RSH (ASX) Product tests &amp; clinical results, facts please

Originally posted by Richney ↑

Let me make something very clear to you again & again & again....
1. Spirometry can no be mentioned with Wheeze detection - because Spirometry measures lung function only.
2. Spirometry can only be used in a clinic by a trained physician - can not be used by a real world patient or carer of asthmatic outside the clinic.
3. Spirometry can not be used as a tool to monitor and manage asthma on a regular basis outside the clinic at regular intervals - it can only be used at a single point in time and usually with months (6 -12 months between readings)
4. A Spirometry test can take up to 30 mins - Wheezo reading take 30 seconds and done by mum and/or dad (carers of asthmatics).
5. Spirometry is used as a tool for diagnosis - too slow and expensive as a suitable tool for ongoing management.
Your fixation on Spirometry is blinding you to the fact that it has minimal if any relevance to Wheezo and RSH suite of products.

Wheezing doesn't mean you are having an asthma attack neither does having a cough mean you have pneumonia, asthma, bronchitis, sleep apnea or lung cancer (or whatever else RAP are trying to hope their concept app can indicate), however measuring the prevalence of & % of Wheeze in a breath-cycle on a regular basis can help detect an increasing amount of Wheeze that can be a precursor to an exacerbation and attack - wow, that is almost pre-emptive! Understanding the primary symptom and getting ahead of it before anything bad takes hold....I call that preventative medicine and proactive management. Parents call it complete peace of mind. You don't know what to call it because you fundamentally don't understand it. (Please let me know if I am going to quickly for you).

As you last post got moderated, I will share a brief history of the Company with you (for your benefit & others) as I know this Company and its products better than most.

Under a previous iteration, the Company had positioned its products to be diagnostics tools. Hence the reference to Karmelsonix and Spirometry back in 2011/12. The Company was heading down the diagnostic path (as RAP is trying and failing to do) until they pivoted to ongoing monitoring and management of chronic respiratory disease. This pivot was based on feedback from the FDA that highlighted the extremely high level of risk and huge hurdles and amount of clinical trials and data the Company would have to capture to meet the FDA's stringent standards. The FDA is highly concerned about diagnostic tools in the hands of consumers and the risk of them "self-diagnosing" and getting it wrong...enormous liability risk. From this feedback and unlike RAP, the Company fortunately woke up and reassessed their commercial pathway. They thankfully pursued the lower risk, higher revenue path of ongoing monitoring and management.

Fast forward to today and we are now have the Wheezo product in market and embarking upon the role of leadership in real-time, objective monitoring and management systems for all asthmatics around the world. As the Company is not diagnosing, there is no need for comparison to Spirometry for which I have clearly outlined above.

Fact - Wheezo is the only product on market in the world which can identify the presence of Wheeze and provide an objective measure (% wheeze per breath cycle) that can allow asthmatics and carers of asthmatic children the ability to understand their symptoms, condition and take proactive measures for medication adherence and compliance to asthma plan.

How do I know this, I use the technology every day in the real world in managing my sons asthma proactively to his asthma plan.

Result - my sons asthma is well controlled and my wife and I have complete peace of mind.
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1) Didn't Wheezo get FDA and CE approval as a Class I device so the device was never going down the diagnostic tool route?
2) Wouldn't you more confident if Wheezo was tested against spirometry which is way less subjective than the stethoscope. This is evident by the disagreement between the physicians in the latest clinical trial result and subsequently the data was removed to get the better accuracy, I've never seen this practice before in clinical trial results!!!!!?????
3) Management has told me a few months ago that the previous version of Wheezo was tested against both the stethoscope and spirometry. Hence why fixated on this as the latest clinical trial didn't.
4) Agree DTC as a screening tool will need to be treated different hence the easier path to approval then diagnostic tool which has to be used by clinician in consultation.

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