Our mission is to regenerate human tissue for patients, starting with blood vessels. We began with lab-grown human tissue models for researchers. That work built our tissue engineering expertise and brought in $5.5M in sales. We now apply that expertise to our first clinical product in development: a living vascular graft designed to be seeded with the patient’s own cells at the bedside.

1. Advancing Toward the Clinic

Our first clinical product in development is a living, tissue-engineered vascular graft. Cardiovascular disease is the leading cause of death worldwide^{1World Health Organization. (2025, July 31). Cardiovascular diseases (CVDs). WHO. https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds)}, and surgeons need better replacement blood vessels. Unlike permanent plastic grafts, which often fail in small vessels, ours is designed to remodel into a natural, living blood vessel inside the patient. In our first preclinical implant it grew its own endothelium within 14 days, and the study won a 2026 VESS Best Paper Award. The vascular graft is our focus because it is the biggest opportunity in front of us: a market of roughly $37 billion worldwide, where permanent plastic grafts still fail in up to 65% of small-vessel cases.

2. Our Human Tissue Expertise

Our expertise comes from years of building human tissue models. Made with human cells, they reproduce selected functions of the brain, lungs and blood vessels, and customers from cell therapy companies to government have used them to study disease and test new therapies. This work generated $5.5M in cumulative sales and the skills we now apply to our vascular graft, and it continues alongside the graft with our partners.

3. Long-Term Vision

Blood vessels are the foundation of every organ. Growing living vessels today lays the groundwork for more complex regenerated tissues and, one day, transplantable organs.

These statements contain forward-looking information based on current expectations and assumptions. Actual results may differ materially due to risks and uncertainties. No assurance can be given that projected outcomes will be achieved. Investing involves risk, including possible loss of principal.

The Problem

From the lab to the operating room, medicine faces ongoing shortages of functional human tissue for research, vascular repair, and organ transplantation.

Pharmaceutical companies still rely heavily on animal testing, and about 90 percent of drugs that pass animal studies fail in human trials.^{2doi: 10.1016/j.jacbts.2019.10.008, doi: 10.1039/c8lc00330k, doi: 10.1038/nrd4539} Human tissue models help close that gap, and we built ours into a business.

In clinical settings, synthetic vascular grafts remain standard for various procedures. These grafts do not biologically integrate with the body and tend to fail in small-diameter vessel applications. Failure rates can reach 65% within two years, leading to additional surgeries, higher costs, and worse outcomes for patients. A potentially ideal solution is a “living scaffold” that transforms into native tissue over time.

The shortage of human tissue affects millions of patients. More than 100,000 people in the U.S. wait for organ transplants. Hundreds of thousands more need vascular grafts for surgery each year. Current solutions rely on synthetic materials that fail or on donor tissue, which is in limited supply. The shortage continues to widen as demand outpaces what's available. New strategies are needed to create functional, living human tissue.

Our Solution

We apply deep expertise in human tissue engineering to two problems: first, regenerating blood vessels for patients, and alongside that, human tissue models for research.

To improve the accuracy of preclinical testing, we create lab-grown human tissue models designed to serve as high-fidelity alternatives to animal studies.

1. High-Fidelity: Our models are engineered to reproduce selected biological functions of the brain, lungs, and blood vessels, providing a human-relevant platform for evaluating safety and biological activity.
2. Commercial Application: These systems are designed to support the evaluation of a range of therapeutic approaches, from pharmaceutical drugs to novel cell therapies. We are currently collaborating with partners to use these models to support the development of next-generation therapies.

We are developing a regenerative graft designed to use the patient’s own stem cells to address the high failure rate of purely synthetic grafts.

1. Seeded at the Bedside, Grown in the Body: By combining the patient’s own cells with a bioresorbable scaffold at the bedside, we aim to mitigate the risk of immune rejection and the need for vein harvesting. The result is a graft that is engineered to transform into a natural blood vessel over time after implantation, designed to provide a long-term solution that overcomes the limitations of purely synthetic materials.
2. Target Applications: We are focusing on critical procedures where current options fall short, starting with peripheral artery disease (PAD) bypass, then trauma repair, dialysis access and coronary artery bypass.
3. Immediate & Regenerative: The graft is engineered to conduct blood flow immediately upon implantation. With this design, over time, the biodegradable scaffold is absorbed and replaced by living tissue to create a durable vessel that integrates naturally designed to minimize the risk of long-term foreign body rejection.

The Path to Engineered Organs

Blood vessels are the foundation of every organ. Developing functional vascular tissue now lays the groundwork for full organ engineering. This core capability positions us to address transplantable tissues and organs such as pancreas, lung, kidney, liver, and heart.

The same biological expertise that powers our human tissue models today forms the foundation for our mission to develop tissue-engineered blood vessels and eventually pioneer lab-grown organs.

Market

Frontier Bio operates in two evolving sectors that are shifting away from synthetic and animal-based models toward human tissue engineering.

Human Tissue Models - An Animal Alternative

The global market for human tissue models is estimated at approximately $2.1 billion^{3Ghosh, S. (2026, January 15). In-vitro human models market size and share forecast outlook 2026 to 2036. Future Market Insights. Retrieved February 22, 2026, from https://www.futuremarketinsights.com/reports/in-vitro-human-models-market} and continues to grow as researchers explore alternative approaches to traditional animal studies. We believe our platform is well positioned to participate in this evolving market as regulatory agencies and research institutions evaluate and expand the use of human-based research tools.

Vascular Grafts

The vascular graft market is massive but severely underserved. For small vessels, surgeons are currently forced to choose between two flawed options: synthetic grafts with significant failure rates, or harvesting the patient’s own vein, which prolongs surgery and causes donor-site injury.^{4Pashneh-Tala S, MacNeil S, Claeyssens F. The Tissue-Engineered Vascular Graft-Past, Present, and Future. Tissue Eng Part B Rev. 2016 Feb;22(1):68-100. doi: 10.1089/ten.teb.2015.0100. Epub 2015 Oct 8. PMID: 26447530; PMCID: PMC4753638. [973 citations via Google Scholar, retrieved February 2026]}

We are developing a solution to address these shortcomings. Our approach combines the patient’s own stem cells with a bioresorbable scaffold, designed to transform into a living vessel inside the body. We estimate the market for small-diameter vascular grafts at roughly $13 billion in the US today, about $15 billion by 2028, and about $37 billion worldwide, based on current procedure counts and graft prices.^{5Frontier Bio, Small-Diameter Vascular Graft Market Analysis, October 2026. Procedure counts from Ciaramella M, LoGerfo F, Liang P. Ann Vasc Surg. 2024;107:17-30; Criqui MH et al. Circulation. 2021;144(9):e171-e191; Allon M et al. JAMA Netw Open. 2023;6(8):e2326458; and US hospital claims data. Prices from current US list prices of synthetic, biologic and tissue-engineered grafts ($1,000 to $30,000).}

Towards Lab-Grown Implantable Organs

According to the World Health Organization, only 10% of global organ demand is met. This scarcity, combined with lifetime care costs that can exceed $1M per patient, has created a $100B+ market opportunity.^{6Yadav U. Global regenerative medicine market size, industry analysis and outlook (2025-2033) [Internet]. DataM Intelligence; 2026 Feb 3 [cited 2026 Feb 22]. Available from: https://www.datamintelligence.com/research-report/regenerative-medicine-market}

For example, the demand for lung transplants is incredibly high, yet they come at a substantial cost.

^{7Thabut G, Mal H. Outcomes after lung transplantation. J Thorac Dis. 2017 Aug;9(8):2684-2691. doi: 10.21037/jtd.2017.07.85. PMID: 28932576; PMCID: PMC5594127. Ortner N, Holzer H. 2025 U.S. organ and tissue transplants: Estimated costs and utilization, emerging issues, and solutions. Milliman. 2025 Feb 13 [cited 2026 Feb 22]. Available from: https://www.milliman.com/en/insight/2025-us-organ-and-tissue-transplants-costs-utilization }

Traction

Capital-Efficient Model

Sales of our tissue models have helped fund our vascular graft development, so investor dollars have gone further than at most preclinical biotechs.

World-Class Partners & Customer Adoption

Top-tier institutions rely on our tissue models to test therapies and study disease.

Clinical Progress: Road to the Clinic

Our vascular graft program is advancing toward human trials. We have engaged the FDA early to help clarify our path to market. In our first preclinical implant the graft stayed open with no thrombosis and grew its own endothelium within 14 days, work that won a 2026 VESS Best Paper Award.

Elite Scientific Backing & Commercial Validation

We are built on elite scientific backing, a defensive IP moat, and disciplined capital execution.

Strategic Consortia & Accelerator Participation

Frontier Bio participates in established defense, manufacturing, and innovation ecosystems that support collaboration, early commercialization efforts, and manufacturing readiness in regenerative medicine, including MTEC, ARMI, StartX, Alchemist Accelerator, Brinc, and the NSF SBIR Beat-the-Odds Bootcamp.

How We Make Money

Revenue today comes from our tissue models and tissue engineering services, grants, and co-development projects with industry, and we are pursuing federal contracts. Our growth will come from the clinic. The vascular graft market is many times larger than the market for human tissue models: roughly $37 billion worldwide today, against about $2 billion for tissue models.

Today: Tissue Models, Contracts and Grants

We generate revenue by providing high-fidelity human tissue models and tissue R&D services to commercial partners, academic institutions, and the government.

1. Customer Base: We serve companies, universities, and government who are developing therapeutics, studying disease, and advancing medical science.
2. High-Value Contracts: Our clients pay for tissues and bespoke R&D. We have secured sizable contracts for our various tissues ranging from $250k up to $1.1M.
3. Contracts, Grants and Co-Development: Grants such as NSF SBIR and the NIH/FDA Complement-ARIE prize and co-development projects with industry partners fund part of our development, and we are pursuing federal contracts and subcontracts.

The Growth Engine: Vascular Grafts (in development)

Our clinical vertical will focus on the sale of our tissue-engineered vascular graft.

1. Model: Direct sales to hospitals and surgical centers for use in operating rooms.
2. Beachhead Application: Peripheral artery disease (PAD) bypass. Many PAD patients have no usable vein of their own, and permanent plastic grafts fail most often in these small vessels. Over 120,000 PAD bypass procedures are performed in the US each year.
3. Expansion: While we advance the PAD graft, we aim to generate validation data for trauma repair, dialysis access and coronary artery bypass to address a significantly larger total market.

Exit Potential

Large companies often acquire regenerative medicine companies before their first product reaches the market.

1. Vertex acquired Semma Therapeutics, a stem cell company, for $950 million in 2019, before its first human trial.
2. Bayer bought out BlueRock Therapeutics in 2019 at a total company value of about $1 billion, before its lead cell therapy entered the clinic.
3. Humacyte, which makes an engineered blood vessel, went public in 2021 at a value of about $1.1 billion while its late-stage trials were still running, more than three years before its vessel was approved.

We believe the strongest point for a partnership or acquisition will come when our vascular graft has human data. Until then, our tissue models, grants and industry partnerships help fund the work.

These examples are other companies’ transactions and do not predict what will happen at Frontier Bio. An acquisition or public listing may never happen, and investors could lose their entire investment.

Use of Funds

This round funds the next preclinical studies of our vascular graft and our regulatory preparation. It also supports our tissue model work and our government and industry partnerships.

*Allocation may change depending on regulatory or operational needs.

The statements above reflect the personal views and opinions of the individuals quoted and are based on their experience with Frontier Bio. These statements do not constitute an endorsement of the Company or its securities offering. No compensation was provided for these testimonials. Past performance and investor opinions are not indicative of future results.

Help Us Bring Living Blood Vessels to Patients

Frontier technology can take years to reach patients.

We have built the expertise, earned revenue along the way, and seen in our first preclinical implant that our vascular graft grows a living inner lining within weeks. The next step is the preclinical work that takes it toward first-in-human trials.

We have the traction, the team and the technology. Now we need you.

Help us regenerate human tissue for patients, starting with blood vessels.

Investing in early-stage biotech carries risk, including total loss of capital. Regulatory approval is not guaranteed. Please review all offering materials and risk factors before investing.