Tuesday, August 27, 2013

VistaGen Therapeutics, Inc. (VSTA) Targets Outdated Drug Testing Paradigm

The pharmaceutical industry’s current drug development paradigm is supposed to assess whether a drug candidate is both safe and effective for use in the treatment of a given disease. It’s an approach that has been used for many years, involving animal and in vitro testing. However, the extremely high cost involved in developing today’s complex and potent drugs has exposed a serious problem. The conventional testing approach only approximates human biology. As a result, millions and even billions of dollars can be spent to get a drug to market, only to see it fail, sometimes after it has already been on the market, due to unanticipated heart or liver toxicity or sometimes adverse drug-drug interactions.

When a drug fails, the pharmaceutical company is often forced to simply discontinue the development program since the evaluation process has been shown to be ineffective. The drug is shelved, and the enormous sums of money spent on developing the drug are largely lost. It’s a horrible blow to the company, but also to the pharmaceutical industry and the public that it is meant to serve. The lost money must ultimately be made up, contributing to higher costs. In addition, a potentially life-saving drug is no longer available. And it’s a problem that is not uncommon. It has been estimated that fully one-third of all potential new drug candidates end up failing in preclinical or clinical trials due to safety concerns.

VistaGen, developers of a proprietary stem cell based drug assay system, is focused on addressing the growing problem of drug testing. Their Human Clinical Trials in a Test Tube platform offers superior testing that is based upon a closer approximation of human biology. Their system has the potential to identify human heart and liver toxicity issues in new drug candidates early in the development process, so that resources can be directed toward those candidates with the highest probability of success. It’s a technology designed to substantially reduce development costs, improving the economics of the current healthcare system, and enabling the creation of more effective and safer drugs.

For additional information, visit www.VistaGen.com

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Response Genetics, Inc. (RGDX) Expands Testing Base with Acquisition of Pathwork Diagnostics Assets

Response Genetics, a CLIA-certified clinical laboratory focused on the development and sale of molecular diagnostic testing services for cancer, has acquired the core assets of Pathwork Diagnostics, including its FDA-cleared cancer diagnostic test, for a $200,000 cash payment and issuance of 500,000 shares of RGDX common stock. RGDX expects the acquisition to be accretive within its first full year of the purchase.

The acquired assets and associated test are based on a proprietary microarray platform and proprietary software used to compare the expression of 2,000 genes in a patient’s tumor with a panel of 15 known tumor types that represent 90 percent of all cancers.

“This acquisition is consistent with our goal to rapidly grow Response Genetics both organically and through a series of acquisitions,” Thomas Bologna, chairman and CEO of RGDX, stated in the press release. “Acquiring the assets of Pathwork Diagnostics adds proprietary, Medicare reimbursed content that we believe addresses the needs of both pathologists and oncologists, further expands both our technology and testing base, leverages our current infrastructure well and most importantly adds to the top line growth of our Dx business.”

RGDX notes that while the identity of most tumors can be determined using traditional methods, poorly differentiated or metastatic tumors with no clear primary origin are harder to diagnose. It is estimated that each year, up to 150,000 newly-diagnosed cancer patients in the United States may have a tumor for which the site of origin is uncertain after the initial diagnostic workup.

“Hard-to-identify tumors pose a significant clinical problem,” said Bologna. “The traditional approach – iterative rounds of testing – may take weeks and still not definitively identify the type of cancer present. This proprietary gene expression approach that we acquired reduces the time to diagnosis and increases physicians’ probability of reaching a definitive diagnosis, a necessary step in therapy selection, and it is well accepted that minimizing the waiting time before treatment maximizes patient outcomes.”

For more information, visit www.ResponseGenetics.com

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InVivo Therapeutics Holdings Corp. (NVIV) Gives Update on Clinical Timeline for Spinal Cord Injury Treatment

InVivo Therapeutics Holdings is a medical technology company focused on utilizing polymers as a platform technology to develop treatments to improve function in patients paralyzed as a result of traumatic spinal cord injury. In 2011, the company earned the prestigious David S. Apple Award from the American Spinal Injury Association for its contributions to spinal cord injury medicine.

The company today gave an update on the clinical timeline for its biopolymer scaffolding to treat acute spinal card injuries. InVivo’s management team now expects that it will enroll the first patient sometime in the first quarter of 2014. It anticipates that, from the date of the first patient enrollment, it will take a minimum of 21 months to complete enrollment.

This time is needed because of the conditions of the FDA approval of the Investigational Device Exemption. The five-person trial will be staggered so that each patient can be followed for three months prior to requesting approval to enroll the next patient. Consistent with FDA guidance, InVivo then expects to conduct a key study with a control group in order to obtain FDA approval to begin commercialization of its biopolymer platform under a Humanitarian Device Exemption.

In addition, the company’s new management team has begun a comprehensive project and timeline review of its hydrogel technologies platform as well as its application to pain treatment, dural sealants, nerve conduits, and fibrosis treatment. It plans to provide updates to the public as soon as possible on these programs.

For further information about InVivo Therapeutics Holdings, please visit www.invivotherapeutics.com

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SecurePay Plays Important Part in Calpian, Inc. (CLPI) Group of Companies

SecurePay is part of the Calpian group of companies providing transaction services and technologies to merchants around the country. In particular, it is an e-commerce solution provider, offering a range of cost-effective merchant payment processing solutions, especially designed for small to mid-size businesses.

Essentially, SecurePay is an online credit card gateway, a set of flexible interface options between merchants and their account processors, including an online Virtual Terminal, the EasyShop shopping cart, and APIs (Application Programmable Interfaces) which allow web developers to write their own interface to SecurePay. The company supports thousands of e-commerce as well as brick-and-mortar merchants nationwide, including retail outlets, publishing companies, delivery services, taxis and limos, charities, craft shows, flea markets, hospitals and clinics, schools, and even individuals.

SecurePay uses all types of communications technologies, such as electronic store fronts and shopping carts, in-store credit card systems, and cellular wireless terminals. It can be used in any location where there are hardwired or wireless connections. Specific services and tools can be selected for a particular enterprise, whether simple credit card processing or a complete design and hosting service. SecurePay allows the Web to do more than just expand business reach beyond a physical location, and can make it a cost effective hub for virtually all enterprise transactions. SecurePay targets merchants who are new to e-commerce as well as those having an already established web presence, with transaction security being a key.

SecurePay represents an important part of Calpian’s overall presence in the marketplace. Calpian sees electronic commerce as the backbone of the world economy, and its Calpian Commerce group of companies serves merchants throughout the U.S., while its India-based subsidiary provides Money-on-Mobile stored value mobile payment services to the fast growing Indian mobile market.

For additional information, visit www.Calpian.com

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RackForce Partners with Mitel (MITL) to Deliver Cloud-Based Communications Solution

RackForce Networks, Canada’s leading provider of VMware-based Hybrid Cloud and Hosting Services, will grow its highly dependable infrastructure and ICT services through a partnership with Mitel® to deliver cloud-based communications and collaboration services specifically designed to address the unique requirements of private business and public sector organizations operating in Canada. The new, Matel powered offering gives RackForce the ability to spread a wide range of communications to its own customer base via the cloud, as well as deliver a white label cloud solution to resellers and service providers to brand on market as their own product.

RackForce operates as the most expansive VMWare Service Provider Partner (VSPP) in Canada and has begun working with several resellers to white label the communications solution. The RackForce Mitel cloud-based communications service is available September 1, 2013.

RackForce provides secure hybrid cloud services, or Infrastructure-as-a-service (IaaS), through the utilization of strategically located data centers across Canada and a resilient high capacity 10 Gbps private IP network. The partnership with Mitel enables RackForce to offer enterprise-class, cloud-based unified communications services to Canadian business across a broad spectrum of sizes, ranging from 25 to 65,000 or more employees.

“We researched a number of unified communications products before we selected Mitel’s MiCollab and MiVoice Business platforms, fully leveraging the virtualization advantages for cloud solutions. No other product compares in feature set or is so ideally suited to our massively scalable VMware cloud infrastructure. MiCollab and MiVoice Business support up to 250 end users on a single VMware vApp, plus the solution will allow us to host large enterprise companies that have 65,000 or more end users with no change in the management systems or software code. That is a great value proposition for growing companies or public sector organizations that need advanced communication capabilities and the ability to grow or shrink communication services on demand,” said Tim Dufour, President and CEO, RackForce Networks.

Mitel and VMWare were the pioneers of cloud-based unified communications and the first companies to supply real-time applications in a virtual environment. Therefore, cloud-enabled partners such as RackForce can take full advantage of Mitel’s mature MiCloud solution and its flexible path to the cloud with private, public and hybrid options.

“RackForce is poised to greatly accelerate cloud-based communications and collaboration services in Canada both through an offering to its own customer base and by leveraging its data center resources to help other service providers deliver their own white-labeled solution. Powered by Mitel, these services can drive innovation, create new efficiencies and boost productivity,” said Ron Wellard, EVP and GM, Mitel Communications Solutions.

For further information, please visit www.rackforce.com/uc

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Mobile Chilli Partners with Virtual Piggy, Inc. (VPIG)

Virtual Piggy, innovator in safe youth payments, announced earlier today that it will be providing its youth-friendly payment platform to Mobile Chilli. This partnership will allow Mobile Chilli to offer users under the age of 18 a secure payment service, complete with full customer service.

One of the UK’s largest independent mobile download sites, Mobile Chilli currently offers ringtones from legendary artists, mobile games, and over six million music tracks for download selection. Thanks to a strategic partnership with Universal Music, Sony, EMI, and Warner Music, the company is able to offer excellent entertainment content. Mobile Chilli’s service is acclaimed by many for having no subscription fees as well as their standard of full transparency.

Teens currently have very limited options for making safe and parent-approved purchases without a credit card. Virtual Piggy enables parents to teach financial management to youths within easy to set-up boundaries. The technology serves as a family wallet that is available online or via mobile, free for all to use.

“The youth market is an important part of our business. Virtual Piggy will help Mobile Chilli continue to deliver a secure and transparent service,” comments Oliver Cooke, Head of Retail at Mobile Chilli. “Having an alternative safe payment method for credit card or mobile to bill for kids and teens will allow us to expand our revenue opportunities while keeping parents in control.”

“Adding Mobile Chilli as a partner merchant will be a huge benefit to our young users, who get excited about shopping for content for their mobile devices,” states General Manager EMEA at Virtual Piggy, Joe Peden, “Now, they’ll be able to shop for their favorite game, song or ringtone and download it within the set parental guideline using Virtual Piggy.”

For information about Virtual Piggy, visit www.VirtualPiggy.com

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Monday, August 26, 2013

LoJack Corp. (LOJN) Announces Matter Communications as AOR

Public relations and social media agency Matter Communications announced earlier today that it is the Agency of Record (AOR) for LoJack Corporation, the company that pioneered the Stolen Vehicle Recovery market. LoJack selected the agency as its AOR after an intensive search for strong qualifications. It was because of a combination of experience and proven expertise that Matter Communications was ultimately chosen, according to LoJack’s Corporate Communications Manager, Jeremy Warnick.

“Matter Communications has a proven track record of success with building public relations and social media programs, as well as in creative narrative and visual storytelling,” commented Warnick. “It’s an exciting time in our company’s history. As we expand our focus into providing more safety, security and protection products for the connected car, we need an agency that shares our passion for our dealers and customers, and understands how to engage with, and convert, an even larger audience.”

Leveraging over 25 years of experience and its innovative integration with law-enforcement, LoJack has helped more than nine million people protect their vehicles. With high brand awareness, millions of units have been installed worldwide, and in addition LoJack did just over a $125 million in vehicles recoveries last year in the United States alone.

“The name LoJack is ubiquitously known and synonymous with innovative technology, safety, security and protection,” states Matter Founder and CEO Scott Signore. “We’re focused on these important attributes as part of a three-tiered PR program aimed at communicating LoJack’s value to auto dealers, consumers and law enforcement.”

For more information please visit www.LoJack.com

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Tuesday, August 20, 2013

Synacor Inc. (SYNC) Senior Vice President Recognized as a Broadcasting & Cable’s Digital All-Star

Today, Synacor announced that its SVP of Product, Michael Bishara, has been named to Broadcasting & Cable‘s 2013 Digital All-Stars list. Broadcasting &Cable’s Digital All-Stars list recognizes television industry professionals who harness the power of the digital world to benefit their businesses.

Michael joins other industry heavyweights on this year’s list, including Michael Biard, Fox Networks; Peter Blacker, Telemundo Media; David Campanelli, Horizon Media; Mark DeBevoise, CBS Interactive; Tamara Franklin, Scripps Networks Interactive; Rebecca Glashow, Discovery Communications; Lisa Hsia, Bravo Digital Media; Rachel Lam, Time Warner Investments; Christine Merrifield, MediaVest USA; Danielle Mullin, ABC Family; Michael Quigley, Turner Broadcasting; Dan Suratt, A+E Networks; and Rob Tuck, The CW.

Bishara was nominated largely due to his involvement in launching Synacor’s award-winning, next-gen TV and TV Everywhere offerings. TV Everywhere offers seamless access to subscribers’ favorite shows and premium programming at any time, on any connected device.

Prior to his current position, Bishara was senior vice president at HBO Broadband/Digital Group. He is credited as a force behind the development and successful launch of HBO GO, an industry milestone. Before HBO, Bishara worked at Time Inc. and AT&T in marketing and product leadership roles.

He is a heavily sought-after speaker, having recently presented at CES, Digital Hollywood, Variety Entertainment and Technology Summit, NextTV Summit, OnScreen Media Summit, Streaming Media East, and TV of Tomorrow Show 2013.

For more information on Synacor and its TV Everywhere services, please visit synacor.com

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Calpian, Inc. (CLPI) Makes Mobile Transaction Processing Easy

Calpian subsidiary Calpian Commerce is actually a set of companies that have joined forces and technologies to provide transaction services for U.S. businesses. The technology part of the equation is critical, since the transaction technology landscape is constantly changing. In particular, an increasing number of merchants want the ability to perform mobile processing, allowing customers to purchase goods and services away from any store or even Internet access. For example, in a recreational environment, away from any store or computer, a vendor may want to sell services or rental items to visitors, people that have nothing but a credit card. Mobility is the new face of commerce, but it has been difficult to deal with until now.

Aircharge, part of the Calpian Commerce community of companies, has the hardware and software necessary to allow any vendor to sell in a totally mobile setting. Their Aircharge wireless terminal operates like an in-store card processing system, except that it communicates with a merchant bank account using a cell phone. Here’s how it works:

The vendor has the special mobile Aircharge wireless terminal, not much bigger than a cell phone, together with a cell phone that contains downloaded Aircharge software.
When a customer wants to buy something, the software on the cell phone automatically and instantly pairs up with the Aircharge terminal.
The customer’s credit card is swiped through the slot on the mobile terminal, and the information is immediately communicated, via the paired cell phone, to the vendor’s merchant account for approval, using secure gateway processing.
The final approval displays on the cell phone, and the Aircharge mobile terminal prints a receipt.
The vendor gets a customer signature, and the transaction is finished. It’s that simple.

Aircharge is compatible with virtually every cell phone/PDA device that’s in the marketplace today, and, their payments software is compatible with most leading Android, Blackberry, cell phones and Sprint / Nextel handset devices.

For additional information, visit www.Calpian.com

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Monday, August 19, 2013

Quantum Fuel Systems Technologies Worldwide, Inc. (QTWW) Lands New $1M Contract

Quantum Fuel Systems, a real trailblazer in high-pressure CNG (compressed natural gas) storage and related vehicle systems integration, as well as renewable energy via their wholly-owned, Schneider Power Inc., subsidiary, was pleased to announce a follow-on development contract today valued at approximately $1M from a leading multinational for their help working on advanced CNG storage and vehicle integration.

QTWW has a real lead on the rest of the industry in ultra-lightweight carbon composite CNG storage tanks with their Q-Lite™ series, geared towards high volume light duty pickups and larger platform vehicles, as well as their Fuel Storage Modules, that satisfy medium and heavy-duty vehicle saddle-mount and back-of-the-cab implementations. The company even runs a Q-Lite™ Accredited Integrator program for installers (as well as inspectors, managers, owners, and sales personnel), leaning heavily on two plus decades of experience as an OEM Tier-1 systems integrator and manufacturer, to deliver accreditation that allows installers to jump start their marketing and draw in new CNG installation customers.

President and CEO of QTWW, Brian Olson, praised the company’s technology and commercialization team for their efforts thus far in continually advancing the state of the art in CNG storage and integration tech, confident that the follow-on contract presents a glowing external endorsement of their progress. The reputation QTWW has earned in this space easily opened the door to this new contract, a contract which will see the company upgrading a natural gas truck using the latest in next-gen high-cap fuel storage, integration, and control systems at their Advanced Vehicle Concepts Center out in Lake Forest, California.

This contract provides an excellent back drop for continued scaling up of the company’s Q-Lite™ carbon-composite natural gas tank technology and will offer a suitable benchmark for the further cementing of Quantum’s lead in such range-enhancing storage tech. The systems integration and engine controls work done as part of this contract will no doubt benefit greatly from the company’s vast experience dealing with not just CNG integration but hybrid, fuel cell, and specialty vehicle integration, as well as modular, transportable hydrogen refueling stations.

This is another juicy contract for QTWW and their low emission solutions that can be delivered rapidly to customers who are looking to take advantage of the benefits possible with such fully-integrated CNG architectures, are picking up some incredible steam, bolstered by success with customers and technology showcasing like they did at the ACT Expo in Washington D.C. early last month (July 9). This one expo gave QTWW direct contact with some 3k attendees representing fleet managers and top systems integrators from across the industry, where they wowed audiences with the specs on their state-of-the-art carbon composite fuel tanks, as well as the related integration and control system technologies.

To learn more about Quantum Fuel Systems Technologies Worldwide, visit www.QTWW.com

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VistaGen Therapeutics, Inc. (VSTA) and the Pluripotent Stem Cell

The magic of stem cells is that, in addition to regenerating themselves, they can also generate the specialized operational cells that make up our body. Researchers are learning that there are many types of stem cells, with different functions, and representing different sources of development. Stem cells that are pluripotent, meaning that they are able to differentiate into any of the specialized cells of the body, are of the most interest, since the potential for their application is so broad. As a result, scientists have tended to focus on ES (Embryonic Stem Cells) and iPS (Induced Pluripotent Stem Cells), two sources of pluripotent stem cells.

ES Cells are not derived from eggs fertilized in a woman’s body. Rather they are derived from excess fertilized eggs produced during clinical in vitro fertilization procedures. Excess fertilized eggs can be donated for research, cultured in vitro, and isolated when the embryo is approximately 100 cells in size, which is well before any organs, tissues, or nerves have developed. ES cells have the best documented potential to differentiate into any of the over 200 cell types in the human body. The differentiation process involves a number of steps that gradually commit the ES Cell to becoming a certain type of mature cell and tissue.

Today, thanks to major developments in stem cell technology, it is possible to obtain pluripotent stem cells from individuals without the use of embryos. Induced pluripotent stem cells, iPS Cells, are adult cells, typically skin or fat cells, that have been genetically reprogrammed to behave like ES Cells. ES and iPS Cells may not be identical in every way, and research continues, but iPS Cells are now an accepted source, and can play a critical role in stem cell research and application.

VistaGen has developed a versatile stem cell technology platform based on the controlled differentiation of human pluripotent stem cells into mature, non-transformed, human cells which can be used to create novel bioassay systems for predictive toxicology, drug metabolism screening, drug discovery, drug rescue, and cell therapy. The company believes that iPS Cell technologies may allow the rapid and efficient generation of pluripotent stem cells from individuals with the desired specific genetic variation. These stem cells may then be used to develop stem cell-based bioassays, for both efficacy and toxicity screening, which reflect the effects of these genetic variations, as well as for cell therapy applications.

VistaGen’s goal is to use their proprietary drug testing technology to economically develop their own portfolio of “rescued” drugs from drug candidates that had been shelved earlier by pharmaceutical companies due to heart or liver toxicity issues.

For additional information, visit the company’s website at www.VistaGen.com

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Friday, August 16, 2013

National Phase Approvals Granted in Ireland and the Netherlands for Apricus Biosciences’ (APRI) Vitaros

Pharmaceutical company Apricus Biosciences announced that both the Irish Medicines Board and the Netherlands’ Medicines Evaluation Board have granted national phase approvals for Vitaros. Indicated to treat patients with erectile dysfunction, Vitaros is a topically applied cream formulation of alprostadil, a vasodilator, combined with DDAIP.HCL, which is Apricus Bio’s proprietary permeation enhancer.

The company has received four national phase approvals so far for Vitaros – from Ireland, the Netherlands, Sweden, and the United Kingdom. In June of this year, the company announced its marketing application for the product had been approved through the European Decentralized Procedure (DCP). Apricus Bio filed its application for marketing approval under the DCP, designating Netherlands as the reference member state (RMS) on behalf of nine other European concerned member states (CMS) that were taking part in the procedure. Apricus Bio continues working both independently and with its commercialization partners to obtain national phase approvals on a country-by-country basis in the remaining CMS territories, including France, Germany, Italy, Spain, Belgium, and Luxembourg. Once these country-by-country national phase approvals have been secured, marketing of Vitaros can be commenced in each country by Apricus Bio’s commercialization partners.

Currently, Vitaros is partnered in key markets with companies that include Takeda in the U.K., Sandoz in Germany, Bracco in Italy, and Abbott in Canada. A comprehensive partnering process was recently launched by Apricus Bio with the aim of licensing Vitaros in the remaining un-partnered territories in Europe, Latin America, and North Africa. Recently received bids from multiple interested parties for the available territories are currently being reviewed, and the company anticipates the Vitaros partnering process will be completed in the fourth quarter of 2013.

Once it has been launched, Vitaros will become the first new and novel erectile dysfunction product to be released in almost a decade. It is well-positioned for commercial success due to its unique profile, which addresses numerous patients who cannot or do not respond well to current therapies or who are intolerant to the systematic effects of PDE5 inhibitors. Existing erectile dysfunction products generated more than $1 billion in 2012 sales in Europe alone. Apricus Bio believes a substantial portion of the market remains as yet untreated or undertreated – which means a considerable commercial opportunity for Vitaros.

For more information, visit www.apricusbio.com

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Cardica, Inc. (CRDC) Files FDA Marketing Clearance Application for MicroCutter XCHANGE 30

Cardica announced it has filed regulatory documents with the U.S. Food and Drug Administration to obtain marketing clearance for the MicroCutter XCHANGE 30, a cutting and stapling device designed for use in multiple open and minimally invasive surgical procedures. The device features a cross-sectional area that is six times smaller than conventional surgical staplers and articulates up to 80 degrees in each direction. Greater access is provided by the lower profile through a 5 mm trocar.

Cardica’s submission to the FDA includes results from the company’s recently completed MicroCutter European Trial (MET1). The MicroCutter XCHANGE 30 met the primary endpoint in the MET1 study, which was freedom from MicroCutter-related severe adverse events when compared with historical controls from the medical literature; only one event occurred out of 160 patients and 423 deployments.

Pending FDA market clearance, Cardica plans to introduce the MicroCutter XCHANGE 30 in the United States, which is the world’s largest surgical stapling market. The device is currently available in select centers in Europe.

Cardica is a designer and manufacturer of proprietary stapling and anastomotic devices for cardiac and laparoscopic surgical procedures. The company’s technology portfolio is intended to minimize operating time and enable minimally invasive and robot-assisted surgeries.

For more information, visit www.cardica.com

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Needham Expounds on Galena Biopharma, Inc. (GALE) Valuation

Needham & Company LLC has initiated coverage on biopharmaceutical company Galena Biopharma with a “Buy” rating and a target price of $3.50. This target price is based on a $236 million enterprise value for the company’s NeuVax vaccine and represents five times Needham’s 2020 U.S. sales forecast of $497 million, discounted back at 40%. Galena’s Abstral drug has been valued at $67 million, based on five times its estimated peak U.S. sales of $50 million and discounted back five years at 30%. Needham adds in $8 million for the company’s share of RXi Pharma.

Currently, Galena is developing NeuVax, which is a targeted vaccine for breast cancer. Already, the vaccine has demonstrated increased survival over placebo when given as an adjuvant to standard-of-care. Interim data for Galena’s 700-patient pivotal PRESENT study is scheduled to be reported in either the fourth quarter of 2013 or the first quarter of 2014. Needham believes adjuvant vaccine therapy will ultimately become standard of care for various types of cancer and views NeuVax as one of the foremost new product candidates for this pioneering treatment modality. Galena also recently acquired Abstral, which is an approved product for breakthrough cancer pain. Abstral has given the company near-term revenue potential and a commercial oncology presence.

Needham recognizes a growing role for vaccines in the treatment of cancer. Though highly effective treatments exist for most types of tumors, many patients relapse – often with a worse prognosis. Utilizing vaccines to activate a cell-specific immune response promises decreasing relapse rates with few toxicities. NeuVax stimulates an immune response to the HER2, which is a well-validated tumor antigen.

NeuVax demonstrated, in a Phase I/II study in the subset of patients most closely resembling the pivotal trial population, a 36-month DFS rate of 100% versus 77.8% in controls. The vaccine is currently being tested in the pivotal PRESENT study in patients with resectable, node-positive breast cancer. Randomizing 700 patients, the PRESENT trial is testing NeuVax’s ability to reduce the three-year relapse rate. Needham expects final data from the trial to be released in mid-2016, with results from an interim analysis expected around year-end 2013 (keeping with protocol stipulations requiring an interim analysis after 70 events).

Differing from Dendreon’s Provenge, which is the only vaccine currently approved for cancer, NeuVax is inexpensive to manufacture and is administered by a simple subcutaneous injection. Resultantly, Needham does not expect NeuVax to encounter the adoption and margin issues experienced during Provenge’s launch.

A biopharmaceutical company based in Portland, Ore., Galena Biopharma is engaged in the development of innovative, targeted oncology treatments to address major unmet medical needs in the advancement of cancer care. For more information about Galena Biopharma, visit www.galenabiopharma.com.

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Retrophin, Inc. (RTRX) to Secure Development and Commercialization Rights on Promising New Autism, Schizophrenia Treatment

Retrophin, the biopharma developer focused on debilitating and life-threatening neurological diseases in unmet and underserved categories, announced signing a deal today which grants the company a 120-day exclusivity window in which to negotiate a royalty-bearing U.S. license for the intellectual property needed to develop, manufacture, and sell an exciting new Autism and Schizophrenia treatment. The deal was signed with an undisclosed, major pharmaceutical company in exchange for an upfront, non-refundable fee, as well as obligation to pay an additional fee upon execution of a suitable license agreement.

For a company that has already pioneered extensive territory in neurological disease, this deal is a major victory. With four current treatments in various stages of development, typified by their lead compound, RE-021 (originally developed for hypertension), which is designed to treat a rare and severe (mostly pediatric) kidney nephropathy affecting some 50k patients in the U.S. alone. This license would put RTRX in control of a potentially break out product that could offer new and significant therapeutic options to patients that suffer from schizophrenia and autism spectrum disorders. With RE-021 slated to start enrollment in a pivotal Phase 2 clinical trial this year, securing this new product license (especially in so broad a category as autism spectrum disorders) is huge news that could even dwarf the rest of the company’s portfolio, despite how good it looks.

President, Founder and CEO of RTRX, Martin Shkreli, emphasized the abundant extant data from numerous studies conducted using the product and assured investors that the company’s own rigorous due diligence confirmed an extremely high probability here for “significant utility” in the given indications.

Retrophin looks to be the perfect company to pick up the ball and run with it here given their established presence in childhood neurological disease. The company’s other three products currently under development are:

RE-001 – designed to combat the most common and most severe form of muscular dystrophy, Duchenne Muscular Dystrophy, which affects nearly 1 in 3.6k male newborns

RE-003 – a recombinant fusion protein targeting the most common genetic cause of infant mortality, Spinal Muscular Atrophy, which affects some 112k infants in the U.S. and Europe alone

RE-024 – which has shown nice results in preclinical animal models at St. Jude’s Children’s Research Hospital as a substitute for phosphopantothenate therapy used to treat pantothenate kinase-associated neurodegeneration, a rare but life-threatening neurological disorder resulting in the inability to metabolize vitamin B5

With solid data on the benefits of this new product for autistic people and patients suffering from schizophrenia to go off of, RTRX should make short work of the development and commercialization cycle, meaning Retrophin could soon have a winning autism spectrum disorder drug ready for market. Taken into consideration alongside the rest of RTRX’s portfolio, investors will want to keep a close eye on this deal and how the company progresses with the execution of the license.

For more information on Retrophin, visit www.Retrophin.com

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Thursday, August 15, 2013

SiriusXM Radio (SIRI) Enters Agreement to Acquire Connected Vehicle Unit of Agero

Sirius XM Radio, the world’s largest radio broadcaster measured by revenue, featuring over than 25 million subscribers, announced today that it has reached a definitive agreement to acquire Agero for $530 million in cash. Agero is the leading provider of vehicle and driver safety and security services, including roadside assistance, consumer affairs, and claims management services.

Agero’s connected vehicle unit is the premier supplier of cutting-edge telematics services, offering safety, security, and convenience services for drivers, as well as comprehensive, turnkey solutions for automakers. Once the acquisition is complete, SiriusXM will supply connected vehicle services to more automotive manufacturers than any other telematics provider. Acura, BMW, Honda, Hyundai, Infinity, Lexus, Nissan, and Toyota are among the companies connected with SiriusXM.

SiriusXM offers unrivaled audio entertainment and data services in over 50 million vehicles through its unique footprint in vehicles from every major carmaker. As technology continues to permeate through the auto industry, telematics and connected vehicle solutions will be key elements in that developing trend. Following the acquisition of the connected vehicle unit of Agero, SiriusXM will be entrenched as the leading provider for services in this realm during a critical period of technological integration into automobiles.

“The acquisition of Agero’s connected vehicle business is a natural fit for Sirius XM. As the world’s leading provider of in-vehicle subscription services, SiriusXM is uniquely positioned to offer world-class end-to-end telematics services,” said Jim Meyer, Chief Executive Officer, SiriusXM. “The transaction accelerates SiriusXM’s development in architecture supporting connected vehicle services, as well as the ability to provide services over both satellite and cellular networks. Agero’s connected vehicle team is known for their experience, innovation and technology, and we look forward to welcoming them to SiriusXM as we work to capture the significant growth opportunities in connected vehicle services.”

The transaction is subject to the expiration or early termination of the Hart-Scott-Rodino antitrust waiting period and other customary closing conditions.

The transaction is expected to close in the fourth quarter of 2013.

For further information, visit www.sirius.com

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Tuesday, August 13, 2013

China Recycling Energy Corp. (CREG) and China State-Owned Unit Create Energy Recycling Fund Targeting Coke Dry Quenching

China Recycling Energy, which has earned a reputation in industrial energy capture and waste-to-energy recycling systems, with their full-spectrum service approach that includes custom design, manufacturing, financing, civil construction, and operations, reported today on recently received approval to join forces with Hongyuan Huifu Venture Capital Co., Ltd. in creating a energy recycling fund that will invest in coke dry quenching (CDQ – capturing heat energy by means of an inert gas) and waste heat generation projects.

Hongyuan Huifu is the wholly owned subsidiary of Hongyuan Securities, a pilot institution created through a direct equity investment by a China Securities Regulatory Commission-approved broker. Registered in Beijing, Hongyuan Securities (net assets of $2.45B in 2012) was initially established back in 2010 with $49M in registered capital ($81.7M authorized) and provides national, extremely comprehensive, and tirelessly innovative securities brokerage services, bearing robust qualifications for all manner of securities business.

Tapping into thermal byproducts at cement factories, coke plants, and steel mills across China to generate energy from otherwise squandered exhausts, heat, pressures, and steam, will not only help meet government mandates readily, but also provide a massive source of lower-cost electricity. To support the fund’s energy recycling projects, Xi’an TCH Energy Technology Co., Ltd., has also formed a new 90% owned subsidiary, Xi’an Zhonghong New Energy Technology Co., Ltd., with registered capital of some $4.85M and will begin tackling projects enabled by the fund. In addition to this, other key players have entered the arena to support the fund’s activities, with Boxing County Chengli Gas Supply Co., Ltd. (Chengli) and Jiangsu Tianyu Energy and Chemical Group Co., Ltd., (Tianyu) both entering into cooperative agreements with Xi’an Zhonghong over CDQ generation projects.

Both of these first two projects will feature primary CDQ systems, as well as CDQ waste heat power systems, with the Chengli project being a single-unit, 25MW deployment and Tianyu consisting of two units, for a total of 50MW. Momentous times to say the least for CREG, which clearly has a bright future as a developer of customized solutions spanning pressure, heat, and gas to energy technologies, as well as biomass, geothermal, waste-to-energy, and wind for Chinese industry. With this fund established, CREG shareholders now stand poised to benefit mightily off continued project implementations in the future and the company will capture pressure from the Chinese government on industry to optimize resource allocation and reduce pollution, especially in the cement, coke, and steel production sectors, with the same efficiency as they would from a blast furnace.

To learn more about China Recycling Energy, visit www.CREG-cn.com/en

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RTI Surgical, Inc. (RTIX) Announces First Human Implantation of map3 Cellular Allogeneic Bone Graft

Global surgical implant company RTI Surgical announced that the first human implantation of the company’s map3 Cellular Allogeneic Bone Graft implant was completed last week.

This first implantation was performed during a spinal surgery in New York by Dr. Franco E. Vigna, M.D., M.P.H., who is a board certified orthopedic surgeon with Spine Surgery of Buffalo Niagara and a fellow with the American Academy of Orthopaedic Surgeons. Dr. Vigna used the implant’s chips allograft configuration, which is one of two configurations that will be available once the implant is launched.

Vigna, who was honored in 2009 as one of the top American orthopedists in spinal care by the Consumers’ Research Council of America, said he is excited to have map3 available as an option for his patients, due to the implant’s specific osteogenic and angiogenic properties.

“The future of spine surgery is biologics,” Vigna said. “We can place the best metal implants, but if the bony fusion does not take place those implants will loosen and the fusion will fail. Having top-quality natural biologics along with excellent metal implants gives physicians and patients the best of both worlds.”

A natural and safe alternative to autograft, map3 cellular allogeneic bone graft provides a streamlined approached to bone grafting and, in a single allograft, supplies the three elements necessary for bone repair: osteogenesis, osteoinduction, and osteoconduction. Map3 incorporates multipotent adult progenitor cell-based (MAPC-based) technology with stem cells that are isolated from the same donor as the other bone material. This technology, which is licensed from Athersys for this specific orthopedic application, represents a distinct type of stem cell with recognized angiogenic and immune-modulatory properties. Once it has been launched, map3 will be available in multiple configurations and sizes and will provide bone grafting options for a variety of bone repair, reconstruction, and fusion procedures.

RTI anticipates map3’s market release to take place later this year. Surgeons can learn more about the implant and RTI’s other offerings at the North American Spine Society’s (NASS) Annual Meeting, which will take place Oct. 9-12 in New Orleans. RTI’s exhibit will be located at booth #621.

For more information, visit www.rtix.com

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Brett Reynolds Appointed as Senior VP and CFO of Uroplasty, Inc. (UPI)

Yesterday, medical device company Uroplasty announced that Brett A. Reynolds has been appointed as Senior Vice President and Chief Financial Officer.

Mr. Reynolds’ experience spans over 20 years in finance and operations. He spent 10 years with Synovis Life Technologies, a Twin Cities-based medical device manufacturer acquired by Baxter International last year. While with Synovis, he held various senior positions, including CFO.

Prior to Synovis, Mr. Reynolds served in executive financial positions at Chiquita Processed Foods, Arthur Andersen, and Deloitte & Touche. Mr. Reynolds is a Certified Public Accountant and holds a BA in Accounting and an MBA from the University of Minnesota’s Carlson School of Management.

Rob Kill, Uroplasty’s President and CEO, remarked, “Brett’s significant industry operational experience and proven public company financial leadership will be a valuable asset to Uroplasty. His track record of building strong financial organizations and processes expands the depth of our executive leadership team and we are delighted to have him on board in this key role.”

For more information, visit www.uroplasty.com

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Exceed Company Ltd. (EDS) Appoints Additional Directors to the Board

Owner and operator of the Xidelong brand, one of China’s leading domestic sportswear brands, Exceed Company Ltd. announced earlier today that the board of directors has recruited Pang Xiaozhong as an independent non-executive director, and Ding Dongdong to the position of executive director, both effective as of today. In addition Xiaozhong has been added by the Board as a member to the Board’s compensation committee, audit committee, and to its nomination committee.

Xiaozhong has been dedicated to the promotion of sports science in China for over 30 years. Most recently Xiaozhong was the director of the research and development department of the Institute of Sports Science under the General Administration of Sport in China. He has implemented a number of essential national projects. With a profound understanding of national science and technology policies, both domestic and international, Xiaozhong will be a great addition to the Exceed Company. In addition the government and enterprises for promotion of social and economic benefits have honored Xiaozhong, noting his success in organizing various technology projects in sports industry campaigns.

Dongdong, appointed to Executive Senior Vice President, is set to oversee the conceptual design and development of footwear and apparel. First joining the Exceed family in September of 2001, he was the development manager of the apparel department of Fujian Xidelong Sports Goods Co., Ltd, Exceed’s PRC subsidiary. From 2002 to 2003, Dongdong’s experience includes apparel design, production, data collection, quality management, and overseeing the after-sales of the apparel department. Additionally Dongdong holds a diploma in apparel design from the Guangdong Apparel Institute and on a personal note, is the brother-in-law of executive director of Exceed Company Ltd., Lin Shuipan.

“On behalf of the board of directors, I am pleased to welcome Mr. Pang Xiaozhong and Mr. Ding Dongdong to the Board. Mr. Pang and Mr. Ding will bring to Exceed a wealth of experience gained from their extensive services in the areas of academia and business. Their expertise in these areas will be a valuable asset to the Company, and we look forward to working closely with them,” stated Exceed’s founder, Chairman and CEO, Lin Shuipan,

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Digital Cinema Destinations Corp. (DCIN) and the Theater Digital Transformation

DCIN has been growing revenue dramatically through the company’s strategy of acquiring and converting movie theaters around the country into interactive entertainment centers, providing more than simply the latest from Hollywood. It’s a strategy driven by one of the most successful entrepreneurs in the theater industry, DCIN CEO A. Dale “Bud” Mayo, developer of companies that have pioneered the industry’s move to digital and related technologies. The idea is to use digital technology to leverage theater assets, through more flexible market-oriented presentation scheduling along with the addition of a wide range of entertainment alternatives.

The long association of neighborhood theaters with Hollywood movies can make it difficult to imagine them as anything more, which is the brilliance of the DCIN approach. Although traditional motion picture fare will continue to make up the larger part of theater offerings, digital technology opens the door to an almost unlimited potential of live and recorded entertainment presentations, including sporting events, all types of concerts, classic films, exclusive independent movies straight from major film festivals around the world, even the best of the arts such as opera and ballet. Digital technology also makes possible large scale corporate conferences and other types of meetings in a way not previously economic.

In addition, theaters will now be able to economically present a variety of special interest shows, such as these that DCIN has either already shown or will be showing:

Sports – The United States of Football is an award-winning and compelling documentary that every football fan and family of a player should see. It explores the cumulative effects of repetitive trauma in America’s Game from Pee Wee leagues to the pros. In conjunction with the movie, audiences can expect live in-theater appearances from legendary football stars on opening night. Digiplex will also host a live Question and Answer Session with the filmmaker and featured former players. A portion of box office proceeds will go to the Kevin Turner Foundation and the Gridiron Greats Assistance Fund. Visit www.diginextfilms.com or www.theusof.com for more.

Music – On a blistering summer day in 1972, the Grateful Dead took the stage on the grounds of the Oregon Country Fair for what would become one of the most legendary concerts of the band’s storied history. Previously unreleased “Sunshine Daydream” features concert footage as well as recent interviews with Ken Babbs, Sam Cutler, Wavy Gravy and Carolyn “Mountain Girl” Garcia.

Dance – Audiences are transported to exotic India with an encore performance of La Bayadere (the temple dancer) presented by the Bolshoi Ballet. The Bolshoi later returns with a classic audience favorite that has been called a mighty Egyptian fresco. The Pharaoh’s Daughter follows an English Lord on an expedition to the pyramids where reality and fantasy merge and ancient mysteries weave a complicated love story.

For more information on Digital Cinema Destinations, visit www.DigiplexDest.com

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CombiMatrix Corp. (CBMX) Enters Strategic Partnership with Manhattan Labs

CombiMatrix is a molecular diagnostics company specializing in DNA-based testing services for developmental disorders and cancer diagnostics. CombiMatrix performs genetic testing utilizing a variety of advanced cytogenomic techniques including microarray, standardized, and customized FISH, and high resolution karyotyping.

The company today announced a strategic partnership with Manhattan Labs, an independent clinical laboratory that serves the New York City area. Its emphasis is on women’s health, particularly obstetrics and reproductive issues. Manhattan labs will market and distribute in New York City CombiMatrix microarray tests for the miscarriage management testing market.

The agreement between the two firms was directly enabled by the announcement in June that CombiMatrix miscarriage management tests had received conditional approval from the New York State Department of Health for testing on patient samples within New York state.

Miscarriage management testing allows OB/GYN doctors to better determine if there is a genetic cause for a miscarriage or other related events. Microarray testing is believed by many in the industry to be the coming standard of care since it can identify a greater number of possible genetic abnormalities more accurately than currently available technology.

The partnership is a key step for CombiMatrix. First, it shows that microarray testing is indeed becoming more and more accepted as a diagnostic tool in the women’s health field. Secondly, it gives the company access into the large New York City market for its leading growth product. For additional information about CombiMatrix and its entire product line, please visit www.combimatrix.com.

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Engage Mobility, Inc. (ENGA) Announces Release of Mobile Engagement System for Business

Engage Mobility, a prominent mobile technology and marketing company, announced today that it has completed and released its Mobile Engagement System® for business. The system combines an innovative augmented reality APP with a proprietary cloud based video delivery system, a mobile CRM, and Dynamic Data® delivery system, and has been made available commercially.

The Engage APP is currently available in the Google Play® store and is in queue to become available in the iTunes store in the next couple days. The APP can be downloaded at no cost to the user, and allows users to interact with their favorite brands within an augmented reality environment through the Engage Mobile Engagement System.

Jim Byrd, CEO of Engage, stated, “The completion and launch of our Mobile Engagement System is truly a landmark event for us and our shareholders. Our team has worked so tirelessly to turn our vision into reality, and we could not be more excited as we now bring this game changing technology and platform to market. Our business clients will now have access to the most powerful, compelling and cost effective marketing solution ever conceived, and we are thrilled that the Engage product offerings will lead business into the mobile age.”

The Mobile Engagement System features Engage’s proprietary video delivery system that recognizes and converts any form of video into the necessary format for mobile delivery, compresses, and optimizes the video for mobile, as well as a mobile CRM that gives businesses the ability to continuously engage with its customers using geo-targeting, geo-fencing, loyalty, sharing and rewards programs, as well as other useful tools. This cutting edge video delivery system is integrated with the Engage Dynamic Data® platform of over 40 million users, enabling Engage clients to grow their business with a highly targeted and cost effective mobile marketing solution.

For further information, please visit www.engagemobility.com

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Calpian, Inc. (CLPI) Highlights Northern Merchant Services

Calpian Commerce, wholly owned subsidiary of Calpian, Inc., is made up of companies which together offer a comprehensive range of transaction software and services for U.S. merchants, such as debit and credit card processing. The operations support both online and physical entities, for settings requiring wired as well as wireless/portable payment solutions.

One of the Calpian Commerce companies is Northern Merchant Services (NMSI), which, for over a decade, has been providing affordable payment processing solutions. The company was founded as a local service provider in 1997, and quickly became a top producer for NOVA (now Elavon), a major credit card processing subsidiary of U.S. Bancorp. NMSI was chosen as a premier servicing agent for Elavon’s community bank program. In addition, NMSI continues to develop their own programs specific to the needs of community banks and their business deposit customers.

Card Present Processing – Retail locations receive the lowest rates available for face-to-face processing.
Software Solutions – Turns a PC into a virtual terminal with many software options.
Card Not Present Processing – Offers many solutions for key-entered transactions.
eCommerce Solutions – Gateways and Virtual Terminals through a web browser.
Wireless Processing – AirCharge units or wireless terminals allow on-the-spot processing.
Telephone Processing – Phone in transactions to an 800 number with a flat discount rate.

Northern Merchant Services is a member of the Independent Community Bankers of America (ICRA), considered the nation’s voice for community banks, representing nearly 5,000 community banks of all sizes and charter types throughout the U.S. The ICRA is dedicated exclusively to representing the interests of the community banking industry. NMSI is also a member of the Independent Bankers Association of New York State (IBANYS), which serves independent community banks across New York State. IBANYS member institutions provide loans and other financial services in their respective local communities which encourage a vibrant local economy.

For additional information, visit www.Calpian.com

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Friday, August 9, 2013

Galena Biopharma, Inc. (GALE) Reports Q2 Achievements, Financial Results

Galena Biopharma, a biopharmaceutical company commercializing and developing targeted oncology treatments that address major unmet medical needs to advance cancer care, in reporting its second-quarter results, highlights several company milestones, including its advances in taking Abstral® to market.

“We have made rapid progress toward successfully commercializing Abstral®,” Mark J. Ahn, Ph.D., president and CEO, stated in the press release. “While the NeuVax™ PRESENT trial continues its enrollment and our other development programs advance, Galena has now evolved into a fully integrated biopharmaceutical company. Building our capabilities allows us to seize opportunities to better serve patients and increase shareholder value.”

Abstral is the company’s treatment option for breakthrough cancer pain (BTcP) in patients who are already receiving, and who are tolerant to, opioid therapy for their persistent baseline cancer pain. The Abstral formulation delivers the analgesic power of micronized fentanyl in a sublingual tablet, which dissolves under the tongue in seconds, designed to provide rapid relief that lasts the entire duration of the breakthrough pain episode. GALE points to key achievements toward the commercialization of Abstral:

Scaled up commercial operations with field leadership, field sales, and account management teams in preparation for the official fourth quarter Abstral launch.

Abstral now available commercially nationwide. Galena has secured stocking and distribution partnerships with major wholesalers and specialty distributors, and Abstral is available to patients and healthcare professionals at pharmacies nationwide. Established broad and easy access to patient assistance programs to ensure efficient and timely patient access to Abstral treatment.

GALE’s lead product, NeuVax™, is the first adjuvant breast cancer vaccine to enter pivotal phase 3 clinical trials. NeuVax works by stimulating the body’s own immune system to seek out and destroy micrometastatic cancer cells that may be circulating in a patient’s body after their cancer treatment. The company is currently enrolling its randomized, multi-national phase 3 trial entitled PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax treatment). The study is being conducted under a Special Protocol Assessment (SPA) granted by the FDA, and is currently enrolling in more than 130 clinical sites worldwide.

The company is also enrolling patients for a 300-patient phase 2b clinical trial to study NeuVax in combination with Herceptin®.

Also in the second quarter, GALE made changes to its management team and expanded its board of directors with the addition of experts in oncology commercialization:

Christopher S. Lento joined Galena as its vice president of sales and commercial operations to launch Abstral. Lento has 20 years of experience in senior level positions managing the sales, business development and operations at major healthcare companies including Genentech BioOncology, Altos Solutions, Abraxis Bioscience (acquired by Celgene Corporation), and US Oncology Network.

William L. Ashton joined GALE’s board in May. He is a senior executive with more than 28 years of experience in biotechnology and pharmaceutical leadership and management. Most recently, at Amgen, Inc., he served as vice president of corporate and government affairs and vice president of sales, and was directly responsible for product launches, as well as interaction with key government agencies including the Centers for Medicare and Medicaid Services. After retiring from Amgen, Ashton joined the University of the Sciences in Philadelphia where he currently serves as associate provost and senior vice president of strategic business development, founding dean, Mayes College of Healthcare Business and Policy, and assistant professor of Pharmaceutical Business.

On the financial side, GALE’s second-quarter operating loss was $7.9 million, including $0.5 million in stock-based compensation charges, compared with an operating loss of $5.7 million for the comparable quarter of 2012, which includes $0.2 million in stock-based compensation charges. However, with the impending Abstral launch and two promising therapies currently in clinical trials, investors are very optimistic about the financial performance expected in following quarters.

As of June 30, 2013, Galena had cash, cash equivalents, and marketable securities of $26.8 million, compared with $35.6 million as of December 31, 2012.

For more information, visit www.galenabiopharma.com

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Local Corporation (LOCM) Video Chart for Friday, August 9, 2013

LOCM has had a strong month, rising 25 percent in the past four weeks. While the indicators are in bullish positions, the chart finds itself once again near a stout resistance. The resistance has not been broken on two occasions, but technical traders will be looking to see if the third time is the charm.

To view the video chart, visit the following link: http://www.missionir.com/videos.html

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ROTH Maintains ‘Buy’ Rating, $7 Price Target for Galena Biopharma, Inc. (GALE) In May, ROTH Capital Partners, LLC valuated biopharmaceutical company Galena Biopharma, Inc. with a “Buy” rating and a 12-month price target of $7. ROTH’s valuation remains in force as Galena – which closed with a price of $2.04 on Aug. 8 – continues forward with ongoing clinical programs for NeuVax and the forthcoming launch of Abstral. In a presentation at the American Pain Society meeting, the company highlighted its Abstral drug as a model for the REMS program for transmucosal immediate-release fentanyl products (Abstral is the only available sublingual tablet formulation of fentanyl for the breakthrough cancer pain market). ROTH continues looking forward to the launch of Abstral, which is on track to take place in the fourth quarter of 2013. Recognizing Abstral benefits from key differentiating attributes, ROTH sees two potential synergies for the product with Galena’s drug development efforts: Abstral should allow for earlier detailing of physicians (especially those treating breast cancer) to build relationships for the anticipated success of the company’s NeuVax vaccine; and projected revenues from Abstral could help effectively manage Galena’s burn rate. While it’s difficult to predict timing, ROTH believes that Galena is remaining active on the partnering front, with Leica Biosystems on board for the development of companion diagnostics and Teva Pharmaceutical Industries Ltd. on board to commercialize NeuVax in Israel. ROTH also continues focusing on the ongoing clinical programs for NeuVax, Galena’s lead development candidate, including the Phase III PRESENT study (under SPA), which is enrolling participants at more than 125 sites internationally. NeuVax is a vaccine designed to train the immune system to recognize and destroy breast cancer cells. A planned interim analysis of the PRESENT study is scheduled to occur with 70 events and is expected in either late 2013 or early 2014. ROTH believes Galena is well positioned for a successful outcome of the Phase III NeuVax PRESENT study, based on both optimized selection of the dosing regimen (including boosting) and patient population. A 300-patient randomized Phase IIb study of NeuVax in combination with Herceptin is also ongoing. A biopharmaceutical company based in Portland, Ore., Galena Biopharma is engaged in the development of innovative, targeted oncology treatments to address major unmet medical needs in the advancement of cancer care. For more information about Galena Biopharma, visit www.galenabiopharma.com. About MissionIR MissionIR is committed to connecting the investment community with companies that have great potential and a strong dedication to building shareholder value. We know our reputation is based on the integrity of our clients and go to great lengths to ensure the companies represented adhere to sound business practices. Sign up for “The Mission Report” at www.MissionIR.com Please see disclaimer on the MissionIR website http://www.missionir.com/disclaimer.html Local Corporation (LOCM) Video Chart for Friday, August 9, 2013 LOCM has had a strong month, rising 25 percent in the past four weeks. While the indicators are in bullish positions, the chart finds itself once again near a stout resistance. The resistance has not been broken on two occasions, but technical traders will be looking to see if the third time is the charm. To view the video chart, visit the following link: http://www.missionir.com/videos.html About MissionIR MissionIR is committed to connecting the investment community with companies that have great potential and a strong dedication to building shareholder value. We know our reputation is based on the integrity of our clients and go to great lengths to ensure the companies represented adhere to sound business practices. Sign up for “The Mission Report” at www.MissionIR.com Please see disclaimer on the MissionIR website http://www.missionir.com/disclaimer.html $GALE Reports Q2 Achievements, Financial Results

In May, ROTH Capital Partners, LLC valuated biopharmaceutical company Galena Biopharma, Inc. with a “Buy” rating and a 12-month price target of $7. ROTH’s valuation remains in force as Galena – which closed with a price of $2.04 on Aug. 8 – continues forward with ongoing clinical programs for NeuVax and the forthcoming launch of Abstral.

In a presentation at the American Pain Society meeting, the company highlighted its Abstral drug as a model for the REMS program for transmucosal immediate-release fentanyl products (Abstral is the only available sublingual tablet formulation of fentanyl for the breakthrough cancer pain market). ROTH continues looking forward to the launch of Abstral, which is on track to take place in the fourth quarter of 2013. Recognizing Abstral benefits from key differentiating attributes, ROTH sees two potential synergies for the product with Galena’s drug development efforts: Abstral should allow for earlier detailing of physicians (especially those treating breast cancer) to build relationships for the anticipated success of the company’s NeuVax vaccine; and projected revenues from Abstral could help effectively manage Galena’s burn rate. While it’s difficult to predict timing, ROTH believes that Galena is remaining active on the partnering front, with Leica Biosystems on board for the development of companion diagnostics and Teva Pharmaceutical Industries Ltd. on board to commercialize NeuVax in Israel.

ROTH also continues focusing on the ongoing clinical programs for NeuVax, Galena’s lead development candidate, including the Phase III PRESENT study (under SPA), which is enrolling participants at more than 125 sites internationally. NeuVax is a vaccine designed to train the immune system to recognize and destroy breast cancer cells. A planned interim analysis of the PRESENT study is scheduled to occur with 70 events and is expected in either late 2013 or early 2014. ROTH believes Galena is well positioned for a successful outcome of the Phase III NeuVax PRESENT study, based on both optimized selection of the dosing regimen (including boosting) and patient population. A 300-patient randomized Phase IIb study of NeuVax in combination with Herceptin is also ongoing.

A biopharmaceutical company based in Portland, Ore., Galena Biopharma is engaged in the development of innovative, targeted oncology treatments to address major unmet medical needs in the advancement of cancer care. For more information about Galena Biopharma, visit www.galenabiopharma.com.

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BofI Holding, Inc. (BOFI) Posts Record Earnings, Reports Positive Growth Outlook

BofI Holding, Inc., the holding company for BofI Federal Bank, recently announced record financial results for the fourth quarter and fiscal year ending June 30, 2013.

BofI’s net income for the fiscal year ended June 30 was $11,132,000 – a company record and an increase of 30% over the previous year’s net income of $8,565,000 for the same quarter. Earnings of $11,055,000 or $0.78 per diluted share, attributable to the company’s stockholders, represented an increase of 35% over the same quarter of the previous year, which amounted to $8,187,000 or $0.64 per diluted share.

Core earnings for the company – excluding the after-tax impact of gains and losses associated with its securities portfolio – were $12,046,000 for the fourth quarter ending June 30, which represents a 36.6% increase from $8,817,000 for the same quarter of the previous year.

For the fiscal year ending June 30, BofI’s net income was $40,291,000 – also a company record and representing an increase of 36.7% over the previous fiscal year’s net income of $29,476,000. Fiscal year earnings attributable to the company’s stockholders were $39,456,000 or $2.89 per diluted share; this represents an increase of 39.9% from $28,205,000 or $2.33 per diluted share reported for the fiscal year ending June 30, 2012. These record earnings for both the quarter and the fiscal year chiefly resulted from growth in both the bank’s loan portfolio and its fee income business.

In addition to posting record earnings, BofI has made significant progress in diversifying its deposit base. The company achieved significant growth in consumer and business checking account balances and also successfully entered the prepaid sponsorship marketplace. Additionally, the company substantially improved its deposit mix during this fiscal year and continues diversifying its lending businesses as well as developing new sources of fee income. These measures are making the company more resilient to changes in market conditions.

BofI is well-positioned for future growth, boasting a robust pipeline that includes increased jumbo and multifamily mortgages and increased C & I loans, as compared with the company’s pipeline at the conclusion of the quarter ending March 31, 2013. The company anticipates closing its announced acquisition of around $200 million in low-rate consumer deposits from the principal bank by the conclusion of the next quarter, helping fund BofI’s expected future growth. The bank is also well-positioned to deploy capital to grow its loan portfolio. The bank’s Tier 1 capital ratio was 8.63% on June 30, 2013 – before considering $14 million in cash available at the holding company and before considering approximately $43 million of common stock that the holding company can issue “at-the-market” through its ATM public offering, which commenced in March 2013.

A nationwide branchless bank, BofI Federal Bank offers financing for single and multifamily residential properties, small to medium-sized businesses in target sectors, and selected specialty finance receivables. Possessing more than $3.09 billion in assets, the company provides consumer and business banking products through low-cost distribution channels and affinity partners.

For more information about BofI Holding, including investor information and further details regarding the company’s quarter and fiscal year earnings, visit www.bofifederalbank.com

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Hannover House, Inc. (HHSE), NanoTech Entertainment, Inc. (NTEK) Joint Venture Spots Revenue Generating VOD Opportunity

In the last 20 years, Hannover House has transitioned from a boutique book publisher into a full-service media company, becoming the first studio distributor with a dedicated Roku-enabled IPTV site, leveraging strategic partnerships in its path to continued growth and opportunity.

The company is currently focused on a joint-venture (JV) project with NanoTech Entertainment to commercialize the VODwiz, a pay-per-video/video-on-demand (VOD) portal, for which the JV has deployed a beta-launch in preparation for its upcoming consumer roll-out.

NTEK is a technology company is engaged in all aspects of the entertainment industry, operating through three business units focused on gaming, media & IPTV, and mobile apps, complementary to HHSE’s consolidated offering of film, television, and video programming. The JV leverages both companies’ expertise to design and launch the VODwiz Web site (www.VODwiz.com) and IPTV channel designed as a destination site that provides consumers with the ability stream thousands of independent films and major studio titles directly into their home televisions, computers, over the Internet, or mobile device.

Throughout upcoming weeks and months the JV anticipates adding titles from more than a dozen studio labels to reach a short-term goal of at least 2,000 titles for streaming. The long-term goal is to establish VODwiz as a destination for all mainstream and independent programming, offering an alternative to existing VOD sites such as Netflix and iTunes, which have a limited selection of titles.

The revenue model is to price most programming between $0.99 and $2.99, with higher pricing for special events and select major studio titles.

“Hannover managers feel that the VODwiz venture offer presents a major revenue opportunity for the company based on industry data for existing Video-On-Demand sites and the strong support that the VODwiz concept has received from the independent film distribution community,” HHSE CEO Eric Parkinson and President Fred Shefte stated in a recent business overview. “Delivery of films to consumers via Video-On-Demand methods enables Hannover House to avoid the costs of manufacturing, shipping and storing of videos, and also results in a near-instantaneous payment transaction.”

For more information visit www.HannoverHouseMovies.com or www.nanotechent.com

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All Grade Mining, Inc. (HYII) Progressing Expansion of Chilean Project Portfolio

New Jersey-based All Grade Mining is a development-stage company focused on the extraction of iron ore and copper from mines located in the Republic of Chile, where the company owns the Salitrosa Iron Ore Mine comprised of 1,831 acres with more than 40 million tons of iron ore reserves.

The company has hired Foreign Commerce Consultative Services, Inc. as general contractor for the site, responsible for hiring adequate professionals to conduct site planning, excavation engineering, material sampling, concentration methodology, environmental impact declaration, and logistics.

HYII is advancing the start of its initial mining operations at the Salitrosa Property, and recently secured a potable water supply for the project through an agreement with Aguas Chanar, S.A., a Chilean company with extensive experience managing sanitation concessions to produce and distribute water as well as collect and treat waste water.

In July HYII took the initial steps to acquire a second mining project in Chile, the Plateada Copper Sulfide Project located approximately 34 miles south east of Ovalle. This project was one of the first pilot programs established by Foreign Commerce as a joint venture with a group of private investors.

Upon successful completion of the project’s initial phase, projections were achieved and HYII says it is ready to move forward and expand its project portfolio.

For more information, visit www.AllGradeMining.com

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The Pulse Network, Inc. (TPNI) Recruits Talent to Executive Management Team

Event solutions and digital media firm The Pulse Network announced yesterday that Robert Collins is to join as Content and Digital Strategy Director and that Katherine Hee will be recruited to the position of Director of Business Development.

Collins will be in charge of overseeing the social service practice and digital content, while directing the expansion of Pulse’s management team in order to meet exciting growth demands. Hee will implement her knack for crafting creative business plans. Putting those strategic skills to use, she will lead The Pulse Network’s enterprise production and partnership team. In addition she will develop solutions to seamlessly meet clients’ enterprise needs.

Collins has a traditional background in content creation, communications, and agency management experience. With 18 years of marketing experience, he has collaborated with innovative start-ups and international brands. Previously, Collins sat as partner at Human 1.0, a business consultancy, and Principal at New Marketing Labs, a social business agency. Collins was also part of the executive team that brought to conception SHIFT Communications, a leading social media and public relations agency.

“As the host of Boston’s Social Media Breakfast, Robert is a key figure in the digital and social media landscape and leading the industry in effective content creation that builds brands and drives business growth,” stated CEO of The Pulse Network, Stephen Saber. “We are thrilled to be working with Robert again and have him as part of The Pulse Network team as we expand our services and start offering new sales, branding and though leaderships platforms through video and content services to our growing enterprise business groups.”

Joining Pulse as Director of Business Development, Hee has over 25 years of experience in global strategy, sales, marketing, and business. Prior to joining The Pulse Network, Hee held a position with International Business Machines (IBM), working in IBM’s Software, Hardware, and Services division. Hee previously directed a multi-disciplinary team that impressively developed and brought to market, a worldwide industry-based online lead generation tool, which has currently been translated into 7 different languages. Additionally Hee developed market introduction strategies, supporting assets for worldwide marketing, enabling sales teams to be able to efficiently drive awareness. She also developed share best practices and created field enablement materials.

“Katherine is a valuable addition to The Pulse Network’s leadership team,” said Stephen Saber. “Her expertise in business development and creating and executing plans to generate measurable results will make her an integral part of our growing staff. Her past experience and networking skills will provide indispensable insight that will significantly help as we develop and expand our enterprise solutions.”

To learn more, please visit www.thepulsenetwork.com

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Max Sound Corp. (MAXD) Strengthens Corporate Communications with Engagement of DTG

Max Sound Corp. today announces that it has engaged the investor relations (IR) and social media relation services (SMR) of DreamTeamGroup (DTG). Leveraging a network of investor-oriented sites and full team of dedicated professionals, DTG broadens the influence of publicly traded companies and enhances their ability to attract growth capital as well as improve shareholder value.

“MAX-D has fashioned a unique and cutting-edge intellectual property portfolio reflecting years of diligent research and development,” stated Sherri S. Franklin, Director of Marketing at DTG. “We understand MAX-D’s mission is to capture its share of the advancing digital market, and our aim is to assist the company in extending its reach among the investment community, while it pursues numerous multi-million dollar opportunities in the industry.”

John Blaisure, President and CEO of MAX-D, stated, “By engaging a full-service investor relations firm, we are positioned to benefit from a powerful investor relations campaign and enhanced our social media communications strategy. This not only supports our short and long-term growth initiatives, but also greatly increases shareholder value and engagement. DTG is providing a much needed service in the small-cap markets.”

For more information, visit www.MAXD.QualityStocks.net

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Thursday, August 8, 2013

Mabwe Minerals, Inc. (MBMI): 2 New Key Alliances Create Strategic Network for Barite Distribution

Mabwe Minerals, a natural resources company engaged in the mining and commercial sales of industrial minerals and metals, has entered into strategic partnerships with both Steinbock Minerals Limited and Yasheya Limited, successfully establishing its distribution, sales, shipment, and delivery network.

“Both Steinbock Minerals and Yasheya have established, long-term relationships throughout the industrial minerals sector. They are a welcomed addition to our network of strategic partners as we start ramping up production at Dodge Mine,” Al Pietrangelo, CEO of Mabwe Minerals, stated in the press release. “We look forward to providing our shareholders with pending updates through our corporate newsletters.”

WGB Kinsey & Company, MBMI’s minority owned mining & construction company, is currently on site at the Dodge Mine project, engaged in barite production. MBMI is responsible for managing MBMI’s Shamva Rail Depot transfer yard, where MBMI has secured exclusive load rights from the Shamva Rail Depot direct to the Port of Beria utilizing their fleet of rail wagons.

Switzerland-based Steinbock Minerals will operate as the distributor and sales arm for MBMI, leveraging its expertise in the worldwide distribution of industrial minerals, with first focus on barite. As a key distributor in the industrial minerals’ sector, Steinbock Minerals has established an international reach with customers throughout Europe and the Middle East and long-term relationships throughout the oil and gas drilling sector.

“We have no shortage of barite customers who are in need of high quality barite as seen at Dodge Mine,” David Coplet, president of Steinbock Minerals stated. “On behalf of Steinbock Minerals, we are pleased to be part of the Mabwe Minerals team and look forward to helping them bring a new barite source into commercial production to satisfy the high demand.”

Yasheya will be the MBMI’s shipping and delivery arm as it is a globally recognized leader in the transport of industrial minerals specializing in ocean shipping, containers, coasters, barging, railing, trucking, and warehousing.

Abel Coplet, CEO of Yasheya, stated, “With our strategic alliances in place, we are excited to add the Port of Beira into our network of ports servicing the industry’s need for high-grade barite. Our company prides itself in the importance of establishing strong alliances. Mabwe Minerals is our newest strategic partner and we are excited to join forces.”

Raptor Resources Holdings Inc. (OTCQB: RRHI) is the parent/holding company of Mabwe Minerals. For more information visit www.RaptorResourcesHoldings.com

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Smack Sportswear (SMAK) and Phiten USA Team Up to Provide High-Tech Sports Apparel Line

Today, athletic apparel brand Smack Sportswear announced that it has signed a partnership agreement with Phiten, innovator of titanium necklace and precious metal-infused sports accessories. The agreement marks the first exclusive license any company has had in combine Phiten’s AQUA-METAL™ technology with its clothing.

“We are excited to partner with Smack,” said Joe Furuhata, Phiten USA’s Vice-President. “Smack is an accomplished brand and we have great trust in their ability to create quality products with our technology.”

Made with high-end fabrics, Smack’s new “Phitenized” line will range in price from $39.99 – $89.99 USD and will be available in three categories: Beach, Team, and Core Performance apparel. The garments will feature Phiten’s AQUA-METAL technology, which involves microscopic metals broken down into microscopic particles. The moisture wicking technology and other high-tech properties help athletes excel during physical activity and also support a healthy and active lifestyle.

“Phiten’s accessories are worn by thousands of professional athletes worldwide to help them perform at a higher level,” said Bill Sigler, CEO of Smack Sportswear. “With Phiten as our partner, we have a chance to introduce the most innovative technology into fabric since moisture wicking was introduced in the 90′s. It could revolutionize the industry.”

Smack plans to launch its volleyball apparel first, but will expand the offerings to other sports such as baseball, softball, and soccer. Distribution will primarily be through team dealers and retail chains. Smack will launch a Kickstarter campaign in late August 2013 to expand the line’s production, promotions, and distribution.

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