Category: Press Releases

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.

This material is based upon work supported by SSC Pacific under Contact No. N66001- 14-C-4009. Any opinions, findings, conclusions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the SSC Pacific.

June 26, 2012 — Claremont CA—Elephants and Rhinoceroses frequently encounter chronic non- healing infected abscesses and cutaneous wounds that become resistant to traditional antibiotics and treatments. Over time, these wounds can have serious long-term consequences such as systemic infections and impaired mobility. Recognizing the difficulty in treating these types of wounds, the FDA’s Center for Veterinary Medicine has recently allowed Synedgen to market Synoplex®, Synedgen’s veterinary wound rinse product, as an FDA Indexed Product to treat infected, chronic and non-infected wounds in elephants and rhinoceroses. Synoplex is intended for the treatment of chronic foot disease (cracked nails, abscesses, lesions, ulcers, fissures) and chronic non-healing dermal or subdermal wounds such as abscesses and pressure sores caused by chronic inflammation or bacterial species. Synoplex® is also intended for use as a regular treatment for non-infected wounds at a lower dose.

Data have shown that Synoplex breaks up established biofilms, flushes the bacteria from the wounds, and inhibits the formation of biofilms, providing a safe, prophylactic and therapeutic treatment for both chronic and acute infections associated with dermal wounds and foot disease in elephants and rhinoceroses. In addition, Synoplex has been shown to encourage wound healing, unlike other topical disinfectants that are damaging to tissue.

“Synoplex provides a breakthrough technology for treating both chronic and acute topical infections by eliminating the need for antibiotics,” stated Synedgen President Shenda Baker. “This product is perfectly suited for large topical wound application in elephants and rhinoceroses, as it is safe for the veterinarian and animal and heals the wound while preventing or treating infection.”

Currently, wounds in elephants and rhinoceroses are treated with systemic or topical antibiotics as well as topical disinfectants, such as chlorhexidine or Betadine. These disinfectants are great at reducing bacteria, but they are very harsh on the wound and can inhibit healing. The cost of systemic antibiotics in these large animal species can be cost prohibitive and disrupt their gut flora. Synoplex can be used for Gram-positive or Gram negative bacterial infections, as well as in non-infected wounds.

An expert panel of renowned veterinarians unanimously concluded that Synoplex is effective and safe for use in the family Elephantidae and the family Rhinocerotidae in December 2011. The panel notes the importance of new treatments for infection in its recommendation, “Often these chronically infected wounds have been treated repeatedly with various antimicrobials resulting in development of multiple drug resistant strains of bacteria. The advantage of treating these infections without use of an antimicrobial is a major benefit to the patients and to the caretakers.” Synoplex Panel Member Head Veterinarian Dr. Ralph Zimmerman of the Albuquerque BioPark remarked, “Synoplex provides a safe, prophylactic and therapeutic treatment for controlling and preventing bacterial biofilms and treating both chronic and acute infections associated with dermal wounds and foot disease. Use of Synoplex has demonstrated effectiveness without any adverse effects. Likewise, there is minimal concern for the veterinarian or other caretakers applying Synoplex to their patients as there have been no known allergic reactions or adverse events reported.”

The Office of Minor Use and Minor Species Animal Drug Development (OMUMS) maintains an index of legally marketed unapproved new animal drugs and their designated intended uses for minor species. Synoplex® is legally marketed as an FDA Indexed Product under MIF 900-012.