Monogram Engages Contract Research Organization to Oversee mBôs Robot Clinical Trial Activities Outside the U.S.

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 25% reduction in safety event rates. This strategy could save the company significant costs and time, estimated at $1.5M for the trial. Monogram intends to conduct the multi-center Total Knee Arthroplasty clinical trial with the mBôs TKA System using the cemented version of its FDA-cleared mPress TKA implant (K102927, K001456, K110950). Monogram anticipates that once approved, the centers will have sufficient volume to complete enrollment and study execution expeditiously.

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.