-- 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.

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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