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

Potential breakthrough technology for stem-cell based bone replacement

NEW YORKMay 22, 2019 /PRNewswire/ — 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.

SOURCE EpiBone, Inc.

CONTACT: Blake Wheeler, blake@epibone.com

Web Site: https://www.epibone.com/

About Peter Coffaro 510 Articles
Peter Coffaro is a growth-driven and strategic executive with over 25 years of progressive management success in the medical device industry. With a proven track record and recognized expertise, Peter has established himself as one of the top influencers in medical sales, as acknowledged by prestigious publications such as the World Journal of Orthopedics, Exponential Healthtech, and MedReps.com. Throughout his career, Peter has accumulated 10 years of combined sales management experience, excelling in various roles including Director, General Manager, Distributor, and Vice President. He has worked for industry-leading orthopedic companies such as Zimmer, DePuy, and Stryker, solidifying his deep knowledge and network within the field. Peter’s passion for innovation and emerging technologies led him to found OrthoFeed, an award-winning blog covering digital orthopedic news and emerging medical technologies. Through this platform, he stays at the forefront of the industry and contributes to the dissemination of valuable insights. Peter is a three-time Hall of Fame award winner at Johnson and Johnson, demonstrating his exceptional contributions and impact on the organization. His expertise extends to areas such as organizational development, business development, sales management, digital marketing, and professional education. Peter earned a B.S. degree in Biology and Chemistry from Northern Illinois University, further complementing his comprehensive understanding of the medical field. With his wealth of experience, strategic mindset, and dedication to advancing healthcare, Peter Coffaro is a valuable asset and leader in the medical device industry.

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