The purpose of study is to assess the safety and performance of EktoTherix™ Tissue Repair Scaffold in the treatment of full-thickness, dermatologic wounds created by the surgical removal of non-melanoma skin cancers.
EktoTherix™ is a medical device developed by Neotherix Limited, manufactured by the polymer processing technique of electrospinning. Described as a "tissue scaffold", EktoTherix is placed into the surgical wound to help the patients' own cells repair the wound, enhancing healing and improving quality (including cosmetic outcome). The tissue scaffold is completely absorbed by the body during the healing process, which means that there is no need to remove it when the wound is healed.
All patients recruited into this study are treated with EktoTherix, are seen weekly until they heal and seen again at the final follow-up visit three months post-surgery.
The investigators hypothesise that the use of EktoTherix will increase incidence of complete healing and result in an overall better cosmetic result of the healed wound.

开始日期2015-04-23

申办/合作机构

Neotherix Ltd.

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2023-12-15·Biosensors & bioelectronics

Nanophotonic and hydrogel-based diagnostic system for the monitoring of chronic wounds.

Article

作者: Raxworthy, Michael J ; Li, Kezheng ; Sahoo, Pankaj K ; Bakshi, Shrishty ; Johnson, Steven ; Krauss, Thomas F

Chronic wounds present a major healthcare burden, yet most wounds are only assessed superficially, and treatment is rarely based on the analysis of wound biomarkers. This lack of analysis is based on the fact that sampling of wound biomarkers is typically invasive, leading to a disruption of the wound bed while biomarker detection and quantification is performed in a remote laboratory, away from the point of care. Here, we introduce the diagnostic element of a novel theranostic system that can non-invasively sample biomarkers without disrupting the wound and that can perform biomarker quantification at the point of care, on a short timescale. The system is based on a thermally switchable hydrogel scaffold that enhances wound healing through regeneration of the wound tissue and allows the extraction of wound biomarkers non-destructively. We demonstrate the detection of two major biomarkers of wound health, i.e., IL-6 and TNF-α, in human matrix absorbed into the hydrogel dressing. Quantification of the biomarkers directly in the hydrogel is achieved using a chirped guided mode resonant biosensor and we demonstrate biomarker detection within the clinically relevant range of pg/mL to μg/mL concentrations. We also demonstrate the detection of IL-6 and TNF-α at concentration 1 ng/mL in hydrogel dressing absorbed with clinical wound exudate samples. The high sensitivity and the wide dynamic range we demonstrate are both essential for the clinical relevance of our system. Our test makes a major contribution towards the development of a wound theranostic for guided treatment and management of chronic wounds.

2017-02-01·Tissue Engineering Part B: Reviews2区 · 医学

A Clinical, Biological, and Biomaterials Perspective into Tendon Injuries and Regeneration

2区 · 医学

Article

作者: Raxworthy, Mike J. ; Saeed, Aram ; Riley, Graham P. ; Donell, Simon ; Liao, Xin ; Walden, Grace

Tendon injury is common and debilitating, and it is associated with long-term pain and ineffective healing. It is estimated to afflict 25% of the adult population and is often a career-ending disease in athletes and racehorses. Tendon injury is associated with high morbidity, pain, and long-term suffering for the patient. Due to the low cellularity and vascularity of tendon tissue, once damage has occurred, the repair process is slow and inefficient, resulting in mechanically, structurally, and functionally inferior tissue. Current treatment options focus on pain management, often being palliative and temporary and ending in reduced function. Most treatments available do not address the underlying cause of the disease and, as such, are often ineffective with variable results. The need for an advanced therapeutic that addresses the underlying pathology is evident. Tissue engineering and regenerative medicine is an emerging field that is aimed at stimulating the body's own repair system to produce de novo tissue through the use of factors such as cells, proteins, and genes that are delivered by a biomaterial scaffold. Successful tissue engineering strategies for tendon regeneration should be built on a foundation of understanding of the molecular and cellular composition of healthy compared with damaged tendon, and the inherent differences seen in the tissue after disease. This article presents a comprehensive clinical, biological, and biomaterials insight into tendon tissue engineering and regeneration toward more advanced therapeutics.

2015-10-01·Regenerative Medicine4区 · 工程技术

Bringing Regenerative Medicines to the Clinic: The Future for Regulation and Reimbursement

4区 · 工程技术

Review

作者: Bubela, Tania ; Mujoomdar, Michelle ; Kefalas, Panos ; Raxworthy, Mike ; Packer, Claire ; Archibald, Peter ; McCabe, Christopher ; Piret, James ; Soares, Marta ; Atkins, Harold ; Viswanathan, Sowmya ; Bradshaw, Steven E

Significant investments in regenerative medicine necessitate discussion to align evidentiary requirements and decision-making considerations from regulatory, health system payer and developer perspectives. Only with coordinated efforts will the potential of regenerative medicine be realized. We report on discussions from two workshops sponsored by NICE, University of Alberta, Cell Therapy Catapult and Centre for Commercialization of Regenerative Medicine. We discuss methods to support the assessment of value for regenerative medicine products and services and the synergies that exist between market authorization and reimbursement regulations and practices. We discuss the convergence in novel adaptive licensing practices that may promote the development and adoption of novel therapeutics that meet the needs of healthcare payers.

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