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Tucson, AZ

Developing a cardiac patch to improve recovery after open-heart surgery.

• Patent-pending technology: BioXgen’s ECM-based cardiac patch is protected by intellectual property covering material composition and application method.
• Regulatory pathway: A 510(k) predicate device has been confirmed, providing a clear and expedited route to market.
• Clinical partnerships: Partnerships with leading U.S. cardiac surgery centers are in place for first-in-human trials.
• Experienced leadership: The company is led by an MD/PhD CEO and a PhD Chief Science Officer with extensive experience in cardiac physiology and medical device development.
• Market opportunity: The device addresses a significant unmet need in managing post-operative atrial fibrillation, a common complication in cardiac surgery.

BioXgen is advancing its patent-pending ExtraCellular Matrix (ECM)-based cardiac patch to support recovery after open-heart surgery. The patch aims to address post-operative atrial fibrillation (POAF), a common complication affecting over 50% of cardiac surgery patients. This fundraising effort is intended to expedite the path from clinical trials to market entry, with a target for FDA use clearance by 2026. The company is focused on improving patient outcomes and reducing healthcare costs associated with extended ICU stays and readmissions.

BioXgen’s ECM-based cardiac patch is derived from porcine tissue and integrates seamlessly into existing surgical workflows. The device is designed to provide structural support during the critical postoperative recovery period, with the material being absorbed as the tissue heals. The company has identified a 510(k) predicate device, providing a clear regulatory route to market. With clinical partnerships established at leading U.S. cardiac surgery centers, BioXgen is preparing for first-in-human trials to generate the necessary clinical data for FDA submission. The experienced team, led by an MD/PhD CEO and a PhD Chief Science Officer, brings extensive expertise in cardiac physiology and medical device development.

Company Info

BioXgen develops an ECM-based cardiac patch to support recovery after open-heart surgery, aiming to reduce post-operative complications.

BioXgen focuses on developing a patent-pending ExtraCellular Matrix (ECM)-based cardiac patch designed to support recovery after open-heart surgery. This innovative device aims to address post-operative atrial fibrillation (POAF), a common complication affecting over 50% of cardiac surgery patients. The ECM-based patch is derived from porcine tissue and integrates seamlessly into existing surgical workflows, providing structural support during the critical postoperative recovery period.

The company is on a path to secure FDA clearance by 2026, with clinical partnerships established at leading U.S. cardiac surgery centers for first-in-human trials. BioXgen’s approach aligns with modern healthcare systems that prioritize risk mitigation and improved patient outcomes, offering potential cost savings for hospitals and healthcare payers. The device is designed to be absorbed as the tissue heals, leaving no permanent foreign material, and aims to improve patient outcomes while reducing the economic burden of POAF-related complications.