US IPO Encyclopedia: Harvard Apparatus Regenerative has applied for listing on Nasdaq in the US OTC market as a leading global organ regeneration technology company.

Leading global organ regeneration technology company$Harvard Apparatus Regenerative (HRGN.US)$Currently trading on the OTC market, the company has applied for listing on Nasdaq with the stock code "BSTG". As of September 5th, the total market value of Harvard Apparatus Regenerative is approximately $70 million.

Company overview.

Harvard Apparatus Regenerative, formerly known as Harvard Apparatus Regenerative Technology, Inc., is a leading global biotechnology company specializing in organ regeneration. The founder, David Green, graduated from Oxford University and Harvard University.

The company focuses on the repair and regeneration of tubular organs such as the esophagus and respiratory tract, with its core technology being the removable regenerative brackets. The company holds 8 US patents and 2 Chinese patents, and has obtained FDA approval to conduct clinical trials for esophageal regeneration therapy.

Core Technology

Harvard Apparatus Regenerative extracts mesenchymal stem cells from the patient's abdominal fat tissue through a biopsy before surgery. These stem cells are isolated, expanded, and then implanted on a hollow tubular polyurethane bracket. The bracket is incubated in a customized bioreactor, where the stem cells further expand and begin to adhere to the tubular bracket. The final transplant is completed by surgically implanting the graft to replace the removed portion of the damaged organ. Several weeks after surgery, once the conduit is established in the body, the implanted brackets are removed, so there are no permanent artificial implants in the body.

Harvard Apparatus Regenerative's technology represents the next generation solution for organ function restoration, as it allows patients to regenerate their own organs, eliminating the need for human or animal transplants, sacrificing another patient's organ, or permanent artificial implants.

Medical Research and Development

Harvard Apparatus Regenerative's organ regeneration technology has the potential for wide application in the medical field, used to repair or replace diseased or damaged organs. The company's initial focus is on esophageal diseases, including cancer, trauma, and birth defects. Other candidate products in the company's medical research and development pipeline include treatments for cancer, bronchial injuries, and birth defects. Harvard Apparatus Regenerative's technology may also be applicable to the treatment of colon and intestinal cancer, injuries, and birth defects.

Currently, the company has 4 research and development pipelines, including esophageal regeneration therapy (adults), esophageal regeneration therapy (children), bronchial regeneration therapy, and tracheal regeneration therapy. The FDA has approved Harvard Apparatus Regenerative's IND application and the company plans to initiate Phase 1/2 clinical trials for esophageal regeneration therapy in early 2023, for the treatment of severe esophageal diseases.

Financial Situation

Harvard Apparatus Regenerative's financial situation falls into the typical preclinical stage biotechnology company category. As of the first quarter of 2022, the company has not yet turned a profit, with a net loss of $2.177 million, a 149% increase compared to the previous year.

Industry outlook

According to the data from the International Agency for Research on Cancer of the World Health Organization (WHO), there were over 0.6 million cases of esophageal cancer, over 1 million cases of colon cancer, and over 0.02 million cases of lung cancer worldwide in 2020. These cases may be treated using the technology of Harvard Apparatus Regenerative.

Click to view the prospectus of Harvard Apparatus Regenerative.

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