Monogram Engages Contract Research Organization to Oversee mBôs Robot Clinical Trial Activities Outside the U.S.
Monogram Orthopaedics Inc. has engaged a global Contract Research Organization (CRO) to oversee its clinical trial activities for its mBôs Total Knee Arthroplasty (TKA) System outside the U.S., aiming to accelerate its product pipeline development and commercialization opportunities. The CRO will submit the clinical trial data to local regulators and has experience with successful FDA submissions. Monogram plans to conduct a multi-center TKA clinical trial with the mBôs TKA System using the cemented version of its FDA-cleared mPress TKA implant. The company expects to complete enrollment and study execution expeditiously, leveraging the clinical data for post-launch marketing and international clearance. The clinical trial design follows FDA guidance and regulations for investigations conducted outside the U.S., ensuring compliance with GCP guidelines and other regulatory requirements.
Engagement of a global CRO to oversee clinical trial activities, expanding capabilities and accelerating product pipeline development.
Successful FDA submissions experience of the CRO from clinical investigations conducted outside the U.S.
Planned conduct of a multi-center TKA clinical trial using the FDA-cleared mPress TKA implant, anticipating expedited enrollment and study execution.
Leveraging clinical data from the OUS study for post-launch marketing and international clearance.
Compliance with FDA guidance, GCP guidelines, and other regulatory requirements for clinical investigations outside the U.S.
Company cannot disclose the identity of the CRO due to competitive reasons, leaving potential investors uninformed about the partnership specifics.
Focus on safety data collection in the clinical study may limit the availability of additional data that could be beneficial for post-launch marketing.
CRO Expands Clinical Capabilities, Accelerating Product Pipeline Development and Commercialization Opportunities
AUSTIN, TX / ACCESSWIRE / May 13, 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 announced it has engaged a global Contract Research Organization (CRO) to oversee its clinical trial activities for its mBôs Total Knee Arthroplasty (TKA) System and represent its submission to the local regulators outside the United States.
The transnational CRO, which the Company cannot disclose due to competitive reasons, has extensive experience and successful FDA submissions from clinical investigations conducted Outside the United States (OUS).
"Partnering with a CRO expands our capabilities and will accelerate our product pipeline for the next-gen mBôs system," said Ben Sexson, Chief Executive Officer of Monogram. "We were encouraged by the recent formal FDA feedback on the clinical trial protocol and verification plan. After integrating FDA feedback and finalizing the application, our partners at the CRO will submit it to the local regulators. 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 plan to leverage the clinical data from the OUS study for post-launch marketing and to support international clearance and commercialization."
Currently, the company is targeting approximately 100 TKA surgeries at three sites, with three months of follow-up and a
Monogram developed the clinical trial study design considering FDA guidance and regulations for clinical investigations conducted outside the United States (OUS). Good clinical practice (GCP) guidelines will be followed, including review and approval by an independent ethics committee (IEC) and informed consent from subjects. The clinical trial will be conducted to meet the FDA and local regulatory requirements on research with human subjects (21 CFR 50, 54, and 56), Health and Human Services (DHHS) Regulations on research with human subjects (45 CFR 46 Subparts A, B, C, and D), ISO 14155:2011, and ICH's Good Clinical Practices (GCP) guidelines. The future clinical study report (CSR) will include the supporting information outlined in 21 CFR 812.28.
While the clinical study is focused primarily on providing safety data, the Investigators may also collect additional data that could be helpful for post-launch marketing. Such data could include detailed accuracy studies (for example, physical measurements of bone cuts and post-operative laxity gaps) and time studies that researchers could correlate to surgical time and learning curve.
Sexson continued, "The Company continues to see a significant and growing market opportunity for an active cutting robotic system that does not utilize haptic controls. We believe that press fit knee adoption and robot utilization go hand in hand. The IP landscape has created interesting dynamics in orthopedics. We continue to believe there is a significant and growing opportunity for a next-generation active cutting robot that can efficiently resect bone. An OUS clinical pipeline will be helpful for Monogram to try and capitalize on any potential market product gaps."
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 systems to give patients a better-fitting knee replacement with minimally invasive surgery. One hundred thousand knee replacements failing each year in a
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.
Investor Relations
Chris Tyson
Executive Vice President
MZ North America
Direct: 949-491-8235
MGRM@mzgroup.us
SOURCE: MONOGRAM ORTHOPAEDICS INC
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