Cloverleaf Medical Ltd.

Welcome to a unique and excitingly different reality in tissue repair: tissue regeneration with ALLODERM as an ideal biological framework to harness nature's own regenerative healing process.

CORE TECHNOLOGY AlloDerm is an acellular dermal matrix derived from donated human skin tissue supplied by US AATB-compliant tissue banks utilizing the standards of the American Association of Tissue Banks (AATB) and Food and Drug Administration's (FDA) guidelines. Since AlloDerm is regarded as minimally processed and not significantly changed in structure from the natural material, the FDA has classified it as banked human tissue.

Human skin consists of both epidermis and dermis. In nature, the dermis contains a framework of biochemical and structural components that allow it to regenerate and replace itself continually throughout life. This complex natural framework consists of a three-dimensional arrangement of:

Proteins with a structurally intact
     basement membrane
Intact collagen fibres and bundles to
     support tissue ingrowth
Intact elastin filaments for
     biomechanical integrity
Hyaluronan and proteoglycans

HOW IS ALLODERM MODIFIED FROM NATURAL TISSUE?

When AlloDerm is prepared, the human donor tissue undergoes a multi-step proprietary process that removes both the epidermis and the cells that can lead to tissue rejection and graft failure, without damaging the matrix.

Once the dermal tissue has been decellularized, the final step is preservation. The processed tissue matrix is preserved with a patented
freeze-drying process that prevents damaging ice crystals from forming.

The cells responsible for immune response and graft rejection are removed. What remains is a matrix or framework of the natural biological components, ready to enable the body to mount its own tissue regeneration process.

Hernia formation, trauma, surgery, age-related diseases, infection, tumour, and degenerative conditions can lead to tissue loss or damage. Tissue loss or damage can be a devastating experience for you.

Fortunately, there are several options available for the replacement of your lost or damaged tissue. Ideally, the option you choose will not cause additional pain or introduce further complications. In addition, the option you choose will ideally result in new tissue growth so that after complete healing it will be as if you have regained your own tissue.

The two most commonly used repair options -autografts and synthetic materials - are not ideal. But, there is a better alternative - AlloDerm.

An autograft involves taking your own tissue from another part of your body for the repair. Using your own tissue is a good option, as it will not be rejected by your body. The autograft is accepted by your body and can restore the structure and function in the area of placement.

But, you would have to face two surgeries instead of one - one at the repair site and the other at the site where tissue for the repair is taken (referred to as the donor site). In addition, you could have complications such as infection, and healing might leave a scar at the donor site.

You could also have complications at the repair site: the donor tissue could be damaged, leading to inflammation; the donor tissue could die, leading to transfer failure and leaving you with two surgical sites and still no repair; or the donor tissue could tear while it is being stitched, leading to problems in healing.

ALLODERM BENEFITS

THE ALLODERM PROCESS - delivers a safe and effective biological matrix for use on abdominal wall and hernia repair. The benefits of AlloDerm include:

STRONG AND INTACT - As strong as synthetics, yet far more pliable; proprietary process results in an intact matrix.

EASY TO USE - Retains tensile characteristics to ensure excellent handling; requires no change in procedures.

VERSATILE ACELLULAR MATRIX - Exhibits remarkable versatility to be remodelled by the recipient into many types of tissue ranging from gingiva to fascia.

RESISTS ADHESIONS - Helps prevent adhesion of the visceral contents to the graft.

RESISTS INFECTION AND REJECTION - Supports rapid revascularization and remodelling into native tissue, minimizing the risk of infection and rejection.

REDUCES COSTLY COMPLICATIONS - Substantially fewer complications than synthetics, including seroma, dehiscence and recurrence.

SAFE - Screened and tested according to FDA regulations, American Association of Tissue Banks Standards, and appropriate state regulations.

BEFORE USE - Physicians should review all risk information, which can be found in the "Directions for Use" attached to the packaging of each AlloDerm graft.

ALLODERM - A Safe and Effective Alternative to Your Own Tissue

Synthetic materials, also called meshes, made of
materials such as ePTFE (expanded polytetrafluoroethylene) and polypropylene can be used as alternatives to your own tissue for repair. The repair process for these materials is based not on regenerative healing, but on scar formation in and around the mesh.

The advantage of using these materials is that they do not present the donor site issues encountered with using your own tissue for repair. They are strong and do not tear easily, are readily available, inexpensive, and have a long history of being used for soft tissue replacements.

However, use of synthetic materials is not without problems. As a foreign material, your body may react to its presence by growing around it (encapsulation) in an attempt to exclude it from your body. In the process, your tissue forms a capsule of rigid, fibrous scar tissue around the synthetic material. The rigid capsule could affect the function and the aesthetic outcome of the repair. Furthermore, foreign bodies such as synthetic materials increase the risk of infection when implanted in the body. As part of the foreign body response, the repair site may be subjected to inflammation, infection and pain.

AlloDerm is processed from donated human skin.
The tissue goes through a cell removal process while retaining the important biochemical and structural components. AlloDerm is, thus, acellular human tissue.

Using AlloDerm for tissue repair is like using your
own tissue except that you will avoid a second
surgical site and the potential problems associated with autografts. Also, you will further minimize any potential problems at the repair site because AlloDerm will regenerate into your own tissue.

Since AlloDerm is derived from human tissue, there may be a concern that it might harbor disease carrying viruses. Tissue donors are screened and tested for transmissible diseases including HIV, hepatitis, and syphilis before tissue processing.

A comprehensive review of the donor's medical
records and social history is completed and released by a medical director before allowing the tissue to be processed. Finally, before AlloDerm is released for use, additional tests are performed to assure patient safety. ALLODERM has been utilized in more than 750,000 implants and grafts to date, without any reported incidence of viral disease transmission to a patient.

ALLODERM Supports New Tissue Growth and
Restores Function AlloDerm repairs damaged tissue by providing a foundation for new tissue
regeneration. The skin components preserved in
AlloDerm contain the information that will help your own tissue to grow into the AlloDerm after placement at the repair site.

Soon after the repair, blood will flow from your tissue into the preserved vascular channels in AlloDerm. This is a critical event, as it paves the way for healing.

Next, your own cells will move into AlloDerm and begin the process of new tissue growth or tissue regeneration. This is the same process that your body uses to replace cells that your body sheds as part of your body's regular maintenance cycle.

As the healing progresses, more and more of your cells will move into AlloDerm and transform it into tissue that not only resembles your own but also functions like your own.

AlloDerm Reduces the Risk of Rejection and Infection Because AlloDerm goes through a cell
removal process, AlloDerm is much less likely to be recognized as a foreign body, which helps reduce the chance of rejection by your immune system.

Because AlloDerm regenerates into your own tissue, the occurrence of infection when AlloDerm is used has been less than synthetic materials. In fact, AlloDerm is used by doctors in infected wounds where synthetic materials cannot be used.

Once the repair site has completely healed, you
may be unable to tell the difference between your own tissue and AlloDerm.

The repaired site will look like your own healthy
tissue, and not scar.

To ensure complete healing with AlloDerm and to
obtain the expected results, you must follow the
advice of your doctor.

Complete healing with AlloDerm takes about 2 to 6 months, depending on the repair site and the
procedure. Should you have any concerns or
questions during the healing process, you should
consult your doctor. Individual results may vary and may depend on your specific situation and/or medical condition. Consult with your doctor to ensure that AlloDerm is right for you.