Therapeutic focus area We develop a novel technology for an unmet medical need
We are keen in our commitment to bring the best solution to patients globally. We are constantly developing a technology to address serious wound conditions. We concentrate our efforts on a core set of wound therapeutic areas, where we have already proven the safety and efficacy, and where we feel we can have an even greater impact on wound care and how it is managed.
About wound care
Wound care is an ever-evolving medical device industry that prospers due to its considerable product innovation. Companies are constantly striving to create products that are easier for physicians to use, that fight infection, and that take less time for wound closure. Due to these factors, this market is expected to increase in value over the coming years.
The largest competitors in this field were almost able to collectively capture the majority of the global $US35 billion wound care market in 2018. Products are offered at a variety of price points with diverse device portfolios. Diversification and product bundling are expected to have significant impact on the industry competition in the near future. Reimbursement is also likely to have a large impact on this market as products sold for off-label uses may soon be no longer eligible for reimbursement. Unfortunately, NO drugs, specifically topical pharmaceuticals are available in this market at this time.
As leading experts in wound healing and therapies, we focus on treatments that will improve the standard of care for chronic wounds. Skin wounds in healthy individuals usually heal quite quickly on their own. Nonetheless, a chronic wound is a wound that does not heal in a predictable amount of time like most wounds do in healthy individuals. They close very slowly, keep on opening up, or don't heal at all. People who develop chronic wounds often have an underlying condition that causes even minor pressure to lead to wounds that then no longer heal. The main factors that are involved include circulation problems, venous insufficiency, inflammatory diseases and diabetes. Poorly healing wounds are more common on the feet or lower legs. Doctors consider wounds that do not heal within three months to be chronic. These wounds cause patients severe emotional and physical stress and create a significant financial burden on patients and the whole healthcare system. Treatment for chronic wounds often takes a long time and can be painful. In addition to good wound care that include debridement, cleansing, offloading and control of infection of the wound, and wound coverage with dressings, it's important to treat the underlying condition that contributed to the development of the chronic wound. In addition to good wound care some doctors use technical methods to help chronic wounds to heal faster including smart dressings, hyperbaric oxygen therapy, vacuum-assisted closure (VAC therapy), ultrasound therapy, electromagnetic therapy and Skin grafts.
We fight diabetic foot ulcer...
The diabetic foot ulcer problem is one of the most disabling complications of diabetes and is associated with poor quality of life and, lower-limb amputation and premature mortality. The incidence of diabetes has nearly quadrupled in the past three decades, and the number of diabetic patients has risen to over 420 million among the world’s adult population, and this number is predicted to reach 640 million by 2040. Within the diabetic population, nearly 25% of all diabetic patients have or will develop diabetic foot ulcers during their lifetime making diabetic foot ulcer to become epidemic.
Globally, diabetic foot ulcers are now associated with an astonishing direct annual cost of care reaching US$30 billion including hospitalization, management of wounds and infections, and minor and major amputations. Direct medical costs associated with diabetic foot ulcers present additional considerable indirect economic loss to patients, their families and society through lost income, disability, decreased societal contributions and mortality.
Diabetic foot ulcers are typically categorized as neuropathic, ischaemic, or neuroischaemic ulcers. Of the three types, the most severe adverse outcomes occur with an ischaemic diabetic foot ulcers, because healing time, ulcer recurrence, risk of amputation, and mortality are the largest. The incidence of hospitalization of diabetic patients with a foot ulcer is high because of infection and many of these patients require a limb amputation. Moreover, 55% of patients with diabetic foot ulcers who had a lower extremity amputation will require a subsequent amputation within three years. The risk for mortality of a diabetic patient with a foot ulcer is 2.5 times higher than that of a diabetic patient without a foot ulcer. In addition, up to 70% of patients may die within five years after amputation.
Risk factors for a diabetic foot ulcer can be divided to three groups: pathophysiologic variations, anatomic deformities, and trauma. Pathophysiologic variations happen at the molecular level leading to complications comprising peripheral vascular disease, peripheral neuropathy, a compromised immune system, and defective wound healing. Neuroarthropathy contributes to foot deformity, leading to high plantar pressures and increased risk of skin rupture. These risk factors do not classically occur independently, but rather in combination, further increasing the risk of ulceration. Finally, external influences, such as acute or lasting trauma, are often the originating factors in the development of diabetic foot ulcers.
Development of a diabetic foot ulcer is also exacerbated by defective wound healing due to poor blood flow to the foot and depletion of growth factors and cytokines, which delays its healing and closure. Diabetic foot ulcers have an extended inflammatory phase with impaired neovascularization and fibroblast dysfunction and are characterized by degradation of the extracellular matrix and impeded formation of the provisional matrix that initiate the wound healing repair process.
The management of diabetic foot ulcers is multidisciplinary. The existing guidelines for managing a diabetic foot ulcer include standard-of-care treatment which comprises blood glucose control, treatment of comorbidities, local wound care with efficient debridement, cleansing, control of infection, offloading, vascular evaluation, and revascularization if required, the use of wound dressing types that maintain a moist environment, and increasing patient's awareness to prevention and treatments. In addition, the intricate challenges of the ulcer environment, including ischaemia, hypoxia, oxidative stress, microbial infection, as well as the role played by inflammatory cells have to be considered. Unfortunately, the outcomes are usually unsatisfactory when using these management strategies. Therefore, there is a need to complement the standard-of-care treatment with therapies that promote skin regeneration, accelerate wound healing, restore skin function, and maintain the efficacy of any applied or administered drug in the diabetic foot ulcer environment.
Within the sharp increase in the incidence of diabetes seen in the last four decades, and the complex and costly management of the recurrent ulcers in diabetic patients, diabetic foot ulcer creates a significant societal and health challenge. Moreover, failure to provide a significant safe and effective therapy for healing of foot ulcers, the diabetic foot ulcer problem is further exacerbated. Therefore, an effective solution has become tremendously needed for the debilitating diabetic foot ulcer problem
We create hope to patients suffering of chronic wounds of epidermolysis bullosa...
Epidermolysis bullosa is a distressing and painful genetic rare skin condition that cause the skin layers and internal body linings to separate. It is characterised by extreme fragility of the skin from birth. However, epidermolysis bullosa comprises a clinically and genetically heterogeneous group of disorders characterized by fragility of the skin and mucous membranes and a tendency of the skin to blister in response to minor friction or trauma, resulting in open non-healing wounds. The epidermolysis bullosa genetic disorder comprises of three different subtypes (i) Simplex (EBS), (ii) Dystrophic (DEB), and (iii) Junctional (JEB). All the three subtypes have the same symptoms related to skin blistering and erosions but varying degree of complexity. For example, EBS is the most common and least severe and occurs in around 70% of all epidermolysis bullosa cases. In contrast JEB is very severe and results in low life expectancy, and is extremely rare. The skin fragility is caused among other components of the skin, by a lack of the collagen IIV subtype, the protein that holds skin layers together. Even minor mechanical friction like rubbing or pressure, or trauma of a skin of an epidermolysis bullosa patient will separate the layers of the skin and form blisters and painful sores. Blisters result in skin erosions, i.e. superficial wounds that are painful and susceptible to infection, leading in many cases to non-healing chronic multiple wounds. The wounds are permanently subjected to a painful inflammatory reaction. The sores or wounds of epidermolysis bullosa are compared with third-degree burns. Approximately, the number of epidermolysis bullosa patients is around 65,000 in both EU and USA and around 105,000 in the whole world with a prevalence of 1/17,000 live births. Few patients live beyond the age of 30.
The care of patients with epidermolysis bullosa is complex, requiring the attention of a highly-trained multi-disciplinary team. The development of targeted therapies to the disease such as cell-based therapy, bone marrow transplantation and gene therapy are still under investigation. Currently, there is no cure to this debilitating disorder and the goal of the therapy is prevention of the disease complications and healing the symptomatic wound problem. The current solutions to heal wounds of epidermolysis bullosa patients are wound care products to prevent infection and reduce pain. The existing wound care products are mainly medical devices of multiple type of dressings that are usually expensive and have limited efficacy. Skin grafting of dermal and epidermal tissues for treating the wounds of epidermolysis bullosa patients is another option, but its success rate is limited and its use requires a surgical procedure that demand careful case selection and specialised expertise. Therefore, this solution is very expensive to the healthcare system and causes additional suffering to epidermolysis bullosa patients. Currently, there is no topical drug for wound healing in general and for wounds of EB in particular. Therefore, there is an unmet need to develop a topical drug that is both safe and cost-effective for the treatment of wounds of EB patients.
In epidermolysis bullosa patients, management of a single wound or multiple ones of varying duration and healing stage is complex. Choice of dressings for wounds of EB patients varies from one individual to another. It also depends on the location and characteristics of the wound. Semi-occlusive dressings that are non-adherent, such as soft silicone and foam dressings, are preferable as they absorb the exudate and minimize pain and further blister formation during dressing changes. In critically colonized wounds, topical agents such as diluted bleach baths, topical antiseptics, and topical antibiotics are used. All dressings for all types of epidermolysis bullosa wounds should be changed daily and modified depending on the amount of exudate and odor. If the wound is covered in an eschar, debridement is performed to encourage healing by removal of biofilms that sustain the inflammatory process. In 2012 wound care costs of an epidermolysis bullosa patient in EU or USA ranged from €19.6 to €240 daily for an infant boy and from €48.3 to €591.5 for a 10-year-old boy. Data from the EU suggest that dressing costs in adults with epidermolysis bullosa may exceed €450,000 per annum, and that costs of having paid carers to undertake dressing changes may also exceed €57,000 each year.
We focus on research and development for areas of significant need to improve quality of life skin injured individuals...
Burn is a global public health problem associated with significant morbidity and mortality. Each year, more than 250,000 deaths occur due to burns globally. Some victims of burns suf¬fer from life-long disability, affecting the mental health, and imposing a socioeconomic burden. Additionally, in the military environment, burn injury remains a constant source of morbidity and mortality. Historically, it constitutes up to 20% of all injuries and responsible approximately for 4% mortality. Today, burn management is mostly restricted to intravenous fluids infusions, sterile dressings and antibiotics to avoid infection of a burn wound, and analgesics for pain management. Unfortunately, there is no effective and safe treatment to facilitate burn wound healing other than coverage with autologous skin grafting.
The global burn care product market size was estimated at US$6.3 billion in 2016, and is expected to reach US$8 billion by 2025. Increasing incidence of burn-related injuries is the major factor driving the market growth and is anticipated to fuel the demand for cost-effective treatment over the forecast period. Rising concern regarding aesthetic appearance amongst patients is the major factor attributing toward the demand for advanced products. Moreover, associated advantages with the use of biologics to treat wounds, such as accelerated healing, cost-efficiency, shorter length of hospital stay, and management of acute burn injuries are also expected to drive growth.
Burn wound healing is a complex process that is initiated by tissue injury and involves inflammation, proliferation, migration, neovascularization, matrix synthesis, collagen deposition, formation of granulation and tissue re-epithelialization and remodeling. The process involves interplay of cells, mediators, growth factors, and cytokines. During the proliferative phase angiogenesis occurs, and the formation of new blood vessels facilitates oxygen and nutrient delivery. Large and deep burn wounds are life threatening and wound surfaces need quick coverage by autologous split skin grafts. Other ways they continue to be a major risk for infection, sepsis and death. Because of the destroyed sub-dermal vascular plexuses as well as the released toxic and pro-inflammatory factors, wound healing capacity is impaired, often resulting in harming scar tissue of minor quality. In many cases autologous split skin grafts cannot be taken in the required amount and repetitive harvesting from the same areas is necessary. The dynamic process of burn progression has a major impact on the final outcome in terms of morbidity and quality of life. Irreversible skin necrosis develops at burn. Restoration of adequate perfusion and attenuation of inflammatory reactions may salvage this zone and decrease morbidity associated with burn injury. Keloids may also form subsequent to a burn, particularly in those who are young. Following a burn, people may have significant psychological trauma and experience post-traumatic stress disorder. Scarring may also result in a disturbance in body image, psychological disturbances, and social isolation.
Beyond the effort to reduce mortality rates in burn victims, improving patients' quality of life and reducing costs of treating burn injuries are central to the proactive strategy of burn wound care providers. There is an urgent need for approval of a safe and cost-effective medicinal product to overcome the delayed healing of a burn wound.
Our approach to innovation builds on strong science combined with the drive to find solutions where the need is the greatest...
Venous ulcers are wounds that occur due to improper functioning of venous valves, usually of the legs (leg ulcers). They are the major occurrence of chronic wounds, occurring in 70% to 90% of leg ulcer cases. Venous ulcers develop mostly along the medial distal leg, and can be painful with negative effects on quality of life.
Beauty is in our mind...
Skin care is the range of practices that support skin integrity, enhance its appearance and relieve skin conditions. They can include nutrition, avoidance of excessive sun exposure and appropriate use of emollients. Practices that enhance appearance include the use of cosmetics. Skin care is a routine daily procedure in many settings, such as skin that is either too dry or too moist, and prevention of dermatitis and prevention of skin injuries. Skin care is a part of the treatment of wound healing, radiation therapy and some medications.