News release: CVRx® Raises $50 Million in New Equity Financing

Offering Will Support US Commercialization of BAROSTIM NEO™

MINNEAPOLIS, July 7, 2020 /PRNewswire/ — CVRx, Inc., a private medical device company with a novel technology that treats patients suffering from chronic heart failure (“HF”) and resistant hypertension, announced today that it raised $50 million to close its latest round of equity financing. Proceeds from the financing will be used to support commercialization of the BAROSTIM NEO in the United States (“US”).

HF affects 6.5 million people in the US.1 It is associated with poor life expectancy, frequent heart failure hospitalizations, poor quality of life and substantial limitation in exercise capacity. The BAROSTIM NEO is designed to treat these patients by electrically activating the baroreflex, the body’s natural mechanism to regulate cardiovascular function. The BAROSTIM NEO device is the world’s first neuromodulation device approved for heart failure patients. It has received the sought-after “Breakthrough Device” designation by the United States Food and Drug Administration (“FDA”), and is the first device approved by FDA to use the power of the brain and the nervous system to improve the symptoms of patients with HFrEF.

The financing round was co-led by new investors Strategic Healthcare Investment Partners (“S.H.I.P.”) and Vensana Capital, with participation from other new investors, Hatteras Venture Partners and Venrock Healthcare Capital Partners. Existing investors Johnson & Johnson Innovation, New Enterprise Associates, Gilde Healthcare, and Action Potential Venture Capital also participated in this financing round.

“It is a great vote of confidence in our product and mission that we were able to close this oversubscribed financing round amid such volatile market conditions and general uncertainty,” said Nadim Yared, President and CEO of CVRx. “We are thankful for the support of our new investors as well as our existing investor base, and look forward to utilizing this capital to drive the expansion of our footprint in the US market, and bring our BAROSTIM NEO system to HF and hypertension patients in need.”

S.H.I.P. General Partner, Mudit K. Jain, PhD., said, “CVRx is leveraging valuable clinical experience to accelerate the commercialization of its therapy. Brad Vale and I established S.H.I.P. with a focus to invest in medical technology companies that target large unmet clinical needs and can significantly impact human life. We believe CVRx is at the top of the list for these criteria.”

“CVRx is a pioneer in the field of neuromodulation for cardiovascular diseases. The CVRx team has developed a unique therapy with strong clinical evidence, and we are excited to support the launch of BAROSTIM NEO in the US and beyond,” added Kirk Nielsen, General Partner from Vensana Capital.

As part of this financing, Mudit K. Jain, PhD., and Kirk Nielsen will join the CVRx Board of Directors.

About BAROSTIM NEO
BAROSTIM NEO uses CVRx-patented technology, designed to send electrical pulses to baroreceptors located in the wall of the carotid artery, to deliver BAROSTIM THERAPY™.  The therapy is designed to restore balance to the autonomic nervous system and thereby improve the symptoms of HF. The BAROSTIM NEO is approved by FDA for HF in the US, and has received the CE Marking for HF and resistant hypertension in the European Economic Area.

About CVRx, Inc.
CVRx is a leader in innovative technologies that address the unmet needs in cardiovascular diseases with safe and effective therapies. Headquartered near Minneapolis, Minn., CVRx is dedicated to improving patient outcomes, quality of life and overall cardiovascular health via novel baroreceptor neuromodulation therapies. Learn more at www.cvrx.com.  

1CDC Heart Failure Fact Sheet.

CVRx Contacts:
John R. Brintnall
Chief Financial Officer
jbrintnall@cvrx.com
Phone: +1 763 416 2853

News release: CVRx® Announces Publication of BeAT-HF Clinical Study Results in the Journal of The American College of Cardiology

BAROSTIM NEO™ is the World’s First Heart Failure Neuromodulation Device

MINNEAPOLIS, June 30, 2020 /PRNewswire/ — CVRx, Inc., a private medical device company, announced today that its BeAT-HF phase III randomized clinical trial results were published in the Journal of the American College of Cardiology (“JACC”). Results from the trial were used to obtain Premarket Approval (PMA) from the United States Food and Drug Administration (“FDA”) to market its BAROSTIM NEO device for improvement of symptoms in patients with heart failure (“HF”) in the United States.

“Publication of the BeAT-HF trial results in the esteemed, peer reviewed JACC journal provides further validation that we finally have an effective neuromodulation therapy for advanced HF patients, who did not have access to device-based therapy.” said Michael Zile, M.D., Professor of Medicine at the Medical University of South Carolina and Chair Person of the BeAT-HF Executive Steering Committee. “The BAROSTIM NEO improves patient-centered symptomatic endpoints of quality of life score, exercise capacity and functional status. These results are supported by objective evidence of a significant reduction in NT-proBNP, which in recent studies was associated with a lower rate of cardiovascular death or heart failure hospitalization.”

“The interactive and adaptive design of BeAT-HF is groundbreaking,” wrote James L. Januzzi, M.D. and Nasrien E. Ibrahim, M.D. (Massachusetts General Hospital, Harvard Medical School) in their editorial. “With growing incidence, prevalence, and risk of patients affected by HF, all hands must be on deck to ‘beat the clock’ and get safe, effective treatments to our patients.”

BeAT-HF was a multi-center, prospective, randomized, controlled trial. Patients were randomized one-to-one to receive BAROSTIM NEO plus optimal medical management or optimal medical management alone (control).

Key Qualifications:

  • NYHA Class III or Class II (with recent history of Class III)
  • Left ventricular ejection fraction ≤ 35%
  • On current HF guideline-directed medical therapy
  • NT-proBNP < 1600 pg/mL
  • Excluded patients indicated for CRT according to AHA/ACC/ESC guidelines

The BeAT-HF trial results represent the intended use population that reflects the FDA approved instructions for use included 264 randomized patients.

Key six-month results:   

  • BAROSTIM NEO is safe to use for patients with HFrEF, with a MANCE free rate of 97%*.
  • BAROSTIM NEO demonstrated clinically significant improvements in patient-centered symptomatic endpoints as compared to the control group:
    • Improved quality of life score by 14.1 (p<0.001) points using the Minnesota Living with Heart Failure Questionnaire.
    • Improved exercise capacity by 60 meters (p<0.001) as measured by the standardized 6-minute hall walk test.
    • Improved functional status as assessed by NYHA classification: 65% BAROSTIM NEO versus 31% control patients experienced NYHA class improvement (p<0.001).
  • These results were supported by objective evidence of a significant 25% reduction in NT-proBNP (p<0.001).
  • These clinically significant differences in treatment effect were observed despite an increase in the number of medications in the control arm.

* Major adverse neurological and cardiovascular related device or procedure event free rate (MANCE)

About BAROSTIM NEO
BAROSTIM NEO uses CVRx-patented technology, designed to send electrical pulses to baroreceptors located in the wall of the carotid artery, delivering BAROSTIM THERAPY™, and is designed to restore balance to the autonomic nervous system and thereby improve the symptoms of HF. The BAROSTIM NEO has received the sought-after “Breakthrough Device” designation by the FDA in the United States, and is the first device approved by FDA to use the power of the brain and the nervous system to improve the symptoms of patients with HFrEF. The BAROSTIM NEO has received the CE Marking for HF and resistant hypertension in the European Economic Area (“EEA”).

About CVRx, Inc.
CVRx is a leader in innovative technologies that address the unmet needs in cardiovascular diseases with safe and effective therapies. Headquartered near Minneapolis, Minn., CVRx is dedicated to improving patient outcomes, quality of life and overall cardiovascular health via novel baroreceptor neuromodulation therapies. Learn more at www.cvrx.com.  

CVRx Contact:
John Brintnall
Chief Financial Officer
jbrintnall@cvrx.com

References:
Zile MR, Abraham WT, et al. Baroreflex activation therapy in patients with heart failure with reduced ejection fraction, J Am Coll Cardiol 2020; 76:1-13
https://www.onlinejacc.org/content/76/1/1
Januzzi JL and Ibrahim NE, Innovation in clinical trial design, J Am Coll Cardiol 2020; 14-16

CVRx, BAROSTIM NEO and BAROSTIM THERAPY are trademarks of CVRx, Inc. registered in the United States Trademark Office.
© CVRx, Inc. 2020. All rights reserved.

SOURCE CVRx, Inc.

News release: BAROSTIM™ NEO Associated with Very High Responder Rates in Women

BeAT-HF Trial Results Presented as Late-Breaking Clinical Science at ESC Heart Failure 2020 Meeting

MINNEAPOLIS, June 23, 2020 /PRNewswire/ — CVRx, Inc., a private medical device company, announced new BeAT-HF trial results from late-breaking clinical science presented virtually at the European Society of Cardiology Heart Failure 2020 Scientific Sessions. The BAROSTIM NEO provided significant improvements in quality of life and exercise capacity, with high responder rates in women.1

Heart failure affects millions of women worldwide. It is the leading cause for hospitalizations and a major cause of death in women over 65 years of age.2 There is a need for advances in heart failure therapies for women to improve their symptoms and quality of life. Women have been historically underrepresented in clinical trials.3 Some treatments for heart failure are not as effective in women as in men. Furthermore, despite being more symptomatic than men, women with HFrEF are often undertreated.4 JoAnn Lindenfeld MD, BeAT-HF clinical trial steering committee member, has been active in increasing participation of women in clinical trials for more than 20 years, since one of the early trials with beta blockers for heart failure.5,6,7

“These new results from the BeAT-HF trial demonstrate that the BAROSTIM NEO works quite effectively in women,” said JoAnn Lindenfeld MD, Professor of Medicine, Director of Heart Failure and Transplant at the Vanderbilt University Medical Center. “In symptomatic heart failure patients with a reduced ejection, the BAROSTIM NEO improved multiple measures of functional status and was associated with very high responder rates. The treatment was as effective in women as it was in men. The results support BAROSTIM NEO’s use in all indicated patients.”

The late breaking presentation can be accessed on the ESC-HF website. A copy of the full abstract and presentation can be accessed at: https://www.cvrx.com/newsroom/response-by-gender/.

About BeAT-HF

BeAT-HF was a multi-center, prospective, randomized, controlled trial. Patients were randomized one-to-one to receive BAROSTIM NEO plus optimal medical management or optimal medical management alone (Control)8.

Key Qualifications:

  • NYHA Class III or Class II (with recent history of Class III)
  • Left ventricular ejection fraction ≤ 35%
  • On current heart failure guideline-directed medical therapy
  • NT-proBNP < 1600 pg/mL
  • Excluded patients indicated for CRT according to AHA/ACC/ESC guidelines

About Heart Failure and BAROSTIM NEO

Heart failure with reduced ejection fraction (HFrEF) affects over 3 million people in the United States and 13 million people worldwide.9,10,11 It is associated with poor life expectancy, frequent heart failure hospitalizations, poor quality of life and substantial limitation in exercise capacity. The BAROSTIM NEO is designed to treat these patients by electrically activating the baroreflex, the body’s natural mechanism to regulate cardiovascular function. The BAROSTIM NEO device is the world’s first neuromodulation device approved for heart failure patients.

About CVRx, Inc.

CVRx, Inc. is a privately held company founded in 2001 and headquartered in Minneapolis, Minnesota. The company has developed the BAROSTIM NEO. It is a minimally invasive implantable system approved for use in heart failure in over 30 countries, including the United States and approved for use in resistant hypertension in the European Economic Area, Colombia and New Zealand.

References:

  1. ESC-HF – https://www.escardio.org/Sub-specialty-communities/Heart-Failure-Association-of-the-ESC-(HFA)/Research-and-Publications/HFA-Discoveries#live 
  2. https://www.cdc.gov/heartdisease/women.htm
  3. Walsh MN, Jessup M, Lindenfeld J. Women With Heart Failure: Unheard, Untreated, and Unstudied. J Am Coll Cardiol. 2019; 73(1):41-43.
  4. Dewan P, Rørth R, Jhund PS, et al. Differential impact of heart failure with reduced ejection fraction on men and women. J Am Coll Cardiol. 2019; 73:29–40.
  5. Lindenfeld J, Krause-Steinrauf H, Salerno J. Where are all the women with heart failure? J Am Coll Cardiol. 1997; 30(6):1417-1419.
  6. Merrill M, Sweitzer NK, Lindenfeld J, Kao DP. Sex Differences in Outcomes and Responses to Spironolactone in Heart Failure With Preserved Ejection Fraction: A Secondary Analysis of TOPCAT Trial. JACC Heart Fail. 2019; 7(3):228-238.
  7. Vaduganathan M, Tahhan AS, Alrohaibani A, et al. Do Women and Men Respond Similarly to Therapies in Contemporary Heart Failure Clinical Trials?. JACC Heart Fail. 2019 ;7(3):267-271.
  8. BeAT-HF results – https://www.accessdata.fda.gov/cdrh_docs/pdf18/P180050b.pdf
  9. https://www.ahajournals.org/doi/10.1161/CIR.0000000000000757
  10. Savarese G, Lund L, Global Public Health Burden of Heart Failure Card Fail Rev, 2017 Apr; 3(1): 7-11.
  11. https://pubmed.ncbi.nlm.nih.gov/28834669/

CVRx, BAROSTIM NEO and BAROSTIM THERAPY are trademarks of CVRx, Inc. registered in the United States Trademark Office. © CVRx, Inc. 2020. All rights reserved.

BAROSTIM NEO™ Heart Failure Treatment Results in High Responder and Super-Responder Rates

Symptomatic Responder Rates To Barostim Therapy

Authors: William T. Abraham, MD, JoAnn Lindenfeld, MD, Fred Weaver, MD, Faiez Zannad, MD, Michael R. Zile, MD, Elizabeth Galle, MPH, Jill Schafer, MS and Marwan M. Bahu, MD

Background: Patients with heart failure with reduced ejection fraction (HFrEF) have varying responses to device-based heart failure therapies.

Objective: Evaluate the symptomatic response rate to baroreflex activation therapy at 6 months.

Methods: In a trial in subjects with NYHA class II (recently III) or III HFrEF, left ventricular ejection fraction ≤ 35, stable optimal guideline direct medical HF therapy (GDMT), no Class 1 indication for cardiac resynchronization therapy (CRT), and NT-proBNP<1600 pg/ml, a total of 264 subjects were randomized to either BAROSTIM therapy plus GDMT (BAT) or GDMT alone (Control). Six-minute hall walk distance (6MHW), Minnesota Living with HF Questionnaire (QOL) and NYHA Class (NYHA) was analyzed. Responders were defined by a 6-month improvement in 6MHW of >10%, QOL improvement of >5 points and/or improvement of one NYHA; super-responders were defined by an improvement in 6MHW of >20%, QOL improvement of >10 points and/or improvement to NYHA class I.

Results: Of the 264 randomized, 120 BAT and 125 Control had 6-month data. As shown in the documents below, responder and super-responder rates were significantly higher in BAT versus Control subjects for all endpoints. In BAT subjects, 72% responded to at least two symptomatic endpoints compared to 29% of Control subjects (p<0.001). For super-responders, 28% of BAT subjects had large improvements in at least two symptomatic endpoints versus 10% of Control subjects.

Conclusion: Among subjects with symptomatic HFrEF, treatment with BAT resulted in high responder and super-responder rates of 72% and 28%, respectively. These responder and super-responder rates are similar to those seen with CRT, in CRT-indicated patients.

BAROSTIM NEO™ Shows a Reduction in Serious Cardiovascular Events

Are Intermediate Endpoints Associated With Serious Adverse Cardiovascular Events: Preliminary Results From The BeAT-HF Trial

Authors: Michael R. Zile, MD, William T. Abraham, MD, JoAnn Lindenfeld, MD, Fred A. Weaver, MD, Faiez Zannad, MD, Tyson Rogers, MS and Khaled A. Awad, MD

Background: In a randomized controlled trial, baroreflex activation therapy (BAT) improved exercise capacity (6MHW), quality of life (QOL), NYHA Class and NT-proBNP in patients with heart failure with reduced ejection fraction (HFrEF) and was FDA approved under the Breakthrough Devices Program. We examined whether these symptomatic endpoints are associated with cardiovascular serious adverse events, such as such as hospitalization for serious cardiac arrhythmias, hypotension/syncope and MI/angina.

Objective: This analysis compared the event rate of cardiovascular (CV) serious adverse events in the BAT and Control groups.

Methods: The BeAT-HF study included HFrEF patients, currently or recently with NYHA class III symptoms, LVEF ≤ 35%, NT-proBNP <1600 pg/ml, stable optimal medical heart failure management for at least 4 weeks and not class-1 indicated for cardiac resynchronization therapy. Patients were randomized 1:1 to receive BAT plus optimal medical management (BAT group) or optimal medical management alone (Control group). CV serious adverse events (SAE) within six months of follow-up were adjudicated by an independent committee.

Results: Within the first six months, BAT patients had significantly less events in all CV SAE categories than the Control patients, as shown in the documents below.

Conclusion: The positive association between a reduction in symptomatic endpoints and CV serious adverse events observed in the trial support the Breakthrough Device Program of the FDA. The BEAT-HF trial continues in a blinded manner to assess heart failure morbidity and mortality in a pre-specified post-market study to provide further potential evidence of BAT’s benefit.

BAROSTIM NEO™ Reduces Heart Failure Symptoms for Patients with or without Atrial Fibrillation

Response To Barostim Therapy By Atrial Fibrillation Status

Authors:  Michael R. Zile, MD, JoAnn Lindenfeld, MD, William T. Abraham, MD, Fred A. Weaver, MD, Faiez Zannad, MD, Elizabeth Galle, MPH, Tyson Rogers, MS and Vijendra Swarup, MD

Background: Patients with heart failure (HF) with reduced ejection fraction (HFrEF) can have varying responses to device-based HF therapies particularly when comparing those with and without a history of atrial fibrillation (AF).

Objective: Evaluate the response to baroreflex activation therapy (BAT) at 6 months in subjects with and without AF.

Methods: A multicenter trial (BeAT-HF) conducted in subjects with HFrEF, currently or recently with NYHA class III symptoms, left ventricular ejection fraction (LVEF) ≤ 35%, stable optimal medical HF management for at least 4 weeks, no class-1 indication for cardiac resynchronization therapy, and NT-proBNP<1600pg/ml, randomized subjects 1:1 to receive BAROSTIM Therapy (BAT) or BAT plus guideline directed therapy (GDT) for HF. Change from baseline to 6 months data was collected in 120 BAT subjects and 125 BAT+GDT subjects for outcomes including: 6-minute hall walk distance (6MHW), Minnesota Living with HF Questionnaire (QOL), core lab read NT-proBNP and New York Functional Class (NYHA).

Results: A total of 87 (36%) of the 245 subjects had AF. A response to BAT was demonstrated with an improvement between the two arms for all endpoints as shown in the documents below.

Conclusion: Among subjects with symptomatic HFrEF, treatment with BAT plus GDT, compared with GDT alone, demonstrates improvement in 6MHW, QOL, NT-proBNP, and NYHA in subjects with and without a history of AF.

BAROSTIM NEO™ Reduces the Institutional Cost Burden of Heart Failure

Cost-Impact Analysis Of Baroreflex Activation Therapy In Patients With Chronic Heart Failure In The United States

Authors: Michael R. Zile, MD, John Schneider, PhD, Shawn Davies, MA, Elizabeth Galle, MPH, Ivana Stojanovic, MA and John Bisognano, MD, PhD.

Background: Chronic heart failure (CHF) affects roughly 5.7 million adults in the United States, accounting for $30.7 billion in medical spending each year. One approved therapy for CHF symptomatic treatment in these patients is baroreflex activation therapy (BAT). BAT is delivered by an implantable device designed to modulate the body’s natural blood flow by sending signals to the brain by an electrode attached to the outside of the carotid artery, which activates the process of balancing the body’s sympathetic and parasympathetic activities to regain homeostasis. The BeAT-HF trial evaluated the safety and effectiveness of BAT, resulting in FDA approval in August 2019.

Objective: The study evaluated the cost of BAT + Optimal Medical Therapy (OMT) compared to OMT alone for CHF patients with reduced ejection fraction and New York Heart Association Class II or III.

Methods: A Cost Impact Model was developed from a U.S. health care payer perspective over a 3-year period, comparing BAT + OMT to OMT alone. The expected costs associated with each group were calculated by utilizing data from BeAT-HF trial and existing literature. Rates of serious BAT related adverse events, cardiovascular (non-HF) hospitalizations, progression to LVAD and heart transplantation, and medication utilization were based on BeAT-HF 6-month results and extrapolated beyond 6-months. HF hospitalization rates throughout the model were extrapolated based on observed baseline to 6-month changes in NT-proBNP levels.

Results: At 6 months, BAT + OMT is $37,726/patient more expensive than OMT alone, reflecting initial BAT device and implantation costs. The treatments have equal predicted costs starting between years 2 and 3. At 3 years, predicted costs are $9,008 lower in the BAT+ OMT arm versus OMT-only arm. This stems from an offset of higher short-term BAT+ OMT arm costs with lower rates of significant CV events, hospitalizations, HF hospitalizations, and resource intensive late-stage procedures (LVADs and heart transplants) as compared to the OMT-only arm.

Conclusion: BAT+OMT starts to become less costly than OMT alone between years 2 and 3 and provides significant savings over time. Results are robust to a variety of sensitivity tests and comparisons to the literature.