CVRx, Inc.

Previous wording

Humana, a national health insurance company with the second largest Medicare Advantage program in the U.S., announced that it issued a Medicare Advantage coverage policy for Barostim therapy, effective May 1, 2026. The new policy covers Barostim for patients meeting its current FDA-approved indication as well as patients enrolled in the BENEFIT-HF trial, the landmark heart failure study evaluating Barostim in a significantly expanded patient population initiated earlier this year.

Current wording

On July 17, 2026, Devoted Health issued a Medicare Advantage coverage policy for Barostim therapy. Devoted Health, a national health insurance company with the eighth largest Medicare Advantage enrollment in the U.S., provides coverage to approximately 466,000 Medicare Advantage members across 29 states. The new policy covers Barostim for patients meeting its current FDA-approved indication as well as patients enrolled in the

Previous wording

In July 2026, the Centers for Medicare & Medicaid Services, as part of the proposed rule for the 2027 Outpatient Prospective Payment System, proposed to retain the Barostim implant procedure under New Technology Ambulatory Payment Classification 1580, with an associated outpatient payment rate of approximately $45,000. The final rule is expected to be issued in November and take effect January 1, 2027.

Current wording

In November 2026, the Centers for Medicare and Medicaid Services issued the final rule for the 2027 Outpatient Prospective Payment System, retaining the Barostim implant procedure under New Technology APC 1580 with an outpatient payment rate of approximately $45,000, effective January 1, 2027.

Previous wording

As of June 30, 2026, we had a total of 258 active implanting centers in the U.S., as compared to 240 as of June 30, 2025. Active implanting centers are customers that have completed at least one commercial HF implant in the last 12 months. As of June 30, 2026, we had a total of 56 sales territories in the U.S. as compared to 47 sales territories as of June 30, 2025.

Current wording

As of September 30, 2026, we had a total of 262 active implanting centers in the U.S., compared to 250 as of September 30, 2025. Active implanting centers are customers that have completed at least one commercial HF implant in the last 12 months. As of September 30, 2026, the number of sales territories in the U.S. was 56, compared to 50 sales territories as of September 30, 2025.

Previous wording

Revenue generated in Europe was $0.9 million for the three months ended June 30, 2026, a $0.4 million decrease, or 31%, compared to the three months ended June 30, 2025. Total revenue units in Europe decreased to 40 for the three months ended June 30, 2026, as compared to 61 in the prior year period. We had five sales territories in Europe as of June 30, 2026 and June 30, 2025.

Current wording

Revenue generated in Europe was $0.9 million for the three months ended September 30, 2026, a decrease of $0.3 million, or 27%, compared to the three months ended September 30, 2025. Total revenue units in Europe decreased to 38 for the three months ended September 30, 2026, compared to 50 in the prior year period. The number of sales territories in Europe remained unchanged at five as of September 30, 2026 and September 30, 2025.

Previous wording

Cost of goods sold decreased $0.2 million, or 7%, to $2.0 million for the three months ended June 30, 2026, compared to the three months ended June 30, 2025. This decrease was driven by a lower cost per unit, primarily due to an increase in manufacturing efficiencies.

Current wording

Cost of goods sold decreased $0.1 million, or 5%, to $1.8 million for the three months ended September 30, 2026, compared to the three months ended September 30, 2025. This decrease was driven by a lower cost per unit, primarily due to an increase in manufacturing efficiencies.

Previous wording

SG&A expenses increased $0.3 million, or 1%, to $23.6 million for the three months ended June 30, 2026, compared to the three months ended June 30, 2025. This change was primarily driven by a $0.7 million increase in non-cash stock-based compensation expenses and a $0.5 million increase in legal expenses, partially offset by a $0.6 million decrease in advertising expenses and a $0.3 million decrease in travel expenses.

Current wording

SG&A expenses increased $0.5 million, or 2%, to $22.4 million for the three months ended September 30, 2026, compared to the three months ended September 30, 2025. This change was primarily driven by a $0.7 million increase in legal expenses, a $0.4 million increase in travel expenses, and a $0.4 million increase in consulting and contract labor expenses, partially offset by a $0.8 million decrease in advertising expenses and a $0.1 million decrease in insurance expenses.

Previous wording

Interest expense increased $0.1 million for the three months ended June 30, 2026, compared to the three months ended June 30, 2025. This increase was driven by the interest expense on higher levels of borrowings under the Loan Agreement.

Current wording

Interest expense increased $0.1 million for the three months ended September 30, 2026, compared to the three months ended September 30, 2025. This increase was driven by higher interest expense resulting from increased borrowings under the Loan Agreement.

Previous wording

Consolidated results of operations for the six months ended June 30, 2026, compared to the six months ended June 30, 2025

Current wording

Consolidated results of operations for the nine months ended September 30, 2026, compared to the nine months ended September 30, 2025

Previous wording

Revenue generated in the U.S. was $14.8 million for the three months ended June 30, 2026, an increase of $2.5 million, or 21%, compared to the three months ended June 30, 2025. Revenue units in the U.S. totaled 466 and 391 for the three months ended June 30, 2026 and 2025, respectively. The increases were primarily driven by continued growth in the U.S. HF business as a result of the expansion into new sales territories, new accounts, and increased physician and patient awareness of Barostim.

Current wording

Revenue generated in the U.S. was $41.4 million for the nine months ended September 30, 2026, an increase of $4.5 million, or 12%, compared to the nine months ended September 30, 2025. Revenue units in the U.S. totaled 1,307 and 1,170 for the nine months ended September 30, 2026 and 2025, respectively. The increases were primarily driven by continued growth in the U.S. HF business as a result of the expansion into new sales territories, new accounts, and increased physician and patient awareness of Barostim.

Previous wording

Revenue generated in Europe was $2.0 million for the six months ended June 30, 2026, a $0.4 million decrease, or 18%, compared to the six months ended June 30, 2025. Total revenue units in Europe decreased to 96 for the six months ended June 30, 2026, as compared to 120 in the prior year period.

Current wording

Revenue generated in Europe was $2.9 million for the nine months ended September 30, 2026, a $0.8 million decrease, or 21%, compared to the nine months ended September 30, 2025. Total revenue units in Europe decreased to 134 for the nine months ended September 30, 2026, compared to 170 in the prior year period.

Previous wording

Cost of goods sold decreased $0.3 million, or 7%, to $3.9 million for the six months ended June 30, 2026, compared to the six months ended June 30, 2025. This decrease was driven by a lower cost per unit, primarily due to an increase in manufacturing efficiencies.

Current wording

Cost of goods sold decreased $0.4 million, or 7%, to $5.7 million for the nine months ended September 30, 2026, compared to the nine months ended September 30, 2025. This decrease was driven by a lower cost per unit, primarily due to an increase in manufacturing efficiencies.

Previous wording

Gross profit was $13.7 million for the three months ended June 30, 2026, an increase of $2.3 million, or 20%, over the three months ended June 30, 2025. Gross margin increased to 87% for the three months ended June 30, 2026, compared to 84% for the three months ended June 30, 2025. Gross margin for the three months ended June 30, 2026 was higher due to an increase in the average selling price and a decrease in the cost per unit, primarily due to an increase in manufacturing efficiencies.

Current wording

Gross profit was $38.6 million for the nine months ended September 30, 2026, an increase of $4.1 million, or 12%, over the nine months ended September 30, 2025. Gross margin increased to 87% for the nine months ended September 30, 2026, compared to 85% for the nine months ended September 30, 2025. Gross margin for the nine months ended September 30, 2026 was higher due to an increase in the average selling price and a decrease in the cost per unit, primarily due to an increase in manufacturing efficiencies.

Previous wording

R&D expenses increased $0.7 million, or 27%, to $3.1 million for the three months ended June 30, 2026, compared to the three months ended June 30, 2025. This change was driven by a $0.6 million increase in headcount expenses and a $0.1 million increase in clinical trial expenses.

Current wording

R&D expenses increased $0.7 million, or 9%, to $8.9 million for the nine months ended September 30, 2026, compared to the nine months ended September 30, 2025. This change was driven by a $0.4 million increase in headcount expenses and a $0.3 million increase in non-cash stock-based compensation expenses.

Previous wording

SG&A expenses increased $1.0 million, or 2%, to $45.6 million for the six months ended June 30, 2026, compared to the six months ended June 30, 2025. This change was primarily driven by a $1.0 million increase in non-cash stock-based compensation expense, a $0.9 million increase in headcount expense, and a $0.6 million increase in legal expenses, partially offset by a $0.9 million decrease in advertising expenses, a $0.3 million decrease in consulting expense, and a $0.3 million decrease in travel expenses.

Current wording

SG&A expenses increased $1.5 million, or 2%, to $68.0 million for the nine months ended September 30, 2026, compared to the nine months ended September 30, 2025. This change was primarily driven by a $1.3 million increase in legal expenses, a $1.0 million increase in headcount expenses, a $1.0 million increase in non-cash stock-based compensation expense, and a $0.3 million increase in consulting expenses, partially offset by a $1.7 million decrease in advertising expenses, a $0.2 million decrease in insurance expense, and a $0.1 million decrease in bad debt expenses.

Previous wording

Interest expense increased $0.2 million for the six months ended June 30, 2026, compared to the six months ended June 30, 2025. This increase was driven by the interest expense on higher levels of borrowings under the Loan Agreement.

Current wording

Interest expense increased $0.3 million for the nine months ended September 30, 2026, compared to the nine months ended September 30, 2025. This increase was driven by higher interest expense resulting from increased borrowings under the Loan Agreement.

Previous wording

Other income, net decreased $1.1 million for the six months ended June 30, 2026, compared to the six months ended June 30, 2025. This decrease was primarily driven by decreased interest income on our interest-bearing accounts.

Current wording

Other income, net decreased $1.5 million for the nine months ended September 30, 2026, compared to the nine months ended September 30, 2025. This decrease was primarily driven by decreased interest income on our interest-bearing accounts.

Previous wording

Benefit (provision) for income taxes was nominal for each of the six months ended June 30, 2026 and 2025.

Current wording

Benefit (provision) for income taxes was nominal for each of the nine months ended September 30, 2026 and 2025.

Previous wording

We have incurred significant operating losses and negative cash flows from operations since our inception, and we anticipate that we will incur significant losses for at least the next several years. As of June 30, 2026 and December 31, 2025, we had cash and cash equivalents of $64.6 million and $75.7 million, respectively. For the three months ended June 30, 2026 and 2025, our net losses were $14.0 million and $14.7 million, respectively. For the six months ended June 30, 2026 and 2025, our net losses were $27.2 million and $28.5 million, respectively. Our net cash used in operating activities for the six months ended June 30, 2026 and 2025 was $21.0 million and $20.7 million, respectively.

Current wording

We have incurred significant operating losses and negative cash flows from operations since our inception, and we anticipate that we will incur significant losses for at least the next several years. As of September 30, 2026 and December 31, 2025, we had cash and cash equivalents of $58.7 million and $75.7 million, respectively. For the three months ended September 30, 2026 and 2025, our net losses were $14.2 million and $12.9 million, respectively. For the nine months ended September 30, 2026 and 2025, our net losses were $41.3 million and $41.4 million, respectively. Our net cash used in operating activities for the nine months ended September 30, 2026 and 2025 was $31.9 million and $30.4 million, respectively.

Previous wording

On October 31, 2022, we entered into the Loan Agreement under which we were allowed to borrow, subject to our achievement of certain milestones, up to a total of $50.0 million in a series of Term Loans described in Note 4 to our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q. On January 9, 2026, we entered into an Amendment to our existing Loan Agreement. Pursuant to the Amendment, the term loans available were increased by $50.0 million, to an aggregate principal amount of up to $100.0 million, subject to our achievement of certain milestones. In connection with the Amendment, we borrowed an additional $10.0 million under the Loan Agreement. We had $60.0 millionin outstanding Term Loans under the Loan Agreement as of June 30, 2026.

Current wording

On October 31, 2022, we entered into the Loan Agreement under which we were allowed to borrow, subject to our achievement of certain milestones, up to a total of $50.0 million in a series of Term Loans described in Note 4 to our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q. On January 9, 2026, we entered into an Amendment to our existing Loan Agreement. Pursuant to the Amendment, the term loans available were increased by $50.0 million, to an aggregate principal amount of up to $100.0 million, subject to our achievement of certain milestones, and the maturity date was extended to 2031. In connection with the Amendment, we borrowed an additional $10.0 million under the Loan Agreement. We had$60.0 million in outstanding Term Loans under the Loan Agreement as of September 30, 2026.

Previous wording

On November 4, 2022, we entered into an Equity Distribution Agreement with Piper Sandler & Co., as agent, under which we may offer and sell, from time to time at our sole discretion, shares of our common stock having an aggregate offering price of up to $50.0 million in an ATM offering, to or through the agent. We issued 543,462 shares of common stock for gross proceeds of $9.5 million during the year ended December 31, 2025. On November 4, 2025, we and the agent mutually agreed to terminate the Equity Distribution Agreement for the ATM, effective on November 6, 2025. On January 12, 2026, we entered into a Sale Agreement with Jefferies

Current wording

On November 4, 2022, we entered into an Equity Distribution Agreement with Piper Sandler & Co., as agent, under which we may offer and sell, from time to time at our sole discretion, shares of our common stock having an aggregate offering price of up to $50.0 million in an ATM offering, to or through the agent. We issued 543,462 shares of common stock for gross proceeds of $9.5 million during the year ended December 31, 2025. On

Previous wording

LLC, as agent. Pursuant to the terms of the Sale Agreement, we may offer and sell, from time to time at our sole discretion, shares of common stock having an aggregate offering price up to $50.0 million in an ATM offering, to or through the agent. We issued 102,154 shares of common stock for gross proceeds of $0.8 million during the six months ended June 30, 2026. We have remaining capacity to issue and sell up to approximately $49.2 million of additional shares of common stock under this ATM offering.

Current wording

November 4, 2025, we and the agent mutually agreed to terminate the Equity Distribution Agreement for the ATM, effective on November 6, 2025. On January 12, 2026, we entered into a Sale Agreement with Jefferies LLC, as agent. Pursuant to the terms of the Sale Agreement, we may offer and sell, from time to time at our sole discretion, shares of common stock having an aggregate offering price up to $50.0 million in an ATM offering, to or through the agent. We issued 1,940,668 shares of common stock for gross proceeds of $6.3 million during the nine months ended September 30, 2026. We have remaining capacity to issue and sell up to approximately $43.7 million of additional shares of common stock under this ATM offering.

Previous wording

Net cash used in operating activities for the six months ended June 30, 2026 was $21.0 million and consisted primarily of a net loss of $27.2 million, partially offset by a non-cash charge of $6.6 million related to stock-based compensation expense, and a change in net operating assets of $1.0 million. Net operating assets consisted primarily of accrued expenses, accounts receivable, inventory, prepaid expenses and other current assets, and accounts payable to support the growth of our operations.

Current wording

Net cash used in operating activities for the nine months ended September 30, 2026 was $31.9 million and consisted primarily of a net loss of $41.3 million, partially offset by a non-cash charge of $9.5 million related to stock-based compensation expense, and a change in net operating assets of $0.9 million. Net operating assets consisted primarily of inventory, accounts receivable, accrued expenses, accounts payable, and prepaid expenses and other current assets to support the growth of our operations.

Previous wording

Net cash used in operating activities for thesix months ended June 30, 2025 was $20.7 million and consisted primarily of a net loss of $28.5 million, partially offset by a non-cash charge of $5.4 million related to stock-based compensation expense and a change in net operating assets of $1.9 million. Net operating assets consisted primarily of accounts receivable, accrued expenses, accounts payable, inventory, and prepaid expenses and other current assets to support the growth of our operations.

Current wording

Net cash used in operating activities for thenine months ended September 30, 2025 was $30.4 million and consisted primarily of a net loss of $41.4 million, partially offset by a non-cash charge of $8.3 million related to stock-based compensation expense, and a change in net operating assets of $2.0 million. Net operating assets consisted primarily of accounts receivable, accounts payable, inventory, prepaid expenses and other current assets, and accrued expenses to support the growth of our operations.

Previous wording

Cash used in investing activities was $0.2 million for each of the six months ended June 30, 2026 and 2025, respectively, and consisted of purchases of property and equipment.

Current wording

Cash used in investing activities was $0.3 million and $0.5 million for the nine months ended September 30, 2026 and 2025, respectively, and consisted of purchases of property and equipment.

Previous wording

Net cash provided by financing activities for the six months ended June 30, 2026 was $10.1 million and consisted of $8.9 million related to net proceeds from the debt financing, $0.7 million related to proceeds from the issuance of common stock, $0.4 million related to proceeds from the ESPP, and $0.1 million related to proceeds from the exercise of common stock options.

Current wording

Net cash provided by financing activities for the nine months ended September 30, 2026 was $15.3 million and consisted of $8.9 million related to net proceeds from the debt financing, $5.9 million related to proceeds from the issuance of common stock, $0.4 million related to proceeds from the ESPP, and $0.1 million related to proceeds from the exercise of common stock options.

Previous wording

Net cash provided by financing activities for the six months ended June 30, 2025 was $10.0 million and consisted of $9.2 million related to net proceeds from the issuance of common stock through the ATM offering, $0.4 million related to proceeds from the exercise of common stock options and $0.4 million related to proceeds from the ESPP.

Current wording

Net cash provided by financing activities for the nine months ended September 30, 2025 was $10.1 million and consisted of $9.2 million related to net proceeds from the issuance of common stock through the ATM offering, $0.6 million related to proceeds from the exercise of common stock options and $0.4 million related to proceeds from the ESPP.

Previous wording

There have been no material changes to our contractual obligations as of June 30, 2026, as compared to those disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025.

Current wording

There have been no material changes to our contractual obligations as of September 30, 2026, compared to those disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025.

Previous wording

For a discussion of our potential risks and uncertainties, see the information in Part II, Item 7. “Management's Discussion and Analysis of Financial Condition and Results of Operations—Critical accounting policies and estimates" in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025. We have reviewed and determined that those critical accounting policies and estimates remain our critical accounting policies and estimates as of and for the six months ended June 30, 2026.

Current wording

For a discussion of our potential risks and uncertainties, see the information in Part II, Item 7. “Management's Discussion and Analysis of Financial Condition and Results of Operations—Critical accounting policies and estimates" in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025. We have reviewed and determined that those critical accounting policies and estimates remain our critical accounting policies and estimates as of and for thenine months ended September 30, 2026.