0001193125-13-321964.txt : 20130806 0001193125-13-321964.hdr.sgml : 20130806 20130806172703 ACCESSION NUMBER: 0001193125-13-321964 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20130801 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20130806 DATE AS OF CHANGE: 20130806 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Cardium Therapeutics, Inc. CENTRAL INDEX KEY: 0000772320 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 840635673 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-33635 FILM NUMBER: 131014495 BUSINESS ADDRESS: STREET 1: 12255 EL CAMINO REAL STREET 2: SUITE 250 CITY: SAN DIEGO STATE: CA ZIP: 92130 BUSINESS PHONE: (858) 436-1000 MAIL ADDRESS: STREET 1: 12255 EL CAMINO REAL STREET 2: SUITE 250 CITY: SAN DIEGO STATE: CA ZIP: 92130 FORMER COMPANY: FORMER CONFORMED NAME: Cadium Therapeutics, Inc. DATE OF NAME CHANGE: 20060118 FORMER COMPANY: FORMER CONFORMED NAME: CARDIUM THERAPEUTICS, INC DATE OF NAME CHANGE: 20060118 FORMER COMPANY: FORMER CONFORMED NAME: ARIES VENTURES INC DATE OF NAME CHANGE: 20000523 8-K 1 d581122d8k.htm FORM 8-K Form 8-K

 

 

UNITED STATES

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): August 1, 2013

001-33635

(Commission file number)

 

 

CARDIUM THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   27-0075787
(State of incorporation)  

(IRS Employer

Identification No.)

12255 El Camino Real, Suite 250  
San Diego, California 92130   (858) 436-1000
(Address of principal executive offices)   (Registrant’s telephone number)

 

 

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 (17 CFR 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))

 

 

 

ITEM 8.01 OTHER EVENTS.

On August 1, 2013, Cardium Therapeutics, Inc. (“Cardium”) issued a press release announcing that it has entered into a distribution agreement with AvKARE Inc. to become the new sales and distribution partner for Excellagen® in government medical facilities throughout the United States, and which replaces an earlier arrangement with Academy Medical, LLC. On August 5, 2013, Cardium announced the filing of a new 510(k) submission for its current FDA-cleared Excellagen advanced wound care product to reflect additional and specific structural and functional properties of Excellagen based on the Company’s supplemental research and development activities. Cardium also provided an update on the Excellagen CE mark submission. In addition, on August 6, 2013, Cardium announced it has entered into an agreement with Orbsen Therapeutics Ltd and the National University of Ireland, Galway, to utilize Excellagen as a delivery agent for Orbsen’s proprietary stromal cell therapy in pre-clinical studies for the potential treatment of diabetic foot ulcers. Copies of the press releases are attached hereto as Exhibit 99.1, Exhibit 99.2 and 99.3 respectively, and incorporated by reference herein.

ITEM 9.01 FINANCIAL STATEMENTS AND EXHIBITS.

(d) Exhibits.

 

99.1    Press Release of Cardium issued on August 1, 2013
99.2    Press Release of Cardium issued on August 5, 2013
99.3    Press Release of Cardium issued on August 6, 2013

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.

 

   CARDIUM THERAPEUTICS, INC.
Date: August 6, 2013    By:   

/s/ Christopher J. Reinhard

      Christopher J. Reinhard
      Chief Executive Officer
 EX-99.1 2 d581122dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

LOGO

 

Bonnie Ortega   Hanna Wagari
VP – Corporate Communications   VP – Sales and Marketing
Cardium Therapeutics, Inc.   Cardium Therapeutics, Inc.
Tel: (858) 436-1018   Tel: (858) 436-1042
Email: InvestorRelations@cardiumthx.com   Email: HWagari@cardiumthx.com

CARDIUM REPORTS ON NEW EXCELLAGEN DISTRIBUTION

AGREEMENT WITH AVKARE FOR VETERANS HOSPITALS AND OTHER GOVERNMENTAL

MEDICAL FACILITIES

SAN DIEGO, CA – August 1, 2013 – Cardium Therapeutics (NYSE MKT:CXM) today announced that it has entered into a distribution agreement with AvKARE Inc. to become the new sales and distribution partner for Excellagen® in government medical facilities throughout the United States. This new agreement and commercialization arrangement with AvKARE effectively replaces an earlier arrangement with Academy Medical, LLC. Cardium elected to transfer the Excellagen distribution responsibilities to AvKARE, which provides five direct wound care experts and allows Cardium’s 25 distributor representatives access to all government accounts. AvKARE services a diverse customer base that includes government (federal, state and municipal) and commercial sectors.

About AvKARE

AvKARE, a HealthKARE company, is a licensed manufacturer/wholesaler of pharmaceuticals, disposable medical supplies and capital medical equipment. The officers and management team at AvKARE have more than 80 years’ experience in the pharmaceutical and medical supply industry. AvKARE, which is known for its national distribution, services a diverse customer base that includes government (federal, state and municipal) and commercial sectors. AvKARE serves the Department of Defense, Veterans Hospitals, NASA, TriCare, Dept. of Agriculture, Indian Health Services, USDA, U.S. Army, Air Force, Navy, and USMC, as well as Group Purchasing Organizations that include Amerinet, Innovatix, Health Trust Purchasing Group, IPC, Broadlane/MedAssets and Premier. AvKARE also holds National Government contracts, Federal Supply Schedule, as well as multiple Blanket Purchase Agreements. To learn more about AvKARE, visit www.Excellagen.com/AvKARE.

About Excellagen

Excellagen is a syringe-based, professional-use, pharmaceutically-formulated 2.6% fibrillar Type I bovine collagen homogenate that functions as an acellular biological modulator to activate the wound healing process and significantly accelerate the growth of granulation tissue. Excellagen’s FDA clearance provides for very broad labeling including partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/graft, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns and skin tears) and draining wounds. Excellagen is intended for professional use following standard debridement procedures in the presence of blood cells and platelets, which are involved with the release of endogenous growth factors. Excellagen’s unique fibrillar Type I bovine collagen homogenate formulation is topically applied through easy-to-control, pre-filled, sterile, single-use syringes and is designed for application at only one-week intervals.

 

-3-

There have been important, positive findings reported by physicians using Excellagen. In several case studies, physicians reported a rapid onset of the growth of granulation tissue in a wide array of wounds, including non-healing diabetic foot ulcers (consistent with the results of Cardium’s Matrix clinical study), as well as pressure ulcers, venous ulcers and Mohs surgical wounds. In certain cases, rapid granulation tissue growth and wound closure have been achieved with Excellagen following unsuccessful treatment with other advanced wound care approaches. From a dermatology perspective, a previously unexplored vertical market, remarkable healing responses have been observed following Mohs surgery for patients diagnosed with squamous and basal cell carcinomas, including deep surgical wounds extending to the periosteum (a membrane that lines the outer surface of bones). Additionally, because of the easy-use and platelet activating capacity, physicians have been employing Excellagen in severe non-healing wounds at near-amputation status, in combination with autologous platelet-rich plasma therapy and collagen sheet products. These case studies and positive physician feedback provide additional support of Excellagen’s potential utility as an important new tool to help promote the wound healing process. Excellagen case studies are available at http://www.excellagen.com/surgical-wounds.html.

About Cardium

Cardium is an asset-based health sciences and regenerative medicine company focused on the acquisition and strategic development of innovative products and businesses with the potential to address significant unmet medical needs and having definable pathways to commercialization, partnering or other economic monetizations. Cardium’s current portfolio includes LifeAgain medical data analytics, Tissue Repair Company, Cardium Biologics, and the Company’s To Go Brands® nutraceutical business. The Company’s lead commercial product, Excellagen® topical gel for wound care management, has received FDA clearance for marketing and sale in the United States. Cardium’s lead clinical development product candidate Generx® is a DNA-based angiogenic biologic intended for the treatment of patients with myocardial ischemia due to coronary artery disease. To Go Brands® develops, markets and sells dietary supplements through established regional and national retailers. In addition, consistent with its capital-efficient business model, Cardium continues to actively evaluate new technologies and business opportunities. For more information, visit www.cardiumthx.com.

Forward-Looking Statements

Except for statements of historical fact, the matters discussed in this press release are forward looking and reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from stated expectations. For example, there can be no assurance that this or other distribution agreements will effectively expand access or lead to increased adoption by medical providers; that results or trends observed in a clinical study or follow-on case studies will be reproduced in subsequent studies or in actual use; that new clinical studies will be successful or will lead to approvals or clearances from health regulatory authorities, or that approvals in one jurisdiction will help to support studies or approvals elsewhere; that the company can attract suitable commercialization partners for our products or that we or partners can successfully commercialize them; that our product or product candidates will not be unfavorably compared to competitive products that may be regarded as safer, more effective, easier to use or less expensive or blocked by third party proprietary rights or other means; that the products and product candidates referred to in this report or in our other reports will be successfully commercialized and their use reimbursed, or will enhance our market value; that new product opportunities or commercialization efforts will be successfully established; that third parties on whom we depend will perform as anticipated; that we can raise sufficient capital from partnering, monetization or other fundraising transactions to maintain our stock exchange listing or adequately fund ongoing operations; or that we will not be adversely affected by these or other risks and uncertainties that could impact our operations, business or other matters, as described in more detail in our filings with the Securities and Exchange Commission. We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.

 

-4-

Copyright 2013 Cardium Therapeutics, Inc. All rights reserved.

For Terms of Use Privacy Policy, please visit www.cardiumthx.com.

Cardium Therapeutics®, Generx®, Cardionovo®, Tissue Repair™, Excellagen®, Excellarate™, LifeAgain™, Genedexa™, Neo-Apps®, MedPodium®, Neo-Energy®, Neo-Chill™ and Neo-Carb Bloc® are trademarks of Cardium Therapeutics, Inc. or Tissue Repair Company. To Go Brands®, High Octane®, Green Tea Energy Fusion™, Acai Natural Energy Boost™, Greens to Go®, Extreme Berries to Go®, Healthy Belly®, VitaRocks®, Smoothie Complete®, Trim Green Coffee Bean™, and Trim Energy®, are trademarks of To Go Brands, Inc. Other trademarks belong to their respective owners.

 

-5-

EX-99.2 3 d581122dex992.htm EX-99.2 EX-99.2

Exhibit 99.2

 

LOGO

 

Bonnie Ortega   Hanna Wagari
VP – Corporate Communications   VP – Sales and Marketing
Cardium Therapeutics, Inc.   Cardium Therapeutics, Inc.
Tel: (858) 436-1018   Tel: (858) 436-1042
Email: InvestorRelations@cardiumthx.com   Email: HWagari@cardiumthx.com

CARDIUM ANNOUNCES NEW EXCELLAGEN FDA 510(k) SUBMISSION BASED ON

EXPANDED STRUCTURAL AND FUNCTIONAL PROPERTIES

The Company Also Provides Update on CE Mark Submission

SAN DIEGO, CA – August 5, 2013 – Cardium Therapeutics (NYSE MKT: CXM) today announced that it has filed a new
510(k) submission for its current FDA-cleared Excellagen® advanced wound care product to reflect additional and specific structural and functional properties of Excellagen based on the Company’s supplemental research and development activities.

The new 510(k) submission further characterizes Excellagen as a dermal wound matrix with structural and functional properties that play essential roles in wound healing. Excellagen is a physiologically formulated homogenate of bovine dermal Type I collagen in its native, 3-dimensional fibrillar structural configuration that provides a scaffold for cellular infiltration and wound granulation, and which activates blood platelets that can trigger the release of essential growth factors. The submission is supported by in vitro research findings including electron microscopy data that should allow for more specific labeling to include the unique structural and biological properties of Excellagen and its utilization to potentially enhance platelet activation when used in concert with Platelet Rich Plasma (PRP) therapy. In addition, the Company plans to modify Excellagen’s packaging to include individually pouched applicator syringes and a large volume syringe applicator to allow for easier use in larger-sized wounds such as those found in limb salvage, orthopedic surgery and other surgical applications.

“We believe the research data provided to the FDA in our recent 510(k) submission provide further insight into the significantly accelerated and activated healing response seen with our Excellagen advanced wound care product,” stated Christopher J. Reinhard, Chairman and CEO of Cardium. “Excellagen has multiple attributes that are beneficial to the promotion of wound healing, including activation of human platelets and the release of platelet-derived growth factor (PDGF). These findings are consistent with the role of platelet activation and the release of growth factors for one to two days following application of Excellagen to newly-debrided wounds.”

Regarding the Company’s CE mark submission, in first quarter 2013, Cardium received ISO 13485:2003 certification (a requirement for CE marking) for Excellagen by BSI, one of the world’s leading certification bodies. With the successful completion of ISO certification, the Company reported that it had completed its initial submission of required documentation, including the technical file and design dossier for its CE mark application. The CE mark process involves interaction between the Company and its notified body, BSI. Since the initial submission, Cardium has received requests for supplemental information from BSI. Based on the current status, all information requested has been provided to BSI and the Company believes this process should lead to CE mark certification for its FDA-cleared advanced wound care product.

 

-6-

About Excellagen

Excellagen is a syringe-based, professional-use, pharmaceutically-formulated 2.6% fibrillar Type I bovine collagen homogenate that functions as an acellular biological modulator to activate the wound healing process and significantly accelerate the growth of granulation tissue. Excellagen’s FDA clearance provides for very broad labeling including partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/graft, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns and skin tears) and draining wounds. Excellagen is intended for professional use following standard debridement procedures in the presence of blood cells and platelets, which are involved with the release of endogenous growth factors. Excellagen’s unique fibrillar Type I bovine collagen homogenate formulation is topically applied through easy-to-control, pre-filled, sterile, single-use syringes and is designed for application at only one-week intervals.

There have been important, positive findings reported by physicians using Excellagen. In several case studies, physicians reported a rapid onset of the growth of granulation tissue in a wide array of wounds, including non-healing diabetic foot ulcers (consistent with the results of Cardium’s Matrix clinical study), as well as pressure ulcers, venous ulcers and Mohs surgical wounds. In certain cases, rapid granulation tissue growth and wound closure have been achieved with Excellagen following unsuccessful treatment with other advanced wound care approaches. From a dermatology perspective, a previously unexplored vertical market, remarkable healing responses have been observed following Mohs surgery for patients diagnosed with squamous and basal cell carcinomas, including deep surgical wounds extending to the periosteum (a membrane that lines the outer surface of bones). Additionally, because of the easy-use and platelet activating capacity, physicians have been employing Excellagen in severe non-healing wounds at near-amputation status, in combination with autologous platelet-rich plasma therapy and collagen sheet products. These case studies and positive physician feedback provide additional support of Excellagen’s potential utility as an important new tool to help promote the wound healing process. Excellagen case studies are available at http://www.excellagen.com/surgical-wounds.html.

About Cardium

Cardium is an asset-based health sciences and regenerative medicine company focused on the acquisition and strategic development of innovative products and businesses with the potential to address significant unmet medical needs and having definable pathways to commercialization, partnering or other economic monetizations. Cardium’s current portfolio includes LifeAgain medical data analytics, Tissue Repair Company, Cardium Biologics, and the Company’s To Go Brands® nutraceutical business. The Company’s lead commercial product, Excellagen® topical gel for wound care management, has received FDA clearance for marketing and sale in the United States. Cardium’s lead clinical development product candidate Generx® is a DNA-based angiogenic biologic intended for the treatment of patients with myocardial ischemia due to coronary artery disease. To Go Brands® develops, markets and sells dietary supplements through established regional and national retailers. In addition, consistent with its capital-efficient business model, Cardium continues to actively evaluate new technologies and business opportunities. For more information, visit www.cardiumthx.com.

 

-7-

Forward-Looking Statements

Except for statements of historical fact, the matters discussed in this press release are forward looking and reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from stated expectations. For example, there can be no assurance that we will receive a marketing clearance from the FDA for the new submission; that we can obtain a CE mark for the sale of Excellagen in the European Union and other countries recognizing CE Mark approval; that results or trends observed in a clinical study or follow-on case studies will be reproduced in subsequent studies or in actual use; that Excellagen will perform as anticipated and will be favorably received in the marketplace; that new clinical studies will be successful or will lead to approvals or clearances from health regulatory authorities, or that approvals in one jurisdiction will help to support studies or approvals elsewhere; that the company can attract suitable commercialization partners for our products or that we or partners can successfully commercialize them; that our product or product candidates will not be unfavorably compared to competitive products that may be regarded as safer, more effective, easier to use or less expensive or blocked by third party proprietary rights or other means; that the products and product candidates referred to in this report or in our other reports will be successfully commercialized and their use reimbursed, or will enhance our market value; that new product opportunities or commercialization efforts will be successfully established; that third parties on whom we depend will perform as anticipated; or that we will not be adversely affected by these or other risks and uncertainties that could impact our operations, business or other matters, as described in more detail in our filings with the Securities and Exchange Commission. We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.

Copyright 2013 Cardium Therapeutics, Inc. All rights reserved.

For Terms of Use Privacy Policy, please visit www.cardiumthx.com.

Cardium Therapeutics®, Generx®, Cardionovo®, Tissue Repair™, Excellagen®, Excellarate™, LifeAgain™, Genedexa™, Neo-Apps®, MedPodium®, Neo-Energy®, Neo-Chill™ and Neo-Carb Bloc® are trademarks of Cardium Therapeutics, Inc. or Tissue Repair Company. To Go Brands®, High Octane®, Green Tea Energy Fusion™, Acai Natural Energy Boost™, Greens to Go®, Extreme Berries to Go®, Healthy Belly®, VitaRocks®, Smoothie Complete®, Trim Green Coffee Bean™, and Trim Energy®, are trademarks of To Go Brands, Inc. Other trademarks belong to their respective owners.

 

-8-

EX-99.3 4 d581122dex993.htm EX-99.3 EX-99.3

Exhibit 99.3

 

LOGO

 

Bonnie Ortega   Hanna Wagari
VP – Corporate Communications   VP – Sales and Marketing
Cardium Therapeutics, Inc.   Cardium Therapeutics, Inc.
Tel: (858) 436-1018   Tel: (858) 436-1042
Email: InvestorRelations@cardiumthx.com   Email: HWagari@cardiumthx.com

CARDIUM REPORTS ON NEW EXCELLAGEN-BASED STROMAL CELL

RESEARCH FOR WOUND HEALING WITH ORBSEN THERAPEUTICS

UNDER EUROPEAN FP7 REDDSTAR DIABETES INITIATIVE

SAN DIEGO, CA – August 6, 2013 – Cardium Therapeutics (NYSE MKT: CXM) today announced that it has entered into an agreement with Orbsen Therapeutics Ltd and the National University of Ireland, Galway, to utilize Cardium’s Excellagen® pharmaceutically-formulated gel as a delivery agent for Orbsen’s proprietary stromal cell therapy in pre-clinical studies for the potential treatment of diabetic foot ulcers. The research is being conducted by the Regenerative Medicine Institute (REMEDI), at the National University of Ireland Galway (NUIG), a world-class biomedical research centre focused on mesenchymal stromal cell (MSC) research. The research initiative is funded by REDDSTAR, a European Union Framework 7 (EU FP7) research collaboration focused on treating diabetes and its complications with a defined MSC therapy and enlisting academic and industry partners throughout Europe in the program (www.reddstar.eu).

Cardium’s FDA-cleared Excellagen is an aseptically-manufactured, quaternary fibrillar Type I bovine collagen homogenate that is configured into a staggered array of three-dimensional, triple helical, telopeptide-deleted, tropocollagen molecules. This linear array forms a flowable, biocompatible and bioactive structural matrix that promotes chemotaxis, cellular adhesion, migration and proliferation to stimulate tissue formation. The Excellagen homogenate represents a new product delivery platform that allows for the potential development of a portfolio of advanced tissue regeneration therapeutic opportunities that could include anti-infectives, antibiotics, peptides, proteins, small molecules, DNA, stem cells, differentiated cells and conditioned cell media.

About Excellagen

Excellagen is a syringe-based, professional-use, pharmaceutically-formulated 2.6% fibrillar Type I bovine collagen homogenate that functions as an acellular biological modulator to activate the wound healing process and significantly accelerate the growth of granulation tissue. Excellagen’s FDA clearance provides for very broad labeling including partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/graft, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns and skin tears) and draining wounds. Excellagen is intended for professional use following standard debridement procedures in the presence of blood cells and platelets, which are involved with the release of endogenous growth factors. Excellagen’s unique fibrillar Type I bovine collagen homogenate formulation is topically applied through easy-to-control, pre-filled, sterile, single-use syringes and is designed for application at only one-week intervals.

 

-9-

There have been important, positive findings reported by physicians using Excellagen as part of Cardium’s physician sampling, patient outreach and market “seeding” programs. In several case studies, physicians reported a rapid onset of the growth of granulation tissue in a wide array of wounds, including non-healing diabetic foot ulcers (consistent with the results of Cardium’s Matrix clinical study), as well as pressure ulcers, venous ulcers and Mohs surgical wounds. In certain cases, rapid granulation tissue growth and wound closure have been achieved with Excellagen following unsuccessful treatment with other advanced wound care approaches. From a dermatology perspective, a previously unexplored vertical market, remarkable healing responses have been observed following Mohs surgery for patients diagnosed with squamous and basal cell carcinomas, including deep surgical wounds extending to the periosteum (a membrane that lines the outer surface of bones). Additionally, because of the easy-use and platelet activating capacity, physicians have been employing Excellagen in severe non-healing wounds at near-amputation status, in combination with autologous platelet-rich plasma therapy and collagen sheet products. These case studies and positive physician feedback provide additional support of Excellagen’s potential utility as an important new tool to help promote the wound healing process. Excellagen case studies are available at http://www.excellagen.com/surgical-wounds.html.

About Orbsen Therapeutics

Orbsen Therapeutics Ltd. is a privately-held company founded in 2006 as a spin out from Ireland’s Regenerative Medicine Institute (REMEDI) in NUI Galway. As part of the PurStem EU FP7 program, Orbsen developed proprietary technologies (ORB1) that enable the prospective purification of highly defined and therapeutic stromal cells from several human tissues, including marrow, adipose tissue and umbilical cord. ORB1 stromal cells can be purified from several species including equine and murine tissues, enabling the development of defined equine MSC therapies for the first time. These novel aspects of the ORB1 technology place Orbsen at the leading edge of research, development and regulatory compliance of MSC therapies. The therapeutic ORB1 cells can be purified from a single human donor, expanded and frozen to generate many doses of high-margin, allogeneic (“off-the-shelf”) therapeutic products for indications with unmet need. Orbsen’s proprietary ORB1 MSC therapy is being developed for several indications, including inflammatory disease of the lungs and liver, diabetes, cardiovascular disorders, joint disease, kidney injury, tissue graft rejection and wound repair. For more information, please visit http://www.orbsentherapeutics.com/.

About The Regenerative Medicine Institute at NUI, Galway

The Regenerative Medicine Institute (REMEDI) is a world-class biomedical research centre focusing on gene therapy and stem cell research. REMEDI is a partnership involving scientists, clinicians, and engineers in academic centres and in industry. Researchers at REMEDI work together to combine the technologies of gene therapy and adult stem cell therapy with the aim of regeneration and repair of tissues. The unique feature of the research carried out at REMEDI is the novel integration of both therapies in a complementary research and development programme. Based in the National University of Ireland, Galway, REMEDI was established in 2003 through a Science Foundation Ireland (SFI) Centre for Science Engineering and Technology (CSET) award, and industry funding. The institute is located at the National Centre for Biomedical Engineering Science and incorporates the National Cell and Gene Vector Laboratory, a GMP grade vector and cell production facility. More information is available at http://www.nuigalway.ie/remedi/about-us.

 

-10-

About Cardium

Cardium is an asset-based health sciences and regenerative medicine company focused on the acquisition and strategic development of innovative products and businesses with the potential to address significant unmet medical needs and having definable pathways to commercialization, partnering or other economic monetizations. Cardium’s current portfolio includes LifeAgain medical data analytics, Tissue Repair Company, Cardium Biologics, and the Company’s To Go Brands® nutraceutical business. The Company’s lead commercial product, Excellagen® topical gel for wound care management, has received FDA clearance for marketing and sale in the United States. Cardium’s lead clinical development product candidate Generx® is a DNA-based angiogenic biologic intended for the treatment of patients with myocardial ischemia due to coronary artery disease. To Go Brands® develops, markets and sells dietary supplements through established regional and national retailers. In addition, consistent with its capital-efficient business model, Cardium continues to actively evaluate new technologies and business opportunities. For more information, visit www.cardiumthx.com.

Forward-Looking Statements

Except for statements of historical fact, the matters discussed in this press release are forward looking and reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from stated expectations. For example, there can be no assurance that Excellagen can be effectively applied to a stromal stem cell formulation as a regenerative medicine therapeutic for the potential treatment of diabetic foot ulcers or that it can be successfully developed for this or any other therapeutic application; that case study observations will be reproducible or generalizable, or that results or trends observed in a clinical study or follow-on case studies will be reproduced in subsequent studies or in actual use; that new clinical studies will be successful or will lead to approvals or clearances from health regulatory authorities, or that approvals in one jurisdiction will help to support studies or approvals elsewhere; that the company can attract suitable commercialization partners for our products or that we or partners can successfully commercialize them; that our product or product candidates will not be unfavorably compared to competitive products that may be regarded as safer, more effective, easier to use or less expensive or blocked by third party proprietary rights or other means; that the products and product candidates referred to in this report or in our other reports will be successfully commercialized and their use reimbursed, or will enhance our market value; that new product opportunities or commercialization efforts will be successfully established; that third parties on whom we depend will perform as anticipated; that we can raise sufficient capital from partnering, monetization or other fundraising transactions to maintain our stock exchange listing or adequately fund ongoing operations; or that we will not be adversely affected by these or other risks and uncertainties that could impact our operations, business or other matters, as described in more detail in our filings with the Securities and Exchange Commission. We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.

Copyright 2013 Cardium Therapeutics, Inc. All rights reserved.

For Terms of Use Privacy Policy, please visit www.cardiumthx.com.

Cardium Therapeutics®, Generx®, Cardionovo®, Tissue Repair™, Excellagen®, Excellarate™, LifeAgain™, Genedexa™, Neo-Apps®, MedPodium®, Neo-Energy®, Neo-Chill™ and Neo-Carb Bloc® are trademarks of Cardium Therapeutics, Inc. or Tissue Repair Company. To Go Brands®, High Octane®, Green Tea Energy Fusion™, Acai Natural Energy Boost™, Greens to Go®, Extreme Berries to Go®, Healthy Belly®, VitaRocks®, Smoothie Complete®, Trim Green Coffee Bean™, and Trim Energy®, are trademarks of To Go Brands, Inc. Other trademarks belong to their respective owners.

 

-11-

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