Heart Failure

About the offering

Heart Failure Solutions is aiming to transform care for patients with HFpEF through the PeriCut System—an innovative, investigational, minimally invasive procedure designed to relieve cardiac constraints and restore healthy heart function. Backed by a leadership team with decades of experience in medical device innovation and supported by world-class physicians from Mayo Clinic, we combine proven expertise with a strong development and regulatory strategy. From bench to first-in-human use, our system has already demonstrated encouraging patient outcomes, with enrollment ongoing in an FDA-approved Early Feasibility Study. With a growing and defensible patent portfolio and momentum in both clinical and regulatory pathways, we are now seeking investment to accelerate pivotal trials and drive this technology toward commercialization. Investors have the opportunity to be part of a company addressing one of the largest and fastest-growing unmet needs in cardiology. ​ ​ The Problem & Our Solution Heart Failure with Preserved Ejection Fraction (HFPEF) currently affects over 3 million people in the U.S., leading to a life expectancy of less than five years upon diagnosis (source). To our knowledge, there are currently no FDA-approved device-based therapies for HFpEF and the absence of effective device-based therapies creates an urgent need for solutions. Heart Failure Solutions aims to address this gap through the PeriCut System, which employs a minimally invasive procedure to relieve pressure on the left ventricle, utilizing existing techniques that are designed to be easily identified and implemented within current medical frameworks. The PeriCut System is an investigational device that is still under development and has not yet been cleared or approved by the U.S. Food and Drug Administration. ​ The Market & Our Traction The global congestive heart failure treatment devices market size was estimated at USD 5.6 billion in 2024 and is projected to reach USD 8.2 billion by 2030, growing at a CAGR of 6.7% from 2025 to 2030 (source) Heart Failure Solutions has reached critical milestones, including successful pilot studies at the Mayo Clinic indicating our system's efficacy in significantly improving patient outcomes. With commitments from Mayo Ventures and a path toward pivotal trial initiation, we believe we’re positioned to capture a share of this growing market. Source There are over 6 Million people in the United States diagnosed with HF. Of these patients, there are approximately ~ 2.85 Million (prevalence, 380k incidence) with a condition referred to as HFpEF. These patients demonstrate shortness of breath and inability to exercise. Through the company’s internal market research, we estimate that there are approximately 1 million patient candidates with symptoms. These numbers are significantly larger outside the US, as there are 64 million individuals who have heart failure worldwide. With this estimated patient population and our estimated product pricing, we believe the total addressable market is estimated to be approximately ~$8.5 billion in the US and ~$25 billion globally; these figures are illustrative market size estimates and not projections of revenue. The Team Heart Failure Solutions is guided by a leadership team with over a 100 years of combined experience in medical devices, clinical and regulatory affairs, and quality management. These leaders have driven R&D and product development at some of the world’s most respected firms—including Medtronic, Boston Scientific, Abbott, and Guidant—building and commercializing complex Class II and III devices. Their expertise spans clinical strategy, regulatory navigation, project management, and large-scale quality operations, ensuring that innovation is matched with disciplined execution. Supporting them is a dynamic next generation of engineering talent, bringing fresh technical insight and energy from top universities. The team is further strengthened by internationally recognized medical advisors from Mayo Clinic and CRF, ensuring clinical relevance and scientific rigor at every step. Together, we believe this blend of proven leadership, engineering talent, and world-class medical guidance demonstrates that Heart Failure Solutions has the vision, credibility, and capability to execute on breakthrough opportunities in cardiovascular care. Advisors’ institutional affiliations are provided for identification only and do not imply institutional endorsement of Heart Failure Solutions or its products. ​ Past affiliations shown for reference only. No corporate or institutional endorsement is implied. ​ Progress to Date Since its founding in August 2021, the company has advanced the PeriCut system from initial bench testing to first-in-human procedures. Multiple interactions with the FDA have culminated in approval of an Early Feasibility Study (EFS), which is actively enrolling patients. Several patients have already undergone the procedure successfully, with ongoing enrollment and follow-up assessments proceeding in line with the clinical protocol. These milestones demonstrate both strong regulatory engagement and promising early clinical progress of the technology. The PeriCut System is an investigational device. It is being evaluated under an FDA-approved Early Feasibility Study and has not yet been cleared or approved for commercial use. Reimbursement Pathway We are working to position PeriCut for adoption given the existence of established reimbursement codes for pericardiotomy procedures. Hospitals already classify these cases under Diagnosis-Related Groups (DRGs), which range from approximately $9,600 for major chest procedures without complications to more than $27,000 for cases with complications or comorbidities. On the physician side, Current Procedural Terminology (CPT) codes already exist for creating a pericardial window, with reimbursement of about $830, and for thoracoscopic drainage procedures at $757. While further work with key opinion leaders (KOLs) will support alignment on CPT/DRG pathways, early indicators suggest that existing codes may provide adequate margins for physicians, hospitals, and Heart Failure Solutions, enabling a reimbursement strategy as we move toward broader adoption. The PeriCut System is an investigational device and has not yet received FDA clearance or reimbursement coverage. Coding references shown are based on comparable procedures and are for illustrative purposes only. Intellectual Property Heart Failure Solutions has built a strong and defensible intellectual property portfolio that we believe provides a significant competitive advantage. The company holds an exclusive license from Mayo Clinic covering four foundational patents and has additional joint filings with Mayo currently pending. Beyond the U.S., International Patent protection for Pericardial Systems for Heart Failure has been granted in Great Britain, France, Germany, Spain, Italy and Netherlands. Heart Failure Solutions has also filed its own proprietary patents, further broadening and strengthening its IP position. With multiple U.S. patents already granted, this portfolio creates a solid foundation intended to support the company’s ongoing product development and competitive positioning. Images are computer-generated renderings. The PeriCut System is an investigational device, not FDA cleared, and remains under development. Actual Device Used In IDE EFS Trial Clinical characteristics, disease progression, and survival rates vary among heart-failure patients. Data shown are general estimates from published research. The PeriCut System is an investigational device, not FDA-cleared or approved. Early feasibility data are preliminary and subject to further validation. Why Invest Investing in Heart Failure Solutions offers a unique opportunity to be part of a mission-driven company that is on a mission to address a significant health crisis. With FDA approval secured for our early feasibility study and a strong market demand for innovative heart failure therapies, we invite you to join us as we work to transform patient care and improve lives. Your support can help us bring our life-saving technology to those who need it most. Heart Failure Solutions is an independent company that licenses technology from Mayo Clinic. Mayo Clinic does not endorse any securities offering. Team experience based on combined professional histories of current executives and advisors. Recent Awards 2024 MN Cup Winner for Healthcare / IT Division 2023 MN Innovation Award Winner

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