LITTLE FALLS, N.J., June 12, 2012 /PRNewswire/ -- Regenicin, Inc. (OTC Bulletin Board: RGIN) a biotechnology company specializing in the development of and commercialization of regenerative cell therapies to restore the health of damaged tissues and organs, announced today that the Food and Drug Administration (FDA) has granted Orphan Status approval for the PermaDerm® product, the only tissue-engineered skin prepared from autologous (patient's own) skin cells consisting of both epidermal and dermal layers, that is indicated for catastrophic burn patients. The FDA had previously designated PermaDerm® to be a biological/drug (permanent skin replacement) not a medical device (temporary skin replacement). PermaDerm® is the only skin replacement technology to receive this Biological/drug designation.
PermaDerm™ is being developed to be the only tissue-engineered skin prepared from autologous (patient's own) skin cells consisting of both epidermal and dermal layers. A small harvested section of the patient's own skin can be grown to graft an area one hundred times its size in as little as thirty days.
These living, self-to-self skin graft tissue are intended to form permanent skin tissue that will not be rejected by the immune system of the patient, a critical possibility in porcine or cadaver skin grafts used today.
The technology has been clinically tested in over 150 pediatric, catastrophic burn patients. Currently Regenicin is working with its contract manufacturer to prepare for pre-market approval of PermaDerm™ from the FDA.
PermaDerm™ is being designed to save lives, reduce healthcare costs by decreasing the patient's stay in the Critical Care Unit and reduce the need for additional surgeries. An insurance company procedural code has been approved for reimbursement of costs to hospitals. The American Medical Association has assigned CPT (Current Procedural Terminology) code for cultured skin substitutes under the dermal substitute category which enables insurance companies to process and hospitals to be reimbursed for cultured skin substitutes once approved by the FDA.
According to the American Burn Association, there are currently over 2,000 cases annually involving burns covering over 50% of the patient's total body surface area.
PermaDerm™ is being developed for the treatment of catastrophic, full-thickness burns covering over 50% of the total body surface area.
PermaDerm™ has been used in clinical trials on pediatric patients with catastrophic burns covering from 50 to 90+% of their body.
PermaDerm™ is being developed to require less donor skin from the patient's own body, thus needing fewer surgeries to harvest skin. The result is expected to be less scarring, with fewer infections and faster healing.
Board of Directors
Chief Executive Officer
Randall McCoy has more than 37 years of experience in the healthcare industry. His experience includes executive positions and scientific research and development. His previous employment includes George Washington University, Temple University Medical School and RCA/SRI International (Director of Life Sciences and Electronic Displays). Mr. McCoy has assisted both small and major pharmaceutical/device companies address FDA issues. He has also helped over 225 foreign and domestic companies introduce their FDA regulated drug and medical device products into the US and World market. Mr. McCoy currently has over 30 Patents US and International.
Changed to AMBS
Dr. Joseph Rubinfeld Ph.D
Director at CytRX; Initial Co-Founder of Amgen, Inc.
Dr. Joseph Rubinfeld co-founded SuperGen, Inc. in 1991 and has served as its Chief Executive Officer and President, Chief Scientific Officer and as a director. He has been a director of CytRX since July 2002. Dr. Rubinfeld is also a founder of JJ Pharma. Dr. Rubinfeld was one of the four initial founders of Amgen, Inc. in 1980 and served as a Vice President and its Chief of Operations until 1983. From 1987 until 1990, Dr. Rubinfeld was a Senior Director at Cetus Corporation and from 1968 to 1980, Dr. Rubinfeld was employed at Bristol-Myers Company. Dr. Rubinfeld received a B.S. degree in chemistry from C.C.N.Y. and an M.A. and Ph.D in chemistry from Columbia University.
Regenicin™'s Interim CFO
John Weber most recently served as Executive Vice President of Fujifilm USA, the highest ranked American corporate officer, from 2006 until his departure in 2009. His responsibilities included overseeing all corporate activity with the exception of R&D. During that time Fujifilm was ranked as the fastest growing medical imaging company, consistently ranking #1 or #2 in customer satisfaction. From 1998 through 2006 he served as Senior Vice President, Operations at Fujifilm USA where he spearheaded the transition of the company from a film distributor to a digital medical informatics company. From 1986 until 1998 he served as CFO where he helped to profitably manage Fuji's growth from an employee base of 75 to over 1,000. Prior to his distinguished career at Fujifilm USA, Mr. Weber served as the CFO for the confectionary and drinks division of Cadbury Schweppes Limited for three years and as Corporate Controller for an additional five years.
Dr. Craig Eagle
Dr. Craig Eagle joined Pfizer Australia in 2001 as part of the medical group. In Australia, his role involved leading and participating in scientific research, regulatory and pricing & re-imbursement negotiations for compounds in therapeutic areas including oncology, anti-infectives, respiratory, arthritis and pain management. In 2003, Pfizer relocated Dr. Eagle to the United States where he was appointed as the worldwide lead for development of Celecoxib in oncology to oversee the global research program. Since that time he has had increasing responsibility for overseeing the global research plans and teams for Irinotecan and Dalteparin. In 2007, he became head of Medical Affairs and Outcomes Research for Pfizer, including the US oncology business. Dr. Eagle has led, or been directly involved with, teams that resulted in eight new products or indications. As part of his current role at Pfizer, he has led the integration of the Pfizer/Wyeth oncology businesses and portfolio.
Beneficial Owner Number of shares beneficially owned (1) Percentage owned (2)
Officers and Directors
Randall McCoy 33,727,313(3)
John J. Weber 935,672(4)
Joseph Rubinfeld 1,935,672(5)
Craig Eagle 935,672(6)
Officers and Directors collectively 37,514,329(7)
5 Percent Shareholders
The Broadsmoore Group, LLC 9,223,770(8)
560 Lexington Ave., 16 th Fl.
New York, NY 10022
PDA Associates LLC 7,770,000(9)
560 Lexington Ave., 16 th Fl.
New York, NY 10022
Officers, directors and 5 percent shareholders collectively 54,508,099(10) 59.74%
* Less than 1%
(1) Unless otherwise indicated, each person or entity named in the table has sole voting power and investment power (or shares that power with that person's spouse) with respect to all shares of common stock listed as owned by that person or entity.
(2) A total of 83,807,964 shares of the Company's common stock are considered to be outstanding pursuant to Rule 13d-3(d)(1) under the Securities Exchange Act of 1934.
(3) Includes 32,821,641 shares of common stock held in his name and options to purchase 885,672 shares of common stock.
(4) Includes 50,000 shares of common stock held in his name and options to purchase 885,672 shares of common stock,
(5) Includes 1,050,000 shares of common stock held in his name and options to purchase 885,672 shares of common stock
(6) Includes 50,000 shares of common stock held in his name and options to purchase 885,672 shares of common stock,
(7) Includes 33,971,641 shares of common stock, options to purchase 3,542,688 shares of common stock and shares of Series A Convertible Preferred Stock convertible into 3,350,000 shares of common stock,
(8) Includes 5,706,270 shares of common stock held in its name, warrants to purchase 167,500 shares of common stock and shares of Series A Convertible Preferred Stock convertible into 3,350,000 shares of common stock,
(9) Includes 7,400,000 shares of common stock held in its name and warrants to purchase 370,000 shares of common stock,
(10) Includes 47,077,911 shares of common stock, warrants to purchase 537,500 shares of common stock, options to purchase 3,542,688 shares of common stock and shares of Series A Convertible Preferred Stock convertible into 3,350,000 shares of common stock