HOLLISTON, Mass., March 29, 2018 /PRNewswire/ -- Biostage, Inc. (OTCQB: BSTG), a biotechnology company developing bioengineered organ implants to treat life-threatening conditions of the esophagus, bronchus and trachea, today announced it has been awarded a Fast-Track Small Business Innovation Research (SBIR) grant by the Eunice Kennedy National Institute of Child Health and Human Development (NICHD). The NICHD, which is part of the National Institute of Health, awarded Biostage the grant as part of its mission to "ensure that every person is born healthy and wanted, and that all children have the chance to achieve their full potential for healthy and productive lives." The grant funding will support Biostage's development and preclinical testing of its Cellspan™ Esophageal Implant (CEI) for treatment of pediatric esophageal atresia. Biostage's Sumati Sundaram, PhD and Christine Finck, MD, FACS, Surgeon-In-Chief at Connecticut Children's Medical Center are the principle investigators on this grant.
The funds for this Fast Track SBIR grant will be released in two parts. An initial Phase I award of $225,000 will be granted in the near term. Assuming that this phase of the project is successful, and funding is available, Phase II of the project would support pre-clinical testing of pediatric CEIs planned to begin later this year. Together, the total grant has the potential to provide a total of $1.7 million in nondilutive financial resources.
Jim McGorry, CEO of Biostage, commented, "The SBIR grant program is incredibly competitive and winning this grant is another validation of our therapeutic approach and Biostage's mission to radically improve the surgical treatment of children suffering from esophageal atresia. Biostage is working with Connecticut Children's to develop an innovative solution for the treatment of children with esophageal atresia by using our Cellframe™ technology. We believe that our technology provides a novel approach and that our collaboration will advance a product to the clinic."
Dr. Christine Finck, Surgeon-In-Chief, Connecticut Children's, stated, "Our hospital is committed to translating this novel technology to the clinic to address esophageal atresia in children. There is a tremendous unmet medical need for kids suffering with pediatric esophageal atresia in Connecticut and across the world. This technology shows promise of one day dramatically improving their care and condition. This grant will support scientific rigor as we optimize and get ready for FDA submission."
About Biostage, Inc.
Biostage is a biotechnology company developing bioengineered organ implants based on the Company's 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.
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 development expectations and regulatory approval of any of Biostage's products, including those utilizing its 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 Biostage's products, including those utilizing 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, Biostage's ability to obtain and maintain regulatory approval for its products; Biostage's ability to expand into foreign markets, including China; plus other factors described under the heading "Item 1A. Risk Factors" in Biostage's Annual Report on Form 10-K for the fiscal year ended December 31, 2016 or described in its other public filings. Biostage's results may also be affected by factors of which Biostage is 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.
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