First-In-Human Case Using Biostage's Bioengineered Esophageal Implant is Presented at Major Surgical Meeting

HOLLISTON, Mass., Jan. 28, 2019 /PRNewswire/ -- Dennis Wigle, M.D., Ph.D, chair of thoracic surgery at Mayo Clinic in Rochester, Minnesota, speaking at the Society of Thoracic Surgeons Tech-Con 2019 meeting on January 26, announced for the first time the details of a single-patient case report that describes the use of new technology to repair the patient's esophagus following esophageal reconstruction associated with the removal of a tumor mass in the chest. The technology being developed by Biostage, Inc. (OTCQB: BSTG), the Cellspan™ Esophageal Implant product candidate (CEI), uses a synthetic tubular scaffold seeded with the patient's stem cells to repair and restore a living biologic conduit. For the first time, a segment of a patient's esophagus was successfully reconstructed. This milestone advancement demonstrated that segmental esophageal reconstruction using a stem cell-coated implant can facilitate reconstruction, regrowth and regeneration of a gastrointestinal tissue in a human patient.

BSTG Logo (PRNewsfoto/Biostage, Inc.)

The use of Biostage's proprietary CEI was approved by the Food and Drug Administration (FDA) for compassionate use in this otherwise terminally ill patient who suffered from multiple complications from prior treatments. Current standard of care treatment methods were not considered viable for this patient, which led to the approval of this novel experimental treatment. The procedure took place in 2017. The patient died seven and a half months later due to complications unrelated to the surgery.

In the weeks after surgery, the implant stimulated a positive regenerative response resulting in the formation of a continuous esophageal tube. At three months post-surgery, the stent and scaffold were removed endoscopically, leaving behind a patent esophageal conduit.

Biostage CEO Jim McGorry commented, "We are pleased to see Dr. Wigle present the details of this groundbreaking first compassionate use case of our Cellspan™ technology and are proud to have been involved with this landmark step for regenerative medicine with Mayo Clinic." Mr. McGorry added, "We at Biostage believe this is an exciting moment not just for our company, but the entire field of tissue engineering and regenerative medicine."

Biostage, Inc., a biotechnology company developing bioengineered organ implants to treat conditions of the esophagus, bronchus and trachea has collaborated with Mayo Clinic for several years.

In addition to its collaboration with Mayo Clinic, Biostage has worked with the University of Texas Health Science Center at Houston's (UTHealth) McGovern Medical School Program in Children's Regenerative Medicine directed by Charles S. Cox, Jr. M.D., to transfer the technology into an FDA-compliant product applicable to man, with key contributions by Fabio Triolo, Ph.D., director of the UTHealth cGMP Facilities and Scott D. Olson, Ph.D., director of the UTHealth Translational Laboratory for Pre-clinical Studies. For the compassionate use case, the patient's stem cells were processed, seeded and grown onto the scaffold at UTHealth, prior to the release for transport to Mayo Clinic.

Building on the pre-clinical work performed to date and supported by this compassionate use surgery, Biostage is planning to file an IND for esophageal disease in 2019. Biostage is also pursuing the use of its technology to treat pediatric esophageal atresia, a condition in which infants are born without a complete esophagus.

Mayo Clinic and Dr. Wigle have a financial interest in the technology referenced in this news release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research.

Tech-Con, a meeting of cardiothoracic surgeons to review and examine cutting-edge technologies expected to be available in the next 1-to-3 years in cardiothoracic surgery, was held January 26, 2019 immediately prior to the Society of Thoracic Surgeons Annual Meeting in San Diego.

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.

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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 development expectations and regulatory approval of any of the Company'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 the Company'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, the Company's ability to obtain and maintain regulatory approval for its products; plus other factors described under the heading "Item 1A. Risk Factors" in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2017 or described in the Company's other public filings. The Company's results may also be affected by factors of which the Company is not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. The Company 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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