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HORIZON 2020

FLOWOX

(737964)

Novel treatment for peripheral arterial disease

 

This project has received funding from the European Union's Horizon 2020 research and innovation programme:

  • Horizon 2020

  • Call: H2020-FTIPilot-2016 (Fast Track to Innovation Pilot)

  • Topic: FTIPilot-01-2016

  • Type of action: IA (Innovation action)

  • Proposal number: 737964

  • Proposal acronym: FlowOx

 

The FlowOx Project

Otivio AS, Innokas Medical OY, The University of Salford, and Bangor University were awarded a EU Horizon 2020 Fast Track to Innovation grant in August 16, 2016.

Otivio is the coordinator for the project. The grant is EUR 2.1 million and will fund the project over 30 months - starting 1 Dec 2016.

The Technology

Pulsating negative pressure applied locally, directly on the skin surface increases blood flow, probably due to a combination of dilation of the arterioles and an increased arteriovenous pressure gradient. The pulsating pressure will mechanically increase flow in the veins which have one-way valves. The reason for the pulsations is to avoid setting off the veno-arteriol reflex which constricts arteries when the veins are over-distended. That is also the reason why a constant negative pressure is counter productive.

Status

Clinical documentation of FlowOx™ 

 

University of Salford, Manchester, is responsible for carrying out the clinical trials. The Centre for Health Economics and Medicines Evaluation (CHEME) at Bangor University, Wales (cheme.bangor.ac.uk), will do the health economic analysis.

 

Objectives

  • Gather compelling clinical evidence of efficacy by performing a randomized controlled clinical trial (RCT) in a patient population with a focus on healing chronic ischemic wounds

  • Extend RCT results to health economic assessment (HEA) to support product launch and a case for procurement in the target markets

 

 

Status to date

  • Salford

    • Clinical trail approved

    • HRA approval obtained

    • Ethical approval obtained

    • Site specific agreements for 4 clinical recruitment sites obtained

    • Recruitment is open at 4 clinical sites

    • Agreement process to set up 2 more clinical sites in currently underway

    • 9 participants recruited to date (03/05/18)

    • Second arm added to the study which will allow inclusion of patients who recently have received an intervention. The goal is still to improve healing of chronic ulcers. 

  • Bangor

    • Health economic analysis plan approved

    • Client service receipt inventory developed

    • Tariff of unit costs in development

    • Economic modeller recruited to project team

 

 

Product Industrialization of FlowOx™ 

 

Innokas Medical of Finland will is the main partner for product optimization and industrialization.

 

Objectives

  • Undertake design for future manufacturing and assembling (DFMA) to manufacture the product

 

Status to date

  • Functional prototype reviewed 

  • Usability test conducted

  • Final design approved

  • Tooling ordered and tested

  • First batch manufactured

  • Testing completed

  • Expected CE mark in Q4 2018

 

 

Commercialization of FlowOx™ 

 

Otivio AS have signed distribution agreements for Scandinavia (Vingmed), UK (H&R Healthcare) and Ireland (ProHeal). Test launch of FlowOx1.0™ started in 2017. 

Objectives

  • Market introduction through key opinion leaders KOLs) in Germany, UK and Scandinavia to evaluate the current version (FlowOx™ 1.0) and to fine-tune the commercial model for the future.

Status to date - summary:

  • Distributor networks set up in Scandinavia, UK and Ireland

  • Evaluations at 15 hospitals to date

  • More than 40 systems under evaluation

  • First commercial sales to more than 5 hospitals achieved 

  • Process to expand to Germany initiated. 

 
 

GET IN TOUCH

Drammensveien 130, 0277 Oslo, Norway

+4793446261

 
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