OTC-BB:BSTG

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, Inc. Changes Name to Harvard Apparatus Regenerative Technology, Inc. (OTCQB: HRGN)

Retrieved on: 
Thursday, July 20, 2023
Harvard Apparatus, Regenerative medicine, OTCQB, B cell, FDA, Rejuvenation, Research

HOLLISTON, Mass., July 20, 2023 /PRNewswire/ -- Biostage, Inc. (OTCQB: formerly BSTG) announced today it has changed its corporate name back to Harvard Apparatus Regenerative Technology, Inc. and will trade under the OTCQB symbol "HRGN" effective July 20, 2023. Concurrently, the company launched a new web site www.hregen.com to provide greater clarity and visibility for its regenerative technology and expanding strategy on rejuvenation (anti-aging).

Key Points: 
  • Concurrently, the company launched a new web site www.hregen.com to provide greater clarity and visibility for its regenerative technology and expanding strategy on rejuvenation (anti-aging).
  • The FDA approved a 10-patient phase 1 study for the company's esophageal implant which has recently opened for enrollment.
  • The company intends to use the Harvard Apparatus Regenerative Technology name on its new anti-aging business which it is currently launching in China.
  • Jerry He, CEO, commented, "We have changed our company name back to Harvard Apparatus Regenerative Technology, Inc. because of its recognition in the biotech industry.

Biostage Activated Mayo Clinic as The First Site for Clinical Trial in Severe Esophageal Disease

Retrieved on: 
Tuesday, July 18, 2023
Business development, Mayo Clinic, Clinical trial, Cancer, OTCQB, Esophagus, Esophageal disease, Trial of the century, Regenerative medicine, Hospital, Patient, Clinical professor, Birth, FDA, Trauma, Safety, Pharmaceutical industry, Medical device

HOLLISTON, Mass., July 18, 2023 /PRNewswire/ -- Biostage, Inc. (OTCQB: BSTG) ("Biostage" or the "Company"), a clinical-stage biotechnology company developing the technology to regenerate organs inside the body to treat severe diseases, including cancer, trauma and birth defects initially in the esophagus and the airway, today announced that it officially activated the site with Mayo Clinic for its clinical trial as to severe esophageal disease, being its first clinical trial in the United States.

Key Points: 
  • HOLLISTON, Mass., July 18, 2023 /PRNewswire/ -- Biostage, Inc. (OTCQB: BSTG) ("Biostage" or the "Company"), a clinical-stage biotechnology company developing the technology to regenerate organs inside the body to treat severe diseases, including cancer, trauma and birth defects initially in the esophagus and the airway, today announced that it officially activated the site with Mayo Clinic for its clinical trial as to severe esophageal disease, being its first clinical trial in the United States.
  • "We are thrilled to announce the initiation of our first clinical study for our esophageal implant, marking an important milestone for Biostage," said Jerry He, Chairman and CEO of Biostage.
  • "Our numerous preclinical studies have demonstrated our technology as an effective platform for tubular organ regeneration.
  • We look forward to testing the esophageal implant in the clinics as we further our understanding of its potential benefits for patients.

Biostage to Host Investor Call

Retrieved on: 
Tuesday, June 13, 2023
Cancer, OTCQB, Birth, Esophagus, Trauma, EDT, Pharmaceutical industry, Perfume

HOLLISTON, Mass., June 13, 2023 /PRNewswire/ -- Biostage, Inc. (OTCQB: BSTG) ("Biostage" or the "Company"), a clinical-stage biotechnology company developing the technology to regenerate organs inside the body to treat severe diseases, including cancer, trauma and birth defects initially in the esophagus and the airway, announced today that it will host an investor call on Tuesday, June 20, 2023.

Key Points: 
  • HOLLISTON, Mass., June 13, 2023 /PRNewswire/ -- Biostage, Inc. (OTCQB: BSTG) ("Biostage" or the "Company"), a clinical-stage biotechnology company developing the technology to regenerate organs inside the body to treat severe diseases, including cancer, trauma and birth defects initially in the esophagus and the airway, announced today that it will host an investor call on Tuesday, June 20, 2023.
  • The Company's CEO will provide his background, business plan and updates on clinical and preclinical efforts for the second half of the year.
  • Tuesday, June 20 at 9:00 a.m. EDT

Biostage Announces Chairman and CEO Transition

Retrieved on: 
Thursday, March 2, 2023
NYSE, Birth, MBA, FDA, University of Chicago, Clinical trial, Cancer, University, Regenerative medicine, Patient, Esophageal cancer, OTCQB, Morgan Stanley, CFA, Executive, Master, CFO, Bear Stearns, Peking University, Trauma, Management, Pharmaceutical industry, Chemistry

HOLLISTON, Mass., March 1, 2023 /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 resulting from cancer, trauma or birth defects, today announced that effective as of March 1, 2023, its existing director since November 2021, Mr. Jerry He, was appointed Chairman of the Board and hired as Chief Executive Officer.  Mr. He replaces David Green who is transitioning from such roles and will remain on the Board of Directors.  Mr. Green will provide support to Mr. He during his transition to the Chief Executive Officer role. 

Key Points: 
  • Mr.
  • Mr.
  • I will continue to support Jerry in the transition to CEO and will remain on the Board."
  • He commented, "On behalf of the board, I thank Mr. Green for leading Biostage to clinical stage and his support to my transition to the new role.

Biostage Amends CEO Employment Agreement

Retrieved on: 
Thursday, January 12, 2023
Birth, Clinical trial, OTCQB, Interim, FDA, Smart contract, Trauma, Cancer, Pharmaceutical industry, Amend

HOLLISTON, Mass., Jan. 12, 2023 /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 resulting from cancer, trauma or birth defects, today announced that effective as of January 11, 2023, Biostage, Inc. (the Company) entered into an Amended and Restated Employment Agreement (the Amended Agreement) with David Green, the Chief Executive Officer of the Company, to remove the Interim designation from his Chief Executive Officer title effective immediately, and also amend certain terms of Mr. Green's existing Employment Agreement.   

Key Points: 
  • Biostage removes Interim qualification from Mr. Green's title, making him Chief Executive Officer.
  • HOLLISTON, Mass., Jan. 12, 2023 /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 resulting from cancer, trauma or birth defects, today announced that effective as of January 11, 2023, Biostage, Inc. (the Company) entered into an Amended and Restated Employment Agreement (the Amended Agreement) with David Green, the Chief Executive Officer of the Company, to remove the Interim designation from his Chief Executive Officer title effective immediately, and also amend certain terms of Mr. Green's existing Employment Agreement.
  • I am an investor in Biostage and most of my compensation will be in the form of stock options.
  • Hence my interests are aligned with those of our shareholders in making Biostage successful."

Biostage Selects IQVIA to Manage its FDA-Approved Clinical Trial in Severe Esophageal Disease, including Cancer

Retrieved on: 
Wednesday, December 28, 2022
European Medicines Agency, AmerisourceBergen, OTC, Trauma, Annual report, Patient, Government, Birth, NYSE, Food, Mayo Clinic, B cell, Journal, IQV, Regeneration, American Cancer Society, Privacy, FDA, Running, Safety, Clinical trial, Transplant, Esophagus, Journal of Thoracic Oncology, Esophageal cancer, OTCQB, Chairperson, Thorax, Survival, Risk, Research, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Cardiothoracic surgery, Hospital, Clinical professor, Organic, Pharmaceutical industry, Medical imaging, Medical device, Dentistry, IQVIA, Cancer

HOLLISTON, Mass., Dec. 28, 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 resulting from cancer, trauma or birth defects, today announced that it had selected IQVIA, a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry, as the contract research organization (CRO) to manage its first clinical trial. 

Key Points: 
  • In the first use of the Biostage Esophageal Implant product candidate in a human cancer patient, this endpoint was met by one month.
  • 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.
  • The preliminary contract that Biostage entered into with IQVIA is for the first stage of work to prepare for the clinical trial.
  • Biostage anticipates entering into a second more comprehensive contract with IQVIA that will cover the remaining aspects of the trial.

New Publication Demonstrates Rapid Esophageal Regeneration using the Biostage Esophageal Implant

Retrieved on: 
Friday, December 23, 2022
European Medicines Agency, OTC, Trauma, Annual report, Interim, Esophageal disease, Patient, Birth, NYSE, Food, Journal, Regeneration, Growth, Immunology, FDA, Clinical trial, Animal, BEI, Esophagus, OTCQB, Regenerative medicine, Risk, Cancer, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Ill, Pharmaceutical industry, Dentistry

HOLLISTON, Mass., Dec. 23, 2022 /PRNewswire/ -- Biostage, Inc. (OTCQB: BSTG) ("Biostage" or the "Company"), a cell-therapy biotechnology company with successful first-in-human experience repairing the esophagus after the cancer in the patient's esophagus had been surgically removed* and FDA approval to commence a clinical trial of the Biostage Esophageal Implant for severe esophageal disease including cancer, today announced the publication of a paper in the peer-reviewed Journal of Immunology and Regenerative Medicine that describes the early tissue growth and regeneration processes following the implantation of the Biostage Esophageal Implant (BEI) in nine pigs with full circumferential esophageal segmental replacement. The BEI stimulated new blood vessel growth and all animals regenerated a continuous biological conduit by 28 days. In some animals the continuous biological conduit was seen as early as 14 days. The paper can be accessed through the following  link: https://doi.org/10.1016/j.regen.2022.100068.  The regeneration time period as noted in the paper compares favorably with the primary endpoint of Biostage's FDA-approved clinical trial which is to show a continuous biological conduit by 90 days. Biostage expects to initiate patient recruitment in its first clinical trial in early 2023.

Key Points: 
  • The Biostage Esophageal Implant (previously known as Cellspan Esophageal Implant) stimulates the regeneration of new tissue to repair the esophagus following a full circumferential segmental resection.
  • The BEI bridged the esophageal ends and restored the conduit by stimulating a regeneration process that includes rapid neovascularization followed by mucosal regeneration that was quantified from day 14 to day 28 post-implantation.
  • David Green, Interim Chief Executive Officer of Biostage, commented: "We are pleased to announce the publication of this study which describes the early phases of the rapid tissue regeneration stimulated by the Biostage Esophageal Implant and demonstrates that by as early as day 14 post-implantation a complete biologic esophageal conduit is restored.
  • Dr William Fodor, Chief Scientific Officer of Biostage, added: "This study demonstrates that rapid tissue deposition and the stimulation of angiogenesis (new blood vessel growth) leads to a productive healing and regeneration response.

Biostage Reports Corporate Highlights and Third Quarter Financial Results

Retrieved on: 
Monday, November 14, 2022
Trauma, Technology, OTCQB, Goal, Esophagus, European Medicines Agency, GERD, Stomach, BEI, Clinical professor, Esophageal cancer, Esophageal disease, FDA, Risk, Company, Mayo Clinic, Cancer, Regeneration, Patent, Annual report, Private Securities Litigation Reform Act, NASDAQ, Stenosis, Clinical trial, OTC, Disease, Food, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Birth, Pharmaceutical industry

You can access the live conference call by dialing the following phone numbers toll free 877-407-8293 or international +1 201-689-8349.

Key Points: 
  • You can access the live conference call by dialing the following phone numbers toll free 877-407-8293 or international +1 201-689-8349.
  • On October 25, 2022, Biostage was issued a U.S. patent that protects the extension of the use of Biostage's technology from hollow tubes to patches.
  • On August 8, 2022, Biostage appointed Joseph Damasio as the Company's new Chief Financial Officer.
  • The Company's results may also be affected by factors of which the Company is not currently aware.

Biostage Schedules Conference Call and Webcast for Q3 2022 Results

Retrieved on: 
Thursday, November 10, 2022
Private Securities Litigation Reform Act, Risk, Telephone, Birth, OTC, Esophagus, Food, Regeneration, Mayo Clinic, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Annual report, Trauma, NASDAQ, Goal, Cancer, Company, Clinical trial, Access, European Medicines Agency, FDA, Pharmaceutical industry

We have performed the world's first regeneration of an esophagus in a human cancer patient.

Key Points: 
  • We have performed the world's first regeneration of an esophagus in a human cancer patient.
  • Risk Factors" in the Company's Annual Report on Form 10-K for the fiscal year endedDecember 31, 2021or 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.