EpiBone, Inc. Receives FDA Clearance to Commence its First-In-Human, Phase 1/2 Trial of its Bone Product, EB-CMF

General Press Releases Thursday May 23, 2019 08:15
NEW YORK--23 May--PRNewswire/InfoQuest
  • Potential breakthrough technology for stem-cell based bone replacement

EpiBone, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted its Investigational New Drug (IND) clearance to proceed with a Phase 1/2 clinical trial of its lead bone product EpiBone-Craniomaxillofacial (EB-CMF), as a potential treatment for ramus continuity defects in the mandible. The ramus is a key component of the jaw bone which attaches to the muscles associated with chewing.

EB-CMF is a living anatomically correct bone graft manufactured from a patient's own adipose derived stem cells. This eliminates the need to harvest bone from a patient's body, potentially reducing pain, surgical and hospitalization time while creating a precision fit with the defect.

"We are proud of the work that has been put into this IND, and are grateful to our entire team, as well as all our investors, consultants, and champions in the field who have made this possible," commented Dr. Nina Tandon, CEO and Co-Founder of EpiBone. "Our technology has the potential to change the field of skeletal reconstruction as we know it. Our goal is to help as many patients as we can to regain optimal form and function, in the most seamless, long-term, and natural way possible."

The Phase 1/2 clinical study will evaluate the EB-CMF product directly in patients with mandibular ramus continuity defects which require reconstruction. In addition to the primary safety of EB-CMF, the study is also designed to demonstrate the effectiveness of EB-CMF in bone reconstruction in addition to integration with the native tissue. The company expects to enroll 6 patients in this study. The company hopes this study will inform the exploration of other potential indications for other facial reconstructive surgeries requiring bone grafts, as well as studies for cartilage replacement in the knee, and other areas of the body.

About EpiBone

EpiBone, Inc. is privately-held regenerative medicine company focused on skeletal reconstruction. Sitting at the intersection of biology and engineering, the company harnesses the power of a patient's own cells to create living solutions that become a seamless part of a patient's body. EpiBone is currently developing a pipeline of bone, cartilage, and compound (bone and cartilage) products.

For more information, please visit: https://www.epibone.com/
Disclaimer

This communication contains forward-looking statements which can generally can be identified by words such as "plans," "change," "will," "following", "strengthening," "developing, the negative of these words and similar words and expressions, which are based on EpiBone's current expectations, assumptions, estimates and projections about its business, technology, product development and industry. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and include, without limitation, EpiBone's ability to (1) adequately protect or enforce its intellectual property rights, (2) develop and commercialize new products and technologies on a timely basis (or at all), (3) risks associated with acquisitions and strategic investments and (4) attract and retain qualified personnel. Accordingly, you are cautioned not to place undue reliance on such forward-looking statements. Additionally, this communication does not constitute an offer to sell or a solicitation of an offer to buy securities.

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