CVRX — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-06

• 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 indicati…

• patients enrolled in the BENEFIT-HF trial, the landmark heart failure study evaluating Barostim in a significantly expanded patient population initiated earlier this year.

• 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 ap…

• 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 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 …

Text removed vs the prior filing · source: 10-Q · 2026-05-12

• 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 ann…

• 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…

• 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 2…

• 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. On the closing date, we borrowed an additional $10.0 million under the Loan Agreement.

Text added vs the prior filing · source: 10-Q · 2026-08-06

• controls and procedures were effective, at the reasonable assurance level, as of the end of the period covered by this Quarterly Report on Form 10-Q.

• There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the quarter ended June 30, 2026, that have materially affected, or are reasonably likely to materially affect, our internal control over fi…

Text removed vs the prior filing · source: 10-Q · 2026-05-12

• There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the quarter ended March 31, 2026, that have materially affected, or are reasonably likely to materially affect, our internal control over f…

Text added vs the prior filing · source: 10-Q · 2026-08-06

• From time to time, we may become involved in legal proceedings or be subject to claims arising in the ordinary course of our business. The information included in Note 10 to our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q is incorporated by re…

Text removed vs the prior filing · source: 10-Q · 2026-05-12

• From time to time, we may become involved in legal proceedings or be subject to claims arising in the ordinary course of our business. We are not currently a party to any material legal proceedings.

Text added vs the prior filing · source: 10-Q · 2026-08-06

• During the three months ended June 30, 2026, none of our directors or officers adopted, modified or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.

Text removed vs the prior filing · source: 10-Q · 2026-05-12

• During the three months ended March 31, 2026, none of our directors or officers adopted, modified or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K, except for certain sell-to-cover arrangements with o…