$4.70 !Climbed Roy’s Peak in Wanaka NZ yesterday … what a...

$4.70 !

Climbed Roy’s Peak in Wanaka NZ yesterday … what a remarkable & transformative place .

I’m very hopeful of a deepening relationship with Bayer.
We announced an extension to the Bayer Avanti trial in August 2020, before that an extension to the Bayer Concord trial in Feb 2020. This was not only an extension of the lease of the Xcel devices, but the provision of expanded data management services. Bayer are a customer, and the extension is an endorsement of our product & company( although I understand changing mid trial is problematic ). So they know our business and the sphygmocor tech well.

Michael Kremliovsky, Senior Director Medical Devices and eHealth at Bayer, continues to monitor the progress of CradieX very closely, and takes an active role in the development and use of digital biomarkers.

Both Michael and Purva Pandya, Senior Director Regulatory Strategy- Digital, spoke at the recent Digital Biomarker Summit. Bayer is committed to the use of Digital Biomarkers.

If you jump onto the Bayer website & partnerships they talk to areas of focus, which of course ties into their business, and the first area is Cardiology and cardiovascular disease/function. Cardiovascular risk prevention is a key category for Bayer. With products like Bayer Aspirin being such huge income drivers for them, leveraging this knowledge to an existing customer base just makes financial sense.

The new Precision Health division in Bayer is a strong development in terms of a strategic fit to CardieX.
Bayer invested heavily in Huma Therapeutics in all 3 rounds as a cornerstone investor tipping in $10s of millions. they co-developed an AI App around the cardiovascular/digital marker space for users of Aspirin. It has been very successful, and they are now looking at taking this app global. Nothing like success to breed further investment. Our tech would complement this science and add to the overall proposition.

David Evendon-Challishas conducted a couple of interviews on the new Precison Health Division since it’s announcement in May, 2023. The last on 4th July.
Some comments from this recent interview :

….
Thinking specifically about Bayers new Precision Health business, Evendon acknowledged the power of AI in leveraging datasets generated by the use of self are digital health products to provide personalised insights to consumers. Finding patterns in big data requires AI, so it’s super critical to us.

however this is regulation gets a bit tricky.

In the US, the FDA is exploring a new risk-based review framework …
The new pathway would look at the manufacturer, rather than the product, and will take into account a number of metrics about the manufacturer to decide if the company is trustworthy, and wether it has processes in place to ensure post-approval reliability and safety.

I think in the future it’s going to be really important to make the distinction between something that is there to provide a bit of information, or to help with “wellness”, which may bring anxieties around data security and privacy, and something that is there to actually do some work to diagnose or treat you, he predicted.

…..

All looks very promising to me.