Esophageal atresia

Harvard Apparatus Regenerative Technology Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Business Highlights

Retrieved on: 
Tuesday, April 2, 2024
Uterus, Gynaecology, Longevity, Reproductive Sciences, Patient, Collaboration, University, EMA, MD, European Medicines Agency, European, PIPE, Esophageal atresia, Yale school, OTCQB, Cryptocurrency

The EMA is the centralized regulatory agency for the review and approval of new medicines in the European Union.

Key Points: 
  • The EMA is the centralized regulatory agency for the review and approval of new medicines in the European Union.
  • Company’s subsidiary in Hong Kong launched its longevity product business in Asia, generating more than $100,000 in 2023 sales.
  • Entered into securities purchase agreements with accredited investors for a $6 million private investment in public equity (PIPE) financing.
  • Holliston, MA, April 02, 2024 (GLOBE NEWSWIRE) -- Harvard Apparatus Regenerative Technology, Inc. (OTCQB: HRGN) (“Harvard Apparatus Regenerative Technology” or the “Company”), a clinical-stage biotechnology company developing the technology to regenerate organs inside the body to treat severe diseases, today reported fourth quarter and full year 2023 financial results.

Approval of an Orphan Disease Application for its lead product, the Cellspan Esophageal Implant by the European Medicines Agency

Retrieved on: 
Monday, August 21, 2023
Esophageal atresia, Tissue, EU, Civil service commission, CSO, ODD, European Medicines Agency, OTCQB, Birth, Research, EMA, Incidence, Central Authority, Science, Agency, Rare, Approval, European, European Commission, Disease, Medical device, Pharmaceutical industry

The EMA is the centralized regulatory agency for the review and approval of new medicines in the European Union as well as Iceland, Norway and Liechtenstein.

Key Points: 
  • The EMA is the centralized regulatory agency for the review and approval of new medicines in the European Union as well as Iceland, Norway and Liechtenstein.
  • The Orphan Disease Designation (ODD) was approved to treat Esophageal Atresia, a congenital disorder where children are born with an incomplete, underdeveloped esophagus.
  • Sponsor's may also have access via orphan designation to conditional approval, which is conducted under the centralized procedure.
  • Authorized orphan medicines benefit from ten years of protection from market competition with similar medicines with similar indications once they are approved.

Biostage Hires David Green as Chief Executive Officer

Retrieved on: 
Tuesday, November 30, 2021
Zero, Patient, Private Securities Litigation Reform Act, Mayo Clinic, Man, Sale, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, CEO, European Medicines Agency, Cell, Regeneration, Risk, American Cancer Society, Esophageal cancer, Esophagus, Annual report, Company, Achievement, Cardiothoracic surgery, Connecticut Children's Medical Center, Mouth, Cancer, Transplant, Clinical trial, Thorax, Clinical professor, Esophageal disease, Goal, Colorectal cancer, Large intestine, Histology, Death, Research, Adult, Patent, Biotechnology, Board, OTCQB, Director, FDA, Immune system, Institutional review board, Food, Esophageal atresia, Security (finance), Pharmaceutical industry, Dentistry

HOLLISTON, Mass., Nov. 30, 2021 /PRNewswire/ -- Biostage, Inc. (OTCQB: BSTG) ("Biostage" or the "Company"), a biotechnology company with successful "first-in-human" experience in esophageal cancer and FDA approval to commence a clinical trial of its Biostage Esophageal Implant for esophageal disease, today announced it has hired David Green as its Chief Executive Officer and appointed Mr. Green as Chairman of the Board of Directors (the "Board").

Key Points: 
  • HOLLISTON, Mass., Nov. 30, 2021 /PRNewswire/ -- Biostage, Inc. (OTCQB: BSTG) ("Biostage" or the "Company"), a biotechnology company with successful "first-in-human" experience in esophageal cancer and FDA approval to commence a clinical trial of its Biostage Esophageal Implant for esophageal disease, today announced it has hired David Green as its Chief Executive Officer and appointed Mr. Green as Chairman of the Board of Directors (the "Board").
  • Mr. Green resigned from his roles in Biostage in 2015 after he had been involved in a major road accident.
  • The clinical results of the first-in-human use of our Biostage Esophageal Implant, conducted at Mayo Clinic in 2017, were very positive.
  • Because the Biostage Esophageal Implant is made using the patient's own cells, Biostage does not expect rejection of the implant.

Biostage Reports Q3 2021 Financial Results

Retrieved on: 
Monday, November 15, 2021
Quality of life, Eighth note, Private Securities Litigation Reform Act, SBIR, Medicine, Food, European Medicines Agency, Research, Regulation of tobacco by the U.S. Food and Drug Administration, Annual report, Risk, Esophageal atresia, Company, Regeneration, PPP, OTCQB, Forgiveness, Cell, Esophagus

HOLLISTON, Mass., Nov. 15, 2021 /PRNewswire/ -- Biostage, Inc. (OTCQB: BSTG) ("Biostage" or the "Company"), a bioengineering company developing next-generation esophageal implants based its novel Cellframe and Cellspan technology, today announced its financial results for the three and nine months ended September 30, 2021.

Key Points: 
  • HOLLISTON, Mass., Nov. 15, 2021 /PRNewswire/ -- Biostage, Inc. (OTCQB: BSTG) ("Biostage" or the "Company"), a bioengineering company developing next-generation esophageal implants based its novel Cellframe and Cellspan technology, today announced its financial results for the three and nine months ended September 30, 2021.
  • For the three months endedSeptember 30, 2021, the Company reported a net loss of$0.8 million, ($0.8per share), compared to a net loss of$0.7 million, ($0.07per share), for the three months endedSeptember 30,2020.
  • As ofSeptember30, 2021, the Company had operating cash on-hand of$2.0 million, an increase of $1.5 million from the prior year.
  • The Company's results may also be affected by factors of which the Company is not currently aware.

Biostage™ Appoints Jerry He to Board of Directors and Completes Private Placement of $2.6 Million to Continue Its Clinical Transition

Retrieved on: 
Wednesday, September 8, 2021

"We are pleased to welcome Jerry He to the Biostage Board," said Jason Chen, chairman of Biostage.

Key Points: 
  • "We are pleased to welcome Jerry He to the Biostage Board," said Jason Chen, chairman of Biostage.
  • He commented, "I am very pleased to be joining the Board of Directors for Biostage at this exciting stage of its clinical development.
  • Biostage is developing promising novel cell therapies with the potential to change the lives of patients with significant unmet needs.
  • These placements will enable Biostage to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2021.

Biostage Reports Q2 2021 Financial Results

Retrieved on: 
Friday, August 13, 2021
Regulation of tobacco by the U.S. Food and Drug Administration, European Medicines Agency, PPP, Company, Risk, Food, Private Securities Litigation Reform Act, Medicine, OTCQB, Regeneration, Forgiveness, Research, Cell, Esophageal atresia, Annual report, Eighth note, Esophagus, Quality of life, Paycheck Protection Program, Aquaculture, Cryptocurrency

HOLLISTON, Mass., Aug. 13, 2021 /PRNewswire/ -- Biostage, Inc. (OTCQB: BSTG) ("Biostage" or the "Company"), a bioengineering company developing next-generation esophageal implants based its novel Cellframe and Cellspan technology, today announced its financial results for the three and six months ended June 30, 2021.

Key Points: 
  • HOLLISTON, Mass., Aug. 13, 2021 /PRNewswire/ -- Biostage, Inc. (OTCQB: BSTG) ("Biostage" or the "Company"), a bioengineering company developing next-generation esophageal implants based its novel Cellframe and Cellspan technology, today announced its financial results for the three and six months ended June 30, 2021.
  • As ofJune30, 2021, the Company had operating cash on-hand of$0.5 million, flat from the prior quarter.
  • We expect that our operating cash on-hand as of June 30, 2021 of $0.5 million will enable us to fund our operating expenses and capital expenditure requirements into the third quarter of 2021.
  • The Company's results may also be affected by factors of which the Company is not currently aware.

Biostage Reports Second Quarter 2020 Financial Results

Retrieved on: 
Thursday, August 13, 2020
Esophageal cancer, Gastrointestinal cancer, RTT, OTC Markets Group, Esophageal disease, Esophageal atresia

HOLLISTON, Mass., Aug. 13, 2020 /PRNewswire/ -- Biostage, Inc. (OTCQB: BSTG)("Biostage" or the "Company"), a clinical-stage biotechnology company developing bioengineered organ implants based on the Company's novel Cellspan technology for the treatment of esophageal atresia and esophageal disease, today announced its financial results for the three and six months ended June 30, 2020.

Key Points: 
  • HOLLISTON, Mass., Aug. 13, 2020 /PRNewswire/ -- Biostage, Inc. (OTCQB: BSTG)("Biostage" or the "Company"), a clinical-stage biotechnology company developing bioengineered organ implants based on the Company's novel Cellspan technology for the treatment of esophageal atresia and esophageal disease, today announced its financial results for the three and six months ended June 30, 2020.
  • In the event the Company does not raise additional capital from outside sources before the fourth quarter of 2020, it may be forced to curtail or cease its operations.
  • Biostage is a clinical-stage biotechnology company developing bioengineered organ implants based on the Company's novel Cellspan technology.
  • The Company's results may also be affected by factors of which the Company is not currently aware.

Biostage awarded $1.1 million Phase II NIH SBIR Fast-Track grant to develop Cellspan™ Esophageal Implant (CEI) as a novel treatment for pediatric esophageal atresia

Retrieved on: 
Tuesday, November 6, 2018
Esophageal atresia, Medicine, RTT, Esophageal, Atresia

The grant funding will support Biostage's development and testing of its Cellspan Esophageal Implant (CEI) for treatment of neonatal esophageal atresia.

Key Points: 
  • The grant funding will support Biostage's development and testing of its Cellspan Esophageal Implant (CEI) for treatment of neonatal esophageal atresia.
  • Jim McGorry, CEO of Biostage, commented, "There is a tremendous unmet medical need in children suffering from esophageal atresia.
  • Children born with a gap between their upper and lower esophagus face multiple complications and a reduced quality of life.
  • Biostage recently completed Phase I of the SBIR Fast-Track grant of $225,000 that was awarded in March 2018.