Harvard Apparatus Regenerative Technology Announces Strategic Collaboration with Children’s Hospital Capital institute of Pediatrics in Beijing, China to Advance Treatment for Esophageal Atresia
Harvard Apparatus Regenerative Technology (HRGN) has announced a strategic partnership with the Capital Institute of Pediatrics in Beijing, China, focusing on developing treatments for Esophageal Atresia (EA) using their Cellspan Esophageal Implant (CEI) product candidate. The collaboration aims to conduct Investigator Initiated Trials (IITs) to evaluate CEI's safety and efficacy in treating EA. The partnership combines HRGN's regenerative medicine technology with the institute's pediatric expertise to accelerate regulatory approval and improve patient outcomes.
Harvard Apparatus Regenerative Technology (HRGN) ha annunciato una partnership strategica con il Capital Institute of Pediatrics di Pechino, in Cina, concentrandosi sullo sviluppo di trattamenti per Atresia Esofagea (AE) utilizzando il loro candidato prodotto Cellspan Esophageal Implant (CEI). La collaborazione mira a condurre Studi Iniziati da Investigatori (IIT) per valutare la sicurezza e l'efficacia del CEI nel trattamento dell'AE. Questa partnership combina la tecnologia di medicina rigenerativa di HRGN con l'esperienza pediatrica dell'istituto per accelerare l'approvazione regolatoria e migliorare i risultati per i pazienti.
Harvard Apparatus Regenerative Technology (HRGN) ha anunciado una asociación estratégica con el Capital Institute of Pediatrics en Beijing, China, centrándose en el desarrollo de tratamientos para Atrésia Esofágica (AE) utilizando su candidato a producto Cellspan Esophageal Implant (CEI). La colaboración tiene como objetivo llevar a cabo Ensayos Iniciados por Investigadores (IIT) para evaluar la seguridad y eficacia del CEI en el tratamiento de la AE. La asociación combina la tecnología de medicina regenerativa de HRGN con la experiencia pediátrica del instituto para acelerar la aprobación regulatoria y mejorar los resultados en los pacientes.
하버드 장치 재생 기술(HRGN)은 중국 베이징에 있는 소아과 연구소와의 전략적 파트너십을 발표하였습니다. 이는 Cellspan Esophageal Implant(CEI) 제품 후보를 사용하여 식도 폐쇄증 (EA) 치료법 개발에 집중하는 것입니다. 이번 협업은 EA 치료에서 CEI의 안전성과 효능을 평가하기 위한 연구자 주도 시험 (IIT)을 진행하는 데 목표를 두고 있습니다. 이 파트너십은 HRGN의 재생 의료 기술과 연구소의 소아 전문 지식을 결합하여 규제 승인을 가속화하고 환자 결과를 개선하는 데 기여할 것입니다.
Harvard Apparatus Regenerative Technology (HRGN) a annoncé un partenariat stratégique avec le Capital Institute of Pediatrics à Pékin, en Chine, axé sur le développement de traitements pour Atresie Œsophagienne (AO) en utilisant leur candidat produit Cellspan Esophageal Implant (CEI). La collaboration vise à réaliser des Essais Initiés par des Investigateurs (IIT) pour évaluer la sécurité et l'efficacité du CEI dans le traitement de l'AO. Ce partenariat combine la technologie de médecine régénérative de HRGN avec l'expertise pédiatrique de l'institut afin d'accélérer l'approbation réglementaire et d'améliorer les résultats pour les patients.
Harvard Apparatus Regenerative Technology (HRGN) hat eine strategische Partnerschaft mit dem Capital Institute of Pediatrics in Peking, China, angekündigt, die sich auf die Entwicklung von Behandlungen für Ösophagusatresie (EA) mit ihrem Produktkandidaten Cellspan Esophageal Implant (CEI) konzentriert. Ziel der Zusammenarbeit ist es, Von Forschern initiierte Studien (IIT) durchzuführen, um die Sicherheit und Wirksamkeit von CEI bei der Behandlung von EA zu bewerten. Die Partnerschaft kombiniert die Technologie der regenerativen Medizin von HRGN mit der pädiatrischen Expertise des Instituts, um die behördliche Genehmigung zu beschleunigen und die Patientenergebnisse zu verbessern.
- Strategic partnership with a major Chinese pediatric institution expanding market reach
- Advancement of clinical trials through Investigator Initiated Trials (IITs)
- Potential acceleration of regulatory approval process in China
- None.
Holliston, MA, Oct. 28, 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, is proud to announce a new partnership with the renowned Capital Institute of Pediatrics in China to develop innovative treatments for Esophageal Atresia (EA) using our flagship Cellspan Esophageal Implant (CEI) product candidate. By combining HRGN's pioneering platform technology with the Capital Institute of Pediatrics' world-class expertise in pediatric care, this partnership will focus on clinical research, product development, and patient access to life-saving treatments.
Dr. Lishuang Ma, a chief surgeon at the Children’s hospital Capital Institute of Pediatrics, expressed great enthusiasm about the collaboration: “Partnering with HRGN offers an exciting opportunity to leverage cutting-edge regenerative medicine technology in addressing Esophageal Atresia, a condition that requires innovative solutions. Together, we aim to improve patient outcomes and bring hope to families affected by this challenging condition.”
Jerry He, HRGN’s Chief Executive Officer, Director and Chairman, shared: "Our CEI product holds tremendous potential to improve the quality of life for children with Esophageal Atresia, and this partnership accelerates our ability to bring this innovation to those who need it most."
The partnership will focus on conducting Investigator initiated trials (IITs) to evaluate the safety and efficacy of the CEI product in treating Esophageal Atresia, with the aim of accelerating regulatory approval and expanding access to this novel treatment. Through joint efforts, Harvard Apparatus Regenerative Technology and the Children’s hospital Capital institute of Pediatrics in Beijing, China are committed to setting new standards of care in pediatric medicine.
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. 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.
HRGN has 13 issued U.S. patents, 2 issued in China, 1 issued in Japan, 2 issued in Europe and 2 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.
About Capital Institute of Pediatrics
The Children’s hospital Capital Institute of Pediatricians is a globally recognized leader in pediatric care, specializing in cutting-edge treatments and research for childhood diseases. The institute is dedicated to improving health outcomes for children through advanced medical solutions and compassionate care.
For more information, please visit https://www.shouer.com.cn/index.html
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 in this press release 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, which such success may not be achieved or obtained on a timely basis or at all. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, the Company’s inability to obtain needed funds in the immediate future; the Company's ability to obtain and maintain regulatory approval for its products; plus other factors described under the heading “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 or 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. The Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions or circumstances on which any such statement is based.
Investor Relations Contacts
Joseph Damasio
Chief Financial Officer
774-233-7330
jdamasio@hregen.com
FAQ
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