Periodic Reporting for period 6 - Kerefish (KerecisTM Omega3 Wound: the first fish skin substitute in the European Market for chronic wound care)
Berichtszeitraum: 2023-03-01 bis 2023-08-31
Health care systems around the world are overburdened with snowballing costs for medical care. For many conditions, these economic changes are related to increasing numbers of persons with chronic illnesses, increasing age and higher levels of obesity. In particular, the prevalence of diabetes is increasing among all ages globally and the World Health Organization (WHO) estimates 60 million people currently have diabetes in the European Region. Many persons with diabetes suffer from comorbid conditions including diabetic foot ulcers (DFU) with the incumbent risk of amputation. The increase in hard to heal DFU and increasing cost has created an urgent need for a novel and cost-effective treatment, especially in the European region.
Kerecis® Omega3 Wound is a sustainably manufactured medical device made from decellularized intact fish skin designed to treat chronic wounds, such as hard to heal DFU’s. Kerecis has followed a complex process to bring this medical device to market with no religious or ethical barriers while meeting all regulatory requirements. Clinical research has shown Kerecis Omega3 Wound to be a safe and effective medical device with a rapidly growing list of scientific and clinical use publications around the world. The clinical data derived from this early research serves as a backbone for reimbursement dossiers in the EU and worldwide to support the widespread adoption of this innovative and cost-effective technology into patient care settings following international guidelines.
This project was funded through the Fast Track to Innovation (FTI) funding from Horizon 2020 with the overall objective to conduct a real world, clinically meaningful, randomized controlled trial on the most severe DFUs and to disseminate the results at scientific conferences, and to meet regulatory and reimbursement purposes in Europe, USA and other global geographies. This funding is directly linked, in part, to the commercial success of the consortium partners leading to increased revenue and a 10-fold increase in employment at Kerecis which grew from 50 to over 500 employees during the term of this grant.
This program facilitated completion of a successful randomized controlled trial, scientific publications, and the ongoing adoption of fish skin technology for wound and burn care in Europe, the United States, and other geographies around the world. In addition, Kerecis was acquired by Coloplast in the final days of the project which directly opened distribution potential into 130 new additional countries.
Kerecis® Omega3 Wound is a sustainably manufactured medical device made from decellularized intact fish skin designed to treat chronic wounds, such as hard to heal DFU’s. Kerecis has followed a complex process to bring this medical device to market with no religious or ethical barriers while meeting all regulatory requirements. Clinical research has shown Kerecis Omega3 Wound to be a safe and effective medical device with a rapidly growing list of scientific and clinical use publications around the world. The clinical data derived from this early research serves as a backbone for reimbursement dossiers in the EU and worldwide to support the widespread adoption of this innovative and cost-effective technology into patient care settings following international guidelines.
This project was funded through the Fast Track to Innovation (FTI) funding from Horizon 2020 with the overall objective to conduct a real world, clinically meaningful, randomized controlled trial on the most severe DFUs and to disseminate the results at scientific conferences, and to meet regulatory and reimbursement purposes in Europe, USA and other global geographies. This funding is directly linked, in part, to the commercial success of the consortium partners leading to increased revenue and a 10-fold increase in employment at Kerecis which grew from 50 to over 500 employees during the term of this grant.
This program facilitated completion of a successful randomized controlled trial, scientific publications, and the ongoing adoption of fish skin technology for wound and burn care in Europe, the United States, and other geographies around the world. In addition, Kerecis was acquired by Coloplast in the final days of the project which directly opened distribution potential into 130 new additional countries.
Consortium members worked initially to develop the clinical trial protocol, to identify appropriate hospitals and wound care centers to participate in the clinical trial and to ensure all clinical trial activities were done according to international good clinical practices. This included contracting clinical research organizations (CRO), finalizing all associated study documentation, compiling the dossiers for review, approval and oversight by local institutional ethics committees and institutional review boards and supporting clinical trial sites conducting the study. Kerecis and the consortium partners contracted two General Data Protection Regulation (GDPR) compliant software companies for electronic data capture of the study data. This work was coordinated by Kerecis in co-operation with CERITD in France, Endospin in Italy and Allderma in Sweden; however, Allderma exited the project early.
Managing the study from start to finish coincided with the SARS-COVID 19 Pandemic which resulted in delays for clinical agreements with treatment sites, recruiting and training. The final number of participating centers was 15 with 8 sites in France, 4 sites in Germany, 2 sites in Italy, and 1 site in Sweden. These sites were able to recruit a total of 263 patients during this difficult SARS-COVID 19 Pandemic time. The data were analyzed, and results are being prepared in multiple manuscripts for publication in peer reviewed journal/s. The clinical trial results are favorable and are expected to be published rapidly once all the data cleaning activities are completed.
Other critical project activities were also completed including the development of communications and contracts with key opinion leaders in Europe, the rapid growth of the sales and marketing teams to provide much greater visibility and participation in vital conferences on wounds and burn care and the development of strong relationships with stakeholders including the European Wound Management Association and the European Burn Association as well as employees and experts in reimbursement for different health care systems in Europe.
The activities were key to the successful implementation and translation of clinical data into publications with impacts on future reimbursement dossiers and clinical guidelines anticipated across the globe. The hard work and good collaboration of the consortium members were reflected in the excellent outcomes from this successfully funded project. This project supported the consortium members and catapulted the new medical device company, Kerecis, to new heights while the Kerecis intact fish skin product was directly benefiting patients with excellent outcomes in a cost-effective manner for global health care systems.
Managing the study from start to finish coincided with the SARS-COVID 19 Pandemic which resulted in delays for clinical agreements with treatment sites, recruiting and training. The final number of participating centers was 15 with 8 sites in France, 4 sites in Germany, 2 sites in Italy, and 1 site in Sweden. These sites were able to recruit a total of 263 patients during this difficult SARS-COVID 19 Pandemic time. The data were analyzed, and results are being prepared in multiple manuscripts for publication in peer reviewed journal/s. The clinical trial results are favorable and are expected to be published rapidly once all the data cleaning activities are completed.
Other critical project activities were also completed including the development of communications and contracts with key opinion leaders in Europe, the rapid growth of the sales and marketing teams to provide much greater visibility and participation in vital conferences on wounds and burn care and the development of strong relationships with stakeholders including the European Wound Management Association and the European Burn Association as well as employees and experts in reimbursement for different health care systems in Europe.
The activities were key to the successful implementation and translation of clinical data into publications with impacts on future reimbursement dossiers and clinical guidelines anticipated across the globe. The hard work and good collaboration of the consortium members were reflected in the excellent outcomes from this successfully funded project. This project supported the consortium members and catapulted the new medical device company, Kerecis, to new heights while the Kerecis intact fish skin product was directly benefiting patients with excellent outcomes in a cost-effective manner for global health care systems.
The KEREFISH project has demonstrated that Kerecis Omega 3 Wound is a safe and effective treatment for severe diabetic foot ulcers that reach underlying bone, tendon or joint capsule. Those wounds often lead to lower limb amputations, and, to date, no treatment had been clearly documented to be beneficial in a completed, prospective, randomized controlled trial. As the grant period closes, the economic impact and reimbursement data are being analyzed and publication of this work is pending completion to support the cost-benefit and reimbursement dossiers for the use of the Kerecis intact fish skin graft in the treatment of hard to heal chronic diabetic foot ulcers. Those dossiers will be submitted to health authorities in France and Germany initially and through budget impacts and health technology assessments to various regions in Italy. The healthcare reimbursement data are expected to lead to the compilation of strong reimbursement dossiers for private insurers in the US as well as health care systems around the world with a potential to be adopted into national and international clinical guidelines for the management of severe diabetic foot ulcers.
In addition, with the recent transition from the MDD to the stricter MDR for medical devices in Europe, the results of the Odinn study are being used to support the clinical evaluation report required for CE Mark certification under MDR regulations. This grant has helped Kerecis to ensure ongoing patient access to a sustainably manufactured medical device with a clear clinical and economical benefit. Kerecis is working to reduce the price for health care providers and to provide greater access to this innovative device for European patients in advanced wound therapy settings. The main commercialization strategy goal was to be the first company with a intact fish skin graft used as a human skin substitute and reimbursed by the health systems across Europe.
In addition, with the recent transition from the MDD to the stricter MDR for medical devices in Europe, the results of the Odinn study are being used to support the clinical evaluation report required for CE Mark certification under MDR regulations. This grant has helped Kerecis to ensure ongoing patient access to a sustainably manufactured medical device with a clear clinical and economical benefit. Kerecis is working to reduce the price for health care providers and to provide greater access to this innovative device for European patients in advanced wound therapy settings. The main commercialization strategy goal was to be the first company with a intact fish skin graft used as a human skin substitute and reimbursed by the health systems across Europe.