First Cellspan Esophageal Implant patient treated by Harvard Apparatus (HRGN)
Rhea-AI Filing Summary
Harvard Apparatus Regenerative Technology, Inc. filed an 8-K to share that the first patient has been treated with its Cellspan™ Esophageal Implant (CEI) in a Phase 1 feasibility and safety clinical trial at the Mayo Clinic in Rochester, Minnesota.
The CEI is a combination product using a modified polyurethane CellFrame™ mesh scaffold seeded with a patient’s own adipose-derived Mesenchymal Stromal Cells, temporarily supporting tissue growth before scaffold removal 21–42 days after implantation. The company highlights this as a key milestone in its effort to offer a regenerative option for life‑threatening esophageal disease, which currently relies on highly invasive procedures.
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Insights
First-in-human CEI use marks an early but important clinical milestone.
Harvard Apparatus Regenerative Technology has treated the first patient with its Cellspan™ Esophageal Implant in a Phase 1 feasibility and safety clinical trial at the Mayo Clinic. This moves the program from preclinical and preparatory work into initial human testing.
The Cellspan implant combines a polyurethane CellFrame mesh scaffold with autologous adipose-derived Mesenchymal Stromal Cells, with endoscopic scaffold removal planned at 21–42 days. As a Phase 1 study, the primary focus is safety and feasibility rather than efficacy, so future data readouts will determine how the program progresses.
The company notes prior experience with esophageal regeneration and multiple issued patents and orphan-drug designations in the US and EU. Subsequent disclosures on patient outcomes and safety from this trial will be important for understanding the platform’s potential, but timing for such updates is not detailed here.
8-K Event Classification
Key Figures
Key Terms
Phase 1 feasibility and safety clinical trial medical
Mesenchymal Stromal Cells medical
combination product medical
orphan-drug designations regulatory
market exclusivity regulatory
clinical-stage biotechnology company financial
SECURITIES AND EXCHANGE COMMISSION
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Item 9.01.
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Financial Statements and Exhibits.
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99.1
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Press Release issued by Harvard Apparatus Regenerative Technology, Inc. on April 27, 2026
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104
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HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.
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Date: April 28, 2026
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By:
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/s/ Joseph Damasio
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Joseph Damasio
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Chief Financial Officer
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Exhibit 99.1
Harvard Apparatus Regenerative Technology Announces First Patient Treated with Cellspan Esophageal Implant at Mayo Clinic
Holliston, MA – April 27, 2026 – 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 announced that the first patient has been treated with its Cellspan™ Esophageal Implant (CEI) in the Company’s Phase 1 feasibility and safety clinical trial conducted at the Mayo Clinic in Rochester, Minnesota. This milestone represents a significant advancement in the Company’s clinical program and marks an important step toward offering patients a novel regenerative solution for esophageal disease.
Life-Threatening esophageal disease, including severe strictures, represents a significant unmet medical need. Current treatment options are limited and often involve highly invasive procedures with substantial morbidity. The Cellspan Esophageal Implant is designed to leverage the patient’s own regenerative capacity, offering a potential alternative to conventional surgical reconstruction.
Clinical Trial Overview
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The Company’s Phase 1 clinical trial is a feasibility and safety study in up to ten patients under an FDA-approved IND. |
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We activated three clinical trial sites, the Mayo Clinic, the University of Michigan Medical Center and the University of Southern California in Los Angeles. |
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The primary endpoint of the ongoing trial is the establishment of a continuous biological neoconduit, or tube, by three months post-surgery. |
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One of the secondary endpoints will be the development of a mucosal lining in the esophagus by twelve months post-surgery. |
About the Cellspan™ Esophageal Implant (CEI) CellSpan™ Esophageal Implant (CEI) is a combination product. It consists of a modified polyurethane tubular CellFrame™ mesh scaffold with direct delivery of live autologous adipose derived Mesenchymal Stromal Cells to the esophagus. The CEI provides temporary support during the initial tissue growth phase, and the scaffold is removed endoscopically at 21–42 days post implant.
“This is a defining moment for Harvard Apparatus Regenerative Technology and for the broader field of regenerative medicine. Treating the first patient with our Cellspan Esophageal Implant at one of the world’s most prestigious medical institutions validates the years of scientific rigor, clinical preparation, and dedication that our entire organization has invested in this program. We are deeply grateful to the patient, the clinical team at Mayo Clinic, and all of our partners who have supported us on this journey. We look forward to progressing this trial and bringing this innovative therapy to patients in need,” commented Jerry He, Chief Executive Officer of Harvard Apparatus Regenerative Technology.
“Executing the first patient implant required extraordinary coordination across clinical, manufacturing, quality, and logistics functions, and I am proud of the exceptional performance of our operations team in delivering the Cellspan Esophageal Implant to meet the highest standards of quality and safety,” commented Sean Hu, Vice President of Business Development and Operations.
The Company extends its sincere appreciation to IQVIA Biotech for their exceptional project management, site activation support, and cross-functional coordination throughout this Phase 1 clinical trial. From study start-up through first patient treatment, IQVIA Biotech's dedicated team ensured seamless site readiness, protocol adherence, and operational execution, playing an integral role in bringing this clinical milestone to completion on time and to the highest standards of quality.
Harvard Apparatus Regenerative Technology also extends its deepest appreciation to the entire clinical and research team at the Mayo Clinic for their professionalism, dedication, and collaborative spirit in bringing this milestone to fruition. The Company looks forward to continuing this important partnership as the program advances.
About Harvard Apparatus Regenerative Technology, Inc.
We are a clinical-stage biotechnology company developing regenerative-medicine treatments for disorders of the gastro-intestinal system and other organs 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. Dennis 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.
HRGN has 13 issued U.S. patents, 2 issued in China, 1 issued in Japan, 2 issued in Europe, 2 U.S. orphan-drug designations which can provide seven years of market exclusivity in the US market after market approval from the FDA and 1 EMA orphan drug designation, which can provide ten years of market exclusivity in the European market after market approval from the EMA.
For more information, please visit www.hregen.com and connect with the Company on LinkedIn.
Forward-Looking Statements
Some of the statements in this press release are “forward-looking” and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These “forward-looking” statements include, but are not limited to, statements relating to the capabilities and performance of our products and product candidates; development expectations and regulatory approval of any of the Company’s products by the U.S. Food and Drug Administration, the European Medicines Agency or otherwise, which expectations or approvals may not be achieved or obtained on a timely basis or at all; and success with respect to any collaborations, clinical trials and other development and commercialization efforts of the Company’s products. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release. The forward-looking statements in this press release speak only as of the date of this press release. The Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements.
Investor Relations Contact
Joseph Damasio
Chief Financial Officer
774-233-7330
jdamasio@hregen.com