Oxygen Support Therapy Solution

Non-invasive, simple mechanical CPAP oxygen support device for use in infectious and non-infectious situations which is an ideal intermediate intervention between simple mask or nasal cannula supplemental oxygen and invasive, mechanical ventilation. 

The Solution Lead will be Peter Brierley

The third-world has a dearth of resources.

What has been produced is a simple solution for providing respiratory support to patients requiring this in both a pandemic and non-pandemic situations, taking account of the lack of resources, the lack of skills and the challenges faced in the third-world with lack of infrastructure.

Approximately 15% of the COVID-19 patient population in South Africa required respiratory support (Physiopedia: Respiratory Management of COVID-19). The total patient count in South Africa as at 15th March 2021 was 1,5m, which implies that 225 000 required respiratory intervention/support.

Extrapolating these numbers to the third-world population, (4 billion people or 77% of the world's population) it can be seen that a very large number of people could be helped to recover using this device.

Our primary focus in in helping low-income, under-served communities to obtain favourable outcomes when under treatment for COVID and other highly infectious diseases such as MDR tuberculosis etc.

South Africa has a high incidence of MDR TB, exacerbated by a heavy load of HIV+ people. Although COVID-19 appears to have affected our population at a slightly lower level than in the developed world, it seems likely that statistics are unreliable and many COVID-related deaths may have gone un-reported.

This is a simple, inexpensive solution which can be managed by relatively experienced but unqualified personnel in times of pandemic, or in times of other outbreaks of common third-world diseases.

It can be used in a rural setting and is able to be used with patients in transit to secondary or tertiary care facilities. 

This device and associated breathing circuit has already saved lives and we anticipate with the roll-out to markets other than South Africa it will provide a low-cost and easily administered support to patients requiring oxygen support.

As previously stated, we are in process of gathering data to submit for the final registration of the device and system to the South African Pharmaceutical and Healthcare Authority.

Our Company exports healthcare products to more than 20, mainly third-world countries and the intention is to make this device available initially to these countries.

We are also working with international NGOs such as the Clinton Foundation to make this system as widely available as necessary.

We have capacity to scale the production of the device and this will be additionally transformational in that many sustainable jobs cold be created in the supply chain.  

We manufactured 20 000 units of which more than 9 700 have been deployed.

We are building data on usage and efficacy, but as can be understood, resources are thinly stretched in the field and priority is being given to treatment rather than data collection at this stage. 

We have qualitative data available from a survey undertaken and we are expecting quantitative data shortly. 

The survey results are available, but too long to share here.

CE and FDA approval

Technical files and data being collected to make the necessary submissions for registration.

Registration in countries other than South Africa.

Use of FDA and CE approval to gain rapid acceptance in other countries. Use our existing network of agents and distributors to facilitate this. 

The Council for Scientific and Industrial Research of South Africa

South African Medical Devices Association

The South African Pharmaceutical and Healthcare Devices Authority

ISO 13 485 (TUV Sud)

Clinton Foundation

US Aid

Gift of the Givers

Primarily we want to get rapid exposure for this simple life-saving device into markets where it will make a definite and immediate impact and where resources of all type are in short supply.

To do this we need publicity and assistance in overcoming barriers to entry in markets, which includes helping to expedite registration/approval with FDA and CE notifying bodies.

We will happily partner with NGOs anywhere in the world for assistance in overcoming local regulatory hurdles and to get access to wide-spread distribution networks to supplement our existing agent and distributor networks.

Although we are a profit-oriented Group, our vision and mission are as follows:

Our vision is to improve the quality of healthcare services in a mutually symbiotic relationship with hospitals, clinics and the medical profession and thereby contributing to improving healthcare services to all.

Our mission is to be the recognized global market leader for the provision of quality, service excellence, customer-centric focus and affordable medical and healthcare products and related medical services to the industry in South Africa and other markets.

We will achieve this by actively promoting collaboration and innovation, improving our client experiences and ensuring continuous improvement in the healthcare sector.