CVRX 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-12

• We are a commercial-stage medical device company focused on developing, manufacturing, and commercializing innovative and minimally invasive neuromodulation solutions for patients with cardiovascular disease. Our proprietary platform technology, Barostim, is designed to leverage the power of the bra…

• 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

相对上期删除的文字 · 来源:10-Q · 2025-11-06

• We are a commercial-stage medical device company focused on developing, manufacturing, and commercializing innovative and minimally invasive neuromodulation solutions for patients with cardiovascular disease. Our proprietary platform technology, Barostim, is designed to leverage the power of the bra…

• Ejection Fraction (“HFrEF”) and other cardiovascular diseases. Our second-generation product, Barostim, is the first and only commercially available neuromodulation device indicated to improve symptoms for patients with HFrEF. Barostim provides Baroreflex Activation Therapy by sending imperceptible …

• In October 2025, the Centers for Medicare & Medicaid Services (“CMS”) released the final 2026 Medicare Physician Fee Schedule (“MPFS”). This final rule includes the new Category I CPT codes for the Barostim implant and follow-up services. The rule establishes national pricing for the code series use…

• 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 …

• Consolidated results of operations for the nine months ended September 30, 2025, compared to the nine months ended September 30, 2024

相对上期新增的文字 · 来源: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…

相对上期删除的文字 · 来源:10-Q · 2025-11-06

• During the three months ended September 30, 2025, 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.