Biostage, Inc.

General Information
Business:

(Note: This is NOT an IPO. This is a NASDAQ uplisting from the OTCQB. Biostage, Inc. filed its S-1 on June 21, 2022.) 

We are a clinical-stage biotechnology company developing regenerative-medicine treatments for disorders of the gastro-intestinal system and the airway resulting from cancer, trauma or birth defects. Our technology is based on our proprietary cell-therapy platform that uses a patient’s own stem cells to regenerate and restore function to damaged organs. We believe that our technology represents a next-generation solution for restoring organ function because it allows the patient to regenerate their own organ, thus eliminating the need for human donor or animal transplants, the sacrifice of another of the patient’s own organs or permanent artificial implants.

We conducted the world’s first successful regeneration of the esophagus in a patient with esophageal cancer in August 2017. This surgery was performed by Dr. Denis Wigle, Chair of Thoracic Surgery at the Mayo Clinic. The results were published in the Journal of Thoracic Oncology Clinical and Research Reports in August 2021. The procedure demonstrated that our technology was able to successfully regenerate esophageal tissue, including the mucosal lining, to restore the integrity, continuity and functionality of the esophageal tube.

Our technology uses mesenchymal stem cells that are retrieved via biopsy from the patient’s abdominal adipose tissue prior to surgery. These stem cells are isolated, expanded and then implanted on a hollow, tubular polyurethane scaffold. The scaffold is then incubated in a customized bioreactor where the stem cells expand further and begin to adhere to the tubular scaffold. The finished graft is then surgically implanted to replace the resected portion of the damaged organ. Several weeks after surgery, once a conduit has been established, the implanted scaffold is removed. No permanent artificial implant remains in the body.

We are initially targeting regeneration of the organs of the gastro-intestinal tract and the airway, where organ transplants are not medically possible today. Human-donor organ transplants or animal xenotransplants are currently not performed for these organs due to high rates of rejection. Additionally, we believe that our technology and intellectual property will allow us to develop organ-regeneration treatments for other organs.

Based on our successful first-in-human procedure and our preclinical procedures in 45 pigs, the FDA has approved our Investigational New Drug (IND) application to begin a combined phase 1/2 clinical trial for esophageal regeneration. This open-label trial will assess both safety and efficacy in up to ten patients requiring up to a 6cm esophageal replacement for any reason, including cancer, at up to five U.S. hospitals. We intend to initiate this trial in early 2023.

Industry: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS
Employees: 6
Founded: 2012
Contact Information
Address 84 October Hill Road, Suite 11, Holliston, Massachusetts 01746
Phone Number (774) 233-7300
Web Address http://www.biostage.com/
View Prospectus: Biostage, Inc.
Financial Information
Market Cap
Revenues $0 mil (last 12 months)
Net Income $-9.25 mil (last 12 months)
IPO Profile
Symbol BSTG
Exchange NASDAQ
Shares (millions): 0.0
Price range $0.00 - $0.00
Est. $ Volume $12.0 mil
Manager / Joint Managers Newbridge Securities Corp.
CO-Managers
Expected To Trade:
Status: TBA
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