Ethics Approval Granted for Clinical Trial of World's First Nasal Swab Designed Specifically for Children

• Rhinomed has created the world's first nasal swab designed specifically for children — The Rhinoswab Junior™
• Ethics approval has been received for a clinical trial to commence with the Murdoch Children's Research Institute (MCRI) at The Royal Children's Hospital in Melbourne
• Trial seeks to further validate the child-friendly Rhinoswab Junior™ as a safe and effective alternative to current standard of care swabs

MELBOURNE, Australia, Sept. 7, 2021 /PRNewswire/ -- Rhinomed Limited (ASX:RNO OTCQB:RHNMF), a leader in wearable nasal and respiratory technology, has completed development of the world's first nasal swab designed specifically for children. 

The Rhinoswab Junior has been designed to deliver all the benefits of the existing Rhinoswab but with several novel features that reduce the fear, anxiety and trauma associated with the use of existing standard of care nasal swabs.

The company has received Human Research Ethics Committee (HREC) approval to commence a clinical trial of the Rhinoswab Junior at The Royal Children's Hospital Melbourne.

The trial, known as The Diagnosis of Respiratory Disease in Children with Rhinoswab Study (DIY Rhinoswab Study), will investigate the diagnosis of respiratory viruses in children with Rhinoswab Junior, which is designed to collect a nasal sample from children without the discomfort and distress often associated with the combined throat and deep nasal (CTDN) swabs.

Rhinoswab Junior is a smaller version of the Rhinoswab device with child friendly features to engage children in the sampling process. Rhinoswab's design also allows for standardisation of the site of biological sampling, as compared with CTDN swabs, which are operator dependent. Specifically, the diagnostic validation study will evaluate the Rhinoswab, a self-collection anterior nasal swab, as an alternative method to combined throat and deep nasal (CTDN) swab for respiratory sample collection in children aged 4-18 years at The Royal Children's Hospital (RCH).

The objectives of the study are to investigate:

1. The laboratory test performance of the Rhinoswab compared with the current standard of care CTDN swab
2. The comfort and preference of Rhinoswab compared to the CTDN swab
3. If laboratory handling of Rhinoswab is equivalent to the CTDN swab.

The study will aim to recruit 250 children at the Respiratory Infection Clinic at the RCH for a SARS-CoV-2 test. The CTDN sample will be collected by a healthcare worker (HCW); however, children will self collect the Rhinoswab sample under the supervision of a healthcare worker.

The study will also recruit up to 10 staff to evaluate Rhinoswab against laboratory handling, process and workflow requirements. 

For more information about the Rhinoswab Junior visit https://www.rhinomed.global/about-rhino-med/sample-collection/rhinoswab-junior^[1] 

Rhinomed CEO Michael Johnson commented,

"With SARS-CoV-2 testing now part of our everyday lives, we need easier, more standardised and comfortable sample collection methods to encourage people to get tested. Testing rates in Children remain low due, in no small part to the levels of distress, anxiety and fear children experience when being tested with a standard swab. We have sought to develop a swab that not only works better, but actually removes this fear, anxiety and distress -- not just for the children but also for their parents and the nursing staff who need to administer the tests. We are thrilled to be working with the MCRI and The Royal Children's Hospital on this vitally important program."

Dr Shidan Tosif, Principal Investigator, concurs,

"Taking a combined throat and nose sample from children can be very challenging for all concerned. Rhinoswab Junior has the potential to turn an otherwise unpleasant experience into a far more relaxed and possibly even fun experience for children. The ability of the child to control the insertion of the device, coupled with the comfort and novelty of the Rhinoswab design, offers major improvements in the user experience."

"We are looking for ways to continue to improve SARS-CoV-2 testing systems for children. Rhinoswab has the potential to be a less intrusive alternative method for testing children."

The trial includes 250 children aged 4-18 years conducted over 30-50 days.  The trial will also help assess the use of Rhinoswab^™ for other respiratory diseases.

Rhinoswab^™ works with existing pathology workflows and equipment, and is equivalent in cost with US and European swabs.

Further information about the Rhinoswab can be found at https://www.rhinomed.global/about-rhino-med/sample-collection/^[2]

This media release has been authorised for release to the market by the Board.

Company

Michael Johnson, CEO & Director+61 (0) 3 8416 0900mjohnson@rhinomed.global ^[3]Follow us on Twitter @rhinomedceo

Investor and Media Relations

Rudi MichelsonMonsoon Communications+61(0) 411 402 737rudim@monsoon.com.au^[4]

About Rhinomed Limited (ASX: RNO, OTCQB:RHNMF)

Rhinomed Limited is a Melbourne, Australia based ASX listed medical device company that has developed a novel wearable nasal technology platform that can improve air flow and provide both drug delivery and diagnostic capabilities.

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References

1. ^{^} https://www.rhinomed.global/about-rhino-med/sample-collection/rhinoswab-junior (www.rhinomed.global)
2. ^{^} https://www.rhinomed.global/about-rhino-med/sample-collection/ (www.rhinomed.global)
3. ^{^} mjohnson@rhinomed.global (www.prnasia.com)
4. ^{^} rudim@monsoon.com.au (www.prnasia.com)
5. ^{^} https://www.prnewswire.com/news-releases/ethics-approval-granted-for-clinical-trial-of-worlds-first-nasal-swab-designed-specifically-for-children-301370044.html (www.prnewswire.com)