Pathelen Background

The Cost of Bacterial Wound Infections in the US & Germany

Bacterial wound infections : US market

Is the increase of chronic wounds a threat or burden for our society in the US and Europe ?

A 2018 retrospective analysis of Medicare beneficiaries identified that ∼8.2 million people had wounds with or without infections.

Medicare cost estimates for acute and chronic wound treatments ranged from $28.1 billion to $96.8 billion. Highest expenses were for surgical wounds followed by diabetic foot ulcers, with a higher trend toward costs associated with outpatient wound care compared with inpatient.

Increasing costs of healthcare, an aging population, recognition of difficult-to-treat infection threats such as biofilms, and the continued threat of diabetes and obesity worldwide make chronic wounds a substantial clinical, social, and economic challenge.

In the United States, chronic ulcers are conservatively estimated to cost the health care system $28 billion each year as a primary diagnosis and up to $31.7 billion as a secondary diagnosis (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6389759/)

The Rising Threat Because of Diabetes in the US

26.9 million people of all ages — or 8.2% of the US population — had diagnosed diabetes (see national diabetics report 2020).

Diabetic neuropathy, defined by damage to the foot’s sensory nerves, contributes to foot deformities and / or ulcers that increase the chance of lower-extremity amputations unless treated. It is estimated that up to 25% of all diabetics will develop a diabetic foot ulcer.

At average $ 60,000 per amputation procedure, diabetes-related amputations cost approximately six billion dollars per year.

The prevalence of foot ulcers (FUs) is high in the diabetic population and has a neuropathic origin. The annual prevalence of FUs is estimated to be 4–10%, and the risk of development of these ulcers in diabetics is estimated to be anywhere from 15% to 25%.

The management of DFUs costs $9–$13 billion in the United States. (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6389759/)

With a prevalence of between 2-5% of its respective population chronic wounds have become one of the most pressing problems of western societies.

In the United States, chronic wounds affect 6.5 million patients. An estimated excess of US$25 billion is spent annually on treatment of chronic wounds and the burden is rapidly growing due to increasing health care costs, an aging population and a sharp rise in the incidence of diabetes and obesity worldwide. (NCBI report).

Bacterial wound infections : German market

In Germany chronic wounds affect depending on the source of information 2-4 million patients with an estimated cost of c. 4-6 billion annually (f.e. Medical Data Institute) and in Switzerland chronic wounds affect c. 150.000 -300.000 patients with annual treatment cost of around 500million to 1 billion.

The most common chronic wound diseases are diabetic foot ulcer, pressure ulcer (Dekubitus) and venous ulcers.

Additional to above mentioned reasons for rapidly growing treatment costs of chronic wounds, the increasing antibiotic resistance is causing complications in the treatment of any wound, which will further boost treatment costs significantly and increase yearly incidence rates (today c. 0,8% of total population in Germany).

Due to the huge numbers of affected people medical health care systems try to keep cost under a strict cost regime which sometimes prevents hospitals or ambulant treatments to even cover their own cost. According to German DRG from av. additional costs of c. EUR 10.000,- per hospitalized MRSA patient only EUR 2.000,- will be refunded by the social insurances leaving a hospital with an average loss of EUR 8.000,- per MRSA patient. This often results in a non-adequate service or even a reluctance to accept MRSA or ESBL affected patients.

Modern wound treatment is not a very innovative science, since no or little monetary incentive is given to develop new cures or drugs. Only few efforts to develop new antibiotics are being heard of, due to huge associated cost of such a development (500 mio. EUR up to more than 1 billion EUR) and a high risk of not being able to recoup the investment because of the possibility of a quick bacterial resistance against the new drug and the risk of this drug being used only as a reserve antibiotic by the health care system with resulting lower sales numbers.

Apart from this, new antibiotics might not even help or be the solution for hard-to-heal wounds. As statistics already show, systemic use of antibiotics comes to its limits if a “biofilm” is covering the wound. A biofilm is a thin layer of mucus embedding and thus protecting wound bacteria. Such protected bacteria are extremely resistant to antibiotics and any patients own immunity system. To eliminate “biofilm-protected-bacteria”, a 1,500-fold dose of antibiotics would be required. according to an article from FH Ärztewoche 18/2013 from Springer-Verlag GmbH.

The cost of diabetic foot ulcers is greater than that of the five most costly forms of cancer

(Barshes, et al, 2013)

Pathelen Hybrid - a more effective treatment of wounds

Against this background, PAWT was developed, using a different strategy to wound healing. We believe that PAWT will become the first choice therapy for hard-to-heal wounds, since PAWT is able to cope with Biofilms and antibiotic resistant bacterias.

The surface of the silica is covered with hydroxyl groups that can bind water molecules, so it produces a pronounced dehydrating effect on the tissue that is essential for the removal of edema as part of the inflammatory process.

However, silica, due to lack of porous structure, does not adsorb low and middle molecular weight toxic metabolites.

Pathelen® Hybrid does not show direct antimicrobial action; however, it was found that the sensitivity of pathogenic organisms to antibiotics is increased in the presence of.

Noteworthy is a combination of hydrophilic and hydrophobic sorbents, providing sorption of a wide range of substances and pathogenic microorganisms in wounds. Through a combination of hydrophilic and hydrophobic sorbents these products can provide clean wounds through a selective sorption and draining effect.

The aim of the invention PATHELEN® Hybrid has been to create an universal hydrophilic- hydrophobic composition having an adsorptive and detoxifying effect for the treatment of purulent wounds and other purulent-inflammatory diseases such as chronic purulent-granulomatous inflammation, purulent-necrotic inflammation.

The composition of PATHELEN® Hybrid according to this invention may be varied, depending on the phase of wound healing. This may be achieved by varying the dehydrating ability, adding compounds having a wide range of antimicrobial activity, including against aerobic and anaerobic microorganisms. Moreover, additional compounds may be added which exhibit necrolytic effects on non-vital tissues, enhance the regenerative effect on the young tissue and/or provide a local anesthetic effect.

By using the composition of PATHELEN® Hybrid according to the present invention, a more effective treatment of wounds of different nature in various stages of wound healing may be achieved, which include: exudating wounds, chronic pressure ulcers, venous leg ulcers, diabetic/neuropathic ulcers, fungating, cancerous or malignant lesions and wounds with necrotic tissue.