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Monogram Orthopaedics

Linking 3D printing, machine learning, and robotics for high precision implants

Monogram Orthopaedics is offering securities through the use of an Offering Statement that has been qualified by the Securities and Exchange Commission under Tier II of Regulation A. A copy of the Final Offering Circular that forms a part of the Offering Statement may be obtained both here and below. The contents of the Highlights, Term Sheet sections have been prepared by SI Securities, LLC and shall be deemed broker-dealer communications subject to FINRA Rule 2210 (the “Excluded Sections”). With the exception of the Excluded Sections noted above, this profile contains offering materials prepared solely by Monogram Orthopaedics without the assistance of SI Securities, and not subject to FINRA Rule 2210 (the “Issuer Profile”). The Issuer Profile may contain forward-looking statements and information relating to, among other things, the company, its business plan and strategy, and its industry. These statements reflect management’s current views with respect to future events based on information currently available and are subject to risks and uncertainties that could cause the company’s actual results to differ materially. Investors are cautioned not to place undue reliance on these forward-looking statements as they are meant for illustrative purposes and they do not represent guarantees of future results, levels of activity, performance, or achievements, all of which cannot be made. Moreover, no person nor any other person or entity assumes responsibility for the accuracy and completeness of forward-looking statements, and is under no duty to update any such statements to conform them to actual results.


Company Highlights

  • Founded by practicing Mount Sinai orthopedic surgeon Douglas Unis, and led by a team of experts in the field of surgical robotics and implant design including former Senior Director of Robotics Development Program Management at Stryker and former Director of Engineering for Orchid Design
  • Secured deal with established orthopedic company to distribute FDA approved implants as a source of early revenue; also secured licensing rights to integrate critical FDA approved components into Monogram products
  • Collaborative study with the UCLA Biomechanics Laboratory demonstrated a 7x improvement in initial stability against the current standard, and collaborative research with University of Nebraska Medical Center revealed 72% less micromotion than current standard
  • Validated implants can be manufactured using 3D printing; Monogram’s 3D printed hip passed testing to simulate FDA tests (10 million cycles at 1,200 lbs)
  • Seven patents filed under Exclusive License Agreement as well as a Freedom-to-Operate search ("FTO") for Monogram's knee design with a robotic surgical approach

Fundraise Highlights

  • Total Amount Raised: US $14,569,668
  • Total Investors: 7407
  • Total Round Size: US $20,000,000
  • Raise Description:  Series A
  • Minimum Investment:  US $1,000 per investor
  • Security Type:  Preferred Equity
  • Pre-Money valuation :  US $21,250,000

We are using machine learning (AI), robotics, and 3D printing to improve joint replacement surgeries. We believe the synthesis of these three technologies will define the future of orthopedics.


Monogram is developing a novel approach to joint reconstruction.

Problem:

There are 1,658,200 total hip and knee replacements annually in the US. Over 14.5% of hips and 9.5% of knees fail. One-in-five patients are not satisfied with their knee replacement. Cemented implants are not ideal for younger active patients but remain widely used for knees (over 90%). Leading causes of revision include infection, mechanical loosening, implant failure, dislocation/instability, and fracture. Many of these complications are preventable with technology. Primary ankles, shoulders, and spine are also markets where problems persist that technology can solve.

Innovation advances in orthopedics remain slow and inefficient. Large companies dominate with almost indistinguishable implants. Robots are costly, slow, and redundant. Most implants, even those approved for robotic placement, are also insertable with manual instruments. The enormous inefficiency has built nearly insurmountable barriers to entry, where the top four implant companies account for 76% of the $18B primary hip and knee markets.

Solution:

We use algorithms to plan optimized surgeries pre-operatively. Using patient data, we fabricate implants designed to increase stability and reduce size. We can do this cost-efficiently (with 3D printing) and with high accuracy (with surgical robotics). We are starting with knee implants but expect to develop implants for all joints (hips, ankles, shoulders, and spine). In collaboration with the UCLA Biomechanics Laboratory and the University of Nebraska Medical Center, our patented hip implants were a factor of 7x more stable, and our novel knee showed 73% less micromotion in varus-valgus rotation. Monogram has demonstrated superior restoration of the native anatomy. We showed up to a 13mm improvement in hip center placement.

Pitch Deck

Product & Service

Product:

Monogram is commercializing next-generation orthopedic implants for active young patients. The Monogram implants rely on natural biologic fixation without cement for long term stability in a smaller size. We are optimizing implant contact with design and high precision robotics.

Monogram's principal advantage is in the patents that protect our implant innovations and our methods of delivery. We have filed numerous patents to protect the implant designs, the methods of generation, the methods of insertion, and various improvements to the surgical workflow.

Our long-term monetizable products will include a surgical robot, cutting tools, and navigation consumables, software, and implants.

Implants:

Monogram believes the future of orthopedics is implants designed for active young patients. That means minimally invasive press-fit implants that reconstruct native anatomy and rely on natural biologic fixation, rather than cement. A tight fit and initial stability are critical for the long-life viability of press-fit implants. We have designed the Monogram implants to be more stable and less invasive (i.e., less bone removal) while precisely reconstructing the pre-arthritic anatomy.

Generic implants aren't good enough. Generic hip stems have limited options to restore anatomy. Most hips are only available in two widths despite the human anatomic variation. Generic implant shapes are geometric and inorganic, which limits direct bone contact. Generic knee tibias rely on a flawed design premise of flat-on-flat with a central keel, which isn't optimal for peripheral loading. Monogram will focus on hips & knees, followed by ankles, shoulders, and spine.

Robotics:

Manual bone preparation is often less accurate and subject to surgeon skill. Crude manual instrumentation can lead to suboptimal function outcomes and complications such as periprosthetic fracture, dislocation, leg length discrepancy, malalignment, poor ligament balancing, subsidence, and early loosening.

Monogram is developing a navigated robot with enhancements that will improve the surgeon workflow and cut execution. The robot has seven degrees-of-freedom (the range of motion) with sophisticated controls to optimize performance. The software is capable of simultaneously tracking and avoiding multiple objects at once. For example, surgeons can use tracked objects, such as retractors, to create virtual boundaries around sensitive tissues. 

Development:

Monogram has entered into a binding term sheet with an undisclosed orthopedic technology company. Pursuant to the agreement, the partner will supply Monogram FDA approved Total Knee implants and license to Monogram certain intellectual property rights and pursuant to which, Monogram will be consigned a specified number of FDA approved implant components. Monogram shall have the option, at its sole discretion, to relabel and otherwise remarket under Monogram's name and branding. Monogram will combine components of these FDA approved implants with the 3D printed Monogram implants to release its first product. The product will be a Monogram branded implant system insertable manually or robotically.

This model replicates a highly effective model successfully implemented by startups like Mako and Bluebelt. Monogram believes it has already secured the funding needed to commercialize this product within the next 21 months (assuming no FDA clinical trial request). This deal also gives Monogram funding support from an established orthopedic company with consignment inventory to support our early revenue.

Monogram will continue the rapid development of its robotic surgical system in parallel.  

By 2021:

Monogram expects to be submitting a hybrid implant solution for FDA approval. 

Media Mentions

Team Story

Dr. Douglas Unis, an attending orthopedic surgeon for the Icahn School of Medicine and Chief of Quality Improvement at Mount Sinai West, founded Monogram in 2016 after being awarded a grant from the prestigious ELabNYC biotech startup incubator. Following his deep passion for patient well-being, Monogram was born. After years of consulting with several orthopedic companies on various technologies, including on robotic surgical applications, Dr. Unis grew frustrated by the slow pace of innovation and a lack of focus on improving implant design. Dr. Unis realized that technology could mitigate the persistently high rates of failure and complication in primary joint replacements. He realized that advances in manufacturing, image processing, and robotics formed the ingredients for an entirely new way of thinking about orthopedics.

With an unassailable belief that the answer lies in the thoughtful synthesis of machine learning (AI), robotics, and 3D printing, Monogram Orthopaedics began.    

Founders and Officers

Douglas Unis, Md

Founder and Chief Medical Officer

Dr. Unis is a board certified orthopedic surgeon specializing in adult reconstructive surgery and is the founder and Chief Medical Officer of Monogram Orthopedics. Dr. Unis founded Monogram Orthopedics in 2015. Dr. Unis has served as an Associate Professor at the Icahn School of Medicine since November 2015 and has been a practicing surgeon since 2004. Dr. Unis has consulted with many orthopedic companies including Zimmer Biomet and Think Surgical. Prior to founding Monogram Othopedics Dr. Unis was a consultant with Think Surgical, working to help with the development of their robotic total hip and knee arthroplasty system. Dr. Unis is recognized as a leader and innovator in the NYC area, having performed one of the regions’ first muscle sparing anterior total hip replacement in 2005. Dr. Unis earned his BA from Duke University and Doctor of Medicine from Case Western Reserve University and later completing his residency at Northwestern University and a fellowship from Rush University in Adult Reconstruction.   

Douglas Unis, Md

Founder and Chief Medical Officer

Dr. Unis is a board certified orthopedic surgeon specializing in adult reconstructive surgery and is the founder and Chief Medical Officer of Monogram Orthopedics. Dr. Unis founded Monogram Orthopedics in 2015. Dr. Unis has served as an Associate Professor at the Icahn School of Medicine since November 2015 and has been a practicing surgeon since 2004. Dr. Unis has consulted with many orthopedic companies including Zimmer Biomet and Think Surgical. Prior to founding Monogram Othopedics Dr. Unis was a consultant with Think Surgical, working to help with the development of their robotic total hip and knee arthroplasty system. Dr. Unis is recognized as a leader and innovator in the NYC area, having performed one of the regions’ first muscle sparing anterior total hip replacement in 2005. Dr. Unis earned his BA from Duke University and Doctor of Medicine from Case Western Reserve University and later completing his residency at Northwestern University and a fellowship from Rush University in Adult Reconstruction.   

Benjamin Sexson

Chief Executive Officer

Mr. Benjamin Sexson is the Chief Executive Officer of Monogram Orthopedics. Prior to joining Monogram, Mr. Sexson served as the Director of Business Development at Pro-Dex, an OEM manufacturer of Orthopedic Robotic End-Effectors. In his tenure at Pro-Dex, Mr. Sexson was responsible for the development, management, and launch of a proprietary product solution, helping to negate a distribution agreement with a major strategic partner. In addition, Mr. Sexson helped land and negotiate two additional development agreements and helped to expand the company’s addressable markets from CMF to Thoracic, Trauma, Spine, and Extremities. Mr. Sexson is a named inventor on multiple patent applications at Pro-Dex. Prior to joining Pro-Dex, Mr. Sexson started Brides & Hairpins, a successful B2B retail brand that currently supplies Nordstrom, Bloomingdales, and Urban Outfitters. Prior to that Mr. Sexson worked in various finance positions and is a CFA Charterholder.  Mr. Sexson graduated with honors from Caltech in Mechanical Engineering.

Benjamin Sexson

Chief Executive Officer

Mr. Benjamin Sexson is the Chief Executive Officer of Monogram Orthopedics. Prior to joining Monogram, Mr. Sexson served as the Director of Business Development at Pro-Dex, an OEM manufacturer of Orthopedic Robotic End-Effectors. In his tenure at Pro-Dex, Mr. Sexson was responsible for the development, management, and launch of a proprietary product solution, helping to negate a distribution agreement with a major strategic partner. In addition, Mr. Sexson helped land and negotiate two additional development agreements and helped to expand the company’s addressable markets from CMF to Thoracic, Trauma, Spine, and Extremities. Mr. Sexson is a named inventor on multiple patent applications at Pro-Dex. Prior to joining Pro-Dex, Mr. Sexson started Brides & Hairpins, a successful B2B retail brand that currently supplies Nordstrom, Bloomingdales, and Urban Outfitters. Prior to that Mr. Sexson worked in various finance positions and is a CFA Charterholder.  Mr. Sexson graduated with honors from Caltech in Mechanical Engineering.

Sherif Aly

VP of Engineering

Sherif was instrumental in the development of the Mako Orthopedic Robot and Implant systems. After Stryker acquired Mako, Sherif was the Senior Director of Robotics Development Program Management, reporting to the VP of Robotics R&D. Most recently, Sherif was the VP of Engineering and Regulatory Affairs at Xenex Disinfection Systems. He holds his Ph.D. in Mechanical Engineering from Rutgers University.

Sherif Aly

VP of Engineering

Sherif was instrumental in the development of the Mako Orthopedic Robot and Implant systems. After Stryker acquired Mako, Sherif was the Senior Director of Robotics Development Program Management, reporting to the VP of Robotics R&D. Most recently, Sherif was the VP of Engineering and Regulatory Affairs at Xenex Disinfection Systems. He holds his Ph.D. in Mechanical Engineering from Rutgers University.

Chris Scifert

Director of Product Development Implants & Instruments

Before joining Monogram, 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.

Chris Scifert

Director of Product Development Implants & Instruments

Before joining Monogram, 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.

Notable Advisors & Investors

Pro-dex Inc
Mount Sinai Innovation Partners
Accelerate NY Seed Fund
Laura Gilmour

Advisor, Mentor, Medical

Sophia Sangiorgio, PhD

Advisor, Mentor, Biomechanics

Matt DiCicco

Advisor, Mentor, Robotics

Q&A with the Founder

  • Why SeedInvest vs. traditional VC funding?

    Monogram management believes it is commercializing a "when" not "if" technology. Time to market and our first-mover advantage are crucial. We believe patient optimized (especially for active young patients) 3D printed press-fit implants inserted into robotically prepared cavities is the inevitable future of orthopedics. As such, we believe that time to market, and it follows execution, and a best-in-class team is critical to our success. We believe that we can compete on speed and efficiency as a lean startup, but we need to have top talent to do so. The challenge for startups, however, is finding the money to pay top talent before funding is secured. The reality is that most top-caliber engineers and project managers have real everyday responsibilities and need stable paychecks.

    How does a startup without any funding, get funding without a team? And how does a startup assemble a best-in-class team if it doesn't have money for salaries? Even with equity, most employees need paychecks. SeedInvest recognizes this chicken-and-egg problem and the challenge startups face of needing to hire talent to raise capital but needing capital to recruit talent. To address this challenge, SeedInvest does not require its platform companies to syndicate the full rounds before the close. Once platform companies hit their escrow targets, they get full access to the capital and have regular closes after that.

    Monogram was able to hit its escrow target of $2.75M and has been able to recruit top talent and accelerate its initiatives. SeedInvest has put us ahead of our internal goals.

  • What is your go-to-market strategy?

    Monogram has entered into a binding term sheet with an undisclosed orthopedic technology company. Pursuant to the agreement, the partner will supply Monogram FDA approved Total Knee implants and license to Monogram certain intellectual property rights and pursuant to which, Monogram will be consigned a specified number of FDA approved implant components. Monogram shall have the option, at its sole discretion, to relabel and otherwise remarket under Monogram's name and branding. Monogram will combine components of these FDA approved implants with the 3D printed Monogram implants to release its first product. The product will be a Monogram branded implant system insertable manually or robotically.

    This model replicates a highly effective model successfully implemented by startups like Mako and Bluebelt. Monogram believes it has already secured the funding needed to commercialize this product within the next 21 months (assuming no FDA clinical trial request). This deal also gives Monogram funding support from an established orthopedic company with consignment inventory to support our early revenue. Monogram will continue the rapid development of its robotic surgical system in parallel.

    The discrete commercialization phases will consist of the following:

    Phase I: 100% partner implants & instruments

    Distribution of our orthopedic partner's Total Knee solution with their manual instrumentation to identified surgeon KOLs. Our surgeons will familiarize themselves with the existing FDA approved implants and instrumentation. Monogram has actively recruited a sales and marketing executive who will begin building the sales and distribution channels when the market normalizes.

    Phase II: 50% partner implants | 50% Monogram

    Monogram will introduce a patented press-fit tibia with external fixation and no keel, an exclusive Monogram jig, and a custom burr guide for bone preparation. Monogram believes this will accelerate and de-risk FDA submission. The solution will introduce a highly differentiated and clinically significant press-fit implant designed for active young patients. Ideally, our surgeon KOLs would already be familiar with the partner implants and instruments and would be swapping out the tibial component for the Monogram tibial component. Surgeons would execute the tibial resection with the existing generic instrumentation. The internal target for approval and release is in 2021 (assuming no clinical trial request from the FDA).

    Phase III: Robotic Release

    Monogram would introduce its surgical robot for full execution of all bone cuts. Monogram would begin obtaining clinical data to validate the clinical value proposition long term.

    Phase IV: Full-Customization & New Market Launches

    Our goal is to accelerate our time to market and de-risk the commercialization while driving significant clinical differentiation and capital efficiency. We expect to achieve revenue with tactical high-volume hospitals and academic institutions through the strategic relationships of our founders and sales leadership (actively recruiting). We believe this strategy will help us raise strategic growth capital that will facilitate more rapid growth. This growth will be a mix of in house and independent sales representatives. Comparable company analysis with Mako Surgical helps validate a market premium for FDA approved, differentiated products generating revenue. At the time of their IPO, Mako made $1.9m of revenue and raised $51M in an IPO at a $180M valuation.

  • Why can't someone else do this, and who are your closest competitors?

    Four companies dominate the orthopedic market; Stryker (ticker: SYK), Zimmer Biomet (ticker: ZBH), J&J (DepuySynthes, ticker: JNJ), and Smith & Nephew (ticker: SNN). These four companies enjoy approximately 76% of the joint replacement total market opportunity. None of these companies is using a surgical robot to execute CT based surgical plans with a navigated robot capable of actively milling optimized cavities. It is important to note that soft tissue robots like the Intuitive Surgical (ticker: ISRG) DaVinci robot are not Monogram competitors. Robots that rely on a "master-slave" control paradigm for minimally invasive surgical procedures are not designed or optimized for orthopedic bone preparation.

    Uncemented implants optimized for active young patients are new (less than 10% of knees today are uncemented). None of our competitors are using an actively milling robot to excavate high-accuracy bone cavities for placement of optimized press-fit implants from a CT based preoperative plan. Our approach is extremely technically challenging and would require significant course corrections for most of our competitors. For example, many of our competitors do not utilize image-based planning approaches. These "imageless" systems, in our view, cannot achieve the accuracies needed for custom milling.

    We have filed numerous patents with a favorable Freedom-To-Operate ("FTO") search. We have recruited a best-in-class team that has successfully commercialized robotics and implants with many lessons learned. We believe that we have a significant first-mover advantage with a substantial IP moat around our business.

  • Please describe your target customer.

    We are designing implants for active younger patients that use natural biologic fixation with minimal size and robotic bone preparation for high accuracy placement. The average patient age today is 65 years old, but many implants that get used are designed for older patients. The trend is towards younger and younger patients, but the implants need to keep up with the demands of an active lifestyle.

    Approximately 90% of knee implants today rely on cemented fixation, which is not ideal for young patients. Monogram believes that natural biologic fixation from press-fit implants is. We are developing more stable and minimally invasive press-fit implants. For the average patient, the time between the onset of pain and surgery is significant, often several years or even a decade. Many patients that enjoy activities like hiking, golfing, tennis, etc., put off needed surgery because they don't want to risk an unfortunate outcome that could compromise their activities. We believe we can significantly mitigate the risk of poor results with technology designed to normalize patient outcomes.

  • Please detail the current stage of your development.

    Monogram has put together a team of leading experts to commercialize our novel technology. We currently have a high functioning prototype that successfully autogenerated five patient-specific implants from a simulated specimen, autogenerated the robotic cut paths, and high-precision milled the cavities for each specimen for micromotion testing (this was the testing conducted for the UCLA micromotion studies). The most sophisticated aspect of our robotic execution is the software that controls the robotic arm.

    Concerning implant validation, the primary determinant of the long term viability of an implant is the initial stability. For both our patented hips and our patented knees, we conducted rigorous testing. For the hip, our implant prototype specimens were tested against five manually inserted conventional implants to determine relative performance. The data validated superior placement of the anatomical center of rotation, higher surface area contact, and significantly decreased micromotion. Our knees testing was conducted at the University of Nebraska Medical Center, similarly with highly favorable results.

    For the surgical workflow, our prototype consists of image processing and implant & cut path generation algorithms with a surgeon interface GUI. These algorithms interface with our robotic system, which includes a registration protocol, a real-time camera tracking system, a milling end-effector, and various other user enhancements. Our robot can mill the implant cavities from the cut-paths autogenerated by our algorithm. The result is a stable implant that restores the native anatomy in a minimally invasive form factor. A press-fit (natural fixation) minimally invasive and durable implant is optimal for active patients with a desire to continue their sporting activities.

  • The Q&A with the Founder is based on due diligence activities conducted by SI Securities, LLC. The verbal and/or written responses transcribed above may have been modified to address grammatical, typographical, or factual errors, or by special request of the company to protect confidential information.

    Term Sheet

    Fundraising Description

  • Round type:
    Series A

  • Round size:
    US $20,000,000

  • Raised to date:
    US $14,569,668

  • Minimum investment:
    US $1,000

  • Target Minimum:
    US $2,750,000
  • Key Terms

  • Security Type:
    Preferred Equity

  • Share price:
    US $4.0

  • Pre-Money valuation:
    US $21,250,000

  • Option pool:
    2.0%

  • Liquidation preference:
    1.0x
  • Additional Terms

  • Custody of Shares

    Investors who invest $50,000 or less will have their securities held in trust with a Custodian that will serve as a single shareholder of record. These investors will be subject to the Custodian’s Account Agreement, including the electronic delivery of all required information. 


  • Closing Conditions

    SI Securities, LLC has the authority to prevent a closing from occurring if it determines, in its sole discretion, that this investment is no longer suitable at the time of the closing, which includes, but is not limited to, the Company raising at least US $2,750,000 in connection to the current round.


  • Use of Proceeds

    Investor Perks

    $1,000 – Quarterly investor updates.

    $25,000 – Above plus newly designed Monogram t-shirt.

    $100,000 – Above plus participation in regularly scheduled quarterly call with Monogram senior management.

    $250,000 – Above plus arranged, paid airfare (domestic or domestic equivalent airfare towards international) to a Monogram location for in-person investor tour and a one-time dinner with management. Also includes invitation to annual updates (dinners, calls, etc.) with the Monogram senior management team.

    It is advised that you consult a tax professional to fully understand any potential tax implications of receiving investor perks before making an investment.

    Prior Rounds

    The graph below illustrates the valuation cap or the pre-money valuation of Monogram Orthopaedics's prior rounds by year.


    This chart does not represent guarantees of future valuation growth and/or declines.

    Pre-Seed

  • Round Size
    US $564,000
  • Closed Date
    Dec 14, 2017
  • Security Type
    Convertible Note
  • Valuation Cap
    US $6,000,000
  • Other

  • Round Size
    US $823,000
  • Closed Date
    Dec 21, 2018
  • Security Type
    Convertible Note
  • Valuation Cap
    US $6,000,000
  • Bridge

  • Round Size
    US $275,000
  • Closed Date
    Dec 20, 2018
  • Security Type
    Convertible Note
  • Valuation Cap
    US $8,000,000
  • Other

  • Round Size
    US $50,000
  • Closed Date
    Dec 24, 2018
  • Security Type
    Convertible Note
  • Valuation Cap
    US $10,000,000
  • Market Landscape

    Global reconstructive joint market (in millions)


    The Monogram implants are uncemented and inserted with robotics. We have not identified any robotically inserted press-fit patient-specific implants on the market – for example, the ConforMIS implants are cemented implants inserted with manual instruments.  The Monogram implants are designed to optimize the bone-to-implant interface for optimized natural fixation.

    The level of competition in the orthopedic market is high, with several large, well-capitalized competitors holding a majority share of the market. Currently, we are not aware of any well-known orthopedic companies that broadly offer robotic technology in combination with surgical navigation for the insertion of patient-specific orthopedic implants. The top five market participants in the joint replacement devices market are Zimmer Biomet, DePuySynthes, Stryker, and Smith & Nephew. These companies dominate the market for orthopedic products with around 76% market share. These companies, as well as other companies like ConforMIS,  offer implant solutions, including (depending on the competitor) a combination of conventional instruments and generic implants, robotics and generic implants, or patient-specific instruments and patient-specific implants.

    The market exhibits oligopolistic behaviors as it relates to pricing and differentiation. The average sale price (ASP) of total hip implant components was $5,136 in 2017 and $4,547 for total knee. The range of pricing for these components is not widely distributed. The bill of materials for implants are generally quite similar between vendors and many of the large implant companies outsource a meaningful percentage of their manufacturing to large ISO 13584 contract manufacturers.

    We believe that utilization  and market share over the long term are driven by surgeon adoption which is driven by the clinical benefits of the technology.

    Risks and Disclosures

    We have a limited operating history upon which you can evaluate our performance, and have not yet generated profits. Accordingly, our prospects must be considered in light of the risks that any new company encounters. Our company was incorporated under the laws of the State of Delaware on April 21,2016, and we have not yet generated profits. The likelihood of our creation of a viable business must be considered in light of the problems, expenses, difficulties, complications, and delays frequently encountered in connection with the growth of a business, operation in a competitive industry, and the continued development of our technology and products. We anticipate that our operating expenses will increase for the near future, and there is no assurance that we will be profitable in the near future. You should consider our business, operations and prospects in light of the risks, expenses and challenges faced as an emerging growth company.

    The auditor included a “going concern” note in its audit report. We may not have enough funds to sustain the business until it becomes profitable. Even if we raise funds through this offering, we may not accurately anticipate how quickly we may use the funds and whether these funds are sufficient to bring the business to profitability.

    Our technology is not yet fully-developed, and there is no guarantee that we will successfully develop our technology. Monogram is developing complex technology that will require significant technical and regulatory expertise to develop and commercialize. If we are unable to successfully develop and commercialize our technology and products, it will significantly affect our viability as a company.

    We are subject to substantial governmental regulation relating to the manufacturing, labeling and marketing of our products, and will continue to be for the lifetime of our company. The FDA and other governmental authorities in the United States regulate the manufacturing, labeling and marketing of our products. The process of obtaining regulatory approvals to market a medical device can be expensive and lengthy and applications may take a long time to be approved, if they are approved at all. Our compliance with the quality system, medical device reporting regulations and other laws and regulations applicable to the manufacturing of products within our facilities and those contracted by third parties is subject to periodic inspections by the FDA and other governmental authorities. Complying with regulations, and, if necessary, remediary actions can be significantly expensive. Failure to comply with applicable regulatory requirements may subject us to a range of sanctions, including substantial fines, warning letters that require corrective action, product seizures, recalls, halting product manufacturing, revocation of approvals, exclusion from future participation in government healthcare programs, substantial fines and criminal prosecution.

    We are subject to federal and state healthcare regulations and laws relating to anti-bribery and anti-corruption, and non-compliance with such laws could lead to significant penalties. State and Federal anti-bribery laws, healthcare fraud and abuse laws dictate how we conduct the relationships that we and our distributors and others that market our products have with healthcare professionals, such as physicians and hospitals. We also must comply with a variety of other laws that protect the privacy of individually identifiable healthcare information. These laws and regulations are broad in scope and are subject to evolving interpretation and we could be required to incur substantial costs to monitor compliance or to alter our practices if we are found not to be in compliance. In addition, violations of these laws may be punishable by criminal or civil sanctions, including substantial fines, imprisonment of current or former employees and exclusion from participation in governmental healthcare programs.

    Government regulations and other legal requirements affecting our company are subject to change. Such change could have a material adverse effect on our business. We operate in a complex, highly regulated environment. The numerous federal, state and local regulations that our business is subject to include, but are not limited to: federal and state registration and regulation of medical devices; applicable governmental payor regulations including Medicare and Medicaid; data privacy and security laws and regulations including those under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); the Affordable Care Act (“ACA”) or any successor to that act; laws and regulations relating to the protection of the environment and health and safety matters, including those governing exposure to, and the management and disposal of, hazardous substances; regulations regarding food and drug safety including those of the Food and Drug Administration (“FDA”), and consumer protection and safety regulations including those of the Consumer Product Safety Commission, as well as state regulatory authorities, governing the availability, sale, advertisement and promotion of products we sell; federal and state laws governing health care fraud and abuse; anti-kickback laws; false claims laws; and laws against the corporate practice of medicine. The FDA and state regulatory authorities have broad enforcement powers, including the ability to seize or recall products and impose significant criminal, civil and administrative sanctions for violations of these laws and regulations.

    Changes in laws, regulations and policies and the related interpretations and enforcement practices may significantly affect our cost of doing business as we endeavor maintain compliance with such new policies and laws. Changes in laws, regulations and policies and the related interpretations and enforcement practices generally cannot be predicted may require extensive system and operational changes. Noncompliance with applicable laws and regulations could result in civil and criminal penalties that could adversely affect our business, including: suspension of payments from government programs; loss of required government certifications; loss of authorizations to participate in or exclusion from government programs, including the Medicare and Medicaid programs; loss of licenses; and significant fines or monetary penalties. Any failure to comply with applicable regulatory requirements could result in significant legal and financial exposure, damage our reputation, and have a material adverse effect on our business operations, financial condition and results of operations. 

    We have not yet obtained clearance of our products by the U. S. Food and Drug Administration, or FDA, which is critical to our business plan. In order to sell our products, we must obtain market clearance from the Food and Drug Administration (“FDA”) under Section 510(k) of the Federal Food, Drug, and Cosmetic Act, or the FDCA (see “The Company’s Business – Regulation.”).If Monogram is unable to obtain Section 510(k) clearance, we will not be able to sell our products, and it is unlikely that we will be able to continue to operate as a going concern. In addition, the FDA may request clinical data with our 510 (k) submission. The FDA has indicated an increased focus on robotic technologies that perform automated operations and may request clinical data for our robot and/or implants. If the FDA requests such information, it will materially and adversely impact our development timeline and increase the cost to obtain market clearance. These factors combined may impact our ability to continue to operate as a going concern.

    We anticipate initially sustaining operating losses. It is anticipated that we will initially sustain operating losses in seeking Section 510(k) clearance. Our ability to become profitable depends on obtaining 510(k) clearance, and subsequent success in licensing and selling of products. There can be no assurance that this will occur. Unanticipated problems and expenses are often encountered in offering new products which may impact whether the company is successful. Furthermore, we may encounter substantial delays and unexpected expenses related to development, technological changes, marketing, regulatory requirements and changes to such requirements or other unforeseen difficulties. There can be no assurance that we will ever become profitable. If the company sustains losses over an extended period of time, it may be unable to continue in business.

    Our products may not gain market acceptance among hospitals, surgeons, physicians, patients, healthcare payors and the medical community. A critical element in our commercialization strategy is to persuade the medical community on the efficacy of our products and to educate then on their safe and effective use. Surgeons, physicians and hospitals may not perceive the benefits of our products and may be unwilling to change from the devices they are currently using. A number of factors may limit the market acceptance of our products, including the following:

    • rate of adoption by healthcare practitioners;
    • rate of a product’s acceptance by the target population;
    • timing of market entry relative to competitive products;
    • availability of third-party reimbursement;
    • government review and approval requirements;
    • extent of marketing efforts by us and third-party distributors or agents retained by us; and
    • side effects or unfavorable publicity concerning our products or similar products.

    Our inability to successfully commercialize our products will have a material adverse effect on the value of your investment.

    We could be adversely affected by product liability, personal injury or other health and safety issues. We could be adversely impacted by the supply of defective products. We are also exposed to risks relating to the surgical robotic technology services and products we provide. Defective products or errors in our technology could lead to serious injury or death. Product liability or personal injury claims may be asserted against us with respect to any of the products we supply or services we provide. Monogram is also liable for harms caused by any faults in raw materials or products supplied by third-party manufacturers and suppliers that our company utilizes. It is our responsibility to have a quality management system in place and to audit our suppliers to ensure that products supplied to our company meet proper standards. Should a product or other liability issues arise, the coverage limits under insurance programs and the indemnification amounts available to us may not be adequate to protect us against claims and judgments. We also may not be able to maintain such insurance on acceptable terms in the future. We could suffer significant reputational damage and financial liability if we experience any of the foregoing health and safety issues or incidents, which could have a material adverse effect on our business operations, financial condition and results of operations.

    If third-party payors fail to provide appropriate levels of reimbursement for the use of our products, our revenues could be adversely affected. Sales of our products depend on the availability of adequate reimbursement from third-party payors. In each market in which we do business, our inability to obtain reimbursement approval or the failure of third-party payors to reimburse health care providers at a level which justifies the use of our products instead of cheaper alternatives will hurt our business.

    Moreover, we are unable to predict what changes will be made to the reimbursement methodologies used by third-party payors in the future. Changes in political, economic and regulatory influences may significantly affect healthcare financing and reimbursement practices. For example, there have been multiple attempts through legislative action and legal challenges to repeal or amend the ACA. We cannot predict whether current or future efforts to repeal or amend these laws will be successful, nor can we predict the impact that such a repeal or amendment and any subsequent legislation would have on our business and reimbursement levels. There have also been a number of other proposals and enactments by the federal government and various states to reduce Medicaid reimbursement levels in response to budget deficits, and we expect additional proposals in the future. We cannot assure you that recent or future changes reimbursement policies and practices will not materially and adversely affect our results of operations. Efforts to control healthcare costs, including costs of reconstructive joint replacement, are continuous and reductions in third party reimbursement levels could materially and adversely affect our results of operations.

    We rely on a licensing agreement with Icahn School of Medicine at Mount Sinai. We are party to a licensing agreement (and related option agreement) with Icahn School of Medicine at Mount Sinai (“Mount Sinai”) pursuant to which Mount Sinai has granted Monogram an exclusive license to patents related to customizable bone implants, surgical planning software, and surgical robots (see “The Company’s Business – Intellectual Property”). The patent, software, technical information, know how, etc licensed under this agreement is integral to our company’s core products and technology. As such, we are reliant on the licensing agreement with Mount Sinai to operate our business. Under the terms of our licensing agreement, Mount Sinai has the right to terminate our license for the patent if we materially breach any of our obligations under the licensing agreement. Further, the licensing agreement expires upon the later of (i) 12 years from the first commercial sale of such any product that we sell using the intellectual property covered in the licensed patent or (ii) expiration of the licensed patent. If our arrangement with Mount Sinai were to end, we would no longer be able to use the intellectual property covered by the patent, which could significantly affect our business.

    We operate in a highly competitive industry that is dominated by several very large, well-capitalized market leaders and is constantly evolving. New entrants to the market, existing competitor actions, or other changes in market dynamics could adversely impact us. The level of competition in the orthopaedic market is high, with several very large, well-capitalized competitors holding a majority share of the market. Changes in market dynamics or actions of competitors or manufacturers, including industry consolidation and the emergence of new competitors and strategic alliances, could materially and adversely impact our business. Disruptive innovation by existing or new competitors could alter the competitive landscape in the future and require us to accurately identify and assess such changes and make timely and effective changes to our strategies and business model to compete effectively.

    Currently, we are not aware of any well-known orthopaedic companies that broadly offer robotic technology in combination with surgical navigation for the insertion of patient specific orthopaedic implants. Nonetheless, many of our competitors in this market have significant financial resources and may seek to extend their robotics and orthopaedic implant technology to accommodate the robotic insertion of patient specific implants. Further, a number of companies offer surgical navigation systems for use in arthroplasty procedures that provide a minimally invasive means of viewing the anatomical site. As such, other companies may create similar technology and/or products that we are producing, which would increase competition in our industry. As competition increases, a significant increase in general pricing pressures could occur, which could require us to reevaluate our pricing structures to remain competitive. For example, if we are not able to anticipate and successfully respond to changes in market conditions, it could result in a loss of customers or renewal of contracts or arrangements on less favorable terms.

    Our company does not currently hold any patents on its products or technology. Monogram Orthopaedics currently licenses 5 provisional patents, which includes a patent application with the USPTO, 2 provisional patent applications with the USPTO, and is in the process of submitting 2 additional patent applications to the USPTO (see “The Company’s Business – Intellectual Property”). As of the date of this Offering, the company has not been issued any patents. There is no guarantee that the company will ever be issued patents on the applications it has submitted or has licensed. Our success depends to a significant degree upon the protection of our products and technology. If we are unable to secure patents for our products and technology, other companies with greater resources may copy our technology and/or products, or improve upon them, putting us at a disadvantage to our competitors.

    Successful infringement claims against us could result in significant monetary liability or prevent us from selling some of our products. If successfully developed, our products and technology may be highly disruptive to a very large and growing market. Our competitors are well capitalized with significant intellectual property protection and resources, and may initiate infringement lawsuits against our company. Such litigation could be expensive and could also prevent us from selling our products, which would significantly harm our ability to grow our business as planned.

    Our failure to attract and retain highly qualified personnel in the future could harm our business. As the company grows, it will be required to hire and attract additional qualified professionals such as software engineers, robotics engineers, machine vision and machine learning experts, biomechanical engineers, project managers, regulatory professionals, sales and marketing professionals, accounting, legal, and finance experts. The company may not be able to locate or attract qualified individuals for such positions, which will affect the company’s ability to grow and expand its business.

    We rely on third party manufacturers and service providers. Our third party partners provide a variety of essential business functions, including distribution, manufacturing, and many others. It is possible that some of these third parties will fail to perform their services or will perform them in an unacceptable manner. If we encounter problems with one or more of these parties and they fail to perform to expectations, it could have a material adverse impact on the company.

    Our future success is dependent on the continued service of our small management team. Monogram is managed by three directors and one executive officer. Our success is dependent on their ability to manage all aspects of our business effectively. Because we are relying on our small management team, we lack certain business development resources that may hurt our ability to grow our business. Any loss of key members of our executive team could have a negative impact on our ability to manage and grow our business effectively. We do not maintain a key person life insurance policy on any of the members of our senior management team. As a result, we would have no way to cover the financial loss if we were to lose the services of our directors or officers.

    We expect to raise additional capital through equity and/or debt offerings to support our working capital requirements and operating losses. In order to fund future growth and development, the company will likely need to raise additional funds in the future by offering shares of its Common or Preferred Stock and/or other classes of equity, or debt that convert into shares of common or Preferred Stock, any of which offerings would dilute the ownership percentage of investors in this offering. See “Dilution.” Furthermore, if the company raises capital through debt, the holders of our debt would have priority over holders of common and Preferred Stock and the company may be required to accept terms that restrict its ability to incur more debt. We cannot assure you that the necessary funds will be available on a timely basis, on favorable terms, or at all, or that such funds if raised, would be sufficient. The level and timing of future expenditure will depend on a number of factors, many of which are outside our control. If we are not able to obtain additional capital on acceptable terms, or at all, we may be forced to curtail or abandon our growth plans, which could adversely impact the company, its business, development, financial condition, operating results or prospects.

    Any valuation at this stage is difficult to assess. The valuation for this Offering was established by the company. Unlike listed companies that are valued publicly through market-driven stock prices, the valuation of private companies, especially early-stage companies, is difficult to assess and you may risk overpaying for your investment.

    If we cannot raise sufficient funds, we will not succeed. We are offering shares of our Series A Preferred Stock in the amount of up to $20,000,000 in this Offering on a best-efforts basis and may not raise the complete amount. Even if the maximum amount is raised, we are likely to need additional funds in the future in order to grow, and if we cannot raise those funds for whatever reason, including reasons relating to the company itself or to the broader economy, the company may not survive. If we raise a substantially lesser amount than the Maximum Raise, we will have to find other sources of funding for some of the plans outlined in “Use of Proceeds To Issuer.”.

    All of our assets are pledged as collateral to a lender. We have entered into convertible promissory notes with lenders that contain covenants that limit our ability to engage in specified types of transactions. These covenants limit our ability to, among other things:

    • petition for bankruptcy;
    • assignment of the notes to other creditors;
    • appointment of a receiver of any property of the company; and
    • consolidate, merge, sell or otherwise dispose of all or substantially all of our assets.

    A breach of any of these covenants could result in a default under the notes Upon the occurrence of an event of default under these notes, the lender could elect to declare all amounts outstanding thereunder to be immediately due and payable. We have pledged all of our assets as collateral under our credit facility

    General Risks and Disclosures

    Start-up investing is risky. Investing in startups is very risky, highly speculative, and should not be made by anyone who cannot afford to lose their entire investment. Unlike an investment in a mature business where there is a track record of revenue and income, the success of a startup or early-stage venture often relies on the development of a new product or service that may or may not find a market. Before investing, you should carefully consider the specific risks and disclosures related to both this offering type and the company which can be found in this company profile and the documents in the data room below.

    Your shares are not easily transferable. You should not plan on being able to readily transfer and/or resell your security. Currently there is no market or liquidity for these shares and the company does not have any plans to list these shares on an exchange or other secondary market. At some point the company may choose to do so, but until then you should plan to hold your investment for a significant period of time before a "liquidation event" occurs. A "liquidation event" is when the company either lists their shares on an exchange, is acquired, or goes bankrupt.

    The Company may not pay dividends for the foreseeable future. Unless otherwise specified in the offering documents and subject to state law, you are not entitled to receive any dividends on your interest in the Company. Accordingly, any potential investor who anticipates the need for current dividends or income from an investment should not purchase any of the securities offered on the Site.

    Valuation and capitalization. Unlike listed companies that are valued publicly through market-driven stock prices, the valuation of private companies, especially startups, is difficult to assess and you may risk overpaying for your investment. In addition, there may be additional classes of equity with rights that are superior to the class of equity being sold.

    You may only receive limited disclosure. While the company must disclose certain information, since the company is at an early-stage they may only be able to provide limited information about its business plan and operations because it does not have fully developed operations or a long history. The company may also only obligated to file information periodically regarding its business, including financial statements. A publicly listed company, in contrast, is required to file annual and quarterly reports and promptly disclose certain events — through continuing disclosure that you can use to evaluate the status of your investment.

    Investment in personnel. An early-stage investment is also an investment in the entrepreneur or management of the company. Being able to execute on the business plan is often an important factor in whether the business is viable and successful. You should be aware that a portion of your investment may fund the compensation of the company's employees, including its management. You should carefully review any disclosure regarding the company's use of proceeds.

    Possibility of fraud. In light of the relative ease with which early-stage companies can raise funds, it may be the case that certain opportunities turn out to be money-losing fraudulent schemes. As with other investments, there is no guarantee that investments will be immune from fraud.

    Lack of professional guidance. Many successful companies partially attribute their early success to the guidance of professional early-stage investors (e.g., angel investors and venture capital firms). These investors often negotiate for seats on the company's board of directors and play an important role through their resources, contacts and experience in assisting early-stage companies in executing on their business plans. An early-stage company may not have the benefit of such professional investors.

    Representatives of SI Securities, LLC are affiliated with SI Advisors, LLC ("SI Advisors") Representatives of SI Securities, LLC are affiliated with SI Advisors, LLC ("SI Advisors"). SI Advisors is an exempt investment advisor that acts as the General Partner of SI Selections Fund I, L.P. ("SI Selections Fund"). SI Selections Fund is an early stage venture capital fund owned by third-party investors. From time to time, SI Selections Fund may invest in offerings made available on the SeedInvest platform, including this offering. Investments made by SI Selections Fund may be counted towards the total funds raised necessary to reach the minimum funding target as disclosed in the applicable offering materials.

    Monogram Orthopaedics's Offering Circular

    The offering circular is the legal document filed with the SEC for a Regulation A offering and provides facts that an investor needs to make an informed investment decision. The offering circular includes an overview of company and company's business, historical financials and capitalization, and key risk factors.

    Download Monogram Orthopaedics's  Offering Circular here.

    Frequently Asked Questions

    About Reg A Offerings
    What does it mean that the SEC has qualified this offering?

    "The SEC has qualified this offering" means the SEC has permitted Monogram Orthopaedics to offer for sale the securities described in the Offering Circular to investors such as you. The SEC is not judging the merits, accuracy, or completeness of the offering and information in the Offering Circular.


    Making an Investment in Monogram Orthopaedics
    How does investing work?

    When you complete your investment on SeedInvest, your money will be transferred to an escrow account where an independent escrow agent will watch over your investment until it is accepted by Monogram Orthopaedics. Once Monogram Orthopaedics accepts your investment, and certain regulatory procedures are completed, your money will be transferred from the escrow account to Monogram Orthopaedics in exchange for your securities. At that point, you will be a proud owner in Monogram Orthopaedics.


    What is the difference between preferred equity and a convertible note?

    Preferred equity is usually issued to outside investors and carries rights and conditions that are different from that of common stock. For example, preferred equity may include rights that prevent or minimize the effects of dilution or grants special privileges in situations when the company is sold.

    A convertible note is a unique form of debt that converts into equity, usually in conjunction with a future financing round. The investor effectively loans money to a startup with the expectation that they will receive equity in the company in the future at a discounted price per share when the company raises its next round of financing.

    To learn more about startup investment types check out “How to Choose a Startup Investment” in our academy.


    What will I need to complete my investment?

    To make an investment, you will need the following information readily available:

    1. Personal information such as your current address and phone number
    2. Employment and employer information
    3. Net worth and income information
    4. Social Security Number or passport
    5. ABA bank routing number and checking account number (typically found on a personal check or bank statement)

    What if I change my mind about investing?

    Until a closing occurs, you may cancel your investment at any time, for any reason. You will receive an email when the closing occurs and your securities have been issued. If you have already funded your investment and your funds are in escrow, your funds will be promptly refunded to you upon cancellation. To cancel your investment, please go to your portfolio page by clicking your profile icon in the top right corner.


    After My Investment
    How can I sell my securities in the future?

    Currently there is no market or liquidity for these securities. Right now Monogram Orthopaedics does not plan to list these securities on a national exchange or another secondary market. At some point Monogram Orthopaedics may choose to do so, but until then you should plan to hold your investment for a significant period of time before a “liquidation event” occurs. A “liquidation event” is when Monogram Orthopaedics either lists their securities on an exchange, is acquired, or goes bankrupt.


    How do I keep track of this investment?

    You can return to SeedInvest at any time to view your portfolio of investments and obtain a summary statement.


    Other General Questions
    What is this page about?

    This is Monogram Orthopaedics's fundraising profile page, where you can find information that may be helpful for you to make an investment decision in their company. The information on this page includes the company overview, team bios, and the risks and disclosures related to this investment opportunity. You will also find a copy of the Monogram Orthopaedics's Offering Circular, which has been qualified by the SEC. The Offering Circular includes important details about Monogram Orthopaedics's fundraise that you should review before investing.


    What are the risks of this investment?

    This investment is highly speculative and should not be made by anyone who cannot afford to risk the entire investment amount. In addition to these risks, you should carefully consider the specific information and risks disclosed in Monogram Orthopaedics’s profile and Offering Circular.