Press Releases

Biostage Appoints Ginger Abraham-Freel as Director of Quality and Operations to Advance its Bioengineered Organ Implants

HOLLISTON, Mass., April 22, 2016 /PRNewswire/ -- Biostage, Inc. (Nasdaq: BSTG), a biotechnology company developing bioengineered organ implants for life-threatening conditions of the esophagus, trachea and bronchus, today announced that Ginger A. Abraham-Freel has joined the company as Director of Quality and Operations, a new position at Biostage. Having a dedicated quality and operations process complements Biostage's anticipated progress from pre-clinical to clinical development.  Ms. Abraham-Freel will play an integral role in advancing Biostage to achieve its planned filing of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in late 2016.

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Ms. Abraham-Freel has over 20 years of highly relevant experience and accomplishment in biomaterials pre-clinical development, regulatory filings, quality assurance for clinical trials and product manufacturing. Her experience includes 17 years with Organogenesis Inc. where she focused on the development and commercialization of scaffold biomaterials, cell banks and tissue system operations and the launch of a novel skin product. She also led preclinical safety and efficacy evaluations and contributed to FDA regulatory submissions for the clinical trials of their biomaterial products.

Ms. Abraham-Freel joins Biostage from Diagnostics For All, Inc. where as Director of Quality and Head of Manufacturing, she led the establishment of quality systems, product validation, and maintained the company's compliance with relevant regulations and standards. She previously led quality assurance programs at Cardiosolutions, and Pharmasol Corporations. She earned her B.S. degree in Biology from Stonehill College.

Biostage CEO Jim McGorry commented, "We are solidifying the base of experience and expertise required to advance our Cellframe™ technology from preclinical research into human clinical trials and ultimately into commercialization. Ginger's quality assurance and regulatory affairs experience in the fields of cell therapy and biomaterials make her ideally suited to support our research and development goals in 2016 and beyond."

Biostage is actively engaged in a large-animal pre-clinical research collaboration that began in January of 2016. The research seeks to build upon the base of confirmatory data required to support an IND application. Biostage plans to provide an update on this preclinical research in mid May. The IND application will seek to initiate human clinical trials for Biostage's new Cellspan™  esophageal implants which are based on the Company's Cellframe technology platform.

Ms. Abraham-Freel, stated, "I am honored to join Biostage at this very exciting time. I look forward to working with the team to achieve the milestones they have set to advance their ground-breaking work in the development of bioengineered organ implants for the esophagus, bronchus and trachea."

About Biostage, Inc.: www.biostage.com 
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, trachea or bronchus 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 a collaborative preclinical study. This testing is intended to expand the base of preclinical data in support of Biostage's goal of filing an Investigational New Drug (IND) application with the U.S. FDA in late 2016. The IND will seek approval to initiate clinical trials for its esophageal implants in humans.

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 Biostage products, including its Cellframe ™ technology, by the FDA, EMA, MHRA 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 Biostage products, including its 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 the our Cellframe technology, bioreactors, scaffolds and other devices and product candidates we pursue; 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, 2015 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 

Media/Investor Relations Contact:

Tom McNaughton

David Collins, Bill Jones, Helen Sun

Chief Financial Officer

Catalyst Global LLC

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bstg@catalyst-ir.com

 

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SOURCE Biostage, Inc.