Conexeu Sciences Initiates Preclinical Development Program for B.R.E.A.S.T.™ Bioregenerative Matrix Platform with Wake Forest Institute for Regenerative Medicine

Conexeu to leverage WFIRM's advanced tissue-organ bioprinting infrastructure to evaluate the durability, integration, and resorbability of proprietary CXU™ 3D-printed matrix technology

RENO, Nev., May 27, 2026 (GLOBE NEWSWIRE) -- Conexeu Sciences Inc. ("Conexeu" or the "Company"), a biotechnology company advancing tissue regeneration, today announced the launch of a preclinical development program for B.R.E.A.S.T.™ (BIO-REGENERATIVE ERGONOMICALLY ARCHITECTED SMART TISSUE™), its recently unveiled 3D-printed bioregenerative breast matrix, at the Wake Forest Institute for Regenerative Medicine (“WFIRM”), a leading regenerative medicine research organization.

"This preclinical program design is an important step in the advancement of B.R.E.A.S.T.™ and our overall regenerative medicine strategy," said Miles Harrison, President and CEO of Conexeu. "We believe bioregenerative approaches that work naturally with the body represent a signficant evolution beyond traditional implant technologies."

The program will leverage WFIRM’s advanced tissue-organ bioprinting infrastructure to support a comprehensive preclinical study evaluating the durability, host tissue integration, and resorbability of Conexeu’s proprietary CXU™ 3D-printed B.R.E.A.S.T.™ matrix. The resulting findings will directly inform the design of future studies and guide progression toward clinical development.

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 new possibilities for implantables device for soft tissue restoration: a resorbable and bioregenerative matrix engineered to guide the patient’s own cells towards the formation of new tissue. The technology is being developed as a potential alternative to permanent breast implants and traditional reconstruction approaches.

"The research process is fundamental to the responsible development of regenerative technologies and defining the biological performance and translational potential of B.R.E.A.S.T.™," said Dr. Claudia Chavez-Munoz, Chief Scientific Officer and co-founder of Conexeu. "Access to world-class facilities such as WFIRM allows us to the scalability to evaluate and produce our designs, de-risking innovation, and accelerating the translation toward clinical impact."

To advance this work, Conexeu is leveraging support available through the RegenMed Development Organization (ReMDO) ecosystem, including access to advanced bioprinting infrastructure such as the iTOPS (Integrated Tissue-Organ Printing System) platform at WFIRM.

"The tissue-organ printing system at WFIRM is one of the tools that allows ReMDO to deliver on its mission, accelerating the translation of regenerative medicine technologies by de-risking innovative products and advancing scalable biomanufacturing. Conexeu’s progress on 3D printing is a strong example of that work in action," said Joshua Hunsberger, PhD, Chief Technology Officer, ReMDO.

About Conexeu Sciences Inc

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.

CXU™ is designed to restore soft tissue lost through injury, aging, and GLP-1-associated tissue related weight loss. The Company's lead device candidate, Ten Minute Tissue™, is a CXU-based  ECM that remains fluid at room temperature and designed to 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 and differentiation, with tissue integration 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 end markets, including wound care, periodontal applications, and facial and body contouring (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 an anticipated 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.

Video: Conexeu Sciences Inc. BIO-REGENERATIVE ERGONOMICALLY ARCHITECTED SMART TISSUE™ (B.R.E.A.S.T.™)

About WFIRM

Wake Forest Institute for Regenerative Medicine (WFIRM) is recognized as an international leader in translating scientific discovery into clinical therapies, with many world firsts, including the development and implantation of the first engineered organ in a patient. Over 500 people at the institute, the largest in the world, work on more than 40 different tissues and organs. A number of the basic principles of tissue engineering and regenerative medicine were first developed at the institute. WFIRM researchers have successfully engineered replacement tissues and organs in all four categories – flat structures, tubular tissues, hollow organs and solid organs – and 18 different applications of cell/tissue therapy technologies, such as skin, urethras, cartilage, bladders, muscle, kidney and vaginal organs, have been successfully used in human patients. The institute –which is part of Wake Forest University School of Medicine, the academic core of Advocate Health – is in the Innovation Quarter in downtown Winston-Salem, NC, and is driven by the urgent needs of patients. The institute is making a global difference in regenerative medicine through collaborations with over 600 entities and institutions worldwide, through its government, academic and industry partnerships, its start-up entities, and through major initiatives in breakthrough technologies, such as tissue engineering, cell therapies, diagnostics, drug discovery, biomanufacturing, nanotechnology, gene editing and 3D printing.

About ReMDO

The RegenMed Development Organization (ReMDO) is a 501(c)3 non-profit with a mission to help deliver on the promise of regenerative medicine by advancing research to de-risk technologies, promoting progress of biomanufacturing scale-up and automation to make technologies more affordable, and speeding up the translation to clinical practice. For more information, visit Remdo.org.

Media Contact

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Important Notices

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 not expect", "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 early-stage, preclinical nature of the Company's product candidates, including B.R.E.A.S.T.™ and Ten Minute Tissue™, and the inherent uncertainty of preclinical and clinical development, including the possibility that preclinical results may not be predictive of clinical outcomes; the ability of the Company 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.

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