nir-vana innovation network

This UK SME is an award-winning company based in South Wales and has been operating in the podiatry / medical device sector since 2018. It is driven by a young, ambitious team of qualified podiatrists specialising in ‘offloading’ or pressure-reducing technology for foot lesions caused by excessive pressure. The company aims to provide more environmentally friendly and cost-effective alternatives to existing market offerings, by creating a range of orthotics and medical footwear using patented pressure-relieving technology.

The client has designed and developed an anti-pressure, orthopaedic shoe insole for diabetic wound care purposes. The insole device is currently at the advanced prototype stage in product development and is a self-regulated, non-invasive Class 1 medical device.

The patented product has already undergone an early Proof of Concept study and two successful clinical product evaluations. Previous product evaluations were funded by the client’s commercial partner, a market leader in advanced wound care. It is now beginning the proposed Phase 3 product evaluation which will examine the use of the offloading insole on active diabetic neuropathic ulcerations.

Therefore, the company seeks a private podiatry clinic, with clinical research capabilities and a large patient base, to conduct the product evaluation on patients with diabetic foot ulcerations under a funded research cooperation agreement. This Phase 3 study will be funded by the requesting client and existing commercial partner and so, the potential research partner will not be expected to contribute financially.

Such partners from across the Network are sought to increase the time efficiency of the outsourced Phase 3 product evaluation, which would not be possible if partnering with local/regional facilities.

The requesting client aims to bring the anti-pressure insole to market faster following a third successful product evaluation, as a result of the funded research cooperation agreement with an overseas private clinic partner. The patented design enables the prefabricated insole to be customised by podiatrists / medical practitioners and create an immediate offloading prescription for individuals suffering from diabetic foot ulcerations.

Advantages & innovations

UNITED KINGDOM

Stage of development

Prototype available for demonstration

Partner sought

The requesting client seeks a private podiatry clinic of any size, from across the Network, capable of conducting a Phase 3 product evaluation on patients with active diabetic ulcerations under a research cooperation agreement. As part of the study, the prospective partner should have: • Fluent English speaking and writing abilities. • Academic skills in writing clinical research reports. • A history of conducting clinical research in podiatry settings. • A large patient pool of patients with Type 2 diabetes. • Regular experience in treating diabetic foot ulcers and wounds. This Phase 3 product evaluation will be funded by the requesting client and the commercial partner therefore, the potential research partner will not be required to contribute financially.