Healthcare Industry News: U.S. Food and Drug Administration
News Release - August 7, 2017
Biostage Announces the Use of Its Esophageal Implant Product Candidate in a PatientProcedure approved via the FDA's single-use expanded access program and was performed at a major U.S. hospital
HOLLISTON, Mass., Aug. 7, 2017 -- (Healthcare Sales & Marketing Network) -- Biostage Inc., (Nasdaq: BSTG), ("Biostage" or the "Company"), a biotechnology company developing bioengineered organ implants to treat cancer, congenital abnormalities and other life-threatening conditions of the esophagus, bronchus and trachea, today announced the use of Biostage's Cellspan Esophageal Implant product candidate in a patient at a major U.S. hospital via an FDA-approved single-use expanded access application.
On May 4, 2017, the Cellspan Esophageal Implant was surgically implanted into a 75-year old male with a life-threatening cancerous mass in his chest. The surgery was required to address the tumor's encroachment on the patient's lung, heart, and esophagus. The portion of the esophagus affected by the cancer was removed and the Cellspan Esophageal Implant was utilized to reconstruct the esophagus. The patient is now alive three months after surgery. Biostage believes that the Cellspan Esophageal Implant has performed as designed.
Within a collaborative agreement between Biostage and The University of Texas Health Science Center at Houston (UTHealth), the patient's own stem cells were processed, seeded and grown onto the scaffold at the Cellular Therapy Core of the Program in Children's Regenerative Medicine at UTHealth, prior to release for transport to the institution carrying out the surgery.
Saverio La Francesca, M.D., President and Chief Medical Officer of Biostage, stated, "We are encouraged by the ongoing success of the Cellspan Esophageal Implant in our first in-patient case, and we look forward to additional opportunities to provide an alternative solution to patients in need of an esophageal replacement. Our large-animal preclinical data has been promising, so we are invigorated by the apparent reaffirmation of the regenerative properties of our technology and the clinical benefits in this extremely complex case."
Jim McGorry, CEO of Biostage, commented, "The Cellspan Esophageal Implant has the potential to significantly improve quality of life for a patient who has undergone an esophageal resection, as it improves upon the current standard of care for the treatment of esophageal cancer. Regeneration of the esophagus in a high-risk patient and under extremely trying conditions, such as evidenced to date in this case, indicates that the regenerative properties of the implant may be reproducible in other patients."
About Cellspan™ Esophageal Implants
Cellspan Esophageal Implants utilize the Company'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 regrowth 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.
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.
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 performance, regenerative properties and reproducibility of our technology, including the Cellspan Esophageal Implant, or any success of this approved single-use expanded access use, which expectations may not be achieved; 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 and our ability to complete the private placement on a timely basis or at all; 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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