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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - StrataGRT (An innovative topical drug delivery system for improving chronic wound healing)

Teaser

Summary

Skin is the largest organ in the human body, forming a protective physical barrier against the outside world. Damages to the skin due to physical, chemical and biological factors may lead to wounds. While most wounds heal without further assistance, chronic wounds, defined as wounds that fail to proceed through an orderly and timely process to produce anatomic and functional integrity subject the patient to significant discomfort and distress while draining the medical system of an enormous amount of resources. For instance, chronic wounds, such as diabetic foot ulcers, do not heal within 8 weeks. Wound healing is a complex biological process, and complications affect the quality of life of over 4 million people a year in EU (more than cancer & diabetes) that struggle to live with hard-to-heal injuries, as it can lead to infection, tissue and bone necrosis, pain and in some severe cases even amputation. Apart from wounds, additional afflictions like inflammatory diseases, cutaneous reactions and damaged as well as compromised or diseased skin, cover a large percentage of the entire skin surface and affect patients of various age-groups. Patients with chronic wounds often require specialised wound care and management, and this drastically impacts their quality of life during the wound healing process. Any improvement in therapeutic approaches is, therefore, urgently needed to deliver patient-centred care aiming at maximizing positive health outcomes & quality of life.
Founded in 2005, Stratpharma is a fast-growing, global medical devices company based in Basel, Switzerland. It designs, develops, manufactures and markets breakthrough products for patients around the world. The company specializes in the development and commercialization of medical devices for cosmetic dermatology, plastic surgery, burns, radiation oncology, wounds and scar management. Currently, the company is developing a novel range of products, based on their proprietary gel which unique drug delivery properties to enhance clinical outcomes. Stratpharma has developed StrataGRT, a film-forming gel formulation enhanced with bioactive glass technology for improved chronic wound healing.

Work performed

During the project, Stratpharma defined the minimum viable development path for StrataGRT, user requirements, product specifications, necessary steps for scale-up activities and clinical studies, evaluated the market opportunity with respect to size, customers and competitors, and finally confirmed the business model and commercialisation strategy. The Phase 1 feasibility assessment showed that the development plan for StrataGRT is technically and commercially viable. SME EIC Accelerator funding could provide the correct amount of funding and support to allow the stated activities to be implemented successfully.

Final results

StrataGRT is a safe, simple and non-invasive gel for at-home treatment of chronic wounds. It adapts to all wound surfaces and has powerful antibiotic and antiseptic properties, thereby significantly improving clinical healing outcomes at lower costs. A successful development through clinical validation will advance StrataGRT towards market approval, and ultimately positively impact the quality of life of patients.
Stratpharma\'s easy-to-use solution has superior technical functionality, ensuring better outcomes and a wide range of applicability. StrataGRT has demonstrated excellent results in healing chronic, hard-to-heal wounds on any surface at a faster rate, along with low risk of infections and side effects. Further developing StrataGRT to become an innovative drug delivery system will enhance clinical results. Hospitals and clinics will prefer this solution as wound management is a significant economic and resourcing concern. Costs of wound-care in Europe are approximately 2-4% of the total health-care expenditure, with an average of â‚¬6.000-â‚¬10.000 spent on each patient per year. The time needed by nurses to care for wounds is also a large expense, for instance, in Ireland, up to 66% of nursing time accounts for wound care. Types of wound dressings, frequency of dressing-changes and infection rates are additional concerns for doctors and nurses. StrataGRT addresses all these concerns as it can be applied by patients, avoiding the need to visit clinics for dressing-changes. Patients with chronic, hard-to-heal wounds will also prefer this product at it promises better outcomes, lesser treatment costs, lower infection rates and faster recovery time. Increasing ageing and diabetic populations across the world are more vulnerable to chronic wounds and are looking for ways to relieve pain and improve quality of life. Stratpharma\'s solution promises to deliver exactly these benefits to patients.