Monogram Technologies Reports First Quarter 2025 Financial Results

Rhea-AI Summary

Monogram Technologies (NASDAQ: MGRM) reported its Q1 2025 financial results and achieved significant milestones. The company received FDA 510(k) clearance for its mBôs™ Total Knee Arthroplasty (TKA) System and obtained regulatory approval from India's CDSCO to initiate a 102-patient clinical trial with Shalby Limited. The trial will demonstrate fully autonomous, hands-free, saw-based robotic total knee surgeries on live patients, expected to begin within 90 business days.

Financial highlights for Q1 2025 include: R&D expenses decreased 6% to $2.3M, marketing expenses dropped 63% to $44,000, and G&A expenses were $1.0M. The company reported a net loss of $3.2M, improving from $3.5M in Q1 2024. Cash and equivalents stood at $13.3M as of March 31, 2025.

Positive

• Received FDA 510(k) clearance for mBôs™ TKA System, enabling market access
• Obtained CDSCO approval in India for 102-patient clinical trial
• Reduced net loss to $3.2M from $3.5M year-over-year
• Decreased R&D expenses by 6% to $2.3M
• Significant reduction in marketing expenses by 63% to $44,000

Negative

• Cash position decreased to $13.3M from $15.7M in December 2024
• Still operating at a significant net loss of $3.2M per quarter
• No revenue generation reported in Q1 2025

Insights

Medical Device Regulatory Expert

FDA clearance and India trial approval for Monogram's robotic TKA system represent major regulatory milestones, enabling commercialization despite continued financial losses.

Monogram Technologies has achieved two critical regulatory milestones that substantially advance their commercialization roadmap. The FDA 510(k) clearance for their mBôs™ TKA System is particularly significant as it permits immediate marketing in the US market under general controls provisions. This regulatory designation indicates the FDA determined the device is substantially equivalent to legally marketed predicate devices, avoiding the more rigorous PMA pathway typically required for novel high-risk devices.

The subsequent CDSCO approval in India for a 102-patient clinical trial represents a strategic approach to building clinical evidence. Rather than simply commencing US commercialization, Monogram is pursuing an international evidence-generation strategy with fully autonomous robotic surgeries. This creates a dual-pathway approach: US KOL placements for market development alongside robust international clinical data collection.

The regulatory timing appears well-coordinated, as obtaining these approvals positions Monogram to execute first-in-human autonomous surgeries within approximately 90 business days. From a regulatory perspective, the company has cleared the most significant hurdles for their TKA system and can now focus on execution rather than regulatory uncertainty.

However, the pathway to full commercialization remains complex. While FDA marketing clearance exists, the company still needs to integrate system upgrades into the cleared platform, suggesting potential supplemental submissions may be needed before full-scale commercialization. Their focus on "seed placements" with KOLs rather than immediate broad commercialization indicates a measured approach to market development while building clinical evidence through the India trial.

Healthcare Investment Analyst

Monogram secured key regulatory approvals but faces cash concerns with $13.3M remaining and $3.2M quarterly burn rate limiting runway to 4-5 quarters.

Monogram's Q1 financial results reveal a cash position of $13.3 million, down from $15.7 million at year-end 2024, representing a quarterly cash burn rate of approximately $2.4 million. With net losses of $3.2 million for the quarter (improved from $3.5 million year-over-year), the company appears to have roughly 4-5 quarters of runway at current spending levels before requiring additional capital.

The company reported R&D expenses of $2.3 million (down 6% year-over-year) and G&A expenses of $1.0 million, demonstrating some expense control following completion of the verification and validation phase for their robotic system. The reduction in marketing expenses by 63% to just $44,000 indicates minimal commercial infrastructure ahead of their planned initial KOL placements.

Monogram's strategy appears focused on capital efficiency while transitioning from development to early commercialization. The decision to pursue clinical evidence generation in India rather than immediate full US commercialization likely reflects this capital-conscious approach, potentially allowing the company to generate compelling clinical data at lower cost than a US-based trial.

For investors, the FDA clearance significantly de-risks the regulatory pathway, but commercialization execution risk remains substantial. The upcoming India clinical trial represents a critical value inflection point, with first autonomous robotic surgeries expected within 90 business days. Success could differentiate Monogram's platform in the competitive orthopedic robotics market dominated by larger players.

However, given the limited cash runway, investors should expect additional capital raising will be necessary before reaching meaningful revenue, likely following initial clinical data from the India trial to maximize valuation.

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			$	—

FAQ

What regulatory approvals did MGRM receive for its mBôs TKA System in Q1 2025?

Monogram Technologies received FDA 510(k) clearance for the mBôs TKA System in the US and CDSCO approval in India to conduct a 102-patient clinical trial.

What were Monogram Technologies' (MGRM) key financial metrics for Q1 2025?

MGRM reported a net loss of $3.2M, R&D expenses of $2.3M, marketing expenses of $44,000, and G&A expenses of $1.0M. Cash position was $13.3M as of March 31, 2025.

When will MGRM begin its clinical trials for autonomous robotic knee surgeries in India?

MGRM expects to begin the first live patient surgeries within 90 business days from Q1 2025, approximately by late summer or early fall 2025.

How much cash does Monogram Technologies (MGRM) have as of Q1 2025?

MGRM reported cash and cash equivalents of $13.3M as of March 31, 2025, down from $15.7M at the end of December 2024.

What are the upcoming milestones for Monogram Technologies (MGRM)?

Key milestones include initiating patient enrollment for autonomous robotic surgeries in India, beginning first live patient surgeries, preparing for international commercial launch, and starting initial placements with US-based KOL surgeons.