CYduct Diagnostics Inc (CYDX)

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@)-;-WHY SNDY IS BUZZING-;-(@



SNDY has completed Audit (stage 1) with TÜV 2/26/13

SNDY is days away from its final Audit (stage 2) with TÜV 8/16/13

Expert resources will attend the final Audit to make sure all goes as planned.

-Most recent news -SNDY has Emergo Group as their European Authorized Representative
(final step before notified body TÜV conducts Audit)






Once the successful results of this final Audit is released, SNDY will be FDA + ISO 13485 + CE Mark approved.




2-8 weeks for paperwork and to receive certificates.

At this stage they apply the CE MARK to their devices and products, and distribute them to canadian, european, US markets.




According to this research paper

Impact of the CE mark approval on exit opportunities and valuation for early stage medical device companies





-GREAT POSTS-

LOOKS LIKE SNDY JUST STEPPED UP THEIR GAME...

in the hiring of Emergo Group. SNDY is taking this final audit as serious as they can. Not only do they have Expert Resources to over see this audit but have now brought in Emergo.
What is Emergo role? Here we go:

ISO 13485 Audits for Medical Device Companies.

Medical device manufacturers are required to regularly conduct an audit of their ISO 13485 compliant quality management system. Emergo Group conducts these fully independent quality system reviews for companies that are already ISO 13485 certified as well as for firms about to undergo their initial ISO 13485 certification audit by a Notified Body or Registrar.

Not only that but look how well Emergo takes care of their customers once hired:

Emergo Group provides the following ISO 13485 auditor services:
These ISO 13485 audits help determine the actual status of your current quality management system and processes:

•Off-site review of your current QA/RA documentation prior to your on-site ISO 13485 audit by a Notified Body or Registrar
•Systematic and independent process audit to determine conformity or nonconformity of your Quality Management System to ISO 13485:2003 requirements
•Review of your internal documentation to verify that all requirements have been addressed
•Actual verification of ISO 13485 audit requirements through review of objective evidence
•Physical verification of compliance via interviews and fact-based observations to confirm quality system requirements
•Evaluation of current special controls or validated processes; knowledgeable in various processes such as sterilization, clean-rooms, or software systems

Emergo Group also provides on-site ISO 13485 auditor training in order for clients to effectively audit their own quality systems. Our training is classroom-based and teaches your employees how to become ISO 13485 internal auditors to ensure proper functioning of your QMS. Key topics of the training include why ISO audits are required, planning an internal audit, as well as conduct and performance issues related to ISO 13485 internal audits.

CE Certification – CE Mark Certification for Medical DevicesSee all regulatory consulting services and medical device registration services.

In order to commercialize medical and in vitro diagnostic devices in the European Union, manufacturers must obtain CE Marking certification and affix the CE marking as part of their device registration efforts.

CE Marking certification verifies to EU regulators that your device meets all requirements of the Medical Devices Directive (MDD), In Vitro Diagnostic Device Directive (IVDD) or Active Implantable Medical Device Directive (AIMD) as they apply to your product. You must obtain CE Marking certification prior to marketing, distribution and sale of your product in any EU member state.

You are solely responsible as the medical device manufacturer for maintaining compliance with EU directives and securing CE Marking certification for your product, regardless of whether you outsource any or all components of your manufacturing operation.

Qualifying for CE certification and marketing your medical device in the EU requires the following steps:

1.Prepare a CE Marking Technical File or a Design Dossier for a Class III device that includes data proving compliance with the MDD, IVDD or AIMD.
2.Obtain your CE Marking certificate from a Notified Body.
3.Select and appoint a European Authorized Representative to act on your behalf within the EU.
4.Register your medical device with the appropriate Competent Authority, if necessary.
Completion of these requirements allows you to claim CE Marking certification for your device.

Looks like to me SNDY just took care of #3 with todays news.
Emergo Group has a well-established presence in the EU, with offices in the UK, Germany, France and the Netherlands. We have assisted hundreds of medical device manufactures with their CE Marking certification efforts. Services we provide to help you obtain CE certification include product classification; technical file and design dossier preparation; ISO 13485 quality system implementation and auditing; and ISO 14971 risk assessment and management.

Why choose Emergo Group as your ISO 13485 consultant?

With over 20 local offices worldwide, Emergo Group has helped hundreds of medical device and IVD manufacturers implement quality systems that meet the ISO 13485 standard. Our team of experienced ISO 13485 consultants have implemented numerous quality management systems for companies manufacturing a wide range of medical devices.

Our system has been proven to work efficiently and we have been through the process with many medical device and IVD companies that we guarantee you will pass your first ISO certification audit if you follow our plan.

•We fully customize ISO 13485 quality systems for our clients.
•Our ISO 13485 consulting and project management teams will work closely with you to ensure that your quality system is implemented on time and on budget.
•On-site ISO 13485, CE Marking, and Canadian Medical Devices Regulations training for your key employees is included in the cost of an Emergo Group quality system.
•All of our projects are based on a fixed price.


CE Mark Consultants and CE Marking for Medical Devices

Before you can sell a medical device or IVD within Europe, you must obtain CE Marking certification and place a CE Mark (CE Marking) on your product. The CE Marking for medical devices is not a quality mark nor is it intended for consumers. It is a legally binding statement by the manufacturer that their product has met all of the requirements of the Medical Devices Directive (MDD 93/42/EEC), In Vitro Diagnostic Device Directive (IVDD 98/79/EC) or the Active Implantable Medical Device Directive (AIMDD 90/385/EEC), where applicable. If a Notified Body is required, the Notified Body's four-digit number would appear below the CE Marking symbol.

CE Marking Checklist:
The Medical Devices Directives state that companies must do the following before they can place the CE Marking on a medical device or IVD:

•Compile a medical device CE Marking Technical File (or Design Dossier for Class III) with evidence of compliance to the Medical Devices Directive (or the IVD/AIMD Directives).
•Receive a medical device CE Mark certificate from a Notified Body if Class I with Measuring or Sterile function, Class IIa, IIb, or III, or if Annex II, List A; Annex II, List B, or self-testing IVD.
•Appoint a European Authorized Representative if you have no physical location in Europe.
•Register medical devices with the EU Competent Authorities, where applicable.

Only after these CE Marking requirements are satisfied are you allowed to place the CE Marking on your medical device.

Our CE Marking Services:
Emergo Group has assisted hundreds of companies with medical device CE Marking. Our services include:

•CE Marking Technical File or Design Dossier compilation and review.
•Verification of Essential Requirements.
•Product classification and identification of applicable standards for medical devices.
•Implementation and maintenance of ISO 13485 quality systems.
•Product labeling and packaging review.
•Risk assessment and management (ISO 14971).
•Development of Vigilance and Post Market Surveillance including Vigilance Standard Operating Procedures and Processes.
•Authorized Representative for Europe.
Our quality management systems can meet European CE Marking & other international requirements
Emergo Group can develop a compliant quality management system by applying ISO 13485:2012 to ensure you meet the quality system requirements for Europe. Each system is customized for the manufacturer and can not only ensure compliance to the European Directives for Medical Devices (CE Marking), but also to the Canadian Medical Devices Regulations, United States FDA QSR, Australian TGA requirements, and Japanese Pharmaceutical Affairs Law.

This place is like a Wal-Mart for your one stop shop for all your shopping needs.
Medical Device Logistics ConsultingEmergo Group can assist you with determining the best solutions for shipping your products. When exporting products many medical device companies start by shipping orders direct to distributors or customers. However, as the frequency of orders and order volumes increase it may become lucrative to consolidate orders in bulk shipments or to establish a suitable warehousing arrangement.

Warehousing & Transportation
In situations where companies are shipping direct to multiple distributors or customers, consolidation of these shipments may result in significantly lower shipping costs. And instead of requiring each distributor to keep a minimum inventory level, you as the supplier can decide to keep products warehoused in a centralized location to reduce total inventory levels in the supply chain while maintaining the option to ship next day to the distributors and customers. Results are cost savings in the supply chain, higher service levels to distributors and customers, and increased market share.

When importing products into Europe and warehousing these products in a centralized location, customs duties and value added tax (VAT) apply.

Customs Duties and Value Added Tax (VAT)
Postponement of customs duties can be arranged by warehousing your products in a customs bonded warehouse for an unlimited period of time. During this period no customs duties are due. Customs duties at import need to be paid when the goods are actually imported into the free circulation of the European Union.

Value Added Tax (VAT) is due upon import of products into the European Union and varies per EU country from 15-25%. This is a supply chain tax, and is refundable to businesses, usually by submitting a quarterly VAT return.

Finding and selecting warehousing & transportation partners
When looking for a third party logistics provider for your European warehousing and transportation needs, we can assist you with the following:

Step 1: Determine your medical device logistics needs
Depending on if you are starting up or optimizing your logistics operation(s), your needs can range from a distribution location to warehouse, pick, and ship your products to a full service value-added logistics facility where products can be assembled or customized to the specific needs of your customer base. The choice is yours! It is also possible to select a logistics provider as your fiscal representative.

Step 2: Identify potential EU logistics providers
Through our extensive logistics experience and existing network we are very familiar with the capabilities of logistics service providers specialized in medical devices. Based on your logistics needs we can identify the logistics providers that best fit your needs.

Step 3: Meet with potential logistics partners
Seeing is believing! We can set up on-site meetings for you with logistics providers that fit your needs and if required accompany you on these visits.

Well we don't know what it cost to hire Emergo Group, but I can say this, job well done SNDY for hiring such a great company to take this stock to the next level. If you had to sell some shares to make this happen, you spent our money well. I for one never questioned what was happening behind the doors at SNDY. I guess you can say the quite period is now over. I have said for the past 4 months when they have something of importance to tell us they will. I want to thank all the longs that has believed in SNDY over the past year and contributed to this board. I guess all those people spending 1.6 million dollars in SNDY preferred shares believed in them as well. We all know they was betting on the future of this company as well.

Take care my friends,
Mike

ajsollii
Post # of 60019
When acquired, their shares would be absorbed and converted to the parent/new company's shares. No need to RS. The reason they gave was to make the company attractive to merger/acquisition. CE will do that nicely...as it did with the 95% of companies who exited via merger or acquisition after obtaining both CE and FDA approval. We know what's really going on. This is going to be a fun ride. $1? No. Not in the short term. But .25 isn't outside the realm of the possible. IMO...

Looks like we have been warned over and over and over again that this stock will never go up because of all the diluted shares. Well according to the charts, if we compare price movement and volume the dilution is not hindering the stock price to run.
Lets go to bigcharts and see the facts for ourselves.

bigcharts.marketwatch.com/interchart/interchart.asp?symb=SNDY&insttype=Stock&time=20&freq=3

Once you open the link go to the left box click timeframe, then click chart range, then click 2 years.

Now lets look at volume and price movement. That is the telling story with the tradeable float. Slide your cursor on the bottom part of the chart and you will see for yourself the volume/date and price.
Date.............Price....Volume
Jan 27,2012 .0008 92,780,424
Feb 3, 2012 .001 138,243,856
Feb 10,2012 .003 148,966,600
Feb 17,212 .008 676,904,500
Total Volume 1,056,895,380 That is over 1 billion shares
traded in 3 weeks.
Float at this time was only 379,000,000

Date.............Price....Volume
March 9, 2012 .004 85,953,790
March 16,2012 .007 146,009,456
March 23,2012 .017 335,275,736
March 30,2012 .018 287,097,184
Total Volume 854,336,166 Over 3/4 million shares traded in
3 weeks and a 350% increase in price. Also remember we had big news that came out on March 23 that drove the price.
Float at this time was only 379,000,000.

Date...........Price....Volume
Feb 1,2013 .004 42,879,750
Feb 8,2013 .004 119,606,072
Feb 15,2013.006 103,673,360
Feb 22,2013.008 92,857,000
Total Volume 359,016,182, thats 58% less volume then the run we had from March 9th thru March 30th. Price increase of 100%.
Float at this time was 640,000,000.
A 41% increase in shares from the March 2012 run and yet the price moved just as easily.

Even the run up the July 18 went from .002 to .0038 on only 105,000,000 shares that day. Up over 80% and with a float of over 850,000,000 shares!!

These are FACTS that can't be dispelled no matter what anyone says. Yes the FACTS are they increased the O/S by 261 million shares during that time. But the FACTS also tells us those shares are not in the open market,(meaning when SNDY is selling these shares someone is buying them instead of them being just dumped into the open float of tradeable shares). If the float was that much bigger it would of taken at LEAST TWICE AS MUCH VOLUME TO MOVE THE STOCK PRICE UP ON THE RUN BACK IN FEBRUARY 2013.

I would agree with what many are saying about them diluting shares if they were being added to the tradeable float. The stock price would be very very hard to move up when you have a much larger float. But the FACTS shown in this chart with the price to volume ratio just do not support that the dilution will kill any run up in price. Sorry but it is simply the facts.

Yes SNDY has been selling shares but a lot of people on this board are buying. And this chart tells us that someone is buying them instad of them being dumped in the open market. Booper, Muff1, Blueski, Mgergo, Pennylanepam, Vert, Elcappy1, Frazier, Ichase01 and many others including myself have been buying millions of shares since February 2012. And the chart says exactly that.

Take care my friends,
Mike

We are starting to see why big money...

has been investing in SNDY. The payoff is going to come when they get the CE mark approval. I have been adding every week for that past 3 months. My share totals no longer matters nor do the group of guys that are in this with me. I know what I own and have waited patiently for the payoff to come with a merger or partner/buyout with another medical company.

There is a reason these smart investors/venture capitalist are spending BIG money buying SNDY preferred shares. Remember this, investors that buy preferred shares are buying into the future of the company. They know what is coming and are taking a stake in the company. How much money are we talking about? Well here is the break down.

I have put together a list of the shares and the amount of money SNDY received by going thru their financial since 2nd Q 2011.

In the 2nd Q 2011 SNDY sold 4,000 preferred B stock options for $40,000 in cash. Bottom of Pg.19 of 4Q 2011 report.

In the 4th Q 2011 SNDY owed a contractor $400,000. This contractor took $400,000 worth of preferred B stock options and then gave SNDY $55,000 in cash for the purchase of additional shares. Pg.20 of 4Q 2011 report.

In the 1st Q 2012 a consultant received 26,000 shares of preferred B stock options for payment due of $260,000. Also they sold 10,900 share of preferred B stock options for $109,000 in cash. The entire board of SNDY also gave up their 150,000,000 shares of common stock to take preferred B stock options as well. Pg.15 of 1Q 2012 report.

In the 2nd Q 2012 the company sold 38,580 shares of preferred B stock options for 395,800 in cash. Also an officer and director took 27,015 shares of preferred B stock options for the conversion of $111,240 owed to him. Pg.15 of 2q 2012 report.

In the 3rd Q 2012 the company sold 26,150 shares of preferred B stock options for $261,500 in cash.Also the president recieved 450,000 shares of preferred B stock options for $450,000 owed to him for the signing of an employee contract and personal guarantees to the company. Pg.15 of 3q 2012 report.

There is obviously some major players with really deep pockets that have heavily invested into the future of SNDY. In cash advances to company alone they have received $861,300. Over 3/4 million dollars. Not to mention the contractors, consultants, and one officer receiving shares for money owed, in the amount of $771,240. Actually more cash money went into SNDY then people taking stock options as payments. That should say a lot. So we see that $1,632,540 in cash and stock option payments have been invested into the future of SNDY in a very short time. There is no one that is going to invest this kind of money into SNDY without knowing the payoff will be rewarding.

The thesis has been out for a few years and was one of the reasons while doing my DD that led me to buy so many shares of SNDY. One of the things that caught my attention a year ago in the thesis was at the end of page 52 and the first part of page 53. Here they are talking about venture capital investors buying preferred stock. And that is exactly what I saw with all the money going into SNDY with these investors buying preferred stock options. Also take a look at the last 2 paragraphs on page 83 and the first part of page 84. That is what SNDY did over the past 14 months, got cash flow positive and and reduced almost all debt.

I've been saying this company is in a quiet period and when it is time to release news they will. I'm glad they are not throwing out fluff PR's. It is giving me plenty of time to continue to buy more shares. I will stick by what I have said for the past 15 months. My money is invested into the future of SNDY and I believe my pay off will be well rewarding.

Take care my friends,
Mike

A/S 851M shares with just about 100M before being maxed. Highly unlikely the company increases A/S before a major milestone (CE Mark).

SNDY Current MC $1.702M. Obviously way undervalued even with the current S/S. SNDY BV $2.15M

I didn't particular like 190M new shares to hit the market (it reduces expected ROI) but it was as transparent as it comes. It hasn't been hard (at all) to track where the dilution is coming from, Preferred shares (that have been issued to Boost) are being converted to common shares. It's funny how nobody is talking about how all these shares have been absorbed at or above the 52 week low ahead of the CE Mark. $0.002 continues to be strong support.

The company has been able to continue carrying very little debt (Current Liabilities ~$173K). Solos has been able to keep its balance sheet very healthy despite how long the ISO process has taken. Costs associated with the CE Mark are finished, the company has the opportunity to reach quarterly profitability by increasing revenue a few hundred K.

Also important

Authorized Preferred Shares: 20M shares with only 650K outstanding.

No reason to authorize so many Preferred Shares if you don't expect to use them to generate capital.

A/S will likely increase at some point but the question is by how much. The CE Mark is a huge deal for a small medical device company looking to form a partnership or exit via M&A. CE Mark combined with international distribution would lead to a significantly higher PPS.

GLTA

mgrego