"Regranex Topical Gel - first FDA-approved advanced care biologic topical agent for the treatment of patients with lower extremity neuropathic diabetic foot ulcers.
Excellagen just approved by FDA is a highly purified, physiologically formulated fibrillar bovine Type I collagen-based topical gel (2.6% collagen) designed to support favorable wound care management. There are no other collagen-based wound care management dressings available for professional use in the United States that are considered comparable to Excellagen in terms of its overall formulation, fibrillar nature, and product format. Other professional-use collagen-based products include granulated collagens that require mixing prior to use, as well as a variety of sheet-based products.
Regranex is patient administered, requires daily application followed by a daily cleansing 12 hours after the drug treatment over a 20-week period. As a result, during the prescribed 20-week treatment period, Regranex patients are required to undertake approximately 280 interventions (drug administrations and cleansings) to achieve the potential maximum healing effect.
Excellagen requires one or two physician administered treatment regimen.
Regranex - 50% of patients achieved complete wound closure in 20 weeks.
Excellagen - 83% of patients achieved complete wound closure in 14 weeks.
Regranex - Increase cancer risk in Patients
Excellagen - appears to be both safe and well tolerated, with no serious adverse events attributable to the study product.
The wound care market is projected to experience double digit growth over the next 3 to 5 years, with advanced wound care products comprising the fastest growing segment of the total wound care market. There are an estimated 91.3 million wounds in the U.S., which include 67.0 million surgical wounds, 17.6 million trauma wounds including burn injuries and amputations, 2.5 million pressure ulcers, 3.6 million diabetic ulcers and 3.3 million venous stasis and arterial ulcers. The ability to effectively address even a small proportion of these wounds would represent major new market opportunities for the Company's Excellagen.
In other words Excellagen will be the Number 1 topical gel for wound care which equals..........
The Hedge fund gofer speaks again and it shows old Cramer schooling. At least his old boss claim he was rehabilitated and a good boy now. Adam still in shorts and hedges packets. After all he did help them to cover over 5M shares. I hope he will not have need for Regranex on his feet one day and wonder what he has to say about it with fool FDA approval. You know, the one that has the cancer warning on its label.
Ray H. emails, "Hello Mr. Feuerstein. Cardium Therapeutics(CXM_) just received 510(k) approval for their Excellagen wound healing product. The price almost tripled the day of the announcement, but at the end of the day on Monday, we still only saw about 41 cents per share on the close, roughly the same price it was a year ago (although there was some dilution during this time.) Is this about all we can hope for? I would like your opinion on this company from a fresh perspective since you had previously been skeptical on the clearance. Thanks sir!"
Avoid using the word "approval" when it comes to Excellagen. What Cardium received from FDA was "clearance" to sell Excellagen as a simple medical device used in the treatment of diabetic foot ulcers, or wounds. The regulatory threshold for a 501(k) medical device clearance is considerably less than what drug developers or certain medical device makers need to receive FDA "approval." Excellagen is a cow-derived collagen gel that doctors apply to a diabetic foot ulcer once the wound has been surgically cleaned. Cardium says Excellagen is intended to "support a favorable wound healing environment." Notice Cardium doesn't say Excellagen actually heals diabetic foot ulcers or is in any way superior to competing products used by doctors to manage diabetic wounds. With FDA clearance as a 510(k) device, Cardium can't make such medical claims. When I wrote about Cardium one year ago, I expressed doubts about FDA clearance of Excellagen mainly because the study run by the company wasn't designed originally to study Excellagen. Instead, the study -- know as Matrix -- was set up to test the efficacy and safety of a different product, Excellerate, which combined a gene therapy-like drug with the collagen gel found in Excellagen. The study found that Excellagen (the gel) worked better than Excellerate (the drug plus the gel.) Kudos to Cardium for convincing FDA to grant clearance to Excellagen gel. Making money by selling Excellagen is the real challenge, especially for a company short on cash and which remains at risk of getting booted off the NYSE Amex and on to the bulletin boards.