Navigated Robot System
2. Cutting System
Dr. Gregory Catlett, M.D.
Watch Monogram’s Live Product Reveal
In case you missed Monogram’s live surgical demo, it’s not too late. Watch the recording to see our in-house surgeon use our proprietary surgical robot to operate on a cadaver in real-time. This technology has been five years in the making, and now you can see it for the first time!
Disrupting the Joint Replacement Market
$19.6B
Joint Replacement Market
Over 1M
Annual knee replacements in US
250%
Projected procedure growth by 2030
Under 65-year-olds are the fastest-growing demographic
Patients under 65 years are the fastest-growing population of TKR recipients, expected to account for more than 50% of knee replacement procedures by the year 2030
Market is ripe for disruption
Four companies currently dominate the multi-billion dollar joint reconstruction market with an 82% combined share in knee replacement. Monogram is building critical infrastructure to scale growth. We have signed deals with 2 distributors and have more on the way.
Building Critical Infrastructure to Scale Growth
The Monogram Knee System Won FDA Approval
We have licensed, FDA-approved, clinically well-established implant components that will be integrated into our proprietary Monogram knee system. Monogram is leveraging the testing and proven performance of these components (articulation, locking mechanisms, inserts) to focus on our novel tibial component and robotics.
As Seen In
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"Given the sheer number of knee and hip replacement procedures every year, the fact that joint reconstruction technology has remained unchanged for over 50 years is perplexing."
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"Monogram has a first-to-market advantage in a sector that's about to get even more competitive."
"Monogram Orthopedics is ushering in personalized orthopedic care by combining proprietary 3D printing technology with next-generation navigated surgical robotics".
"Monogram is developing a better way by commercializing highly personalized joint implants unique to every patient and a first-of-its-kind active robotics system that performs precise bone cuts."
"Monogram has conducted studies with UCLA and demonstrated Monogram process was about seven times more stable than current hip replacement techniques."
National Science Foundation
Over 1 Million Knee Replacements a Year
As many as 100,000 total knee replacements fail each year
Solving Real Problems
It is estimated up to ⅓ of TKA patients have chronic pain after their operation
Joint replacement technology has, in many ways, remained the same for more than 40 years. Often crude and finicky instruments like saws and jigs are used to prepare the bone for rigid, generic implants. Monogram’s technology delivers custom-fitting, 3D-printed joints implanted with robotic precision.
50% of early revision surgeries after a knee replacement are related to instability, malalignment or malposition, and failure of fixation.
Knees
Rate of re-admission:
7%-8%.
Approximately 50%-75% are surgical.
36%
Survey: 36% of TKA patients would not have undergone the surgery knowing what it did for them (10 years later).
1 in 5
1 in 5 patients are not satisfied with the results of their total knee replacement.
Potentially Preventable Reasons for revision Procedure
19%
10%
7%
5%
By 2027, approximately 50% of all knee procedures will be robotic, up from 11% in 2019.
Significant Increases
in robotic adoption are expected over the next 5-10 years.
At least 50% of procedures will be robotic by 2027
Estimates for procedure volumes vary but TKA projections are generally between 935,000 and 1,260 and 1,260,000 by 2030
Stryker (Mako) is the only navigated robot arm on the market with a cutting end-effector. Monogram believes we will be the first active navigated arm on the market.
Robotic Surgical Assistants
Monogram’s navigated surgical robot features several enhancements that will improve surgical experiences including:
Closed Loop Tracking
For safety Monogram has implemented a "closed-loop" system. The real-time position of the cutting system is tracked at all times.
Increased Range of Motion
Seven degrees-of-freedom (used to measure range of motion) with control algorithms that leverage the kinematic redundancy to avoid interoperative boundaries and optimize execution.
Active Navigated Milling
High-efficiency rotary cutting system to gently excavate the negative space for the patient-optimized implant.
Keep on Moving.
Our custom-fitted implants will help patients enjoy their lives to the fullest.
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3. Implants
4. Navigation Consumables
5. Cutting Tools
6. Software
1.Navigated Robot System
2. Cutting System
3. Implants
4. Navigation Consumables
5. Cutting Tools
6. Software
The Business Model
We believe that precision implants with precision insertion are the future of orthopaedics. Monograms principal competitive advantage will be our ability to produce customized, robotically inserted orthopaedic implants rapidly and at scale. The product solution architecture we are developing enables rapid fabrication and mass personalization of robotically inserted, patient specific orthopaedic implants.
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Implants designed for uncemented stability.
Monogram implants rely on natural biologic fixation and are smaller, bone conserving, and more stable.
Implant
Monogram Results
Patient-optimized bone sparing press-fit implants
The leading generic equivalent had up to 270% more micromotion than Monogram
The cementless total knee market is expected to grow by $1.2BN from 2020 to 2024 (22% CAGR)
The cementless total knee market is expected to grow by $1.2BN from 2020 to 2024 (22% CAGR)
Approximately 95% of hip implants are press-fit
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Will uncemented knee adoption follow the hip trend?
In a period of 10 years, the use of cement decreased from 54% to 4% in 2019. Similarly, we anticipate there could be a significant decrease in the use of cement in knee replacements over the next decade or so.
The Technology Platform
Monogram Orthopaedics is developing a product solution architecture to enable mass personalization by linking 3D printing and robotics via automated digital image analysis algorithms.
The Robotics
Monogram’s navigated robot features several enhancements that will improve user experience compared to robots currently in use. Specifically, the Monogram robot will feature tracking cameras mounted directly on the robot to mitigate line-of-sight issues. The robot will feature seven degrees-of-freedom (used to measure range of motion) with control algorithms that leverage kinematic redundancy execution. The robot will also utilize complex tracking capabilities for gentle navigation.
Our Implants
Monogram’s components are designed such that cortical contact and stability are maximized while remaining insertable and designed to reconstruct the native patient anatomy as closely as possible. Monogram will commercialize the first patient specific solution to address the primary shortcomings of their generic counterparts.
The Technology Platform
Monogram Orthopaedics is developing a product solution architecture to enable mass personalization by linking 3D printing and robotics via automated digital image analysis algorithms.
The Robotics
Monogram’s navigated robot features several enhancements that will improve user experience compared to robots currently in use. Specifically, the Monogram robot will feature tracking cameras mounted directly on the robot to mitigate line-of-sight issues. The robot will feature seven degrees-of-freedom (used to measure range of motion) with control algorithms that leverage kinematic redundancy execution. The robot will also utilize complex tracking capabilities for gentle navigation.
Our Implants
Monogram’s components are designed such that cortical contact and stability are maximized while remaining insertable and designed to reconstruct the native patient anatomy as closely as possible. Monogram will commercialize the first patient specific solution to address the primary shortcomings of their generic counterparts.
Meet the Team
See Our Team
Douglas Unis, Md
Founder & Chief Medical Officer
Dr. Unis is a board-certified attending orthopedic surgeon for the Mount Sinai Health System and Chief of Quality Improvement for Mount Sinai West.
Benjamin Sexson - CEO
CFA, Chief Executive Officer
Prior to joining Monogram, Mr. Sexson served as the Director of R&D and Business Development at Pro-dex (ticker: PDEX). Mr. Sexson graduated with honors from Caltech in Mechanical Engineering and is a CFA Charterholder.
Paul Riss
CPA, MBA, INTERIM CFO
Experienced executive with a demonstrated history of completing SEC filings, focusing on the Securities Exchange Act of 1934 and Section 4(a)(6) of the Securities Act of 1933. Currently serves as a Director for NetCapital and was a CPA with Ernst & Young.
Kamran Shamaei, PhD
CTO
Kamran Shamaei received a Ph.D. from Yale University and MSc from ETH Zurich and did his postdoctoral research at Stanford University, focusing on Medical Robotics. He has extensive experience developing FDA cleared surgical robots.
Christopher Scifert, PhD
Director of Product Development Implants and Instruments
Chris was the Director of Engineering for Orchid Design, a division of Orchid Orthopedic Solutions, a market-leading outsourced medical services. Chris has held various engineering management roles at Medtronic and Smith & Nephew and obtained a Ph.D. in Biomedical Engineering from the University of Iowa.
Kevin Posey
DIRECTOR OF QUALITY AND REGULATORY ASSURANCE
Muhammad Afnan
Director of Software Engineering
Sophia Sangiorgio, PhD
Director, Orthopaedic Institute for Children
Laura Gilmour
Global Medical B. Development Manager at EOS NA
Matt DiCicco, M.S.
Robotics, MIT
Dr. Roshan Shah
Director of Complex Adult Hip and Knee Reconstruction at Columbia University
Robert Jamieson
Board Certified Orthopaedic Surgeon at The Orthopedic Specialty Center of Northern California
Dr. Matthew E. Heinrich
Total Joint Replacement Specialist at Orthopaedic Specialists of Austin
Darwin Chen
Associate Professor of Orthopaedics at Icahn School of Medicine at Mt Sinai
Dr. Gregory Catlett
Total Joint Replacement Specialist at Orthopaedic Specialists of Austin
Business Updates
Monogram Wins Prestigious Award from National Science Foundation
1/5/2022
Monogram is pleased to announce that it has received an award notice from The National Science Foundation (NSF) for its application "Development of a tracking system for computer-assisted surgery." The SBIR Phase I award will support the research of a novel Monogram tracking system designed to mitigate the occlusion limitations of conventional line-of-sight systems while reducing the OR footprint, lowering capital cost, and minimizing patient trauma associated with secondary incisions. Monogram has filed for patent protection for these novel concepts.
"It is an incredible honor to be chosen for such a prestigious award," said CEO Ben Sexson. "It's a significant endorsement that speaks to the caliber of our team and ideas as well as the tremendous efforts our company is making to further the field of orthopedic medicine. We are especially thankful to Northern Digital for their support with this application.
"The NSF follows a rigorous review process, approving a small number of the full proposals. Per the NSF's Program Solicitation document, "the SBIR/STTR Phase I Programs are highly competitive. While success rates vary year-to-year, approximately 10-15% of the full proposals submitted are selected for an award. Thus, there are many qualified businesses applying to the program each year that do not receive funding." The Small Business Innovation Research Program awards such grants in phases. The Phase I award of $256,000 will help support proof of concept refinement. Monogram intends to file for a more significant Phase II award pending successful completion of Phase I activities. Funding rates for Phase II applications tend to be higher. Once a small business is awarded a Phase I SBIR/STTR grant (up to $256,000), it becomes eligible to apply for a Phase II (up to $1,000,000). Small businesses with Phase II funding are eligible to receive up to $500,000 in additional matching funds with qualifying third-party investment or sales.
"Operating rooms can get very crowded, and the footprints are often not conducive for conventional tracking methods," said CMO Dr. Doug Unis. "And while navigation offers considerable clinical benefits, secondary incisions and similar considerations are not ideal for patients. To receive recognition from such a prestigious organization for our efforts to advance the current state-of-the-art in surgical robotics is a tremendous achievement."
The National Science Foundation (NSF) is an independent agency of the United States government that supports fundamental research and education in all the non-medical fields of science and engineering.
Keep following for more updates on how Monogram uses high precision, patient-specific implants with state-of-the-art robotics to improve patient outcomes.
Monogram Starts Generating Revenue with First TKA Procedure
about 2 months ago
Monogram is pleased to announce that on Monday, March 22nd, 2021, we completed our first Total Knee Arthroplasty ("TKA") procedure as a company and will now be generating revenue. Facilitating the requirements needed to perform our first case is a significant accomplishment for Monogram and the culmination of a tremendous team effort.
Monogram is now:
- HIPAA compliant
- has implemented an ERP system with lot tracing
- has secured implant component supply
- has established distribution relationships
- has implemented several critical insurance policies
- has run its first cadaver lab in its Austin facility
"Our philosophy has always been to build an operating business as quickly as possible, which means much more than having competitive products," said CEO Ben Sexson. "The basic infrastructure and systems required to support and scale growth in our highly regulated market are demanding and cannot be overlooked. Pulling all the pieces together to facilitate sales in such a highly regulated market is a major first step towards our goal of building a real orthopedic company. We believe the first dollars of revenue are always the hardest."
Monogram has not provided sales guidance but would like the investors to calibrate expectations appropriately. "Aggressively driving sales requires a significant working capital investment, and the most compelling components of our product pipeline remain in development and our focus," said CEO Ben Sexson. "We want to build a company that can scale at the appropriate time. The goal right now is forward-thinking, and we are focused on the long-term. In the long-term, innovative products that improve patient lives are what matter to us most."
Monogram expects to continue generating revenues and remains optimistic about its ongoing growth prospects.
Monogram Executes Strategic License of Unicondylar Knee Replacement Implant
3 months ago
Monogram is pleased to announce it has successfully executed a license agreement for an FDA-approved Unicondylar Knee Arthroplasty ("UKA") implant design from an established orthopedic manufacturer. Monogram intends to prioritize the launch of total knee and partial knee robotic applications.
"The orthopedic market today is too siloed. Knee teams optimize knee products. Hip teams optimize hip products. Spine products are a completely different focus altogether. After the fact, large organizations try to force-fit platform technologies into these siloes," said CEO Ben Sexson. "Elon Musk explains this organization problem perfectly here. Monogram is building an orthopedic platform technology. We believe an orthopedic robot capable of addressing multiple clinical applications with a single-arm simplifies the capital equipment sales process with hospitals and will be massively differentiated. Integrating partial knees and other products into our robotic platform is critical for this."
Monogram's strategy is to develop a single, highly robust robotic platform technology that can address clinical opportunities across significant orthopedic applications, for example, knees (both total and partial), hips, shoulders, ankles, and spine. Monogram expects to begin developing its partial knee application when it enters V&V testing on its total knee application.
"If you look at Mako and their success, they started with partial knees, and after Stryker acquired them, they launched the total knee application in 2015," said Chief Medical Officer Dr. Doug Unis. "To compete with Mako, at a minimum, we will need robotic prep for both a total knee and a partial knee. Longer-term, we plan on addressing hips and other markets."
Monogram to Present at OTC Markets Regulation A+ Investor Conference - Register now!
4 months ago
Monogram will be speaking Thursday, February 11, 2021, @ 11:30 AM ET at the OTC Markets Regulation A+ Investor Conference. The presentation is 30 minutes and will include a management Q&A.
Here is the registration link here
Monogram Executes First Hospital Contract: Expect Revenues as early as First Quarter 2021
4 months ago
Monogram is pleased to announce that it has executed a Product Purchase Agreement with its first significant hospital institution. The company expects it could begin placing implants in patients and generating revenue as early as the first quarter of 2021 (although cautions that Covid-19 and unforeseen market factors could impact timing).
"Being accepted by the value analysis committee of a major hospital institution is a significant milestone for our company," said CEO Ben Sexson. "We expect to begin generating revenues very soon. We continue to execute on our strategic initiatives, and we are extremely pleased with the progress of our product pipeline and our pace of growth. Our goal is to become a competitor in the ortho space as quickly as possible."
Monogram management looks forward to sharing our continued progress and is thankful for our shareholders without whom this progress would not have been possible.