Peripheral Arterial Disease (PAD) is caused by the deposition of fatty material in the peripheral arteries caus-ing reduced blood flow to muscles and skin. The disease affects the lower limbs with a range of disabling clinical symptoms such as: pain and chronic wounds. Due to the reduced blood supply to the lower limb, the wounds do not heal, therefore placing the limb at risk of infection and amputation. PAD is common elderly, diabetics, smokers and obese. The condition prevails in 202 million people globally and is increasing at an alarming rate of 20% per annum. PAD related health care costs are estimated to be between $210 and 380 billion per annum. Despite the magnitude of costs, PAD remains under-estimated, under-diagnosed, under-treated and under-researched. Inadequate treatment options call for innovative treatment solutions to prevent the serious consequences of PAD.
Currently, to treat PAD in early stages, the patients are encouraged to adopt behavioral changes such as smoking cessation, improved diet and exercise. Compliance to behavioral recommendations is dismal. When the disease progresses, the ability to exercise is reduced further. These patients suffer from reduced walking distance (40%) unbearable pain, chronic wounds (10%) or gangrene, and follow a trajectory towards costly and inadequate vascular surgery or amputation (1%). There is a critical gap in treatment options between behavioral change and surgical interventions, which makes progression of PAD almost inevitable. The most efficient solutions (surgical intervention) require frequent and/or long visit to health care providers. Current non-surgical solutions have limited cost-efficiency and suffer from insufficient clinical data inferior usability (uncomfortable and long treatment duration). The end result for society is high cost and a very negative impact on quality of life for patients and their relatives.
The overall objective for this research project is to develop a non-surgical solution which provides a cost effective therapy for PAD and thereby filling the treatment gap. It will reduce pain, heal wounds, avoid surgical interventions and prevent amputations.
The FlowOx technology targets the underlying cause (reduced blood flow) of these grave symptoms with a cost effective home treatment solution. The system is a Class 2a medical device which applies negative oscillating pressure to the limb. Our goal is to develop, document, manufacture and sell a the system which halts or reverses the progression of PAD to the benefit of patients and health care providers. The results to date show long term improvements in blood flow in the legs, reduced pain and improved rates of wound healing in patients treated with FlowOx. The rapid healing of several chronic leg wounds, has convinced senior clinicians of FlowOx’ efficacy.
The key objectives of this project are:
1. 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
2. extend RCT results to health economic assessment (HEA) to support product launch and a case for procurement in the target markets
3. undertake design for future manufacturing and assembling (DFMA) to manufacture the product
4. market introduction through key opinion leaders (KOLs) in Germany, UK and Scandinavia to evaluate the current version (FlowOx1.0) and to fine-tune the commercial model for the future model
