Full Press Release Details
Monogram Orthopaedics Secures
First Conditional Purchase Order to Initiate Pilot Program with Global Distributor
Moves from R&D to Commercialization
AUSTIN, TX / ACCESSWIRE
/ July 18, 2023 / Monogram Orthopaedics Inc., (NASDAQ:MGRM) ("Monogram" or the "Company"), a medical technology
company focused on reconstructive joint procedures and orthopedic implants, today announced the Company executed a conditional purchase
order to initiate a pilot program with a global distributor.
Monogram will update its system
software to facilitate robotic surgery with the distributor's implants for comprehensive evaluation. Notably, the Company anticipates
testing may include robotic surgeries on live patients. The distributor will conduct its evaluation outside of the United States.
"This purchase order
marks a pivotal moment for Monogram as we continue executing our strategic roadmap," said Ben Sexson, Chief Executive Officer of
Monogram Orthopaedics. "Our ability to complete the system evaluation successfully is a testament to our team's dedication and the
market potential for our current and next-generation product pipelines. This significant milestone on our journey toward commercialization
brings us many steps closer to adoption of our technology in the operating room while providing an upfront source of revenue and cash
flow. We remain focused on our mission to revolutionize orthopedic surgery while building long-term value for our shareholders."
As Monogram continues to pursue
a 510(k) clearance in the United States, the Company anticipates that this development could help bolster those efforts. The Company anticipates
that following a successful evaluation, an Outside the United States (OUS) commercialization strategy could also help establish the commercial
viability of the system and provide clinical data helpful for a US regulatory submission.
"The FDA has well-established
guidelines for companies to leverage clinical data obtained outside the United States for 510(k) submissions," said Dave McGurl,
Vice President of Regulatory Affairs at MCRA, a leading medical device Clinical Research Organization (CRO) and advisory firm. "Collecting
live patient data internationally, especially if there is commercial interest for the underlying product, can accelerate the time to launch
domestically, reduce the costs of doing so, and greatly mitigate the risks of a failed submission - this could be a favorable development
The Company is currently performing
rigorous testing at its Austin facility and expects to ship the first system in the fourth quarter of 2023, provided developments proceed
as expected. The conditional purchase order provides for the sale of the Company's surgical robot system to an international healthcare
provider and shipment to be made by November 30, 2023. The provider reserves the right to reject or cancel the order.
"Our core mission is
to provide patients with a more personalized surgical experience," said Kamran Shamaei, Chief Technology Officer of Monogram Orthopaedics.
"At Monogram, we believe that perfection must be the standard, and our team is working tirelessly across many fronts to execute.
This institutional validation confirms the tireless efforts invested in developing our product pipeline, which we continue to iterate
on with the goal of surpassing current industry standards."
The Company plans to continue
executing its multi-generational product release strategy by first establishing a market presence, achieving regulatory clearance, and
then introducing increasingly differentiated technologies. The Company is pushing to demo the next generation of its product pipeline
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.
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
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.