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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 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): May 12, 2026
STEREOTAXIS,
INC.
(Exact
Name of Registrant as Specified in Its Charter)
Delaware
(State
or Other Jurisdiction of Incorporation)
| 001-36159 |
|
94-3120386 |
| (Commission
File Number) |
|
(IRS
Employer Identification No.) |
| 710
North Tucker Boulevard, Suite 110, St. Louis, Missouri |
|
63101 |
| (Address
of Principal Executive Offices) |
|
(Zip
Code) |
(314)
678-6100
(Registrant’s
Telephone Number, Including Area Code)
(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)) |
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 ☐
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. ☐
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 |
|
STXS |
|
NYSE
American LLC |
| Item
2.02 |
Results
of Operations and Financial Condition |
On
May 12, 2026, Stereotaxis, Inc. (the “Company”) issued a press release (the “Earnings Press Release”) setting
forth its financial results for the 2026 first quarter. A copy of the Earnings Press Release is being filed as Exhibit 99.1 hereto, and
the statements contained therein are incorporated by reference herein.
Forward-Looking
Statements and Additional Information
Statements
are made herein or incorporated herein that are “forward-looking statements” as defined by the Securities and Exchange Commission
(the “SEC”). All statements, other than statements of historical fact, included or incorporated herein that address activities,
events or developments that the Company expects, believes or anticipates will or may occur in the future are forward-looking statements.
These statements are not guarantees of future events or the Company’s future performance and are subject to risks, uncertainties
and other important factors that could cause events or the Company’s actual performance or achievements to be materially different
than those projected by the Company. For a full discussion of these risks, uncertainties and factors, the Company encourages you to read
its documents on file with the SEC. Except as required by law, the Company does not intend to update or revise its forward-looking statements,
whether as a result of new information, future events or otherwise.
In
accordance with General Instruction B.2. of Form 8-K, the information contained in Item 2.02 and Exhibit 99.1 attached hereto shall not
be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”),
or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Securities
Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
| Item
9.01 |
Financial
Statements and Exhibits |
| 99.1 |
Stereotaxis,
Inc. Earnings Press Release dated May 12, 2026. |
| 104 |
Cover
Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
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.
| |
STEREOTAXIS,
INC. |
| |
|
|
| Date:
May 12, 2026 |
By: |
/s/
Kimberly R. Peery |
| |
Name: |
Kimberly
R. Peery |
| |
Title: |
Chief
Financial Officer |
Exhibit
99.1

Stereotaxis
Reports 2026 First Quarter Financial Results & Business Updates
| ● | Proprietary
robotically-navigated MAGiC catheter received U.S. FDA approval in January and is now being
utilized at multiple sites across the United States as well as Europe |
| ● | Synchrony
digital operating room system received U.S. FDA clearance in April and initial orders and
shipments are ongoing |
| ● | Definitive
agreement to acquire Robocath creates a leading robotic platform, combining complementary
technologies to deliver next-generation fully-integrated robotic solutions for the full spectrum
of endovascular procedures |
St.
Louis, MO, May 12, 2026 (Globe Newswire) – Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally
invasive endovascular intervention, today reported business updates and financial results for the first quarter ended March 31, 2026.
“Stereotaxis
is in one of the most exciting periods of its history. We are achieving significant regulatory approvals, executing strategic acquisitions,
and witnessing the initial green shoots of commercial success with our new product ecosystem,” said David Fischel, Stereotaxis
Chairman and CEO. “The operational and commercial friction to ramp up manufacturing and implement new products makes progress gradual,
but we are efficiently driving broad-based progress on many fronts in parallel towards an attractive business built on solid foundations.”
“The
streak of regulatory success that began last year continued in the first part of this year with two essential FDA approvals for the MAGiC
cardiac ablation catheter and Synchrony digital surgery system. These regulatory approvals brought to market an entirely new foundational
product ecosystem that structurally changes our commercial opportunity. We essentially developed a fresh start-up company on the shoulders
of our legacy technology and funded by our legacy business.”
“The
transformational agreement to acquire Robocath gives Stereotaxis a fully complementary and separate robotic mechanism of action for endovascular
device navigation. The combination of our technologies offers a clear vision for how our robotic solution, including the full ecosystem
of digital innovations, will enable remote, automated and fully robotic treatment for electrophysiology, interventional cardiology and
neurointerventions.”
“The
still minor revenue contribution from our new catheters is being countered by the headwind of winding down our relationship with Johnson
& Johnson. Demand for MAGiC far exceeds supply, and we are rolling out the catheter in both Europe and the US in line with the manufacturing
ramp, which continues to progress towards an expected 500 catheters a month by year end. Initial green shoots of adoption demonstrate
the strength of our strategy to build a synergistic portfolio of catheters, with disposable revenue per procedure several fold higher
than previously. This structural transformation to our disposable business model is taking place as we simultaneously structurally transform
our capital business and prepare for multiple GenesisX placements.”
2026
First Quarter Financial Results
Revenue
for the first quarter of 2026 totaled $6.3 million compared to $7.5 million in the prior year first quarter. System revenue of $1.3 million
and recurring revenue of $5.0 million compared to $2.0 million and $5.5 million respectively, in the prior year first quarter. System
revenue in the quarter reflects partial revenue recognition on the installation of one Genesis system and other ancillary systems. Recurring
revenue is pressured by the transition away from the dependency on legacy J&J catheters with still modest contributions from Stereotaxis’
new proprietary catheters.
Gross
margin for the first quarter of 2026 was 60% of revenue. Recurring revenue gross margin was 66%, and system gross margin was 39%. Operating
expenses in the quarter of $9.8 million included $3.1 million in non-cash charges for stock compensation expense, mark-to-market adjustment
for acquisition related contingent earnout consideration, and amortization of acquired intangible assets. Excluding these non-cash charges,
adjusted operating expenses were $6.7 million, compared to the prior year adjusted operating expenses of $6.8 million.
Operating
loss and net loss in the first quarter of 2026 were ($6.0) million and ($5.9) million, respectively, compared with ($5.9) million and
($5.8) million in the previous year. Adjusted operating loss and adjusted net loss for the quarter, excluding non-cash charges, were
($2.9) million and ($2.8) million, respectively, compared with ($2.7) million and ($2.6) million in the previous year quarter. Negative
free cash flow for the first quarter was ($3.5) million, compared to ($1.8) million in the previous year.
Cash
Balance and Liquidity
At
March 31, 2026, Stereotaxis had cash and cash equivalents of $14.6 million and no debt.
Forward
Looking Expectations
Stereotaxis
anticipates double digit revenue growth for the full year 2026, with annual revenue expected to surpass $40 million. Revenue will grow
sequentially over the course of the year in line with manufacturing increases for GenesisX and MAGiC, with revenue in both the third
and fourth quarters expected to exceed $10 million.
Stereotaxis
believes it can advance its strategy, integrate Robocath, and grow significantly without having to subject investors to substantial dilution.
The Company expects its balance sheet to allow it to advance its transformative product ecosystem to market, fund its commercialization,
and achieve profitability.
Conference
Call and Webcast
Stereotaxis
will host a conference call and webcast today, May 12, 2026, at 4:30 p.m. Eastern Time. To access the conference call, dial 800-715-9871
(US and Canada) or 646-307-1963 (International) and give the participant pass code 6082771. To access the live and replay webcast, please
visit the investor relations section of the Stereotaxis website at www.Stereotaxis.com.
About
Stereotaxis
Stereotaxis
(NYSE: STXS) is a pioneer and global leader in innovative surgical robotics for minimally invasive endovascular intervention. Its mission
is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory.
These innovations help physicians provide unsurpassed patient care with robotic precision and safety, expand access to minimally invasive
therapy, and enhance the productivity, connectivity, and intelligence in the operating room. Stereotaxis technology has been used to
treat over 150,000 patients across the United States, Europe, Asia, and elsewhere. For more information, please visit www.Stereotaxis.com.
This
press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe”,
“estimate”, “project”, “expect” or similar expressions. Forward-looking statements inherently involve
risks and uncertainties that could cause actual results to differ materially. Factors that would cause or contribute to such differences
include, but are not limited to, the Company’s ability to manage expenses at sustainable levels, acceptance of the Company’s
products in the marketplace, the effect of global economic conditions, including tariffs, on the ability and willingness of customers
to purchase its technology, competitive factors, changes resulting from healthcare policy, dependence upon third-party vendors, timing
of regulatory approvals, the impact of pandemics or other disasters, statements relating to our recent acquisitions, including any benefits
expected from the acquisitions, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange
Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions
or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase
orders and other commitments because some of these purchase orders and other commitments are subject to contingencies that are outside
of the Company’s control and may be revised, modified, delayed, or canceled.
Company
Contacts:
David
L. Fischel
Chairman
and Chief Executive Officer
Kimberly
R. Peery
Chief
Financial Officer
314-678-6100
Investors@Stereotaxis.com
Stereotaxis,
Inc.
CONSOLIDATED
STATEMENTS OF OPERATIONS
(Unaudited)
| (in thousands, except share and per share amounts) | |
Three Months Ended March 31, | |
| | |
2026 | | |
2025 | |
| | |
| | |
| |
| Revenue: | |
| | | |
| | |
| Systems | |
$ | 1,319 | | |
$ | 1,964 | |
| Disposables, service and accessories | |
| 4,972 | | |
| 5,508 | |
| Total revenue | |
| 6,291 | | |
| 7,472 | |
| | |
| | | |
| | |
| Cost of revenue: | |
| | | |
| | |
| Systems | |
| 804 | | |
| 1,667 | |
| Disposables, service and accessories | |
| 1,693 | | |
| 1,741 | |
| Total cost of revenue | |
| 2,497 | | |
| 3,408 | |
| | |
| | | |
| | |
| Gross margin | |
| 3,794 | | |
| 4,064 | |
| | |
| | | |
| | |
| Operating expenses: | |
| | | |
| | |
| Research and development | |
| 2,397 | | |
| 2,350 | |
| Sales and marketing | |
| 2,617 | | |
| 3,148 | |
| General and administrative | |
| 4,761 | | |
| 4,495 | |
| Total operating expenses | |
| 9,775 | | |
| 9,993 | |
| Operating loss | |
| (5,981 | ) | |
| (5,929 | ) |
| | |
| | | |
| | |
| Other income | |
| (5 | ) | |
| - | |
| Interest income, net | |
| 125 | | |
| 106 | |
| Net loss | |
$ | (5,861 | ) | |
$ | (5,823 | ) |
| Cumulative dividend on convertible preferred stock | |
| (311 | ) | |
| (314 | ) |
| Net loss attributable to common stockholders | |
$ | (6,172 | ) | |
$ | (6,137 | ) |
| | |
| | | |
| | |
| Net loss per share attributed to common stockholders: | |
| | | |
| | |
| Basic | |
$ | (0.06 | ) | |
$ | (0.07 | ) |
| | |
| | | |
| | |
| Diluted | |
$ | (0.06 | ) | |
$ | (0.07 | ) |
| | |
| | | |
| | |
| Weighted average number of common shares and equivalents: | |
| | | |
| | |
| Basic | |
| 98,891,179 | | |
| 87,769,366 | |
| | |
| | | |
| | |
| Diluted | |
| 98,891,179 | | |
| 87,769,366 | |
STEREOTAXIS,
INC.
CONSOLIDATED
BALANCE SHEETS
| (in thousands, except share amounts) | |
March 31, 2026 | | |
December 31, 2025 | |
| | |
(Unaudited) | | |
| |
| Assets | |
| | | |
| | |
| Current assets: | |
| | | |
| | |
| Cash and cash equivalents | |
$ | 14,616 | | |
$ | 13,421 | |
| Accounts receivable, net of allowance of $630 and $541 at 2026 and 2025, respectively | |
| 5,303 | | |
| 5,847 | |
| Insurance receivable | |
| 4,316 | | |
| 4,316 | |
| Inventories, net | |
| 10,495 | | |
| 9,567 | |
| Prepaid expenses and other current assets | |
| 1,297 | | |
| 698 | |
| Total current assets | |
| 36,027 | | |
| 33,849 | |
| Property and equipment, net | |
| 2,956 | | |
| 3,019 | |
| Goodwill | |
| 3,764 | | |
| 3,764 | |
| Intangible assets, net | |
| 6,193 | | |
| 6,429 | |
| Operating lease right-of-use assets | |
| 4,760 | | |
| 4,912 | |
| Prepaid and other non-current assets | |
| 330 | | |
| 278 | |
| Total assets | |
$ | 54,030 | | |
$ | 52,251 | |
| | |
| | | |
| | |
| Liabilities and stockholders’ equity | |
| | | |
| | |
| Current liabilities: | |
| | | |
| | |
| Accounts payable | |
$ | 4,823 | | |
$ | 4,768 | |
| Accrued liabilities | |
| 1,478 | | |
| 2,065 | |
| Accrued legal liabilities | |
| 4,316 | | |
| 4,316 | |
| Deferred revenue | |
| 6,541 | | |
| 5,675 | |
| Current contingent consideration | |
| 5,266 | | |
| 4,894 | |
| Current portion of operating lease liabilities | |
| 662 | | |
| 642 | |
| Total current liabilities | |
| 23,086 | | |
| 22,360 | |
| Long-term deferred revenue | |
| 523 | | |
| 555 | |
| Long-term contingent consideration | |
| 5,108 | | |
| 4,724 | |
| Operating lease liabilities | |
| 4,618 | | |
| 4,794 | |
| Other liabilities | |
| 1,097 | | |
| 1,097 | |
| Total liabilities | |
| 34,432 | | |
| 33,530 | |
| | |
| | | |
| | |
| Series A - Convertible preferred stock: | |
| | | |
| | |
| Convertible preferred stock, Series A, par value $0.001; 10,000,000 shares authorized, 21,008 shares outstanding at 2026 and 2025 | |
| 5,240 | | |
| 5,240 | |
| Stockholders’ equity: | |
| | | |
| | |
| Common stock, par value $0.001; 300,000,000 shares authorized, 97,491,248 and 95,339,628 shares issued at 2026 and 2025, respectively | |
| 97 | | |
| 95 | |
| Additional paid-in capital | |
| 603,696 | | |
| 596,960 | |
| Treasury stock, 4,015 shares at 2026 and 2025 | |
| (206 | ) | |
| (206 | ) |
| Accumulated deficit | |
| (589,229 | ) | |
| (583,368 | ) |
| Total stockholders’ equity | |
| 14,358 | | |
| 13,481 | |
| Total liabilities and stockholders’ equity | |
$ | 54,030 | | |
$ | 52,251 | |