CVRx, Inc.
For the period ended Jun 30, 2026. Filed Aug 6, 2026.
View on SEC.govAbout this filing
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 6, 2026
CVRX$0.87-40.9%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-12.
0001104659-26-059023
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-06.
0001628280-26-054336
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 83 previous paragraphs and 94 current paragraphs.
41 unchanged; 21 reworded; 26 added; 17 removed; 4 previous and 6 current paragraphs rearranged.
Tables are not compared: 17 previous and 5 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
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 report
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 report
We expect a lower rate of year-over-year revenue growth in the second half of fiscal 2026 than we experienced in the first half of fiscal 2026. This outlook is driven by fewer sales territories than anticipated, lower sales force productivity and a prolonged challenge with one of the largest payers. We are taking direct action to address these headwinds, including continuing to improve our hiring process, investing in onboarding and training and creating multiple field-based reimbursement and business management roles, funded through a reallocation of resources. We also continue to appeal prior authorization denials to advocate on behalf of patients. We continue to see strong growth in our most stable regions, while at the same time we continue to advance our BENEFIT-HF trial and our broader clinical and reimbursement strategies.
Current report
•Growing and supporting our U.S. commercial organization;
Current report
•Promoting awareness among physicians, hospitals, and patients to accelerate adoption of Barostim;
Current report
•Continuing to develop and disseminate clinical evidence supporting the benefits of Barostim;
Current report
•Raising awareness among payers to build upon reimbursement for Barostim;
Current report
•Investing in research and development to foster innovation; and
Current report
•Leveraging our manufacturing capacity to further improve our gross margins.
Current report
Revenue was $15.7 million for the three months ended June 30, 2026, an increase of $2.1 million, or 16%, over the three months ended June 30, 2025.
Current report
Other income, net decreased $0.6 million for the three months ended June 30, 2026 compared to the three months ended June 30, 2025. This decrease was driven by the interest income on lower balances of our interest-bearing accounts.
Current report
Consolidated results of operations for the six months ended June 30, 2026, compared to the six months ended June 30, 2025
Current report
Revenue was $30.5 million for the six months ended June 30, 2026, an increase of $4.5 million, or 17%, over the six months ended June 30, 2025.
Current report
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 report
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 report
Gross profit was $26.6 million for the six months ended June 30, 2026, an increase of $4.8 million, or 22%, over the six months ended June 30, 2025. Gross margin increased to 87% for the six months ended June 30, 2026, compared to 84% for the six months ended June 30, 2025. Gross margin for the six months ended June 30,
Current report
R&D expenses increased $1.2 million, or 25%, to $6.2 million for the six months ended June 30, 2026, compared to the six months ended June 30, 2025. This change was driven by a $0.9 million increase in headcount expenses and a $0.4 million increase in consulting expense.
Current report
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 report
•our investment in our U.S. commercial infrastructure and sales forces;
Current report
•the degree and rate of market acceptance of Barostim and the ability for our customers to obtain appropriate levels of reimbursement;
Current report
•the costs of commercialization activities, including product sales, marketing, manufacturing, and distribution;
Current report
•our R&D activities for product enhancements and to expand our indications;
Current report
•the costs of filing, prosecuting, defending, and enforcing any patent claims and other intellectual property rights;
Current report
•our need to implement additional infrastructure and internal systems;
Current report
•our ability to hire additional personnel to support our operations as a public company; and
Current report
•the emergence of competing technologies or other adverse market developments.
Removed paragraphs (17)
Previous report
As previously disclosed, the Category I CPT codes for Baroreflex Activation Therapy using our Barostim device replaced Category III codes as of January 1, 2026, which eliminates the automatic denials regularly seen with Category III codes and improves prior authorization predictability to fairly pay physicians for the procedure. Early data in 2026 showed an increase in the 30-day approval rate for Medicare Advantage prior authorizations managed by our in-house market access team. At the same time that payers were incorporating this coding change, other regulatory changes took effect January 1, 2026 that accelerated the deadline for Medicare Advantage payers to respond to prior authorization requests. We believe this caused Medicare Advantage payers to respond with a higher rate of initial denials as the quarter progressed, which slowed the 30-day approval rate for March 2026. As a result, the 30-day approval rate for Medicare Advantage prior authorizations managed by our in-house market access team increased from 31% in 2024 to 44% in 2025 and to 46% for the first quarter of 2026. We expect the overall approval rate to continue to increase, although the speed of approval may be temporarily delayed.
Previous report
In November 2025, the FDA granted an investigational device exemption (“IDE”) study designed as a prospective, multi-center, randomized controlled trial to evaluate the Barostim device’s impact on all-cause mortality and HF decompensation events in an expanded population of HF patients. In January 2026, we initiated the trial, supported by CMS Category B IDE coverage. We expect to begin enrolling the trial across approximately 150 centers in the first half of 2026 and complete enrollment within five years. The trial provides for a two-year follow-up period, resulting in the expected conclusion of the trial in five to seven years. On March 31, 2026, the first site was activated in the BENEFIT-HF trial and the first patient was enrolled in the second quarter of 2026.
Previous report
On January 9, 2026, we entered into an Amendment to our existing Loan Agreement. Pursuant to the Amendment, the terms loans available were increased by $50.0 million, to an aggregate principal amount of
Previous report
Cost of goods sold and gross margin
Previous report
Research and development expenses
Previous report
Selling, general and administrative expenses
Previous report
Interest expense
Previous report
Other income, net
Previous report
Benefit (provision) for income taxes
Previous report
Revenue was $14.8 million for the three months ended March 31, 2026, an increase of $2.4 million, or 20%, over the three months ended March 31, 2025.
Previous report
Cost of goods sold and gross margin
Previous report
Research and development expenses
Previous report
Selling, general and administrative expenses
Previous report
Interest expense
Previous report
Other income, net
Previous report
Benefit (provision) for income taxes
Previous report
Net cash provided by financing activities for the three months ended March 31, 2026 was $8.9 million and consisted primarily of $10.0 million related to net proceeds from debt financing partially offset by $1.1 million related to the debt financing costs.
Reworded paragraphs (21)
Previous wording
The costs for the device and implantation procedure are reimbursed through various third-party payers, such as government agencies and commercial payers. In the U.S., we estimate that 67% of our target patient population is Medicare-eligible based on the age demographic of the HFrEF patient population indicated for Barostim. As a result, we have prioritized coverage by the Centers for Medicare and Medicaid Services while simultaneously developing processes to engage commercial payers. All Medicare Administrative Contractors have retired their official automatic coverage denial policies for our Current Procedural Terminology (“CPT”) codes, thereby allowing hospitals to submit payment requests for the Barostim procedure to be adjudicated on a claim-by-claim basis. Our reimbursement strategy involves continuing to broaden our current coverage and build our in-house market access team to obtain appropriate prior authorization approvals in advance of
Current wording
The costs for the device and implantation procedure are reimbursed through various third-party payers, such as government agencies and commercial payers. In the U.S., we estimate that 67% of our target patient population is Medicare-eligible based on the age demographic of the HFrEF patient population indicated for Barostim. As a result, we have prioritized coverage by the Centers for Medicare and Medicaid Services while simultaneously developing processes to engage commercial payers. All Medicare Administrative Contractors have retired their official automatic coverage denial policies for our Current Procedural Terminology ("CPT") codes, thereby allowing hospitals to submit payment requests for the Barostim procedure to be adjudicated on a claim-by-claim basis. Our reimbursement strategy involves continuing to broaden our current coverage and build our in-house market access team to obtain appropriate prior authorization approvals in advance of treatment on a case-by-case basis where positive coverage policies currently do not exist. Outside the U.S., reimbursement levels vary by country and within some countries by region. Barostim is eligible for reimbursement in certain countries in the European Economic Area, such as Germany, where annual healthcare budgets for the hospital generally determine the number of patients to be treated and the prices to be paid for the related devices that may be purchased.
Previous wording
On October 31, 2022, we entered into the Loan Agreement allowing borrowing, 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 terms 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. We had $60.0 million in outstanding Term Loans under the Loan Agreement as of March 31, 2026.
Current wording
On October 31, 2022, we entered into the Loan Agreement allowing borrowing, 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 June 30, 2026.
Previous wording
the percentage of products we sold to distributors as compared to those sold directly to hospitals, as our average selling price is typically higher on products we sell directly. The full system sales typically have a lower gross margin as they include the cost of an IPG and a stimulation lead whereas individual IPG sales only include the cost of an IPG. The manufacturing overhead costs of Barostim are directly aligned to our production volume and therefore the cost per product is reduced if production levels increase. While we expect our gross margin to be positively affected over time to the extent we are successful in selling more product through our direct sales force and by increasing our production volumes, it will likely fluctuate from period to period as we continue to introduce new or modified products and adopt new manufacturing processes and technologies.
Current wording
We calculate gross margin as revenue less cost of goods sold divided by revenue. Our gross margin has been and will continue to be affected by a variety of factors, but is primarily driven by the average sale price of our product, the percentage of products sold that include a full system (i.e., an IPG and a stimulation lead), as compared to individual IPG sales, and the allocated manufacturing overhead. Although we sell the majority of our devices directly to hospitals, the impact of the average selling price on gross margin is driven by the percentage of products we sold to distributors as compared to those sold directly to hospitals, as our average selling price is typically higher on products we sell directly. The full system sales typically have a lower gross margin as they include the cost of an IPG and a stimulation lead whereas individual IPG sales only include the cost of an IPG. The manufacturing overhead costs of Barostim are directly aligned to our production volume and therefore the cost per product is reduced if production levels increase. While we expect our gross margin to be positively affected over time to the extent we are successful in selling more product through our direct sales force and by increasing our production volumes, it will likely fluctuate from period to period as we continue to introduce new or modified products and adopt new manufacturing processes and technologies.
Previous wording
Revenue generated in the U.S. was $13.7 million for the three months ended March 31, 2026, an increase of $2.4 million, or 22%, over the three months ended March 31, 2025. Revenue units in the U.S. totaled 429 and 359 for the three months ended March 31, 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 $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.
Previous wording
As of March 31, 2026, we had a total of 257 active implanting centers in the U.S., as compared to 227 as of March 31, 2025. Active implanting centers are customers that have completed at least one commercial HF implant in the last 12 months. As of March 31, 2026, we had a total of 56 sales territories in the U.S. as compared to 45 sales territories as of March 31, 2025.
Current 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.
Previous wording
Revenue generated in Europe was $1.1 million for the three months ended March 31, 2026, a $27,000 decrease, or 2%, compared to the three months ended March 31, 2025. Total revenue units in Europe decreased to 56 for the three months ended March 31, 2026, as compared to 59 in the prior year period. We had five sales territories in Europe as of March 31, 2026 and March 31, 2025.
Current 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.
Previous wording
Cost of goods sold decreased $0.1 million, or 7%, to $1.9 million for the three months ended March 31, 2026, compared to the three months ended March 31, 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 $0.2 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.
Previous wording
Gross profit was $12.9 million for the three months ended March 31, 2026, an increase of $2.6 million, or 25%, over the three months ended March 31, 2025. Gross margin increased to 87% for the three months ended March 31, 2026, compared to 84% for the three months ended March 31, 2025. Gross margin for the three months ended March 31, 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 $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.
Previous wording
R&D expenses increased $0.6 million, or 23%, to $3.1 million for the three months ended March 31, 2026, compared to the three months ended March 31, 2025. This change was driven by a $0.4 million increase in consulting expenses, a $0.3 million increase in compensation expenses, and a $0.1 million increase in non-cash stock-based compensation expenses, partially offset by a $0.2 million decrease in clinical trial expenses.
Current 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.
Previous wording
SG&A expenses increased $0.7 million, or 3%, to $22.0 million for the three months ended March 31, 2026, compared to the three months ended March 31, 2025. This change was primarily driven by a $1.0 million increase in compensation expenses and a $0.3 million increase in non-cash stock-based compensation expenses, partially offset by a $0.3 million decrease in consulting expenses and a $0.3 million decrease in advertising expenses.
Current 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.
Previous wording
Other income, net was $0.6 and $1.1 million for the three months ended March 31, 2026 and 2025, respectively. These balances consisted of interest income on our interest-bearing accounts. The decrease was primarily driven by the lower cash balance.
Current 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.
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 March 31, 2026 and December 31, 2025, we had cash and cash equivalents of $72.3 million and $75.7 million, respectively. For the three months ended March 31, 2026 and 2025, our net losses were $13.1 million and $13.8 million, respectively. Our net cash used in operating activities for the three months ended March 31, 2026 and 2025 was $12.2 million and $12.8 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 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.
Previous wording
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 terms 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. On the closing date, 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 March 31, 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. 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.
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 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.
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 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
Previous wording
On January 12, 2026, we entered into the 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.
Current 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.
Previous wording
We believe that our existing cash resources together with cash from operations will be sufficient to meet our forecasted requirements for operating liquidity, capital expenditures and debt services for at least the next two years. If these sources are insufficient to satisfy our liquidity requirements, or provide funding to execute or accelerate our growth strategies, however, we may seek to sell additional equity or enter into an additional loan agreement. If we raise additional funds by issuing equity securities, our stockholders would experience dilution. Additional debt financing, if available, may involve covenants further restricting our operations or our ability to incur additional debt. Any such debt financing or additional equity that we raise may contain terms that are not favorable to us or our stockholders.
Current wording
We believe that our existing cash resources together with cash from operations will be sufficient to meet our forecasted requirements for operating liquidity, capital expenditures and debt services for more than eighteen months. If these sources are insufficient to meet our liquidity requirements, or to fund the execution or acceleration of our growth strategies, we may seek additional equity financing or enter into an additional loan agreement. If we raise additional funds by issuing equity securities, our stockholders would experience dilution. Additional debt financing, if available, may involve covenants further restricting our operations or our ability to incur additional debt. Any such debt financing or additional equity that we raise may contain terms that are not favorable to us or our stockholders.
Previous wording
Net cash used in operating activities for the three months ended March 31, 2026 was $12.2 million and consisted primarily of a net loss of $13.1 million, partially offset by a non-cash charge of $2.9 million related to stock-based compensation expense, and a change in net operating assets of $2.2 million. Net operating assets consisted primarily of accrued expenses, accounts receivable, 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 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.
Previous wording
Net cash used in operating activities for the three months ended March 31, 2025 was $12.8 million and consisted primarily of a net loss of $13.8 million and a change in net operating assets of $1.7 million, partially offset by a non-cash charge of $2.5 million related to stock-based compensation expense.
Current 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.
Previous wording
Cash used in investing activities was $0.1 million for each of the three months ended March 31, 2026 and 2025, respectively, and consisted of purchases of property and equipment.
Current 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.
Previous wording
Net cash provided by financing activities for the three months ended March 31, 2025 was $9.6 million and consisted of $9.2 million related to net proceeds from the issuance of common stock through the ATM offering and $0.4 million related to proceeds from the exercise of common stock options.
Current 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.
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 three months ended March 31, 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 the six months ended June 30, 2026.
Rearranged current paragraphs (6)
Current report — wording carried from elsewhere
The following table provides revenue by geography:
Current report — wording carried from elsewhere
Revenue generated in the U.S. was $28.4 million for the six months ended June 30, 2026, an increase of $5.0 million, or 21%, compared to the six months ended June 30, 2025. Revenue units in the U.S. totaled 895 and 750 for the six 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 report — wording carried from elsewhere
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 report — wording carried from elsewhere
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 report — wording carried from elsewhere
Benefit (provision) for income taxes was nominal for each of the six months ended June 30, 2026 and 2025.
Current report — wording carried from elsewhere
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.
Rearranged previous paragraphs (4)
Previous report — wording carried elsewhere
treatment on a case-by-case basis where positive coverage policies currently do not exist. Outside the U.S., reimbursement levels vary by country and within some countries by region. Barostim is eligible for reimbursement in certain countries in the European Economic Area, such as Germany, where annual healthcare budgets for the hospital generally determine the number of patients to be treated and the prices to be paid for the related devices that may be purchased.
Previous report — wording carried elsewhere
up to $100.0 million, subject to our achievement of certain milestones, and the maturity date was extended to 2031. On the closing date, we borrowed an additional $10.0 million under the Loan Agreement.
Previous report — wording carried elsewhere
We calculate gross margin as revenue less cost of goods sold divided by revenue. Our gross margin has been and will continue to be affected by a variety of factors, but is primarily driven by the average sale price of our product, the percentage of products sold that include a full system (i.e., an IPG and a stimulation lead), as compared to individual IPG sales, and the allocated manufacturing overhead. Although we sell the majority of our devices directly to hospitals, the impact of the average selling price on gross margin is driven by
Previous report — wording carried elsewhere
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