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Imaging Diagnostic Systems (OTC:IMDS), a pioneer in laser breast imaging, announced today that a Premarket Notification 510(k) was submitted on Monday, November 22, 2010, to the United States Food and Drug Administration (FDA). With this submission, the company moves forward in the process of seeking marketing clearance for its innovative breast imaging device, the CTLM system.
Volume has already topped 10 million shares, as I write, and IMDS has a gain of 87 percent so far today to boast about. The company has an average daily volume of 1.5 million shares and a market cap of $38 million.
The CTLM system is an innovative breast imaging device intended to aid in the diagnosis of breast cancer in a non-invasive procedure. The patient lies face down comfortably on the scanning bed for approximately 10 minutes until the scan is completed. CTLM uses state-of the-art laser technology and proprietary computed algorithms instead of x-rays and breast compression to create three-dimensional views of the blood supply in the breast. These images can be used to complement current breast imaging modalities, providing additional information on the nature of breast abnormalities.
“This submission is a significant step toward the realization of our dream of marketing this unique breast imaging device throughout the United States,” stated Linda Grable, CEO of Imaging Diagnostic Systems. “CTLM has the potential to be a significant addition to breast imaging facilities, especially in difficult cases, like patients with dense breasts. We are committed to getting this product to market as quickly as possible, while simultaneously developing strong distribution channels and marketing resources for its launch."
As breast cancer is the most common cancer in women worldwide, the emphasis on breast cancer screening and detection has steadily increased. According to the World Health Organization, survival rates vary widely throughout the world, from more than 80 percent in the United States, Sweden, and Japan, to under 40 percent in poorer countries. In the face of these statistics, along with the benefits that the CTLM system offers to women and their physicians, the system is rapidly gaining international recognition.
Imaging Diagnostic Systems will continue to market the CTLM system and to work with its international clinical sites, where the system has gained approval. The documentation and the data submitted to the FDA will now officially enter the 510(k) review process.
If I were Chris Reed CEO of Reed's Beverage I would send cases of his Ginger Brew to Josh Hamilton and CJ Wilson so they could spray Ginger Brew as the Champaign of choice, and clearly Josh has some spraying to do as a runaway winner of the American League’s Most Valuable Player award. Hamilton received 22 first-place votes and 358 points in voting announced Tuesday by the Baseball Writers’ Association of America.
Hamilton overcame eight trips to rehabilitation for drug and alcohol addiction to lead the major leagues in batting average (.359) and slugging percentage (.633) and help the Rangers reach their first World Series. He had 32 homers and 100 RBIs despite missing time with two broken ribs.
Hamilton and roommate CJ Wilson made headlines and set a great example for MLB as team mates sprayed root beer after winning the AL Pennant. In fact if I were Chris I would call Bud Selig head of Major League Baseball and make it the official healthy drink for MLB.
Federal Reserve policymakers clashed over the benefits and risks of launching a $600 billion program to rejuvenate the economy, but voted for it anyway, minutes of their closed-door deliberations show.
Despite a near unanimous 10-1 vote in support of the program, the minutes from the Nov. 3 meeting show that some Fed officials had concerns about embarking on a second round of stimulus.
Some officials thought the additional purchases of government debt would have limited effect in revving up the economy. Some also worried about risks -- unleashing inflation or causing a destabilizing slide in the value of the U.S. dollar.
In the end, Fed Chairman Ben Bernanke persuaded most of his colleagues to back the plan.
The following are newswire headlines about the November FOMC minutes
Some FOMC participants thought QE may put unwanted pressure on dollar
Some FOMC participants saw QE having limited economic impact, they differed over benefits and or costs of QE
Most saw inflation as “subdued”, below Fed mandate
Financial conditions “more supportive of growth”
Housing sector described as “depressed”
They see progress toward meeting dual mandate as too slow
Unemployment to decline somewhat next year
Believed prospect of sliding into recession as “quite unlikely”, but saw economy as vulnerable to shocks
Officials from the FBI, SEC and New York federal prosecutors are currently conducting a major insider trading case that spans both coasts and small to major investment related firms. The investigation appears to center around the fear that independant analysts and consulting firms have passed on inside information to hedge and mutual fund managers who then used that information in financial transactions, making them illegal.
According to a Wall Street Journal article from November 20th, a Portlander is involved in some fashion. It is not clear, however, if this person is under investigation or an innocent witness. From the WSJ article: Independent analysts and research boutiques also are being examined. John Kinnucan, a principal at Broadband Research LLC in Portland, Ore., sent an email on Oct. 26 to roughly 20 hedge-fund and mutual-fund clients telling of a visit by the Federal Bureau of Investigation.
“Today two fresh faced eager beavers from the FBI showed up unannounced (obviously) on my doorstep thoroughly convinced that my clients have been trading on copious inside information,” the email said. “(They obviously have been recording my cell phone conversations for quite some time, with what motivation I have no idea.) We obviously beg to differ, so have therefore declined the young gentleman’s gracious offer to wear a wire and therefore ensnare you in their devious web.”
Horiyoshi Worldwide Inc. (OTC:HHWW) is pleased to announce today that the Company has secured a retail distribution agreement with Saks Fifth Avenue. www.saksfifthavenue.com
Shares of HHWW hit another 52-Week high today as it has been doing quite frequently the past few weeks. In early trading, the stock was up 5 percent at $1.49 per share on heavy volume of nearly 2 million shares compared to its average daily volume of just over 1 million shares. The company has a market cap of $140 million and has been quite the popular buy from the SmallCap space since they first acquired Horiyoshi the Third several weeks ago.
As a result, Horiyoshi the Third's Spring / Summer 2011 Collection will be sold at select Saks Fifth Avenue locations - including their prestigious flagship store in Manhattan.
Saks Fifth Avenue is a luxury American specialty store owned and operated by Saks Fifth Avenue Enterprises (SFAE), a subsidiary of Saks Incorporated. It competes in the high-end specialty store market with Bergdorf Goodman, Neiman Marcus, Barney New York, and Bloomingdales. The company headquarters and the company-designated flagship store are located in Midtown Manhattan, New York City. SFAE consists of 54 Saks Fifth Avenue stores, 48 Saks Off 5th stores, and online direct store, saks.com.
"We are pleased with the SFAE expansion to recognize Horiyoshi the Third as a emerging cutting-edge luxury brand" says Dawn Green, Commercial Director of Horiyoshi Worldwide Inc.
Horiyoshi Worldwide Inc., designs, manufactures, and markets Horiyoshi the Third (HIII) - a high end clothing and accessories product line based on the artistry of World renowned Japanese Tattoo Artist, Yoshihito Nakano (Horiyoshi III). The Company is rapidly expanding its distribution platform with the line currently being sold in approximately 45 luxury retail boutiques located in 25 cities worldwide. Debuting in Fall 2009 - HIII has been featured in leading fashion publications such as the New York Times, International Herald Tribune, the Los Angeles Times, Anotherman Magazine, Vogue and Style.com.
For more information on Horiyoshi the Third, visit: www.horiyoshi-thethird.com
DISCLOSURE: NO POSITIONSLast week we wrote about the vulnerability of the market and how GM may signal a high for 2010. Today many factors are driving prices lower..every thing from Ireland, South Korea, Fed Raids, etc. But the inter realtionships of markets currently say..if the Dollar rallies, equities go down.
I ask the question here? If flight to quality shifts and inverts from the Euro and assigns itself to Oil and Long Dollar how much trouble are US Stocks in? We are 4% off the highs and can easily pull back another 10-15% before year end. I also expect large funds to spend the last few days of the year marking up stocks, so why not do it from lower levels than here.
Stocks fell early Tuesday after North Korea and South Korea exchanged artillery fire near their disputed sea border, killing at least two South Korean marines. Treasury prices and the dollar rose as investors sought safe places to park money. A weak reading on existing home sales for October also dragged stocks lower. Shares were also falling in Europe on concerns that a bailout of Ireland may not be enough to contain Europe's debt crisis. Borrowing costs for Portugal and Spain rose, leading Spain to trim the size of a debt sale. The Dow Jones industrial average fell 135, or 1.2 percent, to 11,042 in morning trading. The Standard & Poor's 500 lost 11, or 0.9 percent, to 1,186. The Nasdaq composite index fell 33, or 1.3 percent, to 2,499.
Not everyone feels like Uncle Milton and since 1929 The G developed a personality reflected by this journalist in the late 20's...... I always contend, you don't want the document to read "US Govt vs Your Name".
" Congress did not take away from the citizen his inalienable right to make a fool of himself. It simply attempted to prevent others from making a fool of him. As to its efficacy in regulating securities issuers, the sunlight theory may be summed up by a saying: Those who are forced to undress in public will presumably pay some attention to their figures."
The great stock market crash of 1929 and the ensuing depression are generally credited with providing the impetus for federal securities legislation. The first major federal legislation enacted in reaction to the stock market crash was the Securities Act of 1933 (the "'33 Act"). The '33 Act, administered by the newly created Securities & Exchange Commission (the "SEC"), provides for the registration of the initial distribution of most securities. During its consideration, some legislators wanted the law to take the form of the New York Fraud Law while others wanted it to provide the type of merit tests which are now found in some blue sky laws.
The original draft of the '33 Act did contain merit tests, but they were deleted in the final draft. The law provides for full disclosure of all material facts. This "sunlight theory of regulation" is based on the assumption that if investors are given all of the necessary information they will make wise investment decisions and clearly FINRA and the New Millenium Manhattan prosecutor have taken the Gallion facts and rooted back into the dark underbelly of research and non public information......more to come on this story.
*North and South Korea exchanged artillery fire earlier today; at least two South Korean marines are said to be dead and several others have been injured on an island that is just off the west coast of the peninsula within disputed territorial waters. As is often the case when dealing with conflicts involving North Korea it is not clear what sparked the conflict, or for that matter if the problem will escalate.
*The final reading of Germany’s Q3 GDP was unrevised +0.7% on a quarter on quarter basis and +3.9% year on year; growth was driven by strong exports and personal consumption.
*The November reading of Germany’s manufacturing sector Purchasing Managers Index was up more than two points on the month to 58.9, well above the estimate for a fractional gain. The November reading of their service sector PMI also beat the forecast with a monthly gain of 2.6 points, it rose to 58.6..
*In October there were 30,766 loans for house purchase in the UK, according to the British Bankers Association, slightly under the estimate.
*The weekly report on chain store sales from ICSC will be released at 6:45am CST. The Johnson Redbook report on the same thing is due out at 7:55am CST.
*The first revision of the Q3 GDP is due out at 7:30am CST. Headline GDP is forecast to be revised up to 2.4% from the initial report of 2.0%. However the key Q3 Personal Consumption component is expected to be revised down one tenth to 2.5% and the GDP Price Deflator is expected to be unrevised at 2.3%. The Core PCE price measure is also expected to be unchanged at 0.8% on a quarter on quarter annualized basis. The October reading of Existing Home Sales is due out at 9:00am CST; Sales are forecast to fall 1.1% from the pace set the month before to an annualized rate of 4.48 million units.
*The November reading of the Richmond Fed Manufacturing Index is due out at 9:00am CST, it is expected to improve one point on the month to 6.
*The FDIC will release their Q3 report on bank earnings at 9:00am CST.
*The Fed is scheduled to buy TIPS today that are due to mature between 7/15/12 and 2/15/40; the results of the operation will be announced just after 10:00am CST.
*The Treasury plans to sell $35 billion 5 Year Notes today; the results of the auction will be announced just after noon CST.
*The minutes from the November 2/3 FOMC meeting are due to be released at 1:00pm CST. In addition to the minutes the Fed will also release their Summary of Economic Projections, which will extend out to 2013 for the first time.
Aisle411, the mobile application designed to help locate items inside retail stores hits the market today. The introduction of Aisle411, currently available only on the iPhone, is among the vast indications that GPS based apps are in high demand within the mobile community. Mobile applications aren’t just changing the way we get our directions, they’re changing the direction of GPS technology. More and more, as evidenced by Aisle 411 and other GPS apps designed to help us save time and eliminate hassle, GPS is undergoing a major shift. It’s not just about getting there any more, it’s about getting their faster and eliminating as much hassle as we can along the way.
Going to the grocery store used to mean wandering around the frozen foods aisle looking for pizza only to find it next to the ice cream and not the frozen vegetables. Now, if you’re shopping in one of the places where Aisle 411’s service is applicable, only in a few grocery stores in San Francisco, Chicago, St. Louis, and San Jose, Calif., that challenge no longer exists. The focused nature of Aisle 411 is representative of a major shift in the way consumers use GPS, not just to get there, but to get there faster.
Earlier this year the release of Happy Hour, a GPS fueled application that points users in the direction of the nearest Happy Hour, with details on the drink specials is also designed to help shave off extra minutes anywhere we can. The same could be said of the popular retail app released last year that employed GPS technology to find the best deal on an item at the nearest retail locations.
The improvements in accuracy of GPS in the last year or so have led to a flurry of new applications, many of which have gained popularity as a result of their capacity for eliminating everyday aggravations once considered inevitable. 83% of people have said they have experienced difficulty finding an item in the grocery store, now they don’t have to. One of worst parts of holiday shopping is finding out you missed out on a deal and now, both of these could conceivably be a thing of the past.
“The rapid rate of smartphone adoption is unparallel to previous technologies that over time became ubiquitous. We are at the very beginning of this wave and already it is larger and has more momentum than ever measured before,” says Patrick Bertagna, the CEO of leading GPS company, GTXO.
Smartphones are a huge game changer for the GPS industry and the more people buy them, the faster that change happens. People now want more from their GPS than just directions. They want to be able to locate items, venues, packages being shipped or lawless teenagers out past their curfew. Today they have applications for all of these things.
If GPS is going to fulfill practical applications outside of the car, that means they have to be as portable as the people who use the technology. Bertagna, like Aisle 411 CEO Nathan Pettyjohn, was able to envision this, concentrating on the practical applications of the technology and how they can apply to personal and business needs beyond the original parameters drawn out at first introduction. Just like we no longer have to spend 30 minutes trying to find our way back to the freeway after taking a wrong turn, GPS is helping us get everywhere faster than we otherwise could, whether it’s to the bar, to the party our teenage son is attending after hours or even just to the produce aisle.
