Our Mission

Pioneering clinically advanced heart failure technologies that offer meaningful treatment solutions for physicians and their patients

About Acute Decompensated Heart Failure

1.8M

Approximately 1.8 million patients are admitted with ADHF in the Unites States annually.1

#1 Cause

Acute Decompensated Heart failure (ADHF) is the leading cause of hospitalization in patients older than 65 years of age.2

30% Mortality

Mortality after ADHF hospitalization approaches 30% annually and readmission is common, despite treatment with currently available pharmacotherapy and device therapy for HF.1,3

Congestion Is Critical Therapy Target

Most hospitalized patients have significant volume overload, and congestive symptoms predominate.4

$40B

Overall annual cost and $20B hospitalization cost, 43% of MediCare part A and Part B spending.5

Unmet Need

While current approaches may alleviate some symptoms, many patients continue to worsen, thus the need for development of new therapies to focus on the critical time during hospitalization.

1. Am. Journal of Epidemiology, February 19,2016; 183(5): 462-470. Temporal Trends in Hospitalizations for ADHF in the US, 1998-2011 2. Am Heart J.  2003;  145:S18-S25. The Problem of Decompensated Heart Failure:  nomenclature, classification and risk stratification.3. Circulation Heart Failure 2010; 3(1): 97-103.  Recent National Trends in Readmission Rates after Heart Failure Hospitalization. 4. J Card Fail. 2016; 22(3): 182-189.  Hemodynamic Predictors of Heart Failure Morbidity and Mortality:  Fluid or Flow? 5. Linden A, Adler-Milstein J. Medicare disease management in policy context. Health Care Financ Rev. 2008;29(3):1-11

Device Description

Acute Decompensated Heart Failure (ADHF). A major clinical unmet need and market.

preCARDIA’S current technology, a proprietary balloon catheter and pump controller, is designed to address ADHF via intermittent superior vena cava (SVC) occlusion. By limiting venous return to the heart, preCARDIA treats fundamental ADHF clinical hemodynamic targets.

The company was founded & incubated by MD Start and is now located in St. Paul, MN USA.

preCARDIA Leadership Team

Lisa Wipperman Heine
President & CEO

28+ years of experience in Medtech industry with significant focus on heart failure and cardiovascular devices.

Strong clinical development, regulatory strategy, reimbursement and market access expertise

Lisa Wipperman Heine
President & CEO
Tim Lenihan
CTO, Co-Founder, & Board Chair

26+ years of engineering and regulatory experience in US and EU.

Managed several CE Marking dossiers and FDA clearance/approvals

Tim Lenihan
CTO, Co-Founder, & Board Chair
Sara Vidmar
SVP, Clinical, Regulatory & Strategic Affairs

25+ years in the medical device space with significant focus on clinical trials in cardiovascular products and procedures.

Significant IDE/PMA, CE Mark and global clinical/regulatory strategy expertise

Sara Vidmar
SVP, Clinical, Regulatory & Strategic Affairs
Nancy Ness
Chief Financial Officer

30+ years of finance experience including CFO roles for multiple medical device companies, including preCARDIA.

Has provided financial and fundraising expertise to over 40 medical device and pharmaceutical early development and commercialization companies both in the US and abroad

Nancy Ness
Chief Financial Officer

preCARDIA Scientific Advisory Board

Navin Kapur, MD

Dual-boarded Interventional cardiologist and advanced heart failure specialist .

Global KOL for the field of acute and durable mechanical circulatory support.

Navin Kapur, MD
Richard Karas, MD PhD

Global KOL on vascular biology and endocrine function in CV disease .

Prior experience as CSO of Tufts MC and Exec Dir of the Molecular Cardiology Research Institute

Richard Karas, MD PhD
Dan Burkhoff, MD PhD

World-renowned expert in heart failure and hemodynamics.

Director of HF at the Cardiovascular Research Foundation.

Dan Burkhoff, MD PhD

News

preCARDIA Enrolls First Patient in Early Feasibility Study

ST. PAUL, Minn., Aug. 15, 2019 /PRNewswire/ — preCARDIA, Inc., a medical device company developing innovative technologies for the treatment of acute decompensated heart failure (ADHF), […]

Novel Therapeutic Approach Effective at Reducing Pressure for Heart Failure Patients

First-in-man study shows potential to improve outcomes for common cardiac condition impacting 26 million people worldwide Image courtesy of Kapur N.K., Karas R.H., […]

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428 Minnesota Street, Suite 500.
St. Paul, MN 55101.

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