Biostage Receives U.S. Patent for Cellularized Patch-Based Scaffolds for Organ Repair

Extends core IP from tubes to patches and from regenerating the esophagus after esophagectomy to treating fistulas and strictures anywhere in the GI tract including the esophagus, stomach and intestine.

HOLLISTON, Mass., Oct. 25, 2022 /PRNewswire/ -- Biostage, Inc. (OTCQB: BSTG) ("Biostage" or the "Company"), a clinical-stage biotechnology company developing regenerative-medicine treatments for disorders of the gastro-intestinal system and the airway, today announced the issuance of a U.S. patent that protects the extension of the use of Biostage's technology from hollow tubes to patches. Biostage expects this new technology to enable it treat fistulas (holes), strictures (narrowings) or damage to the esophagus such as from gastero-esophageal reflux disease, or GERD, as well as damage and disease in other parts of the gastero-intestinal tract such as the stomach and intestine.  This new technology is known as the Biostage Tissue Patch.

The Biostage Tissue Patch is a patch of fibrous material that is seeded with the patient's own mesenchymal stromal cells that are derived from a biopsy of abdominal adipose (fat) tissue. The patch can be made using Biostage's proprietary, and patented, electrospinning technology in any size, shape, or geometry to match the internal surface of a hollow organ. The Biostage Tissue Patch is a temporary cell-delivery device that administers a large dose of the patient's own wound-healing cells to the site where the diseased or damaged tissue was removed. The cells stimulate the body's natural wound-healing process, and the scaffold supports the tissue regeneration and protects the wound from contamination and abrasion. The scaffold is temporary and is removed using a minimally invasive endoscopic procedure after the initial healing is complete.

David Green, Biostage's founder, Chair of the Board and interim Chief Executive Officer commented, "We are very pleased with this new patent because it could extend Biostage's breakthrough therapy for regenerating the esophagus due to cancer, trauma or birth defects to the treatment of benign conditions of the esophagus as well as to the regeneration of other hollow organs including the stomach and intestine."

Dr. Bill Fodor, Biostage's Chief Scientific Officer, commented, "The issuance of this key patent protects Biostage's cell delivery technology to include endoluminal repair without the need for major surgery, in a variety of organ structures. Establishing a non-surgical product portfolio further expands the medical utility for our targeted cell delivery approach."

The new patent is titled, "METHOD AND DEVICE FOR IN VIVO TISSUE REGENERATION ON THE INTERIOR SURFACE OF HOLLOW ORGANS". It was issued on October 11, 2022 by the USPTO as patent number 11,464,887 B2.

Biostage is a clinical-stage biotech company that uses cell therapy to regenerate organs inside the human body to treat cancer, trauma and birth defects. We have performed the world's first regeneration of an esophagus in a human cancer patient. This surgery was performed at Mayo Clinic and was published in August 2021. We have performed the regeneration of the bronchus in pigs.

Biostage has 10 issued U.S. patents and 2 orphan-drug designations which can provide seven years of market exclusivity in addition to any exclusivity granted by patents.

Biostage's current goals include raising capital, uplisting from the OTC bulletin board to NASDAQ and beginning its clinical trial for repair of the esophagus. 

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 capabilities and performance of our products and product candidates, including as to the Biostage Tissue Patch and our other product candidates; our capital raising plans and expectations, including uplifting to NASDAQ; development expectations and regulatory approval of any of the Company's products, including those utilizing its Biostage Esophageal Implant or Biostage Tissue Patch technologies, 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; and success with respect to any collaborations, clinical trials and other development and commercialization efforts of the Company's products, 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 inability to obtain needed funds in the immediate future; 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, 2021 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.

Investor Relations Contact
Joseph Damasio
Chief Financial Officer
774-233-7300
[email protected]

SOURCE Biostage, Inc.

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