UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 7.01. Regulation FD Disclosure.
As announced earlier by CVRx, Inc. (the “Company”), the previously-released preliminary results of the Company’s BeAT-HF post-market randomized clinical trial will be discussed at the second annual Technology and Heart Failure Therapeutics (THT) conference on March 21, 2023. The results will be presented by Dr. Michael Zile, followed by a symposium sponsored by the Company. The Company will also host an investor conference call at 4:30 pm Eastern Time on March 21, 2023 to discuss the results.
A press release summarizing the detailed results and the presentation materials, which will also be used for the investor conference, are attached as Exhibits 99.1 and 99.2, respectively, and are incorporated herein by reference.
The information contained in this Item 7.01, including Exhibits 99.1 and 99.2, is being furnished and shall not be deemed to be “filed” with the Securities and Exchange Commission for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section and is not incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such a filing.
Item 8.01. Other Events.
On March 21, 2023, the Company issued a press release announcing highlights of the data from the BeAT-HF post-market randomized clinical trial, as follows:
| • | Safety - Major Adverse Neurological or Cardiovascular (MANCE) system or procedure-related event-free rate |
| o | MANCE-free rate of 97% (p<0.001) |
| • | Long-term symptom improvement for Barostim Baroreflex Activation Therapy (BAT) vs. Control: |
| o | 6 Minute Hall Walk improved by 44 meters at 12 months (nominal p<0.001) |
| o | Quality of Life improved by 10 points in Minnesota Living with Heart Failure Questionnaire at 24 months (nominal p<0.001) |
| o | NYHA Class improved in 27% more BAT patients at 24 months (nominal p<0.001) |
| • | Mortality (cardiovascular death, LVAD, heart transplant) and morbidity (HF hospitalizations, ER visits) – primary endpoint |
| o | No statistically significant difference [Rate Ratio 0.94, (95% Confidence Interval 0.57, 1.57); p=0.82] |
| • | All-cause mortality (all-cause death, LVAD, heart transplant) |
| o | 34% relative reduction in BAT vs. Control [Hazard Ratio 0.66 (95% CI 0.44, 1.007); nominal p=0.054] |
| • | Hierarchical composite of cardiovascular death, LVAD, heart transplant, HF hospitalization, and Quality of Life using Win Ratio |
| o | Win Ratio of 1.26 favored BAT vs. Control [95% CI 1.02, 1.58; nominal p=0.04] |
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 | Press release of CVRx, Inc., dated March 21, 2023 | |
| 99.2 | Presentation of CVRx, Inc., dated March 21, 2023 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
CVRx, Inc. | ||
| Date: March 21, 2023 | By: | /s/ Jared Oasheim |
| Name: Jared Oasheim | ||
| Its: Chief Financial Officer | ||