BioXgen

About the offering

BioXgen is developing a patent-pending ExtraCellular Matrix (ECM)-based cardiac patch to support patients' recovery after open-heart surgery by addressing post-operative atrial fibrillation (POAF), which affects over 50% of cardiac surgery patients. The Problem POAF is the most common complication following cardiac surgery, with severe clinical consequences including 2x higher death rate, 4x increase in stroke incidence, 7x higher rate of acute kidney injury, 3-7 additional ICU days, and approximately 45% developing recurrent atrial fibrillation. Each POAF case can cost hospitals $10,000-$20,000 through extended ICU stays and readmissions. Current interventions remain limited and inconsistent, leaving surgical teams without reliable tools to support patient recovery. The Solution BioXgen's ECM-based cardiac patch is derived from porcine tissue and applied directly to the heart's surface during surgery. The patch uses porcine ECM material with 100+ years of proven safety in human use, is designed specifically for cardiac applications, and seamlessly integrates into existing surgical workflows requiring no new equipment or additional training. The material is designed to be absorbed as tissue heals, leaving no permanent foreign material while providing structural support during the critical postoperative recovery period. Market Opportunity The U.S. market includes 500,000 open-heart surgeries performed annually, representing approximately $9 billion in POAF-related costs. The cardiovascular medtech sector historically leads to major strategic acquisitions following regulatory clearance. Modern healthcare systems use value-based medical models that incentivize risk mitigation and reward improved patient outcomes, aligning with the product's value proposition. Development Status The company has completed preclinical results and confirmed the FDA 510(k) predicate device pathway, providing a clear regulatory route to market that typically takes less time than de novo approval. Clinical proof-of-concept validation has been completed with over 200 patients undergoing cardiac surgery receiving similar treatment with a human-derived placental (amnion) ECM patch. The company is preparing for first-in-human studies and has partnerships in place at leading U.S. cardiac surgery centers for trials. Business Model BioXgen will generate revenue through direct sales to hospitals and cardiac surgery centers using a standard medical device sales model. Hospitals purchase the cardiac patch as a surgical supply item for cardiac procedures, with pricing designed to deliver clear ROI through complication management and associated cost savings. The per-procedure pricing model aligns with existing hospital purchasing and inventory systems. Team The company is founded by an MD/PhD CEO with background in medical pharmacology/new drug discovery and prior company-building experience. The Chief Science Officer is a PhD Professor of Physiology with 30+ years in cardiac physiology, biomedical engineering, and translational research. The founders have an established history of success from start-ups to acquisition valued in total at approximately $65M. Intellectual Property The company holds patent-pending intellectual property covering both the patch material composition and application methodology, providing protection for the core technology. Current Fundraise BioXgen is raising capital via Regulation Crowdfunding on StartEngine at $1.43 per share with a $500.50 minimum investment (includes 3.5% investor processing fee). The company is targeting FDA clearance in 2026. Use of Funds 87.4% of capital will support clinical trials and regulatory activities (first-in-human studies, data collection, FDA submission preparation, regulatory consulting). 12.6% will fund product development and manufacturing (refining manufacturing processes, scaling production capabilities, quality systems implementation).

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