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The BioMonde Larval Debridement Therapy Products - Larvae 100/200/300 are indicated for debridement of non-healing necrotic skin and soft tissue wounds, including pressure ulcers, venous stasis ulcers, neuropathic foot ulcers, and non-healing traumatic or postsurgical wounds. The BioMonde Larval Debridement Therapy Products - BioBag 50/100/200/300/400 are indicated for debridement of non-healing necrotic skin and soft tissue wounds, including pressure ulcers, venous stasis ulcers, neuropathic foot ulcers, and non-healing traumatic or post-surgical wounds.

The BioMonde Larval Debridement Therapy Products - Larvae 100/200/300 and BioMonde BioBag 50/100/200/300/400 products are live larvae, stage I and II, of the green bottle fly Lucilia sericata, provided either loose or within a sterile bag, respectively. The larvae are derived from disinfected fly eggs. Larvae are transferred under controlled manufacturing conditions into sterilized transport tubes or sterilized bags which are then placed into sterile transport tubes. These tubes are additionally pouched and boxed for transport. Upon arrival at the treatment location, they are applied to the wound and covered with permeable and absorbent dressings (not provided). The modification to these products consists of replacing the feed used for stock flies from liver to a special mixture of nutrients called the "Carnival Diet". The Carnival Diet is also used to rear new fly generations and as a medium to induce egg laying. The reason for changing to this feeding material is to reduce the risk of transmission of viruses by removing the use of unprocessed animal organs and change to using pharmaceutical-grade animal-derived material.

The BioMonde Larval Debridement Therapy Products - BioBag 50/100/200/300/400 are indicated for debridement of non-healing necrotic skin and soft tissue wounds, including pressure ulcers, venous stasis ulcers, neuropathic foot ulcers, and nonhealing traumatic or post-surgical wounds.

The BioMonde BioBag 50/100/200/300/400 products are live larvae, stage I and II, of the green bottle fly Lucilia sericata, provided within a sterile bag. They are manufactured in five (5) configurations: - BioBag 50: at least 50 larvae per container - BioBag 100: at least 100 larvae per container - BioBag 200: at least 200 larvae per container - BioBag 300: at least 300 larvae per container - BioBag 400: at least 400 larvae per container The larvae are derived from disinfected fly eggs. The BioBags are open mesh polyester bags that come in a variety of sizes based on the dose (number) of larvae to be used. The bags are used to constrain the larvae, preventing them from migrating from the wound. The bags also contain sterile PVA foam cubes that serve as spacers' in the BioBags to allow free movement of the larvae within the mesh bag. Larvae are transferred under controlled manufacturing conditions into sterilized bags after which they are placed into sterile transport tubes which are additionally pouched and boxed for transport. Upon arrival at the treatment location, the BioBags are applied to the wound and covered with permeable and absorbent dressings (not provided).

The BioMonde Larval Debridement Therapy Products – Larvae 100/200/300 are indicated for debridement of non-healing necrotic skin and soft tissue wounds, including pressure ulcers, venous stasis ulcers, neuropathic foot ulcers, and non-healing traumatic or post-surgical wounds.

The BioMonde Larvae 100/200/300 products are live larvae, stage I and II, of the green bottle fly Lucilia sericata. They are manufactured in three (3) configurations: - Larvae100: at least 100 larvae per container - Larvae200: at least 200 larvae per container . - Larvae300: at least 300 larvae per container . The larvae are derived from disinfected fly eggs. Larvae are transferred under controlled manufacturing conditions into transport tubes which are additionally boxed for transport. Upon arrival at the treatment location, they are applied to the wound and covered with permeable and absorbent dressings (not provided).

Medical Maggots are indicated for debriding non-healing necrotic skin and soft tissue wounds, including pressure ulcers, venous stasis ulcers, neuropathic foot ulcers, and non-healing traumatic or post surgical wounds. The accessory maggot confinement dressings, Creature Comforts™, and LeFlap™ and LeSoc™, are indicated for confining the medicinal maggots on the area of treatment during debridement therapy for the conditions mentioned above.

Phaenicia sericata larvae (see Figure 1) Common names: Maggot dressings; green blow fly maggots; disinfected maggots; sterile maggots; therapeutic maggots; debriding maggots; maggot debridement therapy. Accessories: MDT dressings; maggot confinement dressings; maggot cage dressings. "Proprietary" name: Medical Maggots; to be used with Creature Comforts or LeSoc (the latter being the new accessory featured in this Special PMN) Maggot therapy is essentially a controlled wound myiasis (maggot infessation). The maggots macerate their food with their mouth hooks, release their digestive enzymes into the local environment, and ingest the liquefying and semi-solid tissue. As they grow, they molt twice. When satiated, the maggots leave their food source, burry themselves in a suitably protected area, and pupate. Adult flies emerge (eclose) approximately 1-3 weeks later. Maggot therapy dressings contain the medical grade larvae on the wound during the period of debridement, and facilitate easy and controlled removal when the patient and therapist determine they have completed their work. The proposed modified accessory ("LeSoc") has the same basic structure and use as the previously approved "Sterile Nylon Stocking," with the exception that we will make the stocking out of a different polyester fabric: the same polyester monofilament fabric that we currently use in the production of our approved Creature Comforts dressing (our flat, non-stocking dressing). This means that the stocking weave will be fixed, not free to move or stretch. The structure, function, technology and indications are the same as in the currently marketed products. The only difference will be the offering of a hybrid dressing accessory to create a stocking-like dressing out of our currently used fixed-weave polyester net instead of the stretch-weave polyester of our Sterile Nylon Stockings.

Medical Maggots are indicated for debriding non-healing necrotic skin and soft tissue wounds, including pressure ulcers, venous stasis ulcers, neuropathic foot ulcers, and nonhealing traumatic or post surgical -wounds. The accessory maggot confinement dressings, Creature Comforts and Creature Comforts II, are indicated for confining the medicinal maggots on the area of treatment during debridement therapy for the conditions mentioned above.

Phaenicia sericata larvae (Medical Maggots) and maggot confinement dressings (Creature Comforts and Creature Comforts II). The maggots are used for debridement of non-healing necrotic skin and soft tissue wounds. The dressings are used to confine the maggots on the wound. The modified accessory is a pre-assembled version of the hydrocolloid-netting cage.

For debriding non-healing necrotic skin and soft tissue wounds, including pressure ulcers, venous stasis ulcers, neuropathic foot ulcers, and non-healing traumatic or post surgical wounds.

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