Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - NATURALSKIN (Rapid absorption denaturalized collagen dressings)

Teaser

The World Health Organization and United Nations issued a warning statement on the world’s health in September 2011 on hard to heal wounds as 2-3% of world population is expected to suffer severe wound in life. Estimated cost of treating chronic wounds is between 2-3% of...

Summary

The World Health Organization and United Nations issued a warning statement on the world’s health in September 2011 on hard to heal wounds as 2-3% of world population is expected to suffer severe wound in life. Estimated cost of treating chronic wounds is between 2-3% of annual healthcare budgets (treatments and hospitalization). Essential part of the wound care treatment (after removal of devitalized tissue) is the use of dressings to promote autolysis and reduce microbial presence.
Most advanced solutions in market currently are collagen dressings made of native collagen that facilitates healing of the wound providing exogenous collagen to the wound. Nonetheless, this solution has several problems: application and removal problems, fixed shapes, limited draining capacity.
EKOLBER has developed a rapid absorption linear (denaturalized) collagen made wound dressing (called NaturalSkin). This solution allows to improve dressings healing characteristics (20% of reduction of time of the treatment) due to rapid and complete absorption of the matrix and reduction of dressing application times with a remarkable low price. Those improvements will contribute to reduce hospitals wound care costs and effectivity considerably.
The advanced wound dressing market is an enormous and growing market because the number of patients suffering from hard to deal and chronic wounds.
The potential customers of the product (either through direct or indirect sales through distributors) are hospitals (severe wounds) and pharmacies (own treated wounds).

The objective of the overall SME Instrument Project is the launch of NaturalSkin business through the demonstration of the effectiveness of NaturalSkin dressings in market (carrying out a clinical study and disseminating results), with configuration of the first commercial range of dressings and the scalation of industrial facilities.

Work performed

This study have been done to analyse the feasibility of the innovation project, to analyse market features, to stablish a clear regulation accomplishment roadmap and to determine the business model to adopt in order to guarantee the profitability of the investment in the identified markets and future scenarios.
• Analyse market features
• Analyse business features
• Analyse costs and revenues of the business.
• Identify and close pre-agreements for clinical trials
• Elaboration of an updated business plans
As a result of the feasibility study, it can be concluded that the business related to the NaturalSkin dressings commercialization is feasible. Business related previous unknowns have been cleared and the path to reach commercialization stage has been marked.
The key step to overcome for the business to come true are to gather enough real evidences through clinical studies. Although the market is coped with collagen dressing solutions, the advantages in healing and application of the treatment will have an important impact in the market, but those advantages must to be proven in real conditions. In first instances a clinical trial has to be made to obtain CE Marking and in second instance mores clinical studies has to be performed to gather enough success cases to boost the market penetration.
Other key aspect for the business success is to create an important distribution network. Distributing companies are key to reach all hospital and pharmacies worldwide. Win-win models with distributor must be sought and the efficacy of the product (Validated with enough clinical evidences) will push to distributors to promote the product among their big portfolio of dressings.
In terms of manufacturing (once assured enough supply of animal skins), a big investment (2 million euros) have to be faced to have own productive facilities. Although some processes can be outsourced (as final transformation processes) the biggest part of the investment (1.5 million) is necessary for core manufacturing part (pellet manufacturing) that should not be outsourced. Soft loans or public loans should be found in addition to a capital increase to fund.

Final results

The advantages of the new product compared to existing collagen dressings are clear:

• The matrix is re-absorbable by the organism and therefore the incorporation of the active principles can be total. By controlling the levels of plasticizer: water and glycerine, and the degree of chewing (molecular weight) the final formulation can be made to dissolve in water or be reabsorbed by the body in a few days, weeks or months. In addition, the pore size and hence the density of the foam can be regulated in order to reabsorption be faster or slower. This facilitates the incorporation of the active principles into the body and economize on the amount of these substances. When the dressing is removed from the patient the foam has practically disappeared and the active ingredients are already incorporated.
• Support part (patch) is made of collagen and doesn’t incorporate any adhesive. In contact with humidity patch acquires adhesive properties itself and to remove is enough to wet the dressing. This way, less nursing time is required, and painful removal process is eliminated, increasing patient’s quality life.
• The collagen of the skin is collagen type I mainly. This type of collagen stimulates cell growth. Studies carried out at the University of the Basque Country confirm that in this type of collagen our cells grow very fast (BIOMAT group).
• Due to the characteristics of the technology (swelling at very high pHs to soften the initial skin (raw material) and high processing temperatures (100-120ºC), the risk of proliferation of foreign bacteria is minimal. Subsequent irradiation ensures the aseptic character of the new product.
• The technology to produce is an advantage compared to reference solutions market. Collagen can be moulded by compression or extrusion due to the thermoplastic nature of the product, the reproducibility and repeatability of the properties of these foams is guaranteed, as well as foam geometry and pore size. Solutions in market have had to be extracted and purified from the skin of an animal, and mechanically manipulated to create the alveolar or porous structure. That makes much more expensive and complex technology than EKOLBERs technology.
• Due to the manufacturing technology, the solution is much more economical than those available in the market. The proposed solution will be around 0.1 €/cm2 or 0.15€/cm2 with active principles, while the most advanced solutions (native collagen) cost around 1 €/cm2.
• Both the foam (matrix) and the support (patch) are more pleasant to the touch, due to their origin of skin. It has been proven that objects shaped with this new thermoplastic collagen rubber, both three-dimensional and films have greater affinity to the skin. The presence of a certain amount of water in the products as it happens in human skin and flesh makes that the affinity to the skin is greater.
• Fully biodegradable dressing: Not having a film of non-biodegradable material opens the option to change the waste management cycle

Benefits for Patient:
-20% of reduction of treatment times
-70-80% Dressing cost reduction
Benefits for Hospitals:
-20% of reduction of wound treatment expenses due to healing properties.
Benefits for Pharmacy:
-Patients demand rise due to healing properties and lower price
Benefits for Product Distributor:
-Hospital and Farmacy demand rise due to healing properties and lower price

Website & more info

More info: http://www.ekolber.com.