Monogram Orthopaedics Partners with Global CRO to Advance mBôs Total Knee Arthroplasty System

Monogram Orthopaedics engages a global Contract Research Organization to oversee clinical trial activities for its mBôs Total Knee Arthroplasty System. The trial aims to accelerate product pipeline development and commercialization opportunities in the growing orthopedic surgery market.

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Nitish Verma
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Monogram Orthopaedics Partners with Global CRO to Advance mBôs Total Knee Arthroplasty System

Monogram Orthopaedics Partners with Global CRO to Advance mBôs Total Knee Arthroplasty System

Monogram Orthopaedics Inc. (NASDAQ: MGRM), an AI-driven robotics company focused on orthopedic surgery, has engaged a global Contract Research Organization (CRO) to oversee clinical trial activities for its mBôs Total Knee Arthroplasty (TKA) System. The partnership aims to accelerate Monogram's product pipeline development and commercialization opportunities.

Why this matters: The development of innovative robotic solutions like Monogram's mBôs TKA System has the potential to significantly improve patient outcomes and reduce healthcare costs in the growing orthopedic surgery market. As the global population ages, advancements in orthopedic surgery technology will play a critical role in addressing the increasing demand for joint replacement procedures.

The CRO, whose name is not disclosed due to competitive reasons, has extensive experience and successful FDA submissions from clinical investigations conducted outside the United States. "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.

The clinical trial will target approximately 100 TKA surgeries at three sites, with three months of follow-up and a 25% reduction in safety event rates. The multi-center study will use the cemented version of Monogram's FDA-cleared mPress TKA implant (K102927, K001456, K110950) and will be conducted to meet FDA and local regulatory requirements, following Good Clinical Practice (GCP) guidelines, including review and approval by an independent ethics committee (IEC) and informed consent from subjects.

Monogram received formal FDA feedback on the clinical trial protocol and verification plan, with integration of the feedback and finalization of the application underway. Submission to local regulators is expected soon. The company anticipates verification and validation to be largely complete in H1 2024, with a planned FDA 510(k) submission in H2 2024.

The strategy is expected to save Monogram significant costs and time, estimated at $1.5M for the trial. The company plans to leverage the clinical data from the study conducted outside the United States for post-launch marketing and to support international clearance and commercialization. Monogram believes there is a significant and growing market opportunity for an active cutting robotic system that does not utilize haptic controls, as well as a growing market for press-fit knee adoption and robot utilization.

Monogram Orthopaedics, headquartered in Austin, TX, is working to develop a product solution architecture that enables patient-optimized orthopedic implants at scale by linking 3D printing and robotics with advanced pre-operative imaging. The company intends to produce and market robotic surgical equipment, orthopedic implants, tissue ablation tools, navigation consumables, and other miscellaneous instrumentation necessary for reconstructive joint replacement procedures.

The engagement of a global CRO marks a significant step forward for Monogram Orthopaedics in advancing its mBôs Total Knee Arthroplasty System toward commercialization. With the clinical trial set to commence soon and key regulatory milestones on the horizon, the company is well-positioned to bring its innovative robotic solution to the growing orthopedic surgery market.

Key Takeaways

  • Monogram Orthopaedics partners with a global CRO to oversee clinical trials for its mBôs TKA System.
  • The clinical trial will target 100 TKA surgeries at 3 sites with 3 months of follow-up.
  • Monogram expects to save $1.5M and accelerate development with this partnership.
  • The company plans to submit to the FDA in H2 2024 and launch the product soon after.
  • The mBôs System aims to improve patient outcomes and reduce healthcare costs in the growing orthopedic surgery market.