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Animal Studies Show Ortec's Fibrin Microbeads Recover Up To Four Times The Number Of Stem Cells As Conventional Methods

September 26, 2017

Ortec International, Inc. (OTC Bulletin Board: ORTN), a company focused on development and commercialization of products applicable to regenerative medicine and stem cell therapy, today announced that an article, entitled "High yield isolation expansion and differentiation of rat bone-marrow-derived Mesenchymal Stem Cells with Fibrin Microbeads (FMB)," will appear in the August edition of the peer-reviewed journal, Tissue Engineering. The article describes results of experiments in a rat model demonstrating that Ortec's Fibrin Microbeads (FMB) technology increases by nearly fourfold the yield of Mesenchymal Stem Cells recovered from bone marrow.

The article details the results of eight experiments, conducted at Hadassah Hebrew University Medical Center, Jerusalem, which evaluated the use of FMB as a matrix for efficient isolation of Mesenchymal Stem Cells from rat bone marrow. The results indicate that the yield of the cells isolated by FMB was three to four times greater than that obtained by use of conventional methods. The results also show that the cells isolated by FMB could be expanded in culture for more than four months and could be differentiated into bone, fat and cartilage cells. Differentiation was accomplished equally well on plastic or directly on the FMB without the need to download onto plastic as required in current stem cell technologies, greatly simplifying this process.

Ron Lipstein, Ortec's Vice Chairman and CEO, commented, "The ability of FMB to isolate four times more Mesenchymal Stem Cells is quite significant, because current methods of isolating Mesenchymal Stem Cells from bone marrow in many cases are not sufficient to generate the amount of cells needed to be therapeutically effective. FMB also demonstrated the ability to allow the isolated stems cells to grow and differentiate while remaining on the FMB, further supporting our belief that FMB is a unique matrix for the isolation and differentiation of adult stems cells. These soon to be published results, combined with recently announced published results showing the ability of FMB to isolate adult Mesenchymal Stem Cells from blood, position FMB to significantly advance and enable autologus adult stem cell therapy."

Continuing, Lipstein noted, "These findings help to further support and validate Ortec's decision to expand its technology platform in the field of regenerative medicine, and specifically in the area of stem cell therapy. We are highly encouraged by these results and the promising therapeutic implications of FMB, and look forward to pursuing the full realization of this potential."

About Ortec International, Inc.

Ortec International, Inc. (ORTN) is a company focused on advancing regenerative medicine and stem cell therapy through the development and commercialization of innovative products by combining advanced cell technology and advanced biomaterials. Ortec's lead product is OrCel(R) (Bilayered Cellular Matrix). Ortec's current focus is the application of OrCel(R) to heal chronic and acute wounds. OrCel(R) is composed of a collagen sponge seeded with allogeneic epidermal and dermal cells. These cells secrete growth factors and cytokines normally found in acute human wounds and are believed to have a beneficial role in promoting tissue repair.

A pivotal clinical trial evaluating a cryopreserved version of OrCel(R) in the treatment of venous leg ulcers has been completed and a Pre Market Approval (PMA) application has been filed. Ortec has recently completed patient enrollment in a confirmatory trial and the data from this trial are expected to be integrated with the results of the pivotal clinical trial and submitted as a clinical supplement to its PMA filing. Ortec has already obtained FDA approvals for use of a non-frozen version of OrCel(R) in the treatment of Epidermolysis Bullosa and donor sites in burn patients. In addition, the FDA has granted Ortec approval to initiate a pivotal (Phase III) trial evaluating OrCel(R) for the treatment of diabetic foot ulcers.

Ortec recently acquired two fibrin derived advanced biomaterial technologies, Fibrin Microbeads (FMB) and Haptides(TM). FMB have the potential to play a significant role in advancing stem cell therapy having demonstrated the ability to efficiently recover adult stem cells and allow for their growth, proliferation, and potential reimplantation into the patient. Haptides(TM) utilize proprietary synthetic peptides that mimic the mechanism of cell attachment to fibrin. These peptides have demonstrated the ability to significantly enhance cell attraction and attachment providing the potential to use Haptides(TM) in the development of product opportunities applicable to the cosmetic tissue augmentation, wound healing, orthopedics, and drug delivery markets. For more information, visit Ortec's website at ortecinternational .

This news release may contain "forward-looking statements" for the purposes of the United States Securities and Exchange Commission's "safe harbor" provisions under the Private Securities Litigation Reform Act of 1995 and Rule 3B-6 under The Exchange Act. Without limitation, statements regarding expected FDA approvals, clinical trial results, product performance, expectations with respect to sales, gross margins, research and development expenditures, earnings per share, capital expenditures, collaborations, or other expansion opportunities would be "forward-looking statements." These statements may be identified by words such as "expects," "anticipates," "intends," "estimates, "believes" or similar expressions in connection with any discussion of future financial and operating performance. The forward- looking statements contained herein involve risks and uncertainties that may cause results to differ materially from the Company's expectations including but not limited to, global economic trends, competitive pricing or product developments, government legislation and/or regulations, technology, manufacturing, legal and patent issues, suppliers, capital availability, personnel changes, cancellation or delays in renewal of contracts, and lack of suitable raw materials or packaging materials. Investors are cautioned to review risk factors in the Company's filings with the United States Securities and Exchange Commission.

Ortec International, Inc.
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