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"That's because practically no one knows OR cares whether DRIO even exists anymore! " There are people who have claimed to have read through the 10k and post comments all day.
"Nevertheless, the 10-K IS indeed a critical event" pps and volume suggests otherwise. Where is the sell off on "BAD NEWS"?
"Put those altogether and you have a highly effective investor "repellent."
Yet it seems that DRIO is getting investors including board members (CFO and Prof Stone) to participate in raising money.They probably didn't read the posts on this board warning them not to invest..so maybe bad DD on their part.
Spot on..Right on the money.Such massive volume and huge down day on the "critical" event of Annual Report filing. Everyone seems to be selling today...Time to buy a new logic book grandpa.
"Either one or the other, I suppose, because the FDA CERTAINLY didn't "force" them".. another clueless attempt from the old logic book. What does "I suppose" mean? Show proof that it was not a FDA requirement.
If Dario wants to serve tea to the participants according to the old logic book FDA would publish that on clinicaltrials.gov site as a study?
New PR says completed the submission of application.
There goes the"Allows to" confusion and now maybe its time to change the "old logic book".
If the study is not required for 501k application
visit the link below and explain why they have it on clinicaltrials.gov if it was not required?
https://clinicaltrials.gov/ct2/show/NCT02357043?term=labstyle&rank=3
and how does the following completed trial
https://clinicaltrials.gov/ct2/show/NCT02352298?term=labstyle&rank=2
help them to "string investors along"
Arguments are fizzling out, time to go back to older PRs to dig up more dirt.
"I whipped out my old logic textbook" ...this made my day.
I just successfully trolled you to write a long reply. no one cares what you have to say.
"The WHOLE idea of a 510(K) is to AVOID trials!" you are completely lost here.It was not a trial but only a user performance evaluation to test accuracy of the device.I am not going to waste any more time on your posts just laugh at the content from now on.
Just like i said before I would like the pps to go down so that I can buy more.
"Hardly, that's still 6-12 MONTHS away" -- where did you pull this from? .Do you have any link or source to this.
"Well, there can be a WIDE gulf between "allows" completion of an application and the ACTUAL completion of the application"
--looks like you are confused with the words again using "can be". Would you care to explain what the wide gulf means.We are only talking about the application here.
(FYI: The same study was done by independent German research institution for Dario in January 2014 but they were asked to conduct it again in the US for 350+ subjects. see previous PR for information.)
"Critical shorter term is the 10-K "
The revenue is not critical at this time. They will have some revenue and that is a positive for a company that is new but I don't expect them to be profitable in the next few months.
I am going to use quoting for your posts in the future and provide analysis for every word.
The application to the FDA is complete. There were some requirements from the FDA last year which has been submitted now as per their PR. Now we wait for the FDA approval which should be in favor and soon as the desired results were met and some exceeded.
When I invest in a stock I make some time to read through the PRs. The management is quiet as some events in the past have backfired when they set some timelines and did not meet them. The critical event for DRIO is FDA approval and you would know when it happens.It will reflect in the pps.
Good job.keep spreading fear.
I am waiting to buy more on dips.You are making it easier for me.
This is the announcement of the successful results.
http://finance.yahoo.com/news/labstyle-innovations-announces-successful-results-130500823.html
See my post 12692 for the link to the white paper on the results. This paper has lower number of participants than were mentioned in the announcement but the results should be same.
Another small step towards FDA approval
LabStyle Innovations HIPAA Compliance Declaration
http://mydario.com/wp-content/uploads/2015/03/HIPPA-Compliance-declaration.pdf
Also for peeps who want to know more about the latest in the product check out the corporate presentation from January. This shows the reimbursement status and expansion/growth plans.
http://mydario.com/wp-content/uploads/2014/09/Dario-Corporate-Presentation-Jan-11-2015.pdf
The recent appointment of VP Regulatory is geared towards these expansion plans to countries like Mexico, India and China.
Darioâ„¢ delivers accuracy beyond the minimum
ISO 15197:2013 requirements
http://mydario.com/wp-content/uploads/2015/02/Accuracy-White-Paper-Brenda.pdf
LabStyle Innovations Raises $1.6 Million in a Non-Brokered Private Placement Financing
Proceeds to fund manufacturing, sales and marketing programs for LabStyle's Darioâ„¢ as well as ongoing FDA efforts
PR Newswire LabStyle
5 hours ago
CAESAREA, Israel, Feb. 25, 2015 /PRNewswire/ -- LabStyle Innovations Corp. (DRIO), developer of the Darioâ„¢ Diabetes Management Solution, today announced that it raised $1.6 million in a private placement offering consisting of shares of common stock and warrants. No placement agent was used for this financing.
LabStyle intends to use the net proceeds from the offering to fund continuing manufacturing and sales efforts in existing and new markets and to continue ongoing regulatory work associated with its pending FDA 510(k) application for Darioâ„¢, as well as for general working capital.
The investors were all institutional or accredited investors. Pertinent terms of the financing are:
LabStyle issued 9,064,222 shares of common stock at $0.18 per share, representing a 5.9% premium to the closing price of LabStyle's publicly traded common stock on February 24, 2015. Such price is not subject to any future adjustments.
Investors were also issued two warrants exercisable for an aggregate of 4,532,114 shares of common stock (or 50% warrant coverage, or 25% coverage for each warrant) as follows: one warrant carries an exercise price per share $0.24 an expires on the nine month anniversary of the closing, and the second warrant carries an exercise price per share $0.30 and expires on the 36-month anniversary of the closing. This second warrant is callable by LabStyle for nominal consideration if LabStyle's common stock maintains a closing price of $0.80 per share for 20 consecutive trading days. The exercise price of these warrants is not subject to any price-based anti-dilution protection.
Erez Raphael, president and chief executive officer of LabStyle, stated "We are very pleased to have accomplished this financing, as it allows us to continue our efforts to introduce the world to our revolutionary Dario diabetes management platform that we believe creates the potential to improve diabetic patient care. Our 2014 soft launch provided us with excellent feedback from patients, and we are now confident that Dario has the potential to make a real difference in lives of diabetic patients and help them stabilize and improve their medical condition."
Zvi Ben-David, chief financial officer of LabStyle, who participated in this round as an investor, stated "This financing helps us to continue our regulatory and marketing efforts during 2015. In addition, the structure of the 9 month warrant also provides us with the potential of some additional funding during this year. In the near term, we will use this funding to continue to improve operating efficiencies and cost reductions as we seek to continue or sales efforts with Dario and complete our regulatory clearance efforts with FDA."
LabStyle separately announced that Dr. Peter Kash, who was appointed as member of the company's board of directors in November 2014, will be resigning from the board due to increased schedule demands from his other commitments and will join LabStyle's advisory board, were he will continue to contribute his extensive knowledge and experience to LabStyle.
Further details of the financing will be available in a Current Report on Form 8-K to be filed by LabStyle with the Securities and Exchange Commission.
About LabStyle Innovations Corp.
LabStyle Innovations Corp. (DRIO) develops and commercializes patented technology providing consumers with laboratory-testing capabilities using smart mobile devices. LabStyle's flagship product is the Darioâ„¢ Diabetes Management Solution. Darioâ„¢ received CE mark certification in September 2013 and began a world rollout in select countries in December 2013. LabStyle filed a Premarket Notification Application, also known as a 510(k), with the US Food and Drug Administration (FDA) for the Darioâ„¢ smart meter (Darioâ„¢ Blood Glucose Monitoring System) in December 2013. LabStyle is pursuing patent applications in multiple areas covering the specific processes related to blood glucose level measurement as well as more general methods of rapid tests of body fluids using mobile devices and cloud-based services. For more information: www.mydario.com and http://mydario.investorroom.com.
Cautionary Note Regarding Forward-Looking Statements
This news release and the statements of representatives and partners of LabStyle Innovations Corp. (the "Company") related thereto contains or may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "plan," "project," "potential," "seek," "may," "will," "expect," "believe," "anticipate," "intend," "could," "estimate" or "continue" are intended to identify forward-looking statements. Readers are cautioned that certain important factors may affect the Company's actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release. Factors that may affect the Company's results include, but are not limited to, regulatory approvals, product demand, market acceptance, impact of competitive products and prices, product development, commercialization or technological difficulties, the success or failure of negotiations and trade, legal, social and economic risks, and the risks associated with the adequacy of existing cash resources. Additional factors that could cause or contribute to differences between the Company's actual results and forward-looking statements include, but are not limited to, those risks discussed in the Company's filings with the U.S. Securities and Exchange Commission. Readers are cautioned that actual results (including, without limitation, the results of the financing described herein and the timing for and results of the Company's commercial and regulatory plans for Darioâ„¢ as described herein) may differ significantly from those set forth in the forward-looking statements. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
© LabStyle Innovations Corp.
Contacts:
Press
Brenda Zeitlin
LabStyle Innovations
1 800 896 9062
Brenda@mydario.com
CFO investing part of $1.6 million at $0.18 shows that the FDA approval is imminent and very likely in favor within the next few months.
This builds immense trust among the existing shareholders. I can now wait without a worry for the next few months till the FDA approval. Stock price will increase in a few days above $0.2 and hopefully the finance report expected in the first week of March should take it a notch up.
There will constantly be devices made around the world. This one is about US college researchers running one in the testing phase. They have not talked about using it commercially.
The race is to get FDA approval and capture around 3% market share. The technologies that you mention will take time to evolve and come to the market and will likely face roadblocks much like Dario is.
Having said that Dario has to keep evolving to stay relevant in the future for testing diabetes and other diseases.Their best best is to sell the company if they cannot do this.
What is your reasoning for more delays?I am just trying to be positive here.
Are you an investor in DRIO or short on this?
Everyone seems to have forgetten the wording in the quarterly report that the estimate for FDA approval was "conservatively" pushed to mid-year .They very well can get an approval earlier than June/July 2015.
I don't think that the data requested by FDA would have taken a long time for Dario to furnish.Anyone with in-depth knowledge on the test related data requirements is welcome to correct me if I am wrong.
From the presentation it looks like Vestigen has just built the hardware . and they are ready to license out the technology.Good for them.
There will always be players in the space .For dario, the race is for the FDA approval and buyout after that.
As for Vestigen-
Proof of concept is with Google ARA project and the ARA is far from being ready for use let alone be popular.
Vestigen is still calling for developers to make the strip low cost.This is a major problem without approval.
The website is a joke.Were you really impressed by their Website?
Do they have a diabetes management app?
Do they have any approvals in any countries?
What makes this a better product than Dario? Any Data to prove this?
Do they have a sales team in place?
Without addressing these questions don't make conclusions..
Dario is looking for 3% of the market share and it allows for other techs to be in the space.
FDA approval only make things lot easier for Dario.
dario has been at this for a few years already and it will take Vestigen or people developing it a few years to get where they want to.
I found answers to some of my questions by digging in on some websites
Currently works with the following devices
Samsung Galaxy S3
Samsung Galaxy S4
Samsung Galaxy S5
Samsung Galaxy Note 2
Samsung Galaxy Note 3
LG / Google Nexus 5
iPhone 4 / 4S / 5 / 5S / 5C / 6/6 Plus
iPod touch 3rd / 4th generation
iPad 2/3 / iPad min
iPad with Retina display
But the list will keep growing according to their Nederlands website
Android version compatible is 4.1 and above but there were some reports of it not working with 4.4.4
Pricing seems to be around 60 euros and 75 AUD so in comparison should be priced at $50 to $60 in the US for the welcome pack.
Any thoughts or facts welcome.
Is Dario addressing the compatibility issues with many android devices?
I was looking through the Google playstore and it seems that all users really like the app but the app/device is not compatible with many android phones that are out there.
Does anyone know if the phone requires Android v5 to work?
Problems like these will hamper the adoption rate so I hope they work diligently on fixing these kinks before the approval comes out.
The stock was down to 12c from 20c right after the Australia reimbursement news. Nothing new here.
Not sure what good news is anymore. Does anyone know the date of the next quarterly report?
There are a few things that are bothering investors and would like answers from management.
1.Why is drio not moving beyond the soft launch when they have been on soft launch for over a year? What is the plan for a launch in rest of the countries?
2. Why is there too much dependability on fda approval?
3. It's there going to be just another dilution or is a r/s on the horizon..
Stop quoting other people and get a life and yes vaffan-cuolo.
It was a total of 4.1m including the institutional investors.
A single investor investing $3 million and quoted as having done thorough due diligence through his investment firm would have made sure that there is no dilution through the estimated period of getting FDA approval. I would have made sure about that if I was investing that amount of money. Not that further near term dilution could not happen but it seems unlikely to me.
What is the deal about $1 ?It is a NASDAQ requirement.OTC does not have any such requirements. If anyone has any answers for the significance of $1 then let me know. Also I don't think uplisting to major exchange is a near term priority for the company.
The RS was to accommodate for more number of outstanding shares if I am right.
The dilution news was negative and that was released 10 days back..Sure the stock can go down from 0.5 after the split but it could have gone down from 0.1 level too .The question is are you a seller on Monday at 0.5 or if this drops to 0.4 just on the basis of RS?
I know that I will be buying if it goes 0.4 post split.
Go for it! as long as it is not monopoly money that you have with you.I am averaged much lower than the conversion price for new shares (and I am holding a lot) . I am not going to sell them at 0.13.
and so is 0.12 ..just around the corner
You are crazy and definitely wrong.There wont be more dilution in the next couple of months at least.
Wow you are working over time here. For a person who has no stakes on this this is a lot of effort. Your generosity knows no bounds.
No one who is truly long on this board is selling tomorrow.You are wasting your time here! Good luck if you are going short on this.
It will not have the same effect and I will tell you why. If you read the PR the new investor is looking forward to being a part of drio for many years. These shares will not be dumped into the market like last time. This is the reason why they went will individual investor and put him on the board with 3 seats. The selloff tomorrow will only consist current retail and institutions are going to pick up cheapies along the way.
Who in this board is selling first thing tomorrow morning.lets take a poll.I know that I am not.
The following excerpt from the PR is very positive to me especially the part "after thorough due diligence".This debunks the people who are questioning the product and its viability.This piece of information is good for me to hold on to this stock.
As of the closing, LabStyle's board has appointed Mr. Rami Yehudiha, the Founder and Chief Executive Officer of LEAD, a top 10 Israeli advertising and marketing agency. Mr. Yehudiha is an appointee of Mr. Edery, and following this financing, and depending on his percentage ownership of LabStyle's common stock from time to time, Mr. Edery shall have the right to appoint between 1 and 3 members of LabStyle's 7 person board of directors.
Commenting on the financing Mr. Edery stated, "After thorough due diligence, we are very pleased to make this fundamental and strategic investment in LabStyle. The Dario Diabetes Management Solution is a novel and cutting edge mobile health software and medical device platform that represents a significant evolution in the diabetes management market. I believe in the future of digital health medicine, where patients are more engaged and empowered by using mobile technologies, and I believe that LabStyle has the right product at the right time to be an important player in digital health market. LabStyle's prospects are driven by significant worldwide market potential, current and pending regulatory approvals, patented intellectual property and the company's strong team of professionals. We are optimistic that this investment will help meet LabStyle's near term requirements and lay the foundation for the achievement of the company's long term goal of transforming the way people with diabetes manage their daily lives. I am very much looking forward to working with LabStyle in the coming months and years as we seek to make this goal a reality."
Do you really think that the investor who picked $3 million shares picked up all these shares to sell it for a 1 cent gain or tomorrow for a loss for that matter?Grow up! The current float will sell off a bit since there are many penny flippers in this but I'm sure that the institutions will accumulate now during this sell off. There are so many positive points in the PR that you choose to ignore.
Yes dilution is bad and we all know that the company was running out of cash which is why the stock is at 10 cents.What was the other option here?
There is no negative on where the company is headed to .They are getting positive reviews in UK and NZ and going into newer markets.
They simply reiterated the expectation that FDA may come in early 2015 yet there are deductions that something went wrong in the process.
I want all these penny flippers to sell tomorrow and get out of this board.F*in pests.
Great News trumps all even dilution and how do you know that they have a toxic dilution or for that matter a dilution?
Not to burst your bubble but this tweet may have originated from our board itself when someone posted the link for Dario device pricing in Farla medical (UK distributor) last night. Funny how things works like a chinese whisper.
Bashing apart who says heart to heart promise.I did my part and got 45K shares at 0.086 in the morning.Buying more if it goes down next week.
If this goes in the 0.08s tomorrow I will be buying 50-80k more depending on the action.Just made a bunch on VHC flip today.
Great find! Device is priced cheap but maybe they should bring down the price of the strips a bit.Also looks like they are having some issues with the app currently. Hopefully they will iron out these issues for the US launch.
Thanks for the informative post Drew.I happened to check the innomed.co.nz website. It has some useful information about Dario including the product user manual and the app user manual.
Bought 30k more at .125 .Buy now in the 12s before its too late.