Tenon Medical (NasdaqCM:TNON) Q3 2025 Earnings Call November 13, 2025 04:30 PM ET Speaker2Greetings and welcome to the Tenon Medical Third Quarter 2025 Financial Results and Corporate Update conference call. As a reminder, this call is being recorded. Your hosts today are Steve Foster, President and Chief Executive Officer, and Kevin Williamson, Chief Financial Officer. Mr. Foster and Mr. Williamson will present results of operations for the third quarter ended September 30, 2025, and provide a corporate up ...

Core Insights - The company reported record revenue of $1.2 million for Q3 2025, marking a 32% year-over-year increase from $0.9 million in Q3 2024 [1][1][1] - The growth is attributed to record volume in Catamaran® SI Joint Fusion System procedures and the introduction of SImmetry® SI Joint Fusion Product Sales [1][1][1] - The launch of SImmetry®+ alpha in Q4 2025 is expected to enhance the strategic portfolio [1][1][1] - The company has established a foundation for sustained growth through portfolio diversification, commercial expansion, and operational alignment [1][1][1] - Following the quarter end, the company announced a PIPE financing with supportive investors, raising total gross proceeds of $2.85 million [1][1][1]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Form 10-Q FOR THE TRANSITION PERIOD FROM _________ to __________ COMMISSION FILE NUMBER 001-41364 TENON MEDICAL, INC. (Exact name of registrant as specified in its charter) | Delaware | 45-5574718 | | --- | --- | | (State or other jurisdiction of | (I.R.S. Employer | | incorporation or organization) | Identification No.) | 104 Cooper Court Los Gatos, CA 95032 (408) 649-5760 (Address of principal executive offices) (Zip Code) (Registrant ...

Core Insights - Tenon Medical, Inc. has received FDA 510(k) clearance for its SImmetry+ SI Joint Fusion System, enhancing its competitive advantage in treating sacro-pelvic disorders [1] Company Developments - The SImmetry+ System is designed for sacroiliac joint fusion, addressing conditions such as sacroiliac joint disruptions and degenerative sacroiliitis [1] - The company is initiating an alpha launch of the SImmetry+ with a select group of physician users to gather initial feedback for a broader launch [1] Product Features - SImmetry+ includes new 3D printed titanium implants, a robust joint decorticator, and a simple bone graft delivery system, providing physicians with treatment options based on established fusion principles [1]

Financial Data and Key Metrics Changes - Revenue for Q2 2025 was $564,000, down from $901,000 in the same period last year, with a six-month revenue of $1,300,000 compared to $1,600,000 in the prior year [9] - Gross profit was $245,000 or 43% of revenue in Q2 2025, compared to $470,000 or 52% of revenue in the prior year quarter, with a six-month gross profit of $568,000 or 44% of revenue compared to $940,000 or 58% in the previous year's period [10] - Operating expenses totaled $3,100,000 in Q2 2025, down from $4,300,000 in the prior year period, reflecting a 29% reduction driven by lower expenses across various departments [11] - Net loss for Q2 was $2,800,000 or $0.36 per share, compared to a net loss of $3,800,000 or $8.16 per share in 2024, with a six-month net loss of $6,400,000 compared to $7,400,000 in the same year-ago period [12] Business Line Data and Key Metrics Changes - The Catamaran platform is advancing with real-world adoption in complex spine procedures, supported by FDA clearance for uses in thoracolumbar fixation [4] - The Catamaran SE, a second-generation low-profile implant, is on track for full commercial launch in the coming weeks, with positive feedback from alpha reviews [4] - The company is preparing for initial alpha surgeries using the newly developed Symmetry Plus system, expected to begin in Q4 2025 [5] Market Data and Key Metrics Changes - The strategic acquisition of SciVantage enhances the company's commercial organization and market access, providing new pathways through hospital approval processes and distribution networks [3] - The acquisition is expected to increase active case volume and revenue-generating technologies, contributing to the company's growth trajectory [2] Company Strategy and Development Direction - The company is focused on delivering solutions that promote true biologic fusion and structural stability for patients with sacropelvic disorders, with a commitment to driving value for patients, physicians, and shareholders [14] - The integration of SciVantage is expected to create a more diversified product offering, allowing the company to address various clinical needs in the sacropelvic region [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in recovering from the recent decline in revenue, anticipating a quick rebound as the integration with SciVantage progresses [28] - The company is optimistic about the upcoming launches of Catamaran SE and Symmetry Plus, which are expected to drive top-line growth [12][44] Other Important Information - The company ended the quarter with $7,800,000 in cash and no debt, providing flexibility to execute its strategic roadmap [12] - The company hosted 16 physician workshops in Q2 to support long-term adoption strategies and accelerate the learning curve for new users [7] Q&A Session Summary Question: How does the acquisition help achieve scale? - Management confirmed that the acquisition provides a pathway to scale and enhances access to hospital systems and contract groups, allowing for a more diversified product offering [17][20] Question: What is the timeline for filing audited financials for the acquisition? - The company indicated a 75-day post-close period to file the audited financials for SciVantage, expected by mid-October [24][27] Question: How should investors view Catamaran revenues in Q3 and Q4? - Management suggested that Q2 was disrupted by the acquisition process but expects a quick recovery in Catamaran revenues moving forward [28][30] Question: What is the reimbursement landscape for the new products? - The new products will participate in existing CPT codes for SI procedures, similar to the Catamaran system, with a focus on supporting technologies with data [40][41] Question: What is the expected impact of the Symmetry Plus launch? - The Symmetry Plus launch is anticipated to begin with alpha surgeries in October, with a full-scale launch expected early next year [44]

Financial Performance - Revenue for fiscal Q2 2025 was $564,000, down from $901,000 in Q2 2024, attributed to lower procedure volumes and a shift in commercial initiatives [20][21] - Gross margin decreased to 43% in Q2 2025 from 52% in Q2 2024, due to reduced procedure volumes and consistent production costs [3][22] - Operating expenses were $3.1 million in Q2 2025, a 29% decrease from $4.3 million in Q2 2024, driven by reductions in G&A, R&D, and sales and marketing costs [3][23] - Net loss for Q2 2025 was $2.8 million, or $0.36 per share, compared to a net loss of $3.8 million, or $0.816 per share, in Q2 2024 [4][24] - Cash and cash equivalents increased to $7.8 million as of June 30, 2025, up from $6.5 million at the end of 2024, with no outstanding debt [4][25] Strategic Developments - The company completed the acquisition of CyVantage post-quarter, enhancing its product portfolio and commercial capabilities [5][10] - The Catamaran SE implant is on track for full commercial launch, supported by positive early feedback and FDA clearance for use as an adjunct to thoracolumbar fixation [6][15] - Initial alpha surgeries for the Symmetry Plus system are expected to begin in Q4 2025, aimed at enhancing outcomes in SI joint fusion procedures [6][16] Clinical and Market Engagement - Sixteen physician workshops were conducted to support adoption of new solutions and accelerate the learning curve for physicians [7][18] - The company is focused on clinical validation, with the second interim analysis from the main sale post-market study expected to provide additional evidence regarding clinical endpoints [7][17] - The CyVantage acquisition is anticipated to provide immediate revenue and enhance the company's commercial infrastructure, enabling cross-selling opportunities [9][10][41] Future Outlook - The integration of CyVantage is expected to unlock new pathways for market access and strengthen the commercial organization [14][19] - The company is optimistic about recovering revenue levels with the upcoming launches and increased physician engagement [36][38] - The focus remains on delivering solutions that promote biologic fusion and structural stability for patients with sacropelvic disorders [26]

PART I. FINANCIAL INFORMATION [Item 1. Condensed Financial Statements (unaudited)](index=4&type=section&id=Item%201.%20Condensed%20Financial%20Statements%20(unaudited)) Unaudited H1 2025 statements reveal decreased revenue, continued net losses, asset growth from financing, and substantial doubt about going concern [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) Condensed Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $7,846 | $6,535 | | Total current assets | $9,884 | $8,210 | | **TOTAL ASSETS** | **$11,114** | **$9,843** | | Total current liabilities | $2,563 | $1,869 | | **Total liabilities** | **$4,401** | **$3,872** | | **Total stockholders' equity** | **$6,713** | **$5,971** | - Cash and cash equivalents increased to **$7.8 million** as of June 30, 2025, from **$6.5 million** at the end of 2024, primarily due to financing activities[14](index=14&type=chunk) [Condensed Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Statement of Operations Summary (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | Six Months 2025 | Six Months 2024 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $564 | $901 | $1,290 | $1,620 | | Gross Profit | $245 | $470 | $568 | $940 | | Loss from Operations | $(2,857) | $(3,872) | $(6,534) | $(7,378) | | Net Loss | $(2,769) | $(3,826) | $(6,385) | $(7,402) | | Net Loss Per Share (Basic & Diluted) | $(0.36) | $(8.16) | $(1.14) | $(17.92) | - Revenue for the three and six months ended June 30, 2025, decreased by **37%** and **20%** respectively compared to the same periods in 2024[17](index=17&type=chunk) [Condensed Statements of Convertible Preferred Stock and Stockholders' Equity](index=6&type=section&id=Condensed%20Statements%20of%20Convertible%20Preferred%20Stock%20and%20Stockholders%27%20Equity) - Total stockholders' equity increased from **$5.97 million** at December 31, 2024, to **$6.71 million** at June 30, 2025[19](index=19&type=chunk)[20](index=20&type=chunk) - During the first six months of 2025, the company issued common stock, pre-funded warrants, and warrants, raising net proceeds of **$2.7 million** from an inducement agreement and **$3.5 million** from other offerings[20](index=20&type=chunk) [Condensed Statements of Cash Flows](index=9&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Cash Flow Summary for Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(4,697) | $(4,758) | | Net cash used in investing activities | $(192) | $(119) | | Net cash provided by financing activities | $6,200 | $4,371 | | **Net Increase (Decrease) in Cash** | **$1,311** | **$(460)** | - Financing activities in the first six months of 2025 provided **$6.2 million** in cash, primarily from the issuance of common stock and warrants, which more than offset the **$4.7 million** cash used in operations[22](index=22&type=chunk) [Notes to Condensed Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) - The company is a medical device firm focused on its Catamaran™ SI Joint Fusion System for treating lower back pain, which received FDA clearance in 2018[25](index=25&type=chunk) - Management has expressed substantial doubt about the company's ability to continue as a going concern for at least one year, as existing cash is insufficient to meet obligations, and plans to raise additional capital to fund operations[29](index=29&type=chunk)[30](index=30&type=chunk) - In March 2025, the company raised net proceeds of **$2.7 million** through a warrant exercise inducement and an additional **$3.5 million** through securities purchase agreements[48](index=48&type=chunk)[50](index=50&type=chunk)[51](index=51&type=chunk) - Subsequent to the quarter end, on August 1, 2025, the company acquired substantially all assets of SiVantage, Inc. (the "SImmetry Acquisition") and SIMPL Medical, LLC (the "SIMPL Acquisition") to expand its product portfolio in sacropelvic fixation and fusion[70](index=70&type=chunk)[72](index=72&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes H1 2025 revenue decline to fewer procedures, reduced operating expenses, but liquidity remains critical with going concern doubt [Overview](index=21&type=section&id=Overview) - The company's core product is the FDA-approved Catamaran™ SI Joint Fusion System, a less invasive implant for treating SI Joint dysfunction, a cause of chronic lower back pain[81](index=81&type=chunk) - Tenon Medical has incurred net losses since its inception in 2012 and had an accumulated deficit of approximately **$75.1 million** as of June 30, 2025[85](index=85&type=chunk) [Results of Operations](index=23&type=section&id=Results%20of%20Operations) Comparison of Operating Results (in thousands) | Metric | Six Months 2025 | Six Months 2024 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Revenue | $1,290 | $1,620 | $(330) | (20)% | | Gross Profit | $568 | $940 | $(372) | (40)% | | Total Operating Expenses | $7,102 | $8,318 | $(1,216) | (15)% | - The decrease in revenue for the first six months of 2025 was primarily due to a reduction in the number of surgical procedures performed using The Catamaran System[96](index=96&type=chunk) - Total operating expenses for the six months ended June 30, 2025, decreased by **$1.2 million** (**15%**) compared to the prior year, driven by reductions in stock-based compensation, insurance costs, and professional fees across all expense categories[98](index=98&type=chunk)[99](index=99&type=chunk)[100](index=100&type=chunk) [Liquidity and Capital Resources](index=26&type=section&id=Liquidity%20and%20Capital%20Resources) - As of June 30, 2025, the company had cash and cash equivalents of **$7.8 million** and an accumulated deficit of **$75.1 million**[103](index=103&type=chunk)[104](index=104&type=chunk) - Management states that existing cash is not sufficient to fund operations for the next 12 months, which raises substantial doubt about the company's ability to continue as a going concern[104](index=104&type=chunk)[105](index=105&type=chunk) - For the six months ended June 30, 2025, net cash provided by financing activities was **$6.2 million**, primarily from stock and warrant issuances, which offset the **$4.7 million** of cash used in operating activities[106](index=106&type=chunk)[108](index=108&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=27&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Tenon Medical is not required to provide this information - The company is not required to provide quantitative and qualitative disclosures about market risk as it qualifies as a "smaller reporting company"[111](index=111&type=chunk) [Item 4. Controls and Procedures](index=27&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were ineffective as of June 30, 2025, due to a material weakness in internal controls - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were not effective as of June 30, 2025[112](index=112&type=chunk) - A material weakness exists in internal controls due to the inability to effectively segregate accounting duties, which is attributed to the company's limited size and resources[113](index=113&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=28&type=section&id=Item%201.%20Legal%20Proceedings) The company reported no legal proceedings during the period - There are no legal proceedings to report[117](index=117&type=chunk) [Item 1A. Risk Factors](index=28&type=section&id=Item%201A.%20Risk%20Factors) As a smaller reporting company, no material changes to risk factors were reported from the prior Annual Report on Form 10-K - There were no material changes in the company's risk factors as previously disclosed in its Annual Report on Form 10-K filed on March 26, 2025[118](index=118&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=28&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - The company reported no unregistered sales of equity securities[119](index=119&type=chunk) [Item 3. Defaults Upon Senior Securities](index=28&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - None reported[121](index=121&type=chunk) [Item 4. Mine Safety Disclosures](index=28&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[122](index=122&type=chunk) [Item 5. Other Information](index=28&type=section&id=Item%205.%20Other%20Information) The company reported no other information - None reported[123](index=123&type=chunk) [Item 6. Exhibits](index=29&type=section&id=Item%206.%20Exhibits) This section indexes all exhibits filed with the Form 10-Q, including corporate governance documents and certifications - This section lists all exhibits filed as part of the quarterly report, including certifications by the CEO and CFO[125](index=125&type=chunk)

Financial Data and Key Metrics Changes - Revenue for the first quarter of 2025 was $726,000, a 1% increase from $719,000 in the first quarter of 2024, primarily driven by an increase in implants for surgical procedures, partially offset by a slight decrease in average selling price (ASP) due to account mix [14][15] - Gross profit for the first quarter of 2025 was $323,000, representing 44% of revenue, compared to $470,000 or 65% of revenue in the same quarter of the previous year [16] - Net loss for the first quarter of 2025 was $3,600,000, consistent with the loss in the same period of 2024 [17][18] Business Line Data and Key Metrics Changes - The upcoming full launch of the new Catamaran SE platform is expected to enhance the product offering for physicians preferring a smaller implant for SI joint fusion procedures [4][5] - The FDA clearance for the Catamaran SI Joint Fusion System for an extended indication to augment thoracolumbar fusion is anticipated to open new market opportunities [5][6] Market Data and Key Metrics Changes - The company received two European patents during the first quarter, enhancing its intellectual property portfolio, which now includes 12 issued patents and 31 pending applications [6] - The Catamaran technology is positioned to address a significant market segment lacking peer-reviewed data, which is crucial for gaining positive coverage from payers [11][12] Company Strategy and Development Direction - The company is focusing on sustainable revenue growth through a stable cost structure and plans to invest heavily in commercial operations, clinical research, and product refinement [12][19] - The strategy includes expanding the sales force and enhancing market access efforts to drive top-line growth [17][19] Management's Comments on Operating Environment and Future Outlook - Management anticipates improvements in the reimbursement environment, which has been a challenge due to coding confusion, and expects this to contribute to incremental growth [22][23] - The launch of the SE platform is viewed as an inflection point that will attract more physicians to adopt the technology [26][27] Other Important Information - The company completed equity financing of $7,100,000 in March 2025, contributing to a cash balance of $10,300,000 at the end of the quarter, with no outstanding debt [12][18] - The ongoing Main Sail study aims to evaluate clinical outcomes for patients treated with the Catamaran system, with interim results showing significant pain reduction and high patient satisfaction [9][10] Q&A Session Summary Question: Expectations for top line revenues trajectory through the year - Management expects incremental growth as reimbursement issues improve and the sales team expands [22][24] Question: Impact of SE launch on revenue - The SE launch is anticipated to be an inflection point, bringing more physicians into the adoption phase [26][27] Question: General and Administrative expenses trends - G&A expenses were lower in the first quarter, and this trend is expected to continue with some additional investments in sales initiatives [28] Question: Expansion of total addressable market due to new indication - The new indication for augmenting spinal fusion is expected to significantly increase the addressable market, particularly in complex spine surgeries [33][36] Question: Physician reaction to new approval and reimbursement considerations - Initial physician reactions are positive, with interest in the sacropelvic component of long constructs, and existing codes are anticipated to apply for the new procedures [37][38] Question: Targeting physicians for workshops - The company has improved its targeting capabilities and is now able to provide training more efficiently at physicians' clinics [40][41]

Financial Data and Key Metrics Changes - Revenue for Q1 2025 was $726,000, a 1% increase from $719,000 in Q1 2024, primarily driven by an increase in surgical implants, partially offset by a slight decrease in average selling price (ASP) due to account mix [16][17] - Gross profit for Q1 2025 was $323,000, representing 44% of revenue, compared to $470,000 or 65% of revenue in the same quarter of the previous year [17] - Net loss for Q1 2025 was $3,600,000, consistent with the loss in Q1 2024, with expectations of continued losses in the future [19][20] Business Line Data and Key Metrics Changes - The upcoming launch of the Catamaran SE platform is expected to enhance the product offering, particularly for physicians preferring a smaller implant for SI joint fusion procedures [5][6] - The FDA clearance for the Catamaran SI Joint Fusion System to augment thoracolumbar fusion expands its indications, potentially increasing market adoption [6][36] Market Data and Key Metrics Changes - The company is focusing on expanding its addressable market through the new indication for multiple spinal fusion surgeries, which is expected to significantly increase the total addressable market [36] - The company has received positive feedback from physicians regarding the new indication, indicating a strong interest in the sacropelvic component of spinal constructs [37] Company Strategy and Development Direction - The company is committed to investing in growth through commercial operations, clinical research, and product refinement, with a focus on expanding its sales force and enhancing market access efforts [14][21] - The company aims to leverage clinical research to reinforce the value proposition of its technologies and achieve positive coverage throughout the payer network [13] Management's Comments on Operating Environment and Future Outlook - Management anticipates improvements in the reimbursement environment, which has been a challenge due to coding confusion, and expects this to contribute to incremental growth [24][26] - The company is optimistic about the upcoming SE launch being an inflection point for growth, particularly in attracting more physicians to adopt the technology [28][29] Other Important Information - The company received $7,100,000 in gross proceeds from equity financing, contributing to a cash balance of $10,300,000 at the end of Q1 2025, with no outstanding debt [20] - The company is actively conducting workshops to train physicians, enhancing their ability to adopt the technology effectively [40] Q&A Session Summary Question: Expectations for top line revenues trajectory through the year - Management expects incremental growth as reimbursement issues improve and the sales team expands [25][26] Question: Impact of SE launch on growth - Management believes the SE launch will serve as an inflection point, attracting more physicians and enhancing revenue [28][29] Question: General and Administrative expenses trends - Management indicates that the lower G&A expenses in Q1 are reflective of the quarter, with expectations for additional investments in sales initiatives moving forward [30] Question: Expansion of total addressable market due to new indication - Management highlights that the new indication for multiple spinal fusion surgeries significantly increases the addressable market, addressing a critical need in the industry [36] Question: Physician reaction to new indication and reimbursement considerations - Management reports positive reactions from physicians and anticipates existing codes will apply for the new procedures [37][38] Question: Targeting physicians for workshops - Management confirms improvements in targeting and training physicians, enhancing retention rates and procedure adoption [40]

[PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Condensed Financial Statements (unaudited)](index=5&type=section&id=Item%201.%20Condensed%20Financial%20Statements%20(unaudited)) The company reports a Q1 net loss of $3.6 million and highlights a going concern uncertainty due to insufficient cash Condensed Balance Sheet Data (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $10,311 | $6,535 | | Total current assets | $11,990 | $8,210 | | **Total Assets** | **$13,394** | **$9,843** | | **Liabilities & Equity** | | | | Total current liabilities | $2,195 | $1,869 | | **Total Liabilities** | **$4,018** | **$3,872** | | **Total Stockholders' Equity** | **$9,376** | **$5,971** | Condensed Statement of Operations (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Revenue | $726 | $719 | | Gross Profit | $323 | $470 | | Loss from Operations | $(3,677) | $(3,506) | | **Net Loss** | **$(3,616)** | **$(3,576)** | | Net Loss Per Share (Basic and diluted) | $(1.01) | $(10.02) | - During Q1 2025, the company issued common stock and warrants, resulting in **net proceeds of $2,735 thousand** from an inducement agreement and **$3,524 thousand** from other offerings[17](index=17&type=chunk) - Total stockholders' equity increased to **$9,376 thousand** as of March 31, 2025, up from $5,971 thousand at December 31, 2024[17](index=17&type=chunk) Summary of Cash Flows (in thousands) | Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(2,483) | $(2,338) | | Net cash used in investing activities | $0 | $(119) | | Net cash provided by financing activities | $6,259 | $4,371 | | **Net Increase in Cash** | **$3,776** | **$1,960** | - The company is a medical device firm focused on its FDA-cleared Catamaran™ SI Joint Fusion System for lower back pain[21](index=21&type=chunk) - Management has **substantial doubt about the Company's ability to continue as a going concern**, as existing cash will not be sufficient to meet obligations for at least twelve months from the filing date[25](index=25&type=chunk)[26](index=26&type=chunk) - In March 2025, the company raised **net proceeds of $2.7 million** through a warrant inducement transaction and an additional **$3.5 million** through two securities purchase agreements[43](index=43&type=chunk)[45](index=45&type=chunk)[46](index=46&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses flat revenue, declining gross margins, and substantial doubt about its going concern status - The company has developed the FDA-approved Catamaran™ SI Joint Fusion System to treat SI Joint dysfunction, a cause of chronic lower back pain[77](index=77&type=chunk) - As of March 31, 2025, the company had an **accumulated deficit of approximately $72.4 million** and has incurred net losses since its inception in 2012[81](index=81&type=chunk) - Management states that **existing cash and cash equivalents will not be sufficient** to fund operating expenses for at least the next 12 months, and they plan to raise additional capital[99](index=99&type=chunk) Comparison of Results for the Three Months Ended March 31 (in thousands) | Metric | 2025 | 2024 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Revenue | $726 | $719 | $7 | 1% | | Cost of goods sold | $403 | $249 | $154 | 62% | | Gross profit | $323 | $470 | $(147) | (31)% | | Gross profit percentage | 44% | 65% | - | - | | Total operating expenses | $4,000 | $3,976 | $24 | 1% | - Sales and marketing expenses **increased by 19%** due to higher commission, payroll, and consulting fees[95](index=95&type=chunk) - General and administrative expenses **decreased by 14%**, primarily due to lower insurance and stock-based compensation costs[96](index=96&type=chunk) - The company had **cash and cash equivalents of $10.3 million** and an **accumulated deficit of $72.4 million** as of March 31, 2025[98](index=98&type=chunk)[99](index=99&type=chunk) - Management believes there is **substantial doubt in the company's ability to continue as a going concern** for the next twelve months due to insufficient capital[101](index=101&type=chunk) Cash Flow Summary for Q1 2025 vs Q1 2024 (in thousands) | Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash used in Operating activities | $(2,483) | $(2,338) | | Net cash used in Investing activities | $0 | $(119) | | Net cash provided by Financing activities | $6,259 | $4,371 | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=27&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exempt from market risk disclosures as a smaller reporting company - Disclosure is not required under Regulation S-K for **"smaller reporting companies"**[107](index=107&type=chunk) [Item 4. Controls and Procedures](index=27&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were not effective as of March 31, 2025, due to a material weakness - Based on an evaluation as of March 31, 2025, the CEO and CFO concluded that the company's **disclosure controls and procedures are not effective** at the reasonable assurance level[108](index=108&type=chunk) - A **material weakness exists** due to the company's inability to effectively segregate accounting duties because of its small size and limited resources[109](index=109&type=chunk) - **No changes in internal control** over financial reporting occurred during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[111](index=111&type=chunk) [PART II. OTHER INFORMATION](index=28&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=28&type=section&id=Item%201.%20Legal%20Proceedings) The company reported no legal proceedings during the period - None[113](index=113&type=chunk) [Item 1A. Risk Factors](index=28&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors were reported since the last Annual Report - There have been **no material changes** in risk factors as previously disclosed in the Annual Report on Form 10-K filed on March 26, 2025[114](index=114&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=28&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[115](index=115&type=chunk) [Item 3. Defaults Upon Senior Securities](index=28&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - None[116](index=116&type=chunk) [Item 4. Mine Safety Disclosures](index=28&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not Applicable[117](index=117&type=chunk) [Item 5. Other Information](index=28&type=section&id=Item%205.%20Other%20Information) The company reported no other information - None[118](index=118&type=chunk) [Item 6. Exhibits](index=29&type=section&id=Item%206.%20Exhibits) This section provides an index of all exhibits filed with the Form 10-Q