ENvue Medical, Inc.
For the period ended Jun 30, 2026. Filed Aug 17, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2026 · Filed Aug 17, 2026
FEED$1.03-69.3%Stored close · as of Sep 15, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-18.
0001493152-26-024191
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-17.
0001493152-26-038778
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 42 previous paragraphs and 65 current paragraphs.
17 unchanged; 17 reworded; 26 added; 8 removed; 0 previous and 5 current paragraphs rearranged.
Tables are not compared: 0 previous and 0 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (26)
Current report
Following the ENvue Merger, the Company has progressively consolidated certain functions and resources across the combined organization in order to reduce duplication and improve operating efficiency. This has included the sharing of personnel and technical resources across the Company’s two product platforms based on their respective development, regulatory, manufacturing and commercial requirements. Accordingly, changes in the level of expenses attributed to either operating segment from period to period may reflect the timing and requirements of particular activities and the deployment of shared Company resources and should be considered together with the operating circumstances affecting each business during the applicable period.
Current report
Revenues. For the three months ended June 30, 2026, and 2025, our revenues were approximately $239 and $494, respectively, a decrease of approximately 51.6%, or $255, between the periods. The decrease was primarily attributable to a halt in production of our PainShield/UroShield products resulting from the war in Israel and the relocation of our PainShield/Uroshield manufacturing operations to the United States. Notwithstanding the temporary disruption to NanoVibronix production during the period, NanoVibronix products continued to represent approximately 18% of the Company’s consolidated revenues for the three months ended June 30, 2026. The Company completed the transition of its NanoVibronix manufacturing operations to the United States in August 2026, and production has been re-established.
Current report
This decline was partially offset by growth in ENvue revenues, which increased by approximately 275%, from approximately $49 to approximately $184, driven by continued expansion of our installed hospital base and adoption of the ENvue Navigation Platform. We also continued to generate revenues through certain sales representatives and our largest direct medical equipment distributor. The decline in NanoVibronix revenues during the period was primarily attributable to the temporary production disruption and manufacturing relocation described above and expect PainShield/UroShield revenues to resume now that production has been re-established, although we can provide no assurance as to the timing or extent of any such recovery.
Current report
Gross Profit (Loss). For the three months ended June 30, 2026, and 2025, gross loss was approximately $266 and $35, respectively, an increase in gross loss of approximately 660%, or $231. The increase in gross loss, as well as the decline in the underlying gross margin percentage, was mainly due to $140 of amortization of technology and trademark intangible assets recognized in connection with the ENvue Merger, the sale of ENvue systems at discounted prices as part of our commercialization strategy of expanding the installed base in order to drive recurring sales of our tubes, lower UroShield sales, and the write-down of $41 of inventory.
Current report
Additionally, the research and development expense decrease is attributed to the relocation of the NanoVibronix manufacturing and research and development testing operations from Israel to the United States, a phased transition that began in 2025 and continued through the first half of 2026 following disruption from regional conflict, together with the deployment of shared Company research and development resources across the two product operating segments.
Current report
Selling and Marketing Expenses. For the three months ended June 30, 2026, and 2025, selling and marketing expenses were approximately $1,198 and $673, respectively, an increase of approximately 78%, or $525 between the periods. The increase was primarily attributable to commercialization efforts for the ENvue Systems and the expansion of UroShield into the United Kingdom, including the hiring of sales employees during the second quarter of 2026, participation in a trade exhibition, and increased social media and other product-awareness marketing activity.
Current report
General and Administrative Expenses. For the three months ended June 30, 2026, and 2025, general and administrative expenses were approximately $3,500 and $2,252, respectively, an increase of 55.4%, or $1,248 between the periods. The increase was primarily attributable to stock-based compensation costs associated with a share issuance, partially offset by a decrease in professional and consulting fees as compared to the prior year.
Current report
Financial income, net. For the three months ended June 30, 2026, and 2025, financial income, net, was approximately $603 and $211, respectively. This primarily pertains to the Company’s change in fair value of warrant liability.
Current report
Income tax expense. For the three months ended June 30, 2026, we recorded an income tax benefit of approximately $2 as compared to income tax expense of approximately $62 in the three months ended June 30, 2025.
Current report
Six Months Ended June 30, 2026, Compared to Six Months Ended June 30, 2025
Current report
Revenues. For the six months ended June 30, 2026 and 2025, our revenues were approximately $892 and $1,519 respectively, a decrease of approximately 41.3%, or $627 between the periods. The decrease was primarily attributable to a halt in production of our PainShield/UroShield products resulting from the war in Israel and the relocation of our PainShield/UroShield manufacturing operations to the United States. Notwithstanding the temporary disruption to NanoVibronix production during the period, NanoVibronix products continued to represent approximately 66% of the Company’s consolidated revenues for the six months ended June 30, 2026. The Company completed the transition of NanoVibronix manufacturing operations to the United States in August 2026, and production has been re-established.
Current report
Additionally, the decline was partially offset by growth in ENvue revenues, which increased by approximately 100%, from approximately $152 to approximately $303, reflecting continued expansion of our installed hospital base and adoption of the ENvue Navigation Platform. This growth was further supported by three-year purchasing agreement renewals with two group purchasing organizations representing over 100 U.S. hospitals, as well as a network-wide standardization agreement with a 12-hospital health system in Virginia and North Carolina. In support of continued clinical adoption and commercial traction, an independent, peer-reviewed study published inCritical Care Nurse (June 2026) documented zero pulmonary misplacements across 531 procedures using the ENvue Navigation Platform, along with a 67% reduction in ventilator-associated pneumonia, supporting continued clinical and commercial adoption. Our revenues may vary from period to period, as new customers are added and existing distributors or consumers may make significant purchases in one quarter and no purchases in the following quarter. Accordingly, revenue trends should not be expected to follow a linear or consistent pattern.
Current report
Gross Profit (Loss). For the six months ended June 30, 2026 and 2025, gross loss was approximately $321 compared to gross profit of approximately $334, respectively, a decrease of approximately 196%, or $655. The decrease was mainly due to $280 of amortization of technology and trademark intangible assets recognized in connection with the ENvue Merger, the sale of ENvue systems at discounted prices as part of our commercialization strategy to increase our installed base and recurring sales of our tubes, lower UroShield sales, and the write-down of $163 of inventory.
Current report
Research and Development Expenses. For the six months ended June 30, 2026, and 2025, research and development expenses were approximately $1,024 and $1,567, respectively, a decrease of approximately 35%, or $543, between the periods. The decrease is mainly attributed to changes in development plans, including the temporary suspension of certain research and development projects related to the voluntary 510(k) withdrawal of our PainShield MD Plus product. The decrease was also attributed to the timing and level of research and development activity across our product operating segments, whose development efforts are currently focused on product enhancements and regulatory compliance.
Current report
Additionally, changes in research and development expense attributed to our operating segments also reflect the relocation of the NanoVibronix manufacturing and research and development testing operations from Israel to the United States, a phased transition that began in 2025 and continued through the first half of 2026 following disruption from regional conflict, together with the deployment of our shared research and development resources across the two product operating segments.
Current report
Selling and Marketing Expenses. For the six months ended June 30, 2026, and 2025, selling and marketing expenses were approximately $1,924 and $1,001, respectively, an increase of approximately 92.2%, or $923 between the periods. The increase was primarily attributable to commercialization activities across the Company’s product portfolio, including commercialization efforts for the ENvue Systems and expansion of UroShield into the United Kingdom, as well as the hiring of sales employees during the second quarter of 2026, participation in a trade exhibition during the quarter, along with increased social media and other product-awareness marketing activity.
Current report
*Interest expense.*For the six months ended June 30, 2026, and 2025, our interest expense was approximately $66 and $197, respectively. This primarily pertains to the interest on the Company’s loan acquired in the business combination, which was fully recognized during 2025.
Current report
*Financial income, net.*For the six months ended June 30, 2026, and 2025, financial income, net, was approximately $561 and $259, respectively. This primarily pertains to the Company’s change in fair value of warrant liability.
Current report
Net Loss. Our net loss for the six months ended June 30, 2026, increased by approximately $2,878, or 49%, reaching approximately $8,721, compared to a net loss of approximately $5,843 for the same period in 2025. This increase in net loss was primarily due to the factors described above.
Current report
Series H Preferred Stock — Additional Investment Right Exercises
Current report
Series H Preferred Stock — Additional Investment Right Conversions
Current report
During the six months ended June 30, 2026, Alpha converted an aggregate value of $7,719 of Series H Preferred Stock and $602 of accrued dividends, into 6,049,233 shares of Common Stock. This consisted of $4,802 of stated value and $451 of accrued dividends converted during the first quarter of 2026 into 2,600,495 shares of Common Stock, and $2,917 of stated value and $151 of accrued dividends converted during the second quarter of 2026 into 3,448,738 of Common Stock.
Current report
Purchase Agreement Facility
Current report
On August 12, 2026, we entered into a Common Shares Purchase Agreement (the “Purchase Agreement”), with Alpha Capital Anstalt (“Alpha”) relating to a committed equity facility (the “Facility”). Pursuant to the Purchase Agreement, we have the right from time to time at our option to sell to the Investor up to $50.0 million of our Common Stock, subject to certain conditions and limitations set forth in the Purchase Agreement.
Current report
Sales of the Common Stock to Alpha under the Purchase Agreement, and the timing of any sales, will be determined by us from time to time in its sole discretion and will depend on a variety of factors, including, among other things, market conditions, the trading price of the Common Stock and determinations by us regarding the use of proceeds of such Common Stock. The net proceeds from any sales under the Purchase Agreement will depend on the frequency with, and prices at which the Common Stock is sold to Alpha. The Company is required to use 40% of the net proceeds from any sales under the Purchase Agreement to redeem outstanding shares of its Series X Preferred Stock, until no such shares of Series X Preferred Stock remain outstanding, with the remainder of any net proceeds to be used for working capital and general corporate purposes.
Current report
Upon the initial satisfaction of the conditions to Alpha’s obligation to purchase Common Stock set forth in the Purchase Agreement (the “Commencement”), including, but not limited to, that a registration statement registering the resale by Alpha of the Common Stock under the Securities Act of 1933, as amended (the “Securities Act”), that may be sold to it by the Company under the Purchase Agreement (the “Initial Resale Registration Statement”), is declared effective by the SEC and a final prospectus relating thereto is filed with the SEC, we will have the right, but not the obligation, from time to time at our sole discretion until the first day of the month next following the 36-month period from and after Commencement, to direct Alpha to purchase up to a specified maximum amount of Common Stock as set forth in the Purchase Agreement by delivering written notice to the Investor prior to the commencement of trading on any trading day. The purchase price of the Common Stock that we elect to sell to Alpha pursuant to the Purchase Agreement will be 90% of the lowest volume weighted average price of the Common Stock during the three (3) trading days immediately preceding the applicable purchase date on which we have timely delivered written notice to Alpha directing it to purchase Common Stock under the Purchase Agreement.
Removed paragraphs (8)
Previous report
Revenues. For the three months ended March 31, 2026, and 2025, our revenues were approximately $653 and $1,025, respectively, a decrease of approximately 36%, or $372, between the periods. The decrease was primarily attributable to the removal of PainShield Ultra from the market, partially offset by revenues generated from the ENvue Systems, as well as continued revenues from sales through certain sales representatives and our largest direct medical equipment distributor. Revenues may fluctuate as new customers are added or when existing distributors or customers place large orders in one period and not in another, as experienced during the three months ended March 31, 2025.
Previous report
Gross Profit (Loss). For the three months ended March 31, 2026, and 2025, gross profit (loss) was approximately ($55) and $369, respectively, a decrease of approximately 115% or $424. Gross margin was also significantly impacted, declining primarily due to the removal of PainShield Ultra from the market, which historically generated higher margins, as well as inventory write-downs associated with PainShield Ultra and ENvue products. In addition, amortization expense related to intangible assets recognized in connection with the ENvue Merger, which is recorded within cost of goods sold, further contributed to the decline in gross margin.
Previous report
Research and development expenses as a percentage of total revenues were approximately 72% and 52% for the three months ended March 31, 2026, and 2025, respectively.
Previous report
Selling and Marketing Expenses. For the three months ended March 31, 2026, and 2025, selling and marketing expenses were approximately $772 and $349, respectively, an increase of approximately 121%, or $423 between the periods. The increase was primarily attributable to a full three months of ENvue operating expenses in the current period compared to only the period from February 14, 2025 (the date of the ENvue Merger) through March 31, 2025 in the prior year, including amortization expense related to intangible assets recognized in connection with the purchase price allocation, as well as higher consulting fees and travel costs associated with system reactivation, new installations, commercialization activities, and rebranding efforts for the ENvue Systems.
Previous report
Selling and marketing expenses as a percentage of total revenues were approximately 118% and 34% for the three months ended March 31, 2026, and 2025, respectively.
Previous report
General and administrative expenses as a percentage of total revenues were approximately 370% and 131% for the three months ended March 31, 2026, and 2025, respectively.
Previous report
On March 24, 2026, the holder also exercised an additional $400 of the Additional Investment Right, resulting in the issuance of 400 new shares of Series H Preferred Stock at a stated value of $1,000 per share (not in thousand).
Previous report
In aggregate, during the three months ended March 31, 2026, the holder exercised a total of $3,900 of the Additional Investment Right resulting in the issuance of 3,900 new shares of Series H Preferred Stock, which remained outstanding as of March 31, 2026.
Reworded paragraphs (17)
Previous wording
We were organized as a Delaware corporation in October 2003. On February 14, 2025, we completed the ENvue Merger pursuant to the Merger Agreement, as further described below. Following the consummation of the ENvue Merger, the Company conducts its operations through its two wholly-owned subsidiaries: (i) NanoVibronix Ltd., a private company incorporated under the laws of the State of Israel (“Nano OpCo”) and (ii) ENvue Medical Holdings LLC, a Delaware limited liability company (together with its respective subsidiaries, “ENvue”). Nano OpCo focuses on non-invasive biological response-activating devices that target biofilm prevention, pain therapy, and wound healing and can be administered at home, without the assistance of medical professionals. ENvue is a medical device company engaged in the research, development, production, marketing, and sale of medical devices in the field of enteral feeding and are in the initial stage of commercializing our products.
Current wording
We were organized as a Delaware corporation in October 2003. On February 14, 2025, we completed the ENvue Merger pursuant to the Merger Agreement, as further described below. Following the consummation of the ENvue Merger, the Company conducts its operations through its two wholly-owned subsidiaries: (i) NanoVibronix Ltd., a private company incorporated under the laws of the State of Israel (“Nano OpCo”), and (ii) ENvue Medical Holdings LLC, a Delaware limited liability company (together with its respective subsidiaries, “ENvue”). Nano OpCo focuses on non-invasive biological response-activating devices that target biofilm prevention, pain therapy, and wound healing and can be administered at home, without the assistance of medical professionals. ENvue is a medical device company engaged in the research, development, production, marketing, and sale of medical devices in the field of enteral feeding and is the initial stage of commercializing its products.
Previous wording
For the three months ended March 31, 2026, the percentage of revenues attributable to our products was: 82% for PainShield and monthly kits and 18% for ENvue system and tubes. For the three months ended March 31, 2025, the percentage of revenues attributable to our products was: 85 % for PainShield and monthly kits: 11% for ENvue systems and tubes; and 4% for ancillary products. For the three months ended March 31, 2026, and 2025, the portion of our revenues that was derived from our largest direct medical equipment distributor, Ultra Pain Products LLC, were 27% and 49%, respectively.
Current wording
For the three months ended June 30, 2026, the percentage of revenues attributable to our products was: 16% for PainShield and monthly kits, 2% for UroShield and monthly kits, 77% for ENvue systems and tubes and 5% for other products. For the three months ended June 30, 2025, the percentage of revenues attributable to our products was: 87% for PainShield and monthly kits, 10% ENvue systems and tubes; and 3% for other products.
Previous wording
Gross profit as a percentage of revenues were approximately (11%) and 36% for the three months ended March 31, 2026, and 2025, respectively. The decrease in gross profit as a percentage of revenues is mainly due to the reasons described above.
Current wording
Gross profit as a percentage of revenues was approximately negative 111% and negative 7% for the three months ended June 30, 2026, and 2025, respectively. The decrease in gross profit as a percentage of revenues is mainly due to the reasons described above.
Previous wording
Research and Development Expenses. For the three months ended March 31, 2026, and 2025, research and development expenses were approximately $468 and $530, respectively, a decrease of approximately 12%, or $62 between the periods. The decrease in research and development expenses is primarily attributable to changes in development plans, including the temporary suspension of certain projects.
Current wording
Research and Development Expenses. For the three months ended June 30, 2026, and 2025, research and development expenses were approximately $510 and $1,016, respectively, a decrease of approximately 50%, or $506, between the periods. The decrease reflects changes in development plans, including the temporary suspension of certain research and development projects, as well as changes in the timing and level of research and development activity across the Company’s product operating segments that vary throughout the year.
Previous wording
Interest expense. For the three months ended March 31, 2026, and 2025, our interest expenses were $36 and $53, respectively. This primarily pertains to the interest on the Company’s loan.
Current wording
*Interest expense.*For the three months ended June 30, 2026, and 2025, our interest expense was approximately $30 and $144, respectively. This primarily pertains to the interest on the Company’s loan acquired in the business combination, which was fully recognized during 2025.
Previous wording
Net Loss. Our net loss increased by approximately $1,950 or 104%, to approximately $3,822 for the three months ended March 31, 2026, from approximately $1,872 during the same period in 2025. The increase in net loss resulted primarily from the factors described above.
Current wording
Net Loss. Our net loss for the three months ended June 30, 2026, increased by approximately $928, or 23%, reaching approximately $4,899, compared to a net loss of approximately $3,971 for the same period in 2025. This increase in net loss was primarily due to the factors described above.
Previous wording
General and Administrative Expenses. For the three months ended March 31, 2026, and 2025, general and administrative expenses were approximately $2,416 and $1,342, respectively, an increase of approximately 80%, or $1,072 between the periods. The increase was primarily attributable to a full three months of ENvue operating expenses in the current period compared to only the period from February 14, 2025 (the date of the ENvue Merger) through March 31, 2025 in the prior year, as well as higher legal fees, accounting and professional consulting fees, payroll costs, and severance and termination costs associated with former executive management and board members.
Current wording
General and Administrative Expenses. For the six months ended June 30, 2026, and 2025, general and administrative expenses were approximately $5,916 and $3,594, respectively, an increase of approximately 64.6%, or $2,322 between the periods. The increase was primarily attributable to a full six months of ENvue operating expenses in the current period compared to only the period from February 14, 2025 (the date of the ENvue Merger) through June 30, 2025 in the prior year, as well as stock-based compensation costs associated with share issuances, higher legal fees and payroll costs, and severance and termination costs associated with former executive management and board members, partially offset by a decrease in professional and consulting fees as compared to the prior year.
Previous wording
Income tax expense. For the three months ended March 31, 2026, our income tax expense was approximately $8 as compared to $15 in the three months ended March 31, 2025.
Current wording
Income tax expense. For the six months ended June 30, 2026, our income tax expense was approximately $31 as compared to $77 in the six months ended June 30, 2025.
Previous wording
We have incurred net losses of approximately $3,822 during the three months ended March 31, 2026, which primarily consisted of decreased revenues and decreased gross margins offset by our operating expenses. We also had negative cash flow from operating activities of $4,312 for the three months ended March 31, 2026. Although we had a cash and cash equivalents of just over $2,235 as of March 31, 2026, we expect to continue to incur losses and negative cash flows from operating activities, and therefore, we do not have sufficient resources to fund our operation for the next twelve months from the date of this filing causing us to have substantial doubt of our ability to continue as a going concern. We will need to continue to raise additional capital to finance its losses and negative cash flows from operations beyond the next years and may continue to be dependent on additional capital raising as long as our products do not reach commercial profitability.
Current wording
We have incurred net losses of approximately $8,721 during the six months ended June 30, 2026, which primarily consisted of decreased revenues and decreased gross margins offset by our operating expenses. We also had negative cash flow from operating activities of $7,003 for the six months ended June 30, 2026. Although we had cash and cash equivalents of approximately $1,084 as of June 30, 2026, we expect to continue to incur losses and negative cash flows from operating activities, and therefore, we do not have sufficient resources to fund our operations for the next twelve months from the date of this filing causing us to have substantial doubt of our ability to continue as a going concern. We will need to continue to raise additional capital to finance our losses and negative cash flows from operations beyond the next years and may continue to be dependent on additional capital raising as long as our products do not reach commercial profitability.
Previous wording
During the three months ended March 31, 2026, we met our short-term liquidity requirements from proceeds of the exercise of additional investment rights and from our existing cash reserves. Our future capital requirements and the adequacy of our available funds will depend on many factors, including our ability to successfully commercialize our products, our development of future products and competing technological and market developments as well as our ability to overcome obstacles that may be presented due to macroeconomic and geopolitical developments, including the ongoing conflict in the Middle East and the war between Russia and Ukraine. We expect to continue to incur losses and negative cash flows from operations. We intend to use the proceeds generated from equity financings, or strategic alliances with third parties, either alone or in combination with equity financing to meet our short-term liquidity requirements as well as to advance our long-term plans. There are no assurances that we will be able to raise additional capital, as required, on terms favorable to us.
Current wording
During the six months ended June 30, 2026, we met our short-term liquidity requirements from proceeds of the exercise of additional investment rights by our existing investor and from our existing cash reserves. Our future capital requirements and the adequacy of our available funds will depend on many factors, including our ability to successfully commercialize our products, our development of future products and competing technological and market developments as well as our ability to overcome obstacles that may be presented due to macroeconomic and geopolitical developments, including the ongoing conflict in the Middle East and the war between Russia and Ukraine. We expect to continue to incur losses and negative cash flows from operations. We intend to use the proceeds generated from equity financings, or strategic alliances with third parties, either alone or in combination with equity financing to meet our short-term liquidity requirements as well as to advance our long-term plans. There are no assurances that we will be able to raise additional capital, as required, on terms favorable to us.
Previous wording
During the month of January 2026, the holder of the Series H Preferred Stock exercised $3,500 of the Additional Investment Right pursuant to the July 2025 Purchase Agreement resulting in the issuance of 3,500 new shares of Series H Preferred Stock at a stated value of $1,000 per share (not in thousand).
Current wording
During the six months ended June 30, 2026, Alpha, as the holder of the Series H Preferred Stock, exercised the Additional Investment Right pursuant to the July 2025 Purchase Agreement on six occasions, for an aggregate value of $7,600, resulting in the issuance of 7,600 new shares of Series H Preferred Stock at a stated value of $1,000 per share (not in thousands), all of which remained outstanding as of June 30, 2026.
Previous wording
General. As of March 31, 2026, we had cash and cash equivalents of approximately $2,235, compared to approximately $571 as of March 31, 2025. We have historically met our cash needs through a combination of issuance of equity, borrowing activities and sales. Our cash requirements are generally for product development, research and development costs, marketing and sales activities, general and administrative costs, capital expenditures and general working capital.
Current wording
General. As of June 30, 2026, we had cash and cash equivalents of approximately $1,084, compared to approximately $4,030 as of June 30, 2025. We have historically met our cash needs through a combination of issuance of equity, borrowing activities and sales. Our cash requirements are generally for product development, research and development costs, marketing and sales activities, general and administrative costs, capital expenditures and general working capital.
Previous wording
Cash used in our operating activities was approximately $4,312 for the three months ended March 31, 2026, and was approximately $1,343 for the same period in 2025.
Current wording
Cash used in our operating activities was approximately $7,003 and was approximately $4,726 for the same period in 2025.
Previous wording
Cash used in our investing activities was approximately $17 and cash provided by investing activities was $143 for the three months ended March 31, 2026, and 2025, respectively. Cash used in the three months ended March 31, 2026, was primarily for the purchase of plant and equipment.
Current wording
Cash used in our investing activities was approximately $44 for the six months ended June 30, 2026, and cash provided by investing activities was $139 for the six months ended June 30, 2025, respectively. Cash used in the six months ended June 30, 2026, was primarily for the purchase of plant and equipment.
Previous wording
Cash provided by financing activities during the three months ended March 31, 2026, was approximately $2,340, which was primarily composed of the net proceeds from issuance of common stock and preferred stock. Our future capital requirements and the adequacy of available funds will depend on many factors, including our ability to successfully commercialize our products, our development of future products and competing technological and market developments. Cash provided by financing activities for the three months ended March 31, 2025, was approximately $1,050 which resulted from the issuance of note payable from a related party.
Current wording
Cash provided by financing activities during the six months ended June 30, 2026, was approximately $3,934, consisting of net proceeds of $6,974 from the issuance of common stock, preferred stock and warrants, partially offset by $3,040 used to repurchase shares of Series X Preferred Stock. Our future capital requirements and the adequacy of available funds will depend on many factors, including our ability to successfully commercialize our products, our development of future products and competing technological and market developments. Cash provided by financing activities during the six months ended June 30, 2025, was approximately $7,900, primarily resulting from net proceeds of $8,215 from the sale of Series G Preferred Stock, $1,300 in proceeds from issuance of notes payable to a related party, $360 from the issuance of a short-term loan payable, and $102 in proceeds from exercise of options, partially offset by payments of $1,300 on a related party note payable and $777 on a short-term loan to a related party. The Company’s future capital requirements and the adequacy of available funds will depend on a variety of factors, including the successful commercialization of its products, the development of future product offerings, and the impact of technological advancements and competitive market dynamics.
Previous wording
More broadly, macroeconomic conditions, including changes in reimbursement policies and healthcare spending in the markets in which we operate, may impact on customer demand for our products.
Current wording
More broadly, macroeconomic conditions, including changes in reimbursement policies and healthcare spending in the markets in which we operate, may impact customer demand for our products.
Previous wording
Following a review, we have identified certain inaccuracies in our 510(k) application for the PainShield MD Plus product, and have submitted a request to FDA to withdraw the clearance. The company is unaware of any safety issue related to PainShield MD Plus, but intends to halt future sales of the product. The Company is subject to risks and uncertainties common to companies in the biopharmaceutical industry, including but not limited to, risks associated with completing studies and clinical trials, receiving regulatory approvals for product candidates, development by competitors of new biopharmaceutical products, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. In addition, the consequences of the ongoing geopolitical conflicts, such as the ongoing conflict in the Middle East, conflicts between Russia and Ukraine and the ongoing conflict between Israel and Hamas, including related sanctions and countermeasures, and the effects of rising global inflation, are difficult to predict, and could adversely impact geopolitical and macroeconomic conditions, the global economy, and contribute to increased market volatility, which may in turn adversely affect our business and operations. Additionally, recent changes to U.S. policy implemented by the U.S. Congress, the Trump administration or any new administration have impacted and may in the future impact, among other things, the U.S. and global economy, tariffs, international trade relations, unemployment, immigration, healthcare, taxation, the U.S. regulatory environment, inflation and other areas. Although we cannot predict the impact, if any, of these changes to our business, they could adversely affect our business. For a further discussion of factors that may affect future operating results see the section entitled “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on April 15, 2026. Other than as discussed above and elsewhere in this Quarterly Report on Form 10-Q, we are not aware of any trends, events or uncertainties that are likely to have a material effect on our financial condition.
Current wording
Following a review, we identified certain inaccuracies in our 510(k) application for the PainShield MD Plus product and have submitted a request to FDA to withdraw the clearance. The Company is unaware of any safety issue related to PainShield MD Plus, but intends to halt future sales of the product. The Company is subject to risks and uncertainties common to companies in the medical device industry, including but not limited to, risks associated with completing studies and clinical trials, receiving regulatory approvals for product, development by competitors of new medical device products, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. In addition, the consequences of the ongoing geopolitical conflicts, such as the ongoing conflict in the Middle East, conflicts between Russia and Ukraine and the ongoing conflict between Israel and Hamas, including related sanctions and countermeasures, and the effects of rising global inflation, are difficult to predict, and could adversely impact geopolitical and macroeconomic conditions, the global economy, and contribute to increased market volatility, which may in turn adversely affect our business and operations. Additionally, recent changes to U.S. policy implemented by the U.S. Congress, the Trump administration or any new administration have impacted and may in the future impact, among other things, the U.S. and global economy, tariffs, international trade relations, unemployment, immigration, healthcare, taxation, the U.S. regulatory environment, inflation and other areas. Although we cannot predict the impact, if any, of these changes to our business, they could adversely affect our business. For a further discussion of factors that may affect future operating results see the section entitled “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on April 15, 2026. Other than as discussed above and elsewhere in this Quarterly Report on Form 10-Q, we are not aware of any trends, events or uncertainties that are likely to have a material effect on our financial condition.
Rearranged current paragraphs (5)
Current report — wording carried from elsewhere
Our research and development expenses consist mainly of expenses related to subcontracted research and development, as well as payroll expenses to employees, and the associated facilities’ costs, who are involved with research and development activities.
Current report — wording carried from elsewhere
For the six months ended June 30, 2026, the percentage of revenues attributable to our products was: 45% for PainShield and monthly kits, 19% for UroShield and monthly kits, 34% for ENvue systems and tubes and 2% for other products. For the six months ended June 30, 2025, the percentage of revenues attributable to our products was: 84% for PainShield and monthly kits, 10% for ENvue systems and tubes, and 6% for other products.
Current report — wording carried from elsewhere
Gross profit as a percentage of revenues was approximately negative 36% and positive 22% for the six months ended June 30, 2026, and 2025, respectively. The decrease in gross profit as a percentage of revenues is mainly due to the reasons described above.
Current report — wording carried from elsewhere
Selling and marketing expenses consist mainly of payroll expenses to direct sales and marketing employees, travel expenses, conventions, advertising and marketing expenses, rent and facilities expenses associated with and allocated to selling and marketing activities.
Current report — wording carried from elsewhere
Our general and administrative expenses consist mainly of payroll expenses for management and administrative employees, accounting, legal and facilities expenses associated with general and administrative activities and costs associated with being a publicly traded company.