# EDGAR Filing Document

**Accession Number:** 0001235912
**File Stem:** 0001104659-23-034843
**Filing Date:** 2023-3
**Character Count:** 42799
**Document Hash:** 2218f222269eb9511930ec423998bb8d
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001104659-23-034843.hdr.sgml**: 20230321

**ACCESSION NUMBER**: 0001104659-23-034843

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 50

**CONFORMED PERIOD OF REPORT**: 20230321

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230321

**DATE AS OF CHANGE**: 20230321

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** CVRx, Inc.
- **CENTRAL INDEX KEY:** 0001235912
- **STANDARD INDUSTRIAL CLASSIFICATION:** SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
- **IRS NUMBER:** 000000000
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-40545
- **FILM NUMBER:** 23748317

**BUSINESS ADDRESS:**
- **STREET 1:** 9201 WEST BROADWAY AVENUE
- **STREET 2:** SUITE 650
- **CITY:** MINNEAPOLIS
- **STATE:** MN
- **ZIP:** 55445
- **BUSINESS PHONE:** 7634162850

**MAIL ADDRESS:**
- **STREET 1:** 9201 WEST BROADWAY AVENUE
- **STREET 2:** SUITE 650
- **CITY:** MINNEAPOLIS
- **STATE:** MN
- **ZIP:** 55445

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** CVRX INC
- **DATE OF NAME CHANGE:** 20030527

?xml version="1.0" encoding="utf-8"?

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**Washington, D.C. 20549**

**FORM 8-K**

**CURRENT REPORT**

**Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934**

Date of report (Date of earliest event reported): **March 21, 2023**

**CVRx, Inc.**

(Exact name of registrant as specified in its charter)

---

| | | |
|:---|:---|:---|
| **Delaware** | **001-40545** | **41-1983744** |
| (State or other jurisdiction of<br> incorporation) | (Commission<br> File Number) | (I.R.S. Employer<br> Identification No.) |

---

**9201 West Broadway Avenue** **, Suite 650** 

**Minneapolis** **, MN 55445**

(Address of principal executive offices) (Zip Code)

**(763) 416-2840**

(Registrant's telephone number, including area code)

**N/A**

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (<u>see</u> General Instruction A.2. below):

◻ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

◻ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

◻ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

◻ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

---

| | | |
|:---|:---|:---|
| Title of each class | Trading Symbol(s) | Name of each exchange<br> on which registered |
| **Common stock, par value $0.01 per share** | **CVRX** | **The Nasdaq Global Select Market** |

---

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ⌧

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ◻

**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:

&nbsp;&nbsp;&nbsp;&nbsp;• **Safety - Major Adverse Neurological or Cardiovascular (MANCE) system or procedure-related event-free rate** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o MANCE-free rate of 97% (p<0.001)

&nbsp;&nbsp;&nbsp;&nbsp;• **Long-term symptom improvement for Barostim Baroreflex Activation Therapy (BAT) vs. Control:** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o 6 Minute Hall Walk improved by 44 meters at 12 months (nominal p<0.001)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o Quality of Life improved by 10 points in Minnesota Living with Heart Failure Questionnaire at 24 months (nominal p<0.001)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o NYHA Class improved in 27% more BAT patients at 24 months (nominal p<0.001)

&nbsp;&nbsp;&nbsp;&nbsp;• **Mortality (cardiovascular death, LVAD, heart transplant) and morbidity (HF hospitalizations, ER visits) – primary endpoint** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o No statistically significant difference [Rate Ratio 0.94, (95% Confidence Interval 0.57, 1.57); p=0.82]

&nbsp;&nbsp;&nbsp;&nbsp;• **All-cause mortality (all-cause death, LVAD, heart transplant)** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o 34% relative reduction in BAT vs. Control [Hazard Ratio 0.66 (95% CI 0.44, 1.007); nominal p=0.054]

&nbsp;&nbsp;&nbsp;&nbsp;• **Hierarchical composite of cardiovascular death, LVAD, heart transplant, HF hospitalization, and Quality of Life using Win Ratio** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;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<br> No.** | **Description** |
| [99.1](tm2310097d1_ex99-1.htm) | [Press release of CVRx, Inc., dated March 21, 2023](tm2310097d1_ex99-1.htm) |
| [99.2](tm2310097d1_ex99-2.htm) | [Presentation of CVRx, Inc., dated March 21, 2023](tm2310097d1_ex99-2.htm) |
| 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.** | **CVRx, Inc.** |
| Date: March 21, 2023 | By: | /s/ Jared Oasheim |
|  |  | Name: Jared Oasheim |
|  |  | Its: Chief Financial Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

**Totality of Evidence from BeAT-HF Study Shows CVRx's Barostim Provides Long-term Benefits for Patients with Heart Failure**

**MINNEAPOLIS, Mar. 21, 2023 –** <u>CVRx, Inc</u>. (NASDAQ: CVRX) ("CVRx"), a commercial-stage medical device company focused on developing, manufacturing and commercializing Barostim™, an innovative extravascular implantable neuromodulation device for patients with cardiovascular diseases, announced detailed preliminary results of the post-market phase of the BeAT-HF trial at the second annual Technology and Heart Failure (HF) Therapeutics (THT) conference on Tuesday, March 21, 2023. These results are being presented by Dr. Michael Zile, Professor of Cardiology at the Medical University of South Carolina (MUSC).

Highlights of the data presented by Dr. Zile include:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• **Safety - Major Adverse Neurological or Cardiovascular (MANCE) system or procedure-related event-free rate** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o MANCE-free rate of 97% (p<0.001)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• **Long-term symptom improvement for Barostim Baroreflex Activation Therapy (BAT) vs. Control:** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o 6 Minute Hall Walk improved by 44 meters at 12 months (nominal p<0.001)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o Quality of Life improved by 10 points in Minnesota Living with Heart
 Failure Questionnaire at 24 months (nominal p<0.001)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o NYHA Class improved in 27% more BAT patients at 24 months (nominal
 p<0.001)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• **Mortality (cardiovascular death, LVAD, heart transplant) and morbidity (HF hospitalizations, ER visits) – primary endpoint** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o No statistically significant difference [Rate Ratio 0.94, (95% Confidence
 Interval 0.57, 1.57); p=0.82]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• **All-cause mortality (all-cause death, LVAD, heart transplant)** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o 34% relative reduction in BAT vs. Control [Hazard Ratio 0.66 (95% CI
 0.44, 1.007); nominal p=0.054]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• **Hierarchical composite of cardiovascular death, LVAD, heart transplant, HF hospitalization, and Quality of Life using Win Ratio** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o Win Ratio of 1.26 favored BAT vs. Control [95% CI 1.02, 1.58; nominal
 p=0.04]

Dr. Zile's presentation concludes that the "Totality of evidence indicates that BAT is a safe, effective and durable treatment for patients with heart failure with reduced ejection fraction." The slides from Dr. Zile's featured presentation, as well as key slides that will be presented as part of the CVRx-sponsored THT symposium, can be found at ir.cvrx.com.

"We are happy to see the significant long-term data that favored Barostim," added Nadim Yared, President and CEO of CVRx. "Interest and adoption of the therapy continue to expand based on the previously-approved claims, and now we look forward to submitting this new data to the FDA to pursue expanded labeling for Barostim. We are forever grateful to the patients, investigators, nurses, and research staff involved in the study."

The full results of BeAT-HF, including a number of additional analyses and endpoints, will be submitted by the executive steering committee for publication in one or more peer-reviewed journals. CVRx anticipates that regulatory submission to the FDA for expanded labeling will be made in the coming months.

**About CVRx, Inc.**

CVRx is a commercial-stage medical device company focused on the developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases. Barostim™ is the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients with heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. Baroreceptors activate the body's baroreflex, which in turn triggers an autonomic response to the heart. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has also received the CE Mark for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit <u>www.cvrx.com</u>.

**Forward-Looking Statements**

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forward-looking statements, including statements regarding our future financial performance, our anticipated growth strategies, anticipated trends in our industry, our business prospects and our opportunities, including specifically those related to potential new indications, labelling or marketing opportunities, our continued review and analysis of trial data and future business and financial impacts. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "outlook," "guidance," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words.

The forward-looking statements in this press release are only predictions and are based largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions, including, uncertainties related to obtaining regulatory approvals, further analysis and understanding of clinical trial data, physician and patient adoption, and other important factors that could cause actual results, performance or achievements to differ materially from those projected in the forward-looking statements that are found in "Part I, Item 1A. Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2022, as such factors may be updated from time to time in our other filings with the Securities and Exchange Commission. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

**Media Contact:**

Laura O'Neill

Finn Partners

212-867-1762

<u>laura.oneill@finnpartners.com</u>

**Investor Contact:**

Mark Klausner or Mike Vallie

ICR Westwicke

443.213.0501 <u>ir@cvrx.com</u>

## Exhibit 99.2

**Exhibit 99.2**

---

| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](tm2310097d1_ex99-2img001.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;March 21, 2023 Preliminary Results of the Post-Market Phase of the BeAT-HF Randomized Clinical Trial |

---

---

| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](tm2310097d1_ex99-2img002.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2 Forward-looking statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forward-looking statements, including statements regarding our future financial performance, our anticipated growth strategies, anticipated trends in our industry, our business prospects and our opportunities, including specifically those related to potential new indications, labelling or marketing opportunities, our continued review and analysis of trial data and future business and financial impacts. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "outlook," "guidance," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. The forward-looking statements in this press release are only predictions and are based largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this presentation and are subject to a number of known and unknown risks, uncertainties and assumptions, including, uncertainties related to obtaining regulatory approvals, further analysis and understanding of clinical trial data, physician and patient adoption, and other important factors that could cause actual results, performance or achievements to differ materially from those projected in the forward-looking statements that are found in "Part I, Item 1A. Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2022, as such factors may be updated from time to time in our other filings with the Securities and Exchange Commission. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. |

---

---

| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](tm2310097d1_ex99-2img003.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;BeAT-HF Executive Steering Committee: Michael R. Zile JoAnn Lindenfeld Fred A. Weaver Faiez Zannad William T. Abraham Baroreflex Activation Therapy (BAT) in Patients with Heart Failure and a Reduced Ejection Fraction (BeAT-HF) Trial: Long – Term Outcomes Study Sponsor: CVRx |

---

---

| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](tm2310097d1_ex99-2img004.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Company Grant/Research Support NHLBI, VA, DOD Consulting Fees/Honoraria Abbott, Boston Scientific, CVRx, Corvia, Edwards, EBR, Lilly, Medtronic, Merck, Novartis, Vectorious, V Wave Major Stock Shareholder/Equity None Royalty Income None Ownership/Founder None Intellectual Property Rights None Other Financial Benefit None Disclosure Statement of Financial Interest Faculty disclosure information can be found on the app |

---

---

| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](tm2310097d1_ex99-2img005.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Carotid Sinus Lead • Extravascular • 2 mm electrode • Unipolar design • 5 year longevity • Personalized therapy • Average programming at 6 Mo: • 8.4 mA amplitude • 107 ms duration • 43 pps frequency IPG Baroreflex Activation Therapy (BAT) Device (Barostim) Heart Rate Remodeling Diuresis Renin Secretion Vasodilation Blood Pressure Baroreceptor Stimulation Parasympathetic Activity Sympathetic Activity |

---

---

| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](tm2310097d1_ex99-2img006.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Prospective, multicenter, randomized, 2-arm, parallel-group, open-label with blinded evaluation trial Groups: - BAT plus optimal medical management (BAT group) - Optimal medical management alone (Control group) Sites: 103 US centers and 5 United Kingdom centers Eligibility criteria: - NYHA Class III or Class II (with a recent history of Class III) - Left ventricular EF ≤ 35% - 6MHW 150 – 400 m - HF Hospitalization or NT-proBNP > 400 - Stable optimal medical management ≥ 4 weeks - No Class of Recommendation I indication for CRT - NT-proBNP < 1600 pg/ml Designated by FDA as Breakthrough Device in HFrEF BeAT-HF Trial Design |

---

---

| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](tm2310097d1_ex99-2img007.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Pre-Market Phase (n=264) Primary endpoint @ 6 months: • Exercise capacity improvement (6MHW) • Quality-of-life improvement (MLWHQ) • NYHA class improvement • Reduction in NT-proBNP Control 134 BAT 130 Post-Market Phase (additional n=59) Primary endpoint: CV mortality and HF morbidity Pre-specified additional endpoints: • Hierarchical composite Win Ratio Analysis • All-cause mortality • Durability of safety • Durability of patient-centered symptoms Control 26 BAT 33 Using an Intention-to-treat analysis, 323 randomized patients, experienced 332 primary events over a 1036 patient-year of follow-up, with median 3.6 years/patient Control 134 + 26 = 160 BAT 130 + 33 = 163 FDA Approval August 2019 improvement of heart failure symptoms BeAT-HF Trial Design |

---

---

| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](tm2310097d1_ex99-2img008.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Baseline Characteristics BAT (n=163) Control (n=160) Age at Screening (years) 63 ± 11 63 ± 10 Female 28 (17.2%) 35 (21.9%) Race White 120 (73.6%) 116 (72.5%) Black or African American 29 (17.8%) 24 (15.0%) Asian 3 (1.8%) 2 (1.3%) Other/Unknown 11 (6.7%) 18 (11.3%) SBP (mmHg) 120 ± 16 121 ± 16 DBP (mmHg) 74 ± 10 73 ± 10 HR (bpm) 75 ± 10 75 ± 11 BMI (kg/m2) 31 ± 5 31 ± 5 eGFR 62.5 ± 16.3 61.1 ± 18.9 NYHA: Class III 155 (95.1%) 151 (94.4%) LVEF (%) 27 ± 6 28 ± 6 6 Minute Walk (m) 314 ± 66 300 ± 71 QOL 53 ± 24 51 ± 24 NT-proBNP (pg/mL) 736 (474, 1057) 704 (442, 1044) LBBB 4 (2.5%) 2 (1.3%) At Least One HF Hospitalization 66 (40.5%) 79 (49.4%) Number of HF Hospitalizations 0.6 ± 0.9 0.7 ± 0.8 BeAT-HF Baseline Characteristics No significant difference between BAT and Control |

---

---

| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](tm2310097d1_ex99-2img009.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Baseline Characteristics BAT (n=163) Control (n=160) Coronary Heart Disease Coronary Artery Disease 104 (63.8%) 107 (66.9%) Myocardial Infarction 89 (54.6%) 97 (60.6%) CABG 35 (21.5%) 44 (27.5%) PCI 72 (44.2%) 72 (45.0%) Cardiac Arrhythmia Bradycardia 19 (11.7%) 18 (11.3%) Tachycardia 54 (33.1%) 56 (35.0%) Atrial Fibrillation 53 (32.5%) 66 (41.3%) Stroke or TIA 29 (17.8%) 37 (23.1%) Chronic Kidney Disease 45 (27.6%) 43 (26.9%) Diabetes Type I 0 (0.0%) 2 (1.3%) Type II 74 (45.4%) 80 (50.0%) No significant difference between BAT and Control BeAT-HF Baseline Characteristics |

---

---

| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](tm2310097d1_ex99-2img010.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Baseline Medications BAT (n=163) Control (n=160) Number of Meds 4.0 ± 1.3 4.1 ± 1.5 ACE-I / ARB / ARNI 143 (88%) 129 (81%) ARNI 57 (35%) 43 (27%) Beta-Blocker 152 (93%) 147 (92%) MRA 74 (45%) 64 (40%) SGLT2i 1 (0.6%) 0 (0%) Diuretic 138 (85%) 139 (87%) Ivabradine 4 (2.5%) 9 (5.6%) ICD 125 (77%) 127 (79%) Pacemaker (non-ICD) 3 (1.8%) 2 (1.3%) CRT 4 (2.5%) 5 (3.1%) Other cardiac device (e.g., CardioMEMS) 8 (4.9%) 4 (2.5%) No significant difference between BAT and Control BeAT-HF Baseline HF Treatment |

---

---

| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](tm2310097d1_ex99-2img011.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Cardiovascular (CV) Mortality And Heart Failure (HF) Morbidity • Assessed using a negative binomial model • Includes recurrent HF morbidity events • Pre-specified event–driven (n=320 events minimum) CV Mortality: • Cardiovascular deaths • LVAD and heart transplants HF Morbidity: • Non-elective HF hospitalization • HF emergency room visit Primary Endpoint • Hierarchical composite analysis using Win Ratio • All-cause mortality • Durability of safety • Durability of improved patient-centered symptom status • Quality of Life (MLWHFQ) • Exercise Capacity (6MHWD) • Functional Status (NYHA Class) Pre-specified additional endpoints Study Endpoints |

---

---

| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](tm2310097d1_ex99-2img012.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Description Composite CV Mortality and HF Morbidity Rate Ratio = 0.94 CV Mortality (CV death, LVAD, heart transplant) Hazard Ratio = 0.73 HF Morbidity (Heart failure hospitalization, ER/ED visit) Rate Ratio = 1.08 All-cause Mortality (death, LVAD, heart transplant) Hazard Ratio = 0.66 Hierarchical Win Ratio (CV mortality, HF morbidity, QOL) Win Ratio = 1.26 Related MANCE-free Rate\* \*Major Adverse Neurologic and Cardiac Events 96.9% Quality of Life – MLWHF (6 / 12 / 24 Month) -13 / -8 / -10 Exercise Capacity – 6MHW (6 / 12 Month) +55 / +44 Functional Status – NYHA Class % Improved (6 / 12 / 24 Month) 30% / 32% / 27% Primary endpoint Additional Analyses Long-term Safety Long-term Symptom Improvement BeAT-HF Summary of Key Evidence 1.0 2.0 1.0 0.1 Favors CONTROL Favors BAT 0.1 2.0 70% 100% +20 pts -20 pts -60 m +60 m 85% 0 pts 0 m -50% 0% +50% 2.0 1.0 0.1 |

---

---

| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](tm2310097d1_ex99-2img013.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;No statistically significant difference between BAT and Control 0 0.5 1 1.5 2 0 1 2 3 4 RR\* 0.94 (95% CI 0.57, 1.57); p=0.82 Control BAT BAT: N = 163 151 140 100 61 Control: N = 160 141 121 87 51 years Primary Composite Endpoint: CV Mortality and HF Morbidity Cumulative events per patient\* \* Cumulative events per patient and rate ratio (RR) of treatment / control and 95% confidence interval estimated by negative binomial method |

---

---

| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](tm2310097d1_ex99-2img014.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;0 0.2 0.4 0.6 0.8 1 1.2 1.4 1.6 1.8 2 0 1 2 3 4 0.00 0.05 0.10 0.15 0.20 0.25 0.30 0.35 0.40 0 1 2 3 4 HR 0.73 (CI 95% 0.46, 1.17) nominal p=0.19 RR 1.08 (CI 95% 0.63, 1.84) nominal p=0.78 Control BAT Control BAT Event rate per 100 years (events / patient-years at risk) BAT Control CV Mortality 5.8 (32 / 544) 7.9 (39 / 492) HF Morbidity 26.6 (145 / 544) 23.6 (116 / 492) Components of Primary Endpoint Cumulative CV Mortality Event Rate BAT: N = 163 151 140 100 61 Control: N = 160 141 121 87 51 Cumulative HF Morbidity Event Rate BAT: N = 163 151 140 100 61 Control: N = 160 141 121 87 51 No statistically significant difference between BAT and Control |

---

---

| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](tm2310097d1_ex99-2img015.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Rationale: • CV Mortality + HF Morbidity: 40% of patients contributed to the end point • Win ratio: 100% of patients contribute to the end point • Used in many recent heart failure randomized controlled trial, drugs and devices Stats: Finkelstein - Schoenfeld Hierarchical Composite Using Win Ratio Analysis Tie Did one patient survive longer vs. the other? Did one patient have fewer hospitalizations vs. the other? Did one patient have better symptomatic outcomes vs. the other? No Did one patient avoid LVAD or transplant vs. the other? Winner Winner Winner Winner No No Yes Yes Yes Yes CV Death LVAD/ Transplant HF Hospitalization Quality of Life No Each BAT patient (n=163) Each Control patient (n=160) vs. Total Patient Pairs n = 26,080 Win Ratio = Total wins for BAT Total wins for Control |

---

---

| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](tm2310097d1_ex99-2img016.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Win Ratio = 1.26 (1.02, 1.58) nominal p-value = 0.04 BAT Control BAT Control 0 5000 10000 15000 Total Total Wins Hierarchical Composite Using Win Ratio Analysis 0 5000 10000 15000 Total Mortality Morbidity Symptoms CV Mortality 34% HF Morbidity 30% Quality of Life 37% \* Sensitivity Test (All time M&M + 24 Month QOL) Win Ratio = 1.34 (95% CI 1.07, 1.68); nominal p=0.01 CV Mortality HF Morbidity QOL BAT CONTROL |

---

---

| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](tm2310097d1_ex99-2img017.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 0 1 2 3 4 HR 0.662 (95% CI 0.435, 1.007); nominal p=0.054 Freedom from all-cause death, LVAD and transplant BAT N = 163 151 140 100 61 CONTROL N = 160 141 121 87 51 BAT resulted in a 34% reduction in relative risk Control BAT Event rate per 100 years (events / patient-years at risk) BAT Control All-cause deaths, LVAD, Heart Transplants 7.0 (38 / 544) 10.4 (51 / 492) \* Curves estimated using Kaplan-Meier method. Hazard ratio and p-value from Cox proportional hazards model. Freedom From All-cause Death, LVAD, and Transplant |

---

---

| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](tm2310097d1_ex99-2img018.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Number of Subjects Number of Subjects MANCE-Free MANCE-Free Rate One-Sided 95% Lower Bound P-value\*\* 159 154 96.9% 93.5% <0.001 Durable Safety Profile: MANCE\* (Major Adverse Neurological or Cardiovascular system or procedure-related event rate) Device was surgically implanted in an outpatient procedure, totally extravascular \* Major Adverse Neurological or Cardiovascular system or procedure-related event rate \*\*Clopper-Pearson exact binomial method. One-sided hypothesis test p-value versus 85% performance goal. |

---

---

| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](tm2310097d1_ex99-2img019.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6 months 12 months 24 months Durable Improvement in Quality of Life (MLWHF) \*Statistics are estimated mean improvement and 95% confidence interval from repeated measures model \*\*From generalized estimating equation repeated measures model with covariate for baseline value -19.8 -17 -18 -6.3 -8.6 -8 -13.5 -8.4 -10 -25 -20 -15 -10 -5 0 BAT Control Diff\*\* BAT Control Diff\*\* BAT Control Diff\*\* Clinically Meaningful Group Difference -5 points Quality of Life (MLWHF)\* (Change from Baseline) (Improved) \*\*nominal p-value < 0.001 for between group differences at all time points No statistical differences in effect size across time points |

---

---

| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](tm2310097d1_ex99-2img020.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;\*Statistics are estimated mean improvement and 95% confidence interval from repeated measures model \*\*From generalized estimating equation repeated measures model with covariate for baseline value 46.8 40.6 -8.7 -3 55.5 43.5 -40 -20 0 20 40 60 80 6 months 12 months BAT Control Diff\*\* BAT Control Diff\*\* Clinically Meaningful Group Difference + 25 meters Exercise Capacity (6 Minute Hall walk Distance)\* (Change from Baseline) Durable Improvement in Exercise Capacity (6MHWD) (Improved) \*\*nominal p-value < 0.001 for between group differences at all time points No statistical differences in effect size across time points |

---

---

| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](tm2310097d1_ex99-2img021.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;66.6% 72.7% 68.0% 36.8% 40.8% 41.1% 29.8% 31.9% 26.9% 0% 10% 20% 30% 40% 50% 60% 70% 80% Durable Improvement in Functional Status (NYHA Class) 6 months 12 months 24 months NYHA Class\* (% of Patients Improved by at least one class) \*nominal p-value < 0.001 for between group differences at all time points No statistical differences in effect size across time points \*Statistics are estimated proportion and 95% confidence interval from repeated measures model \*\*From generalized estimating equation repeated measures model with covariate for baseline value |

---

---

| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](tm2310097d1_ex99-2img022.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Totality of Data Favors BAT BeAT-HF Summary of Key Evidence Description Composite CV Mortality and HF Morbidity Rate Ratio = 0.94 CV Mortality (CV death, LVAD, heart transplant) Hazard Ratio = 0.73 HF Morbidity (Heart failure hospitalization, ER/ED visit) Rate Ratio = 1.08 All-cause Mortality (death, LVAD, heart transplant) Hazard Ratio = 0.66 Hierarchical Win Ratio (CV mortality, HF morbidity, QOL) Win Ratio = 1.26 Related MANCE-free Rate\* \*Major Adverse Neurologic and Cardiac Events 96.9% Quality of Life – MLWHF (6 / 12 / 24 Month) -13 / -8 / -10 Exercise Capacity – 6MHW (6 / 12 Month) +55 / +44 Functional Status – NYHA Class % Improved (6 / 12 / 24 Month) 30% / 32% / 27% Primary endpoint Additional Analyses Long-term Safety Long-term Symptom Improvement 1.0 2.0 1.0 0.1 Favors CONTROL Favors BAT 0.1 2.0 70% 100% +20 pts -20 pts -60 m +60 m 85% 0 pts 0 m -50% 0% +50% 2.0 1.0 0.1 |

---

---

| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](tm2310097d1_ex99-2img023.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Conclusion Totality of evidence indicates that BAT is a safe, effective and durable treatment for patients with heart failure with reduced ejection fraction |

---

---

| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](tm2310097d1_ex99-2img024.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;CVRx-Sponsored Lunch Symposium at 12:15 – 1:15 pm Grand Ballroom A-B, Concourse Level an in-depth discussion on the findings from BeAT-HF and potential confounders (COVID-19, Medications) and real-world experience using Barostim Presented by: • William T. Abraham • JoAnn Lindenfeld • Patrick J. McCann • Michael R. Zile Additional Excerpts from the Symposium |

---

---

| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](tm2310097d1_ex99-2img025.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Improved: • Subject does not meet any worsening category AND • Fewer HF hospitalizations in 12 months post-enrollment vs 12 months pre-enrollment, • OR improved NYHA class at 12 months vs. baseline; Same: • Neither worsened nor improved • AND evaluable for both HF hospitalizations and NYHA; Worsened: • Died prior to 12 months, • OR more HF hospitalizations in 12 months post-enrollment as compared to 12 months pre-enrollment, • OR higher NYHA class at 12 months vs. baseline Clinical Stability Analysis \* 75.8% 60.0% 12.4% 26.2% 11.8% 13.8% BAT Control Improved Same Worsened Proportional Odds = 1.917 (1.206, 3.227) nominal p-value = 0.009 \* Similar to that used in: Packer et al, Circulation. 2021;143:326–336, EMPEROR-Reduced Trial |

---

---

| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](tm2310097d1_ex99-2img026.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Win Ratio = 1.26 (1.02, 1.58) nominal p-value = 0.04 BAT Control BAT Control 0 5000 10000 15000 Total Total Wins Hierarchical Composite Using Win Ratio Analysis 0 5000 10000 15000 Total Mortality Morbidity Symptoms CV Mortality 34% HF Morbidity 30% Quality of Life 37% \* Sensitivity Test (All time M&M + 24 Month QOL) Win Ratio = 1.34 (95% CI 1.07, 1.68); nominal p=0.01 CV Mortality HF Morbidity QOL BAT CONTROL |

---

---

| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](tm2310097d1_ex99-2img027.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;0 5000 10000 15000 Total All Mortality HF Morbidity Quality of Life Win Ratio = 1.27 (1.02, 1.59) nominal p-value = 0.04 Total Wins All Mortality, 41% HF Morbidity, 24% Quality of Life, 35% BAT CONTROL Sensitivity Analysis – All-Cause Mortality Win Ratio |

---

---

| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](tm2310097d1_ex99-2img028.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;0 0.5 1 1.5 2 0 1 2 3 4 RR\* 0.94 (95% CI 0.57, 1.57); p=0.82 Control BAT BAT: N = 163 151 140 100 61 Control: N = 160 141 121 87 51 years Primary Composite Endpoint: CV Mortality and HF Morbidity Cumulative events per patient\* \* Cumulative events per patient and rate ratio (RR) of treatment / control and 95% confidence interval estimated by negative binomial method No statistically significant difference between BAT and Control |

---

---

| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](tm2310097d1_ex99-2img029.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;0 0.2 0.4 0.6 0.8 1 0 1 2 24 Months: RR\* 0.82 (95% CI 0.43, 1.57) Control BAT BAT: N = 163 151 140 Control: N = 160 141 121 years Primary Composite Endpoint at 12 and 24 Months Cumulative events per patient\* \* Cumulative events per patient and rate ratio (RR) of treatment / control and 95% confidence interval estimated by negative binomial method 12 Months: RR\* 0.76 (95% CI 0.35, 1.66) -18% -24% |

---

---

| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](tm2310097d1_ex99-2img030.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;0 0.05 0.1 0.15 0.2 0.25 1-Jan-17 1-Jan-18 1-Jan-19 1-Jan-20 31-Dec-20 474 PATIENT-YEAR OF FOLLOW-UP (46%) 249 PATIENT-YEAR OF FOLLOW-UP (24%) 313 PATIENT-YEAR HF morbidity rate per patient OF FOLLOW-UP (30%) - year \* \*Normalized by total patient-years of follow-up per arm (BAT: 544 patient-years, Control: 492 patient-years) 787 PATIENT-YEAR OF FOLLOW-UP (76%) OUTSIDE 2020 249 PATIENT-YEAR OF FOLLOW-UP (24%) DURING 2020 Control BAT Impact of COVID-19 Pandemic on HF Morbidity |

---

---

| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](tm2310097d1_ex99-2img031.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Potential Confounder: Impact of COVID Pandemic Time Period BAT † Control† 2020 0.28 0.07 2016, 2017, 2018, 2019, 2021, 2022 0.26 0.29 † Number of hospitalizations or emergency department visits for heart failure per patient-year of follow-up Heart Failure Morbidity • COVID definitely impacted the results of the study. • The COVID impact was differentially expressed more in the control group than in the BAT group. • Why COVID has these differential effects has not been thoroughly investigated yet. • Whether and to what extent COVID acted to limit our ability to identify an effect of BAT on the HF Morbidity awaits further analysis. |

---

---

| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](tm2310097d1_ex99-2img032.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Totality of Data Favors BAT BeAT-HF Summary of Key Evidence Description Composite CV Mortality and HF Morbidity Rate Ratio = 0.94 CV Mortality (CV death, LVAD, heart transplant) Hazard Ratio = 0.73 HF Morbidity (Heart failure hospitalization, ER/ED visit) Rate Ratio = 1.08 All-cause Mortality (death, LVAD, heart transplant) Hazard Ratio = 0.66 Hierarchical Win Ratio (CV mortality, HF morbidity, QOL) Win Ratio = 1.26 Related MANCE-free Rate\* \*Major Adverse Neurologic and Cardiac Events 96.9% Quality of Life – MLWHF (6 / 12 / 24 Month) -13 / -8 / -10 Exercise Capacity – 6MHW (6 / 12 Month) +55 / +44 Functional Status – NYHA Class % Improved (6 / 12 / 24 Month) 30% / 32% / 27% Primary endpoint Additional Analyses Long-term Safety Long-term Symptom Improvement 1.0 2.0 1.0 0.1 Favors CONTROL Favors BAT 0.1 2.0 70% 100% +20 pts -20 pts -60 m +60 m 85% 0 pts 0 m -50% 0% +50% 2.0 1.0 0.1 |

---

---

| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](tm2310097d1_ex99-2img033.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Conclusion Totality of evidence indicates that BAT is a safe, effective and durable treatment for patients with heart failure with reduced ejection fraction |

---

---

| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](tm2310097d1_ex99-2img034.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;34 The post-market phase of BeAT-HF confirmed the long-term durability of safety and symptomatic improvements, and the sustainability of the extent of the improvements. The reduction of all-cause death, LVAD and heart transplant is meaningful (34% reduction, nominal p-value 0.054). The pre-specified hierarchical composite endpoint was well balanced, and demonstrated meaningful benefit (Win ratio = 1.26, nominal p-value=0.04), stable over multiple sensitivity analyses Key takeaways Barostim is currently FDA-approved for the improvement of heart failure symptoms based on the pre-market phase of BeAT-HF at 6 months. |

---

---

| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](tm2310097d1_ex99-2img035.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;35 One or more manuscripts will be written by the executive steering committee for submission to peer-reviewed journals The PMA Clinical report is being prepared by CVRx to be submitted to FDA, to seek an expansion of the labeling, commensurate with the recommendation of the Executive Steering Committee of BeAT-HF. We agree with the committee that the totality of evidence supports the use of Barostim as a Treatment for heart failure Next steps |

---

---

| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](tm2310097d1_ex99-2img036.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Questions? |

---