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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): October 20, 2023
Monogram Orthopaedics Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-41707 | 81-3777260 | ||
|
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification Number) |
3919 Todd Lane, Austin, TX 78744
(Address of principal executive offices, including zip code)
Registrant’s telephone number, including area code: (512) 399-2656
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
||
| Common Stock, par value $0.001 per share | MGRM | The Nasdaq Stock Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company x
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 7.01. Regulation FD Disclosure
On October 20, 2023, Monogram Orthopaedics Inc. (the “Company”) prepared a presentation regarding the business of the Company. This presentation is being made available publicly on the Company’s website located at ir.monogramorthopedics.com. A copy of that presentation is being furnished herewith as Exhibit 99.1.
Additionally, on October 20, 2023, the Company sent an email to its existing stockholders notifying them of the presentation regarding the business of the Company and providing certain other general updates on the Company. A copy of this email is being furnished herewith as Exhibit 99.2.
The Company also issued a press release on October 20, 2023 announcing the presentation, a copy of which is being furnished herewith as Exhibit 99.3.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Company presentation dated October 19, 2023 | |
| 99.2 | Company letter to stockholders dated October 19, 2023 | |
| 99.3 | Press release dated October 20, 2023 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| MONOGRAM ORTHOPAEDICS INC. | ||
| By: | /s/Benjamin Sexson | |
| Name: Benjamin Sexson | ||
| Title: Chief Executive Officer | ||
Dated: October 20, 2023
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NASDAQ: MGRM Revolutionizing Orthopedic Surgery & Implants 1 |
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Forward-Looking Statements Legal Disclaimer This presentation by Monogram Orthopaedics, Inc. (“Monogram”) may include ''forward-looking statements.'' To the extent that the information presented in this presentation discusses financial projections, information, or expectations about Monogram’s business plans, results of operations, products or markets, or otherwise makes statements about future events, such statements are forward-looking. Such forward-looking statements can be identified by the use of words such as ''should,'' ''may,'' ''intends,'' ''anticipates,'' ''believes,'' ''estimates,'' ''projects,’’ “forecasts,'' ''expects,'' ''plans,'' 'goal", "target" and ''proposes.’’ Although Monogram believes that the expectations reflected in this presentation are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. 2 |
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Our Vision: One robot, to perform safe and fast orthopedic surgeries. Coupled with best-fit implants, to drive better patient outcomes. 3 |
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$37.99B1 $18.08B2 2030 By 2027, 50% of knee replacements may be robotic3 The global spinal implants and surgery devices market size is expected to grow by a CAGR of over 12% between 2022-20324 Joint reconstruction & spine surgery are large & growing markets $22.28B1 2022 2030 4 $11.42B2 2021 Global orthopedic joint replacement market size Global spinal implants and surgery devices market size |
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88% of surgeries are manual5 Most implants are one-size-fits-none Robots in the market are expensive & becoming outdated In-market solutions not automated or slow, limiting adoption But current orthopedic surgery is inefficient and untailored 5 |
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We’re revolutionizing orthopedic joint replacement 6 |
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1 life changing solution What makes us different? 7 750+ Precision parts 23 Patent Applications 1,500,000+ Lines of code |
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No External Fixation Fast Registration Fast Cutting Advanced Imaging Platform Capability AR Integration Differentiating factors *In development pipeline Our technology: 8 More advanced than the largest incumbent and the only other autonomous player Most advanced robotics (1.5M+ lines of proprietary code) Active Sagittal Cutting Non-invasive tracking* Fortressed IP AR Integrations Personalized implants* |
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40 minutes 20 minutes ~81 minutes to perform surgery6 Monogram Orthopedics Future Game-changing innovation in robotic orthopedics Efficient autonomous robotics Proprietary markerless tracking system The only active 7-joint robot with sagittal cutting (patented) Other Current Robotics Goal: State-of-the-art Press Fit implants Patient-optimized implants *1 month Robotic Arm Assisted Total Knee Arthroplasty mean surgical time currently 81 min 9 Pre-Clinical Trial Cadaver Lab Results: |
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10 Current registration process is primary obstacle to robotics adoption Fixed Marker System Our Proprietary Markerless System Steep learning curve Lowers learning curve Time-consuming* Eliminates Inherent pin-site fracture/infection risk Eliminates High cost of ownership Greatly-reduced cost of ownership Per-procedure component cost $175 Eliminates per-procedure cost Inventory burden Eliminates 36 components and $10,000/Robot Sterile reprocessing burden Minimized with reduced components Overall surgery time: ~81 minutes Target surgery time: 20 minutes *Knee Surgery, Sports Trauma Arthroscopy (2019) 27:1132-1141 |
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Markerless Tracking Game-Changing Innovation: Markerless Tracking Goal: disrupting ortho with the 20 minute knee* Patent applications filed Proprietary tracking system would eliminate a major pain point in robotic surgery Development Goal: Significantly reduced surgical time Minimized learning curve Eliminates infection & fracture risk from array pins7 Minimized occlusion 11 |
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Sources: AlliedMarketResearch $1.9B8 2022 Cementless knee transplant market size vs. 12 Advanced robotics enables press-fit knees $3B 2032 Cementless knee transplant market size Cement fixates the implants in the bone, longer surgical times9 Bone ingrowth into the implants, faster surgical times |
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Multi-generational product strategy 13 Next-generation Knee & Hip Implants • State-of-the-art FDA-cleared press fit total knee implant with a clinical track record for robot launch • Licensed Total Hip and partial knee Now: Next: • 3D-printed implants • Customization solves the inventory problem • Multiple patents protecting our implant creation • Designed to be press-fit, bone sparing, highly stable, easier to revise, and more anatomic loading for younger or active patients Outcome from testing with UCLA and UNMC labs… outperformed market leading knee and hip designs in simulated testing |
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Studies conducted with Differentiated and heavily fortressed IP 23 Patents filed 5 Patents in immediate pipeline 7 Patents expected in the next 24-36 months Now: Proprietary robotic system First-of-its-kind software (1.5M+ lines of proprietary code) Augmented Reality system Unique system morphology Autonomous sagittal cutting Markerless tracking system Next: Patient-optimized implants Specifics of autonomous robotics in other clinical applications Future: 14 Improved predictive modeling Improved autonomous functionality Additional novel tracking methods Press Fit implants Improved methods to laxity assessment Automated planning & custom instrumentation |
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Expand international relationships Road to a 20-minute surgery 1H 2024 2H 2024 2025 and beyond Anticipated FDA approval of clinical trial plan Submit 510(K) application Expect to finalize FDA clinical trials Launch in US market 15 Launch commercially Outside US (see next page) First live-patient surgery (OUS) |
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*Trials expected to lead to de-risking filing with US FDA Massive opportunity outside US Counterparty : Major international medical company History of placing major purchase orders with similarly-profiled companies Active orthopedic robotics system distributor Pilot program launching Q4 2023 Live surgery trials starting 1H 2024 16 |
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Led by experts in running and scaling major tech and medical companies 17 Doug Unis, MD Founder & CMO Ben Sexson, CFA Co-founder & CEO Kamran Shamaei, Ph.D. CTO Noel Knape, CPA CFO Muhammad Afnan Director of Software Kevin Posey Director of QA/RA |
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Gross Margin Billing Cycle Once-off Easy to adopt technology with built-in annual revenue 18 Target ASP: $500,000 (goal to provide financing options) Capital Equipment (the razor) » Surgical robot cart and tracking cart » Cutting system » Surgical instrumentation Target ASP: $5,000 Consumables (the razorblades) » Implants – primary TKA includes femur, tibia and insert » Cutting tools (blades) & Navigation consumables Target ASP: $50,000 Recurring Licensing Annuity » Price target 10% of capital equipment revenue annually » Additional extended warranty Robot Systems Consumables License Per Procedure ARR ~55% ~65% ~70% 5-Year Margin Targets |
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Cash on Hand $15 494 845 Debt — Common Shares 29 302 640 Current Valuation $78 238 049 Warrant 547 944 Conversion Price $1.83 Expiration: Feb 2024 Summary Balance Sheet 19 |
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Large Target Market » Focused on High Growth Target Segment » Multiple Revenue Drivers We’re on our way to lead the market 20 Revolutionary Product Solution Architecture » Autonomous Surgical Robotics » Patient-optimized Orthopedic Implants Durable Competitive Advantages » Proprietary Technology » Strong IP backed by 20+ Patent Filings » First-mover Advantage Strong Management/Advisory Team » Deep Medical/Technology/Capital Markets Experience |
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monogramorthopedics.com NASDAQ: MGRM MZ North America Direct: 737-289-0835 Michael Kim MGRM@mzgroup.us |
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Appendix 22 |
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References 23 1. Orthopedic joint replacement market size, share, growth, 2030. Orthopedic Joint Replacement Market Size, Share, Growth, 2030. (n.d.). https://www.fortunebusinessinsights.com/industry-reports/orthopedic-joint-replacement-market-100314 2. Base Year: 2021 |. (n.d.). Spinal implants and surgery devices market size: Growth 2030. STRATEGIC MARKET RESEARCH. https://www.strategicmarketresearch.com/market-report/spinal-implants-and-surgery-devices-market 3. Medtech 360 Orthopedic Surgical Robotic Devices | Market Analysis | Global | 2019 4. Spine surgery robots market (by application: Spinal Fusion, minimally invasive procedures, scoliosis, osteoporotic compression fractures, others; by method: Minimally Invasive Surgery, open surgery; by end user: Hospitals, Ambulatory Surgical Centers) - global industry analysis, size, share, growth, trends, regional outlook, and forecast 2023-2032. Precedence Research. (n.d.). https://www.precedenceresearch.com/spine-surgery-robots-market 5. ONN, 2021 Hip and Knee Implant Review (Volume 33, Number 3, August 2022) 6. Marchand, Kevin & Ehiorobo, Joseph & Mathew, Kevin & Marchand, Robert & Mont, Michael. (2020). Learning Curve of Robotic-Assisted Total Knee Arthroplasty for a High-Volume Surgeon. The Journal of Knee Surgery. 35. 10.1055/s-0040-1715126. 7. Nogalo, C., Meena, A., Abermann, E., & Fink, C. (2022). Complications and downsides of the robotic total knee Arthroplasty: A systematic review. Knee Surgery, Sports Traumatology, Arthroscopy, 31(3), 736–750. https://doi.org/10.1007/s00167-022-07031-1 8. https://www.alliedmarketresearch.com/cementless-total-knee-arthroplasty-market-A131520 9. https://news.hss.edu/study-finds-cementless-knee-replacement-outcomes-comparable-to-standard-knee-implant-less-time-needed-in-or/ |
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» Board Certified Orthopedic Surgeon » University Hospital in Newark Residency » The Hospital for Joint Diseases Fellowship » Heavy Mako user, former Stryker consultant » Icahn School of Medicine at Mount Sinai » The University of Texas at Houston Medical School » The University of Texas at Houston residency » Duke University fellowship » Zimmer, OrthoAlign » Orthopaedic Specialists of Austin » Board Certified Orthopedic Surgeon » University Hospital in Newark Residency » The Hospital for Joint Diseases Fellowship » Heavy Mako user, former Stryker consultant » Icahn School of Medicine at Mount Sinai » Board Certified Orthopedic Surgeon » Northwestern University Residency » Rush University Fellowship » Chief of Quality Improvement Mount Sinai West » 19+ years of clinical practice Advised by our end-users 24 Doug Unis, MD NYC Edward Adler, MD NYC Gregory Catlett, MD Austin Adam Cohen, MD NYC » Board Certified Orthopedic Surgeon » Kansas City University Medical School » Michigan State University Residency » Depuy Synthes » Orthopedic Specialty Center » MBA Stern School of Business » Columbia University College of Physicians and Surgeons Medical School » The Mount Sinai Hospital residency » Former consultant with Smith & Nephew, Sryker & Depuy Synthes » Icahn School of Medicine at Mount Sinai » Board Certified Orthopedic Surgeon » Texas Tech School of Medicine » Baylor College of Medicine Residency » OrthoAlign » Orthopaedic Specialists of Austin » Board Certified Orthopedic Surgeon » Yale University School of Medicine » University of Pennsylvania Residency » Rush University Fellowship » Zimmer BIomet » Columbia Orthopedics Roshan Shah, MD NYC Darwin Chen, MD NYC Bobby Jamieson, MD California Matthew Heinrich, MD Austin Scientific Advisory Board » Professor Orthopaedic Surgery Research UNMC » Director Biomedical Engineering Research and Advanced Surgical Technologies » President of ISTA » Adjunct Professor UCLA » Director Biomechanics Laboratory » PhD in Biomedical Engineering, UCLA Hani Haider, PhD UNMC Biomechanics Lab Sophia Sangiorgio, PhD UCLA Biomechanics Lab |
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25 We lead to better hospital unit economics Standardized revenue per surgery: $4K Average time per knee operation: 20 Minutes (Goal) Other robot surgery companies 80+ Minutes |
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The current one size fits none paradigm makes no sense with robotics, preoperative planning and 3D printing. Monogram’s proprietary patient optimized 3D printed implants are designed with robotic bone preparation in mind. High inventory burden is wasteful; two leading companies average 456 average days sales in inventory 26 Monogram's Solution: 3-D Printed Custom Implants |
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Exhibit 99.2
Dear Reader,
On October 20th, 2023, Monogram Orthopaedics Inc. (the "Company") prepared a presentation regarding the business of the Company. We have provided a copy of that presentation here: https://bit.ly/monogram_update
This presentation is also available publicly on the Company's website at ir.monogramorthopedics.com.
We want to thank our dedicated shareholders and the many supporters who have continued to support the Monogram mission of advancing the standard of care in orthopedic medicine. It is remarkable and motivating to the Monogram team how dedicated our community is to the long-term vision. Notably, the majority of our investors have remained as holders. Management shares this long-term vision of the potential clinical impact of our products and is dedicated to the continued execution of our milestones. We are confident our community has not mistaken our silence for a lack of progress.
To that end, Monogram has come an incredibly long way over the past six years. Our system is moving quickly through verification and is now actively cutting without needing external fixation (or custom holders) and with extremely tight accuracy and high speeds. We believe our system is on track to be one of the most (if not the most) advanced open platform systems internationally and highly competitive with the current state-of-the-art domestically. No high-performance autonomous (active) robot on the market today comes remotely close to the performance of current market-leading semi-active systems in competitive markets like knees. We plan to change this.
Our convictions have only solidified as we observe emergent market trends. Our view is that the future of orthopedic robotics will be autonomous (active). If Monogram can successfully develop a high-performance autonomous robot that competes with current semi-active systems in one of the most competitive (if not most competitive) and technically challenging applications in orthopedics (knees), we anticipate the value proposition of our efforts will become self-evident.
Our vision is to enable a “one robot for the operating room” model, the benefits of which are numerous - efficient servicing, cross-application sales synergies, economies of scale, and attractive cost of ownership (fits trend to outpatient care). We believe only advanced autonomous robotics have the technical potential to realize this vision and drive ubiquitous robotic adoption. The limitations of semi-active robotics in non-knee applications could be significant. We aim to develop a robot that could enhance a technology portfolio by driving continued market penetration in knees while enabling new market (clinical application) opportunities. We now have over 1.5 million lines of code and a first-mover advantage in autonomous robotics with arguably the most sophisticated robot arm in the world, and we hope to achieve this. We believe that such a solution would be accretive.
Our platform architecture is modular and designed to enable new application development efficiently. We are confident that proving our technical capabilities with a high-performance system for knees will speak to our development competence for addressing new markets. It is especially exciting given that we anticipate we will soon be moving from hypotheticals to competing in the real world with our system internationally.
Monogram now employs 27 full-time employees and approximately 30 contractors working flat out to hit our objectives. Monogram recently received FDA Clearance for Export with a Certificate to Foreign Government/Certificate of Exportability that advances us on our path to launch outside the US for a Pilot Program with a Global Distributor. The system is performing at a high level, testing with pilot program implants is on schedule, and we remain on track to ship on or ahead of schedule (pending overseas regulatory approvals that are in process). The international surgical robotics market opportunities may be sizable and are likely underappreciated. Monogram's mission has always been to advance the standard of care in orthopedics. We certainly highly anticipate a launch in the US, but your support may impact patient lives sooner than expected. The pace of adoption of advanced technologies in orthopedics outside the US is noteworthy.
We continue to move forward on an aggressive schedule for the domestic market. Our first-generation implants are FDA-cleared, and the focus remains on clearing the next piece, the robot. While discussions with the FDA are ongoing, we have preemptively retained a clinical expert and have started laying the groundwork for an Investigational Device Exemption (IDE) application if one should be needed. We anticipate having the required surgeon and institutional support to move quickly and have established our predicate device and clinical pathway (510(k) pathway) with the agency. Traction with a commercial deployment internationally could derisk the scope and outcome risk of a clinical trial and help establish our products' relative competitiveness faster than expected.
We remain optimistic about our prospects and trust that our dedicated team's hard work and efforts will be rewarded. The Monogram team is deeply committed to the Company's mission. We recently announced the early conversion (2+ years early) of an approximately $6.1M warrant liability, which further bolstered our balance sheet ($1.25M) and was welcome support.
We look forward to hosting you at our annual shareholder meeting on November 30th, 2023. Monogram management will provide an update to shareholders that will include a question-and-answer session. We will be sending details to the event separately. We also anticipate hosting a technology demo to update our shareholders on our technical progress and next-generation product pipeline.
In closing, I remind our supporters that we operate in a highly competitive environment. There may be strategic reasons for keeping quiet. I assure you the team is hard at work.
Thank you for your support.
Kind regards,
Ben Sexson, CEO
Exhibit 99.3
Monogram Orthopaedics Files Updated Presentation on Form 8-K
– Presentation Highlights MGRM’s Competitive Differentiation and Multi-Stage Growth Strategy –
Austin, TX - October 20, 2023 - Monogram Orthopaedics Inc. (NASDAQ: MGRM) ("Monogram" or the "Company"), a medical technology company focused on reconstructive joint procedures and surgical robotics, today announced the filing of an 8-K with the U.S. Securities and Exchange Commission (“SEC”) that included an updated presentation regarding the business of the company. The presentation highlights the Company’s vision, competitive differentiation, multi-stage product strategy, and market opportunities.
To access the Presentation, please go to: https://ir.monogramorthopedics.com/.
“Monogram has come an incredibly long way over the past six years. Our system is moving quickly through verification and is now actively cutting without needing external fixation or custom holders with extremely tight accuracy and high speed. We believe our system is on track to be one of the most, if not most, advanced open platform systems internationally and highly competitive with the current state-of-the-art domestically. No high-performance autonomous active robot on the market today comes remotely close to the performance of market-leading semi-active systems in competitive markets," said Ben Sexson, Chief Executive Officer of Monogram Orthopaedics.
“Monogram recently received FDA Clearance for Export with a Certificate to Foreign Government/Certificate of Exportability that advances us on our path to launch outside the U.S. for a Pilot Program with a Global Distributor. The system is performing at a high level, testing with pilot program implants is on schedule, and we remain on track to ship on or ahead of schedule pending overseas regulatory approvals that are in process.”
About Monogram Orthopaedics
Monogram Orthopaedics (NASDAQ: MGRM) is working to develop a product solution architecture with the long-term goal of enabling patient-optimized orthopedic implants at scale by linking 3D printing and robotics with advanced pre-operative imaging. The Company has a robot prototype that can autonomously execute optimized paths for high-precision insertion of implants in synthetic bone specimens. Monogram intends to produce and market robotic surgical equipment and related software, orthopedic implants, tissue ablation tools, navigation consumables, and other miscellaneous instrumentation necessary for reconstructive joint replacement procedures. The Company has not yet made 510(k) premarket notification submissions or obtained 510(k) clearances for its robotic products. FDA approval is required to market these products, and the Company has not obtained FDA approval for any of its robotic products, and it cannot estimate the timing or assure the ability, to obtain such clearances.
Monogram Orthopaedics is working to advance the way orthopedic surgery is done. Our system is being developed to combine personalized knee implants with precision robotic surgical assistants to hopefully give patients a better-fitting knee replacement with minimally invasive surgery. One hundred thousand knee replacements failing each year in a $19.4B market represents an enormous opportunity for us.
To learn more, visit www.monogramorthopedics.com.
Forward-Looking Statements
This press release may include "forward-looking statements.'' To the extent that the information presented in this presentation discusses financial projections, information, or expectations about Monogram Orthopaedics Inc.'s business plans, results of operations, products or markets, or otherwise makes statements about future events, such statements are forward-looking. Such forward-looking statements can be identified by the use of words such as ''should,'' ''may,'' ''intends,'' ''anticipates,'' ''believes,'' ''estimates,'' ''projects,'' ''forecasts,'' ''expects,'' ''plans,'' and ''proposes.''
Although Monogram Orthopaedics Inc. believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. You are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading "Risk Factors" and elsewhere in the offering statement filed with the SEC. Forward-looking statements speak only as of the date of the document in which they are contained, and Monogram Orthopaedics Inc. does not undertake any duty to update any forward-looking statements except as may be required by law.
Investor Relations
Michael Kim
Managing Director
MZ North America
737-289-0835
MGRM@mzgroup.us
