After nearly 2 years, PulseFlowDF has been successfully cleared for marketing by the KSA FDA. Part of the delay is explained by a global rebranding of the original Pulseboot product name to PulseFlowDF to better reflect the fact that our product is a Class2 medical device.
That meant the whole registration process had to be resubmitted due to the name change.
We had at one stage, specifically designed a sandal type footwear system to allow for the searing heats that can be encountered in Saudi Arabia.
As part of the design process it was interesting to understand that apart from "Mad Dogs and Englishmen", most people don't leave the air conditioning behind for too long, and that part of the legacy of neuropathy is that DFU patients don't sweat much or have a feeling of hot feet. We abandoned that design when it became apparent that it was impossible to design a sandal that prevented foreign body (e.g.small stones) ingress which could lead to tissue damage rather than healing.
Saudi Arabia is a significant market for us as a high proportion, maybe 30%, of the population are diabetic or pre diabetic, and we have in-market estimates of between 300-600,000 DFUs amongst a population of 25 million people.
We have chosen Advanced Medicine as our partners for KSA, and we are currently organising training dates in September.They have placed their first order with us, and we have agreed a deal that allows some free units to generate case studies in key opinion leader units.
We are planning training sessions that include many of the KSA key opinion leaders in DFU therapy.
KSA is also a key target market due to it's influence around the other Gulf States, and potential inclusion of our products on the wider GCC contract (Qatar relationships notwithstanding) at a later date.
We will now begin submitting an approval for Aresta, Preventa and FootForte class 1 products to the KSA FDA.