FlowOx 2.0, developed in co-creation between Norwegian company Otivio AS and Innokas Medical, has now reached a significant milestone as the device has received CE mark and the sales has started. The first 100 FlowOx 2.0 devices have already been shipped from Innokas’ Kempele factory.
Innokas Medical has been a partner in a consortium led by Norwegian company Otivio AS, to develop the next version of FlowOxTM. It is a clinically promising, patented and cost-efficient home treatment solution for Peripheral Arterial Disease (PAD). The market potential for FlowOx is extremely high as peripheral arterial disease affects more than 200 million people globally, and the patient population is increasing at a rate of 20% per annum due to an aging population, smoking and epidemic growth of diabetes. The global costs of treating PAD amount to $210-380 billion annually.
“It’s been an honor for Innokas to be part of the team developing the next version of FlowOx. Through this innovation, we can contribute to improving healthcare all over the world and the quality of daily life of millions of people”, says Antti Virtanen, Head of PMO at Innokas Medical.
Peripheral Artery Disease is caused by the deposition of fatty material on the inner walls of peripheral arteries, reducing perfusion and nutrition to the muscles and skin. The non-invasive FlowOxTM system is based on negative pulsating pressure therapy, and patient testing has documented that it increases blood flow, reduces pain and heals wound in patient’s feet and legs, in order to prevent amputations and increase life quality.
Co-operation across borders
The co-creation of the next version of FlowOxTM begun already in 2016 when the consortium created by Otivio was granted over 2M€ EU funding. The consortium consisted of partners from Norway, Finland and the UK.
“Otivio has been the owner of FlowOxTM IP and the main coordinator of the consortium. Innokas Medical has been responsible for design - and now also for manufacturing - and the University of Salford and Bangor University have been responsible for clinical trials and evaluations, and health economic evaluations”, says Andreas Mollatt, CEO at Otivio.
After about two years of design and development work, Otivio’s FlowOx 2.0 device received a CE mark in the end of 2018 and today the mass manufacturing of the device has started in Innokas’ Kempele factory. Innokas is also taking care of the after sales support, as well as the needed design and development support of the device. Mollatt is very excited about finishing the product development phase of the device, seeing the successful early manufacturing and the start of the marketing and sales work.
“With the selected partners, the development of our product has benefited from a very strong base of clinical and technical expertise. As in all development projects, we encountered some problems, but Innokas’ performance was efficient in addressing and fixing the problems”, Mollatt says and continues:
“All in all, the co-operation with Innokas has went well, as we expected. Now we’re up and running as the manufacturing of the device has finally started - the first 100 FlowOx 2.0 devices have already been shipped from Innokas Kempele factory to final destinations. We’re very excited!”
Virtanen is also very happy about the cooperation with Otivio. He sees that Innokas has been able to create concrete and valuable benefits to Otivio concerning the cost-efficiency and the product launching schedule because the company has all the needed competencies in house to support Otivio’s project.
“We at Innokas Medical have been extremely happy about the opportunity to partner with Otivio. First in device co-creation, and thereafter to continue the cooperation as their contract manufacturing partner”, Virtanen says and continues:
“The team at Innokas has broad experience in transforming health tech ideas to finished medical equipment, mass-manufacture these for the global market, and to take care of all quality and regulatory matters. I believe that these capabilities have created value for Otivio as well.”
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