typing on the computer about my status
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Only hunnnned I see is 100% success rate! Guaranteed old sport!
@)-;-Expert resource - GUARANTEES to pass final Audit-;-(@
"ER's approach to Management Systems consulting is very comprehensive, flexible, and affordable. Our consultants maintain a 100% success rate of attaining registration upon first attempt. ER also offers a compliance guarantee! Expert Resource guarantees that your documentation prepared by ER will pass the final audit, regardless of which registrar you choose to audit your management system. Beware of consultants who only guarantee based on the registrar they choose for you."
http://www.expertresource.net/ISO_Systems_index.html
After looking at the chart, it has "breakout" written all over it. IMO of course. I'm not telling anybody to buy or sell, but as for me nothing will change what I believe to be the outcome.
SNDY
@)-;-Expert resource - GUARANTEES to pass final Audit-;-(@
"ER's approach to Management Systems consulting is very comprehensive, flexible, and affordable. Our consultants maintain a 100% success rate of attaining registration upon first attempt. ER also offers a compliance guarantee! Expert Resource guarantees that your documentation prepared by ER will pass the final audit, regardless of which registrar you choose to audit your management system. Beware of consultants who only guarantee based on the registrar they choose for you."
http://www.expertresource.net/ISO_Systems_index.html
SNDY has state-of-the-art devices and will be primed for exit. Investors seemed to be more concerned with pre milestone activity and timetables without understanding future potential impact they provide. We are headed toward a inflection point where much higher values could be generated.
POSTS THAT DESERVE ANOTHER LOOK
(I know I missed a bunch but this is what I could do in the time I had!)
ICHASE01
Wednesday, August 14, 2013 11:09:33 AM
Summary of President's Letter:
1. Stage 1 Audit with TUV SUD America was completed on 2/26/13.
2. Stage 2 Audit for ISO 13485 is scheduled 8/16/13; once completed and CE certification obtained, MammoView devices will be able to be sold in Canada and EU.
3. Solos Endoscopy has retained Emergo Group as authorized representative in Europe.
4. Core business is development and marketing of medical technology, applications, medical devices and procedural techniques.
5. Assets decreased, but so did liabilities.
6. Positive Net Book Value.
7. Increase of sales from same period last year.
8. Increase in revenues.
9. Expenses decreased as did Net Loss.
10. Stock was issued to CEO, not cash, for salary.
MGREGO
Thursday, August 08, 2013 5:34:23 PM
It is pretty much a given that SNDY common shares or Preferred shares would be part of any path to obtaining distribution channels. The shear size of the increase does immediately give the company enormous flexibility to secure a wide variety of deals.
Any M&A (whether Solos is on either end of the equation) or JV would be contingent/necessary on the company increasing its authorized capital (A/S).
An A/S increase is a necessary part of the equation. The condition is often referred to as an amendment to the Articles of Incorporation.
HIGHFLIER
Dilution is paying for the salaries of the folks at SNDY. We have heard a few hundred times how they are screwing us by living it up on our hard earned money. Well that is simply not the case. You need facts, here it is.
The Company decreased its Net Loss for period ended June 30, 2013 by $471,290. The significant financial improvement from the same period in 2012 is due to the fact that the Company will not be charged again
for the issuance of stock to its CEO to guarantee his contract. This improvement of $450,000, combined with an increase in sales of $26,203, resulted in a significant turnaround for the Company. According to Management, total salaries are only $45,404 or approximately 40% of sales. The Company has spent additional monies on professional fees to complete the TUV Audit which is scheduled to take place on August 16, 2013. Therefore, Operating Expenses going forward should remain constant. The reduction of these onetime expenses, coupled with an expected increase in sales the 3rd and 4th quarters in 2013, should result in a very positive end of the year for Solos Endoscopy.
1. According to this their TOTAL SALARIES(plural)is $45,404.
2. The Company has spent additional monies on professional fees to the past several months that all this dilution by the company was to complete the TUV Audit which is scheduled to take place on August 16, 2013. Well according to this additional money has been spent to pay for obtaining the CE mark. Now recently they have hired Emergo Group. Most likely those 100,000,000 million shares was to pay for their services.
Being told they sold millions of shares for the lavish salaries of the folks at SNDY is simply not true.
HIGHFLIER
THE REAL REASON PAST R/S HAPPENED...
I just want everyone to look at the real reasons that are factual as to why SNDY did 4 past R/S. That is what one has to look at and then see if this is the same company now as it was back during the time. Let's consider what was going on during that time.
Solos Endoscopy made a bad business decision when they bought medical devices from Lifeline Bitechnologies for $4 million dollars during tough economic times.
August 2, 2006
Solos Endoscopy Completes Acquisition of Early Cancer Detection Products From Lifeline Biotechnologies for $4 Million
By: Solos Endoscopy, Inc. via Marketwire News Releases
Solos Endoscopy, Inc. (PINKSHEETS: SLSE) today announced the Company has acquired the Lifeline Biotechnologies' early cancer detection product line for $4 Million in restricted shares of Solos Endoscopy. Solos Endoscopy has obtained medical assets from Lifeline Biotechnologies, which included the MastaScope(TM), First Warning System(TM), OvaScope(TM), and the intellectual properties relative, to those products.
Lifeline Biotechnologies will also receive compensation, in the form of a royalty, once sales of the MastaScope(TM), First Warning System(TM), and OvaScope(TM) exceed $4 Million. Lifeline Biotechnologies, Inc. has announced existing shareholders will receive a dividend in Solos Endoscopy for their support of Lifeline Biotechnologies in the development of these products.
Now that these new technologies have been acquired, Solos Endoscopy plans to continue the testing and development of these products in an effort to add them to the current line of women's health care products currently in development at Solos Endoscopy.
"We are happy that we have completed this transaction successfully," stated Jim Holmes, President of Lifeline Biotechnologies.
"We look forward to adding these products to our growing line of endoscopic devices and feel that they will help enhance our position within the women's endoscopic healthcare market," stated Robert Segersten, President of Solos Endoscopy, Inc.
business.highbeam.com/436102/article-1G1-148999918/solos-endoscopy-completes-acquisition-early-cancer
Here we can all see this was toxic for SNDY when they purchased these products for $4 million dollars when the economy was not doing well. They needed to say focused on what they do best and that is make their own medical devices. It was during this time from Aug. 2006 thur Aug. 2010 that the R/S happened. They did need to do R/S to keep the company going. They made a bad mistake in extending themselves in spending $4 million dollars plus royalities during this time.
They were at least smart enough to realize it was time to do something to correct their mistake in buying this from Lifeline. So they sold the devices back to Lifeline Biotechnologies.
Newsline:
Solos Endoscopy, Inc. Sells Ovascope and Mastascope Product Line to Lifeline Biotechnologies, Inc.
March 20, 2009
BOSTON, /-- Solos Endoscopy, Inc. (Pink Sheets: SNDY) is pleased to announce that the Company has signed an agreement with Lifeline Biotechnologies, Inc. (Pink Sheets: LLBO) to sell the Ovascope and Mastascope product line to Lifeline Biotechnologies for a combination of stock, assumption of debt and other consideration. Solos Endoscopy originally purchased the products from Lifeline Biotechnologies in 2007.
Lifeline Biotechnologies has agreed to assume a convertible debt from Solos, which will result in less dilution for its shareholders. In addition, the sale of the Ovascope and Mastascope will allow Solos to use its resources to support its expanding core business. Solos is currently in negotiations with Lifeline regarding distribution rights to these products once they are finally ready for the market. Solos will continue to focus its efforts in the area of women's healthcare by concentrating on its Mammoview product line, which is currently sold to hospitals nationwide.
"Although we feel that there is great potential in the Mastascope and Ovascope technology, due to the current state of the economy, our resources will be better utilized in strengthening our current product lines to an expanding customer base," stated Bob Segersten, President of Solos Endoscopy, Inc.
http://boston.citybizlist.com/article/solos-endoscopy-inc-sells-ovascope-and-mastascope-product-line-lifeline-biotechnologies-in-0
Ok now we have some pretty factual reasons SNDY had to do the prior 4 R/S. And to me it would make perfect sense why SNDY had to do those past R/S. It was because they were in major debt because they made a bad choice in an investment decision to buy these medical devices. It happens to companies all the time, not just Solos Endoscopy. As business owners we want to do things to grow our business and we step out and do things that may not of been so great of an idea. But you have to be smart enough and realize when a mistake has been made and correct it. That is what SNDY did.
Did it hurt those investors back then? Absolutely! But it was their choice to be invested in a company that had MAJOR DEBT. I would of NEVER CHOOSEN TO INVEST in a company with that much debt. It was a BAD decision for ANY INVESTOR AT THAT TIME TO have done that. AND SNDY DID NOT make ANYONE invest in their stock. IT WAS A CHOICE, A VERY BAD CHOICE FOR ANYONE TO INVEST IN A COMPANY WITH THAT MUCH DEBT IN A HORRIBLE ECONOMY!!!!
THAT is the real reason why they had to do those past R/S. Bad debt, plain and simple. You never quite tell the real reason why those past R/S happened. But they have turned the corner and the president has said since last year we would see this thru to get the CE mark and then have global distribution of their products bringing value to the share holder. That is about to happen. The future growth of SNDY is about to happen.
HIGHFLIER
both know it was not cheap to hire these companies to get the job done for Solos. It cost money, a lot of money. When I look at these 3 companies, especially Emergo, I think you said it best, PRICELESS. Solos has positioned themselves with some very good companies that can take them to the next level. I just believe the possibilites are endless where this could go, examples: merger/acq./buyout/increase revenue.
People keep thinking only the Mammoview. But I keep looking also at the SteriTap and this article on how huge this market is and the major companies little old Solos is mentioned with:
SOLOS ENDOSCOPY MENTIONED IN $3.6 MILLION LAPAROSCOPIC ARTICLE...
US Laparoscopic Device Market to Grow Moderately to Nearly $3.6 Billion by 2017 Growth Driven by Increasing Demand for Minimally Invasive Procedures, According to Millennium Research Group
January 14, 2013—Toronto—According to Millennium Research Group (MRG), the global authority on medical technology market intelligence, the United States market for laparoscopic devices will grow moderately, reaching a value of $3.59 billion by 2017. Growth will come largely from expanding procedure volumes, as the demand for minimally invasive techniques continues to grow. Direct energy, hand assist and single-port devices will grow most quickly.
Laparoscopic procedures will grow significantly faster than open surgeries through 2017 as surgeons continue to take advantage of the patient benefits of laparoscopic techniques, such as faster recovery, less post-operative pain, and better cosmetic results. Bowel resections will be the fastest growing laparoscopic procedure, followed by sleeve gastrectomies and hernia repairs. Sleeve gastrectomies will grow at the expense of gastric banding, which has suffered from safety and efficacy concerns.
Single-port procedures will grow strongly, driven by uptake in high-volume procedures such as cholecystectomies and appendectomies. These are procedures where surgeons are either extremely experienced with laparoscopic techniques, or where the anatomy lends itself to straightforward access from the umbilicus.
Robotic techniques will also show strong adoption in urological and gynecological procedures, particularly in prostatectomies, partial nephrectomies and hysterectomies.
“Outside of these growth segments, there is a strong emphasis on cost cutting,” said MRG Analyst Chantal Dougan. “Reusable and reposable products have taken ground from disposable products, particularly in the access device and hand instrument segments. While disposable products generate higher per-procedure revenues, over the next few years the conversion to reusable devices will aid revenues, as facilities invest in entire sets of reusables.”
CareFusion, Solos Endoscopy and Integra LifeSciences all launched modular reusable hand instruments in 2012 to combine convenience with cost-savings.
Here we see Solos is getting mentioned with some big name companies. These people writing these article know the products SNDY has. And out of all the companies they could of mentioned they DID MENTION SNDY!! SNDY spending the money last year to bring out new products is going to pay off big time. They know their market and are taking every step to position themselves to be a player in this market. And a company like Emergo Group can get this type of product into a Global market quickly.
HIGHFLIER
I SURE HOPE EMERGO GROUP IS OUR PARTNER....
Emergo Group consultants will assist Solos with a wide variety of regulatory, quality assurance, and distribution. Who will help us in distrubution? A group of their consultants.
So here is one of their distribution consultants
David Christie, BSc, MBA
Distribution Consultant
David Christie is a highly accomplished President and Chief Executive Officer with a proven ability for commercializing technology, facilitating change and increasing shareholder value by delivering compelling financial results. Unique combination of experiences in early stage start-ups, turnarounds, revenue and profit acceleration, mergers and acquisitions across various industries, including environmental, information/communication technologies and medical devices. Mr. Christie’s strengths include implementing strategic change – quickly analyzes the current situation, creates a compelling vision for the future, documents the action plan to move from here to there and executes on the plan with tenacity and precision; delivering financial results – very adept at improving revenue and profit performance through sustainable growth and with appropriate financing; effectively commercializing technology – understands the challenges of turning brilliant concepts in to inventions, creating an effective intellectual property portfolio, overcoming regulatory, reimbursement, quality, manufacturing and logistic challenges, to deliver products to market and realize double-digit returns on investment, especially with innovative new technologies.
EXPERIENCE:
Christie Consulting Services – 2009 to present
Christie Consulting is a sole proprietorship dedicated to helping early-stage and emerging technology companies expand their business. By working with the client’s senior executives in a collegial, advisory and consultative capacity, Christie adds real value by objectively analyzing their business problems, identifying opportunities to accelerate growth and rolling up his sleeves to make results happen. Leveraging his broad and deep experience, he is able to contribute quickly and effectively. Clients include:
• Romich Medical – very early stage, exploring new gynecological applications for existing medical devices
• ARC Pharmaceuticals – early pre-clinical commercial stage, assessing clinical markets here and abroad
• Emergo Group – international regulatory and distribution firm, providing Canadian market assessments
• Hemosonics – start-up stage, advisor to the CEO on all aspects of technology commercialization
So what about the president of Emergo Group:
René van de Zande
President & CEO
René is responsible for all operations of the Emergo Group of companies worldwide. René founded Emergo Group in 1997 and as its President & CEO, he has a consistent record of delivering results in growth, revenue, operational performance, and profitability. Today, he spearheads the international expansion of Emergo Group's operations and service offerings, and provides guidance and support to Emergo Group teams on five continents.
www.massdevice.com/emergo-group-doubles-office-space-accommodate-growth
Emergo Group doubles office space to accommodate growth
Emergo Group, an international regulatory consulting firm, has completed a move into its new headquarters in downtown Austin, leasing more than 13,000 square feet at 816 Congress Avenue.The expansion comes in response to strong demand for the company’s services from medical device manufacturers in the US, Canada and Europe. Emergo Group specializes in assisting medical device companies with US and international regulatory compliance. The company currently employs 55 people at its headquarters in Austin, with plans to continue hiring throughout 2013.
Asked about the driving factors for growth at the company, Emergo Group President and CEO Rene van de Zande notes: “We’re seeing strong demand from companies that want to expand overseas, but might have been intimidated by the regulatory process. That’s especially true in challenging markets such as China, Brazil, Japan, Mexico and Russia, where having local expertise is key. We now have offices in 23 countries, which allows us to help our 2,500 clients grow by accessing markets they might not otherwise have considered.”
Emergo Group plans to expand throughout 2013, with new offices planned for the Middle East, South America and Southeast Asia.
“We don’t see things slowing down. Healthcare spending continues to rise, especially in fast growing markets like Brazil and China. Medical device companies in the US and Europe are looking for ways to boost the top line and the rate of growth in those countries far exceeds what they can expect in their home markets,” notes van de Zande.
About Emergo Group
Emergo Group is an international medical device consultancy serving medical device companies in 55 countries worldwide. The firm assists manufacturers with medical device registration, quality system compliance, clinical trials, in-country representation, reimbursement and distributor search consulting. The company was founded in 1997 and can be found online at www.emergogroup.com
Emergo Gruop knows people on top of people. They are beyond connected across the world. If they have a product then it will have the attention of the companies they distribute to. The possibilities are endless with how all this will unfold with SNDY over the next 2-4 months.
HIGHFLIER
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.
TANGERINE
Thursday, August 15, 2013 12:13:17 AM
My conclusion thus far.
The CE mark is a significant milestone. Those on both sides of the argument seem to clearly believe this. With all of the arguments against SNDY, it is clear all believe this to be a big achievement for the company and a lot of money and dilution has gone into ensuring this would happen. So all sides including the company believe this is a big achievement.
Will this CE mark generate significant revenue? Not by itself but it opens markets. Who will be selling this product and who will be buying these products? Who knows at this point. I haven't seen a real answer but it would be a prerequisite to sell the company or merge.
I also don't see anyone arguing that mammoview does not work. So that would be the biggest and best argument to me but it is pretty obvious to me and from reading some of the technical docs, that it probably does work. How come it hasn't been picked up more my others, journals, every hospital in the free world wanting it? Does make you wonder.
I don't see any real short volume and I am not sure you even could short this stock. The downside and upside and the fees probably make this a poor choice.
Is the argument really about a trading opportunity and entry price? Probably, at least it would seem that way.
Buyout? For the tech maybe but the trading wouldn't indicate it so far from what I can see but maybe with CE mark as some are predicting.
Will I buy some more shares? Probably
AQUA
Thursday, August 15, 2013 1:24:01 AM
To bring this into perspective, Solos management realized a long time ago that their products have not met much success in the US healthcare system in terms of revenues and profitability. Their strategic initiative objective was to open Solos to new markets. But the only barrier to entry into the markets in Europe and Canada was obtaining the expensive CE Mark certification. In the process, Solos had to make sacrifices, which were unfortunately at the expense of shareholders after multiple attempts of dilution to their stock. Keep in mind that management's ambition to pursue the CE Mark is valid given the survival of the company is at stake due to least spectacular product sales. With one day away, we await a defining moment in Solos history and its existence as a global company with the purpose of saving lives. Cheers!
SimmerDownNow
Shh... there's an audit going on.
Go SNDY!
EKIM88
ELCAPPY1
3 Month Daily Chart
200MA Leveling out as Resistance...
50MA Turning up for higher levels of support...
Keep in mind what happens when the 50MA crosses above the 200MA with stellar news to back it... Future short term press releases, ISO 13485 (2+yr process), C.E. Certification (2+yr process), Limited Dilution (ISO & CE paid for), New partnerships, Merger, Acquisitions, Share buyback, Retirement of shares, Dividend...
2 Year Daily Chart
Please take a look @ January 2012. This 1000%+ run to the end of March was caused only by the ANTICIPATION of the Stage 2 Audit August 16th 2013... Please take note to the mid March Golden Cross...
2 Year Weekly Chart
EXTREMELY BULLISH
RSI 49.04
20MA RED
50MA BLUE
Expert resource - GUARANTEES to pass final Audit
"ER's approach to Management Systems consulting is very comprehensive, flexible, and affordable. Our consultants maintain a 100% success rate of attaining registration upon first attempt. ER also offers a compliance guarantee! Expert Resource guarantees that your documentation prepared by ER will pass the final audit, regardless of which registrar you choose to audit your management system. Beware of consultants who only guarantee based on the registrar they choose for you."
http://www.expertresource.net/ISO_Systems_index.html
Please let's see what deserves credit....
Trips? Nope
RS? Nope
.0016? Nadda
.0009? Zip
Stage 1 audit? No delay and was successful....yup wrong again
Stage 2 audit? No delay..... Not this one
Now lets see what happens next.
A/S was expected. This is common before M/A, so really do you feel as if credit should be due for this?
I know I'm not the only one who saw the 6 market makers trying franticly to keep the price below .0033 the past couple of weeks. Looks to me they want to make it look like a wall, but I don't honestly believe they want to sell many shares. I mean if they did why didn't they just sell at .0031 or .0032? Instead they pile up on .0033?
I'm buying more when I see a PR of successful Audit.
Today is the day for the Audit, nobody is changing their position. Lets see what the results are before anybody starts pointing fingers.
SNDY is holding just fine, we will be hearing from them real soon. ISO 13485 is a game changer. When they pass the audit, to me that's just like slapping the marks right on there products that day.
And when that happens SNDY is a new company, one that can not be compared to itself 3 years ago.
Everybody knows it. Sorry but SNDY is going up.
It will be a great day for shareholders to receive confirmation that Audit 2 was successful. They will receive CE mark soon after.
Has anybody found another pink trading at this level with FDA & CE mark? Still looking.........
Agreed, lots of accumulation at this level by the MM's. Wouldn't be surprised to see 40%+ next week.
I know I'm trading in the pinks, therefore I have to adjust my point of view to reflect it. With SNDY I noticed something different, and unlike any other pink it actually surprised me to see that SNDY was actually using the funds to bring value and growth to the company. Delays are unpredictable, and if the end result is achieved well...its really the only thing that matters to me.
Highflier, according to this diagram from the TÜV website, it showing a time period of 3-8 weeks to be issued certificates. Is that just the ISO 13485 or will that both ISO and CE mark?
Also I have heard of instances where the majority of the paperwork to receive the CE mark is done at the same time as the final audit to speed up the process. Do you think this could be a possibility?
To see the PR about successful Audit 2 will be so satisfying!
ISO 13485 will look good, and CE markings will look even better on all their products.
GLTA SNDY
Well hopefully you will be around when it does...
Tomorrows successful completion of the Stage 2 Audit, including a review of the Auditor’s report and resolution to any corrective actions, Solos will be certified to ISO 13485:2003, the internationally recognized standard for quality systems for medical device manufacturers. Certification to ISO 13485:2003 will in turn facilitate Solos Endoscopy obtaining the CE Mark on its MammoView® devices to sell the MammoView® in the European Union.
http://www.otcmarkets.com/financialReportViewer?symbol=SNDY&id=109547
CE marking approval, is but one of many important value inflection points in the entire lifecycle of the company...
Nice post
SNDY CHARTS
Nice Post ELcappy1
3 Month Daily Chart
200MA Leveling out as Resistance...
50MA Turning up for higher levels of support...
Keep in mind what happens when the 50MA crosses above the 200MA with stellar news to back it... Future short term press releases, ISO 13485 (2+yr process), C.E. Certification (2+yr process), Limited Dilution (ISO & CE paid for), New partnerships, Merger, Acquisitions, Share buyback, Retirement of shares, Dividend...
2 Year Daily Chart
Please take a look @ January 2012. This 1000%+ run to the end of March was caused only by the ANTICIPATION of the Stage 2 Audit August 16th 2013... Please take note to the mid March Golden Cross...
2 Year Weekly Chart
EXTREMELY BULLISH
RSI 49.04
20MA RED
50MA BLUE
R&D is what they are really trying to sell, 25 years of it.
This may help understand...
February 13, 2007 -- Solos Endoscopy, Inc. announce that the Company's board of directors has approved a new acquisition and merger strategy.
"Our strategy through mergers and acquisitions is to continue offering top-of-the-line medical products while developing innovative new devices and increasing our presence in the endoscopic market," stated Bob Segersten, President of Solos Endoscopy, Inc.
If unreadable, the heres the link page 80,81,82
http://dspace.mit.edu/handle/1721.1/37978
When the president of the company mentions the date in a letter to share holders 2 days before the Audit, I'm pretty confident that theres no delay...
as far as the schedule on their website....
Definition....
Schedule (project management):a list of a project's milestones, activities, and deliverables with intended start and finish dates
I agree, SNDY will help in bringing affordable early detection to many which in turn will save lives. Even if they sold one, that one MammoView could help and save numerous lives by detecting breast cancer at its earliest stages.
I believe when a company reaches a milestone such as CE Mark, this changes the company entirely. A new chapter is written from that day forward, IMO and it all starts with a successful Audit. You just wouldn't be able to compare the SNDY R&D startup with the SNDY FDA & CE global distributer.
Glad to have you on the boards, your input is always appreciated!
SNDY is a champ, success on Friday IMO
Looks like SNDY is holding well, when the time comes she will run....
Yeah if that was the case they would sell at a lower PPS...
Nope, I didn't see it.
Emergo group will be a nice fit for SNDY, big sign of growth IMO.
With ISO 13485 completed it will further support the positive direction we are headed.
A rare gem, FDA & CE mark in the pinks. Can't wait!
GLTA !
8/14/13. Dear Solos Endoscopy, Inc. Shareholders,
I am very pleased to be able to communicate with our loyal shareholders directly and to give you an update on our impressive progress for the second quarter; the three month period ended June 30, 2013.
Solos Endoscopy, Inc. has been at the forefront of breakthrough medical devices and technologies for the treatment and management of diseases for over 25 years. The Company markets over 200 items to the endoscopic market and is continuing the development of products that will enhance the ability of medical professionals to perform minimally invasive surgical techniques.
Solos Endoscopy completed the Stage 1 Audit with TÜV SÜD America on Tuesday, February 26, 2013. Solos Endoscopy's Quality Manual and 28 Quality System Procedures were reviewed by TÜV SÜD for compliance to the international quality system standard ISO 13485:2003, to the European Union's Medical Device Directive (MDD 93/42/EEC) and to the Canadian Medical Device Regulations (SOR/98-282). Since the completion of the Stage 1 Audit, the Company has been diligently working, with the support of Expert Resources, to continually develop, implement and master the Quality Manual and Quality System procedures.
Solos Endoscopy and TÜV SÜD America has scheduled its Stage 2 ISO 13485 Audit to be completed on August 16, 2013. Upon successful completion of the Stage 2 Audit, including a review of the Auditor’s report and resolution to any corrective actions, Solos will be certified to ISO 13485:2003, the internationally- recognized standard for quality systems for medical device manufacturers. Certification to ISO 13485:2003 will in turn facilitate Solos Endoscopy obtaining the CE Mark on its MammoView® devices to sell the MammoView® in the European Union. According to a 2009 report published by Frost & Sullivan, the European Union represents $94 Billion, or 30%, of the worldwide demand for medical instruments. ISO 13485:2003 certification is also necessary for the company to sell the MammoView® product line in Canada. Recently, as part of the process to obtain the CE Mark, Solos Endoscopy has retained Emergo Group to act as the Company's authorized representative in Europe. Emergo Group will provide Solos assistance related to communications with authorities and importation of Solos instruments into Europe.
The company previously was successful in completing the Food and Drug Administration (FDA) Level II Baseline Inspection in which it received a NAI (No Action Indicated) for the inspection. It is standard for the FDA to perform unannounced inspections periodically for medical device manufacturers, and the successful inspection by the FDA validates the Company's quality system and its strict adherence to that system.
Solos has several exciting new advances in product development that will change the way minimally invasive procedures are utilized in the medical field in order to treat and prevent disease. These products will allow the physician to examine organs and tissues within the body without the need for intrusive surgery. The Company is currently marketing its next generation breast endoscopy system, the MammoView® system, for early breast cancer detection.
Solos Endoscopy’s core business is the development and marketing of medical technology, applications, medical devices and procedural techniques for the screening, diagnosis, treatment and management of disease and medical conditions.
Solos Endoscopy 2nd Quarter 2013 Analysis
Balance Sheet
Solos Endoscopy’s Total Assets decreased to $2,262,785 for the period ended June 30, 2013 from $2,426,883 for same period in 2012. This represents a decrease of ($164,098), which is mainly attributable to a cash and inventory decrease of more than $167,000 for the period ended June 30, 2013 as compared to the same period in 2012.
Solos Endoscopy reduced its Total Liabilities from $214,827 for the period ended June 30, 2012 to just $148,000 for period ended June 30, 2013. As a result, the Company has a Positive Net Book Value when it posted its financials for the period ended June 30, 2013.
Income Statement
Solos Endoscopy showed an increase in sales from $81,752 for period ended June 30, 2012 to $107,955 for period ended June 30, 2013. This represents an increase in revenues of $26,203. The Company’s Gross Profit increased from $53,214 for period ended June 30, 2012 to $59,520 for the period ended June 30, 2013. The Company’s Cost of Goods increased by more than $18,000 as a result of the Company writing off obsolete inventory in the 2nd Quarter.
Solos Endoscopy’s Total Expenses decreased from $642,963 for period ended June 30, 2012 to $177,978 for period ended June 30, 2013. The significant decrease in Total Expenses is due to the $450,000 expense the Company incurred for stock issued to the CEO in 2012 to guarantee his contract. Otherwise, the Company actually reduced its General and Administrative Expense from $192,963 for period ended June 30, 2012 to just $177,978 for period ended June 30, 2013.
Conclusion
The Company decreased its Net Loss for period ended June 30, 2013 by $471,290. The significant financial improvement from the same period in 2012 is due to the fact that the Company will not be charged again for the issuance of stock to its CEO to guarantee his contract. This improvement of $450,000, combined with an increase in sales of $26,203, resulted in a significant turnaround for the Company. According to Management, total salaries are only $45,404 or approximately 40% of sales. The Company has spent additional monies on professional fees to complete the TUV Audit which is scheduled to take place on August 16, 2013. Therefore, Operating Expenses going forward should remain constant. The reduction of these onetime expenses, coupled with an expected increase in sales the 3rd and 4th quarters in 2013, should result in a very positive end of the year for Solos Endoscopy.
In closing, I want to thank our shareholders for your patience and continued support of Solos Endoscopy. We will continue to keep our shareholders updated through regular posting on www.otcmarkets.com and Company press releases. To learn more information about the Company and its products visit www.solosendoscopy.com.
Regards,
Robert Segersten
President and CEO
Solos Endoscopy, Inc.
Certain statements in this document may contain forward-looking information within the meaning of Rule 175 under the Securities Act of 1933 and Rule 3b-6 under the Securities Exchange Act of 1934, and are subject to the safe harbor created by those rules. All statements, other than statements of fact, included in this document, including, without limitation, statements regarding potential future plans and objectives of the company, are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Technical complications that may arise could prevent the prompt implementation of any strategically significant plan(s) outlined above. The company cautions that these forward-looking statements are further qualified by other factors including, but not limited to, those set forth in the company's Annual Report filing and other filings with the OTC Markets Group (available at www.otcmarkets.com). The company undertakes no obligation to publicly update or revise any statements in this release, whether as a result of new information, future events, or otherwise.
Okay who bought in 2010 can they post please?
IMO, many are waiting for successful stage 2 results.
They are opinions when you add words like addicted, massive, or devastating.
Thanks for your opinions, but SNDY has again built my confidence as a shareholder. Exciting times for SNDY.
Nice post, seems to me that Emergo Group is just what they need.
Quote:
The net loss cut of 46% will be attractive for any merger/acq/buyout or if they are just plan old gearing up for global distribution of sales. And by SNDY hiring Emergo Group they just added huge leverage in making any of the above happen.
Consider just one of Emergo Groups consultants resume:
David Christie, BSc, MBA
Distribution Consultant
David Christie is a highly accomplished President and Chief Executive Officer with a proven ability for commercializing technology, facilitating change and increasing shareholder value by delivering compelling financial results. Unique combination of experiences in early stage start-ups, turnarounds, revenue and profit acceleration, mergers and acquisitions across various industries, including environmental, information/communication technologies and medical devices. Mr. Christie’s strengths include implementing strategic change – quickly analyzes the current situation, creates a compelling vision for the future, documents the action plan to move from here to there and executes on the plan with tenacity and precision; delivering financial results – very adept at improving revenue and profit performance through sustainable growth and with appropriate financing; effectively commercializing technology – understands the challenges of turning brilliant concepts in to inventions, creating an effective intellectual property portfolio, overcoming regulatory, reimbursement, quality, manufacturing and logistic challenges, to deliver products to market and realize double-digit returns on investment, especially with innovative new technologies.
EXPERIENCE:
Christie Consulting Services – 2009 to present
Christie Consulting is a sole proprietorship dedicated to helping early-stage and emerging technology companies expand their business. By working with the client’s senior executives in a collegial, advisory and consultative capacity, Christie adds real value by objectively analyzing their business problems, identifying opportunities to accelerate growth and rolling up his sleeves to make results happen. Leveraging his broad and deep experience, he is able to contribute quickly and effectively.
Clients include:
• Romich Medical – very early stage, exploring new gynecological applications for existing medical devices
• ARC Pharmaceuticals – early pre-clinical commercial stage, assessing clinical markets here and abroad
• Emergo Group – international regulatory and distribution firm, providing Canadian market assessments
• Hemosonics – start-up stage, advisor to the CEO on all aspects of technology commercialization
Why bring this up. Because in the new release last week about Emergo Group it stated, "Emergo Group consultants will assist Solos with a wide variety of regulatory, quality assurance, and distribution". That is exactly what Mr. Christie does for Emergo Group, a consultant who helps with distribution and merger and acq. You get my point.
The time is coming when news is going to break of a merger/acq/buyout or global distribution of their products. Either way I believe we the share holders win.
Take care my friend,
Mike
so you don't believe a company needs to raise the A/S before a merger/acquisition to protect themselves from a hostile takeover.
interesting.
So your frightened of the thought of delay in achieving CE MARK?
so when will the scary finishing move "The Leg Drop" that will let us know sndy is out for the count? after or before Audit?
Questions....
Thanks for the opinions
Do you know of any pinks who have FDA and after receiving CE mark fall to the trips with a R/S? how about one? Seems to me that a milestone such as CE mark is a game changer, does that make any difference?
What do you think about 95% exit via merger/acquisition when receiving both CE mark and fda approval. Do you think this was imaginary and is not important?
How about the scheduled Audit stage 2... You believe it was imaginary as well?
Will Expert Resources have its first failed audit staining its 100% success rate?
Does Robert Segersten plan on diluting when hes 90 years old?
Does your opinion change if you have a position in sndy?
Do you still think the PPS will go to .0009 this week?month?year?
Should I load up at .0009 but watch out for the R/S at the same time?
Well everyone agrees (Including yourself) a company need to raise the A/S before a merger/acquisition to protect themselves from a hostile takeover.
(@)-;--'-FINAL AUDIT #2 FRIDAY 8/16-'--;-(@)
thats nice, did you know that SNDY will be ISO 13485 approved and CE Mark green light after friday? That makes SNDY a GLOBAL company. How many pinks are distributing products GLOBALLY?