Bone-fusion protein goes from revolutionary advance to health alert after side effects surface

When the U.S. Food and Drug Administration in 2002 approved a product many thought would revolutionize back surgery, the agency did so despite concerns the product might cause serious side effects.

Six years later the FDA warned doctors that this remarkable product, known as bone morphogenetic protein-2, was causing life-threatening complications.

What caused the product to go from revolutionary advance to public health alert?

A series of complications and side effects have piled up since 2002. Many of them have occurred when BMP-2 was used in an unapproved or so-called off-label manner, now about 85% of the time.

The concerns are so serious that Medicare is weighing whether to stop covering BMP-2, which is made by Medtronic, and a similar product made by another company. Advisers to the program will hold a hearing on that question Sept. 22.

Medical studies have found a variety of problems since Infuse was approved:

Trial halted: Because bone morphogenetic proteins are powerful promoters of new bone growth, there has been concern that BMP-2 could cause bone to form outside the fusion area in places where it could be harmful. The phenomenon is known as ectopic bone formation.

Ectopic bone formation is of special concern when BMP-2 is used off-label, such as in surgery that uses an approach from the back, or posterior method.

In 1999, a Medtronic-funded clinical trial of BMP-2 in an unapproved type of fusion surgery was halted because CT scans showed troubling bone formation in the spinal canal of 75% of the BMP-2 patients.

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Quepasa Corporation owner of Quepasa.com, an online social network targeting the Latino community, today announced that the website saw its registered users grow by 1.8MM in August, up from 1.4MM members during the month of July, resulting in a total user base of 18.7MM members. At the same time, monthly unique visits totaled 14.4MM visits, an increase of 16% compared to the month of July.

Quepasa saw continued growth momentum in its Brazilian user base, which accounted for 446,000 of the site’s new users, an increase of 53% over the month of July. Following Brazil, Mexico represented the second largest source of new users, with 313,000 new members in August, a 28% increase over the month of July.

Quepasa.com also had record traffic on August 31st

Gold Resource Corporation (GORO) is pleased to announce it has declared its second 2010 Special Cash Dividend of $0.03 per common share to its shareholders of record September 17th, payable September 29th, 2010. Gold Resource Corporation is a low-cost gold producer with operations in southern Mexico.

Gold Resource Corporation commenced Commercial Production July 1, 2010 from its El Aguila Project’s operations in the southern state of Oaxaca, Mexico. The Company continues to be pleased with the Project’s performance and by using cash flow generated from operations the Board of Directors declared another Special Cash Dividend increasing the year to date dividend payment to $0.06.

Gold Resource Corporation’s President, Mr. Jason Reid stated, “We are pleased to announce our second special cash dividend in as many months and remain committed to returning approximately one third cash flow back to the owners of the Company, its shareholders. We are also pleased to now be listed on the NYSE Amex.”

O’Brien: Considering The PayPal Mafia’s place in Silicon Valley history

Google’s purchase of social media company Slide for a reported $182 million earlier this month marked the latest triumph of a remarkable group of entrepreneurs and investors whose impact on Silicon Valley in the Web 2.0 era is unrivaled:

The PayPal Mafia.

That’s the alumni of the online payment company that went public in February 2002 and was acquired by eBay eight months later. They earned the nickname several years ago when PayPal alums started a string of successful companies.

But the acquisition of Slide, which was started by PayPal co-founder Max Levchin, got me thinking about how this network’s influence has continued to grow. Several PayPal alums have started companies since that initial flurry, while others have moved onto their next start-up, or have re-invested their wealth into their former colleagues’ ventures. In a region built on networks, the PayPal Mafia ranks as one of the most significant in the history of Silicon Valley.

It would be hard for any network to top the impact of the “Traitorous Eight,” the employees who left Shockley Semiconductor to start Fairchild Semiconductor. Almost every chip company in the valley, including Intel and AMD, can trace its roots to that group. Cisco Systems alumni have produced a string of startups, while Oracle has spawned countless business software companies.

But the reach of PayPal alumni compares favorably to those, and is more impressive if you consider that the company

had only about 220 employees, not counting a mid-western call center.

The company’s IPO and sale to eBay generated huge wealth for several co-founders, including Elon Musk, who went on to co-found Tesla and Space X; Peter Thiel, who started a billion-dollar hedge fund called Clarium Capital Management, was the first investor in Facebook and launched the venture firm Founders Fund with two other PayPal co-founders; and Levchin, who created a startup incubator before launching Slide. But they weren’t the only PayPal alumni to move on to big things.

“You had a lot of people familiar with the startup process, but still hungry,” said Dave McClure, a PayPal alum and founding general partner at 500 Startups, a venture fund and incubator that just raised a $30 million investment fund this summer. “Many of us went right out and went on to the next company.”

Within a couple of years, PayPal execs Jeremy Stoppelman and Russel Simmons had co-founded Yelp; executive vice president Reid Hoffman started LinkedIn; and engineers Chad Hurley, Steven Chen, and Jawed Karim started YouTube, which Google bought in 2006 for $1.6 billion.

More recently:

The company’s website, www.VoipSwitch.com continues to make new traffic records, now ranked 135,000 on alexa worldwide.  This is really good considering it’s just a corporate website.

http://www.alexa.com/siteinfo/voipswitch.com#

VSRV is presenting at three industry conferences in October and November in Dubai, Brazil and California, and they are presenting at their very first investor conference on December 9^th in LA.

VSRV had its first profitable quarter this past quarter and expects to continue to show 10-20% sequential quarterly revenue growth for the foreseeable future while increasing profitability.

I just got back from Vegas last night.  I spent the day with Galaxy Gaming CEO on Wednesday.  It was a great meeting.  The company has everything you look for, high margins (90%+), high reoccurring revenues (90%+), high barriers to entry, and an inflection point which is upon us.

You read all over the news how Las Vegas and Atlantic City are down significantly, and this is true, but what you don’t hear too much about is how gambling/casinos are popping up everywhere else.  This is mainly do to the state/municipality budget crisis’s that are occurring nationwide.  States see gambling revenues as an easy way to increase tax revenues.  Three states just this year started allowing table games, my home state of Pennsylvania being one of them.  In fact in PA alone, the acceptance of table games have added 12,000 jobs this year.  Ontop of this, last month PA brought in more gambling tax revenue then the state of Nevada..an impressive statement but one must also consider PA’s gambling tax rate is 55% compared to Nevada 16%.  None the less more and more states are allowing gambling in their borders, and the companies that supply these casinos with hardware, software, tables, games will be the winners.  GLXZ is the 2nd largest table games company (1700 tables) in the world (SHFL is #1 with 4500 tables).  GLXZ just got approved in PA to roll out its “Lucky Ladies” table game, and the company expects to roll out 150 of this one table game alone over the next 60 days.  GLXZ’s newest table game, Triple Attack Blackjack, won Best New Game for 2010, a prestigious industry award.  The inflection point is upon us.

I will write more about the company in the following days/weeks.

LONG GLXZ

Approximately 57 million Americans have tried or played a social network game recently — a large number of consumers for what is a fairly new genre in the video-game industry — according to a survey done by the market research firm NPD Group.

According to NPD, approximately 20% of the U.S. population older than 6 years of age has at least tried or regularly played a game on a social network like Facebook in the past three months.

The Rest of the Article

Source: By Ken Sweet | FOXBusiness

In our experience, it is rare for a company to have come this far in developing such an advanced and broadly applicable platform technology as quickly and as cost effectively.  Intezyne is preparing to file INDs for two of its oncology programs to bring these compounds forward into clinical studies.

Intezyne Introduction Presentation

Ravi Mehta is vice president of product for Viximo, where he drives the product strategy for Viximo’s social game distribution platform and helps social networks monetize via social games and virtual goods. For more information on virtual goods, visit his blog, Virtual Goods Insider, and follow him on Twitter.

In 2009, an estimated $2.2 billion in virtual goods were sold to consumers globally, and that number is expected to rocket to over $6 billion by 2013. Although virtual worlds and MMOs have historically driven the growth in virtual goods, today the fastest growing segment is social games.

Social games not only represent a lucrative new revenue channel for social media sites but they also signal a fundamental change in the structure of the social media industry. Social networks can no longer afford to rely solely on advertising revenue—they must master the intricacies of directly monetizing their users via virtual currency, virtual goods, and social games.

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Viximo is one of Quepasa Corp’s (QPSA) third party partners.

VoiceServe is a software platform provider focusing primarily on delivering affordable, complete, next generation services to Internet Telephony Providers (ITSPs). Voiceserve Inc. is better known throughout the world as VoipSwitch (voipswitch.com).  To-date, the Company has successfully installed over 16,000 VoipSwitch systems around the world.  To further the breadth of VoipSwitch’s system, the Company added VoIP dialers for cellular phones.  Over the last twelve months, the Company has introduced dialers for Blackberry and Apple’s iPhone, in addition to its existing dialers for Symbian (Nokia, Motorola, Samsung, Sony, etc.), Android and Windows® cellular phones.  Subsequent to the June 30, 2010, the fiscal first quarter close, the Company introduced softphone dialers for Apple ,iPads and iPods, enabling the devices to conduct economical VoIP calls, worldwide.  So in a nutshell VSRV makes money by selling VoipSwitch licenses and modules.  The company plans to roll out an IPTV module in calendar Q4 2010, which it believes will be the first of its kind in the marketplace.

VSRV has grown 10-20% sequentially quarter to quarter since the company went public a couple years ago.  This past quarter was the first quarter where revenues topped $1 million and the company reported its first profit.  I participated in a PIPE in May/June which raised $690,000 for growth capital.  The company since this time has increased its sales force from 5 to 10, and added ~20 engineers to facilitate and support its expected growth and R&D efforts.  With all these new additions SG&A as a percentage of revenue is still expected to decrease throughout the year.  The company believes it will double revenues to $7 million this year and be profitable all four quarters (April 1, 2010 – March 31, 2011).  VSRV believes they will exit the year with 20% operating margins.  I expect the company will report somewhere between $1.2 – 1.3 million in revenues for their Q2 2011 (Sept 30^th 2010), with accelerated growth in Q3/Q4 to get them to $7 million for the year.

VSRV is planning to attend 10 industry conferences this year (up from 4 last year) as they usually come away with several hundred leads after each conference.  With the expanded and autonomous sales force, Voiceserve’s management is concentrating their individual efforts on larger contracts.  Management feels very confident in their ability to go head to head against the likes of Cisco for large VoIP contracts.  I believe we could see the fruits of this labor over the coming months.  Management is also very excited about new opportunities that have popped up in the transportation industries (cruise lines, shipping, airlines, etc).  Just think of the ability for passengers on a cruise ship or airline to quickly download a softphone on your blackberry, iPhone, symbian, android or windows mobile device and make calls utilizing wifi while you are flying to your destination for pennies on the dollar.

The company has ~36m shares outstanding and doesn’t believe it will ever need to raise money again.  If the company is able to double revenue this year and show a nice 3-4c EPS bottom line the stock will be much higher than the current stock price.  I’ve accumulated a chunk of stock around the current price in the open market earlier this year, also participated in a PIPE and look forward to following this little gem throughout the year.  VSRV is scheduled to present at a couple investor conferences in November/December which will likely be the company’s coming out party so to speak.   With a lot of buzz brewing lately around Vonage (VG), a Skype IPO, and the MagicJack reverse merger into Vocaltec Communications (CALL), Voiceserve (VSRV) may be small but at least it is a profitable way to play the space.  To learn more about the company and its products, visit www.VoipSwitch.com and www.CalltoPBX.com