CDX Discussion

Quiltman

Regular
Kicking off the CardieX thread. 2022 is the year of “Delivery” , CONNEQT Pulse, CONNEQT Band and Mobvoi Ticwatch , on the journey towards owning Vascular Health.
 
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hedrox

Regular
I hope that Stormer doesn't find us here...haha. The hard work is done here by CDX....2022 the year of delivery.
 
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Quiltman

Regular
Great to have you here Hedrox. I actually think Stormer is one of the stooges that has ruined HC ... just to much negativity combined with several posts a day for someone that doesn't even hold !
Clean air here, and we can start building some interest as our disruptive products hit the market.
 
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hedrox

Regular
Same same @Quiltman ....lets get it cracking here....
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kickit2me

Member
Hi Guys :)

Just added myself here.

Will need to investigate the "rules" under which this site is running. I can't see the point coming here unless there are processes in place to stop the infiltration of unwanted posters.

Ive recently joined another new forum - Bulls eye - it has aims to keep the site "clean" of rubbish. Can't see room for two new sites to make it in the long run.

kickit
 
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Quiltman

Regular
Hi Guys :)

Just added myself here.

Will need to investigate the "rules" under which this site is running. I can't see the point coming here unless there are processes in place to stop the infiltration of unwanted posters.

Ive recently joined another new forum - Bulls eye - it has aims to keep the site "clean" of rubbish. Can't see room for two new sites to make it in the long run.

kickit
Spot on, but I think the majority of the stooges that cause the real pain were paid protagonists from the owners of HC, *****************. Sure we will still get the odd annoying character ... but I can live with that ... it's the broker led manipulation that I could simply no longer endorse. Given this site has been setup by BRN holders who have just been the recipients of a sustained attack by said protagonists I have no doubt they will do what they can to keep it "clean".
 
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Quiltman

Regular
The recent appointment ( Dec 21 ) of Susan Boekhoff screams near term commercialisation, see how she describes her role at CardieX :

CardieX Limited logo
Senior Operations SpecialistSenior Operations Specialist
CardieX Limited · Full-timeCardieX Limited · Full-timeDec 2021 - Present · 3 mosDec 2021 - Present · 3 mos

    • • Responsible for developing customer service protocols to manage the overall online customer service experience through the company’s e-commerce channel(s).
      • Build call center, online, and other customer communication channels.
      • Manage communications with 3PL and Asia-based contract manufacturers to ensure seamless digital fulfillment process.
      • Negotiate with contract manufacturers on build scheduling based on demand forecast.
      • Source & work with 3PL to address any product delivery and product return issues.
      • Audit 3PL and contract manufacturers on an as-needed basis.
 
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Quiltman

Regular
A little bit of dot joining ...
CDX will vote next week of share consolidation 10 : 1.
The aim is to get the SP > USD $.25 to facilitate the OTCQX secondary quotation.
Craig Cooper wants to facilitate easier access to US institutions & funds.
He'll need a cash injection before the year is out, and I think this might be where it is coming from :

Listed as an employee of CardieX since 2018 is ZiHan L, describing himself on LInkedIn as follows :

Business development, commercialization and marketing executive with deep operating experience in medtech industry and proven track record of organizational growth management and strategic market development in US and Asia.

Strategic advisor for various technology startups in digital health, healthcare services, life sciences and medical devices. Proud investor in SpringTide Investments, Yard Ventures and Spike Ventures.


SpringTide Ventures
SpringTide is a venture capital firm supporting the world's best health-tech founders.
Visit their website springtide.com

Here is a piece from their 2022 Investment Thesis

Our mission is rooted in Clayton Christensen’s The Innovator’s Prescription, which lays out the roadmap for healthcare reform in the United States. Clay’s theory of disruptive innovation underpins this roadmap, and describes how a product or service initially gains hold by reducing barriers to access. This can be done by lowering cost, increasing ease of use, or even changing a product’s form factor, ultimately enabling the new entrant to displace more established competitors.

Our investment thesis - data innovation to improve human health - is how we intend to execute on our mission. Data innovation, by our definition, is the use of new or unique data sources and methods to gain a better understanding of, and provide a compelling solution to, a meaningful problem. We see meaningful innovation using the methods of data science – predictive analytics (AI, ML, pattern recognition, data mining), causal inference, and prescriptive analytics (decision making under uncertainty, optimization) – and also in the unique strategies to source and assemble data in proprietary ways. We seek to invest in companies with highly technical founding teams applying these methods to improve human health.

There are seven key areas, our investment themes, where we have identified the highest potential opportunities to execute on our thesis and therefore our mission.

  1. Home-based care: healthcare delivered in or to the home using innovative technologies, including at-home dialysis, fitness programs, and fertility testing, among many others.
  2. Biological signal processing: software solutions using biological signal data such as vital signs, EEG, voice, laboratory data, imaging, pathology, EMG, and more.
  3. Process automation: automation of institutional processes on the payer or provider sides that increase efficiency and/or revenue, and lower costs.
  4. Precision medicine: breakthrough solutions targeted at individuals, groups, and populations based on genetics, environment, lifestyle, or behavior.
  5. Chronic condition management: innovations in chronic disease management, such as cardiovascular, immunologic, hematologic, and dermatologic diseases.
  6. Value-based care: technology and services that facilitate the shift to value-based care delivery and financial arrangements.
  7. Consumerism: healthcare products and services driven by the patient experience, both within and outside of the traditional care delivery paradigm.
I believe CDX clearly delivers on 2), 5) and 7)
I think ZiHan L may be recommending to his SpringTime Venture Partners to invest.
IMO
 
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writer

Emerged
Thanks for the heads-up on the site, Q. Let's see how it goes. Re CDX, Looking forward to increased news flow as we get to the pointy end of this multi-year project. It still all hangs on FDA Clearance. Got badly burned with UNS and FTT. Not interested in a threepeat. I know it's not the same level of scrutiny for Clearance, and they have predicate device etc, but the FDA can be a minefield at the best of times. Any hint of delay or more info required will not be well received by the market.

On the other hand, Notification of Clearance will be serious re-rate time. Backing Craig and the Executive Team he has assembled as much as anything.

So, Mobvoi, Consolidation, OTCQX, lodge FDA docs.....what else to look forward to?
 
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Quiltman

Regular
Andon seem to have a pretty good record on obtaining FDA clearance and have just had some more success on devices. It is cleared, not approved, so you only need to establish that the device is substantially equivalent to another approved product. We have already seen published results that show conneqt pulse has achieved this substantial equivalence … so I am very positive on getting an FDA Cleared result.
Thanks for joining the thread !
 
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Jritch90

Emerged
Hi Team,
I’m also joining you here, stormers negativity was driving me insane. Quiltman I had a read about your hunch with Springtide Investments, their website indicates they normally only invest in companies with 100-200k. I think Craig will be chasing a much larger fish. I like the thinking but CDX will be looking for 10-50Mfor the next phase.
 
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Hercepin

Emerged
How's it going team, looks like the CDX brains trust is following Quiltman across, and I can already see why! Liking the look of this forum a lot already and excited for the forums not to be flooded with trash/manipulators who the mods allow free reign to do what they please.
I'm not expecting any news prior to the EGM on the 16th, but the share price is capitulating and it seems like we are the people trying to keep this afloat and remaining patient.
I've been following the below website to see if/when AtCor and Andon will be submitting to the FDA - noting the website isn't associated with the FDA, they are managing to track submissions (Andon actually made a separate submission on Jan 28 so they are definitely quite active here).

edit, here's the AtCor page on the website https://fda.report/Company/Atcor-Medical-Pty-L-T-D

Cheers guys and hoping this turns around soon :)
 
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P77

Emerged
Thanks @Quiltman for posting the clue on HC about this forum. I think a lot of HC users were looking for a decent alternative.
 
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Quiltman

Regular
Hi Team,
I’m also joining you here, stormers negativity was driving me insane. Quiltman I had a read about your hunch with Springtide Investments, their website indicates they normally only invest in companies with 100-200k. I think Craig will be chasing a much larger fish. I like the thinking but CDX will be looking for 10-50Mfor the next phase.
Bit off the mark there then, and I agree they will be looking at around $20M plus. Maybe it’s the inevitable dilution that is causing someone to abandon ship, or maybe some retail holders just simply giving up and fear of the consolidation… darkest before dawn and all that. Looks like a nice core group of quality posters turning up here which is fantastic.
 
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Quiltman

Regular
How's it going team, looks like the CDX brains trust is following Quiltman across, and I can already see why! Liking the look of this forum a lot already and excited for the forums not to be flooded with trash/manipulators who the mods allow free reign to do what they please.
I'm not expecting any news prior to the EGM on the 16th, but the share price is capitulating and it seems like we are the people trying to keep this afloat and remaining patient.
I've been following the below website to see if/when AtCor and Andon will be submitting to the FDA - noting the website isn't associated with the FDA, they are managing to track submissions (Andon actually made a separate submission on Jan 28 so they are definitely quite active here).

edit, here's the AtCor page on the website https://fda.report/Company/Atcor-Medical-Pty-L-T-D

Cheers guys and hoping this turns around soon :)

Have any of you guys had a look at the pedigree of Sumathy Ramesh, our Regulatory Affairs Manager, who joined us in September 2021.
It really does give you confidence in regards regulatory approvals and FDA clearance success

She says of her role in Atcor :

My role as Regulatory Affairs Manager at ATCOR is to enable realization of the the proprietary technology intent through products in line with the market vision of Cardiex.

Sumathy has had a distinguished career with ResMed and Medtronic.
A little of her background with these organisations. For the period between Medtronic and Atcor she has been working for ARCS, a not-for-profit peak-body association of regulatory and clinical professionals, as the education manager for regulatory affairs,

MEDTRONIC
Regulatory Affairs/Post Market Specialist
Apr 2012 - Apr 2018 · 6 yrs 1 mo

    • Medtronic designs, manufactures and distributes medical devices and solutions for the treatment, management and/or diagnosis of a broad range of conditions. Having gained ample knowledge of the product development phases of the medical device life cycle at ResMed, I joined Medtronic (formerly Covidien)to get hands on post market experience across a wide range of devices.
      In my role I managed the premarket compliance activities for new products and changes to approved products in the ANZ region. I brought several medical devices in Medtronic's Minimally Invasive Therapeutic range of devices and accessories ranging from Class I to Class III to market, removing regulatory compliance from the critical path giving the marketing team the necessary advantage for a competitive launch. I managed the post market issues of a portfolio of respiratory and monitoring devices and primary patient care products collaborating with globally dispersed stake holders.

RESMED

Cross Functional Project Manager
ResMed Ltd..Sep 2007 - Oct 2009 · 2 yrs 2 mos

    • I delivered the first FDA approved device for changing the therapy parameters of another medical device using GSM technology; the end-to-end wireless Health Informatics system include a GSM mobile device custom built for machine to machine communication, a back-end communication server application and associated database, an internet based front end application server and associated database, a manufacturing processes and test system for manufacturing the GSM mobile device.
      Additionally I,
      Defined innovative execution plans for successful project delivery that fully utilised the scope offered by the Quality System.
      Prepared contingencies to handle unanticipated variations to the sales forecast mitigating inventory risk
      Co-ordinated the activities of a diverse team of global stake holders, design and manufacturing engineers, suppliers, off-shore development contractors and service providers across multiple timezones and delivered projects meeting the market needs under stringent time lines and budget.

  • RESMED Regulatory Affairs Manager
    2005 - 2007 · 2 yrs
      • Identified and executed the strategy to drive efficiencies in software development and testing by adopting the risk based approach prescribed in IEC 62304, the medical device software life cycle standard. I had watched the development of the standard and incorporated the principles into product development strategy thus, enabling the submission of a device for FDA approval straight after the formal publication of the standard. Its noteworthy that currently IEC 62304 is a mandatory standard for all medical devices incorporating software.
        Executed regulatory strategies that successfully brought several products to the global market: ANZ, US, Canada, Japan, Europe, and a host of Latin American and Asian countries.
        Implemented key standards and regulatory requirements that underpin ResMed products that improved the ability to efficiently compete in the global market place.
I think we are in good hands as she liaises with Andon to get the job done !
 
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Quiltman

Regular
Should just add that I was prompted to look for who would be controlling regulatory matters on our behalf after this prompt in the quarterly.
I can imagine a situation where Craig is calling Sumathy regularly saying " hurry up " , or something similar, and unperturbed Sumathy continues with the task at hand until she is 100% confident in submission ( via Andon )

CONNEQT Pulse & App

The final steps towards lodging the CONNEQT Pulse & App for FDA 501(k) clearance are being undertaken, with technical and product development work now complete and regulatory documentation in the final stages of completion. The FDA lodgement, via our manufacturing partner Andon, is expected shortly in the current quarter.

Upon launch, (and post FDA-clearance) the CONNEQT Pulse will be the world’s first home-use dual blood pressure (BP) management system incorporating the Company’s “SphygmoCor® technology.
 
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kickit2me

Member
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Quiltman

Regular
As well as another endorsement of our technology, it is great to see the majority of funds will fall in FY22, which will give cash flow a little more breathing room until cash injection required ...
 
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hedrox

Regular
Didn't Cops mentioned that the Atcor devision will be cashflow positive this year....looking more likely now.
Tomorrow will be the meeting to vote for the consolidation and listing in the US ...Conneqt Health will get then the
missing tailwind....plenty of news to look forward to.
 
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Jritch90

Emerged
Well looks like the consolidation passed with huge majority. The share price has to fall 20% before the new price will be under list price so we still have a decent margin. I think Craig is confident it won’t fall much more. It’s darkest just before the dawn, every Friday I’m watching the Mobvoi socials, could be any week from here on in. Good luck to all, hold strong.
 
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