BIOSTAGE, INC. (NASDAQ:BSTG) Files An 8-K Other Events

BIOSTAGE, INC. (NASDAQ:BSTG) Files An 8-K Other Events
Item 8.01.

On March 20, 2020, Biostage, Inc. (the Company) issued a press release announcing that its Investigational New Drug application for its lead product candidate, the Cellspan™ Esophageal Implant, was approved by the U.S. Food and Drug Administration (FDA). The press release discussed the approval and related matters, including that the FDA removed its clinical hold and that the Company may proceed with its study.

The full text of the Company’s press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

(d) Exhibits.

Exhibit Number Title
99.1 Press Release issued on March 20, 2020

Biostage, Inc. Exhibit
EX-99.1 2 tm2013311d1_ex99-1.htm EXHIBIT 99.1   EXHIBIT 99.1     Biostage Announces IND Approval from FDA for its Lead Product Candidate Cellspan™ Esophageal Implant   HOLLISTON,…
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Biostage, Inc., formerly Harvard Apparatus Regenerative Technology, Inc., is a biotechnology company. The Company is engaged in developing bioengineered organ implants based on its Cellframe technology. Its Cellframe technology consists of a biocompatible scaffold that is seeded with the recipient’s own cells. It is developing its Cellframe technology to treat life-threatening conditions of the esophagus, trachea or bronchus that are caused due to cancer, infection, trauma or congenital abnormalities. Its Cellframe technology is engineered to stimulate the body’s signaling pathways and natural healing process to regenerate and restore organ function. Its Cellframe technology platform is used to create organ specific Cellspan implants. Its product candidates are in development and have not yet received regulatory approval for sale anywhere in the world.

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