaedics Inc. does not undertake any duty to update any forward-looking statements except as may be required by law.
Executive Vice President
Direct: 949-491-8235