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Novel treatment for peripheral arterial disease

Periodic Reporting for period 2 - FlowOx (Novel treatment for peripheral arterial disease)

Reporting period: 2018-03-01 to 2019-11-30

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
The FlowOX project was extended to last 36 months and involved development of a second generation device, established requirements for market introduction including improved clinical documentation. The work performed during the 36 months have resulted in the following key achievements:
1. Establishment of a distributor network through which Otivio introduction FlowOx in Scandinavia, Ireland and UK. In Germany Otivio have worked directly with a key opinion leaders without a distribution partner. Initially more than 40 units of the old FlowOx was introduced to the clinic. Valuable clinical experience and design feedback was collected. Through out the project Otivio have worked with the distributors and KOLs to understand potential routs of payments and pricing models. Since FlowOx2.0 was CE marked and manufactured in 2019 more than 100 new FlowOx systems have been used on patients for more than 6 weeks. The key findings has resulted in improved understanding of relevant patient populations. It has increased our believe in the overall concept. The early testing with key opinion leaders has resulted in sale in Norway, Sweden, Denmark, UK, Germany and Irleand. Furthermore, in Ireland a reimbursement code has been identified and successfully used to pay for a system in a rental model. The feedback from early market introduction has been very positive. Both overall design and usability of the second generation device has been satisfactory.
2. Another critical part of the project was the development of the second generation device. An updated system requirements specification, risk analysis and device development plans has been developed. Several important new technical features are developed of which most are protected by patent applications. Tools have been developed, a CE mark has been obtained The overall manufacturing cost is within the target of the project. Most importantly, the usability has improved significantly.
3. Originally a large clinical trial was planned. It was decided to do the trial in two steps to first establish feasibility of the overall trial concept. The pilot study was started in May 2017. Since then, 4 sites was recruited to the study and 16 patients enrolled. We experience that the patient population is challenging due to very advanced disease. To further strengthen the clinical documentation additional resources were applied to introduce FlowOx2.0 to the market. Both additional clinical experience and commercial sales has been realized. Finally, a health economic assessment has been done and will be used to illustrate the impact towards NHS and other national payers for the treatment.
The FlowOx project enables Otivio and Innokas to enter the world-wide PAD market, gain a strong market position for PAD home-treatment. There are no good solutions for home treatment of PAD patients to date. This is clearly an advancement of the state of the art. It will contribute to the European competitive position in the growing medical device sector. Completion of the project objectives leads to a significant business opportunity for the two SMEs, with expected sales of over €220 million over 5 years following the launch in 2020 while at the same time reduce treatment costs of €1.44bn over 5 years for the health care society.
FlowOx2.0 developed as part of the project