Biostage Announces Positive Preclinical Data of Cellspan™ Esophageal Implant Presented at the International Society for Stem Cell Research 2017 Annual Meeting

HOLLISTON, Mass., June 19, 2017 /PRNewswire/ -- Biostage Inc., (Nasdaq: BSTG), ("Biostage" or the "Company"), a biotechnology company developing bioengineered organ implants to treat cancers and other life-threatening conditions of the esophagus, bronchus and trachea, announced today that it presented positive preclinical data of its proprietary Cellspan™ Esophageal Implant at the International Society for Stem Cell Research (ISSCR) 2017 Annual Meeting held June 14-17, 2017 in Boston, MA.

KaLia Burnette, Biostage's Senior Research Associate, presented the poster (No. F-3043) titled, "Esophageal Regeneration with a Cell-Seeded Tissue Engineered Graft," in a poster presentation on Friday, June 16, 2017.

"Current reconstruction approaches are limited to utilization of an autologous conduit such as the stomach, small bowel, or colon, and we believe that our Cellspan Esophageal Implant, which provides the potential for esophageal replacement or regeneration for circumferential, full thickness defects, would have significant clinical application and provide a groundbreaking solution for this unmet medical need," Saverio La Francesca, MD, Biostage's President and Chief Medical Officer, stated.

A synthetic graft was seeded with autologous adipose-derived mesenchymal stem cells (aMSCs). Confirmation of aMSC-based seeding was performed and anesthetized pigs have undergone full thickness circumferential resection of a length of the esophagus in the ongoing preclinical study. Implantation of the Cellspan Esophageal Implant and esophageal stent deployment was performed, and the scaffolds were then removed endoscopically after 3 weeks following the regeneration of vascularized tissue, having reconstituted the continuity and structural integrity of the esophagus. Animals surviving up to 10 months showed durable tolerance to oral intake and weight gain. Progressive esophageal regeneration, initiated by the Cellspan Esophageal Implant, was observed over the course of this study,as results from these animals showed gradual structural regeneration of endogenous esophageal tissue layers, including squamous esophageal mucosa, submucosa, and blood vessel formation. Results from the study have implications for the esophagus as a regenerative organ, and for novel applications in human esophageal resection.

Charles S. Cox, Jr., MD, Professor of Pediatric Surgery, McGovern Medical School at UTHealth, George and Cynthia Mitchell Distinguished Chair of Neuroscience, stated, "Biostage's tissue engineered esophageal replacement offers new therapeutic options in difficult reconstructive circumstances, reducing the need for tissue transfers and more extensive operations."

Jim McGorry, CEO of Biostage, commented, "In our ongoing large-animal model preclinical studies, we have been able to continually and consistently demonstrate that esophageal regeneration is feasible and reproducible with our Cellspan Esophageal Implant utilizing our proprietary Cellframe™ technology. This gives us additional confidence as we look forward to transitioning this technology into its first-in-human clinical study by the end of 2017."

Cellspan Esophageal Implants utilize the Company's proprietary Cellframe™ technology and may offer improved outcomes for patients by potentially simplifying surgical techniques to reduce postoperative complications and improve quality of life, by prompting regeneration of the patient's own esophagus. Cellspan implants are intended to offer numerous advantages over standard surgical resection including: eliminating the use of the stomach or intestine to create a mock esophagus, reduced complications and improve post-surgical morbidity.

In November 2016, the Company's Cellspan Esophageal Implant was granted Orphan Drug Designation by the U.S. Food and Drug Administration ("FDA") to restore the structure and function of the esophagus subsequent to esophageal damage due to cancer, injury or congenital abnormalities.

About Biostage

Biostage is a biotechnology company developing bioengineered organ implants based on the Company's new Cellframe™ technology which combines a proprietary biocompatible scaffold with a patient's own stem cells to create Cellspan organ implants. Cellspan implants are being developed to treat life-threatening conditions of the esophagus, bronchus or trachea with the hope of dramatically improving the treatment paradigm for patients. Based on its preclinical data, Biostage has selected life-threatening conditions of the esophagus as the initial clinical application of its technology.

Cellspan implants are currently being advanced and tested in collaborative preclinical studies. Preclinical, large-animal safety studies, conducted in compliance with the U.S. Food and Drug Administration ("FDA") Good Laboratory Practice ("GLP") regulations, for the Company's Cellspan Esophageal Implant product candidate are ongoing, in support of Biostage's goal of filing an Investigational New Drug application ("IND") with the FDA in the third quarter of 2017. Upon IND approval, the Company plans to initiate its first-in-human clinical trials for its esophageal implant product candidate by the end of 2017.

For more information, please visit www.biostage.com and connect with the Company on Twitter and LinkedIn.

Forward-Looking Statements:

Some of the statements in this press release are "forward-looking" and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These "forward-looking" statements in this press release include, but are not limited to, statements relating to the development expectations and regulatory approval of any of our products, including those utilizing our Cellframe technology, by the U.S. Food and Drug Administration, the European Medicines Agency or otherwise, which expectations or approvals may not be achieved or obtained on a timely basis or at all; or success with respect to any collaborations, clinical trials and other development and commercialization efforts of our products, including those utilizing our Cellframe technology, which such success may not be achieved or obtained on a timely basis or at all. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, our ability to obtain and maintain regulatory approval for our products; plus other factors described under the heading "Item 1A. Risk Factors" in our Annual Report on Form 10-K for the fiscal year ended December 31, 2016 or described in our other public filings. Our results may also be affected by factors of which we are not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. Biostage expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions or circumstances on which any such statement is based.

SOURCE Biostage Inc.

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