NanoVibronix, Inc.

Previous wording

On February 14, 2025, pursuant to the terms of that certain Agreement and Plan of Merger (the “Merger Agreement”), dated as of February 14, 2025, by and among us, NVEH Merger Sub I, Inc., a Delaware corporation and a wholly-owned subsidiary of the Company (“First Merger Sub”), NVEH Merger Sub II, LLC, a Delaware limited liability company and a wholly-owned subsidiary of the Company (“Second Merger Sub”), and ENvue Medical Holdings, Corp. (“Predecessor ENvue” or “ENvue”), the Company and Predecessor ENvue effected (i) a merger of First Merger Sub with and into Predecessor ENvue, with the First Merger Sub ceasing to exist and Predecessor ENvue becoming a wholly-owned subsidiary the Company and (ii) the merger of Predecessor ENvue with and into Second Merger Sub (the “Second Merger” and, together with the First Merger, the “Merger”), with Second Merger Sub being the surviving entity of the Second Merger (“Surviving Entity”). At the effective time of the Second Merger, the certificate of formation of the Surviving Entity was amended and restated to, among other things, to change the name of the Surviving Entity to “ENvue Medical Holdings LLC.” In connection with the Merger Agreement, we issued (i) 3,318 shares of common stock (the “Merger Shares”), which such number of shares represented no more than 4.9% (the “Exchange Cap”) of the outstanding shares of common stock as of immediately before the First Effective Time and (ii) Pre-Funded Warrants to purchase up to 12,526 shares of our common stock (the “Merger Pre-Funded Warrants”) at an exercise price of $0.001 per share, and (iii) 5,772 shares of Series X Non-Voting Convertible Preferred Stock (the “Series X Preferred Stock”) in excess of the Exchange Cap to the holders of Predecessor ENvue in consideration for 100% of Predecessor ENvue. Each share of Series X Preferred Stock will be convertible into 100 shares of our common stock, subject to and contingent upon the affirmative vote of a majority of the shares of common stock present or represented and entitled to vote at a meeting of stockholders of Company to approve, for purposes of the Nasdaq Listing Rules, the issuance of shares of our common stock to the stockholders of Predecessor ENvue upon conversion of any and all shares of Series X Preferred Stock in accordance with the terms of the Certificate of Designation for the Series X Non-Voting Convertible Preferred Stock.

Current wording

On February 14, 2025, pursuant to the terms of that certain Agreement and Plan of Merger (the “Merger Agreement”), dated as of February 14, 2025, by and among us, NVEH Merger Sub I, Inc., a Delaware corporation and a wholly-owned subsidiary of the Company (“First Merger Sub”), NVEH Merger Sub II, LLC, a Delaware limited liability company and a wholly-owned subsidiary of the Company (“Second Merger Sub”), and ENvue Medical Holdings, Corp. (“Predecessor ENvue” or “ENvue”), the Company and Predecessor ENvue effected (i) a merger of First Merger Sub with and into Predecessor ENvue, with the First Merger Sub ceasing to exist and Predecessor ENvue becoming a wholly-owned subsidiary the Company and (ii) the merger of Predecessor ENvue with and into Second Merger Sub (the “Second Merger” and, together with the First Merger, the “ENvue Merger”), with Second Merger Sub being the surviving entity of the Second Merger (“Surviving Entity”). At the effective time of the Second Merger, the certificate of formation of the Surviving Entity was amended and restated to, among other things, to change the name of the Surviving Entity to “ENvue Medical Holdings LLC.” In connection with the Merger Agreement, we issued (i) 3,318 shares of common stock (the “Merger Shares”), which such number of shares represented no more than 4.9% of the outstanding shares of common stock as of immediately before the First Effective Time and (ii) Pre-Funded Warrants to purchase up to 12,526 shares of our common stock (the “Merger Pre-Funded Warrants”) at an exercise price of $0.001 per share, and (iii) 57,720 shares of Series X Non-Voting Convertible Preferred Stock (the “Series X Preferred Stock”).

Previous wording

On July 18, 2025, we entered into a Securities Purchase Agreement (the “Series H Purchase Agreement”) with a certain institutional investor (the “Series H Investor”), pursuant to which it agreed to sell to the Series H Investor (i) an aggregate of 889 shares of our newly-designated Series H Convertible Preferred Stock, with a par value of $0.001 per share and a stated value of $10,000 per share (the “Stated Value”), initially convertible into up to 880,099 shares of our common stock, at an initial conversion price of $10.10 per share (the “Series H Preferred Stock”) pursuant to the Certificate of Preferences, Rights and Limitations of the Series H Convertible Preferred Stock (the “Series H Certificate of Designations”) and (ii) warrants to acquire up to an aggregate of 467,836 shares of common stock (the “Series H Warrants”) at an exercise price of $22.50 (such closing, the “July 2025 Initial Closing”).

Current wording

On July 18, 2025, we entered into a Securities Purchase Agreement (the “Series H Purchase Agreement”) with a certain institutional investor (the “Series H Investor”), pursuant to which it agreed to sell to the Series H Investor (i) an aggregate of 8,889 shares of our newly-designated Series H Convertible Preferred Stock, with a par value of $0.001 per share and a stated value of $1,000 per share (the “Stated Value”), initially convertible into up to 880,099 shares of our common stock, at an adjusted conversion price of $7.01 per share (the “Series H Preferred Stock”) pursuant to the Certificate of Preferences, Rights and Limitations of the Series H Convertible Preferred Stock (the “Series H Certificate of Designations”) and (ii) warrants to acquire up to an aggregate of 467,836 shares of common stock (the “Series H Warrants”) at an exercise price of $22.50 (such closing, the “Series H Initial Closing”).

Previous wording

Pursuant to the terms of the Series H Purchase Agreement, we have also agreed to issue 222 shares of Series H Preferred Stock with a total stated value of $2,222 in a second closing, subject to the satisfaction of customary closing conditions. Additionally, pursuant to the terms of the Series H Purchase Agreement, we have agreed that during the period ending 36 months from the effective date of the registration statement (the “Resale Registration Statement”) registering the resale of the shares of common stock underlying the Series H Preferred Stock and the Series H Warrants, the Series H Investor shall have the right, but no obligation, upon notice to us from time to time, to purchase up to an aggregate of $44,000 stated value (representing 4,400 shares of Series H Preferred Stock and $39,600 of subscription amount) of additional Series H Preferred Stock, which shall have identical terms to the Series H Preferred Stock issued at the Series H Initial Closing, except that the initial conversion price of such additional shares of Series H Preferred Stock shall be equal to 85% of the arithmetic average of the three (3) lowest VWAPs during the ten trading days prior to the date of the Series H Investor’s exercise of such right.

Current wording

Pursuant to the terms of the Series H Purchase Agreement, we have also agreed to issue 2,222 shares of Series H Preferred Stock with a total stated value of $2,222 thousand and warrants to purchase up to 116,960 shares of common stock at an exercise price of $22.50 in a second closing which such second closing was consummated on October 30, 2025 (the “Second Closing”). Additionally, pursuant to the terms of the Series H Purchase Agreement, we have agreed that during the period ending 36 months from the effective date of the registration statement (the “Resale Registration Statement”) registering the resale of the shares of common stock underlying the Series H Preferred Stock and the Series H Warrants, the Series H Investor shall have the right, but no obligation, upon notice to us from time to time, to purchase up to an aggregate of $44,000 thousand stated value (representing 44,000 shares of Series H Preferred Stock and $39,600 thousand of subscription amount) of additional Series H Preferred Stock, which shall have identical terms to the Series H Preferred Stock issued at the Series H Initial Closing, except that the initial conversion price of such additional shares of Series H Preferred Stock shall be equal to 85% of the arithmetic average of the three (3) lowest VWAPs during the ten trading days prior to the date of the Series H Investor’s exercise of such right.

Previous wording

The Series H Initial Closing occurred on July 22, 2025 (the “Closing Date”). The aggregate gross proceeds from the Series H Initial Closing were $8 million, prior to deducting placement agent fees and other offering expenses payable by us.

Current wording

The Series H Initial Closing occurred on July 22, 2025. The aggregate gross proceeds from the Series H Initial Closing were $8 million, prior to deducting placement agent fees and other offering expenses payable by us.

Previous wording

For customers of both NanoVibronix and ENvue, payments are typically due between 30 and 60 days.

Current wording

The payments are typically due between 30 and 60 days.

Previous wording

For the three months ended June 30, 2025, and 2024, the portion of our revenues that was derived from our largest direct medical equipment distributor, Ultra Pain Products LLC, were 4% and 38%, respectively, and customers introduced by our two largest sales representatives were 82% and 41%, respectively.

Current wording

For the three months ended September 30, 2025, and 2024, the portion of our revenues derived from our largest direct medical equipment distributor, Ultra Pain Products LLC, was 0% and 24%, respectively, and customers introduced by our largest sales representative was 30% and 29, respectively.

Previous wording

Gross Profit. For the six months ended June 30, 2025 and 2024, gross profit was approximately $334 thousand and $1,092 thousand, respectively, a decrease of approximately 69% or $758. The decrease was mainly due to the write off of $159 thousand of inventory and the addition of ENvue products which were sold at lower gross margins than Nanovibronix products in 2024.

Current wording

Gross Profit. For the three months ended September 30, 2025, and 2024, gross profit was approximately $189 thousand and $133 thousand, respectively, an increase of approximately 42% or $56 thousand. The increase in the gross profit was mainly due to the addition of the ENvue sales.

Previous wording

Gross profit as a percentage of revenues was approximately 22% and 63% for the six months ended June 30, 2025 and 2024, respectively. The decrease of the gross margin percentage was mainly due to the write off of $159 thousand of inventory and the amortization of technology of $186 thousand.

Current wording

Gross profit as a percentage of revenues were approximately 26% and 35% for the three months ended September 30, 2025, and 2024, respectively. The decrease in gross profit as a percentage of revenues is mainly due to the write off of $204 thousand of inventory and the amortization of technology of $123 thousand.

Previous wording

Our research and development expenses consist mainly of expenses related to subcontracting research and development and clinical trial activities, as well as payroll expenses to employees, and the associated facilities’ costs, who are involved with research and development activities.

Current wording

Our research and development expenses consist mainly of expenses related to subcontracting research and development and clinical trial activities, as well as payroll expenses to employees involved in research and development activities, and the associated facilities costs.

Previous wording

Selling and Marketing Expenses. For the three months ended June 30, 2025, and 2024, selling and marketing expenses were approximately $717 thousand and $199 thousand, respectively, an increase of approximately 260%, or $518 thousand between the periods. The increase was primarily due to the inclusion of ENvue’s operations following the ENvue Merger.

Current wording

Selling and Marketing Expenses. For the three months ended September 30, 2025, and 2024, selling and marketing expenses were approximately $812 thousand and $181 thousand, respectively, an increase of approximately 349%, or $631 thousand between the periods. The increase was primarily due to the inclusion of ENvue’s operations following the ENvue Merger.

Previous wording

General and Administrative Expenses. For the three months ended June 30, 2025, and 2024, general and administrative expenses were approximately $2,252 thousand and $716 thousand, respectively, an increase of approximately 215%, or $1,536 thousand between the periods. The increase was primarily due the costs of professional fees incurred related to our Merger. Furthermore, the inclusion of ENvue’s operations following the ENvue Merger which increased the general and administrative expenses by approximately $748 thousand.

Current wording

General and Administrative Expenses. For the three months ended September 30, 2025, and 2024, general and administrative expenses were approximately $1,403 thousand and $673 thousand, respectively, an increase of approximately 108%, or $730 thousand between the periods. The increase was primarily due to the inclusion of ENvue’s operations following the ENvue Merger.

Previous wording

*Financial income, net.*For the six months ended June 30, 2025 and 2024, financial income, net was approximately $259 thousand compared to an expense of $45 thousand, respectively, an increase of approximately $214 thousand between the periods mainly due to the change in fair value of warrant liability of $1,410 thousand, offset by $1.1 million in professional fees related to the warrant liability and the inclusion of ENvue’s operations following the ENvue Merger added $13 thousand of financial expense.

Current wording

*Financial income, net.*For the three months ended September 30, 2025, and 2024, financial income, net was approximately $2,845 thousand compared to $8 thousand, respectively, an increase of approximately $2,837 thousand between the periods mainly due to the change in fair value of warrant liability of $3,203 thousand, partially offset by $332 thousand in issuance costs related to the warrant liability.

Previous wording

Interest expense. For the three months ended June 30, 2025, and 2024, our interest expenses were $144 thousand and $34 thousand, respectively. This primarily pertains to the amortization of debt discount on the Alpha loans (see note 9).

Current wording

Interest expense. For the three months ended September 30, 2025, and 2024, our interest expenses were $53 thousand and $33 thousand, respectively.

Previous wording

*Income tax expense.*For the three months ended June 30, 2025, our income tax expense was approximately $62 thousand as compared to $4 thousand in the three months ended June 30, 2024.

Current wording

*Income tax expenses.*For the three months ended September 30, 2025, our income tax expenses were approximately $35 thousand as compared to $3 thousand in the three months ended September 30, 2024.

Previous wording

Net Loss. Our net loss for the three months ended June 30, 2025, increased by approximately $3,283 thousand, or 477%, reaching approximately $3,971 thousand, compared to a net loss of approximately $688 thousand for the same period in 2024. This increase in net loss was primarily due to the factors described above.

Current wording

Net Income (Loss). Our net income for the three months ended September 30, 2025, increased by approximately $1,508 thousand, or 151%, to approximately $510 thousand, compared to a net loss of approximately $998 thousand for the same period in 2024. This increase was primarily due to the factors described above.

Previous wording

Six Months Ended June 30, 2025, Compared to Six Months Ended June 30, 2024

Current wording

Nine Months Ended September 30, 2025, Compared to Nine Months Ended September 30, 2024

Previous wording

Gross profit as a percentage of revenues were approximately negative 7% and positive 52% for the three months ended June 30, 2025, and 2024, 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 23% and 58% for the nine months ended September 30, 2025, and 2024, 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 six months ended June 30, 2025 and 2024, research and development expenses were approximately $1,502 thousand and $308 thousand, respectively, an increase of approximately 388%, or $1,194 thousand, between the periods. The increase was mainly due to the costs of our clinical trial test program with the University of Michigan of approximately $624 thousand and the inclusion of expenses from ENvue’s operations following the ENvue Merger of approximately $318 thousand.

Current wording

Research and Development Expenses. For the nine months ended September 30, 2025, and 2024, research and development expenses were approximately $1,723 thousand and $557 thousand, respectively, an increase of approximately 209%, or $1,166 thousand, between the periods. The increase was mainly due to the costs of our clinical trial test program with the University of Michigan of approximately $624 thousand and the inclusion of expenses from ENvue’s operations following the ENvue Merger of approximately $464 thousand.

Previous wording

Selling and Marketing Expenses. For the six months ended June 30, 2025 and 2024, selling and marketing expenses were approximately $1,066 thousand and $364 thousand, respectively, a decrease of approximately 193%, or $702 thousand, between the periods. The increase was primarily due to the inclusion of approximately $741 thousand in expenses from ENvue’s operations following the ENvue Merger.

Current wording

Selling and Marketing Expenses. For the nine months ended September 30, 2025, and 2024, selling and marketing expenses were approximately $1,878 thousand and $545 thousand, respectively, an increase of approximately 245%, or $1,333 thousand, between the periods. The increase was primarily due to the inclusion of $1,157 thousand of expenses from ENvue’s operations following the ENvue Merger.

Previous wording

Selling and marketing expenses as a percentage of total revenues were relatively steady totaling approximately 70% and 21% for the six months ended June 30, 2025 and 2024, respectively.

Current wording

Selling and marketing expenses as a percentage of total revenues were relatively steady totaling approximately 84% and 26% for the nine months ended September 30, 2025, and 2024, respectively.

Previous wording

General and Administrative Expenses. For the six months ended June 30, 2025 and 2024, general and administrative expenses were approximately $3,594 thousand and $1,662 thousand, respectively, an increase of approximately 116%, or $1,932 thousand, between the periods. The increase was primarily due to professional fees incurred in connection with our Merger. Additionally, the inclusion of ENvue’s operations following the ENvue Merger led to an increase of approximately $939 thousand in general and administrative expenses.

Current wording

General and Administrative Expenses. For the nine months ended September 30, 2025, and 2024, general and administrative expenses were approximately $4,997 thousand and $2,335 thousand, respectively, an increase of approximately 114%, or $2,662 thousand, between the periods. The increase was primarily due to professional fees incurred in connection with the ENvue Merger and the inclusion of $1,496 thousand of expenses from ENvue’s operations following the ENvue Merger.

Previous wording

*Financial income, net.*For the three months ended June 30, 2025 and 2024, financial income, net was approximately $211 thousand compared to $24 thousand, respectively, an increase of approximately $187 thousand between the periods mainly due to the change in fair value of warrant liability of $1,410 thousand, offset by $1.1 million in professional fees related to the warrant liability and the inclusion of ENvue’s operations following the ENvue Merger added $11 thousand of financial expense.

Current wording

*Financial income, net.*For the nine months ended September 30, 2025, and 2024, financial income, net was approximately $3,104 thousand compared to an expense of $53 thousand, respectively, an increase of approximately $3,051 thousand between the periods mainly due to the change in fair value of warrant liability of $4,613 thousand, partially offset by $1,420 thousand in professional fees related to the warrant liability.

Previous wording

Interest expense. For the six months ended June 30, 2025 and 2024, interest expense was $197 thousand and $68 thousand, respectively. This primarily pertains to the amortization of debt discount on the Alpha loans (see note 9 to the consolidated condensed interim financial statements).

Current wording

Interest expense. For the nine months ended September 30, 2025, and 2024, interest expense was $250 thousand and $101 thousand, respectively. This primarily pertains to the amortization of debt discount on the Alpha loans (see note 9 to the consolidated condensed interim financial statements).

Previous wording

Income tax expenses. For the six months ended June 30, 2025 and 2024, tax expenses were $77 thousand and $11 thousand, respectively.

Current wording

Income tax expenses. For the nine months ended September 30, 2025, and 2024, tax expenses were $112 thousand and $14 thousand, respectively.

Previous wording

Net loss. Our net loss for the six months ended June 30, 2025, decreased by approximately $4,567 thousand, or 358%, totaling approximately $5,843 thousand, compared to a net loss of approximately $1,276 thousand for the same period in 2024. This decrease in net loss was primarily due to the factors described above.

Current wording

Net loss. Our net loss for the nine months ended September 30, 2025, increased by approximately $3,059 thousand, or 135%, totaling approximately $5,333 thousand, compared to a net loss of approximately $2,274 thousand for the same period in 2024. This decrease in net loss was primarily due to the factors described above.

Previous wording

As of June 30, 2025, the Company incurred recurring losses and negative cash flows from operations and had an accumulated deficit of $75,988. For the six months ended June 30, 2025, the Company used approximately $4,726 of cash in operating activities. During the same period, the Company received approximately $8,215 in net proceeds from the issuance of Series G Convertible Preferred Stock, $360 from the issuance of a short-term loan payable, $1,300 in proceeds from issuance of notes payable to a related party, and $102 from the exercise of options, and made payments on loans totaling $2,077. As a result, the Company reported a cash balance of approximately $4,060 as of June 30, 2025. Subsequent to period end, on July 18, 2025, the Company received gross proceeds of $8,000 from the sale of Series H Convertible Preferred Stock.

Current wording

As of September 30, 2025, the Company had incurred recurring losses and negative cash flows from operations and had an accumulated deficit of approximately $76.9 million. For the nine months ended September 30, 2025, the Company used approximately $6,696 thousand of cash in operating activities. During the same period, the Company received net proceeds of approximately $17.1 million from the issuance of common stock, preferred stock, and warrants, $2,000 thousand from a subscription payable, $1,300 thousand from the issuance of notes payable to a related party, $360 thousand from the issuance of a short-term loan payable, and $102 thousand from the exercise of options. These inflows were partially offset by $5,000 thousand used to repurchase certain shares of our Series X Preferred Stock, $1,300 thousand in payments of notes payable to a related party, and $1,777 thousand in payments of a short-term loan to a related party. As a result, the Company reported a cash balance of approximately $6,980 thousand as of September 30, 2025.

Previous wording

Because the Company does not have sufficient resources to fund our operation for the next twelve months from the date of the issuance of these unaudited interim condensed consolidated financial statements, management has substantial doubt regarding the Company’s ability to continue as a going concern. During the six months ended June 30, 2025, we met our short-term liquidity requirements 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. We expect to continue to incur losses and negative 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 are able to raise additional capital, as required, on terms favorable to us.

Current wording

Because the Company does not have sufficient resources to fund its operation for the next twelve months from the date of the issuance of these unaudited interim condensed consolidated financial statements, management has substantial doubt regarding the Company’s ability to continue as a going concern. During the nine months ended September 30, 2025, we met our short-term liquidity requirements 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. We expect to continue to incur losses and negative 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 are able to raise additional capital, as required, on terms favorable to us.

Previous wording

General. As of June 30, 2025, we had cash of approximately $4,060, compared to approximately $752 as of December 31, 2024. 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 September 30, 2025, we had cash and cash equivalents of approximately $6,980 thousand, compared to approximately $752 thousand as of December 31, 2024. 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 $4,726 for the six months ended June 30, 2025, and approximately $1,132 for the same period in 2024.

Current wording

Cash used in our operating activities was approximately $6,696 thousand for the nine months ended September 30, 2025, and approximately $1,968 thousand for the same period in 2024.

Previous wording

Cash provided in our investing activities was approximately $139 and cash used in investing activities was $3 for the six months ended June 30, 2025, and 2024, respectively. Cash provided in the six months ended June 30, 2025, is mainly from the cash acquired in the Merger.

Current wording

Cash provided in our investing activities was approximately $111 thousand and cash used in investing activities was $3 thousand for the nine months ended September 30, 2025, and 2024, respectively. Cash provided in the nine months ended September 30, 2025, is mainly from the cash acquired in the Merger.

Previous wording

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.

Current wording

Cash provided by financing activities during the nine months ended September 30, 2025 and 2024, was approximately $12.8 million and $1 thousand, respectively. This primarily resulted from net proceeds of $17.1 million from the issuance of common stock, preferred stock, and warrants, $2,000 thousand from proceeds of a tranche financing liability, $1,300 thousand from the issuance of notes payable to a related party, $360 thousand from the issuance of a short-term loan payable, and $102 thousand from the exercise of options. These inflows were partially offset by a $5,000 thousand repurchase of Series X Preferred Stock, payments of $1,300 thousand on notes payable to a related party, and $1,777 thousand on a short-term loan to a related party.

Previous wording

We believe that our future operating results will continue to be subject to quarterly variations based upon a wide variety of factors, including the ordering patterns of our distributors, timing of regulatory approvals, the implementation of various phases of our clinical trials and manufacturing efficiencies due to the learning curve of utilizing new materials and equipment as well issues that may continue to occur due to the development of the coronavirus outbreak. Our operating results could also be impacted by increased tariffs which may add additional costs to our manufacturing process, the hostilities in Israel, and the Middle East, including the interruption or curtailment of trade within Israel or between Israel and its trading partners, or the ability to ship our products overseas or a weakening of the Euro and strengthening of the New Israeli Shekel, or NIS, both against the U.S. dollar. Lastly, other economic conditions we cannot foresee may affect customer demand, such as individual country reimbursement policies pertaining to our products.

Current wording

We believe that our future operating results will continue to be subject to quarterly variations based upon a wide variety of factors, including the ordering patterns of our distributors, timing of regulatory approvals, the implementation of various phases of our clinical trials and manufacturing efficiencies due to the learning curve of utilizing new materials and equipment. Our operating results could also be impacted by increased tariffs which may add additional costs to our manufacturing process, the hostilities in Israel, and the Middle East, including the interruption or curtailment of trade within Israel or between Israel and its trading partners, or the ability to ship our products overseas or a weakening of the Euro and strengthening of the New Israeli Shekel, or NIS, both against the U.S. dollar. Lastly, other economic conditions we cannot foresee may affect customer demand, such as individual country reimbursement policies pertaining to our products.