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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.

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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: Annual Report (10-k) 01/16/2018 03:16:02 PM
RGIN News: Notification That Annual Report Will Be Submitted Late (nt 10-k) 12/29/2017 06:15:03 AM
RGIN News: Quarterly Report (10-q) 08/10/2017 12:55:19 PM
RGIN News: Current Report Filing (8-k) 08/08/2017 02:50:00 PM
PostSubject
#2545  Sticky Note New Zeland , Funding, IND , FDA,all great Nicole1129 11/01/17 02:39:02 AM
#2709   Ah what a surprise.... Whole lot of skept 01/21/18 03:26:43 PM
#2707   Has "no time" come and gone, its difficult Scotttrader80 01/20/18 11:48:25 AM
#2706   Here you go Wag/Nip, as I said earlier Scotttrader80 01/19/18 12:06:39 AM
#2705   Scott...yes, pls post the pR..thx nidan7500 01/18/18 03:20:48 PM
#2704   Scott...put up the link to the pr twitter wags7820 01/18/18 02:28:29 PM
#2703   Dont wait too long, he put out a Scotttrader80 01/18/18 01:48:15 PM
#2702   That sounds like a good move...I may do wags7820 01/18/18 01:39:45 PM
#2701   Im not familiar with funding for cultured skin Scotttrader80 01/18/18 11:23:38 AM
#2700   Well what have I learned...How is it that wags7820 01/18/18 11:19:15 AM
#2699   If McCoy holds true to his pattern he'll Scotttrader80 01/18/18 10:16:36 AM
#2698   Scott, looks like we need a partner w/an nidan7500 01/18/18 10:13:43 AM
#2696   As I suspected, Scotttrader80 01/17/18 01:03:09 PM
#2695   We'll see how the market views their "milestones" Scotttrader80 01/16/18 04:57:39 PM
#2694   10K is out Jesse411 01/16/18 03:32:12 PM
#2693   Regenicin's 10K is due this week, with a Scotttrader80 01/15/18 11:41:32 PM
#2692   Hahahahahaha Winthorpe! He has 10 business days to Scotttrader80 01/11/18 10:43:18 AM
#2691   When does Mccoy have to put the reports wags7820 01/11/18 10:37:18 AM
#2690   Lets see which it is: skept 01/10/18 06:25:47 PM
#2687   Guaranteed Money Money Money Funding Coming Up Nicole1129 01/09/18 03:43:44 AM
#2686   1 week left for McCoy to submit his Scotttrader80 01/08/18 04:34:05 PM
#2685   Dead right. So the link you posted skept 01/07/18 03:35:08 PM
#2684   United States Partner Companies Scotttrader80 01/05/18 12:03:54 AM
#2682   Here is some basic info. The site skept 01/04/18 08:07:21 PM
#2681   Prove it Scotttrader80 01/04/18 07:11:13 PM
#2680   These are the people and plant at Hikurangi skept 01/04/18 04:17:09 PM
#2679   This needs some follow up; Scotttrader80 01/04/18 04:05:01 AM
#2678   It’s Going To Be A Great 2018 Huge Nicole1129 01/03/18 11:34:39 PM
#2677   Yep, agree with most of that except they skept 01/03/18 09:23:01 PM
#2676   There are so many moving parts. Jesse411 01/03/18 09:00:03 PM
#2675   Had a little more info from NZ, - skept 01/03/18 04:26:54 PM
#2674   Thx...I am reading it as positive also...2 wks nidan7500 12/29/17 09:40:35 AM
#2673   Typically NT's have 2 weeks to file before Scotttrader80 12/29/17 09:36:51 AM
#2672   Anyone see the extension date? New due date nidan7500 12/29/17 08:17:40 AM
#2671   Extension granted... nidan7500 12/29/17 08:02:10 AM
#2670   a trickle of volume. McCoy hasnt deployed his Scotttrader80 12/28/17 11:09:24 PM
#2669   You must be kidding. applevision 12/28/17 12:30:20 AM
#2668   This stock is opening some eyes... wags7820 12/27/17 07:59:29 PM
#2667   I'm good thanks anyways nidan7500 12/26/17 02:56:25 PM
#2666   Want to buy my shares? nwsun 12/26/17 02:27:10 PM
#2665   Huh, over the past year or so we nidan7500 12/26/17 02:24:20 PM
#2664   My take is this...for the last three to wags7820 12/26/17 02:23:45 PM
#2663   From a technical setup, its not the best nwsun 12/26/17 01:38:23 PM
#2662   Any thoughts on recent price/volume activities? nidan7500 12/26/17 11:06:04 AM
#2661   Santa McCoy needs a new GPS cause he Scotttrader80 12/25/17 09:53:22 PM
#2660   According to you, lol and youre who 2 Scotttrader80 12/22/17 05:25:31 AM
#2659   If true, that's insider information and posted and nwsun 12/22/17 12:02:47 AM
#2658   I'm pretty cautious about the so called good skept 12/21/17 09:17:35 PM
#2657   Jessie, great info. Thanks buddy...keep us all posted wags7820 12/21/17 07:38:35 PM
#2656   No one really knows where this will go. Jesse411 12/21/17 07:00:57 PM
#2655   Great insight Jesse. What do you think wags7820 12/21/17 05:06:04 PM
PostSubject