10-Q: Encision Reports Wider Q2 Loss Amid Revenue Decline, Secures $500K Private Placement
Quarterly Report
Encision Inc. reported a significant increase in net loss and a decrease in product revenue for the quarter ended September 30, 2025, despite securing $500,000 through a private placement to bolster working capital.
Summary
- Net loss for the three months ended September 30, 2025, increased to $267,833 from $170,262 in the prior year period.
- Net product revenue decreased by 10% to $1,481,802 for the quarter, primarily due to reduced sales of disposable products and lower procedural volume.
- Net service revenue for the quarter decreased to $46,248 from $101,568, attributed to a short delay in services under an agreement with Vicarious Surgical Inc.
- Gross profit for the quarter declined by 16% to $697,333, with gross margin decreasing to 46% from 47%.
- For the six months ended September 30, 2025, net loss increased to $308,966 from $148,222 in the prior year period.
- Cash balance decreased by $185,702 to $71,731 at September 30, 2025, from $257,433 at March 31, 2025.
- Working capital increased to $1,375,301 at September 30, 2025, from $1,036,850 at March 31, 2025, primarily due to the private placement.
- Completed a private placement on August 19, 2025, issuing 5,000,000 shares of common stock at $0.10 per share, raising gross proceeds of $500,000.
- Management has identified substantial doubt about the company's ability to continue as a going concern beyond the first fiscal quarter of 2027.
- The company extended its non-cancelable lease agreement for its Boulder, Colorado facilities through October 31, 2028.
- A material weakness in internal control over financial reporting exists due to inadequate segregation of duties, with remediation efforts underway.
Sentiment
Score: 3
Explanation: The company reported significantly increased net losses and decreased product revenue, alongside a substantial decline in cash and a going concern warning. While a capital raise was completed and some expenses were reduced, the overall financial performance and outlook are concerning, indicating significant challenges ahead.
Positives
- Successfully completed a private placement, raising $500,000 in gross proceeds, which contributed to an increase in working capital.
- Working capital increased by $338,451 to $1,375,301 at September 30, 2025, from $1,036,850 at March 31, 2025.
- Net service revenue for the six months ended September 30, 2025, increased by 11% to $156,144 compared to the prior year period.
- Sales and marketing expenses decreased by 14% for the quarter and 9% for the six months ended September 30, 2025, due to reduced trade shows and commission expenses.
- General and administrative expenses decreased by 4% for the quarter and 5% for the six months ended September 30, 2025, due to decreased outside accountants' costs and reduced insurance expenses.
- Secured a lease extension through October 31, 2028, for its facilities, including a potential $150,000 Tenant Improvement Allowance or rent credit.
Negatives
- Net loss for the three months ended September 30, 2025, increased to $267,833 from $170,262 in the prior year period.
- Net loss for the six months ended September 30, 2025, increased to $308,966 from $148,222 in the prior year period.
- Net product revenue decreased by 10% for the quarter and 8% for the six months ended September 30, 2025, primarily due to reduced sales of disposable products and lower procedural volume.
- Net service revenue for the quarter decreased to $46,248 from $101,568, attributed to a short delay in services under an agreement with Vicarious Surgical Inc.
- Gross profit for the quarter declined by 16% to $697,333, and for the six months by 11% to $1,575,792, due to reduced sales and an unfavorable change in product mix.
- Gross margin decreased to 46% for the quarter and 50% for the six months ended September 30, 2025, from 47% and 52% respectively in the prior year periods.
- Cash balance decreased by $185,702 to $71,731 at September 30, 2025, from $257,433 at March 31, 2025.
- Net cash used in operating activities was $242,149 for the six months ended September 30, 2025, a significant shift from $192,699 provided in the prior year period.
- Accumulated deficit increased to $23,074,211 at September 30, 2025.
- Research and development expenses increased by 30% for the quarter and 24% for the six months ended September 30, 2025, due to increased allocated resources for product development.
Risks
- Substantial doubt exists about the company's ability to continue as a going concern beyond the first fiscal quarter of 2027 due to operating losses and insufficient cash resources.
- Inability to obtain additional equity or debt financing in sufficient amounts or on acceptable terms could adversely affect operating results and prospects.
- Surgeons' preference for other instruments over AEM products, based on factors like ergonomics, quality, and ease of use, could negatively impact business results.
- The omission or delay of elective surgeries would negatively impact the extent and timing of revenue growth.
- The company may operate at a net loss due to the ongoing need to develop, optimize, and train sales networks, support product line refinements, and increase sustained sales to cover operating costs.
- Material weakness in internal control over financial reporting due to inadequate segregation of duties (management comprised of only two persons) poses a risk to financial reporting reliability.
- Net operating loss carryforwards totaling approximately $8.2 million may expire starting March 31, 2026, if not utilized, and may be limited by tax regulations.
- The company's estimates for bad debts, inventories, sales returns, contingencies, and litigation may differ from actual results under different assumptions or conditions.
- Potential for additional inventory write-downs if actual market conditions are less favorable than projected.
- Need to adjust useful lives of patents based on advances in technology or competitor actions, potentially leading to impairment charges.
- The current downward sales trend, if it continues, will have a material adverse effect on business viability, financial position, results of operations, and cash flows.
Future Outlook
Management expects net losses to continue due to ongoing investments in commercialization and new product development. The company anticipates increased product revenue in the U.S. from new and existing customers as the medical device industry stabilizes and sales networks become more efficient. Efforts include optimizing sales execution, expanding market awareness of AEM technology, maximizing new hospital/surgery center accounts, and retaining existing customers. The company also plans to develop next-generation AEM products, explore overseas markets, and capitalize on AEM technology via licensing and strategic alliances, though these longer-term initiatives may not materialize. R&D expenses are expected to increase to support quality improvement and product line refinements.
Management Comments
- We believe that the patented AEM (Active Electrode Monitoring) AEM EndoShield Burn Protection System is changing the marketplace for electrosurgical devices and laparoscopic instruments by providing a solution to a well-documented hazard unique to laparoscopic surgery.
- Management concludes that it is probable that cash resources and line of credit will only provide funding for our operations into the first fiscal quarter of 2027.
- Our management is evaluating and pursuing different strategies to obtain the required funding for our operations.
- We expect that the replacement sales of electrosurgical instruments and accessories will also increase as additional facilities adopt AEM technology.
- We anticipate that the efforts to improve the productivity of sales representatives carrying the AEM product line, along with the introduction of next-generation products, may provide the basis for increased sales and profitable operations.
- We believe that the unique performance of the AEM technology and our breadth of independent endorsements provide an opportunity for continued market share growth.
- Our objectives for the remainder of fiscal year 2026 are to optimize sales execution, expand market awareness of the AEM technology, and maximize the number of additional hospital and surgery center accounts switching to AEM instruments while retaining existing customers.
- We are investing in research and development efforts to develop next-generation versions of the AEM product line.
- We have invested in manufacturing equipment to manufacture disposable scissors inserts internally and to reduce our cost of product revenue.
Industry Context
Encision operates in the medical device industry, specifically focusing on minimally-invasive surgery (MIS) and electrosurgery. Its AEM (Active Electrode Monitoring) technology addresses a critical patient safety risk: unintended collateral tissue damage from stray electrosurgical energy during laparoscopic procedures. This risk is well-documented, and the Center for Medicare and Medicaid Services' Hospital-Acquired Condition Reduction Program levies penalties for accidental puncture and laceration (APL), which AEM technology aims to prevent. The company positions its products as providing enhanced patient safety without requiring changes in surgeon technique and being cost-competitive, aiming to capitalize on the increasing adoption of MIS and robotic electrosurgery. The market opportunity is driven by the need for safer electrosurgical devices, with AEM technology having received endorsements from various medical and legal groups.
Comparison to Industry Standards
- The company's AEM technology directly addresses the patient safety risk of unintended electrosurgical burn injury in laparoscopic surgery, a well-documented hazard that conventional instruments or alternative energy sources may not fully mitigate.
- The AEM EndoShield Burn Protection System is presented as a solution to a patient safety risk that can lead to accidental puncture and laceration (APL), a quality indicator for which the Center for Medicare and Medicaid Services (CMS) levies penalties on hospitals. This implies AEM offers a competitive advantage in meeting regulatory and safety standards compared to devices that do not prevent such injuries.
- AEM Surgical Instruments are designed to be equivalent to conventional 5mm instruments in size, shape, ergonomics, functionality, and competitive pricing, suggesting they meet existing industry standards for usability while adding a safety benefit.
- The company believes there is no directly competing technology to supplant AEM products, indicating a unique market position in its specific niche of electrosurgical safety.
Corporate Governance
| Change Type | Description | Effective Date | Impact Assessment |
|---|---|---|---|
| Internal Control Weakness Identified | Management determined that internal control over financial reporting was not effective as of September 30, 2025, due to inadequate segregation of duties, as management is comprised of only two persons (CEO and PFAO). | 2025-09-30 | This material weakness is reasonably likely to adversely affect the company's ability to record, process, summarize, and report financial information reliably. |
| Remediation Efforts Initiated | Remedial actions include evaluating additional review and approval processes for key financial reporting activities, expanding documentation of internal controls and policies, evaluating opportunities to restructure financial reporting responsibilities, and evaluating options to hire external consultants. | Ongoing | These actions are intended to mitigate the segregation of duties issues and enhance internal control over financial reporting, but require additional time for full implementation and assessment of sustainability. |
Legal Proceedings
- The company is not currently aware of any legal proceedings or claims that are believed to have a material adverse effect on its business, financial condition, or results of operations.
Related Party Transactions
- In September 2025, the company entered into a services agreement with Rader Industries LLC, a company owned by Jessica Rader, an immediate family member of the CEO, Gregory Trudel.
- Rader Industries provides telemarketing and promotional sales campaign services for a two-month period.
- Compensation is an hourly fee of $25 per hour, plus 10% of invoiced promotional sales generated by Rader Industries during the contract term.
- As of September 30, 2025, the company had paid $1,094 to Rader Industries under this agreement.
- Management believes the terms are comparable to arms-length transactions.
Stakeholder Impact
- Shareholders: Dilution from the private placement (5,000,000 new shares), increased net losses, and the going concern warning could negatively impact share value and investor confidence. The capital raise provides short-term liquidity but does not resolve underlying profitability issues.
- Employees: The need for cost reductions if operating losses continue could impact employment stability or compensation.
- Customers (Hospitals/Surgery Centers): Continued product development and focus on patient safety (AEM technology) could benefit customers, but financial instability might raise concerns about long-term product support.
- Suppliers/Creditors: The going concern warning and reliance on additional financing could increase perceived risk for creditors and potentially impact terms with suppliers.
- Regulatory Authorities (FDA): The company believes it is in substantial compliance with FDA regulations, which is positive for continued operations.
Next Steps
- Actively pursue additional equity or debt financing to address capital needs and going concern uncertainty.
- Implement cost reductions or other operational changes if liquidity diminishes further due to operating losses.
- Optimize sales execution and expand market awareness of AEM technology.
- Maximize the number of additional hospital and surgery center accounts switching to AEM instruments while retaining existing customers.
- Continue to develop next-generation versions of AEM products.
- Explore overseas markets for sales growth opportunities.
- Explore opportunities to capitalize on AEM technology via licensing arrangements and strategic alliances.
- Continue remediation efforts for the material weakness in internal control over financial reporting, including evaluating additional review/approval processes, expanding documentation, restructuring financial reporting responsibilities, and hiring external consultants.
Key Dates
| Date | Description |
|---|---|
| 2004-06-03 | Original Lease Agreement date. |
| 2006-11-20 | First amendment to Lease Agreement. |
| 2007-06-30 | Date of Proxy Statement for 2007 Stock Option Plan. |
| 2007-10-30 | Date of Current Report on Form 8-K for Bylaws. |
| 2009-03-26 | Second amendment to Lease Agreement. |
| 2011-05-18 | Third amendment to Lease Agreement. |
| 2013-11-07 | Fourth amendment to Lease Agreement. |
| 2016-11-14 | Employment Agreement date with Gregory J. Trudel. |
| 2017-05-31 | Date of Current Report on Form 8-K for First Amended and Restated Bylaws. |
| 2017-11-09 | Fifth Amendment to Office Building Lease date. |
| 2018-02-12 | Date of Quarterly Report on Form 10-Q for Fifth Amendment to Office Building Lease. |
| 2019-06-14 | Date of Annual Report on Form 10-K for Description of Capital Stock. |
| 2019-10-01 | Latest FDA inspection occurred. |
| 2020-04-01 | Sixth amendment to Lease Agreement. |
| 2020-08-04 | Received $150,000 EIDL loan funding from SBA. |
| 2020-09-01 | Promissory note date for EIDL loan. |
| 2020-09-28 | U.S. Bank Note agreement for $92,000. |
| 2021-08-23 | Supply Agreement dated between Auris Health, Inc. and Encision Inc. |
| 2022-06-01 | U.S. Bank Note agreement for $115,004. |
| 2022-11-02 | Entered into a loan and security agreement with Pathward, N.A. (line of credit). |
| 2023-08-28 | Seventh amendment to Lease Agreement. |
| 2024-01-01 | Start date for SEC Reports filing period. |
| 2024-03-31 | Audited Balance Sheet date. |
| 2024-09-30 | End of prior year's three and six month reporting period. |
| 2024-11-01 | Effective date for ASU 2024-03 for annual periods. |
| 2025-01-01 | FASB issued ASU 2025-01. |
| 2025-03-31 | Fiscal year end for 2025, balance sheet date. |
| 2025-05-01 | FASB issued ASU 2025-03. |
| 2025-06-05 | Eighth Amendment to Lease signed, extending lease term. |
| 2025-07-01 | FASB issued ASU 2025-05. |
| 2025-08-19 | Effective Date of Securities Purchase Agreement and Closing Date for private placement. |
| 2025-09-01 | Related party services agreement with Rader Industries LLC commenced. |
| 2025-09-30 | End of current three and six month reporting period, Unaudited Balance Sheet date. |
| 2025-10-31 | Deadline for Tenant to request disbursement of Tenant Improvement Allowance or make Allowance Rent Credit Election. |
| 2025-11-10 | Latest practicable date for shares outstanding count (16,879,645 shares). |
| 2025-11-13 | Date of filing of this 10-Q report. |
| 2026-03-31 | Start date for expiration of net operating loss carryforwards. |
| 2026-11-01 | Commencement date of Extended Term for lease agreement. |
| 2026-12-15 | Effective date for ASU 2024-03 for annual periods beginning after this date. |
| 2027-01-01 | Expected end of funding from cash and line of credit (first fiscal quarter of 2027). |
| 2027-12-15 | Effective date for ASU 2024-03 for interim periods within fiscal years beginning after this date. |
| 2028-10-31 | End date of Extended Term for lease agreement. |
Recommendation
sellThe filing reveals a deteriorating financial position with significantly increased net losses, declining product revenue, and a substantial decrease in cash. The explicit 'going concern' warning, indicating insufficient funds beyond Q1 2027, is a critical red flag. While a $500,000 private placement provides some short-term capital, it's insufficient to address the underlying operational losses and long-term funding needs. The material weakness in internal controls further adds to governance concerns. Given the severe liquidity issues, persistent losses, and the high risk of business viability, a seasoned investor would likely recommend selling to mitigate further potential losses.
Keywords
medical device, surgical instruments, AEM technology, electrosurgery, minimally invasive surgery, SEC filing, 10-Q, financial results, private placement, going concern, product development, corporate governance, risk management, Encision Inc.
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