Exhibit 99.1

 

Biostage Reports Third Quarter 2019 Financial Results

 

-        Submits Investigational New Drug (IND) Application in October for Lead Product Candidate CellspanTM Esophageal Implant for Treatment of Esophageal Conditions

 

Holliston, MA – November 12, 2019 –

Biostage, Inc. (OTCQB: BSTG), a bioengineering company developing next-generation esophageal implants, today announced its financial results for the three and nine months ended September 30, 2019.

 

During the third quarter, Biostage continued its focus to complete the submission of its first Investigational New Drug (IND) application.

 

On October 29, 2019, Biostage submitted its IND application to the U.S. Food and Drug Administration (FDA) for the Company’s lead product candidate, the Cellspan™ Esophageal Implant (CEI).

 

Biostage CEO James McGorry remarked, “This milestone marks the start of Biostage’s transition to a clinical stage company and, subject to FDA approval, will allow Biostage to begin clinical trials of our Cellspan Esophageal Implant. Implantation of this bioengineered tissue during surgical resection of a short segment of the esophagus addresses important and unmet public health needs, those of adults as well as children. This initial clinical trial will enroll adults and will enable a subsequent regulatory filing for a pediatric-focused clinical trial. Biostage’s technology has the potential to enable patients to avoid multiple complex surgeries, while also improving the patient’s quality of life compared to the current standard of care.”

 

Mr. McGorry continued, “The CEI is innovative in its composition and utility, while also providing surgeons with a new option that holds the promise of reducing morbidity both short and near-term.”

 


The following information was filed by Biostage, Inc. (BSTG) on Tuesday, November 12, 2019 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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