SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
____________________
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): June 12, 2012
REGENICIN, INC.
(Exact name of registrant as specified in its charter)
| Nevada | 333-146834 | 27-3083341 | ||
| (State or other jurisdiction of incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) |
| 10 High Court, Little Falls, NJ 07424 |
| Address of principal executive offices |
Registrant’s telephone number, including area code: (646) 403 3581
|
________________________________________________ (Former name or former address, if changed since last report) |
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| [ ] | Written communications pursuant to Rule 425 under the Securities Act (17CFR 230.425) |
| [ ] | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| [ ] | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| [ ] | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
SECTION 7 – Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure
On June 12, 2012, we issued a press release announcing that the Food and Drug Administration (FDA) has granted an Orphan Status designation to the PermaDerm™ product. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K. Subsequently, on June 13, 2012, we issued a follow-up press release to clarify certain misinterpretations that were published by unrelated third parties following the original release. A copy of the follow-up press release is attached as Exhibit 99.2 to this Current Report on Form 8-K.
The information in Item 7.01 of this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.
SECTION 9 – Financial Statements and Exhibits
Item 9.01 Financial Statements and Exhibits
99.1 Press release, dated June 12, 2012
99.2 Press release, dated June 13, 2012
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
REGENICIN, INC.
/s/ Randall McCoy
Randall McCoy
CEO and Director
Date: June 12, 2012
| 2 |
FDA Issues Orphan Status Approval for PermaDerm®
6/12/2012
LITTLE FALLS, N.J., June 6, 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.
PermaDerm® consists of harvesting a small section of the patient's own skin to be grown to graft an area one hundred times its size in as little as thirty days. These living, self-to-self skin graft tissues are intended to form permanent skin tissues that will not be rejected by the immune system of the patient, a critical possibility in porcine or cadaver skin grafts used today. PermaDerm® is being designed to not only save lives, but to reduce healthcare costs by decreasing the patient’s stay in the Critical Care Unit and to reduce the need for additional surgeries. To date, the technology has been clinically tested in over 150 pediatric and adult, catastrophic burn patients with very encouraging results. For more information on PermaDerm®, please visit the Regenicin website (www.regenicin.com).
The FDA approval designation of Orphan Status is granted to promote the development of new therapies for rare diseases and disorders. Orphan Status can be applied to products proven safe and effective in treating conditions that affect a relatively small number of patients, and the designation may entitle up to seven years of US marketing exclusivity upon regulatory approval. Companies whose drugs have an orphan designation also receive certain tax credits and are exempted from paying prescription drug user fees normally required of companies submitting products for approval. For more information on the FDA’s policies governing the development of Orphan drugs for rare diseases and conditions, as well as the publication of today’s designation announcement on this matter, please visit the FDA website links at:
www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/
and
www.accessdata.fda.gov/scripts/opdlisting/oopd/
“We are very excited about this Orphan Status designation for PermaDerm®, ” said Randall McCoy, CEO of Regenicin. “This is extremely good news and a huge step for the product, which we are all very proud of.”
About Regenicin
Regenicin, Inc. (OTC Bulletin Board: RGIN), 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. The
company is publicly traded with headquarters in New Jersey. For more information on Regenicin, Inc., as well as its technologies
and products, please visit the company website at www.regenicin.com.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934. These forward-looking statements are based on the current plans and expectations of
management and are subject to a number of uncertainties and risks that could significantly affect the company's current plans and
expectations, as well as future results of operations and financial condition. A more extensive listing of risks and factors that
may affect the company's business prospects and cause actual results to differ materially from those described in the forward-looking
statements can be found in the reports and other documents filed by the company with the Securities and Exchange Commission. The
company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information,
future events or otherwise.
SOURCE: Regenicin, Inc.
Clarification of Prior Press Release on FDA Issuance of Orphan Status for PermaDerm®
6/13/2012
LITTLE FALLS, N.J., June 13, 2012 /PRNewswire/ -- Yesterday, on June 12, 2012, 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, issued a press release that the Food and Drug Administration (FDA) had granted Orphan Status for the PermaDerm® product. While the Company believes it was accurate in representing the FDA’s action, the press release has been misinterpreted by some to suggest that PermaDerm is approved as a skin graft for immediate use on burn patients. As stated in the Company’s earlier press release, the FDA’s action was the designation of PermaDerm as an Orphan product. Such a designation has certain benefits to the recipient, but, just to be clear, these do not include the immediate commercialization of the product. The Company will still need to work with the FDA for the development of the product, now with the advantages of the Orphan designation. For more information on the FDA’s policies governing the development of Orphan drugs for rare diseases and conditions, as well as the publication of today’s designation announcement on this matter, please visit the FDA website links at:
www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/
and
www.accessdata.fda.gov/scripts/opdlisting/oopd/
“We hope this clarifies any confusion
that may have been caused by the wording of the prior press release,” said Randall McCoy, the Companies CEO.
About Regenicin
Regenicin, Inc. (OTC Bulletin Board: RGIN), 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. The
company is publicly traded with headquarters in New Jersey. For more information on Regenicin, Inc., as well as its technologies
and products, please visit the company website at www.regenicin.com.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934. These forward-looking statements are based on the current plans and expectations of
management and are subject to a number of uncertainties and risks that could significantly affect the company's current plans and
expectations, as well as future results of operations and financial condition. A more extensive listing of risks and factors that
may affect the company's business prospects and cause actual results to differ materially from those described in the forward-looking
statements can be found in the reports and other documents filed by the company with the Securities and Exchange Commission. The
company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information,
future events or otherwise.
SOURCE: Regenicin, Inc.
10 High Court
Little Falls, NJ 17424
(646) 403-3581
PR@regenicin.com
info@regenicin.com