Monarch Labs announces first wound dressing in US specifically for maggot therapy

March 10, 2009

Irvine, Calif. -- Monarch Labs, LLC, announced today the market launch of its new, proprietary wound dressing specifically designed to make maggot therapy more easy, quick and simple to administer. It has been allowed by the U.S. Food and Drug Administration for manufacturing and marketing under the trade name LeFlap™.

In the United States, maggot therapy is used to clean or "debride" non-healing wounds such as many types of pressure ulcers ("bed sores"), foot and leg ulcers, and traumatic or post-surgical wounds. This method of treating chronic wounds has seen a steady rise in use ever since the U.S. Food and Drug Administration (FDA) granted marketing clearance to the Medical Maggots™ brand of medicinal maggots in 2004. Over 1,000 health care practitioners regularly use maggot therapy in caring for their patients with chronic wounds.

Medicinal maggots are usually kept on the wound within cage-like dressings that are placed over the wound. Up to this point, maggot therapy dressings have been constructed by doctors, nurses, podiatrists, veterinarians and wound care technicians at the bedside-- taping or gluing together conventional medical dressings to make the cage.

Specifically designed for maggot therapy, LeFlap™ is the first pre-manufactured cage dressing available for the U.S. market. The single-piece LeFlap™ maggot confinement dressing is intended to prevent medicinal maggots from leaving the wound before the treatment is scheduled to end and reduce the time and cost necessary to confine them to the wound.

The LeFlap™ wound dressing consists of a bottom hydrocolloid pad that can be cut to fit the patient's wound dimensions. This foundation layer is hinged to a polyester monofilament netted fabric coated with an adhesive. When the adhesive liner is removed, the netting will directly adhere to the hydrocolloid base, containing the maggots within. Unless the patient is active or the wound area is subject to a lot of movement or soiling, no additional dressing materials or adhesives should be required.

The cost of Medical Maggots™ for a single treatment is about $100 but the dressings that keep the maggots on the wound can be just as expensive and take 30 minutes or more to construct. The estimated retail price of LeFlap™ will be about $25, and it will take less than 10 minutes to apply.

"Monarch Labs undertook the design, construction, testing, patenting and regulatory approval of LeFlap™ in response to growing customer demand to simplify the application of maggot therapy. I believe this new wound dressing will make maggot therapy in the United States much more widely accepted." says Ronald Sherman, M.D., the inventor of LeFlap™ and Monarch's laboratory director. "In multiple clinical studies, maggot therapy has been documented to eliminate the need for amputation in 40 to 50% of all cases so we wanted to find ways to simplify utilization of maggot therapy," he added.
-end-
About Maggot Therapy

Maggot therapy (also known as maggot debridement therapy (MDT), larval therapy, larva therapy, larvae therapy, biodebridement or biosurgery) is a type of biotherapy involving the intentional introduction by a health care practitioner of specially raised and disinfected maggots (fly larvae) into non-healing skin and soft tissue wounds for the purpose of selectively cleaning out ("debridement") only the dead ("necrotic") tissue ("gangrene") within the wound.

About Monarch Labs, LLC

Monarch Labs is a specialty medical device company focused on commercializing biotherapy products. Biotherapy is the use of living animals for medical treatment or diagnosis. Monarch's first commercial biotherapy product is Medical Maggots,™ (disinfected Phaenicia sericata larvae) for maggot therapy. Medical Maggots™ are indicated for use in the care and treatment of chronic wounds of humans or other animals. In the United States, Medical Maggots™ are regulated by the Food and Drug Administration as a prescription only medical device. For further information regarding Monarch Labs, please visit the company's website at www.MonarchLabs.com.

Monarch Labs

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