Egiderma is an advanced textured highly absorbent medicated dressing which adequately addresses the problems associated with chronic wounds and hypertrophic scars. Featuring a patented  fiber technology, it guarantees optimal wound management enabling patients to achieve a complete and functional recovery even in cases when the function is impaired. Laced with ancillary agents that prevent hypertrophic scars and infections, Egiderma is the go-to treatment for complex wounds such as those arising from severe burns.

Patent Status

DEPOSITATO

Priority Number

EP19201160

Priority Date

02/10/2019

License

INTERNATIONAL

Market

TAM – Global advanced wound care market $18 billion; CAGR* of 6.0%

Wound dressing segment 54% share (2020)

SAM – European advanced wound care market $3,67 billion; CAGR* of 4.63%

SOM   Italian wound care market $652.27 million; CAGR* of 7.0%

*from 2022 to 2027

Problem

The economic cost of wounds is estimated to be in billions of euros, representing nearly 4% of total costs of the health care system (The Economic Cost of Wounds, 2022). Interestingly, health system managers may not be fully cognizant of the true cost of wound care due to the hidden costs of hospitalization and nursing time.

A common complication of complex wounds are hypertrophic scars which result from aberrant wound inflammation response or infection. Scars and associated functional as well as aesthetic concerns represent a huge burden on health care.

Depending on the wounding pathway, the scarring wound healing response has a pathological spectrum, ranging from cosmetic annoyance to grave functional impairment. Although hypertrophic scars can occur anywhere on the body, when the wound occurs over a joint, where the injury is subject to tension and motion, it’s more likely to develop a hypertrophic scar. The incidence rates of hypertrophic scarring range from 40% to 70% post-surgical to 91% post-burn, depending on the depth of the wound. Such pathological scarring can lead to severe functional impairment, psychological morbidity, and costly long-term healthcare.

Current Technology Limits

Complex wounds require advanced therapeutic medications that take active part in wound healing to achieve rapid and complete healing of wounds. The main dressings include medicated moist dressings, tissue-engineered substitutes, biomaterials-based biological dressings, biological and naturally derived dressings, medicated sutures, and various combinations of the above classes.

Commodity products, like bandage rolls (natural and synthetic), gauze dressings and sponges, lint, plaster and cotton or tulle dressings are not intended for treating severe wounds because they have the sole function of covering the wound.

There are not products on the market suitable as prophylactic treatment of hypertrophic scars. Cicacareâ is the only product already on the market by Smith & Nephew having antifibrotic activity; however, it is not intended for open wounds (as burns).

Skin grafting is a well-established technique commonly used by surgeon in cases of skin wounds after trauma, amputation and chronic ulcerations, however, the cost per unit (10 x12,5 cm2) of a cultured skin substitute is about €1800.

Other potentially therapeutic treatments, such as pressure and laser therapies, corticosteroids and interferon injections, are not taken in consideration because they are commonly used as therapeutic treatments when pathological healing has occurred.

Killer Application

The beneficiaries of Egiderma’s technology may be found in specialized burn centers, hospitals, long-term facilities:

  • Patients at burn centers – Egiderma will be essential to accelerate healing in severe burn patients, for which it is required extensive treatments ranging from 6 months to several years.
  • Plastic surgery patients – Egiderma will reduce the risk of scar permanence caused by plastic injuries and it will improve cosmetic outcomes.
  • Patients in home care settings – with Egiderma the healing time will be shortened reducing the cost of treatment and faster recovery from wounds
  • Patients in long term care facilities – Egiderma represents a valid therapeutic support to treat ulcerative lesions rapidly and efficiently, accelerating wound healing, and setting patients on the path to improved quality of life.

Our Technology and Solution

Egiderma is an advanced wound care dressing that increases the healing rate of scars and prevents formation of hypertrophic scars. It is a patented innovative scaffold that promotes healing, and it can also be loaded with drugs to function maximally. With respect to products on the market Egiderma presents some advantages including:

  • IP-protected technology – Egiderma is protected by a PCT patent (see 2.6), and it has international counterpart patents which provide coverage in the EU, China and USA
  • Designed with Innovative Technology – Egiderma dressing has a unique shape and texture that are integral to its high performance. It offers high flexibility and conformability that represent key performance features with a remarkable impact on product suitability in the clinical environment.
  • Prophylactic Treatment – Egiderma provides an antifibrotic prophylactic treatment for open wounds.
  • Combination Therapy – Egiderma combines antimicrobial  and antifibrotic activity making it ideal for various combination therapies.
  • Low Dressing Change Frequency – Egiderma will reduce the time spent by nurses in attending to each patient because the patch will be changed every 3 days unlike for traditional therapy that may require a daily change. This will improve their productivity, driving down overall costs of material and treatment. Inadvertently, patient compliance increases, and healing times are notably decreased.

Advantages

Egiderma will have a socio-economic impact by:

  • Increasing the healing rate of scars
  • Reducing the average length of hospitalization and consequently and hence the cost of treatment.
  • Reducing rate of infections during healing process leading to reduced cost of treatment and facilitating functional recovery of tissue.
  • Improving cosmetic outcome and thus directly impacting enhanced self-image and societal acceptance.
  • Improving psychological wellbeing of patients.

Roadmap

Batch validation and production for clinical trials will require additional important investments:

  • Clinical batches manufacturing
  • Safety and efficacy of medical device by clinical trials (Phase I, II and III)
  • Approval by the regulatory body
  • Large-scale medical device production by a certified third-party
  • Distribution and marketing
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