Esophageal, bronchial, and tracheal cancers and trauma, have a devastating impact on patients. The current surgical treatment options are complex and include procedures like moving the patient's stomach or a portion of their colon into the chest to replace a portion of the esophagus or removing a healthy lung as part of the resection of a diseased bronchus. Biostage is currently investigating its Cellframe technology to treat life-threatening conditions of the esophagus, trachea and bronchus with the objective of dramatically improving the treatment options available to those patients.
"The procedures of replacing the diseased sections of these organs carry serious risks of organ dysfunction and damage, leading to high complication rates and a drastically reduced quality of life," stated Saverio La Francesca, MD, EVP and Chief Medical Officer of Biostage. "The Cellframe technology offers a completely new way of treating these potentially life-threatening conditions and we believe it holds the potential to improve mortality rates, reduce complications often involved in these procedures and drastically enhance the patient's quality of life."
Biostage has a collaboration agreement with Mayo Clinic to develop solutions for diseases of the esophagus and bronchi and bring them to the clinic. In addition to its product development collaboration with Mayo Clinic, the Company has an ongoing collaboration with Connecticut Children's Medical Center to develop an innovative process for repairing or replacing the esophagus to treat life-threatening pediatric conditions such as esophageal atresia. Esophageal atresia is a congenital condition where a baby is born without a fully-developed esophagus, so that the esophagus does not reach the stomach.
The Company expects to file an Investigational New Drug ("IND") application with the U.S. Food and Drug Administration ("FDA") for the esophageal implant by year end.
About the NI Engineering Impact Awards
National Instruments provides a graphical system design platform for test, control, and embedded design applications that is transforming the way engineers and scientists design, prototype, and deploy systems. The NI Engineering Impact Awards are presented to applicants that showcase the most innovative projects based on NI software and hardware. Awards are given to one finalist and one winner in each of the seven categories; Industrial Machinery and Control, Advanced Research, Aerospace and Defense, Electronics and Semiconductor, Energy, Wireless and Mobile Communications, and Transportation and Heavy Equipment.
About Cellframe™ Technology
The Company's proprietary Cellframe technology is designed to harness the full potential of the in vivo microenvironment to achieve tissue regeneration and restore organ function. It employs a multistep process in which the patient's own stem cells are taken from a simple adipose/fat tissue biopsy, expanded and banked, and then seeded onto a proprietary scaffold that mimics the natural dimensions of the organ being regenerated. After several days in a rotating bioreactor, the biocompatible scaffold containing the stem cells is ready to be implanted. Preclinical studies suggest that the organ implant signals the stem cell niche in the surrounding native tissue to guide the regeneration of a biological structure. This technology is based on the concept of in situ tissue regeneration using the body's own biologic resources and reparative capability in combination with tissue-specific biomaterials implanted at the sites of disease or injury.
Biostage is a biotechnology company developing bioengineered organ implants based on the company's new CellframeTM technology which combines a proprietary biocompatible scaffold with a patient's own stem cells to create CellspanTM 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 pre-clinical studies. Pre-clinical, large-animal safety studies, conducted in compliance with the FDA Good Laboratory Practice (GLP) regulations, for the Company's Cellspan Esophageal Implant product candidate have begun, 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 implant product candidate in humans.
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 development expectations and regulatory approval of any of our products, including those utilizing our 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 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, 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 any such statement is based.
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SOURCE Biostage, Inc.