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Supporting Cardiac Recovery Starts Here
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.
This raise supports our progress from clinical trials toward potential market entry, positioning us to address post-operative surgery complications and improve patient outcomes. If successful, our solution may also help reduce costs for hospitals and healthcare payers.
Reasons to Invest
Unmet need
Up to 50% of cardiac (open-heart) surgery patients develop POAF, the #1 postoperative complication in this patient population
Market opportunity
500,000 open-heart surgeries performed annually in the U.S., representing approximately $9 billion in POAF-related costs.
FDA pathway identified
510(k) predicate device confirmed, providing a clear regulatory route to market that typically takes less time than de novo approval.
Healthcare payer savings
Up to 45% of patients who experience POAF will exhibit recurrent atrial fibrillation (Afib) costing healthcare payers ~$50,000 per patient.
Patent-pending technology
ECM-based cardiac patch with intellectual property protection covering material composition and application method.
Product / Company Pitch
Addressing Cardiac Surgery's Most Common Complication
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.
The Problem
Cardiac Surgery's Billion-Dollar Complication
Postoperative atrial fibrillation remains the most common complication following cardiac surgery. The clinical consequences are severe:
Mortality
2x higher death rate compared to patients without POAF
Stroke risk
4x increase in stroke incidence
Kidney injury
7x higher rate of acute kidney injury
Hospital stay
3 to 7 additional days in the ICU
Long-term complications
~45% develop recurrent Afib
Current POAF interventions remain limited, are contraindicated or ineffective, leaving surgical teams without reliable POAF strategies to support their patients during recovery.
Our Solution
BioXgen’s patent-pending ECM-based patch is designed to support cardiac surgery recovery. The device features:
Porcine tissue-derived ECM
Biocompatible, non-immunogenic ECM-based patch that provides structural support
Epicardial application
Designed for precise, customized, and easy application directly to the heart's surface during surgery
Surgical workflow integration
Works with existing procedures without requiring new equipment or extensive team training
Natural material
ECM-based approach rather than synthetic materials or pharmaceutical interventions
Sustainability
ECM-based materials are resorbable, “disappearing” into the heart tissue, thereby eliminating any chemical footprint or medical waste, unlike synthetic materials or pharmacological interventions.
Scalability
Ethical sourcing from a virtually unlimited raw material supply permits rapid scaling to meet the clinical demand.
The Economics of Cardiac Surgery
Market
The market for POAF management aligns with fundamental healthcare economics. Cardiac surgery represents one of the most common and expensive procedures in modern medicine worldwide.
Market size indicators
500,000
open-heart surgeries are performed annually in the United States
30% to 50%
POAF incidence rate across cardiac procedures
$9 billion
estimated annual U.S. hospital costs attributable to POAF complications
Growing surgical volume
Aging population driving increased cardiac procedure rates
Hospitals operate under diagnosis-related group (DRG) payment models, receiving fixed reimbursement regardless of complications. POAF complications eat directly into hospital margins through extended ICU stays, additional monitoring, and readmissions. This creates strong economic incentives for hospitals to adopt technologies that support better recovery outcomes.
The cardiac surgery market also benefits from established purchasing patterns. Hospitals regularly evaluate and adopt new devices that demonstrate clinical value and cost reduction potential. Cardiac surgery centers maintain dedicated budgets for technologies that improve patient outcomes and reduce complications.
Building Toward Clinical Validation
Traction
BioXgen has laid the foundation for advancing from preclinical development to clinical trials.
Regulatory progress
FDA 510(k) predicate pathway identified
We've confirmed the regulatory route for clearance, providing clarity on requirements and timeline
FDA 510(k) predicate pathway identified
We've confirmed the regulatory route for clearance, providing clarity on requirements and timeline
Clinical POC validation completed
Over 200 patients undergoing cardiac surgery received a similar treatment with a human-derived placental (amnion) ECM patch
Current stage
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.
Clinical partnerships
U.S. cardiac surgery center partnerships
Agreements in place with leading cardiac surgery centers for first-in-human trials
Surgeon engagement
Early discussions with cardiac surgeons confirm adoption readiness and workflow compatibility
Team and infrastructure
Experienced founder-led team
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.
IP protection
Patent-pending intellectual property covering both the patch material composition and application methodology
Capital Allocation for Clinical Development
Use of Funds
This raise supports the critical path to FDA clearance and market entry.
87.4%
Clinical trials and regulatory
First-in-human studies, data collection, FDA submission preparation, and regulatory consulting
12.6%
Product development and manufacturing
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.
What Is Equity Crowdfunding?
Equity crowdfunding lets everyday people invest in private companies -like startups or small businesses – and become part-owners.
- You invest money in a private company (not on the stock market)
- You get shares in the company (called “equity”)
- If the company grows, your shares may become more valuable
- If the company fails, you could lose your investment
- Not listed on the stock market (like Apple or Google)
- Usually early-stage or growing businesses
- You’re investing early—before most people can
- You invest online through a regulated platform like DealMaker
- These are long-term investments (you might not see returns quickly)
- Always read the company’s fundraising page and disclosures
- You can lose money—only invest what you can afford
FAQ
Regulation CF allows investors to invest in startups and early-growth companies. This is different from helping a company raise money on Kickstarter; with Regulation CF Offerings, you arenʼt buying products or merchandise – you are buying a piece of a company and helping it grow.
Accredited investors can invest as much as they want. But if you are NOT an accredited investor, your investment limit depends on either your annual income or net worth, whichever is greater. If the number is less than $124,000, you can only invest 5% of it. If both are greater than $124,000 then your investment limit is 10%.
To calculate your net worth, just add up all of your assets and subtract all of your liabilities (excluding the value of the personʼs primary residence). The resulting sum is your net worth.
We cannot give tax advice, and we encourage you to talk with your accountant or tax advisor before making an investment.
Individuals over 18 years of age can invest.
There will always be some risk involved when investing in a startup or small business. And the earlier you get in the more risk that is usually present. If a young company goes out of business, your ownership interest could lose all value. You may have limited voting power to direct the company due to dilution over time. You may also have to wait about five to seven years (if ever) for an exit via acquisition, IPO, etc. Because early-stage companies are still in the process of perfecting their products, services, and business model, nothing is guaranteed. Thatʼs why startups should only be part of a more balanced, overall investment portfolio.
The Common Stock (the “Shares”) of BioXgen (the “Company”) are not publicly-traded. As a result, the shares cannot be easily traded or sold. As an investor in a private company, you typically look to receive a return on your investment under the following scenarios: The Company gets acquired by another company. The Company goes public (makes an initial public offering). In those instances, you receive your pro-rata share of the distributions that occur, in the case of acquisition, or you can sell your shares on an exchange. These are both considered long-term exits, taking approximately 5-10 years (and often longer) to see the possibility for an exit. It can sometimes take years to build companies. Sometimes there will not be any return, as a result of business failure.
Shares sold via Regulation Crowdfunding offerings have a one-year lockup period before those shares can be sold under certain conditions. The exceptions are sales to:
(i) to the Company;
(ii) to an “accredited investorˮ within the meaning of Rule 501 of Regulation D under the Securities Act;
(iii) as part of an offering registered under the Securities Act with the SEC; or
(iv) to a member of the Investorʼs family or the equivalent, to a trust controlled by the Investor, to a trust created for the benefit of a member of the family of the Investor or equivalent, or in connection with the death or divorce of the Investor or other similar circumstance.
In the event of death, divorce, or similar circumstance, shares can be transferred to:
- The company that issued the securities
- An accredited investor
- A family member (child, stepchild, grandchild, parent, stepparent, grandparent, spouse or equivalent, sibling, mother-in-law, father-in-law, son-in-law, daughter-in-law, brother-in-law, or sister-in-law, including adoptive relationships)
If a company does not reach their minimum funding target, all funds will be returned to the investors after the close of the offering.
All available disclosure information can be found on the landing pages for our Regulation Crowdfunding offering.
You can cancel your investment at any time, for any reason, until 48 hours prior to a closing occurring. If youʼve already funded your investment and your funds are in escrow, your funds will be promptly refunded to you upon cancellation. To submit a request to cancel your investment please email: info@dealmakersecurities.com
At a minimum, the company will be filing with the SEC and posting on itʼs website an annual report, along with certified financial statements. Those should be available 120 days after the fiscal year end. If the company meets a reporting exception, or eventually has to file more reported information to the SEC, the reporting described above may end. If these reports end, you may not continually have current financial information about the company.
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