Project: Development & validation of a novel technology for Treatment and Prophylaxis of arterial Ulcers for Home and Nursing Home Use
Peripheral Arterial Occlusive Dieses (PAOD) is caused by occluded arteries due to atherosclerosis. This clinical condition is common in elderly, diabetics, smokers and obese people. PAOD affects very small blood vessels feeding the skin, leading to reduced pulse in the feet and sometimes to a point when no pulse can be found. Such lack of healthy blood flow leads to ischemia and ulceration. The graphical illustration of “cause and effect” of POAD is presented in Figure 1 of “Annex - Illustrations and graphics”. _x000D_ _x000D_Currently, there are no dedicated prophylaxis solutions on the market and the suffers rely on range of generally less effective methods such as massage, special dressings or herbal drugs that often provide temporary relief from suffering. When the condition worsens, cardiovascular surgery, balloon angioplasty, or amputation is the next step. Many patients are in a condition not allowing for surgery or other interventions. These patients often have no other option than amputation. _x000D__x000D_In FlowOX, we propose a solution for treatment of PAOD with specific focus Chronic Ulcers in patients with reduced peripheral circulation. The device can be used at home or nursing homes for treatment of mild arterial ulcers and potentially also as a prophylaxis. _x000D__x000D_Prevention of chronic ulcers can be achieved by increasing blood flow and thereby the tissue oxygen concentration in the lower limbs in the diabetes sufferers. Otivio AS, has developed a novel pulsating negative pressure technology that can increase blood flow in extremities by about 30%. This technology is based on an innovative, patent protected pulsating negative pressure method in which short pulses of mild (around -40 mmHg) negative pressure applied in short sequence bursts to one or both lower extremities. Such pressure pulses are barely noticed by patients. In earlier projects Otivio has developed “proof of concept” prototypes of the technology and done tests on volunteers, leading to patenting of this innovative technology. Results from pilot study on improving blood flow and oxygen tension in the skin to allow for better wound healing are presented in Figure 2 of “Annex - Illustrations and graphics”. The CO goal of FlowOX is to develop and evaluate the device for treatment of chronic ulcers. The graphical illustration of proposed technology is presented in Figure 2 of “Annex - Illustrations and graphics”_x000D__x000D_The analysis of the market sector, market size and expected market shares of FlowOx is presented in section 2.3.1 and 2.3.2. The largest patient population consists of patients with reduced peripheral circulation due to arteriosclerosis. These patients are at higher risk of getting chronic ulcers, they often experience rest pain and have a reduced quality of life. Many of these patients develop into a more sever condition with chronic ulcers. These ulcers are very difficult to treat due to the reduced peripheral circulation. The consortium believes this patient population offers the best chance of being able to document a clinical effect from this novel technology. There are well established methods for evaluation of arterial ulcers, normal healing times is well documented and the economic aspects associated with chronic ulcers are well understood. We believe strong scientific evidence documenting the technology’s ability to heal small ulcers will pave the way for commercial sale and for further clinical studies which can document a prophylactic effect. Documentation of a potential prophylactic effect would require larger studies and over longer time, similarly a documented ability to reduce number of amputations (which is a common outcome for many of these patients) would also require additional studies post project. _x000D__x000D_To address the challenges in development and validation of this novel technology we have assembled a consortium of two companies; Otivio AS with rights to a unique technology improving blood flow to the limbs of patients. The company own prototypes and clinical data which demonstrates the technology's ability to manage patient temperature and improve blood flow to the limbs of patients, Otivio is aiming to be ISO 13485 certified in 2013. Today Otivio has deep insight in conducting clinical trials and fulfilling regulatory requirement for medical devices. Otivio is with wound healing market insight and project management skills. HotSwap COtains a quality assurance system certified in accordance with ISO 13485:2012. The company has a focus on medical device product development and is active in all phases of the life cycle of a product. The core skills HotSwap will be offering to this project will be biomechanics and mechanics, electronics, software, regulatory advice, industrial design and ergonomics. With these complementary skills these two innovative SME are fully equipped with necessary skills to achieve market launch of FlowOX within two years post project completion. _x000D_
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Acronym
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FlowOx
(Reference Number: 8284)
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Duration
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01/09/2013 - 01/04/2016
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Project Topic
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FlowOx is a novel solution for treatment and prophylaxis of arterial ulcers. Currently, there is no dedicated solution on the market. We will develop and clinically validate this technology which can be used at home or in nursing homes, for prophylaxis and for treatment of mild sufferers.
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Network
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Eurostars
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Call
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Eurostars Cut-Off 10
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Project partner
