FlowOx is a Pulsating Negative Pressure Therapy
FlowOx 2.0 is a novel Class IIa Medical Device which improves blood flow to patients’ legs by applying a negative oscillating pressure. It is comfortable, it can be used while patients are at rest and we believe the barrier for regular use is small. It can transiently increase blood flow in lower extremities by about 60% in the small arteries and more than 100% in the capillaries. FlowOx is a noninvasive device enabling patients to treat themselves in their own home.
FlowOx enables active home treatment.
Otivio has developed FlowOx for patients suffering from the effects of PAD such as leg pain and chronic wounds. Early long-term testing documents increased blood flow, pain reduction, wound healing and amputation prevention.
Where does FlowOx fit in?
FlowOx is large for a boot, but small for a medical appliance. It is perfectly fine to use at home, and can easily be tidied away if needed be. It’s also easy to use with the press of a button, so no assistant is needed.
Otivio is the legal manufacturer of FlowOx. The control unit is supplied by Innokas Medical and the pressure chamber and spareparts are assembled by Specialplast. Specialplast is our main logistics partner. The current supply chain is designed for a capacity of 10,000 FlowOx systems per year. Otivio is cooperating with a network of distributors who are serving customers in the UK (H&R Healthcare), Norway (DMedical) and Denmark (Vingmed).
Frequently asked questions
What is FlowOx?
1. FlowOx is a revolutionary new technology for the treatment of reduced peripheral micro circulation.
2. The FlowOx technology is based on a tested and gentle intermittent negative pressure/vacuum technology.
3. Unlike other vacuum therapies, FlowOx is simple to use and cost effective. It is designed for patients to operate in their own homes.
How does FlowOx work?
1. FlowOx works by “exercising” the peripheral blood circulation.
2. Through repeating shifts between a light negative pressure (-40 mm Hg) and normal atmospheric pressure, the natural dynamics and function of the vascular system is exercised. Everything from the small arteries to the capillaries in the outer layers of the skin experience the fluctuations and thereby improving supply of oxygen and nutrients which is essential for restoring and maintaining normal function of the skin and musculature.
3. FlowOx thus addresses the underlying problems behind poor PMC and not just the symptoms caused by lack of micro-circulation.
Which patients can benefit from using FlowOx?
1. FlowOx is suitable for most patients with poor peripheral micro circulation, and specifically for patient in the following groups:
a) Patients with peripheral arterial disease (PAD)
b) Patients with diabetic foot ulcers
c) Dialysis patients with chronic wounds
d) Spinal cord injury/persons with paralysis.
Problems caused by reduced micro-circulation?
1. Reduced micro circulation can lead to lack of nutrition, oxygenation, and reduced removal of metabolites from the tissue.
2. These effects may lead to:
a) Ischemic pain
b) Poor oxygenation will lead to reduced local immune function and thereby increased risk of infections
c) Lack of oxygenation also led to reduced ability to produce collagen and thereby limited the tissues ability to heal itself. Collectively this reduce the body’s ability to form new blood vessels and its ability to heal wounds.
3. Over time, the condition will become chronic and progressive, increasing the need for long term pain management, wound healing, and palliative care.
4. The condition often deteriorates to a stage were amputation is unavailable.
What are the effects of Poor Microcirculation?
1. Chronically poor peripheral circulation has a significant and accelerating negative impact on patients’ quality of life.
2. A major reason for the poor quality of life for this type of patient is due to limited options for treatment (often limited to palliative care).
3. The financial burden of treating patients with insufficient peripheral microcirculation is extensive and increasing:
a) The annual cost of treating chronic wounds in home care amounts to NOK 100,000 per patient1.
b) Approximately 4,000 surgical procedures (revascularizations) are performed on patients with reduced peripheral blood circulation. The number is increasing by about 5% per an. 2
c) More than 800 amputations are carried out annually in Norway and the cost of this is NOK 500-800 million. 3
4. It is expected that the cost as well as the societal impact of reducedquality of lifedue to reduced micro-circulation will increase significantly with the ageing population and increase in diabetes.
1 Jorunn Hagen Rønsen; UiO 201 2:Costs for the treatment of chronic leg ulcers in home nursing.
2 Wendt K, et al. BMJ Open 2017;7.
What is the benefit of FlowOx
1. Home treatment. FlowOx is designed so that the patient can self-administer FlowOx at home. This will reduce the pressure on both the primary and secondary health care systems
2. FlowOx addresses the underlying cause – decreased micro-circulation. The use of FlowOx, once the therapeutic targets are reached will result in a reduction or an elimination of the need for continuous symptomatic treatment.
3. This leads to significant health-economic savings, but just as important, an improvement in the individual patient’s quality of life.
4. FlowOx’s business model – a service & rental model – means that treatment with FlowOx is as low as NOK 250,-/ €27,- per treatment day:
a) “Pay As You Go” ensures that only the actual days a patient is in treatment.
b) “No Cure No Pay” ensures that a treatment can be stopped at no additional cost in case FlowOx treatment must be stopped or does not have the expected effect.
c) The FlowOx Rental & Service model ensures that follow-up of patients in home care included in the price.
What evidence is available for FlowOx
Sundby, Ø., Høiseth, L., Irgens, I., Mathiesen, I., Lundgaard, E., Haugland, H., . . . Hisdal, J. (2018). Intermittent negative pressure applied to the lower limb increases foot macrocirculatory and microcirculatory blood flow pulsatility in people with spinal cord injury. Spinal Cord, 56(4).
Sundby, Ø., Høiseth, L., Mathiesen, I., Jørgensen, J., Sundhagen, J., & Hisdal, J. (2016). The effects of intermittent negative pressure on the lower extremities’ peripheral circulation and wound healing in four patients with lower limb ischemia and hard-to-heal leg ulcers: a case report. Physiological Reports, 4(20).
Sundby, Ø., Høiseth, L., Mathiesen, I., Jørgensen, J., Weedon-Fekjær, H., & Hisdal, J. (2016). Application of intermittent negative pressure on the lower extremity and its effect on macro- and microcirculation in the foot of healthy volunteers. Physiological Reports, 4(17).
Sundby, O., Høiseth, L., Mathiesen, I., Weedon-Fekjær, H., Sundhagen, J., & Hisdal, J. (2017). The acute effects of lower limb intermittent negative pressure on foot macro-and microcirculation in patients with peripheral arterial disease. PLoS ONE, 12(6).
Sundby, Ø., Irgens, I., Høiseth, L., Mathiesen, I., Lundgaard, E., Haugland, H., . . . Hisdal, J. (2018). Intermittent mild negative pressure applied to the lower limb in patients with spinal cord injury and chronic lower limb ulcers: A crossover pilot study. Spinal Cord, 56(4).
Hoel H, Høiseth LØ, Sandbæk G, Sundhagen O, Mathiesen I & Hisdal J, The acute effects of different levels of intermittent negative pressure on peripheral circulation in patients with peripheral artery disease. Physiological Reports Physiol Rep, 7 (20), 2019
Sophie M. Holder, Ellen A. Dawson, Áine Brislane, Jonny Hisdal, X Daniel J. Green, and Dick H. J. Thijssen, Fluctuation in shear rate, with unaltered mean shear rate, improves brachial artery flow-mediated dilation in healthy, young men. J Appl Physiol 126: 1687–1693, 2019