BioXgen’s patent-pending ExtraCellular Matrix (ECM)-based cardiac patch supports patients’ recovery after open-heart surgery. Post-surgery complications such as post-operative atrial fibrillation (POAF) can affect over 50% of cardiac surgery patients within 3-4 days after surgery. We are on an accelerated track for FDA use clearance in 2026. This raise expedites the path from clinical trials to market entry, positioning us to address post-operative surgery complications, improve patient outcomes while saving hospitals and healthcare payers billions each year.

The founders have an established history of success from start-ups to acquisition valued in total at ~$65M.
Up to 50% of cardiac surgery patients develop POAF, the #1 postoperative complication in this patient population.
500,000 open-heart surgeries performed annually in the U.S., representing approximately $9 billion in POAF-related costs.
510(k) predicate device confirmed, providing a clear regulatory route to market that typically takes less time than de novo approval.
POAF can cost hospitals $10,000 to $20,000 per patient through extended ICU stays and readmissions.
ECM-based cardiac patch with intellectual property protection covering material composition and application method.
Preclinical results completed, with partnerships in place at leading U.S. cardiac surgery centers for first-in-human trials.
Founded by an MD/PhD CEO with a background in medical pharmacology / new drug discovery and prior company-building experience, alongside a PhD Chief Science Officer- a Professor of Physiology with 30+ years in cardiac physiology, biomedical engineering, and translational research.
Post-operative complication management has become prioritized. Modern Healthcare systems use value-based medical models that incentivize risk mitigation and reward improved patient outcomes.
BioXgen operates in cardiovascular medtech, a sector where successful products have historically led to major strategic acquisitions following regulatory clearance.
Founded by an MD/PhD CEO with a background in medical pharmacology / new drug discovery and prior company-building experience, alongside a PhD Chief Science Officer- a Professor of Physiology with 30+ years in cardiac physiology, biomedical engineering, and translational research.

Every day, cardiac surgery teams face a predictable problem. Despite advances in surgical technique, up to half of their open-heart patients develop POAF. For hospitals operating under fixed reimbursement models, each case represents thousands in uncompensated costs. This cost extends to healthcare payers after hospitalization.
BioXgen developed an ECM-based cardiac patch to address this.
Derived from porcine tissue applied directly to the heart’s surface during surgery
Uses porcine ECM material with 100+ years of proven safety in human use
Designed specifically for cardiac applications
Seamlessly integrates into existing surgical workflows, requiring no new equipment or additional training
Our ECM-based device is designed to provide structural support for the heart during the critical postoperative recovery period.
Our product sits at the intersection of cardiovascular devices and regenerative biomaterials. We designed it for everyday cardiac teams, not research labs. With our regulatory pathway confirmed and clinical partnerships established, we’re positioned to bring this technology through validation and into operating rooms where it can make a difference.
Postoperative atrial fibrillation remains the most common complication following cardiac surgery.
The clinical consequences are severe:
2x higher death rate compared to patients without POAF
4x increase in stroke incidence
3 to 7 additional days in the ICU
2x higher death rate compared to patients without POAF
~45% develop recurrent Afib
Current interventions remain limited and inconsistent, leaving surgical teams without reliable tools to support their patients during recovery.
BioXgen’s patent-pending ECM-based patch is designed to support cardiac surgery recovery. The device features:
Porcine tissue-derived ECM
Epicardial application
Surgical workflow integration
Natural material
Sustainability
Scalability
The material is designed to be absorbed as the tissue heals, leaving no permanent foreign material.
The market for POAF management aligns with fundamental healthcare economics. Cardiac surgery represents one of the most common and expensive procedures in modern medicine.
BioXgen has laid the foundation for advancing from preclinical development to clinical trials.
We've confirmed the regulatory route for clearance, providing clarity on requirements and timeline
Over 200 patients undergoing cardiac surgery received a similar treatment with a human-derived placental (amnion) ECM patch
We're preparing for first-in-human studies, the critical step that will generate the clinical data needed for FDA submission. Our partnerships with cardiac surgery centers provide access to patient populations and the surgical expertise required for successful trials.
Agreements in place with leading cardiac surgery centers for first-in-human trials
Early discussions with cardiac surgeons confirm adoption readiness and workflow compatibility
Founded by an MD/PhD CEO with a background in medical pharmacology / new drug discovery and prior company-building experience, alongside a PhD Chief Science Officer who is a Professor of Physiology with 30+ years in cardiac physiology, biomedical engineering, and translational research.
Patent-pending intellectual property covering both the patch material composition and application methodology
The material is designed to be absorbed as the tissue heals, leaving no permanent foreign material.
Derived from porcine tissue applied directly to the heart’s surface during surgery
Pricing designed to deliver clear ROI through complication management and associated cost savings
Per-procedure pricing model aligns with existing hospital purchasing and inventory systems
Once we receive FDA clearance, we’ll target cardiac surgery centers through a combination of direct sales and established medical device distribution channels. The value proposition centers on demonstrated cost savings, making the economic case straightforward for hospital decision-makers.
Hospital purchasing committees evaluate devices based on clinical evidence, cost-effectiveness, and ease of implementation. Our design specifically addresses these criteria by integrating into existing workflows, requiring minimal training, and targeting a complication with clear cost implications.
This raise supports the critical path to FDA clearance and market entry.
First-in-human studies, data collection, FDA submission preparation, and regulatory consulting
Refining manufacturing processes, scaling production capabilities, and quality systems implementation
Clinical trials are our primary capital deployment. The first-in-human studies will generate the safety and efficacy data required for an FDA 510(k) submission. This includes patient enrollment, surgical procedure costs, follow-up monitoring, and data analysis.
Manufacturing scale-up ensures we can produce the cardiac patch at volumes needed for clinical trials while establishing the quality systems and documentation the FDA requires for commercial production.
Postoperative atrial fibrillation has been accepted as an inevitable complication of cardiac surgery for too long. Thousands of patients each year face doubled mortality risk, extended ICU stays, and increased stroke danger because of POAF.
BioXgen’s ECM-based cardiac patch is designed to support the recovery process. By providing structural support during the critical postoperative period, we aim to help cardiac surgery teams support better patient outcomes.
The next phase requires clinical trials to evaluate this approach in real cardiac surgery patients.
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