Caution: Federal law restricts the sale of this product to, or on the order of a licensed clinician.

Patient Information Guide

How does BioBag work?

Larvae do not have teeth so they do not bite or chew, instead they

produce liquid secretions which pass through small holes in the

polyester BioBag dressing onto the wound. The secretions break down

the devitalized tissue and bacteria into a liquid which they ingest as

nutrition. They are able to complete this process very effectively while

being completely contained within the BioBag.

What is BioBag used for?

The FDA cleared, prescription only medical device BioBag is indicated

for the debridement (cleaning) of necrotic skin and soft tissue

wounds such as pressure ulcers, diabetic ulcers, venous stasis ulcers,

surgical wounds and traumatic wounds. Debridement is the removal

of unviable tissue and bacteria from a wound to allow progression

through the wound healing process.

Thank you for considering BioBag as a

wound debridement option.

We understand that you may have a lot of

questions, let us answer them for you.

What is Larval Therapy?

Larval Therapy (also known as Maggot Therapy or Biosurgery) is a

natural form of wound debridement (cleaning) using the living larvae

of the greenbottle fly species called Lucilia sericata. The larvae of

the greenbottle fly are safe to use and the treatment has a long and

successful history. BioMonde has a unique approach to Larval Therapy

and packages the larvae within a sealed dressing called BioBag.

Where do the larvae come from?

BioMonde have been producing larvae for wound care since 1994.

BioMonde have a specialist facility in Gainesville, Florida which houses

the greenbottle fly Lucilia sericata. The life cycle is nurtured to allow the

creation of the fly larvae which are produced using an aseptic process

which means that they are free from contamination. BioMonde are

dedicated to your safety and work to strict quality standards.

Why should I use Larval Therapy?

The benefits of Larval Therapy have been witnessed for thousands of years. BioMonde has brought the therapy into

the 21st century by containing the benefits in the easy to use, contained BioBag dressing. Larval Therapy is a rapid

and efficient way to clean a wound and debridement can be achieved in as little as one treatment. Larvae are able

to remove what cannot always visually be identified as being unviable tissue or bacterial burden – which are two

things known to stall wound progression. Larvae actively remove devitalized tissue and bacteria (including MRSA

and biofilm) from a wound and because their secretions are selective and precise the larvae cannot take away any

healthy or viable tissue.

Note: Specific indications, contraindications, warnings and side effects exist for BioBag.

Further information can be obtained in the Instructions for Use, or by visiting www.biomonde.com

If you are going to be caring for your larvae at home please see our Patient Home Care Guide for further instructions.

We wish you every success on your journey towards wound healing.

How big are the larvae?

What does the treatmentprocess entail?

Will I feel the larvae on my wound?

It might surprise you to hear that the larvae of the greenbottle fly

species we use, Lucilia sericata, is very small. Smaller than larvae you

may have seen on television and definitely smaller than the image you

will have in your mind. They are around 2mm in length when they are

first applied to your wound and they grow to around 10mm after four

days of removing nutrition from your wound.

BioBag is very easy to use and is simply placed on top of your wound

much like a conventional dressing. The BioBag is covered with moist

gauze and a breathable wound pad and the dressing is secured using a

bandage or tape. From the outside it should look the same as your usual

dressing. Each BioBag treatment stays in place for up to four days and

the outer dressing is changed daily.

The BioBag can be applied at your home, in any healthcare facility or

outpatient clinic. On average one to three treatments are needed to

achieve successful wound cleaning. Your healthcare practitioner should

assess your wound at application and at the end of the treatment to

ensure successful debridement or that the correct follow-on treatment

is used.

Most people are unaware of the larvae’s presence, although it would be

normal to feel a tickling, pulsating or tingling sensation. Don’t forget

the larvae are contained within the BioBag dressing. Some patients,

particularly those with poor circulation or painful/sensitive wounds, can

experience an increase in pain during the treatment but this is typically

controlled with pain relieving medication.

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Patient Information Guide