0001085037-21-000096.txt : 20211102 0001085037-21-000096.hdr.sgml : 20211102 20211102123125 ACCESSION NUMBER: 0001085037-21-000096 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 6 CONFORMED PERIOD OF REPORT: 20211102 FILED AS OF DATE: 20211102 DATE AS OF CHANGE: 20211102 FILER: COMPANY DATA: COMPANY CONFORMED NAME: REPLICEL LIFE SCIENCES INC. CENTRAL INDEX KEY: 0001205059 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 000000000 STATE OF INCORPORATION: A1 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-50112 FILM NUMBER: 211370012 BUSINESS ADDRESS: STREET 1: SUITE 900 - 570 GRANVILLE STREET CITY: VANCOUVER BC STATE: A1 ZIP: V6C 3P1 BUSINESS PHONE: 604-248-8693 MAIL ADDRESS: STREET 1: SUITE 900 - 570 GRANVILLE STREET CITY: VANCOUVER BC STATE: A1 ZIP: V6C 3P1 FORMER COMPANY: FORMER CONFORMED NAME: NEWCASTLE RESOURCES LTD. DATE OF NAME CHANGE: 20081128 FORMER COMPANY: FORMER CONFORMED NAME: PAN AMERICAN GOLD CORP DATE OF NAME CHANGE: 20040521 FORMER COMPANY: FORMER CONFORMED NAME: TRI LATERAL VENTURE CORP DATE OF NAME CHANGE: 20021109 6-K 1 form6knovember.htm FORM 6K

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C.  20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of November, 2021
Commission File Number 000-50112
RepliCel Life Sciences Inc.
(Translation of registrant’s name into English)
Suite 900 – 570 Granville Street, Vancouver, British Columbia  V6C 3P1
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.     Form 20-F  [X]  Form 40-F  [  ]
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1)  [  ]
Note:  Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____
Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant’s “home country”), or under the rules of the home country exchange on which the registrant’s securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant’s security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.




SUBMITTED HEREWITH

99.1
99.2
99.3

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, thereunto duly authorized.
RepliCel Life Sciences Inc.

/s/ Lee Buckler 
Lee Buckler, President
Date:  November 2, 2021

EX-99.1 2 ex99_1.htm EXHIBIT 99.1 - NEWS RELEASE DATED OCTOBER 27, 2021
NEWS RELEASE


RepliCel Announces Dermal Injector Update

Testing progresses to next-phase; results lead to some component upgrades to ensure optimal performance, quality compliance, and commercial-scale production capabilities

VANCOUVER, BC, CANADA – 27 October 2021 – RepliCel Life Sciences Inc. (OTCPK: REPCF) (TSXV: RP) (FRA:P6P2) (“RepliCel” or the “Company”), a company developing next-generation technologies in aesthetics and orthopedics, provided an update on its dermal injector program.

Early testing results have proven the injector meets all primary product and functionality specifications while revealing some technical issues which have now been addressed regarding the transfer of the pilot-scale technologies to commercial scale production. Based on testing feedback, certain component, software, and production modifications have been made and others are awaiting delivery.  These were required to ensure seamless compliance with RepliCel’s product specifications and multinational regulatory quality guidelines. The first production run of units will be completed upon successfully passing the early testing round currently underway which involves signing off on all components and commercial-scale production.

“This is why we do testing,” added RepliCel CEO, R. Lee Buckler. “Rigorous testing produces a rigorously high-quality product which we can confidently say meets specifications and complies with all relevant safety standards in various markets around the world. While this testing feedback and consequent modifications have pushed back our anticipated timeline for marketing application submission by several weeks, we have continued to make significant progress and meet the anticipated timelines in other areas such as the assembly line for component production and initiating one of the next-phases of testing we call ‘clinical simulation’ testing to be conducted at a third party facility using donated, post-surgical human tissue.”

The Company looks forward to revealing the pre-commercial device to the market and submitting our marketing application submission to regulators in the weeks to come.

About the RepliCel Dermal Injector Product Line

The RepliCel Dermal Injector Product Line is comprised of a desktop touchscreen control unit wired to a handheld electronic injector wand with a push-button trigger rather than a manual plunger. In addition to offering unparalleled electronic control and consistency of injection depth and dose, the injector includes a cooling element intended to cool the skin to minimize sensation prior to injection. The proprietary consumables include two different multi-needle heads, syringe cartridges, and liners.

RepliCel management and advisors have engaged key clinical opinion leaders on the identification of high-value market applications for the device including the injection of various substances into the dermal and subcutaneous layers. Such substances include toxins, dermal fillers, drugs, biologics, PRP, fat, and cells. Potential uses for the devices include injections to treat hair loss, hyperhidrosis, migraines, skin aging/damage, skin pigmentation, and wounds, as well as cosmetic procedures such as skin rejuvenation, aesthetic sculpting, and reduction of fine wrinkles.

1 | Page


Commercial, clinical-grade units of the consumables and injector are now in production and testing for the purpose of gathering all necessary data to complete the submission to regulatory agencies seeking marketing approval. Plans are actively underway to pursue regulatory approvals for market launch initially in the United States, Europe, Hong Kong, and Japan to be followed by other markets globally.

About RepliCel Life Sciences

RepliCel is a regenerative medicine company focused on developing cell therapies for aesthetic and orthopedic conditions affecting what the Company believes is approximately one in three people in industrialized nations, including aging/sun-damaged skin, pattern baldness, and chronic tendon degeneration. These conditions, often associated with aging, are caused by a deficit of healthy cells required for normal tissue healing and function. These cell therapy product candidates are based on RepliCel’s innovative technology, utilizing cell populations isolated from a patient’s healthy hair follicles.

The Company’s product pipeline is comprised of RCT-01 for tendon repair, RCS-01 for skin rejuvenation, and RCH-01 for hair restoration. RCH-01 is exclusively licensed in Asia to Shiseido Company Limited. RepliCel maintains the rights to RCH-01 for the rest of the world. RCT-01 and RCS-01 are exclusively licensed in Greater China to YOFOTO (China) Health Company. RepliCel and YOFOTO are currently co-developing these products in China. RepliCel maintains the rights to these products outside of Greater China.

RepliCel has also developed a proprietary injection device, RCI-02, and related consumables, which is expected to improve the administration of its cell therapy products and certain other injectables. YOFOTO has exclusively licensed the commercial rights for the RCI-02 device and consumables in Greater China for dermatology applications and is expected to first launch the product in Hong Kong upon it being approved for market launch in either the United States or Europe. Please visit www.replicel.com for additional information.

      Notable Facts:

RepliCel's three cell therapy products have now been tested in over 100 patients in four countries on three continents.

RepliCel now has key strategic partners in the United States, China, and Japan each of which are now investing heavily in the further clinical testing and development of RepliCel's products for their markets. Data from each of the clinical programs will strengthen the product development initiatives for RepliCel and its other partners worldwide.

For more information, please contact:
Lee Buckler, CEO and President
604-248-8693
info@replicel.com

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
2 | Page

EX-99.2 3 ex99_2.htm EXHIBIT 99.2 - NEWS RELEASE DATED OCTOBER 28, 2021


NEWS RELEASE

RepliCel Announces DermaPrecise Trademark for Dermal Injector Product Line

Trademark registrations kickoff pre-commercial planning

VANCOUVER, BC, CANADA – 28 October 2021 – RepliCel Life Sciences Inc. (OTCPK: REPCF) (TSXV: RP) (FRA:P6P2) (“RepliCel” or the “Company”), a company developing next-generation technologies in aesthetics and orthopedics, announced today the DermaPrecise trademark for its dermal injector product portfolio.

“The DermaPrecise Injector is an electronic injection system which will bring new levels of control over any injection into the dermal and subcutaneous layers for which precision of depth, dose and/or delivery matters, “ states dermatologist and clinical researcher Dr. Rolf Hoffmann who has been a clinical advisor on the injector’s development.

Immediate high-value medical applications being explored for the DermaPrecise Injector are for dermal and subcutaneous delivery of cell and gene therapies, antibody therapeutics, toxins, and certain medical dermatology applications.

Aesthetic applications for the DermaPrecise Injector will include the injection of enzymes for fat dissolution, platelet rich plasma (PRP) for skin and hair applications, fat transfers, and certain applications of toxins and dermal fillers where there is a need to minimize injection pain and/or ensure broad, even dispersion of product as broadly as possible.

“RepliCel is very proud of the DermaPrecise injection product line which promises not only a high-level of electronic precision with control over pre-fixed depths and dose but a cooling system to numb the skin’s sensitivity immediately prior to injection and, for those holding the injector, a simple push-button rather than a plunger,” stated the company’s President and CEO, R. Lee Buckler.

The DermaPrecise injection system is supplied with single-use cartridges and multi-needle heads for use with injectables of varying viscosity including highly viscose products such as some of the newer crosslinked hyaluranic acid-based dermal fillers and antibody therapeutics.

RepliCel initially developed the DermaPrecise injection system to ensure optimized, precise, and  consistent delivery of its cell-based regenerative medicine products in development to reverse hair loss due to androgenetic alopecia and to regenerate the extracellular matrix under aging skin. For the rapidly growing cell and gene therapy industry, injection-related shear force can threaten to burst cells during the delivery process thus obviating the product’s effectiveness. In the coming weeks, RepliCel intends publish data demonstrating the superiority of the DermaPrecise Injector, over traditional methodologies, for the delivery of cells into the skin and subcutaneous layer.

1 | Page



About the DermaPrecise Injector Product Line

The DermaPrecise Injector Product Line is comprised of a desktop touchscreen control unit wired to a handheld electronic injector wand with a push-button trigger rather than a manual plunger. In addition to offering unparalleled electronic control and consistency of injection depth and dose, the injector includes a cooling element intended to cool the skin to minimize sensation prior to injection. The proprietary consumables include two different multi-needle heads, syringe cartridges, and liners.

RepliCel management and advisors have engaged key clinical opinion leaders on the identification of high-value market applications for the device including the injection of various substances into the dermal and subcutaneous layers. Such substances include toxins, dermal fillers, drugs, biologics, PRP, fat, and cells. Potential uses for the devices include injections to treat hair loss, hyperhidrosis, migraines, skin aging/damage, skin pigmentation, and wounds, as well as cosmetic procedures such as skin rejuvenation, aesthetic sculpting, and reduction of fine wrinkles.

Commercial, clinical-grade units of the consumables and injector are now in production and testing for the purpose of gathering all necessary data to complete the submission to regulatory agencies seeking marketing approval. Plans are actively underway to pursue regulatory approvals for market launch initially in the United States, Europe, Hong Kong, and Japan to be followed by other markets globally.

About RepliCel Life Sciences

RepliCel is a regenerative medicine company focused on developing cell therapies for aesthetic and orthopedic conditions affecting what the Company believes is approximately one in three people in industrialized nations, including aging/sun-damaged skin, pattern baldness, and chronic tendon degeneration. These conditions, often associated with aging, are caused by a deficit of healthy cells required for normal tissue healing and function. These cell therapy product candidates are based on RepliCel’s innovative technology, utilizing cell populations isolated from a patient’s healthy hair follicles.

The Company’s product pipeline is comprised of RCT-01 for tendon repair, RCS-01 for skin rejuvenation, and RCH-01 for hair restoration. RCH-01 is exclusively licensed in Asia to Shiseido Company Limited. RepliCel maintains the rights to RCH-01 for the rest of the world. RCT-01 and RCS-01 are exclusively licensed in Greater China to YOFOTO (China) Health Company. RepliCel and YOFOTO are currently co-developing these products in China. RepliCel maintains the rights to these products outside of Greater China.

RepliCel has also developed a proprietary injection device, DermaPrecise, and related consumables, which is expected to improve the administration of its cell therapy products and certain other injectables. YOFOTO has exclusively licensed the commercial rights for the DermaPrecise device and consumables in Greater China for dermatology applications and is expected to first launch the product in Hong Kong upon it being approved for market launch in either the United States or Europe. Please visit www.replicel.com for additional information.

      Notable Facts:

RepliCel's three cell therapy products have now been tested in over 100 patients in four countries on three continents.

RepliCel now has key strategic partners in the United States, China, and Japan each of which are now investing heavily in the further clinical testing and development of RepliCel's products for their markets. Data from each of the clinical programs will strengthen the product development initiatives for RepliCel and its other partners worldwide.

2 | Page




For more information, please contact:
Lee Buckler, CEO and President
604-248-8693
info@replicel.com

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

3 | Page


EX-99.3 4 ex99_3.htm EXHIBIT 99.3 - MATERIAL CHANGE REPORT

51-102F3
MATERIAL CHANGE REPORT
Item 1   Name and Address of Company
RepliCel Life Sciences Inc. (“RepliCel” or the “Company”)
900 – 570 Granville Street
Vancouver, BC  V6C 3P1
Item 2   Date of Material Change
October 27, 2021 and October 28, 2021
Item 3   News Release
The news releases dated October 27, 2021 and October 28, 2021 were disseminated through Accesswire.
Item 4   Summary of Material Change
On October 27, 2021, the Company provided an update on its dermal injector program.  Early testing results have proven the injector meets all primary product and functionality specifications while revealing some technical issues which have now been addressed regarding the transfer of the pilot-scale technologies to commercial scale production. Based on testing feedback, certain component, software, and production modifications have been made and others are awaiting delivery.  These were required to ensure seamless compliance with RepliCel’s product specifications and multinational regulatory quality guidelines. The first production run of units will be completed upon successfully passing the early testing round currently underway which involves signing off on all components and commercial-scale production.
The Company looks forward to revealing the pre-commercial device to the market and submitting our marketing application submission to regulators in the weeks to come.
On October 28, 2021, the Company announced the DermaPrecise trademark for its dermal injector product portfolio.
Immediate high-value medical applications being explored for the DermaPrecise Injector are for dermal and subcutaneous delivery of cell and gene therapies, antibody therapeutics, toxins, and certain medical dermatology applications.
Aesthetic applications for the DermaPrecise Injector will include the injection of enzymes for fat dissolution, platelet rich plasma (PRP) for skin and hair applications, fat transfers, and certain applications of toxins and dermal fillers where there is a need to minimize injection pain and/or ensure broad, even dispersion of product as broadly as possible.
The DermaPrecise injection system is supplied with single-use cartridges and multi-needle heads for use with injectables of varying viscosity including highly viscose products such as some of the newer crosslinked hyaluranic acid-based dermal fillers and antibody therapeutics.

RepliCel initially developed the DermaPrecise injection system to ensure optimized, precise, and  consistent delivery of its cell-based regenerative medicine products in development to reverse hair loss due to androgenetic alopecia and to regenerate the extracellular matrix under aging skin. For the rapidly growing cell and gene therapy industry, injection-related shear force can threaten to burst cells during the delivery process thus obviating the product’s effectiveness. In the coming weeks, RepliCel intends publish data demonstrating the superiority of the DermaPrecise Injector, over traditional methodologies, for the delivery of cells into the skin and subcutaneous layer.
About the DermaPrecise Injector Product Line
The DermaPrecise Injector Product Line is comprised of a desktop touchscreen control unit wired to a handheld electronic injector wand with a push-button trigger rather than a manual plunger. In addition to offering unparalleled electronic control and consistency of injection depth and dose, the injector includes a cooling element intended to cool the skin to minimize sensation prior to injection. The proprietary consumables include two different multi-needle heads, syringe cartridges, and liners.
RepliCel management and advisors have engaged key clinical opinion leaders on the identification of high-value market applications for the device including the injection of various substances into the dermal and subcutaneous layers. Such substances include toxins, dermal fillers, drugs, biologics, PRP, fat, and cells. Potential uses for the devices include injections to treat hair loss, hyperhidrosis, migraines, skin aging/damage, skin pigmentation, and wounds, as well as cosmetic procedures such as skin rejuvenation, aesthetic sculpting, and reduction of fine wrinkles.
Commercial, clinical-grade units of the consumables and injector are now in production and testing for the purpose of gathering all necessary data to complete the submission to regulatory agencies seeking marketing approval. Plans are actively underway to pursue regulatory approvals for market launch initially in the United States, Europe, Hong Kong, and Japan to be followed by other markets globally.
Item 5   Full Description of Material Change.
5.1         Full Description of Material Change
A full description of the material changes are described in Item 4 above and in the News Releases which were filed on SEDAR at www.sedar.com.
5.2         Disclosure for Restructuring Transactions
N/A
Item 6   Reliance on subsection 7.1(2) or (3) of National Instrument 51-102
N/A
Item 7   Omitted Information
None
Item 8   Executive Officer
Contact:           Lee Buckler, CEO and President
Telephone:       604.248.8693

Item 9   Date of Report
November 2, 2021


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