FDA Clears First Quick-Med product

 

Monday, Mar 16,2009, 11:32:37 AM   Click:

27 February 2009 - Published in the insurance, fire insurance, accident, dental, financial services, general insurance, health insurance, insurance companies, online insurance, liability insurance, Life Insurance, Pet Insurance, property insurance

Quick-Med Technologies, Inc.announced it has received authorization from the U.S. Food and Drug Administration to market and distribute its NIMBUS ® patented barrier gauze wound care dressings. This is the first FDA approval NIMBUS - an innovative technology that is so unique and avant-garde that was submitted to the FDA on De Novo, a special authorization for medical devices which are not substantially equivalent "to predicate device.

What makes NIMBUS gauze treated different from other antimicrobial dressings are its standing and its ability to be effective even in the presence of large quantities of serum and exudate. The active agent is permanently bonded to the canvas, keeping the biocide of exhaustion, while killing germs (such as MRSA, VRE, and others) who are drawn into the absorbent dressing. NIMBUS allows control of microbes without leaching any material into the wound bed, which eliminates interference with the healing process of wounds. Is linked to the antimicrobial dressing keeps the complete test results show that even in 90% serum, gauze NIMBUS continues to kill germs better than the other antimicrobial agents.

Anticipating FDA Quick-Med has already authorized NIMBUS gauze for marketing in the United States and Canada to Derma Sciences, Inc., a leading provider of products for wound care. Derma Sciences' CEO Ed Quilty, NIMBUS recently characterized as representing "the first true fusion of tradition and wound care technologies." Derma Sciences, and the company that the product for launch in spring 2009.

NIMBUS provide safe, affordable and very effective barrier of protection for $ 14 billion wound care market worldwide is expected to continue rapid growth in the coming years, mainly due to the aging population. The Company is actively negotiating with other manufacturers of medical devices for the application of NIMBUS to other substrates.

NIMBUS is non-toxic, durable and not blocked by organic as blood, urine and sweat. The labeling of the product was allowed indicates that various organisms such as MRSA, VRE, Pseudomonas aeruginosa and Escherichia coli are killed in proportions greater than 99,999%.

NIMBUS is a new generation of wound care technology. According to Gregory Schultz, a professor at the Research Institute for the wound at the University of Florida and former president of the Wound Healing Society, NIMBUS poses no risk of developing resistant bacteria, or the release of substances toxic in the wound and prevent the healing process. This is a new technology, bonded and effective even in high concentrations of body fluids. "We believe that health professionals will have more to offer comfort NIMBUS wound dressings acute or chronic, difficult to heal wounds. Unlike silver dressings, NIMBUS technology causes discoloration and not damage cells.

Roy Carr, Quick-Med Business Development Manager, noted "Nimbus has several advantages over the money, the current market leader for antimicrobial medical devices, summed up: better performance, less than one tenth of the cost. It is also less likely to hamper or delay wound healing because it is bound and kept in the cell inactivation.

"This authorization is an important milestone for Quick-Med will be a predicate for other medical devices incorporating deposits NIMBUS technology," according to J. Ladd Greeno, Quick-Med's CEO. NIMBUS technology is flexible, and FDA permission to market, can be made available in other formats dressing wounds, including adhesives, foams, hydrogels, films and hydrocolloids.

Novo clearance valid NIMBUS technology to meet all FDA requirements, above and beyond 510 (k) process. The Company believes that such permission through the process of De Novo May potential benefits of the market that we have understood that the FDA in May to take a new antimicrobial posture that could increase the barrier to entry.