Regenicin Inc.RGIN

Regenicin, Inc., (OTC Bulletin Board: RGIN.OB) is a biotechnology company specializing in the development of regenerative cell therapies to restore the health of damaged tissues and organs. Regenicin, which was founded in 2010, has assembled a world class management team with a proven track record for developing and bringing innovative medical devices and biotechnology products to market. Regenicin is currently working to bring the product candidate, PermaDerm™, to market.  PermaDerm™ is an exciting breakthrough technology that uses the patient’s own skin cells to generate living, tissue-engineered skin for the treatment of chronic burns and wounds. The company is publicly traded with headquarters in  New Jersey. http://www.regenicin.com

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.

Overview

PermaDerm™ is composed of cultured fibroblast and kerotinocytes on an absorbable collagen substrate (biomedical polymer) that produces a living skin substitute that contains both epidermal and dermal components. This model has been shown in preclinical studies to generate a functional skin barrier and in clinical studies to promote closure and healing of burns.

A small full thickness section of skin is harvested from the patient.  Skin cells (kerotinocytes and fibroblasts) are then isolated from the harvested section in the cell therapy facility and cultured separately in nutrient media in order to expand the cell populations.  Cell expansion in the cell therapy facility allows for the production of a large number of grafts from a small harvested section from the patient.  The cells are then combined with the proprietary biopolymer substrate which is fabricated from collagen.  Cells organize themselves on the biopolymer to ultimately mimic the structure of normal skin.  The final skin product would be shipped to the clinical site and surgically grafted onto the burned areas of the patient.

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.

Management Team


Randall McCoy
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.

John Weber
Interim CFO
John Weber most recently served as Executive Vice President of Fujifilm Medical Systems 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 Fujifilm's growth from an employee base of 75 to over 1,000. Prior to his distinguished career at Fujifilm Medical Systems 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.

Chris Hadsall
Chief Operating Officer
Chris Hadsall is a 10-year veteran of the United States Marine Corps. He took a break from the profit world to start and run the VET Foundation. In his role as the Executive Director of the VET Foundation Chris designed, developed and implemented a holistic reintegration program teaching wounded, ill and injured veterans a life altering transition methodology. Chris was also responsible for the financial health of the organization and served as the chief fundraiser. Prior to starting the VET Foundation Chris worked as a Regional Manager for Professional Staffing ABTS. In that role Chris guided the day-to-day operations, business development, and customer relations for a major West Coast Expansion. He was promoted to that job after a successful stand up of a division inside Professional Staffing ABTS that focused on hiring returning Veterans from Iraq and Afghanistan. He also was responsible for managing community relations and outreach for the Company.

Richard Koeninger
Director of Regulatory Affairs
Richard Koeninger has 29 years as a Field Investigator, Drug and Device Specialist with The US Food and Drug Administration. His duties overseas included Associate Director for the Division of Emergency and Investigational Operations, Criminal Investigator, Compliance Officer and Resident in Charge. Mr. Koeninger has served on clinical trials Institutional Review Boards (IRB) and has conducted FDA pre-approval medical device and pharmaceutical investigations. While at the FDA, Mr. Koeninger held the distinction of being the International FDA Expert for Drugs and Devices.

Lauri-Ann Hahn R.N., B.S.N.
Director of Clinical Trials
Lauri Hahn has been involved with clinical trials/research since 1998. She has developed and trained Good Clinical Practices quality systems. Lauri is experienced in all areas of Clinical Research from planning and conducting studies to Clinical Report submissions to the FDA. Lauri served as Associate Director of Clinical Trials/Senior Project Manager for Lonza Walkersville, Inc. (an affiliate of Lonza Group Ltd.) from 2006 to 2008 wherein she gained direct experience working with the Cultured Skin Substitute. Prior to working at Lonza, Lauri work at the National Institutes of Health (NIH). From 2001 to 2005, Ms. Hahn was the Head of Clinical Research at the University of Pittsburgh Department of Urology. Lauri has held positions as a Sponsor, a member of a Clinical Research Organization and Clinical Sub-Investigator. She graduated from the University of Pittsburgh in 1993 with a Bachelors of Science Degree in Nursing.

Robert O. Baratta, M.D
Vice President of Business Development
Robert O. Baratta, M.D. is Chief Executive Officer of Ascent Surgical Partners and was previously chairman and chief executive officer of Ascent, L.L.C. headquartered in Stuart FL. Prior to joining Ascent, L.L.C. in 2004, Dr. Baratta was president, chief executive officer and vice chairman of the board of directors of Ecosphere Technologies, Inc., formerly known as UltraStrip Systems, Inc. ("Ecosphere"), an environmentally protective marine industrial company. Prior to joining Ecosphere in 2001, Dr. Baratta engaged in the private practice of ophthalmology in Stuart, Florida, where he served as president and chairman of the board of directors of Stuart Eye Institute. Dr. Baratta began practicing medicine in 1973. He has served as a director of the FPIC Insurance Company (FPIC:NASDAQ) since its formation in 1996 and served as Chairman of the Board of Directors from 1999 until May 2007. Dr. Baratta currently serves as Immediate Past Chairman of the Board of Directors. Dr. Baratta also served as a director of First Professionals Insurance Company from 1993 to 2000. He has owned and managed surgery centers for 25 years. He worked as a surgeon in a surgery center and understands the needs of the surgeon as well as the essentials of a successful center.

Board of Directors


Randall McCoy
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.

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.

John Weber
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 1986until 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
Pfizer Oncology
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.

Stock Information

http://www.regenicin.com/Investor-Relations/S...index.html