Here are the 10-K annual reports from Harvard Apprats REG TCH (HRGN) in our archive since June 2025, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 10-K covers the audited annual report, with the full financial statements, so if you follow HRGN and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full HRGN filings page.
Harvard Apparatus Regenerative Technology, Inc. (HRGN) is a clinical-stage regenerative medicine company developing cell-based implants to restore damaged organs, initially focusing on the esophagus. Its Cellspan Esophageal Implant uses a patient’s own mesenchymal stem cells seeded on a removable polyurethane scaffold to regenerate functional tissue without permanent implants or donor organs.
The FDA has approved an investigational phase 1 trial in up to ten U.S. patients who need resection of up to six centimeters of esophagus; three sites are activated, but the company has yet to enroll its first eligible patient due to strict criteria and logistical hurdles. HRGN leverages encouraging data from over 50 pig procedures and a first-in-human compassionate-use case at Mayo Clinic, and holds U.S. and EU orphan drug designations that could provide multi-year market exclusivity if a product is approved.
The pipeline extends to pediatric esophageal atresia, colon reconstruction and uterine adhesion prevention, supported by collaborations with institutions including Mayo Clinic, Connecticut Children’s and Capital Medical University in China. The company also runs a Hong Kong subsidiary for consumer health products. Research and development expenses were about $2.7 million in 2025 and $2.3 million in 2024. As of March 9, 2026, HRGN had 17,580,744 common shares outstanding, and non-affiliate equity market value was approximately $15.6 million as of June 30, 2025 at a $1.70 share price.