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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) 02/20/2018 02:51:52 PM
RGIN News: Amended Annual Report (10-k/a) 01/23/2018 04:39:44 PM
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
PlusOneCoin Top Posts
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PostSubject
#2545  Sticky Note New Zeland , Funding, IND , FDA,all great Nicole1129 11/01/17 02:39:02 AM
#2763   Whittling down shares slow and controlled dive to applevision 04/19/18 10:02:51 PM
#2762   Someone's keeping it floating. Question is why? applevision 04/17/18 09:47:10 PM
#2761   People are waking up to this scam. skept 04/15/18 03:39:55 PM
#2760   It's a fundamental shame that at this point applevision 04/12/18 09:31:47 PM
#2759   Don't hold your breath. There is nothing serious applevision 04/11/18 11:50:21 PM
#2758   Where is Nicole now? I am eagerly awaiting Scottmoney 04/11/18 03:55:11 PM
#2754   Should be a big day. Plenty of time applevision 04/08/18 11:06:55 PM
#2753   Is there a credible/plausible story on the current nidan7500 04/07/18 09:03:57 AM
#2751   This is dodgy and getting dodgier..... skept 04/04/18 06:17:30 PM
#2750   Yup .. 1st of the month. Bills applevision 04/03/18 09:10:03 PM
#2749   Somebody dig a hole. This dog is dead. applevision 03/30/18 09:10:32 PM
#2746   So your leading investors to believe that the applevision 03/27/18 11:24:08 PM
#2742   Your certainty has shifted. You don't seem to applevision 03/21/18 11:34:15 PM
#2741   Randy nows exactly what has to be done, Nicole1129 03/20/18 12:52:56 PM
#2740   Not quite the end of the month. Randy applevision 03/15/18 11:38:07 PM
#2739   Nicole where are you. We are hanging wags7820 03/15/18 07:23:06 PM
#2738   Just wait everyone, dont overreact. Nicole/Randy will skept 03/14/18 05:08:36 PM
#2737   Nicole seems to be way off with her analysis Scottmoney 03/14/18 09:41:00 AM
#2736   Wow lots of action.... Complete spiral downward. All applevision 03/13/18 08:51:43 PM
#2735   From a technical standpoint, its hard to say nwsun 03/04/18 06:25:56 PM
#2734   RGIN trades in the whackiest of ways. Some Scotttrader80 03/04/18 12:55:14 PM
#2733   How were they able to get a huge nwsun 03/04/18 11:31:14 AM
#2731   Overview As we move into 2018, the Company will stk_maniac 03/04/18 10:34:11 AM
#2730   That big trade is possibly a Broadsmoore or skept 03/01/18 05:50:26 PM
#2729   Eventually a Q will surface detailing the news Scotttrader80 03/01/18 03:17:55 PM
#2728   Thanks, I bought back in. nwsun 03/01/18 02:48:39 PM
#2727   No idea, someone has been hawking for months Scotttrader80 03/01/18 02:01:37 PM
#2726   Anybody know what was behind all that volume nwsun 03/01/18 01:26:06 PM
#2725   This thing is dead in the water and applevision 02/27/18 11:32:39 PM
#2724   Maybe someday RGIN shareholders will get a PR Scotttrader80 02/27/18 09:45:17 AM
#2723   Righto Randall/Nicole. Promise number 89. skept 02/26/18 06:03:37 PM
#2720   Big Bucks Coming Nicole1129 02/23/18 07:55:44 AM
#2719   Good Volume for a Thursday in Regenicin land. Scotttrader80 02/22/18 10:44:59 PM
#2718   Maybe Nicole is cashing in roadside cans, she Scotttrader80 02/20/18 06:38:02 PM
#2717   Just a photocopy of the last 20 odd skept 02/20/18 04:31:45 PM
#2716   OK...Now What? They say they need $$$ nidan7500 02/20/18 03:38:48 PM
#2715   Ammended Annual Report(period ending Sep 2017) filed with stk_maniac 02/06/18 09:51:39 PM
#2714   A miracle skept 02/06/18 05:06:47 PM
#2713   What will it take to get RGIN to $2.00? nidan7500 02/06/18 04:45:19 PM
#2712   I see that last post refers to a skept 02/01/18 06:43:31 PM
#2711   if i am reading correctly if Amarantus decide stk_maniac 01/30/18 09:49:09 PM
#2710   http://scheduleatxwest.designnews.com/session/design-for-demand-the-creation-of- stk_maniac 01/30/18 09:35:05 PM
#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
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