Regenicin, Inc. Obtains Sufficient Funding from Product Pre-Sales to Begin Engineering Runs on NovaDerm Manufacturing
LITTLE FALLS, NJ, UNITED STATES, May 16, 2024 /EINPresswire.com/ -- Regenicin, Inc. obtains sufficient funding from product pre-sales to begin engineering runs on NovaDerm manufacturing
With the completion of several limited product presales at the end of last year, Regenicin, Inc. has engaged Minaris Regenerative Medicine to manufacture its NovaDerm product and assist in preparing its module 3, manufacturing section of its planned IND filing with the FDA. Currently, the company is working with Minaris on transfer runs leading to full engineering runs planned for May 2024. Assuming the success of these engineering runs and its required pre-clinical experiments, the company plans to complete and file an IND in order to begin its NovaDerm® Clinical Trials.
NovaDerm®
Our first cultured skin substitute product candidate, NovaDerm®, is a multi-layered, autologous, cultured living skin product that contains both epidermal and dermal components with a collagen base. Because this product is a self-to-self skin graft, we believe that it will not be rejected by the patient’s immune system like porcine or cadaver cellular grafts. Such immune system rejection is a serious concern in Xeno-transplant procedures which have a cellular component. Moreover, the use of our uniquely designed Cultured Skin Substitute (CSS) should not require any specialized physician training because it is applied in the same manner as used in a standard split thickness allograft procedure. Unlike split thickness allograft skin, however, NovaDerm® will not require a large skin harvest and is not as limited in coverage area. Typical allograft skin replacement is limited to covering an area only 2 to 4 times its original size while NovaDerm® is expected to expand in excess of 100 times its original skin coverage. This results in a substantial advantage for injured patients, especially those with larger sections of full thickness burns where there is simply not enough healthy skin available on the patient to harvest and repair the damaged area.
Further information will be made available as events develop.
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Scott A Blow
REGENICIN INC
+1 800-211-6348
email us here
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