Synedgen Receives FDA Clearance for its SynePure Wound Cleanser
CLAREMONT, Calif. — August 24, 2015– Synedgen announces U.S. Food and Drug Administration 510(k) clearance to market its SynePureTM Wound Cleanser (K143444). SynePure Wound Cleanser is intended for the cleansing and rinsing of dermal wounds such as pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor irritations of the skin.
The SynePure Wound Cleanser is designed as an advanced irrigation technology to cleanse wounds by providing superior wound cleaning with no deleterious effects on wound healing. The development of the SynePure Wound Cleanser was funded by DARPA, the Defense Advanced Research Projects Agency, to meet the immense challenges of cleansing deep, dirty and complicated wounds often incurred by US soldiers in combat. These wounds are frequently full of debris and contaminated, and if not cleansed early, can lead to significant complications such as wound sepsis and failure of the wounds to heal properly.
SynePure Wound Cleanser is specifically designed to provide immediate and effective irrigation of wounds following injury and could become part of the first aid kit carried by all U.S. soldiers. It is packaged for use in a squeezable bottle fitted with a nozzle to direct a focused stream of cleanser with sufficient force to help dislodge debris and contamination. The advanced technology also aggregates particles in the wound to help facilitate their removal. Synepure Wound Cleanser is also suitable for hospital and emergency care use with clearance for both single and multiple use bottles.
“The SynePure irrigation system is easily delivered with one hand to rinse debris and contamination from wounds, allowing self-application at the time of injury. This design is ideally suited for use in the field and pre-hospital environment in both military and civilian environments,” said Shenda Baker, PhD, Synedgen President and COO. “We worked closely with our military sponsor to develop a highly effective and easy to use product that does not impede wound healing. This clearance is a key step in the roll-out of our comprehensive wound care platform.”
“While this cleanser was tailored to the extreme needs of the military, it has equally great application for the cleansing and rinsing of any skin, external wounds, non-healing ulcers, post surgical wounds, severe burns, and lacerations,” said William Wiesmann, MD, Synedgen CEO.
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