Completion of the Development Phase Represents a Key Milestone Toward Product Commercialization
AUSTIN, TX / ACCESSWIRE / August 14, 2023 / Monogram Orthopaedics Inc. (NASDAQ:MGRM) ("Monogram" or the "Company"), a medical technology company focused on reconstructive joint procedures and surgical robotics, today announced the completion of the Development Phase and the start of the Verification Phase for the Company's next-generation autonomous surgical robotic system, a key milestone in Monogram's commercialization journey.
The development cycle for medical devices involves several phases to ensure their effective and safe production, including Conceptualization, Feasibility Studies, Design and Development, Verification, Validation, Regulatory Approval and Clinical Evaluation, and Manufacturing and Commercialization.
During the Verification phase, Monogram will rigorously test and validate its autonomous surgical robotics and related software to ensure the required design specifications, functionality, standards, and quality under different conditions and scenarios are met before surgeons use the product in the operating room on patients. The team will perform extensive tests and evaluations to ensure the product performs as intended. Any identified issues will be addressed and rectified before moving forward.
"The determination we were ready to close the Development phase and initiate Verification, which will include testing the accuracy and repeatability of our system, reinforces the potential of our highly differentiated surgical robot," said Ben Sexson, Chief Executive Officer of Monogram Orthopaedics. "The system has come a long way and is performing at a high level. The verification process involves a shift to rigorous testing as we move closer to production. This testing will ensure our robots meet critical safety, reliability, and functionality requirements before commercial use in the operation room.
"We expect the Verification Phase to be near complete by the time we anticipate shipping our first commercialization units planned in November. We intend to include clinical data in our 510(k) submission to the FDA."
After completing the Verification phase, the Company expects to enter the Validation phase to validate that the technology meets end-users' and customers' needs and expectations. The Validation phase will assess the product's overall usability and appropriateness in real-world scenarios, including surgeons running simulated surgeries on cadavers and evaluating iatrogenic injury and general product performance (for example accuracy and repeatability).
"As a practicing orthopedic surgeon and extensive technology user today, I can say that the Monogram product is performing very well," said Dr. Douglas Unis, Founder & Chief Medical Officer of Monogram Orthopaedics. "Active, autonomous robotics is the future of orthopedic medicine, and there is nothing on the market today that is remotely close to what Monogram's platform offers. Our patent-protected autonomous robots have been engineered with efficiency and versatility in mind. We have the potential to improve surgical efficiency across a wide range of orthopedic procedures which aligns well with the trend toward surgeon-owned outpatient surgery centers. We aren't just designing a knee robot - it's an orthopedic robot that will enable new applications."
Monogram has now filed over 20 patent applications related to various aspects of autonomous robotic execution, custom implants and novel tracking methods. It aims to be the first autonomous system on the market to utilize a robot-mounted sagittal saw. In March 2023, Monogram made history with the first fully remote simulated robotic surgery.
"Closing the development phase is the culmination of many hours of work and dedication," said Kamran Shamaei, CTO of Monogram Orthopaedics. "As we move through the next steps in pursuit of an FDA 510(k) clearance, we believe Monogram is well positioned to gain share in this high-growth market. We continue to solidify our intellectual property moat and grow our highly experienced technical team to capitalize on our first mover advantage in the market."
Mr. Sexson concluded: "In July, we announced our plans to initiate a pilot program with a global distributor that will put the Company on a path to start performing surgeries in 2024, establish commercial viability of the product, and provide clinical data for U.S. regulatory submission. We look forward to additional announcements for Monogram's commercialization journey in the months to come as we work to bring our product to market and create long-term value for our shareholders."
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 robot prototype 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.
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.
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SOURCE: MONOGRAM ORTHOPAEDICS INC
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