Cardium Therapeutics today announced market introduction of its Excellagen™ professional-use, syringe-based wound care product for the management of diabetic foot ulcers, pressure ulcers and other dermal wounds.
Excellagen is a new, FDA-cleared highly-refined fibrillar collagen-based topical gel (2.6%) designed to support favorable wound care management. Excellagen’s unique high molecular weight bovine Type I collagen formulation is topically applied through easy-to-control, pre-filled, single use syringes. Excellagen is intended for physician use following surgical debridement procedures, and is engineered to support a favorable wound healing environment for non-healing lower extremity ulcers in diabetic patients. Excellagen’s viscosity optimized biocompatible gel formulation requires application at only one or two week intervals. It is recommended that Excellagen be applied following surgical debridement in the presence of blood cells and platelets, which are involved with the release of endogenous growth factors.
Cardium’s market research indicates that physicians seek easy-to-use products to reduce preparation time and facilitate product application – and Excellagen’s unique, ready-to-use syringe-based collagen gel requires no thawing or mixing. Because of its specialized formulation, only a thin layer needs to be applied over the wound area, and one syringe containing 0.5 cc of Excellagen covers wounds up to 5cm(2) in size using the supplied 24-gauge sterile, single-use flexible applicator tip. To learn more about new Excellagen and for product ordering information, please visit www.excellagen.com and view the informational YouTube video, Excellagen: A New Wound Care Pathway for Diabetic Foot Ulcers, at http://www.youtube.com/watch?v=D2GYCYc_8JE.
The Company also announced a logistics and cold chain services agreement with Smith Medical Partners, a subsidiary of H. D. Smith focused on specialty distribution of specialty, brand and generic pharmaceuticals, vaccines, injectables and medical/surgical materials. Smith Medical Partners provides practitioners with valuable product insights, information about patient assistant programs and can provide next-day delivery to all 50 states, allowing physicians and wound care clinics to receive Excellagen swiftly and reliably. Additional information about Smith Medical Partners can be found at http://www.smpspecialty.com/.
Initially, the Company’s marketing efforts will be centered on web-based marketing and supported by the new unilateral logistics capabilities of Smith Medical Partners. Cardium also plans to present and exhibit at medical trade shows, provide a website physician locator, build a network of key opinion leaders, create patient assistant programs and additional sales and marketing programs. The Company is currently exhibiting Excellagen at the APWCA 2012 Meeting in Orlando, Florida and will be exhibiting at the upcoming SAWC Symposium on Advanced Wound Care Meeting, April 19-22, 2012 in Atlanta, Georgia. Consistent with Cardium’s business strategy (similar to the business strategy for the Company’s InnerCool operating unit, which was sold to Philips Electronics), Cardium does not plan to establish an internal sales force, and following Excellagen’s initial market introduction, will look to strategic partners in the U.S., as well as internationally. In line with this strategy, in January 2012, the Company announced an agreement for the sale and distribution of Excellagen in South Korea, which represents the first of what the Company plans to be a series of marketing and distribution agreements with commercialization partners in the U.S. and other markets.
“We are pleased to announce the market introduction of Excellagen, which is an important milestone for the Company. Following initial market introduction, we look forward to advancing the commercialization of Excellagen in the U.S. and into international markets with strategic and distribution partners having access to podiatrists and other wound care specialists,” stated Christopher J. Reinhard, Chairman and CEO of Cardium Therapeutics. “We are also pleased to announce our logistics agreement with Smith Medical Partners, a subsidiary of H. D. Smith and one of the leading national specialty distributors with strong logistics and cold chain capabilities, to provide exceptional ordering and customer support, inventory control and shipping logistics.”
Based on Excellagen’s technology platform, Cardium plans to conduct post-clearance clinical studies to confirm findings from the formulated collagen Matrix clinical study, consider product line extensions, and pursue therapeutic claims for the treatment of non-healing diabetic foot and pressure ulcers, as well as other wounds. Cardium’s Excellagen fibrillar collagen topical gel also represents a new product platform that allows for the potential development of a portfolio of advanced wound care and therapeutic products. Cardium’s Gene Activated Matrix (GAM) technology represents one extension of Cardium’s FDA-cleared viscosity optimized, fibrillar collagen-based matrix for the localized topical delivery of agents that could include anti-infectives, antibiotics, peptides, proteins, small molecules, DNA, stem cells, differentiated cells and conditioned cell media.
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