RCI-02

Press Release,Product - RCI-02
RepliCel Announces Material Patent Milestones
New DermaPrecise™ patent application and patents granted for tendinopathy and skin rejuvenation technologies in key...
Press Release
RepliCel Ships DermaPreciseTM Injector Prototypes and Consumables to Independent Laboratory for Clinical Simulation Testing
Independent dermatology research experts at Monasterium Laboratory GmbH will test, analyze and validate various injection...
Press Release
RepliCel Announces DermaPrecise Trademark for Dermal Injector Product Line
Trademark registrations kickoff pre-commercial planningVANCOUVER, BC, CANADA – 28 October 2021 – RepliCel Life Sciences...
Press Release,Product - RCI-02
RepliCel Announces Dermal Injector Update
Testing progresses to next-phase; results lead to some component upgrades to ensure optimal performance, quality...
Press Release
RepliCel Launches Testing of Dermal Injector Units
Initial units delivered and first phase of functional testing nearly completeVANCOUVER, BC, CANADA – 25...
Press Release
RepliCel Life Sciences Retains Dermatology Sales and Marketing Executive to Guide the Global Commercial Strategy for its Automated Dermal Injector
RepliCel Life Sciences Retains Dermatology Sales and Marketing Executive to Guide the Global Commercial Strategy...
{
  "Params": {
    "type": "module",
    "source": "Blog Post",
    "layout": "List",
    "displaypagination": "true",
    "filterby": "itemtags",
    "limit": "20",
    "filtervalue": "RCI-02",
    "sortby": "releasedate",
    "sortorder": "DESC",
    "collectionvariable": "posts"
  },
  "Pagination": {
    "CurrentPage": 1,
    "ItemsPerPage": 20,
    "NumberOfPages": 1,
    "TotalItemsCount": 6
  },
  "Parent": {
    "Id": 1929,
    "Name": "News",
    "Url": "/news",
    "Url_List": [
      "/news"
    ],
    "UrlSlug": "news",
    "ParentId": 1528,
    "ParentId_List": [
      -1
    ],
    "ParentName": "",
    "ParentUrl": "",
    "TemplateName": "News Template (Overall)",
    "Module_Alias": "Blog",
    "Module_ID": 1528,
    "Enabled": true,
    "ReleaseDate": "2018-11-27T17:00:00",
    "ExpiryDate": "2099-12-11T17:00:00",
    "SiteSearchKeywords": [],
    "Description": "",
    "Weighting": 0,
    "DisableForSiteSearch": false,
    "CreatedByMemberId": "0",
    "ItemCategories": [],
    "ItemCategoryIdList": [],
    "ItemTags": [],
    "Author": 0,
    "Author_Name": "",
    "Author_Url": "",
    "ShowPageForSearchEngine": true,
    "MetaTitle": "Replicel News",
    "SEOTitle": "Replicel News",
    "MetaDescription": "",
    "CanonicalLink": "",
    "SocialMetaTags": "",
    "SeoPriority": 0.0,
    "EnableAMP": false,
    "AMPContent": "",
    "OpenGraphProperties": {
      "title": "",
      "type": "",
      "url": "",
      "locale": "",
      "image": ""
    },
    "ExternalId": 0,
    "Params": {
      "type": "snippet",
      "alias": "header",
      "name": "Header",
      "content": "
\r\n
\r\n \r\n
\r\n
\r\n", "enabled": true } }, "Items": [ { "Id": 3138, "Name": "RepliCel Announces Material Patent Milestones", "Url": "/news/replicel-announces-material-patent-milestones", "Url_List": [ "/news/replicel-announces-material-patent-milestones" ], "UrlSlug": "replicel-announces-material-patent-milestones", "ParentId": 1929, "ParentId_List": [ 1929 ], "ParentName": "News", "ParentUrl": "/news", "TemplateName": "", "Module_Alias": "BlogPost", "Module_ID": 1534, "Enabled": true, "ReleaseDate": "2022-01-10T06:15:00", "ExpiryDate": "2099-12-31T00:00:00", "SiteSearchKeywords": [], "Description": "

New DermaPrecise™ patent application and patents granted for tendinopathy and skin rejuvenation technologies in key markets

 VANCOUVER, BC, CANADA – 10 January 2022 – RepliCel Life Sciences Inc. (OTCPK: REPCF) (TSXV: RP) (FRA:P6P2) (“RepliCel” or the “Company”), a company developing novel, next-generation injection technologies as well as regenerative medicine products in aesthetics and orthopedics, is pleased to announce the filing of a new patent application covering novel aspects of the DermaPrecise™ product portfolio as well as the granting and/or allowance of three patent applications in key markets.

The DermaPrecise™ Injector is an electronic injection system designed to offer new levels of control over any injection into the dermal and subcutaneous layers for which precision of depth, dose and/or delivery matters. The new provisional patent application, filed on November 11, 2021 covers new commercial embodiments of certain technologies related to its dermal injector product portfolio which are not covered in previous patent applications.  

“As we continue to innovate the DermaPrecise™ injector, control unit and consumables, we will continue to file patents protecting all aspects of this product portfolio,” stated RepliCel President and CEO, R. Lee Buckler. “The testing being conducted on the DermaPrecise™ injection system is generating new ideas, innovations, and specifications which will lead to more patent filings covering new technologies and applications as we march toward commercialization of the DermaPrecise™ product line.”

With respect to the newly granted and allowed patents, RepliCel has been issued a key patent in Japan related to the Company's RCT-01 cell therapy for the treatment of chronic tendinopathy and two patents, one in Brazil and another in Mexico, relating to its RCS-01 regenerative cell therapy for skin rejuvenation. 

About the DermaPrecise 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. 

High-value market applications for the device include the injection of various substances into the dermal and subcutaneous layers. Such substances include toxins, dermal fillers, drugs, biologics, PRP, fat, and cells. Other 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.

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 hyaluronic acid-based dermal fillers and antibody therapeutics.

About RepliCel's Skin and Tendon Programs 

RepliCel is currently preparing for the clinical testing and commercialization of two cell-based regenerative medicines in Japan - one for skin rejuvenation (RCS-01) and one for tendon regeneration (RCT-01). RepliCel’s partner in Greater China, YOFOTO China Health Company, is currently preparing for phase 2 studies in China of these same therapies in collaboration with RepliCel. Both RCT-01 and RCS-01 have been the subject of successful phase 1 clinical studies.. 

Both products are the subject of active, ongoing partnership discussions in Japan and have already been the subject of two successfully completed consultations with Japan's Pharmaceutical and Medical Devices Agency (PMDA). Planning for clinical research studies under Japan's Act for the Safety of Regenerative Medicines (ASRM) is underway. Manufacturing of the clinical product will be performed by a Japanese-owned contract manufacturer preparing now for PMDA-certification under Japan's Ministry of Health, Labour, and Welfare (MHLW) applicable guidelines. Conduct of the clinical research studies will be managed by a high-quality Japanese clinical research organization.  

RepliCel aims to be one of the first foreign regenerative medicine companies based outside of Asia to directly engage in a clinical study of a cell therapy product under the ASRM regulatory pathway to commercialization. RepliCel will also be one of the first such companies to apply for certification of a manufacturing facility outside of Asia for the production of a cell therapy product to be imported for use in a clinical study governed by the ASRM regulations. 

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 cell therapy product pipeline is comprised of RCT-01 for tendon repair, RCS-01 for skin rejuvenation, and RCH-01 for hair restoration. RCH-01 has been the subject of successful safety and dose-finding clinical studies and is now the subject of its third clinical study evaluating efficacy for the treatment of male and female hair loss due to androgenetic alopecia. This ongoing study is being funded by Shiseido Company Limited pursuant to a license agreement which has now been terminated but is the subject of an arbitration regarding Shiseido’s rights to the product for Asia. RepliCel maintains the undisputed 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 (DermaPreciseTM) 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 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 regional partners 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.", "Weighting": 0, "DisableForSiteSearch": false, "CreatedByMemberId": "0", "ItemCategories": [ "News - Press Release", "Product - RCI-02" ], "ItemCategoryIdList": [ 2397, 2398 ], "ItemTags": [ "Partnerships", "Press Release", "RCI-02" ], "Author": 0, "Author_Name": "", "Author_Url": "", "Image": "/Blog/2017/RP-press-release.jpg", "ShowPageForSearchEngine": true, "MetaTitle": "", "SEOTitle": "", "MetaDescription": "", "CanonicalLink": "", "SocialMetaTags": "", "SeoPriority": 0.5, "EnableAMP": false, "AMPContent": "", "OpenGraphProperties": { "title": null, "type": null, "url": null, "locale": null, "image": null }, "ExternalId": 0, "Params": { "type": "module", "source": "Blog Post", "layout": "List", "displaypagination": "true", "filterby": "itemtags", "limit": "20", "filtervalue": "RCI-02", "sortby": "releasedate", "sortorder": "DESC", "collectionvariable": "posts" } }, { "Id": 3104, "Name": "RepliCel Ships DermaPreciseTM Injector Prototypes and Consumables to Independent Laboratory for Clinical Simulation Testing", "Url": "/news/replicel-ships-dermaprecisetm-injector-prototypes-and-consumables-to-independent-laboratory-for-clinical-simulation-testing", "Url_List": [ "/news/replicel-ships-dermaprecisetm-injector-prototypes-and-consumables-to-independent-laboratory-for-clinical-simulation-testing" ], "UrlSlug": "replicel-ships-dermaprecisetm-injector-prototypes-and-consumables-to-independent-laboratory-for-clinical-simulation-testing", "ParentId": 1929, "ParentId_List": [ 1929 ], "ParentName": "News", "ParentUrl": "/news", "TemplateName": "News Template", "Module_Alias": "BlogPost", "Module_ID": 1534, "Enabled": true, "ReleaseDate": "2021-11-11T06:15:00", "ExpiryDate": "2099-12-31T00:00:00", "SiteSearchKeywords": [], "Description": "

Independent dermatology research experts at Monasterium Laboratory GmbH will test, analyze and validate various injection parameters using donated human tissue

VANCOUVER, BC, CANADA – 11 November 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 it has shipped DermaPreciseTM Injector prototypes and consumables to an independent laboratory in Germany to conduct validation studies of injection parameters in various types of donated human skin tissue*.

“The design of the DermaPreciseTM system is intended to deliver a high level of control and consistent precision over dermal and subcutaneous injections,” stated R. Lee Buckler, President and CEO of RepliCel Life Sciences, which developed and owns all rights to the DermaPreciseTM product portfolio and its underlying technologies. “As we continue to prepare for commercial launch of the DermaPreciseTM product line, it is critical we have independent validation of the injection parameters and our ability to deliver best-in-class precision to our end users. Testing with donated human skin samples is a valuable tool in convincing clinicians to evaluate new technologies in real clinical treatment settings.”

“As clinicians learn more about the mechanisms and effects of the various types of substances we inject into the dermis and subcutaneous tissue – including neurotoxins, fillers, antibody therapeutics, fat-dissolving enzymes, cell therapies, and other injectables – we are increasingly realizing that precision of depth, dose and/or delivery matters more to efficacy than was often originally believed,” stated dermatologist and clinical researcher Dr. Rolf Hoffmann who has been a clinical advisor on the DermaPrecise™ development. 

The pre-clinical simulation testing to be conducted at Monasterium Laboratory Skin & Hair Research Solutions GmbH in Münster Germany, will include testing a wide array of injection depths in various skin tissues to demonstrate the achieved depth and biodistribution of injected substances by way of histological and imaging analysis. 

About Monasterium Laboratory GmbH

Monasterium Laboratory GmbH is a fast-growing, independent dermatological research company specialized in preclinical skin, hair, pigmentation, neuroendocrinology, immunology, and wound healing research in the human system. 

* Note: All experiments on human tissue are performed according to Helsinki guidelines and samples are collected after written patient consent and ethics approval.

About the DermaPreciseTM Injector Product Line

The DermaPreciseTM Injector platform is an electronic injection system which will bring new levels of control over dermal or subcutaneous injections where precision of depth, dose and/or delivery matters.

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, DermaPreciseTM, 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 DermaPreciseTM 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.", "Weighting": 0, "DisableForSiteSearch": false, "CreatedByMemberId": "0", "ItemCategories": [ "News - Press Release" ], "ItemCategoryIdList": [ 2397 ], "ItemTags": [ "RCI-02", "Skin" ], "Author": 0, "Author_Name": "", "Author_Url": "", "Image": "/Monasterium logo .png", "ShowPageForSearchEngine": true, "MetaTitle": "", "SEOTitle": "", "MetaDescription": "", "CanonicalLink": "", "SocialMetaTags": "", "SeoPriority": 0.5, "EnableAMP": false, "AMPContent": "", "OpenGraphProperties": { "title": null, "type": null, "url": null, "locale": null, "image": null }, "ExternalId": 0, "Params": { "type": "module", "source": "Blog Post", "layout": "List", "displaypagination": "true", "filterby": "itemtags", "limit": "20", "filtervalue": "RCI-02", "sortby": "releasedate", "sortorder": "DESC", "collectionvariable": "posts" } }, { "Id": 3038, "Name": "RepliCel Announces DermaPrecise Trademark for Dermal Injector Product Line", "Url": "/news/replicel-announces-dermaprecise-trademark-for-dermal-injector-product-line", "Url_List": [ "/news/replicel-announces-dermaprecise-trademark-for-dermal-injector-product-line" ], "UrlSlug": "replicel-announces-dermaprecise-trademark-for-dermal-injector-product-line", "ParentId": 1929, "ParentId_List": [ 1929 ], "ParentName": "News", "ParentUrl": "/news", "TemplateName": "News Template", "Module_Alias": "BlogPost", "Module_ID": 1534, "Enabled": true, "ReleaseDate": "2021-10-28T06:15:00", "ExpiryDate": "2099-12-31T00:00:00", "SiteSearchKeywords": [], "Description": "

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 hyaluronic 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.

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. 

 

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.

", "Weighting": 0, "DisableForSiteSearch": false, "CreatedByMemberId": "0", "ItemCategories": [ "News - Press Release" ], "ItemCategoryIdList": [ 2397 ], "ItemTags": [ "Partnerships", "RCI-02" ], "Author": 0, "Author_Name": "", "Author_Url": "", "Image": "/Blog/2017/DermaPrecise version 1 + basestation.png", "ShowPageForSearchEngine": true, "MetaTitle": "", "SEOTitle": "", "MetaDescription": "", "CanonicalLink": "", "SocialMetaTags": "", "SeoPriority": 0.5, "EnableAMP": false, "AMPContent": "", "OpenGraphProperties": { "title": null, "type": null, "url": null, "locale": null, "image": null }, "ExternalId": 0, "Params": { "type": "module", "source": "Blog Post", "layout": "List", "displaypagination": "true", "filterby": "itemtags", "limit": "20", "filtervalue": "RCI-02", "sortby": "releasedate", "sortorder": "DESC", "collectionvariable": "posts" } }, { "Id": 3037, "Name": "RepliCel Announces Dermal Injector Update", "Url": "/news/replicel-announces-dermal-injector-update", "Url_List": [ "/news/replicel-announces-dermal-injector-update" ], "UrlSlug": "replicel-announces-dermal-injector-update", "ParentId": 1929, "ParentId_List": [ 1929 ], "ParentName": "News", "ParentUrl": "/news", "TemplateName": "News Template", "Module_Alias": "BlogPost", "Module_ID": 1534, "Enabled": true, "ReleaseDate": "2021-10-27T06:15:00", "ExpiryDate": "2099-12-31T00:00:00", "SiteSearchKeywords": [], "Description": "

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.  

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.

", "Weighting": 0, "DisableForSiteSearch": false, "CreatedByMemberId": "0", "ItemCategories": [ "News - Press Release", "Product - RCI-02" ], "ItemCategoryIdList": [ 2397, 2398 ], "ItemTags": [ "Hair", "RCI-02" ], "Author": 0, "Author_Name": "", "Author_Url": "", "Image": "/Blog/2017/injecctor (clear housing).jpg", "ShowPageForSearchEngine": true, "MetaTitle": "", "SEOTitle": "", "MetaDescription": "", "CanonicalLink": "", "SocialMetaTags": "", "SeoPriority": 0.5, "EnableAMP": false, "AMPContent": "", "OpenGraphProperties": { "title": null, "type": null, "url": null, "locale": null, "image": null }, "ExternalId": 0, "Params": { "type": "module", "source": "Blog Post", "layout": "List", "displaypagination": "true", "filterby": "itemtags", "limit": "20", "filtervalue": "RCI-02", "sortby": "releasedate", "sortorder": "DESC", "collectionvariable": "posts" } }, { "Id": 2733, "Name": "RepliCel Launches Testing of Dermal Injector Units ", "Url": "/news/replicel-launches-testing-of-dermal-injector-units", "Url_List": [ "/news/replicel-launches-testing-of-dermal-injector-units" ], "UrlSlug": "replicel-launches-testing-of-dermal-injector-units", "ParentId": 1929, "ParentId_List": [ 1929 ], "ParentName": "News", "ParentUrl": "/news", "TemplateName": "", "Module_Alias": "BlogPost", "Module_ID": 1534, "Enabled": true, "ReleaseDate": "2021-05-25T06:15:00", "ExpiryDate": "2099-12-12T09:00:00", "SiteSearchKeywords": [], "Description": "

Initial units delivered and first phase of functional testing nearly complete

VANCOUVER, BC, CANADA – 25 May 2021 – RepliCel Life Sciences Inc. (TSX.V:RP) (OTCPK:REPCF) (FRA:P6P2) (“RepliCel” or the “Company”), a company developing next-generation technologies in aesthetics and orthopedics, is pleased to announce that it has received the first units of its dermal injector and is nearing completion of the preliminary phase of functional testing required to launch executing on the larger-scale production and testing plan.

“In our February update, we announced that manufacturing of RepliCel’s initial batch of commercial-grade dermal injectors and related consumables was resuming and that, upon delivery of the first units, we would commence functional testing. I am pleased to report we have now entered this phase,” stated RepliCel President and CEO, R. Lee Buckler.  

Having received the first few units of the dermal injector earlier this month, a team of assigned engineers and technicians initiated a battery of functional testing to stress the units and ensure compliance with strict functional specifications set by the RepliCel team. This testing phase has resulted in a small number of component upgrades and software modifications which, when data shows full specification compliance, will signal the end of this initial phase of testing. 

A comprehensive testing plan including a wide range of required functional and safety tests has been put in place to which over forty units will be subjected to produce the data needed for the submission to regulators seeking marketing approval later this year. All this is being done in collaboration with and under the supervision of the regulatory team at MainPointe Pharmaceuticals which is RepliCel’s partner for the products’ commercialization in the United States.

“While we execute on the dermal injector product line pre-submission testing, we are also engaged with Japanese authorities on procuring permission to use the dermal injector and consumables in RepliCel’s clinical study of its RCS-01 cell-based skin rejuvenation product in Japan for which planning and preparations have now commenced,” stated Buckler.  

About the RepliCel (RCI-02) Injector Product Line

The RepliCel 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.  

Headquartered in Canada with a base of operations in Europe, RepliCel has existing partnerships in the United States, Japan and China.

The Company’s cell therapy product pipeline is comprised of RCT-01 for tendon repair, RCS-01 for skin rejuvenation, and RCH-01 for hair restoration. All RepliCel’s cell therapy product candidates are based on RepliCel’s innovative technology, utilizing cell populations isolated from a patient’s healthy hair follicles.  RepliCel's three cell therapy products have now been tested in over 100 patients in four countries on three continents and successfully reviewed by three different regulatory agencies.  

RepliCel has also developed a proprietary injection device, RCI-02, optimized for the administration of its products and licensable for use with other dermatology applications. Certain commercial rights for RCI-02 have been licensed to YOFOTO for Greater China and a limited-term exclusive distributorship to MainPointe for the United States.

The co-development and commercial rights for RCH-01 for most of Asia have been exclusively licensed to Shiseido Company. Though the legal status of this license is currently the subject of some disagreement between the parties, Shiseido continues to finance the development of the licensed product based on RepliCel’s technology in their territory.  The co-development and commercial rights for RCT-01 and RCS-01 have been exclusively licensed to YOFOTO (China) Health for Greater China. 

For more information, please visit www.replicel.com or contact:


For more information, please contact:

Lee Buckler, CEO and President

info@replicel.com


", "Weighting": 0, "DisableForSiteSearch": false, "CreatedByMemberId": "0", "ItemCategories": [ "News - Press Release" ], "ItemCategoryIdList": [ 2397 ], "ItemTags": [ "RCI-02" ], "Author": 0, "Author_Name": "", "Author_Url": "", "Image": "/Blog/2017/RCI-02.png", "ShowPageForSearchEngine": true, "MetaTitle": "", "SEOTitle": "", "MetaDescription": "", "CanonicalLink": "", "SocialMetaTags": "", "SeoPriority": 0.5, "EnableAMP": false, "AMPContent": "", "OpenGraphProperties": { "title": null, "type": null, "url": null, "locale": null, "image": null }, "ExternalId": 0, "Params": { "type": "module", "source": "Blog Post", "layout": "List", "displaypagination": "true", "filterby": "itemtags", "limit": "20", "filtervalue": "RCI-02", "sortby": "releasedate", "sortorder": "DESC", "collectionvariable": "posts" } }, { "Id": 2633, "Name": "RepliCel Life Sciences Retains Dermatology Sales and Marketing Executive to Guide the Global Commercial Strategy for its Automated Dermal Injector", "Url": "/news/replicel-life-sciences-retains-dermatology-sales-and-marketing-executive-to-guide-the-global-commercial-strategy-for-its-automated-dermal-injector", "Url_List": [ "/news/replicel-life-sciences-retains-dermatology-sales-and-marketing-executive-to-guide-the-global-commercial-strategy-for-its-automated-dermal-injector" ], "UrlSlug": "replicel-life-sciences-retains-dermatology-sales-and-marketing-executive-to-guide-the-global-commercial-strategy-for-its-automated-dermal-injector", "ParentId": 1929, "ParentId_List": [ 1929 ], "ParentName": "News", "ParentUrl": "/news", "TemplateName": "News Template", "Module_Alias": "BlogPost", "Module_ID": 1534, "Enabled": true, "ReleaseDate": "2019-08-29T06:00:00", "ExpiryDate": "2099-12-12T01:00:00", "SiteSearchKeywords": [], "Description": "

RepliCel Life Sciences Retains Dermatology Sales and Marketing Executive to Guide the Global Commercial Strategy for its Automated Dermal Injector

Management strengthens its commitment to a successful upcoming market launch of RepliCel’s dermal injector and consumables product line by addition of Damien King

VANCOUVER, BC, CANADA – August 29, 2019 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) (“RepliCel” or the “Company”), a company developing next-generation technologies in aesthetics and orthopedics, announces it has retained the services of Damien King, an aesthetic dermatology product specialist and former executive in several top-tier companies, to help build out the global commercial strategy for the Company’s automated dermal injector, RCI-02, and related consumables (the “RCI-02 Product Line”). RepliCel’s RCI-02 Product Line is expected to market launch next year in Europe and Hong Kong after receiving CE marketing approval in the first half of 2020.

Mr. King has more than 20 years of in-depth experience in the sales and marketing of pharmaceutical, biologic, and medical device products for some of the world’s largest life science companies. Most recently he was a Director of Sales and Franchise Development for Merz Pharmaceuticals with past experience including roles with Allergan, Purdue and Eli Lilly. Mr. King holds a Bachelor of Science and a Master of Business Administration from Cornell University. He currently sits on the Board of Directors for Aequus Pharmaceuticals and has recently launched Avari Medical to distribute emerging and innovative products in the aesthetic and dermatology sector to select markets. “Bringing Damien King on board along with his extensive consulting network of leading dermatology experts in clinical affairs, regulatory compliance, sales and marketing, and business analysis,” stated RepliCel President & CEO, R. Lee Buckler, “is a perfect complement to our existing team of experts including our Chief Medical Officer and practicing medical dermatologist, Dr. Rolf Hoffmann, our Head of Clinical and Regulatory Affairs, Dr. Petra Goessens-Rueck, and our medical device engineering partner, the Agency for Medical Innovations.”

“With the anticipated marketing approval of the products in RepliCel’s RCI-02 Product Line in the first half of next year, RepliCel management is currently heavily engaged in developing its global commercial strategy. Mr. King and team have been retained to provide critical insights and advice on all aspects of the business modelling and its execution including the targeted clinical applications, pricing, marketing, key opinion leader engagement, and sales and distribution,” Buckler summarized. 

About the RCI-02 Product Line

RepliCel’s RCI-02 injector was designed with input from dermatologists, industrial designers, and electronic and medical device engineers to improve the delivery of a variety of injectables in a controlled, precise manner, removing the risks and uncertainties of injection outcomes currently resulting from manually operated, single-needle syringes.

The RCI-02 Product Line is now in the final stages of development with final prototypes expected within the next few weeks after which the Company will transition to product manufacture, testing, and regulatory marketing approval. Upon successful delivery and assessment of the final device prototypes, a first production run of commercial-grade units of the RCI-02 injector and related consumables will be manufactured later this year to be used for both functional testing and clinical safety evaluation. 

RCI-02 dermal injector is the world’s first motorized injection device with programmable depth and volume, a built-in Peltier element for pre-injection numbing of the skin and interchangeable needle head configurations. It is designed to deliver a variety of injectable substances, including cells, dermal fillers, drugs or biologics intradermally (dermis) and subcutaneously (fat) via an array of needle configurations, starting with a 16-needle configuration (4×4) on one head. This needle head will be used to perform a variety of procedures, increase surface area coverage and speed-up procedure times.

RCI-02 automates and simplifies the injection process. Equipped with a touch screen on its accompanying docking station, the device’s programmability allows for the delivery of precise quantities of material, at specific depths, through fine-gauge needles, on a single plain or trailing through multi-plains, as the needle retracts through the skin.

Overall benefits of this next-generation dermal injector technology are anticipated to include improved handling, reduction or elimination of the need for pre-injection local anesthetic, quicker procedure times, improved patient experience, and a significant expansion of the areas that can be addressed with dermal fillers due to the ability to conduct broad, shallow and evenly-dispersed injections.

The Company anticipates marketing approval to launch sales of the initial RCI-02 Product Line next year. Management is committed to being fully prepared for market launch in Europe and Hong Kong in 2020 as it continues to plan for further product line innovation and pursue marketing approvals in the United States, Asia, and other key global markets. 

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. 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 currently being co-developed with, and under exclusive license by, Shiseido for certain Asian countries. All product candidates are based on RepliCel’s innovative technology, utilizing cell populations isolated from a patient’s healthy hair follicles. RepliCel has also developed a proprietary injection device, RCI-02, optimized for the administration of its products and licensable for use with other dermatology applications. Please visit www.replicel.com for additional information.

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.

", "Weighting": 0, "DisableForSiteSearch": false, "CreatedByMemberId": "0", "ItemCategories": [ "News - Press Release" ], "ItemCategoryIdList": [ 2397 ], "ItemTags": [ "Press Release", "RCI-02" ], "Author": 0, "Author_Name": "", "Author_Url": "", "Image": "/_images/products/PRlogo.png", "ShowPageForSearchEngine": false, "MetaTitle": "", "SEOTitle": "", "MetaDescription": "", "CanonicalLink": "", "SocialMetaTags": "", "SeoPriority": 0.5, "EnableAMP": false, "AMPContent": "", "OpenGraphProperties": { "title": null, "type": null, "url": null, "locale": null, "image": null }, "ExternalId": 0, "Params": { "type": "module", "source": "Blog Post", "layout": "List", "displaypagination": "true", "filterby": "itemtags", "limit": "20", "filtervalue": "RCI-02", "sortby": "releasedate", "sortorder": "DESC", "collectionvariable": "posts" } } ] }

DISCLAIMER:
The information in these press releases is historical in nature, has not been updated, and is current only to the date indicated in the particular press release. This information may no longer be accurate and therefore you should not rely on the information contained in these press releases. To the extent permitted by law, RepliCel Life Sciences Inc. and its employees, agents and consultants exclude all liability for any loss or damage arising from the use of, or reliance on, any such information, whether or not caused by any negligent act or omission.

THIRD PARTY CONTENT
Please note that any opinion, estimates or forecasts made by the authors of these statements are theirs alone and do not represent opinions, forecasts or predictions of RepliCel Life Sciences Inc. or its management. RepliCel Life Sciences Inc. does not, by its reference or distribution of these links imply its endorsement of, or concurrence with, such information, conclusions or recommendations.