Reasons to InvestThe ProductThe Problem & Solution
Invest in BioXgen
Invest in BioXgen
Invest in BioXgen

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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. 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.

$1.43

Share price

$500.50

Min. Investment

3.5%

Investor Processing Fee

Reasons to Invest

Proven Entrepreneur Success

The founders have an established history of success from start-ups to acquisition valued in total at ~$65M.

Unmet need

Up to 50% of cardiac 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.

Hospital cost savings

POAF can cost hospitals $10,000 to $20,000 per patient through extended ICU stays and readmissions.

Patent-pending technology

ECM-based cardiac patch with intellectual property protection covering material composition and application method.

Clinical validation stage

Preclinical results completed, with partnerships in place at leading U.S. cardiac surgery centers for first-in-human trials.

Experienced 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- a Professor of Physiology with 30+ years in cardiac physiology, biomedical engineering, and translational research.

Market alignment

Post-operative complication management has become prioritized. Modern Healthcare systems use value-based medical models that incentivize risk mitigation and reward improved patient outcomes.

Early Entry Into a Historically High-Value Medtech Segment

BioXgen operates in cardiovascular medtech, a sector where successful products have historically led to major strategic acquisitions following regulatory clearance.

Experienced 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- a Professor of Physiology with 30+ years in cardiac physiology, biomedical engineering, and translational research.

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

3 to 7 additional days in the ICU

Hospital stay

2x higher death rate compared to patients without POAF

Long-term complications

~45% develop recurrent Afib

Current interventions remain limited and inconsistent, leaving surgical teams without reliable tools to support their patients during recovery.

Sources:
  1. Helgadottir S, Sigurdsson MI, Ingvarsdottir IL, Arnar DO, Gudbjartsson T. Atrial fibrillation following cardiac surgery: risk analysis and long-term survival. J Cardiothorac Surg 2012;7:87. DOI: 10.1186/1749-8090-7-87.
  2. Dobrev D, Aguilar M, Heijman J, Guichard JB, Nattel S. Postoperative atrial fibrillation: mechanisms, manifestations and management. Nat Rev Cardiol 2019;16(7):417-436. DOI: 10.1038/s41569-019-0166-5.
  3. Woldendorp K, Farag J, Khadra S, Black D, Robinson B, Bannon P. Postoperative Atrial Fibrillation After Cardiac Surgery: A Meta-Analysis. Ann Thorac Surg. 2021 Dec;112(6):2084-2093. doi: 10.1016/j.athoracsur.2020.10.055. Epub 2020 Dec 16. PMID: 33340521.
  4. Guenancia C, Pujos C, Debomy F, Malapert G, Laurent G, Bouchot O. Incidence and Predictors of New-Onset Silent Atrial Fibrillation after Coronary Artery Bypass Graft Surgery. Biomed Res Int 2015;2015:703685. DOI: 10.1155/2015/703685.
  5. Swinn T, Pezard-Snell M, Brain L, Dimitropoulos G, Dastidar A, Sammut E, Barman P. Recurrence of atrial fibrillation after cardiac surgery: long-term evidence from cardiac devices. Front Cardiovasc Med. 2025 Oct 3;12:1669461. doi: 10.3389/fcvm.2025.1669461. PMID: 41112224; PMCID: PMC12531181.
  6. Taha A, Nielsen SJ, Bergfeldt L, Ahlsson A, Friberg L, Björck S, Franzén S, Jeppsson A. New-Onset Atrial Fibrillation After Coronary Artery Bypass Grafting and Long-Term Outcome: A Population-Based Nationwide Study From the SWEDEHEART Registry. J Am Heart Assoc. 2021 Jan 5;10(1):e017966. doi: 10.1161/JAHA.120.017966. Epub 2020 Nov 30. PMID: 33251914; PMCID: PMC7955471.
  7. Melduni RM, Schaff HV, Bailey KR, Cha SS, Ammash NM, Seward JB, Gersh BJ. Implications of new-onset atrial fibrillation after cardiac surgery on long-term prognosis: a community-based study. Am Heart J. 2015 Oct;170(4):659-68. doi: 10.1016/j.ahj.2015.06.015. Epub 2015 Jun 28. PMID: 26386789.
  8. Ahlsson A, Bodin L, Fengsrud E: Patients with postoperative atrial fibrillation have a doubled cardiovascular mortality. Scand Cardiovasc J. 2009, 43 (5): 330-336. 10.1080/14017430802702291.
  9. Ahlsson, A., Fengsrud, E., Bodin, L. & Englund, A. Postoperative atrial fibrillation in patients undergoing aortocoronary bypass surgery carries an eightfold risk of future atrial fibrillation and a doubled cardiovascular mortality. Eur. J. Cardiothorac. Surg. 37, 1353–1359 (2010).

Our Solution

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.

Invest in Bioxgen >

The Economics of Cardiac Surgery

Market Opportunity

The market for POAF management aligns with fundamental healthcare economics. Cardiac surgery represents one of the most common and expensive procedures in modern medicine.

Sources:
  1. Vervoort D, Lee G, Ghandour H, Guetter CR, Adreak N, Till BM, Lin Y. Global Cardiac Surgical Volume and Gaps: Trends, Targets, and Way Forward. Ann Thorac Surg Short Rep. 2023 Dec 9;2(2):320-324. doi: 10.1016/j.atssr.2023.11.019. PMID: 39790140; PMCID: PMC11708342.

Building Toward Clinical Validation

Traction

BioXgen has laid the foundation for advancing from preclinical development to clinical trials.

Regulatory Process

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

What's happening now

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 & 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

Medical Device Sales Model

How We Make Money

The material is designed to be absorbed as the tissue heals, leaving no permanent foreign material.

Medical Device Sales Model

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

Go-to-Market Approach

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.

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.

Capital Allocation for Clinical Development

Supporting Cardiac Recovery Starts Here

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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BioXgen

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Amount Based Perks

Investor Perks

$500

Bonus Units: 1%

$1,000

Bonus Units: 3%

$5,000

Bonus Units: 5%

$10,000

Bonus Units: 7%

$25,000

Bonus Units: 10%

$50,000

Bonus Units: 15%

$100,000

Bonus Units: 20%

Perks for the first two weeks (early bird)

$500

Bonus Units: 3%

$1,000

Bonus Units: 5%

$5,000

Bonus Units: 7%

$10,000

Bonus Units: 10%

$25,000

Bonus Units: 15%

$50,000

Bonus Units: 20%

$100,000

Bonus Units: 25%

FAQ

Why invest in startups?

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.

How much can I invest?

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%.

How do I calculate my net worth?

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What are the tax implications of an equity crowdfunding investment?

We cannot give tax advice, and we encourage you to talk with your accountant or tax advisor before making an investment.

Who can invest in a Regulation CF Offering?

Individuals over 18 years of age can invest.

What do I need to know about early-stage investing? Are these investments risky?

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.

When will I get my investment back?

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.

Can I sell my shares?

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.

Exceptions to limitations on selling shares during the one-year lockup period:

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)

What happens if a company does not reach their funding target?

If a company does not reach their minimum funding target, all funds will be returned to the investors after the close of the offering.

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All available disclosure information can be found on the landing pages for our Regulation Crowdfunding offering.

What if I change my mind about investing?

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

How do I keep up with how the company is doing?

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.

What relationship does the company have with DealMaker Securities?

DealMaker Securities is serving as the intermediary for this offering. Once an offering ends, there is no guarantee that DealMaker Securities will have a relationship with the company. The company may continue its relationship with DealMaker Securities for additional offerings in the future. DealMaker Securitiesʼ affiliates may also provide ongoing services to the company. There is no guarantee any services will continue after the offering ends.

Equity crowdfunding investments in private placements, and start-up investments in particular, are speculative and involve a high degree of risk and those investors who cannot afford to lose their entire investment should not invest in start-ups. Companies seeking startup investment through equity crowdfunding tend to be in earlier stages of development and their business model, products and services may not yet be fully developed, operational or tested in the public marketplace. There is no guarantee that the stated valuation and other terms are accurate or in agreement with the market or industry valuations.

Further, investors may receive illiquid and/or restricted stock that may be subject to holding period requirements and/or liquidity concerns.
Forward looking statements were included here that the Company believes to be accurate given the current information. They involve known and unknown risks, uncertainties and other important factors which if changed may affect the outcome(s).

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