Receives FDA Clearance for the mBôs™ TKA System
Groundbreaking Trial Set to Deliver one of the World’s First Autonomous Saw-Based Robotic TKA Surgeries on Live Patients
Management to Host Business Update Conference Call Today at 4:30 p.m. Eastern Time
AUSTIN, Texas, May 14, 2025 (GLOBE NEWSWIRE) -- Monogram Technologies Inc. (NASDAQ: MGRM) ("Monogram" or the "Company"), an AI-driven robotics company focused on improving human health with an initial focus on orthopedic surgery, has reported its financial and operational results for the first quarter ended March 31, 2025.
First Quarter 2025 and Subsequent Operational Highlights
- The U.S. Food and Drug Administration (“FDA”) granted 510(k) clearance for the Monogram mBôs™ Total Knee Arthroplasty (“TKA”) System. This determination means that Monogram may market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act.
- Following the end of the quarter, Monogram received regulatory approval from India’s Central Drugs Standard Control Organization (“CDSCO”) to import the mBôs TKA System and initiate a 102-patient, multi-center clinical investigation evaluating its safety and effectiveness in collaboration with Shalby Limited (“Shalby”), one of India’s leading orthopedic hospital networks.
- Patient enrollment for the trial is expected to begin shortly, with the first live patient surgeries anticipated within 90 business days.
- Clinical trial will be the first demonstration of fully autonomous, hands-free, saw-based robotic total knee surgeries on live patients, showcasing the potential of robotic precision and setting a new standard for robotic surgery.
Management Commentary
“The first quarter was transformational for Monogram. We received FDA clearance for the mBôs TKA System and subsequently obtained regulatory approval from India’s CDSCO to initiate a multi-center clinical trial in collaboration with Shalby Hospitals,” said Ben Sexson, Chief Executive Officer of Monogram Technologies. “These milestones validate the underlying technology and provide a clear path to commercial adoption in key markets.
“This study will be the first to evaluate autonomous saw-based robotic total knee surgeries on live patients. We believe this represents a historic step for the field of surgical robotics. It is our first opportunity to demonstrate that a fully active, hands-free, unconstrained robotic system can safely, precisely, and efficiently execute bone resections in a real-world clinical setting. The trial is expected to demonstrate the value proposition of autonomous robotics.
“We are now working to integrate recent system upgrades into the cleared mBôs platform and are preparing for initial placements with key opinion leader surgeons in select U.S. geographies. These early placements are designed to build real-world clinical evidence, deepen surgeon engagement, and establish a strong foundation for long-term growth. At the same time, we are advancing enrollment preparations in India, where the first live patient surgeries are expected to begin by late summer or early fall.
“Our recent milestone execution has demonstrated the strength of our team and the momentum behind our platform. We remain aggressively focused on enhancing system performance, including optimizing workflow efficiencies and reducing cut times, to strengthen long-term competitiveness further. We are also actively exploring additional domestic and international relationships as we move toward commercialization and executing our long-term roadmap. Collectively, these initiatives position us to create significant strategic value as we advance,” concluded Sexson.
Upcoming Milestones
- Initiate patient enrollment for fully autonomous hands-free robotic surgeries for the multi-center clinical trial. Begin first live patient surgeries with the fully autonomous hands-free mBôs TKA System in India.
- Advance preparation for an international (“OUS”) commercial launch of the mBôs TKA System, leveraging strategic partnerships.
- Launch initial seed placements with U.S.-based key opinion leader (“KOL”) surgeons in strategically selected geographies. Explore any new opportunities for Monogram as we move toward commercialization that could support broader adoption both internationally and domestically.
- Continue to refine and enhance the mBôs system and support next-generation product development.
- Advance regulatory submissions for additional clinical applications to expand system capabilities and establish a versatile multi-application platform.
- Evaluate strategic opportunities that could support domestic and international growth.
First Quarter 2025 Financial Results
Research and development expenses for the first quarter ended March 31, 2025, decreased 6% to $2.3 million, compared to $2.4 million in the prior-year quarter. The R&D decrease was primarily due to the completion of the verification and validation phase of the development of its Monogram mBôs™ TKA System robotic system, partially offset by a $250,000 performance-based compensation accrual during the first quarter of 2025 from the grant of FDA 510(k) clearance for its Monogram mBôs™ TKA System.
Marketing and advertising expenses for the first quarter ended March 31, 2025, decreased 63% to $44,000, compared to $120,000 in the prior-year quarter. During the first quarter of 2025, these expenses primarily related internal payroll-related expenses. During the first quarter of 2024, these expenses primarily related to external marketing efforts intended to increase market awareness of Monogram and its offerings for fund raising purposes.
General & administrative expenses for the first quarter ended March 31, 2025, were $1.0 million compared to $1.1 million in the prior-year quarter. In both periods, general and administrative expenses were composed primarily of payroll-related expenses and required public company expenses including insurance expenses, regulatory expenses, and professional services.
Net loss was $3.2 million for the quarter ended March 31, 2025, as compared to a net loss of $3.5 million for the prior-year quarter.
Cash and cash equivalents totaled $13.3 million as of March 31, 2025, compared to $15.7 million as of December 31, 2024. The company continues to direct its resources with a focus on commercializing the mBôs™ TKA System as capital efficiently as possible.
First Quarter 2025 Results Conference Call
Monogram Chief Executive Officer Ben Sexson and Chief Financial Officer Noel Knape will host the conference call, followed by a question-and-answer period.
To access the call, please use the following information:
| Date: | Wednesday, May 14, 2025 |
| Time: | 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) |
| Registration Link: | https://streamyard.com/watch/uKXmYngpKg5P |
The conference call webcast will be broadcast live and available for replay at the investor relations section of the Company's website here.
About Monogram Technologies Inc.
Monogram Technologies (NASDAQ: MGRM) is an AI-driven robotics company focused on improving human health, with an initial focus on orthopedic surgery. The Company is developing a product solution architecture to enable patient-optimized orthopedic implants at scale by combining 3D printing, advanced machine vision, AI and next-generation robotics.
Monograms mBôs precision robotic surgical system is designed to autonomously execute optimized paths for high-precision insertion of its FDA-cleared mPress press-fit implants. The goal is well balanced, better-fitting bone sparing knee replacements. The Company initially 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. Other clinical and commercial applications for the mBôs with mVision navigation are also being explored.
Monogram has obtained FDA clearance for mPress implants and applied for 510(k) clearance for its robotic products. The Company is required to obtain FDA clearance before it can market its products. Monogram cannot estimate the timing or assure the ability to obtain such clearances.
The Company believes that its mBôs precision robotic surgical assistants, which combine AI and novel navigation methods (mVision), will enable more personalized knee implants for patients, resulting in well balanced better-fitting knee replacements with bone sparing implants. Monogram anticipates that there may be other clinical and commercial applications for its navigated mBôs precision robot and mVision navigation.
To learn more, visit www.monogramtechnologies.com.
Forward-Looking Statements
This press release may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Statements other than statements of historical facts included in this press release may constitute forward-looking statements and are not guarantees of future performance or results and involve a number of risks and uncertainties.. Forward-looking statements, other than statements of historical fact, are highly likely to be affected by other unknowable future events and conditions, including elements of the future that are or are not under our control, and that the Company may or may not have considered; accordingly, such statements cannot be guarantees or assurances of any aspect of future performance. Actual developments and results are highly likely to vary materially from any forward-looking statements as a result of a number of factors, including those described in the prospectus and the Company's other filings with the SEC. The Company undertakes no duty to update any forward-looking statement made herein. All forward-looking statements speak only as of the date of this press release.
Investor Relations
Chris Tyson
Executive Vice President
MZ North America
Direct: 949-491-8235
MGRM@mzgroup.us
| MONOGRAM TECHNOLOGIES INC. CONDENSED BALANCE SHEETS (in thousands, except share and per share amounts) | ||||||||
| March 31, | December 31, | |||||||
| 2025 | 2024 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 13,270 | $ | 15,658 | ||||
| Account receivable | — | — | ||||||
| Prepaid expenses and other current assets | 584 | 625 | ||||||
| Total current assets | 13,854 | 16,283 | ||||||
| Equipment, net | 911 | 810 | ||||||
| Intangible assets, net | 286 | 339 | ||||||
| Operating lease right-of-use assets | 306 | 338 | ||||||
| Total assets | $ | 15,357 | $ | 17,770 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,187 | $ | 1,174 | ||||
| Accrued liabilities | 650 | 229 | ||||||
| Operating lease liabilities, current | 141 | 138 | ||||||
| Total current liabilities | 1,978 | 1,541 | ||||||
| Operating lease liabilities, non-current | 190 | 226 | ||||||
| Other liability | 1,500 | 1,500 | ||||||
| Total liabilities | 3,668 | 3,267 | ||||||
| Commitments and contingencies | — | — | ||||||
| Stockholders’ equity: | ||||||||
| Series D Preferred Stock, $0.001 par value; 6,000,000 shares authorized; 4,284,486 and 4,361,249 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively; aggregate liquidation preference of $9,640 and $9,812 at March 31, 2025 and December 31, 2024, respectively | 4 | 4 | ||||||
| Common stock, $.001 par value; 90,000,000 shares authorized; 35,346,518 and 35,167,673 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively | 35 | 35 | ||||||
| Additional paid-in capital | 83,027 | 82,452 | ||||||
| Accumulated deficit | (71,377 | ) | (67,988 | ) | ||||
| Total stockholders’ equity | 11,689 | 14,503 | ||||||
| Total liabilities and stockholders’ equity | $ | 15,357 | $ | 17,770 | ||||
| MONOGRAM TECHNOLOGIES INC. CONDENSED STATEMENTS OF OPERATIONS (UNAUDITED) | ||||||||
| Three months ended | ||||||||
| March 31, | ||||||||
| 2025 | 2024 | |||||||
| Product revenue | $ | — | $ | — | ||||
| Cost of goods sold | — | — | ||||||
| Gross profit | — | — | ||||||
| Operating expenses: | ||||||||
| Research and development | 2,258 | 2,406 | ||||||
| Marketing and advertising | 44 | 120 | ||||||
| General and administrative | 1,032 | 1,084 | ||||||
| Total operating expenses | 3,334 | 3,610 | ||||||
| Loss from operations | (3,334 | ) | (3,610 | ) | ||||
| Other income: | ||||||||
| Interest income and other, net | 146 | 103 | ||||||
| Total other income | 146 | 103 | ||||||
| Net loss before taxes | (3,188 | ) | (3,507 | ) | ||||
| Income taxes | — | — | ||||||
| Net loss | (3,188 | ) | (3,507 | ) | ||||
| Less: dividends declared for preferred shareholders | (201 | ) | — | |||||
| Net loss allocable to common shareholders | $ | (3,389 | ) | $ | (3,507 | ) | ||
| Basic and diluted loss per common share | $ | (0.10 | ) | $ | (0.11 | ) | ||
| Weighted-average number of basic and diluted shares outstanding | 35,210,827 | 31,535,795 | ||||||
| MONOGRAM TECHNOLOGIES INC. CONDENSED STATEMENTS OF CASH FLOWS (UNAUDITED) (in thousands) | ||||||||
| Three months ended | ||||||||
| March 31, | ||||||||
| 2025 | 2024 | |||||||
| Operating activities: | ||||||||
| Net loss | $ | (3,188 | ) | $ | (3,507 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | 292 | 295 | ||||||
| Other expenses settled with stock issuances | — | 38 | ||||||
| Loss from change in fair value of common stock make-whole obligation | — | 45 | ||||||
| Depreciation and amortization | 108 | 106 | ||||||
| Changes in non-cash working capital balances: | ||||||||
| Account receivable | — | 365 | ||||||
| Other current assets | 41 | (111 | ) | |||||
| Accounts payable | 13 | (1,141 | ) | |||||
| Accrued liabilities | 421 | 258 | ||||||
| Operating lease assets and liabilities, net | (1 | ) | 1 | |||||
| Cash used in operating activities | (2,314 | ) | (3,651 | ) | ||||
| Investing activities: | ||||||||
| Purchases of equipment | (156 | ) | (11 | ) | ||||
| Cash used in investing activities | (156 | ) | (11 | ) | ||||
| Financing activities: | ||||||||
| Proceeds from issuances of Common Stock, net of cash costs | — | 151 | ||||||
| Proceeds from warrant exercises, net of cost | 82 | — | ||||||
| Cash provided by financing activities | 82 | 151 | ||||||
| Decrease in cash and cash equivalents during the period | (2,388 | ) | (3,511 | ) | ||||
| Cash and cash equivalents, beginning of the period | 15,658 | 13,589 | ||||||
| Cash and cash equivalents, end of the period | $ | 13,270 | $ | 10,078 | ||||
| Cash paid for interest | $ | — | $ | — | ||||
| Cash paid for income taxes | $ | — | $ | — | ||||
| Noncash investing and financing activities: | ||||||||
| Amortization of deferred issuance costs of Common Stock Purchase Agreement | $ | — | $ | 146 | ||||
| Series D Preferred Stock dividends settled through issuance of Common Stock | $ | 201 | $ | — | ||||
