The Smartweave Story

Smartweave is building a more personal approach to regenerative medicine by starting with the patient’s own biology. We use biological data, including factors such as inflammation risk, to shape connective tissue treatments designed for the individual rather than built around a standard model of care.

That idea sits at the center of everything we are developing. Smartweave brings regenerative materials, AI, and patient-specific data together to create treatments that can respond more closely to how each person heals. We're applying the same underlying approach across pelvic health, orthopedic repair, cardiovascular care, and periodontal restoration.

For us, the science is most meaningful when it improves recovery for the person on the other side of it. Smartweave exists to bring more precision and individuality into tissue repair, with the aim of helping patients heal in ways that better reflect their own bodies, needs, and lives.

Smartweave’s pre-clinical results are based on studies conducted in laboratory and animal models. These studies are preliminary and are not indicative of safety or effectiveness in humans.

Results observed in pre-clinical settings may not be replicated in clinical trials. Further testing, including human clinical studies, will be required to evaluate safety and efficacy.

The Problem

Statements regarding limitations of existing medical devices and treatment approaches are based on published studies, reported outcomes, and industry observations. While Smartweave believes there are opportunities for improvement, existing treatments may be effective for many patients, and clinical outcomes can vary widely based on individual circumstances.

Smartweave brings patient biology into the treatment design process from the beginning. Our technology uses patient-specific data, including factors such as inflammation risk, to help guide the combination of regenerative materials and therapies used for connective tissue repair.

Smartweave combines AI, regenerative materials, and digital modeling to develop treatments shaped more closely to the individual patient. The aim is to reduce the mismatch between standardized devices and the people receiving them, while supporting tissue integration and the body’s own healing response.

The SMARTS™ System

SMARTS™ is the core system behind Smartweave’s product portfolio. It uses patient-specific data and digital modeling to help guide the combination of regenerative materials, therapies, and scaffold technologies used for each application.

The system can incorporate components such as injectable gels, anti-inflammatory agents, biocoated scaffolds, cells, and regenerative factors. SmartCoating™ focuses on AI-designed anti-inflammatory coatings for devices such as meshes and slings, while SmartScaffold™ supports structural repair and tissue integration using cell-seeded scaffold technology.

Product Lines

HeraWeave™ is being developed for stress urinary incontinence and pelvic organ prolapse using regenerative hydrogels and AI-designed biocoated slings.

OrthoWeave™ is focused on ACL and tendon reconstruction using bioprinted patches designed to better match the structure and mechanics of native tissue.

CardioWeave™ is being developed for customized cardiac valve replacement, with designs shaped around each patient’s individual heart function.

DentaWeave™ is focused on periodontal restoration using a light-curable regenerative gel designed to conform to damaged oral tissue and account for the patient’s inflammatory profile.

Smartweave’s technologies are currently in the pre-clinical stage of development. Statements regarding potential performance characteristics—including reduced inflammation, improved tissue integration, or regenerative outcomes—are based on early-stage research, design objectives, and pre-clinical data, including animal models. These findings have not been validated in human clinical trials.

There is no assurance that these technologies will demonstrate similar results in humans or receive regulatory approval. Actual product performance, if commercialized, may differ materially from current expectations.

Smartweave is developing its technology for several large, established areas of medicine, including pelvic health, orthopedic reconstruction, and cardiovascular repair. Together, those applications place the company within a connective tissue restoration market projected to exceed $100 billion by 2030, with opportunities spanning both direct product commercialization and technology licensing.

1. Total Addressable Market: $100B+ for connective tissue restoration by 2030
2. Serviceable Addressable Market: approximately $15B across licensing and direct product applications
3. Serviceable Obtainable Market: $150M to $250M within 5+ years across both revenue tracks

Market size estimates and growth projections are based on third-party reports, industry publications, and internal assumptions. These estimates are inherently uncertain and subject to change.

Smartweave’s ability to capture any portion of the identified market is dependent on numerous factors, including regulatory approval, clinical outcomes, commercialization execution, competition, and market adoption. There can be no assurance that the company will achieve meaningful market penetration.

Traction

We’re entering this next stage with pre-clinical research, outside funding, institutional recognition, and a growing intellectual property portfolio already behind the Smartweave technology.

Scientific and Pre-Clinical Validation

Pre-clinical studies of SMARTS™ system components have demonstrated pelvic tissue regeneration and tendon repair in rodent models. Smartweave is also preparing for FDA engagement around its initial regulatory pathways as it moves its first technologies closer to commercialization.

Institutional Support and Recognition

Smartweave has secured $6.4 million in grants and institutional support, while clinical collaborators have secured more than $12 million to advance enabling research tied to the company’s technology.

Dassault Systèmes also selected the company from more than 1,000 global ventures for access to BIOVIA and the 3DEXPERIENCE environment used in its digital modeling work.

Intellectual Property

Smartweave has secured multiple U.S. patents and filed additional applications, with a growing portfolio spanning scaffold design, AI, regenerative formulations, and 3D printing methods.

IP Revenue

Smartweave has generated $1.2 million in revenue from its intellectual property portfolio, providing early commercial validation for a model that includes both licensing and direct product development.

Smartweave’s products are subject to review and approval by the U.S. Food and Drug Administration (FDA) or comparable regulatory authorities outside the United States. Any discussion of potential regulatory pathways, classifications, or timelines reflects current expectations only.

There can be no assurance that Smartweave will obtain FDA clearance or approval within any anticipated timeframe, or at all. Regulatory processes are inherently uncertain and may require additional testing or clinical trials.

Commercialization Roadmap

Smartweave is moving from pre-clinical development toward its first targeted commercial applications, beginning with technologies within the HeraWeave™ product line.

1. Q4 2026 — SMARTS™ System proof of concept complete
2. Q2 2027 — Targeted market entry for SmartCoating™ within HeraWeave™
3. Q4 2027 — Targeted HeraWeave™ expansion with SmartGel™ for stress urinary incontinence

All development milestones and commercialization timelines represent current goals and expectations. These timelines are subject to significant risks and uncertainties, including but not limited to regulatory review, clinical validation, technical feasibility, manufacturing constraints, and funding availability.

How We Make Money

We are building two revenue paths from the same underlying technology and intellectual property.

Smartweave Inside™ | B2B Licensing

Through Smartweave Inside™, we license our IP, biomaterial formulations, AI algorithms, and training modules to established device manufacturers. This gives partners access to regenerative technologies they can incorporate into their own products while we earn licensing fees and royalties.

This path lets us commercialize our technology through existing industry infrastructure while building a broader track record for the portfolio.

Direct Product Commercialization

We are also advancing HeraWeave™, OrthoWeave™, and CardioWeave™ toward direct market entry through the appropriate regulatory pathways.

As those products progress, the clinical data and intellectual property they generate can strengthen our licensing business, while licensing revenue can help support continued product development. Both paths grow from the same technology base.

Use of Funds

We are raising $1.2 million to help move our technology from pre-clinical development toward our first commercial revenue milestones.

1. R&D and Platform Development | 50%: Advancing our AI platform and refining SMARTS™ formulations.
2. Operations and Team | 20%: Adding key capabilities across regulatory affairs, clinical operations, and business development.
3. Clinical and Regulatory | 20%: Supporting FDA engagement and regulatory work for HeraWeave™ and SMARTS™.
4. Business Development | 10%: Expanding Smartweave Inside™ partnerships and the infrastructure needed to commercialize our IP.

This raise is intended to support the next steps in our commercialization roadmap, including SMARTS™ proof of concept, SmartCoating™ within HeraWeave™, and the planned expansion of the HeraWeave™ product line.

Join us as we build a more personal future for regenerative medicine.

We’ve spent the past several years building the science, technology, and intellectual property behind Smartweave. Now, we’re working to move those technologies toward commercialization and bring a more personalized approach to connective tissue repair closer to the patients who could one day benefit.

We invite investors to join us as we move this work forward and build the next chapter of Smartweave together.

Invest in Smartweave

This content is prepared for Regulation Crowdfunding (Reg CF) purposes. Forward-looking statements, including financial projections and commercialization timelines, involve risks and uncertainties and are not guarantees of future results. Pre-clinical data from animal models do not guarantee equivalent outcomes in humans. Smartweave has not received FDA approval or clearance for any product as of this date. Investing in early-stage companies involves significant risk, including the possible loss of your entire investment. Nothing herein constitutes financial, legal, or investment advice.