BioXgen Seeks Community Funding for Cardiac Patch to Address $9 Billion Post-Surgery Complication

BioXgen, a medical device company developing a cardiac patch to prevent post-operative atrial fibrillation (POAF), has opened a Community Investment Round under Regulation Crowdfunding. POAF is the most common complication following open-heart surgery, affecting approximately 50% of the 500,000 Americans who undergo the procedure annually. The condition significantly increases risks of stroke, recurrent atrial fibrillation, kidney failure, and death, with no FDA-cleared device currently available for prevention.

The company’s cardiac patch is placed directly on the heart’s surface during surgery. Pre-clinical data published in Circulation shows POAF rates dropping from about 50% to under 5%, representing a tenfold reduction. According to the company, over 200 additional patients have been treated with similar results in unpublished data. The annual cost to the U.S. healthcare system from this complication is approximately $9 billion.

BioXgen is pursuing FDA clearance through the 510(k) pathway, which establishes substantial equivalency to materials already cleared by the agency. The company has completed its Q-submission to the FDA, solidifying this regulatory path. Total development time to clearance is targeted at under 18 months if critical funding needs are met, with the goal of establishing the device as standard of care within 36 to 48 months of approval.

The investment offering is hosted by DealMaker Securities, with investments starting at $500. This structure allows retail investors to participate in a medical device category historically reserved for institutional capital. The company will host a live investor presentation on Monday, April 7, 2025, at 1:30 PM PT via Zoom Webinar, requiring registration at https://dnagency.lpages.co/bioxgen-investor-presentation/.

Dr. David Skinner, BioXgen’s President and CEO, stated the company has the data, regulatory path, clinical partner, and team necessary for success. The offering details and investment opportunity can be viewed at https://invest.bioxgen.life/. BioXgen has filed a Form C with the Securities and Exchange Commission in connection with its offering, with a copy available through the same investment portal.

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