Fair enough comments, Jritch, although the CES soft launch of Pulse was subject to FDA clearance. We all know what happened there - repeatedly delayed throughout 2022, eventually granted end of April 2023.
Your comments around industry partnerships/sales are highly relevant.
June Update:
Since receiving FDA clearance, we have initiated the process to mass manufacture the device, as well as actively showcasing the Pulse at tradeshows and conferences around the United States in advance of launch.
Our strategy is to build a strong pre-launch sales channel and order book as well as to establish key industry partnerships to join us in our product launch activities.
Then came the major distraction of the proposed Nasdaq listing which eventually consumed the bulk of management time and focus. Then came the Clinichain cancellation and associated legal action, then came the cancellation of the Nasdaq listing at which point the company went onto life support. At that stage, I don't think any industry partner/PE players worth their salt would risk commercial agreements with a company struggling to survive, no matter how good the tech. In all likelihood they'd be more like buzzards circling the carcass.
In hindsight, the various updates throughout '23 make sobering reading. I think there was a perception - certainly I was guilty of it - that they would just start manufacturing Pulse units and 'the market' would fall over itself to get them. Et voila, overnight success!
Was all the below predicated on having the necessary funds via the Nasdaq listing? The answer would now appear to be a definite yes especially as they had ruled out targeting the retail OTC market.
Oct Update:
It is important to acknowledge the significant up-front engineering and development effort that is required to bring new medical devices to market. As such, as an early-stage growth technology company, we have a high capital requirement in the current pre-commercialisation phase of the Company.
We are currently managing the product development of:
• Two (2) new medical devices that we are bringing to market in the near term (Pulse and CONNEQT Band) – each having separate FDA-clearance.
• An associated mobile app for both of the above devices together with all related content, and healthcare and media programming.
• Our Patient Management Portal and Decentralised Clinical Trial Cloud Portal (see more details below).
• Multiple mobile applications (both iOS and Android) for each of these devices.
This is now a turn-around play. They either make it or they don't.
In terms of potential commercial partnerships, the situation is not much changed. Craig and Niall have stumped up the bulk of the necessary funding. Shareholders/investors have tipped in some more. It now remains to be seen if they can reach some kind of investability leverage with the wider market and commercial partners.
But there are still a lot of moving parts to this before they realise the undoubted potential of the technology, achieve profitability and cross the finish line as winners.
Craig and Niall are backing themselves to do just that.
That's the punt.
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