The current study tested the biomechanical strength of newly regenerated esophageal tissue and demonstrated that the strength of the tissue was comparable to adjacent native tissue.
Holliston, Mass., June 15, 2022 /PRNewswire/ — Biostage, Inc. (OTCQB: BSTG) (“Biostage” or the “Company”), a cell therapy biotechnology company with successful first-in-human experience in repairing the esophagus after cancer surgery and approval of the The FDA to begin a clinical trial of the Biostage esophageal implant for serious esophageal disease, including cancer, today announced the publication of a peer-reviewed article in the Journal of Biomechanics describing a study involving the mechanical strength of regenerated esophageal tissue. The document is accessible here.
The Biostage Esophageal Implant (formerly known as the Cellspan Esophageal Implant) stimulates the regeneration of new tissue to repair the esophagus after segmental resection of the thoracic esophagus. Using a porcine model, the Journal of Biomechanics article describes a study that tested the mechanical strength of newly grown tissue as well as flanking native tissue using a burst pressure test of probe on explanted tissues at three time points after implantation. The BEI bridged the proximal and distal ends of the native esophagus to restore the conduit by stimulating a regeneration process that progressed from a fibrovascular scar at 30 days to a fully epithelialized lumen at 90 days, followed by regeneration under -mucosa and “laminated” regeneration. adventitia with smooth muscle development in the 365-day cohort. The burst strength of the regenerated tissue at all three time points was comparable to that of the native tissue flanking the implant, and the overall pressure required to burst through the tissue increased with increasing postoperative time.
David GreenActing Chief Executive Officer of Biostage, said, “We are delighted to publish this article in the Journal of Biomechanics. We believe this publication shows that the Biostage Esophageal Implant (BEI) stimulates the body to regenerate the esophagus and that the regenerated tissue is comparable in strength to the native esophagus.”
Doctor William FodorScientific Director of Biostage, added, “Presenting evidence that the mechanical strength of the regenerated tissue was comparable to that of the native tissue is a critical finding and a key question for the FDA regarding the safety of the technology. In collaboration with Exponent, Inc., the paper demonstrates that the new tissue can withstand bursting pressures similar to native tissue, as early as 30 days after implantation and throughout the one-year study . These results established a favorable safety profile, which was an integral part of our approved IND.”
Biostage is a clinical-stage biotechnology company that uses cell therapy to regenerate organs inside the human body to treat defects due to cancer surgery, trauma, terminal illness or birth defects of the esophagus and potentially other tubular organs.
Biostage has 8 issued US patents, 2 orphan drug designations (which provide 7 years of market exclusivity on top of any patents) and the possibility of 2 FDA priority review vouchers.
Biostage’s current goals include raising capital, moving from the OTC bulletin board to Nasdaq, and beginning its clinical trial for esophageal regeneration and repair.
For more information, please visit www.biostage.com and connect with the Company on Twitter and LinkedIn.
Certain of the statements in this press release are “forward-looking” and are made pursuant to the disclaimer of the Private Securities Litigation Reform Act of 1995. Such “forward-looking” statements in this press release include, but are not limited to statements relating to the capabilities and performance of our products and product candidates, including the strength of regenerated tissue; our capital raising plans and expectations, including the move to Nasdaq; development expectations and regulatory approval of any of the Company’s products, including those utilizing its Biostage esophageal implant technology, by the United States Food and Drug Administration, European Medicines Agency or otherwise, which expectations or approvals may not be met or obtained in a timely manner or at all; and success with respect to collaborations, clinical trials and other efforts to develop and commercialize the Company’s products, such success may not be achieved or achieved in a timely manner or at all. These statements involve risks and uncertainties that could cause results to differ materially from the statements set forth in this press release, including, among other things, the Company’s inability to obtain necessary funds in the immediate future; the Company’s ability to obtain and maintain regulatory approval for its products; as well as other factors described under “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 or described in the Company’s other public filings. The results of the Company may also be affected by factors of which the Company is not currently aware. The forward-looking statements contained in this press release speak only as of the date of this press release. The Company expressly disclaims any obligation or undertaking to post updates or revisions to these statements to reflect any change in its expectations with respect thereto or any change in events, conditions or circumstances on which any such statement is based.
Vice President of Business Development
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SOURCE Biostage, Inc.