HOLLISTON, Mass., May 9, 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 collaborative data with Connecticut Children’s Medical Center was presented at the American Pediatric Surgical Association (“APSA”) 2017 Annual Meeting held May 4 7, 2017 in Hollywood, FL.
Biostage is currently evaluating its Cellspan Esophageal Implant for use to treat pediatric esophageal atresia (“EA”) in collaboration with Connecticut Children’s Medical Center. EA is a congenital defect where a baby is born with a missing segment of their esophagus, preventing food from reaching the child’s stomach. Christine Finck, MD, FACS of Connecticut Children’s Medical Center, an investigator in the study [or] co-author of the poster presented at APSA presented proof of concept data from initial preclinical studies using Biostage’s proprietary implant to address EA in a poster entitled, “Esophageal scaffolds seeded with epithelial cells for esophageal replacement therapy.”
“The Cellspan bioengineered scaffold may provide a novel translational treatment approach for neonates suffering from long gap esophageal atresia. We’re excited to explore the possibilities and partner with Biostage in this endeavor,” said Christine Finck, MD, FACS, Surgeon-in-Chief at Connecticut Children’s Medical Center.
Dr. Joseph Vacanti, Surgeon-in-Chief and Chief of Pediatric Surgery at Mass General Hospital for Children and Co-Chair of Biostage’s Scientific Advisory Board, stated, “Thirty years ago, we presented our first paper in the field of tissue engineering and regenerative medicine which has led to this important milestone. I am so pleased that Biostage is focusing on addressing the pediatric challenge of esophageal atresia, and I congratulate them and Dr. Finck for their presentation which was awarded the best poster in basic science.”
Jim McGorry, Chief Executive Officer of Biostage, commented, “There was a significant positive reaction to Dr. Finck’s collaborative data with Biostage. Drs. Vacanti and Finck were instrumental in helping Biostage establish key relationships with pediatric surgical thought leaders. This APSA meeting has established clear scientific validation for our Cellspan technology in the treatment of pediatric atresia.”
Cellspan Esophageal Implants utilize Biostage’s proprietary Cellframe technology and may offer improved outcomes for patients by potentially simplifying surgical techniques to reduce post-operative 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 improved 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. The Company remains on track to file its Investigational New Drug (“IND”) application with the FDA for adult esophageal cancer in the third quarter of 2017 and commence its first-in-human studies for its Cellspan esophageal implant before the end of 2017.
About the APSA Annual Meeting
The APSA Annual Meeting provides direct access to a targeted audience of leading pediatric surgeons, pediatric training program directors, nurses and managers who have influence over the products and services used in their universities, hospitals and practices. These professionals come together at the APSA meeting to share research and advances in the field of pediatric surgery and patient care.
Members of APSA have helped advance research and education in pediatric surgery for nearly 50 years. APSA is widely recognized as the nation’s premier pediatric surgical association, and its members are greatly respected in the research and surgical communities. For more information, please visit www.eapsa.org.
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 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 U.S. 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.
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SOURCE Biostage, Inc.