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 fourteen patent filings.
Winner of award from National Science Foundation (NSF): Recipient of SBIR Phase I award for "Development of a tracking system for computer-assisted surgery."

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.

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“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, fourteen 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 fourteen 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 fourteen 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.

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Future of Joint Replacement