· Conexeu’s B.R.E.A.S.T.™ was developed using the Company’s proprietary CXU™ regenerative tissue platform to support gradual tissue remodeling
· Designed as a resorbable, bioregenerative tissue matrix rather than a permanent implant prosthesis
· Technology informed by more than a decade of preclinical research and proprietary extracellular matrix development
RENO, Nev. May 19, 2026 – Conexeu Sciences Inc. (“Conexeu”or the “Company”), a biotechnology company advancing tissue regeneration, today announced the development of BIO-REGENERATIVE ERGONOMICALLY ARCHITECTED SMART TISSUE™ (B.R.E.A.S.T.™), a novel 3D-bioprinted breast matrix designed to advance reconstruction beyond implant-based replacement and toward tissue regeneration.
B.R.E.A.S.T.™was developed using Conexeu’s proprietary CXU™ platform, an extracellular matrix (ECM)-based biofabrication technology. B.R.E.A.S.T.™ introduces a new implantable device in soft tissue restoration: a resorbable and bioregenerative matrix engineered to guide the patient’s own cells towards the formation of new tissue.
Miles D. Harrison, President and CEO of Conexeu, added: “For more than 50 years, breast reconstruction has been defined by substitution, replacing what was lost with a foreign body. We are fundamentally shifting the paradigm from substitution to restoration. Conexeu was founded on the belief that the promise of regenerative medicine is real, but only if it is supported early, advanced with rigor, and translated into clinical practice. The field has accepted repair and implants as the ceiling. We refuse to. If we settle for those limitations, true bio-regeneration will remain out of reach.”
Each year in the U.S., more than 100,000 women undergo mastectomies and roughly two-thirds of those women who undergo a mastectomy do not pursue breast reconstruction.1,2,3 Today's breast reconstruction options of implants, tissue flaps, and fat grafting, are designed to restore the shape and volume of the breast, not to regenerate the breast's own living tissue4. Conexeu is changing that by developing a structure the body recognizes as its own, serving as a temporary guide for the body to rebuild itself, not a permanent implant.
"We did not set out to design abetter implant. We set out to eliminate the need for one,” said Dr. Claudia Chavez-Munoz, Chief Scientific Officer and co-founder of Conexeu. “By combining controlled 3D architecture with a biomimetic extracellular matrix, we are developing a structure that the body can recognize, integrate, and ultimately replace with its own living tissue."
Conexeu’s B.R.E.A.S.T.™is being developed as an acellular, resorbable, regenerative scaffold, rather than a permanent implanted prosthesis. The platform combines structural architecture with naturally derived extracellular matrix proteins that allow for a controlled cell migration, vasculogenesis, tissue integration,and remodeling, all supported by the patient’s body. 1, 2, 3, 4, 5, 7 Unlike synthetic polymers-based scaffold approaches, the Conexeu platform is designed to provide both mechanical support and biological support intended to facilitate direct tissue remodeling rather than merely occupying space.
The Conexeu platform is grounded in more than ten years of preclinical evidence across eleven peer-reviewed publications and proprietary preclinical data.1-12 Dr. Z. Paul Lorenc, Plastic Surgeon and Director at Conexeu, said: “Nothing can be more beneficial to a patient than knowing their own body could have the ability to repair and regenerate itself. Whether for reconstructive purposes or for aesthetic autologous breast and body enhancement, Conexeu’s 3-D bioprintable matrix offers the potential towards true regenerative medicine.”
The CXU™ platform contemplates personalized, patient-specific designs and fabrication. Medical imaging such as CT scans could be used to create customized 3D structures tailored to a patient’s anatomy and reconstructive requirements. The design intent for the B.R.E.A.S.T.™ matrix is to transition from mechanical support to biological integration, with the host tissue progressively replacing the scaffold volume on a timeline aligned with tissue formation and remodeling.1, 2, 4, 5, 7
The announcement comes asregenerative medicine technologies continue to advance beyond traditional repair and replacement paradigms towards biologically integrated tissue restoration approaches. Additional information for clinicians, patients, and investors is available at Conexeu.com.
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About Conexeu Sciences
Building a new class of regenerative tissue therapies.
Conexeu Sciences is a preclinical-stage regenerative tissue platform company. Our patented bioregenerative extracellular matrix (ECM) platform, CXU™, is built on a single structural principle: one formula, one device, designed to scale across multiple addressable markets without reformulation.
CXU™ is designed to restore softtissue lost through injury, aging, and GLP-1-associated tissue related weightloss. The Company's lead product, Ten Minute Tissue™, is a CXU-based injectable ECM that remains fluid at room temperature and transitions to a stable gel in situ at body temperature within approximately ten minutes. In preclinical studies, Ten Minute Tissue™ has demonstrated enhanced healing dynamics, organized scaffold formation, and a favorable (low) inflammatory profile, collectively supporting cell migration, proliferation, differentiation, and new tissue formation.
The platform is grounded in more than a decade of university preclinical research and protected by issued patents across the U.S., E.U., Japan, and Australia, with additional filings pending. Conexeu holds all rights, title, and interest in the platform IP, with no royalty or licensing obligations and full freedom to expand across new indications and markets.
Conexeu is targeting large, multi-billion-dollar endmarkets, including wound care, periodontal applications, and facial and bodycontouring (encompassing GLP-1 driven skin laxity), with further expansion opportunities in 3D printing and biofabrication workflows and the veterinary market. The Company is advancing a predicate-based U.S. regulatory strategy with a 510(k) submission in early 2027 for its initial indication, subject to regulatory review.
Conexeu is led by an experienced leadership team with deep expertise in biomaterials, regenerative medicine, and medical device commercialization and development.
Media Contact
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Important Notices
All cited studies [1]–[11] are preclinical findings generated from in-vitro models, animal models, or both, and [12] preclinical company data. Animal physiology differs from human physiology, and these findings are not predictive of clinical performance or safety in humans. None of the cited studies evaluated CXU™ specifically in breast tissue reconstruction; the breast reconstruction program represents the design-intent application of the underlying CXU™platform, and supporting evidence in breast-specific preclinical models is being developed by the Company.
Conexeu’s BIO-REGENERATIVE ERGONOMICALLY ARCHITECTED SMART TISSUE™ (B.R.E.A.S.T.™) is an investigational medical device candidate. Safety and effectiveness have not been established. It has not been submitted to or reviewed by the U.S. Food and Drug Administration.Limited by U.S. federal law to investigational use.
Safe Harbor Statement
Except for the statements of historical fact contained herein, the information presented in this news release constitutes "forward-looking statements" as such term is used in applicable United States securities laws. These statements relate to analysis and other information that are based on forecasts or future results, estimates of amounts not yet determinable, and assumptions of management. Any other statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions or future events or performance (often, but not always,using words or phrases such as "expects", or "does note xpect", "is expected", "anticipates" or "does not anticipate", "plans", "estimates" or"intends", or stating that certain actions, events or results"may", "could", "would", "might" or"will" be taken, occur or be achieved) are not statements of historical fact and should be viewed as "forward-looking statements".We have based these forward-looking statements on our current expectations about future events or performance. While we believe these expectations are reasonable, such forward-looking statements are inherently subject to risks and uncertainties, many of which are beyond our control. Our actual future results may differ materially from those discussed or implied in our forward-looking statements for various reasons. Factors that could contribute to such differences include, but are not limited to: international, national and local general economic and market conditions; demographic changes; the ability of theCompany to sustain, manage or forecast its growth; the ability of the company to develop and commercialize its products; the ability of the Company to raise capital to complete its plans and fund its operations; the commercial viability of the contemplated processing plant; the continued availability of key leadership personnel; adverse publicity; competition and changes in the advanced wound care market, medical aesthetics market and tissue engineering and reconstruction; fluctuations and difficulty in forecasting operating results; business disruptions, such as technological failures and/or cybersecurity breaches. There can be no assurance that such statements will prove to be accurate as actual results, and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements contained in this news release and in any document referred to in this news release. The forward-looking statements included in this release are made only as of the date hereof. The Company assumes no obligation to update or supplement any forward-looking statements whether as a result of new information, future events or otherwise. This news release shall not constitute an offer to sell or the solicitation of any offer to buy our securities.
1. Each year in the UnitedStates, more than 100,000 women undergo a mastectomy, Agency for HealthcareResearch and Quality (AHRQ). Healthcare Cost and Utilization Project (HCUP)Statistical Briefs on mastectomy procedures, Rockville, MD.hcup-us.ahrq.gov
2. Roughly two-thirds of women who undergomastectomy do not pursue breast reconstruction.
3. Nelson JA, et al. PlastReconstr Surg. 2024 Dec. (32.7%immediate reconstruction rate, 2005–2017, n=1.5M+). ² Cancer Therapy Advisor.Breast reconstruction after mastectomy: making an informed decision. UpdatedOctober 8, 2024. https://www.cancertherapyadvisor.com/factsheets/breast-reconstruction/
4. ¹ Stoian A et al. Tissue Eng Part BRev. 2025. doi:10.1177/19373341251372961; National Cancer Institute.Breast Reconstruction After Mastectomy. Updated 2024. https://www.cancer.gov/types/breast/treatment/surgery/breast-reconstruction.
