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Regenicin, Inc (RGIN)

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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) 08/10/2017 12:55:19 PM
RGIN News: Current Report Filing (8-k) 08/08/2017 02:50:00 PM
RGIN News: Quarterly Report (10-q) 05/17/2017 03:37:10 PM
RGIN News: Notification That Quarterly Report Will Be Submitted Late (nt 10-q) 05/15/2017 05:59:30 PM
PostSubject
#2517   Thats is wonderful news Nicole1129, by chance, what Scotttrader80 10/22/17 02:56:09 AM
#2516   There is about 10 million in funding coming Nicole1129 10/20/17 09:05:32 PM
#2515   Anyone have an idea on status of IND nidan7500 10/20/17 11:16:23 AM
#2514   Grtherd...thanks for reply. Any thoughts on status of nidan7500 10/20/17 09:04:17 AM
#2513   $$$$$$$$$$$ Nicole1129 10/20/17 04:06:59 AM
#2512   Guys there is big big news coming out Nicole1129 10/20/17 02:35:15 AM
#2511   Hi Randy, grtherd 10/17/17 10:35:25 PM
#2508   Hello out there, grtherd 10/16/17 10:22:18 PM
#2507   Yes, I called one time...I think I spoke w/him nidan7500 10/05/17 04:40:19 PM
#2506   I really cant say since I dont know Scotttrader80 10/03/17 10:25:06 AM
#2505   Scott...any guess on timing? It will not take nidan7500 10/03/17 07:53:41 AM
#2504   I havent paid attention since I sold but Scotttrader80 09/27/17 12:04:49 AM
#2503   Clocks ticking.,...... Lack of input and info will applevision 09/26/17 09:57:08 PM
#2502   Sold the .055's when RGIN hit .13, looks Scotttrader80 08/20/17 10:13:25 AM
#2501   Is RGIN static b/c we await new FDA nidan7500 08/08/17 11:06:11 AM
#2500   They already have orphan drug designation.Funding for phase2 stk_maniac 07/03/17 02:14:37 PM
#2499   https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm565148.htm Th nidan7500 07/03/17 09:50:06 AM
#2498   Skin...appreciate the new information. I would normally be nidan7500 06/22/17 05:23:23 PM
#2497   I am surprised that no one picked up skin of my teeth 06/22/17 03:12:12 PM
#2496   I am and remain a believer. Just need nidan7500 06/20/17 07:56:07 AM
#2495   This will turn and run up shortly. Needs applevision 06/14/17 08:56:13 PM
#2494   Nothing on specific direction or data dump. Ya applevision 06/14/17 01:27:03 AM
#2493   Apple...hope you are right. I have confidence in nidan7500 06/12/17 08:48:33 AM
#2492   Things will be looking up soon.. Milestones to applevision 06/11/17 10:12:42 PM
#2491   No idea, 400 shares traded isnt a sign Scotttrader80 06/04/17 08:33:21 PM
#2490   Anyone know why this thing poped 40% today? nidan7500 05/31/17 05:15:47 PM
#2489   When is this stinker going to grow some legs? Scotttrader80 05/04/17 10:07:44 PM
#2488   Still holding above 12. applevision 04/18/17 09:31:16 PM
#2487   Don't let those sneaky market makers steal shares Jesse411 03/29/17 06:50:35 PM
#2486   Again.. sshhh. This is long haul. There is applevision 03/29/17 01:02:16 AM
#2485   Anyone have ANY news?!? WAY TOO QUIET! Currytime316 03/26/17 02:47:50 PM
#2484   Ssshhhh. Everybody's busy working... Pass it on. applevision 03/17/17 09:22:50 PM
#2483   why are there no new messages here? JFK1 03/13/17 12:58:49 AM
#2482   aggressive buyer this morning - news out soon shurtha2000 02/21/17 09:48:15 AM
#2481   Surprisingly no uptick on the positive positioning and applevision 02/06/17 10:42:37 PM
#2480   Gotta stop flipping and let this one ride shurtha2000 01/19/17 12:31:08 AM
#2479   Regenicin Reports 2016 Operating Results, Outlines Milestones for 2017 stk_maniac 01/18/17 09:13:15 PM
#2478   Here are other companies in 10K, either bought Jesse411 01/18/17 07:45:11 PM
#2477   in some -looking real good shurtha2000 01/18/17 11:45:36 AM
#2476   Interesting. Upturn and stable hold. applevision 01/13/17 12:00:45 AM
#2475   Being accumulated shurtha2000 12/13/16 10:02:46 AM
#2474   bids stacked shurtha2000 12/12/16 11:09:48 AM
#2473   picked up some more at 10 shurtha2000 12/12/16 09:50:04 AM
#2472   RGIN bullish 0.10 stocktrademan 12/11/16 03:12:13 PM
#2471   Stealth climb shurtha2000 12/10/16 10:18:20 PM
#2470   Regenicin Signs Supplier Agreement with Pure Med Farma stk_maniac 11/21/16 08:36:30 AM
#2469   "Our agreement with the FDA on the Scotttrader80 11/15/16 11:53:36 AM
#2468   Regenicin, Inc. Completes Successful Pre-IND Meeting with Food stk_maniac 11/02/16 09:31:51 PM
#2467   Regenicin, Inc. Announces Scheduled Pre-IND Meeting with U.S. stk_maniac 10/14/16 03:38:45 PM
#2466   http://www.regenicin.com/pr01.html stk_maniac 10/07/16 08:14:38 PM
PostSubject