Monogram Orthopaedics

Future of Joint Replacement

Monogram Orthopaedics

Future of Joint Replacement

Austin, TX
Health Tech
Monogram is a medical technology company ushering in the future of joint reconstruction. Monogram Orthopaedics is developing a product solution architecture to enable mass personalization of orthopedic implants by linking 3D printing and robotics via automated digital image analysis algorithms. We are designing our state-of-the-art surgical robot with the aim of mitigating the risks of poor placement, fracture, and subsidence to give surgeons confidence that they can install implants that fit every patient - perfectly.

$11,909,159

raised
7,559
Investors
$89.9M
Valuation
$7.52
Price per Share
$250.80
Min. Investment
Common
Shares Offered
Equity
Offering Type
$34.9M
Offering Max
Reg A+
Offering

$11,909,159

raised
7,559
Investors
$89.9M
Valuation
$7.52
Price per Share
$250.80
Min. Investment
Common
Shares Offered
Equity
Offering Type
$34.9M
Offering Max
Reg A+
Offering

Rewards

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$5,000+
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5% Bonus Shares
Invest $5,000 and receive 5% Bonus Shares on your investment
$10,000+
Investment
10% Bonus Shares
Invest $10,000 and receive 10% Bonus Shares on your investment

Offering Circular | Risks Related to this Offering | SEC EDGAR Filings


Monogram has not yet applied for or obtained FDA approval for our novel Monogram products and sales of novel Monogram products may not commence until approval is received.


Reasons to Invest

  • World-class team with a track record of execution: led by a team of experts in robotics and medical technology, and advised by surgeon consultants from institutions such as Columbia and Icahn School of Medicine.
  • First revenues in 2021 & new product launches: we have generated our first revenue in 2021 and expect to launch our first-gen implants during the first half of 2022.
  • Already raised $16.7M from 6,793 investors: We have been through 3 successful financing rounds and continue to execute.
  • Established product-market fit: the leading orthopedic robot on the market (technology from a startup acquired in 2013) outsells its next largest competitor over 12-to-1 with an 87% share. We understand its limitations and have the team to build the future of robotics.
  • Novel technology for massive growing market: The joint replacement market is approximately $19.6BN, with over 1 million knee replacements per year. We believe we will be one of the first to market with our technology and eight patent filings. 


Overview


Our mission is to make orthopedics personal

Monogram Orthopedics will use the latest in robotic, AI, and 3-D printing technologies to make orthopedic care personal. Monogram will try and make every design and development decision by focusing on what we think will most benefit patients and improve clinical outcomes (note: this is based on management opinion and has not been demonstrated in live patients).


Four companies currently dominate the multi-billion dollar joint reconstruction market with an 82% combined share in knees (source). Many companies fail to penetrate this market, as many believe change isn’t possible.


*above image is computer generated and not yet available for commercial sales

With what we believe to be innovative robotic and implant technologies, we will try to improve the accuracy of implant placement, and we hope thereby improve patient outcomes at a lower cost (note: this is based on management opinion and has not been demonstrated in live patients). Our priority is clinical benefits for patients and true patient satisfaction. We believe patients and surgeons alike deserve better.  Monogram's goal is to try and lead what we believe to be the future of joint reconstruction.


(Source 1)

The Problem


One size fits none approach leaves patients behind


Up to 10% of all knee and 15% of hip replacements fail annually (source).  These failures are in part because the technology is inherently inefficient and subject to surgeon error.  Joint replacement technology has, in many ways, remained the same for 40 to 50 years. Often crude and finicky instruments like saws and jigs are used to prepare the bone for geometric and rigid generic implants that don't accurately fit.  Insertions are often eyeballed and subject to proper surgeon execution. Management believes we may be able to design the Monogram workflow for efficiency and accuracy by leveraging the technical manufacturer specifications of our robot arm. 




Furthermore, four large companies dominate the market, leaving little room for innovation. This consolidation hurts patients and surgeons by limiting patient options and slowing the pace of technological progress.  


Traditional surgeries are also highly inefficient, with underutilized instruments and unused implants that add to the treatment burden. Monogram aims to reduce the required instrumentation needed to perform joint replacement procedures and streamline inventory requirements. We believe this will be especially beneficial as the market shifts to Ambulatory Surgery Centers.


(Source 1), (Source 2), (Source 3)

Our primary focus is the wellbeing of our future patients.  Revisions and failures are serious and far too frequent. We plan our cases for execution with a state-of-the-art surgical robot.  We believe the combined improvements to the robot and implants could potentially benefit patient outcomes and mitigate risk - this is based on management opinion and has not been demonstrated in live patients.

Patients and surgeons need more comprehensive, clinical focused solutions that truly fit their needs.


The Solution


The next-gen 3D implant solution

We design implants for active patients that want to restore their quality of life. Management believes our integrated solution may eliminate the cost and improve efficiency in the operating room by reducing instrumentation and optimizing the cut path execution.


We have optimized our next-generation joint replacement solution with a state-of-the-art robot.



Monogram is committed to developing patient-optimized orthopedic implants, inserted with a surgical robot for unparalleled precision. Our navigated surgical robot relies on a CT-based pre-operative plan and has more reach (approximately 4.2 feet), with 7-degrees of freedom. (source, pg 5)


(Source 1)

Our fully-personalized system breaks the barriers of traditional, cemented implant procedures that rely on manual instrumentation. While the underlying technologies are highly sophisticated and complex, the workflow remains straightforward and capital efficient.


GIF 1

GIF 2

GIF 3

GIF 4

GIF 5

“By failing to plan, you are planning to fail.” – Benjamin Franklin

The Market


A $19.6 billion joint replacement market in need of innovative disruption

The joint replacement market is currently at $19.6BN (source) with hip and knee replacements being the most common. The knee replacements market is $8.7 billion (source). Despite the market's significant size, innovation has plateaued because just four large companies dominate. Monogram's first addressable market will be total knee replacements, with almost 1 million knee replacements performed in the United States annually (source). Some market estimates project there will be nearly 3.5 million annual Total Knee Replacement procedures by the year 2030 (source)


(Source 1)

By 2027, approximately 50% of all knee procedures will be robotic, up from 11% in 2019 (source). In the United States, we currently cement 92% of knees versus only 3% of hips. We believe that surgeons prefer uncemented or "press-fit" implants (source) and management believes press-fit knee adoption represents one of the most significant growth opportunities in orthopedics. Monogram is developing a next generation uncemented knee designed that we expect will benefit from these macro trends. 



A significant driver of press-fit implant utilization (the type of implant Monogram is developing) is patient demographics.  Improved low wear plastics make joint replacements more suitable for younger patients. In particular, patients less than 65 years of age represent the fastest-growing population of TKR recipients, expected to account for more than 50% of knee replacement procedures by the year 2030 (source).  We are designing the Monogram implants to meet the demands of younger active patients.


Another tectonic market shift that we see driving the adoption of technologies is the growing outpatient trend to Ambulatory Surgery Centers.  In January 2018, the Centers for Medicare & Medicaid Services (CMS) removed knee replacement procedures from the inpatient-only list, allowing procedures to be conducted on an outpatient basis.  


Across the country, the average cost for an inpatient knee replacement is $30,249, compared to $19,002 in the outpatient setting (source)- we believe these cost savings will drive significant volumes away from high volume hospitals. 


Our Traction


Significant capital raised, eight patents filed, and trusted surgeon advisors to support product-market fit

Monogram has raised $16.7 million with 6,793 trusted shareholders. We are actively deploying this capital to develop our novel orthopedic technologies and the operating and sales infrastructure needed to support their distribution. Monogram has recruited five practicing surgeons to support our development and validation efforts and provide practical user input. We aim for our products to be suitable for both the surgeon user and our patients.  



To date, we have signed contracts with two distributors that will market Monogram to select geographies.  We expect to generate revenue from licensed implants in 2021. We have a newly completed 350 square foot Monogram cadaver lab based in Austin, Texas, along with a team of 16 full-time employees. We have filed eight patents related to our proprietary technologies, as well as a Freedom-to-Operate (FTO) search for Monogram's knee design with a robotic surgical approach. 


Our internal cadaver lab allows our engineers to develop and validate many of our products more efficiently and economically.  In parallel, the lab supports our sales channels by allowing our team to demonstrate the product pipeline and share the vision with distributors and surgeons with live cadaveric surgeries before FDA approval.


*future events are anticipated based on full funding of the company in this offering or from other sources, and there is no guarantee the company will be able to meet those future milestones

What We Do


Implants that perfectly match every patient

At Monogram, we believe that there is a better, less-invasive way to treat patients. We combine 3D printing and robotics with CT-based pre-operative planning to enable mass personalization of the next generation of orthopedic implants.


Implant Design, Reimagined

The process starts with a CT scan, which is the starting point for personalization. From the CT scan, we can create an accurate patient-specific 3D models of the bony anatomy. By building a customized implant for every patient, we believe we may be able to more fully restore anatomical function and mitigate clinical risks (note: this has not been demonstrated in live patients). We believe bone conserving highly stable press-fit implants that rely on natural biologic fixation will improve patient outcomes and usher in the future of orthopedics (note: this is based on management opinion and has not been demonstrated in live patients).

GIF 6

3D Printed Implants

Unlike conventional, expensive, labor-intensive manufacturing, Monogram will deliver highly personalized implants efficiently at scale by leveraging state-of-the-art manufacturing methods and 3D printing. 


All Monogram implants will undergo rigorous validations and testing to ensure the highest industry quality standards. Monogram has conducted extensive mechanical strength testing that tries to simulate the rigorous ISO strength testing standards mandated by the FDA (we have not yet submitted our implants for the ISO strength tests mandated by the FDA and we can make no assurances that our implants will pass such testing). Our implants will be a biocompatible medical-grade titanium alloy (Ti64) with a chemical composition corresponding to ISO 5832-3, ASTM F1472, and ASTM B348.

GIF 7

Robotic Milling Cavity Technology

Monogram takes surgical robotics to the next level. There are currently no CT-based, navigated robots that actively execute bone cuts without user-initiated movements. Monogram aims to be the first company to release such a robot. 


Our goal is to combine groundbreaking software with world-class hardware, delivering an integrated robotic system that addresses major clinical concerns today - cost, time, and a lack of efficient control.

GIF 8

The Business Model


Goal to Lower cost and try to improve accuracy and efficiency

We are developing the implant and robotics in parallel, but we plan to de-risk the commercialization with discrete FDA submissions. We have entered into a distribution agreement for an FDA approved total knee system, specific components of which we intend to integrate into our novel knee system for future release. As part of this agreement, we recruited the Senior Director of US Sales from the manufacturer to support early sales efforts. 

Monogram intends to secure distribution relationships for these existing products before releasing our novel products as a Phase I release. 

Monogram has not yet applied for or obtained FDA approval for our novel Monogram products and sales of novel Monogram products may not commence until approval is received.

In the second phase, Phase II, we intend to commercialize our patient-specific implants inserted manually (the "Gen 2" implant) as a discrete FDA submission. We hope to drive sales through the distribution channels established during the first phase, Phase I. In Phase III, we will release our surgical robot.

Monogram will have two primary revenue streams; a revenue stream from the sale of capital equipment and a revenue stream from our consumable products' sale.  We expect to price our implants like the national ASP, and we will undercut competitive pricing for our capital equipment.

In the future, we intend to develop applications for additional clinical applications, including partial knees and hips, and we are investigating applications for shoulders, spine, and extremities.  

How We Are Different


A fully integrated medical solution never seen in the market before

The Monogram management team sees a clear growth opportunity for an efficient and strategically priced navigated robotic surgical system that relies on advanced imaging like a CT-scan. We will design the Monogram implants and robotic system to have a good product-market fit for the growing demographic of patients age 64 and younger. 


The current market consolidation also presents opportunities for Monogram. The size and operational complexity of our large competitors, with so many stakeholders and product lines, can make it difficult for them to advance disruptive innovations efficiently. Monogram sees a greenfield opportunity for a surgical robot that uses advanced imaging to actively and efficiently mill cavities for a perfect fit with 3D-designed implants. We believe we are on track for it to be the first of its kind in the market if we are successful.


In our testing conducted with our research partners, our implants appear to outperform leading generic equivalents by, in some variations, a considerable margin.  We think we can design more stable bone conserving implants that rely on natural biologic fixation through an innovative design approach, and we think we can leverage the high accuracy manufacturer specifications of the robotic arm for accurate bone preparation and customization of the implant design and surgical plan to the specific patient.  Personalization also minimizes the inventory and instrumentation, which eases the burden on hospitals and ASCs.  

In summary, we provide a fully integrated, personalized orthopedic solution that combines custom bone preparation with optimized 3D printed implants that has never been done before.  From the trend to ASCs to a younger patient demographic to increased robotic utilization, the underlying market dynamics all bode favorably.

The Vision


Commercialize a differentiated surgical robot for multiple orthopedic applications

The total orthopaedic market is over $53BN annually. Our initial focus is total knee replacements followed by partial knee and hip replacements - we are actively investigating shoulders, ankles, and spine. We expect to generate revenue in 2021.

Our vision is to improve the standard of care in orthopedics with personalized technology solutions. With a differentiated, navigated surgical robot that prepares the bone for clinically differentiated press-fit orthopedic implants, we will be able to make implants more stable that preserve the bone and rely on natural biologic fixation.

Monogram has executed two distribution agreements thus far. We expect to generate revenue in 2021, and we anticipate continuing to grow our sales network as we gain traction. We will leverage our dedicated cadaver lab, housed in our 4,000 square foot Austin facility, to demo our product pipeline to continue to build our distributor and surgeon relationships.

OUR LEADERSHIP


Led by surgeons and Medtech executives with engineering and finance expertise

Our founder and Chief Medical Officer, Dr. Douglas Unis, is a board-certified attending orthopedic surgeon for the Mount Sinai Health System. Dr. Unis, along with Caltech graduate and CEO - Benjamin Sexson, CFA, lead a team of experts in surgical robots and implant design. Our VP of Engineering is Kamran Shamaei, Ph.D., who worked with Think Surgical Inc. on the TSolution One Robot and supported the development of Monarch robots at Auris Health Inc. Chris Scifert, Ph.D., the former Director of Engineering for Orchid Orthopedic Solutions Design, one of the largest manufacturers of implants globally, is running the development of our implants and instruments.

Monogram has recruited five practicing surgeons to support our development and validation efforts and provide practical user input. These surgeons include doctors from The Orthopedic Specialty Center of Northern California, Orthopaedic Specialists of Austin and Columbia University.

Monogram currently employs 16 full-time employees and is actively contracting with four consulting firms with significant subject matter expertise.

Why Invest


Take medical robotics to the next level

The reasons to invest are straightforward; we have a proprietary technology for products that don't currently exist for a large and growing $19.6BN joint replacement market. We have protected our products with multiple IP filings that we know have a product-market fit because the only similar technology on the market has an 87% market share. While we have ambitious goals, we have successfully raised $16.7M to date and have assembled a differentiated team with the experience needed to execute. We believe we will be early to market with a solution with the potential to change the standard of care in orthopaedics.

Many companies are trying various solutions to compete - imageless registration, small footprints, portability, and cost. We think they are overthinking the proven solution and will struggle with adoption. We believe that the market desperately needs a viable alternative and none currently exists. 

By investing in Monogram, you will be supporting an experienced team to develop the future of orthopedics, which we believe is patient optimized 3D printed implants designed for high accuracy robotic placement. With our eight patents pending, a leadership team of experts in medical and surgical technology, and a highly differentiated solution fit for the growing $19.6BN joint replacement market, we can minimize surgical risks and restore patients to their active lifestyles.

We hope you will join the adventure and invest in the future of orthopedics!

Monogram has not yet applied for or obtained FDA approval for our novel Monogram products and sales of novel Monogram products may not commence until approval is received.


AN OFFERING STATEMENT REGARDING THIS OFFERING HAS BEEN FILED WITH THE SEC. THE SEC HAS QUALIFIED THAT OFFERING STATEMENT, WHICH ONLY MEANS THAT THE COMPANY MAY MAKE SALES OF THE SECURITIES DESCRIBED BY THE OFFERING STATEMENT. IT DOES NOT MEAN THAT THE SEC HAS APPROVED, PASSED UPON THE MERITS OR PASSED UPON THE ACCURACY OR COMPLETENESS OF THE INFORMATION IN THE OFFERING STATEMENT.


THE OFFERING CIRCULAR THAT IS PART OF THAT OFFERING STATEMENT CAN BE FOUND HERE.


THE OFFERING MATERIALS MAY CONTAIN FORWARD-LOOKING STATEMENTS AND INFORMATION RELATING TO, AMONG OTHER THINGS, THE COMPANY, ITS BUSINESS PLAN AND STRATEGY, AND ITS INDUSTRY.  THESE FORWARD-LOOKING STATEMENTS ARE BASED ON THE BELIEFS OF, ASSUMPTIONS MADE BY, AND INFORMATION CURRENTLY AVAILABLE TO THE COMPANY’S MANAGEMENT.  WHEN USED IN THE OFFERING MATERIALS, THE WORDS “ESTIMATE,” “PROJECT,” “BELIEVE,” “ANTICIPATE,” “INTEND,” “EXPECT” AND SIMILAR EXPRESSIONS ARE INTENDED TO IDENTIFY FORWARD-LOOKING STATEMENTS, WHICH CONSTITUTE FORWARD LOOKING STATEMENTS. THESE STATEMENTS REFLECT MANAGEMENT’S CURRENT VIEWS WITH RESPECT TO FUTURE EVENTS AND ARE SUBJECT TO RISKS AND UNCERTAINTIES THAT COULD CAUSE THE COMPANY’S ACTUAL RESULTS TO DIFFER MATERIALLY FROM THOSE CONTAINED IN THE FORWARD-LOOKING STATEMENTS.  INVESTORS ARE CAUTIONED NOT TO PLACE UNDUE RELIANCE ON THESE FORWARD-LOOKING STATEMENTS, WHICH SPEAK ONLY AS OF THE DATE ON WHICH THEY ARE MADE.  THE COMPANY DOES NOT UNDERTAKE ANY OBLIGATION TO REVISE OR UPDATE THESE FORWARD-LOOKING STATEMENTS TO REFLECT EVENTS OR CIRCUMSTANCES AFTER SUCH DATE OR TO REFLECT THE OCCURRENCE OF UNANTICIPATED EVENTS.

Quick Insert

Updates

Invitation to Monogram Surgical Live Stream & Product Reveal!

5 days ago

We are pleased to announce that on  Monday, 24 January 2022, at 3:00 PM CST, we will be live-streaming a cadaveric surgery with our robotic system in a first-of-its-kind reveal!  This event is a massive moment for Monogram... 


Livestream start: Monday, 24 January 2022, 3:00 PM
Registration link: https://bit.ly/3D4HLzV


If you don't have a Linkedin account you can register here.

For likely the first time in the history of orthopaedic surgery, Monogram is live-streaming a product reveal with A SURGEON WHO HAS NEVER SEEN OR USED OUR SYSTEM.  The live audience will share his real-time discovery and watch his actual first impressions - unfiltered, unedited, live!  We are incredibly thankful to our generous shareholders, whose contributions have made this exciting event possible.  We dedicate this event to you!  We appreciate your dedication to our mission.

We hope you join us!


This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment.

Q2 Monogram Investor Update

about 1 month ago

Greetings,


We appreciate the opportunity to update you on our second quarter's progress and provide some general comments.  


Industry Update:

The past year has undoubtedly been a challenging one for our industry. Third-party reports trusted by management indicate that approximately 760,240 primary TKA procedures were conducted in the United States in 2020, compared to 884,000 TKA procedures in 2019. This decrease in primary TKA procedures represents a year-over-year decrease in surgical volume from 2019 to 2020 of 14% for primary TKA procedures. While we believe this decrease is transitory and related to the effects of the COVID-19 pandemic, the reduction exceeded our expectations. A silver lining is that year-over-year implant ASPs remained stable and, in some cases, increased slightly. 


The most significant macro trend that has directly impacted Monogram is manufacturing lead times. Anecdotally, we are seeing lead times getting pushed across the board. For example, manufacturers that previously quoted 6-8 week turnarounds have been pushing out to 10-12 week deliveries. One of our suppliers had to shut down a manufacturing cell for a short period. We have been actively managing these impacts, but they have impacted some of our development timelines. A positive is that we have been using time delays from hardware bottlenecks to incorporate software features previously planned for the second generation robot release.  


Strategy Execution:  

In the first six months of 2021, Monogram generated $628,000 in revenue from the sale of licensed implants. The Company has negotiated and executed its strategic objectives with the inventory purchased and will discontinue marketing these products as-is for the foreseeable future. Monogram is actively developing implants that will upgrade features of its licensed implants and incorporate elements from the licensed implants into novel implants. 


Notably, as part of this strategy, Monogram is now HIPAA compliant, has implemented a scalable ERP system, and has worked through some of the early kinks often associated with becoming a revenue-generating entity. The past quarter was a terrific "dry run" that has positioned our organization for our novel product launch.


The Company intends to submit a first-generation press-fit implant for FDA approval by Q2 2022. The timing for this FDA submission will depend on the availability of third-party manufactures to prepare our physical inventory to be evaluated by the FDA. The Company does not currently have any manufacturing capabilities itself for what is required by the FDA. As such, we could encounter longer production lead times or supplier disruptions that could materially impact our development timelines, delaying submission beyond Q2 2022. If we cannot submit our FDA submissions in a timely manner, it could adversely affect our financial position and ability to generate sales.


Figure 1: The first-generation press-fit TKA will feature aggressive asymmetric porous coating and is insertable both robotically and with manual instrumentation. We anticipate this product may be competitive with current offerings.

We look forward to exhibiting our products at AAOS in March 2022 for those interested in attending. We invite all of our shareholders to check out our booth (additional details to be announced)!


Development:  

Monogram has made significant technical progress this quarter. We are exceptionally proud of the team effort made to accomplish our goals. We capped our quarter with a successful end-to-end procedure run on a cadaveric specimen in our lab. The current Monogram surgical workflow is as follows: 


a) Pre-operative planning & case management: this workflow generates the patient case file, links it with important patient data (like the CT scan), and generates all necessary patient-specific inputs required for robotic execution. This workflow is highly automated. Our team has trained machine learning algorithms on many thousands of images to auto-identify patient anatomy. Currently, our identification algorithm is nearly perfect (near 100% accuracy), and our segmentation algorithm is getting close (approximately 99% accuracy). Trained operators and the surgeon will review all outputs, but we can minimize risk by implementing these powerful AI tools.      

b) Guidance application: this software executes surgeon inputs during the operation. We have implemented registration, soft tissue management, virtual implant placement, and various cut screens. We have devoted significant resources to our guidance application development. This application is how surgeons will interact with our technology, so it must be polished and flawless. A considerable advantage of navigated robotic execution is the ability to help surgeons properly tension ligaments before making cuts via predictive simulations.  


Figure 2: The guidance application allows the surgeon to interact with the robot during the case.  An advantage of navigated robotics is the ability to balance soft tissues before making cuts.


c) Autonomous robotic execution: with inputs from the surgeon entered through the guidance application, our software autonomously executes optimized bone cuts. We are implementing highly complex patient-specific workflows to facilitate dynamic cut paths that are specific to the patient. As far as we know, competitive systems do not do this. Cut boundaries of competitive systems appear to correspond to the chosen implants (notably to generic implants). We believe this could cause unfinished cuts (for example, the medial posterior portion of tibial resections). 

Developing cutting tools that overcome the numerous challenges of active robotic execution has not been easy. For example, vibration is a significantly increased challenge for an active robotic system. When a surgeon is holding the cutting tool, it absorbs considerable vibration, but there is no such damping with active systems.  We have prototyped two different novel cutting end-effectors intended to optimize different cut types and applications. We also expect to receive the second build of our robot carts with many design improvements in December. 


Ultimately our internal development goal is to commercialize a robotic system that is cheaper and faster than a manual procedure. Stryker has already demonstrated the cost savings vs. manual approaches with Mako (Robotic arm–assisted knee surgery: An economic analysis. (2020). The American Journal of Managed Care, 26(7). https://doi.org/10.37765/ajmc.2020.43763). Our goal is now to push the envelope on cost with cheaper hardware and to overcome, in our view, the most significant barrier to adoption, speed. We have our work cut out for us. Still, if we are to disrupt the orthopedic market by making robotics ubiquitous, it will require significant advances to the current state of the art, especially execution speed. As a benchmark, current robotic systems take on average over an hour to complete a TKA (Kayani, B., Konan, S., Huq, S. S., Tahmassebi, J., & Haddad, F. S. (2018). Robotic-arm assisted total Knee Arthroplasty has a learning curve of seven cases for integration into the surgical workflow but no learning curve effect for accuracy of implant positioning. Knee Surgery, Sports Traumatology, Arthroscopy, 27(4), 1132–1141. https://doi.org/10.1007/s00167-018-5138-5). We believe there are opportunities to streamline robotic execution.


d) Implants: as we shared previously, Monogram is commercializing via a multi-generational product release strategy. We believe it prudent to kick-off our robotic launch with an implant that is insertable both robotically and with manual instrumentation (like every other robotic system today) and similar to devices with which surgeons are familiar. Our robot is the "trojan-horse" for implant sales. Once placed, we believe our robots will facilitate upselling of differentiated novel designs.


Our first-generation Mongoram TKA will capitalize on what we view as one of the most significant growth opportunities in large joint reconstruction, the cementless knee segment.  Uncemented TKA's are projected to grow by an estimated 400,000 procedures from 2020-2024 ($1.21 billion). Notably, ASPs on cementless knees are also higher than cemented (about 10% higher). Cementless TKAs accounted for 42% of Stryker's TKA volume in 2020, up from 30% in 2018. Monogram will be starting with a press-fit TKA that we think could be competitive with the current state of the art. We believe we are early to this opportunity (for example, one of the prominent four players doesn't currently have a competitive uncemented TKA). We believe uncemented TKA's is where the market is quickly moving, and we will have a product to address this growing opportunity.   


Figure 3: Monogram has licensed the rights and supply pricing cap for the supply of an FDA-approved partial knee.  The Company plans to incorporate the partial knee for robotic execution once the TKA application enters V&V.



As mentioned above, the timeline for submitting our first-generation implant is by the second quarter of 2022. We are working extremely hard to improve that timeline. Notably, we have licensed the rights to an FDA approval partial knee. Our development plan is to submit our robot for FDA approval for the total knee application and then submit for a partial knee application as quickly as possible. We should note that our team is also developing manual instrumentation to enhance the marketability of our implant system.


In summary, we have made considerable progress, but work remains. Over the next few months, we expect to file on the order of 4 to 5 additional patents based on our recent learnings. We take heart with every technical headwind we face, knowing this is a challenging and non-trivial exercise to replicate.


Important Next Steps: Monogram intends to selectively reveal our products to significant industry stakeholders over the coming six months. To date, while Monogram has undoubtedly communicated with others in the industry, we have only ever hosted one major strategic in our facility, and that was well over two years ago (before relocating to Austin and building our team). We have our final internal cadaver lab scheduled for the fourth quarter of 2021, after which we intend to reveal our progress to select industry peers strategically in addition to the public. Given the intellectual property and novel approaches to certain technical hurdles, we are thankful to our shareholders for letting the development efforts mature privately and giving us the time and space needed to focus our engineering efforts. We are incredibly grateful for your dedication to our mission. In March 2022, Monogram intends to exhibit at the AAOS meeting.    


Fundraising:

Thank you to everyone who has joined the Monogram journey. As a management team, we very much appreciate you. We want to make sure all of you are well aware that we expect to continue accessing capital as we work to advance our technology. We think this is a necessary step in building a company with such a complex product.  We anticipate a Series-C capital raise will be forthcoming. We believe ongoing access to capital is in the best interest of our shareholders as we continue to devote significant capital resources to our development efforts.    


Thank you for your continued support and commitment. 


Kind regards,

Benjamin Sexson, CEO


This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment.

Monogram Reaches A Major Milestone - $11M Raised!

about 1 month ago


We are very excited to announce that we’ve reached an astounding $11M in funding from our current StartEngine round. 


The brave team at Monogram is diving headfirst into the previously undisrupted $19.6B joint replacement market with cutting-edge AI that’s about to shift the industry norm completely. 


By combining highly personalized, 3D printed, and press-fit joint implants with high precision navigated surgical robotics, the market is about to witness something never seen before - a new paradigm for surgical robotics and implant design. 


Monogram’s system is set to be the first of its kind. Become an investor today to stay one step ahead. Invest now!


This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment.

You’re Invited - Join Our Live Investor Webinar

2 months ago

Hi,


We'd like to invite you to join us on Tuesday, October 5th at 3 PM EST for a Live Investor Webinar where you will hear a series of pitches from some of the most notable and exciting private offerings currently available for investment through Regulation A.


This webinar features Monogram's CEO and Co-Founder, Ben Sexson, as well as 2 other disruptive startups from some of this year's fastest-growing markets including reAlpha and NowRx. We’ll also be joined by the Co-Founder and VP of Marketing at Rocket Dollar, to discuss how investors can better leverage self-directed IRAs to invest in opportunities Reg A+, crypto, real estate, and more. Learn how these companies are revolutionizing their respective industries and hear directly from the founders about their plans for the future.


You can register here today - spots are limited!


Kind regards,

Monogram Orthopedics


This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment.

Monogram Reaches $10M in Investments!

2 months ago

We are pleased to announce that our crowdfunding campaign on StartEngine recently surpassed $10M in funding.

Right now, when you invest, you can receive up to 10% bonus shares!

Investors that invest at least $5,000 in this offering will receive a 5% bonus, and investors that invest at least $10,000 will receive a 10% bonus on their investment.

Join thousands of investors worldwide by investing in Monogram's mission to disrupt this $19.6b market by combining high precision, patient-specific implants with state-of-the-art robotics to improve patient outcomes.

Keep following for more updates on how Monogram uses high precision, patient-specific implants with state-of-the-art robotics to improve patient outcomes. Support our mission to shape the future of joint replacement and click here to learn more and invest in Monogram through our page on StartEngine.

This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment.

Monogram Live Chat with UBS Managing Director!

2 months ago

Greetings,

I appreciate your interest in Monogram. In our last webinar, we promised to mix things up and bring in an industry expert to ask us questions from an institutional perspective. We've delivered!

Matt Taylor, CFA Managing Director at UBS, has agreed to host us for a lively discussion about all things Ortho! We provide more details on Matt's credentials below, but as a headline, he leads US Medical Supplies and Devices equity research for UBS, a major investment bank and one of the largest private banks in the world. Matt and his team actively cover all the major ortho players in the space.  

Matt has been following the Monogram story. We asked him to host a call for our community and ask us anything any knowledgeable ortho investor might ask or want to know; no holds barred.

The call will be on Thursday, 30 Sep 2021, at 10:00 AM EST.  Register HERE

The discussion with Monogram's CEO Ben Sexson and CMO Doug Unis will be unscripted and include live audience Q&A.  

Discussion Topics Include:

  • The current state of robotics with thoughts on solutions from the established players.

  • Monogram's solution and vision for differentiation in robotics.

  • Understanding Monograms cutting edge surgical tools and personalized implants.

  • Views on where robotics can go in Ortho in 5-10 years.

You can register here.

About Matt Taylor, CFA:

Matt Taylor is a Managing Director and leads coverage of US Medical Supplies and Devices equity research at UBS. Matt has received recognition for his work as a MedTech analyst, achieving a top-5 position and 'runner-up' ranking in the 2019 Institutional Investor poll and he was named an 'up-and-comer' in the 2011-13 surveys. Prior to joining UBS, Matt was the senior analyst covering Medical Supplies and Devices at Barclays, joining the organization as a senior associate in 2009. Matt also worked as an associate analyst in MedTech at BMO Capital Markets from 2007-2009 and began his career in finance working in a business risk role at Morgan Stanley. Matt was trained as a biomedical engineer and holds a BS in Biomedical Engineering from Boston University, an MBA from Fordham University, participating in the Beijing MBA program, and is a CFA Charterholder.

Kind regards,

Ben


This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment.

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Monogram Reaches $9M in Investments!

4 months ago

We are pleased to announce that our crowdfunding campaign on StartEngine recently surpassed $9M in funding.

Right now, when you invest, you can receive up to 10% bonus shares!

Investors that invest at least $5,000 in this offering will receive a 5% bonus, and investors that invest at least $10,000 will receive a 10% bonus on their investment.

Join thousands of investors worldwide by investing in Monogram's mission to disrupt this $19.6b market by combining high precision, patient-specific implants with state-of-the-art robotics to improve patient outcomes.

Keep following for more updates on how Monogram uses high precision, patient-specific implants with state-of-the-art robotics to improve patient outcomes. Support our mission to shape the future of joint replacement and click here to learn more and invest in Monogram through our page on StartEngine.

This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment.

Monogram Investor Webinar

4 months ago

Join us on Tuesday, August 31st at 5:00 PM ET for a live investor webinar! In this webinar, Benjamin Sexson, CEO, and Doug Unis, Founder and Chief Medical Officer of Monogram will discuss the company's current crowdfunding campaign on StartEngine, the development progress of Monogram's innovation in orthopedic medicine, and host a live Q&A. You won't want to miss this, and spots are limited, so reserve your seat today.


Keep following for more updates on how Monogram uses high precision, patient-specific implants with state-of-the-art robotics to improve patient outcomes. Support our mission to shape the future of joint replacement and click here to learn more and invest in Monogram through our page on StartEngine.

This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment.

Reasons to Invest

4 months ago

The future of orthopedic medicine is personal, and Monogram is on a mission to transform the $19.6 Billion market.


Reasons to Invest in Monogram:

  • World-class team: led by a team of experts in robotics and medical technology, and advised by surgeon consultants from institutions such as Columbia and Icahn School of Medicine.

  • Expecting revenues in 2021: we expect to start generating revenue from implants sales in 2021 and have signed strategic contracts with two Monogram distributors and recruited the Senior Director of US Sales from our manufacturer to support early sales efforts.

  • Already raised $16.7M from 6,793 investors: we have been through 3 successful financing rounds and continue to execute.

  • Established product-market fit: the leading orthopedic robot on the market (technology from a startup acquired in 2013) outsells its next largest competitor over 12-to-1 with an 87% share.  Our VP of Engineering helped develop that technology. Together with our team's support, we want to build the future of robotics.

  • Novel technology for the massive growing market: The joint replacement market is approximately $19.6BN, with over 1 million knee replacements per year. We believe we will be one of the first to market with our technology and eight patent filings.

  • 8 Patent Applications Filed: We believe we will be early to market with our novel technology and a Freedom to Operate on our knee implant.


Keep following for more updates on how Monogram uses high precision, patient-specific implants with state-of-the-art robotics to improve patient outcomes. Support our mission to shape the future of joint replacement and click here to learn more and invest in Monogram through our page on StartEngine.

This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment.

Monogram Featured in Newsweek

4 months ago

Monogram Featured in Newsweek! 


We are excited to announce that recently Monogram Orthopedics was featured in a Newsweek article! Newsweek covered our investment opportunity and how our revolutionary surgical robotics fixes industry-wide issues. It is an honor to be named as a leader at the forefront of industry change. Check out the full article here.


This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment.

Cut Test Teaser!

5 months ago

We completed our first end-to-end system cut test run through the guidance application.  You can watch a teaser here (https://youtu.be/u7NUejgMPsE)!

Monogram has implemented a pipeline that includes auto-segmentation of patient scans and surgical planning for robotic execution with our guidance application. We successfully ran our first end-to-end system test, including registration, robotic execution, and implant placement, all within the guidance application.

The next steps include many system optimizations and known enhancements, but we now largely have the architecture in place to accelerate those efforts. This cut test was the culmination of an incredible amount of work and coordination between teams.

Our next goal is to run our first-time studies within 2-3 sprints (targeting the end of August). We have highly ambitious cut time goals, and our team is pushing this extremely hard.

We look forward to hopefully sharing more in-depth information and video when the timing is right! Thank you all for your incredible support.

Keep following for more updates on how Monogram uses high precision, patient-specific implants with state-of-the-art robotics to improve patient outcomes. Support our mission to shape the future of joint replacement and click here to learn more and invest in Monogram through our page on StartEngine.

This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment.  

Monogram Reaches $8M in Investments!

5 months ago

We are pleased to announce that our crowdfunding campaign on StartEngine recently surpassed $8M in funding.

Right now, when you invest, you can receive up to 10% bonus shares!

Investors that invest at least $5,000 in this offering will receive a 5% bonus, and investors that invest at least $10,000 will receive a 10% bonus on their investment.

Join thousands of investors worldwide by investing in Monogram's mission to disrupt this $19.6b market by combining high precision, patient-specific implants with state-of-the-art robotics to improve patient outcomes.

Monogram Starts Generating Revenue with First TKA Procedure

8 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.

AMA with Surgeon Founder Doug Unis!

8 months ago

We are always looking for ways to engage with our community.  We get many clinical questions. We thought it would be a great idea to allow our shareholders or individuals interested in Monogram to engage with our founder surgeon, Dr. Unis, and ask him any clinical questions you may have…for example...


  • Get his thoughts on stem cell treatments and research

  • Get his thoughts on when to get knee replacements

  • What to expect and how to improve your outcomes

  • Get his input on surgical techniques and his preferences

  • Get insights on what to ask your surgeon


This “Ask Me Anything” event will be an open opportunity for you to engage in a constructive conversation.  Our CEO, Ben Sexson, will also be available to help answer any questions about Monogram.


If you are interested in participating, please register below:

Thursday, 8 April 2021, 6:00 PM ET
Registration link: https://event.webinarjam.com/channel/monogram_ama

Monogram Passes $5M in Investments!

9 months ago

We just passed the $5,000,000 mark! Thank you to all of our investors so far for your support!

Don't forget that if you have already invested, you can invest multiple times during a campaign; it's not just a one-time investment!


Monogram Invited to Present at Wavemaker Labs Webinar March 10th!

9 months ago

Registration Link: http://bit.ly/3ustHwZ

Details: Wednesday, March 10th @ 10:00 AM Pacific Time (US and Canada)


Monogram Executes Strategic License of Unicondylar Knee Replacement Implant

9 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 Passes $3.7M in Investments!

10 months ago

We just passed the $3,700,000 mark! Thank you to all of our investors so far for your support!

Don't forget that if you have already invested, you can invest multiple times during a campaign; it's not just a one-time investment!


Monogram to Present at OTC Markets Regulation A+ Investor Conference - Register now!

10 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

10 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.

Monogram Passes $3M in Reservations! Will be last chance to reserve!

11 months ago

We just passed the $3,000,000 mark!


If you are interested, reserve your shares now before this Test The Waters period closes!  Our investment minimum is only $250.79.

AND...


Right now, you can become eligible for bonus shares just for indicating interest in an investment.  For a limited time, during our “Testing The Waters” period (which we’re in now), you can become eligible to get 10% bonus shares when you invest just for indicating your interest in an investment now (not actually investing).


BUT...


This bonus will only be available during our Testing The Water period. We aren’t sure yet how long this period will last, but it will be a limited time, so we recommend joining sooner rather than later.


Please note that even if you do not make a reservation, you can still be eligible to receive Bonus Shares by investing at least $5,000 once we open for investments.  Reserving” shares is simply an indication of interest. There is no binding commitment for investors that reserve shares in this manner to ultimately invest and purchase the shares reserved of the company, or to purchase any shares of the company whatsoever. 

Monogram Passes $1.5M in Reservations! Limited Time Bonus!

12 months ago

Big news!  We just passed the $1,500,000 mark!


If you are interested, reserve your shares now before this Test The Waters period closes!  Our investment minimum is only $250.79.

AND...


Right now, you can become eligible for bonus shares just for indicating interest in an investment.  For a limited time, during our “Testing The Waters” period (which we’re in now), you can become eligible to get 10% bonus shares when you invest just for indicating your interest in an investment now (not actually investing).


BUT...


This bonus will only be available during our Testing The Water period. We aren’t sure yet how long this period will last, but it will be a limited time, so we recommend joining sooner rather than later.


Please note that even if you do not make a reservation, you can still be eligible to receive Bonus Shares by investing at least $5,000 once we open for investments.

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