~ FDA Clearance of Catamaran® SI Joint Fusion System for New Indication to Augment Spinal Fusion ~
~ Catamaran® SI Joint Fusion Technology Protected with Robust Patent Portfolio of Twelve U.S. and International Patents ~
~ Received Gross Proceeds of ~$7.0 Million from Equity Financing Transactions ~
~ National Commercial Launch of Catamaran SE in Mid-2025 ~
LOS GATOS, CA / ACCESS Newswire / May 13, 2025 / Tenon Medical, Inc. (NASDAQ:TNON) ("Tenon Medical" or the "Company"), a company transforming care for patients suffering from certain Sacroiliac Joint (SIJ) disorders, today reported financial results for the first quarter ended March 31, 2025.
Financial Results and Business Updates
First Quarter 2025 Results:
Revenue of $0.7 million, in line with the first quarter of 2024.
Gross profit of $323,000, as compared to $470,000 in the first quarter of 2024.
Gross margin of 44%, as compared to 65% in the first quarter of 2024.
Cash and cash equivalents of $10.3 million as of March 31, 2025.
Tenon received a total of $7.1 million in aggregate gross proceeds from equity financing transactions in March 2025, strengthened balance sheet to fund growth initiatives.
U.S. Food and Drug Administration (FDA) provided clearance of an expanded indication for the Catamaran® SI Joint Fusion System for use in augmenting thoracolumbar fusion. With this approval, the Catamaran is now indicated to treat the SI joint as either a stand-alone treatment or to augment a spinal fusion.
Granted issuance of two additional European patents highlighting a commitment to enhancing SI joint stabilization systems and methods, addressing the need for revision of other ineffective SI joint devices and as a patent protection mechanism.
Hosted 34 physicians in targeted workshop activities and Catamaran focused training sessions within the First Quarter.
Full commercial launch of Catamaran SE expected in mid-2025.
Steve Foster, President and Chief Executive Officer of Tenon Medical, commented, "The first quarter of 2025 was underscored by a steady revenue improvement, partially impacted by reimbursement preauthorization headwinds that we believe to be transient in nature. Throughout the quarter we continued to invest in sales and marketing initiatives, with our sales operation highlighting compelling published clinical data and the upcoming full launch of the new SE platform mid-year. This new platform continues to receive positive responses from initial clinical experiences with its focus on reduction in access and implant size, providing options for physicians seeking a smaller profile for primary and revision SI applications.
During the quarter we received clearance from the FDA for an expanded indication to utilize Catamaran in augmenting thoracolumbar fusion. With this approval, Catamaran is now indicated to treat the SI joint as either a stand-alone treatment or to augment a spinal fusion. We believe this can be an important tool in the complex spine surgeon arsenal to support the foundation of a multi-level fusion and to protect the various alar/iliac hardware used in such cases. By providing physicians with an option to augment the pelvic component of their construct we expect to unlock access to a significant market share and increased adoption.
We continued to build on our global intellectual property portfolio with two additional European patents within the European Community. With the issuance of three US patents during the fourth quarter, the Catamaran® SI Joint Fusion System now comprises twelve issued U.S. and foreign (International) patents, and thirty-one pending U.S. and foreign patent applications. The additional patents recognize the novel Catamaran® SI joint prostheses as a solution to specifically address the need for revision of other ineffective SI joint devices and reinforces our commitment to innovation.
Operationally, we took several steps to opportunistically strengthen our balance sheet allowing us to execute on upcoming milestones and fund growth initiatives. Three transactions totaling $7.1 million in aggregate gross proceeds from equity transactions contributed to a cash and cash equivalents balance of $10.3 million at quarter end. Combined with a balanced financial discipline, we are confident that we have the cash runway to advance Tenon into our next phase of growth.
Looking ahead, upcoming catalysts include the full enrollment of our MAINSAIL post-market clinical trial for the Catamaran SI Joint Fusion System® and the next release of the study's interim analysis, which will be published mid-year 2025. Our restructured sales operation will continue to deliver results through our revamped training and education program, participation in trade shows, and marketing efforts throughout 2025. Taken together, as our clinical experience grows and the data from our clinical trial emerges, we believe we are ideally positioned to ramp up our broader market introduction and commercialization," concluded Foster.
First Quarter 2025 Financial Results
Revenue was $0.7 million in the first quarter of 2025, in line with revenue of $0.7 million in the comparable year ago period. The number of surgical procedures in the first quarter was flat as compared to the same period in 2024. The increase in revenue was driven by an increase in implants per procedure, partially offset by a slight decrease in ASP due to account mix.
Gross profit in the first quarter of 2025 was $0.3 million, or 44% of revenues, compared to $0.5 million, or 65% of revenues in the comparable year ago quarter. Gross margin percentage continues to sustain a healthy level and varied from period to period driven by the absorption of production overhead costs into our standard cost and operating leverage created by lower relative fixed costs.
Operating expenses totaled $4.0 million for the first quarter of 2025, as compared to expenses of $4.0 million in the first quarter of 2024. Operating expenses were flat due to increases in sales and marketing commission and payroll expenses, offset by decreases in professional fees, stock-based compensation and insurance costs. Continued investment in commercial activities will include sales force expansion, market access programs and reimbursement and coverage initiatives. As a result, increases in sales and marketing expenses are expected in future quarters.
Net loss was $3.6 million for the first quarter of 2025, as compared to a loss of $3.6 million in the same period of 2024. The Company expects to incur additional losses in the future.
As of March 31, 2025, cash and cash equivalents totaled $10.3 million, as compared to $6.5 million as of December 31, 2024. Tenon received a total of $7.1 million in aggregate gross proceeds from equity financing transactions in March 2025. As of March 31, 2025, the Company had no outstanding debt.
First Quarter 2025 Earnings Conference Call
Management will host a conference call at 4:30 p.m. ET (1:30 p.m. PT) today, Tuesday, May 13, 2025, to discuss Tenon's first quarter 2025 financial results, provide a corporate update, and conclude with Q&A with the Company's covering analyst. To participate, please use the following information:
Date: | Tuesday, May 13, 2025 |
Time: | 4:30 p.m. Eastern time |
Dial-in: | 1-877-407-0792 |
International Dial-in: | 1-201-689-8263 |
Webcast: | TNON Conference Call |
Please dial in at least 10 minutes before the start of the call to ensure timely participation.
An audio playback of the call will be available through May 28, 2025 by dialing 1-844-512-2921 (USA) or 1-412-317-6671 (International). The access code will be 13752970. In addition, a webcast replay will be available on Tenon's Investor Relations website at http://ir.tenonmed.com.
About Tenon Medical, Inc.
Tenon Medical, Inc., a medical device company formed in 2012, has developed The Catamaran SI Joint Fusion System that offers a novel, less invasive approach to the SI joint using a single, robust titanium implant. The system features the Catamaran Fixation Device which passes through both the axial and sagittal planes of the ilium and sacrum, stabilizing and transfixing the SI Joint along its longitudinal axis. The angle and trajectory of the Catamaran surgical approach is also designed to provide a pathway away from critical neural and vascular structures and into the strongest cortical bone. Since the national launch of the Catamaran SI Joint Fusion System in October 2022, Tenon is focused on three commercial opportunities with its System in the SI Joint market which includes: 1) Primary SI Joint procedures, 2) Revision procedures of failed SI Joint implants and 3) SI Joint fusion adjunct to a spine fusion construct. For more information, please visit www.tenonmed.com.
The Tenon Medical logo shown above, and Catamaran®, PiSIF®, CAT PiSIF®, ETAD®, Posterior Inferior Sacroiliac Fusion®, CAT SIJ Fusion System®, Catamaran SIJ Fusion System®, Catamaran Inferior Posterior Fusion System®, Catamaran Transfixation Fusion System®, and Catamaran Transfixation Fusion Device® are registered trademarks of Tenon Medical, Inc. MAINSAILTM is also a trademark of Tenon Medical, Inc.
Safe Harbor
This press release contains "forward-looking statements," which are statements related to events, results, activities or developments that Tenon expects, believes or anticipates will or may occur in the future. Forward-looking often contains words such as "intends," "estimates," "anticipates," "hopes," "projects," "plans," "expects," "seek," "believes," "see," "should," "will," "would," "target," and similar expressions and the negative versions thereof. These forward-looking statements, include, but are not limited to, statements regarding the completion of the Offering, the satisfaction of customary closing conditions related to the Offering and the anticipated use of proceeds therefrom. Such statements are based on Tenon's experience and perception of current conditions, trends, expected future developments and other factors it believes are appropriate under the circumstances, and speak only as of the date made. Forward-looking statements are inherently uncertain and actual results may differ materially from assumptions, estimates or expectations reflected or contained in the forward-looking statements as a result of various factors. For details on the uncertainties that may cause Tenon's actual results to be materially different than those expressed in any forward-looking statements, please review Tenon's Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and updated from time to time in our Form 10-Q filings and in our other public filings on file with the SEC at www.sec.gov, particularly the information contained in the section entitled "Risk Factors." We undertake no obligation to publicly update or revise any forward-looking statements to reflect new information or future events or otherwise unless required by law.
Investor Contact
Shannon Devine
MZ North America
203-741-8811
tenon@mzgroup.us
Tenon Medical, Inc.
Condensed Balance Sheets (Unaudited)
(In thousands, except share data)
| March 31, |
|
| December 31, |
| |||
| 2025 |
|
| 2024 |
| |||
ASSETS |
|
|
|
|
|
| ||
Current assets: |
|
|
|
|
|
| ||
Cash and cash equivalents |
| $ | 10,311 |
|
| $ | 6,535 |
|
Accounts receivable, net |
|
| 886 |
|
|
| 863 |
|
Inventory, net |
|
| 607 |
|
|
| 606 |
|
Prepaid expenses and other current assets |
|
| 186 |
|
|
| 206 |
|
Total current assets |
|
| 11,990 |
|
|
| 8,210 |
|
Property and equipment, net |
|
| 698 |
|
|
| 752 |
|
Deposits |
|
| 51 |
|
|
| 51 |
|
Operating lease right-of-use asset |
|
| 334 |
|
|
| 399 |
|
Deferred offering costs |
|
| 321 |
|
|
| 431 |
|
TOTAL ASSETS |
| $ | 13,394 |
|
| $ | 9,843 |
|
|
|
|
|
|
|
|
| |
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
| |||||
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
| $ | 496 |
|
| $ | 369 |
|
Accrued expenses |
|
| 911 |
|
|
| 910 |
|
Current portion of accrued commissions |
|
| 493 |
|
|
| 303 |
|
Current portion of operating lease liability |
|
| 295 |
|
|
| 287 |
|
Total current liabilities |
|
| 2,195 |
|
|
| 1,869 |
|
Accrued commissions, net of current portion |
|
| 1,758 |
|
|
| 1,862 |
|
Operating lease liability, net of current portion |
|
| 65 |
|
|
| 141 |
|
Total liabilities |
|
| 4,018 |
|
|
| 3,872 |
|
|
|
|
|
|
|
|
| |
Stockholders' equity: |
|
|
|
|
|
|
|
|
Series A convertible preferred stock, $0.001 par value; 4,500,000 shares authorized at March 31, 2025 and December 31, 2024; 256,968 shares issued and outstanding at March 31, 2025 and December 31, 2024 |
|
| 3,300 |
|
|
| 3,300 |
|
Series B convertible preferred stock, $0.001 par value; 491,222 shares authorized at March 31, 2025 and December 31, 2024; 86,454 shares issued and outstanding at March 31, 2025 and December 31, 2024 |
|
| 452 |
|
|
| 452 |
|
Common stock, $0.001 par value; 130,000,000 shares authorized at March 31, 2025 and December 31, 2024; 7,589,965 and 3,138,804 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively |
|
| 8 |
|
|
| 3 |
|
Additional paid-in capital |
|
| 77,978 |
|
|
| 70,962 |
|
Accumulated deficit |
|
| (72,362 | ) |
|
| (68,746 | ) |
Total stockholders' equity |
|
| 9,376 |
|
|
| 5,971 |
|
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY |
| $ | 13,394 |
|
| $ | 9,843 |
|
Tenon Medical, Inc.
Condensed Statements of Operations and Comprehensive Loss (Unaudited)
(In thousands, except per share data)
| Three Months Ended March 31, |
| ||||||
| 2025 |
|
| 2024 |
| |||
Revenue |
| $ | 726 |
|
| $ | 719 |
|
Cost of revenue |
|
| 403 |
|
|
| 249 |
|
Gross Profit |
|
| 323 |
|
|
| 470 |
|
|
|
|
|
|
|
|
| |
Operating Expenses |
|
|
|
|
|
|
|
|
Research and development |
|
| 691 |
|
|
| 669 |
|
Sales and marketing |
|
| 1,647 |
|
|
| 1,381 |
|
General and administrative |
|
| 1,662 |
|
|
| 1,926 |
|
Total Operating Expenses |
|
| 4,000 |
|
|
| 3,976 |
|
|
|
|
|
|
|
|
| |
Loss from Operations |
|
| (3,677 | ) |
|
| (3,506 | ) |
|
|
|
|
|
|
|
| |
Other Income (Expense), net |
|
|
|
|
|
|
|
|
Gain on investments |
|
| 61 |
|
|
| 27 |
|
Interest expense |
|
| - |
|
|
| (34 | ) |
Other expense |
|
| - |
|
|
| (63 | ) |
Total Other Income (Expense), net |
|
| 61 |
|
|
| (70 | ) |
Net Loss |
| $ | (3,616 | ) |
| $ | (3,576 | ) |
Net Loss Per Share of Common Stock |
|
|
|
|
|
|
|
|
Basic and diluted |
| $ | (1.01 | ) |
| $ | (10.02 | ) |
|
|
|
|
|
|
|
| |
Weighted Average Shares of Common Stock Outstanding |
|
|
|
|
|
|
|
|
Basic and diluted |
|
| 3,597 |
|
|
| 357 |
|
|
|
|
|
|
|
|
| |
Consolidated Statements of Comprehensive Loss: |
|
|
|
|
|
|
|
|
Net loss |
| $ | (3,616 | ) |
| $ | (3,576 | ) |
Foreign currency translation adjustment |
|
| - |
|
|
| 46 |
|
Total Comprehensive Loss |
| $ | (3,616 | ) |
| $ | (3,530 | ) |
SOURCE: Tenon Medical, Inc.
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/tenon-medical-reports-first-quarter-2025-financial-results-1027266
