Conditions

Developments in treatments of skin ulcers have made tremendous strides over the last couple of decades. However, there is still an overwhelming need for new products to not only treat skin ulcers but also to prevent them. More recently, significant advancements are taking place daily with some truly sophisticated, highly effective skin ulcer treatments. These revolutionary advances include tissue engineering, growth factors, animal-fetal-cell research, stem-cell research and gene therapy offering new hope to patients who experience acute and chronic skin ulcers.

OmegaSkin™ introduced by NeuEsse Inc. directly targets the dressing and closure of the following types of ulcers. OmegaSkin applied in either sheet form or through our “no touch” spin blower medical device directly on the patients affected areas has the potential to revolutionize ulcer treatment for these patients.

PRESSURE OR DECUBITUS ULCERS

An unfortunate problem for a bedridden individual may be the development of pressure sores, or decubitus ulcers. Because thinning epithelial cells and blood vessels have a slower rate of repair, the incidence of decubitus ulcers is higher and the ulcer more severe in the elderly with healing of damaged skin being slower. Pressure sores are localized areas of cellular necrosis resulting from prolonged pressure between any bony prominence and an external object such as a bed or wheelchair. The tissues are deprived of blood supply and eventually die. Areas frequently affected in older individuals include the heels, greater trochanter, sacrum, dorsal and scapular regions of the spine, and elbows. Long-term pressure increases vulnerability to decubitus ulcer development. High pressure maintained for a short time is less dangerous than low pressure continued for a long time.

DIABETIC ULCERS OR NEUROPATHIC ULCERS

Neuropathic skin ulcers, also known as diabetic neuropathic ulcers, occur in people who have little or no sensation in their feet due to diabetic nerve damage. These skin ulcers develop at pressure points on the foot, such as on the heel, the great toe or other spots that rub on footwear. Diabetics are prone to ulcers, especially foot ulcerations due to neurologic and vascular complications. Peripheral neuropathy is often experienced by diabetics and causes an altered or complete loss of sensation in the foot and/or leg. Therefore, any cuts or trauma to the foot can go completely unnoticed for days or weeks in a patient with neuropathy. There is no known cure for neuropathy.

VENOUS ULCERS

Venous skin ulcers are the most common, accounting for up to 80% of all leg ulcers. Chronic venous insufficiency can lead to venous stasis ulceration, which may occur because of previous deep venous thrombosis. The basic dysfunction is incompetent valves of the deep veins. The ulcers usually develop around the ankles. The skin texture of the lower leg is leathery, with a characteristic red-brown appearance. Edema has usually been present for a prolonged period. The ulcer is a concave lesion below the margin of the skin surface and may become extensive. Pain may occur when the limb is in a dependent position or during ambulation. If the ulcer is untreated, the lesion becomes more extensive, eroding wider and deeper. The likelihood of infection is increased. Scar tissue formation around the rim of the ulcer is found.

Wounds that are breaches of skin can arise from a variety of sources, including trauma, surgery, burn, chronic diabetic foot, venous, pressure or other ulcer. Wound care encompasses responding to a number of different needs, from staunching bleeding to providing an immediate physical barrier to cleaning and debriding the wound bed to fighting infection to promoting wound closure to reducing scarring and restoring skin appendages such as hair follicles and sweat glands.

Serious acute and chronic wounds that have difficulty closing and healing typically are dressed with autologous skin grafts, or skin substitutes from human tissue, including from cadavers, or from animal sources, such as bovine collagen or porcine small intestine submucosa.

The gold standard in dressing wounds that have difficulty closing and healing is an autologous skin graft. However, such a procedure requires significant practitioner time and expertise, imposes ancillary trauma and risk to the patient, and is costly and limited in the area of a patient’s skin that can be harvested and grafted.

Skin substitutes currently on the market are made from human cells or tissue (e.g., neonatal foreskin, amniotic tissue, cadaverous skin) or animal products (e.g., bovine collagen, porcine small intestine submucosa, and other components from equine, ovine, piscine and other sources). There are also synthetic approaches (e.g., made from biocompatible polymers), although they are not materially represented among current products in the relevant market segments.

Skin substitutes are expensive (ranging from about $10 to over $200 per cm2). High cost has limited penetration to single digit percentages of addressable patients in various clinical segments (such as full or partial thickness trauma wounds, 2nd degree burns, or diabetic foot ulcers). Furthermore, cultural or religious sensitivities to sources of material (cadavers, embryonic materials, cows or pigs), as well as the high cost, have essentially blocked access to skin substitutes for millions of patients around the globe.

Thus, there is an urgent need for an effective culturally sensitive skin substitute at affordable prices. 

Burns are one of the most common and devastating forms of trauma to normal tissue. Patients with serious thermal injury require immediate specialized care in order to minimize morbidity and mortality. Burn care usually involves local wound care and/or surgical wound closure using skin grafts or skin substitutes. The challenge with split thickness skin grafting is the size of a burn to be reconstructed requires an equivalent amount of tissue to be harvested from another part of the body or to be supplied by a substitute.

Further, the prevalence of patients with severe burns is even higher in emerging economies. For example, according to the World Health Organization over 1,000,000 people in India are moderately to severely burnt every year and approximately 265,000 people worldwide die from burn related injuries¹. According to Critical Care, an international clinical medical journal, burns are also among the most expensive traumatic injuries because of long and costly hospitalization, rehabilitation and wound and scar treatment. OmegaSkin’s advantage of culture and religious compliance could mitigate the reluctance to secure care.

Since each burn patient, each burn wound on a given patient, and each patient’s clinical status differs from all others. Because of the unique nature of burns, each burn surgeon, acting on the patient’s behalf, is the only clinician qualified to determine the appropriate treatment that is medically necessary for the patient in his/her care. As a result, initial hospitalization costs and physicians’ fees for specialized care of a patient with a major burn injury are currently estimated to be $200,000. Overall, costs escalate for major burn cases because of repeated admissions for reconstruction and rehabilitation therapy. In the U.S., current annual estimates show that more than $18 billion is spent on specialized care of patients with major burn injuries².

Burn injuries account for a significant cost to the health care system in North America and worldwide. In the U.S. there are currently 127 centers specializing in burn care. Recent estimates in the U.S. show that 40,000 patients are admitted annually for treatment with burn injuries, over 60% of the estimated U.S. acute hospitalizations related to burn injury were admitted to burn centers. Such centers now average over 200 annual admissions for burn injury and skin disorders requiring similar treatment. The other 4,500 U.S. acute care hospitals average less than 3 burn admissions per year.

Data from the National Center for Injury Prevention and Control in the U.S. show that approximately 2 million fires are reported each year which result in 1.2 million people with burn injuries³. Moderate to severe burn injuries requiring hospitalization account for approximately 100,000 of these cases.

A burn is defined as an injury to the skin or other organic tissue primarily caused by thermal or other acute trauma. It occurs when some or all of the cells in the skin or other tissues are destroyed by hot liquids (scalds), hot solids (contact burns), or flames (flame burns). Injuries to the skin or organic tissues due to radiation, radioactivity, electricity, friction or contact with chemicals are also identified as burns.

 

1: Source: World Health Organization "Burns: Fact Sheet No. 365," reviewed September 2016) truncated available at: http://www.who.int/mediacentre/factsheets/fs365/en/

2: Church D, Elsayed, S, Reid O, Winston B, Lindsay R "Burn wound infections" Clinical Microbiology Reviews 2006;19(2):403-34

3: American Burn Association Burn Incidence and Treatment in the US: 2000 Fact Sheet, available at: http://www.ameriburn.org