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Regenicin, Inc.
10 High Court
Little Falls, NJ 07424

**updated and correct phone number**  (973) 557-8914

 they filed this on aug 22 2016-  http://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=11558959  
 

   
Name: Randall McCoy
Title: Principal Executive Officer and Director
Date: August 22, 2016

 

   
Name: John J. Weber
Title: Principal Financial Officer and Director
Date: August 22, 2016


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FDA Issues Status Approval for PermaDerm®    sold to AMBS for 3,500,000$ in cash + 3,000,000$ in AMBS stocks

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.

COMPANY HIGHLIGHTS:

  • PermaDerm® is the only skin replacement technology to receive this Biological/drug designation
    Only 83million shares outstanding A/O May 18th, 2012
    Recently release their 10Q CLICK HERE TO VIEW
    PermaDerm 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.
    Cambrex Biosciences, the company that owned Cutanogen, which holds the license rights to PermaDermTM, to help in the regulatory process to gain FDA approval of PermaDermTM. When Lonza purchased Cambrex they also purchased Cutanogen. Lonza's core business is contract manufacturing of cell therapy bio medical products. They did not wish to pursue FDA approval or market the product. Mr. McCoy, understanding the value of the product and familiar with the regulatory process, offered to purchase the rights to the product. So we believe that Lonza entered into the Know-How and License Agreement (the "Agreement") because we have expertise in working with the FDA on the approval




 

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About PermaDerm

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.

home
 

For Burns

burn-1_380

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

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.


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.


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 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
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.


 

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)

Chris Hadsall

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



http://ih.advfn.com/p.php?pid=nmona&article=5144097

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RGIN News: Quarterly Report (10-q) 08/14/2018 03:23:07 PM
RGIN News: Quarterly Report (10-q) 05/21/2018 05:22:43 PM
RGIN News: Notification That Quarterly Report Will Be Submitted Late (nt 10-q) 05/15/2018 07:00:31 AM
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PostSubject
#2861   Not sure if this refers to the fact skept 10/22/18 05:44:48 PM
#2860   Can you guys explain what you see in hans gruber1 10/19/18 05:32:27 AM
#2859   Pretty sure that this confirms my previous allegations. What applevision 10/18/18 09:54:03 PM
#2858   https://www.bloomberg.com/research/stocks/people/person.asp?personId=30005877&pr Scotttrader80 10/17/18 11:40:35 AM
#2857   I see that people here are referring to skept 10/14/18 08:13:47 PM
#2856   Look at the filings, RGIN doesnt announce anything Scotttrader80 10/11/18 01:11:33 PM
#2855   This stock looks to be in bad shape. hans gruber1 10/10/18 10:10:18 AM
#2854   Scotttrader - that camel semen info has way skept 10/09/18 01:16:07 AM
#2853   This whole thing was a good thought to applevision 10/07/18 11:16:40 PM
#2852   Haha! hans gruber1 10/06/18 03:42:47 PM
#2851   That link doesnt work, but Yeah, McCoy is Scotttrader80 10/06/18 02:56:43 PM
#2850   I will admit, the lack of news for hans gruber1 10/05/18 08:33:27 AM
#2849   I think that was the idea Hans, but skept 10/04/18 10:25:59 PM
#2848   It seems to me that with the formation hans gruber1 10/04/18 08:34:44 AM
#2847   There are a couple broken relationships, this is huntman 10/03/18 09:12:12 PM
#2846   Not what I've heard Huntman... McCoy still skept 10/03/18 08:37:52 PM
#2845   Closed herd did not fall through in New huntman 10/03/18 05:42:40 PM
#2844   triple post sorry hans gruber1 10/03/18 02:39:54 PM
#2843   Hi guys. Been lurking for a while. hans gruber1 10/03/18 02:39:26 PM
#2842   hi guys long time lurker. Any thoughts hans gruber1 10/03/18 02:36:22 PM
#2841   You obviously do not have the current status updates... nidan7500 10/03/18 01:12:36 PM
#2840   You obviously do not have the current status updates..... trade2brich 10/02/18 08:13:47 PM
#2839   More volume at 3.3c..... skept 10/02/18 08:03:41 PM
#2838   That would apply to the prior day trades applevision 09/26/18 09:54:39 PM
#2837   13,500...not much of an exodus trade2brich 09/26/18 08:15:22 PM
#2836   And here comes the Exodus applevision 09/25/18 09:41:14 PM
#2835   To each is thier duty of diligence when applevision 09/16/18 11:20:44 PM
#2834   Yep, if the investment is "gambling" money, may skept 09/06/18 11:02:45 PM
#2833   Possibly, time will tell. Like I said before huntman 09/05/18 09:53:03 PM
#2832   I think applevision is more likely right. skept 09/05/18 08:22:56 PM
#2831   Applevision, you have the right to stay in huntman 09/05/18 05:32:28 PM
#2830   Just curious, anyone ever tell you that your nidan7500 09/05/18 09:40:44 AM
#2829   Nobody can be that nieve or uniformed. Google applevision 09/04/18 11:43:26 PM
#2828   I’ve been patient for several years now so nidan7500 08/27/18 04:28:05 PM
#2827   Thanks trade2brich 08/27/18 07:48:13 AM
#2826   No point to give up now. My understanding huntman 08/26/18 09:03:24 PM
#2825   Anybody? Hello? Have we given up? trade2brich 08/26/18 08:18:30 PM
#2824   When are we going to hear about these trade2brich 08/21/18 07:14:24 PM
#2823   Maybe things might start happening sooner rather than nidan7500 08/18/18 11:03:04 AM
#2822   Boy you sure won't get rich selling $600 configman 08/17/18 05:03:57 PM
#2821   Yep, par for the course, another filing saying skept 08/15/18 08:14:59 PM
#2820   From 10Q filed today. stk_maniac 08/14/18 10:52:48 PM
#2819   From 10Q filed today. stk_maniac 08/14/18 10:47:52 PM
#2818   Exactly. What a scumbag. Nearing the end of the applevision 08/14/18 10:16:06 PM
#2817   Volume is so low....looks like nobody is buying trade2brich 08/13/18 09:34:53 AM
#2816   Keep calm and don't sell message number 80 skept 08/12/18 05:32:36 PM
#2815   Does “positive things” mean funding is happening very trade2brich 08/08/18 06:40:38 PM
#2814   Very positive things are happening, keep calm Nicole1129 08/08/18 06:35:49 PM
#2813   Any updates or insight from anybody? trade2brich 08/02/18 10:07:59 AM
#2812   If you dig around enough you can find skept 07/30/18 07:29:26 PM
PostSubject