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CorMedix, Inc. (CRMD) Building Shareholder Value through Development and Commercialization of Neutrolin®

CorMedix, Inc. (NYSE MKT: CRMD) is a commercial-stage biopharmaceutical company seeking to in-license, develop and commercialize therapeutic products for the prevention and treatment of cardiac, renal and infectious diseases. The company’s first commercial product, Neutrolin®, is currently marketed in Europe as a catheter lock solution for the prevention of catheter-related bloodstream infections in hemodialysis, oncology and critical care patients. In the coming months, CorMedix plans to expand commercial distribution of Neutrolin into the United States, Asia, the Middle East, South America and Africa following appropriate regulatory approval.

In June, CorMedix took a significant step toward the eventual commercialization of its innovative product in the United States when it received positive feedback from the FDA regarding a second pivotal clinical trial protocol. This protocol is designed to assess Neutrolin as a catheter lock solution in oncology patients who require total parental nutrition. Previously, the FDA also reviewed the company’s phase III clinical trial protocol to evaluate the use of Neutrolin in hemodialysis patients. With this feedback received, CorMedix expects to initiate the corresponding clinical trials in the fourth quarter of this year. Since the company’s product received fast track designation earlier this year, these trials will be eligible for priority review of FDA submissions and accelerated clinical results in the future.

“CorMedix is thankful for the valuable feedback provided by the FDA, and we are encouraged by their continued enthusiasm and support of Neutrolin,” Randy Milby, chief executive officer of CorMedix, stated in a news release. “We are optimistic that this trial will further our efforts to bring Neutrolin to market in the United States so that more patients can benefit from its use.”

Following FDA approval, Neutrolin will provide CorMedix with access to an underserved market within the biopharmaceutical industry. According to the company’s data, central venous catheters are the most frequent cause of healthcare-associated bloodstream infections, accounting for approximately 25 percent of the 1.7 million recorded hospital infections each year. Among these infections, approximately 20 percent are fatal, further demonstrated the immense market potential of the company’s product.

For prospective shareholders, CorMedix’s continued progress toward commercialization of Neutrolin in the United States could foreshadow an opportunity for the company to realize strong financial growth in the months to come. Look for CorMedix to continue preparing for the initiation of two phase III clinical trials moving forward.

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Venaxis, Inc. (APPY) Developing Cost-Effective Alternative to Current Diagnostic Solutions for Appendicitis

Venaxis, Inc. (NASDAQ: APPY) is an in vitro diagnostic company focused on the development and commercialization of its leading product candidate, the APPY1™ Test. This novel blood-based diagnostic test is designed to aid in the evaluation of patients at low risk for acute appendicitis, allowing physicians to more effectively manage the large number of children and adolescents who enter hospital emergency departments with abdominal pain. Currently, determining if a patient requires emergency surgery for appendicitis normally requires diagnostic CT imaging, which is both expensive and time-intensive. In cases where imaging capacity is limited, patients are often admitted to the hospital in order to avoid the risk of appendicitis rupture at home, which adds significant cost for both patients and hospitals.

When fully commercialized, the APPY1 Test will provide physicians with a more cost-effective approach to diagnosing appendicitis. According to the Centers for Disease Control and Prevention, physicians ordered an estimated 7.5 million blood tests for abdominal pain in 2010, and approximately one million were performed on patients less than 21 years old. Statistically, these young patients have the highest risk of long-term health effects resulting from CT imaging. For this reason, Venaxis is initially developing the APPY1 Test for pediatric, adolescent and young adult patients.

In January, the FDA determined that the Appy1 Test did not meet the criteria for substantial equivalence based upon data and information submitted by Venaxis. As of the company’s latest business update in June, FDA clearance process and status for the APPY1 Test was still under evaluation. However, Venaxis is continuing to advance toward the commercialization of its innovative product through a limited launch in select European countries scheduled to begin in the coming months.

“The FDA decision is very disappointing,” Steve Lundy, president and chief executive officer of Venaxis, stated in a January news release. “We believe that the strong clinical trial results we achieved and the additional clinical utility information we provided to the FDA in response to its requests for additional information were compelling, and we intend to continue to work with the FDA to advance the progress of a blood-based diagnostic test to assist in the evaluation of appendicitis.”

Despite beginning the year with a disappointing FDA ruling, Venaxis has made significant strides toward improved financial results through the continued development of the APPY1 Test. For prospective shareholders, Venaxis’s unwavering commitment to the development of innovative alternatives to current appendicitis diagnostic techniques could provide a platform upon which to realize sustainable returns in the years to come.

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ClearSign Combustion Corp. (CLIR) Demonstrates Strong Performance and Efficiency Benefits of Innovative Platform Technologies

ClearSign Combustion Corp. (NASDAQ: CLIR) designs, develops and markets technologies that improve key performance characteristics of combustion systems – including emissions and operational performance, energy efficiency and overall cost-effectiveness. The company’s patent-pending Duplex™ and Electrodynamic Combustion Control™ (ECC) platform technologies are designed to dramatically improve the performance of the world’s commercial, industrial and utility combustion systems. By providing simple retrofit strategies that are utilized during combustion, ClearSign allows its customers to optimize performance at a fraction of the cost of more common legacy after-treatment methods.

The potential market for ClearSign’s products is immense. Nearly two-thirds of global energy consumption can be attributed to the combustion of hydrocarbons and other fuels in boilers, furnaces, kilns and turbines. In the United States, these power generating processes account for more than 50 quadrillion British thermal units (BTUs) of energy each year. As a result of this scale, even modest increases in efficiency can lead to massive savings across a broad range of markets – including the chemical, petrochemical, refinery, power and commercial boiler industries.

In the first quarter of 2015, ClearSign achieved several significant commercial milestones that could set the stage for considerable industry growth in the future. In particular, the company validated the effectiveness of its Duplex technology by demonstrating a meaningful reduction in energy consumption in a field demonstration at Aera Energy in California. Following these results, the company was invited to present its technical results to environmental regulators in Texas, providing a platform upon which to expand its market share in the Lone Star State, which currently refines more than one quarter of the nation’s gasoline. The company also presented its technology to experts from the American Petroleum Institute (API) in April.

“The refinery and petrochemical segment is a significant market opportunity for ClearSign,” Steve Pirnat, chairman and chief executive officer of ClearSign, stated in a news release. “We are very encouraged by the positive feedback we received from the API membership and also believe that successful installations at the two refinery projects already in our trial order backlog will build further confidence and interest in Duplex technology for refinery applications.”

For prospective investors, ClearSign’s recent progress toward industry growth could foreshadow an opportunity for the company to realize improved financial results in the months to come. Look for ClearSign to leverage the strong performance of its proprietary technologies in order to promote sustainable returns moving forward.

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Advanced Photonix, Inc. (API) Merges with Luna Innovations, Inc. (LUNA) to Promote Industry Growth

Advanced Photonix, Inc. (NYSE MKT: API) is a leading supplier of optoelectronic sensors, devices and instruments used by original equipment manufacturers in vital markets around the globe. The company offers three innovative product lines designed to meet the needs of clients across a collection of industries. The Optosolutions line enables the measurement of physical color, including temperature, particular counting, color and fluorescence, for medical and process control applications. API’s high-speed optical receiver (HSOR) products are most commonly used by the telecommunications market in the manufacture of market-specific equipment. The terahertz sensor product line provides nondestructive testing and measurement of subsurface physical properties for the industrial process control market.

In February, API announced an agreement with Luna Innovations, Inc. (NASDAQ: LUNA) to merge the two companies. Founded in 1990, Luna researches, develops and commercializes innovative technologies that drive breakthroughs in a diverse collection of markets – including aerospace, automotive, energy, defense, healthcare and telecommunications.

The combined company, which will maintain the Luna name, is expected to provide a broader market base and a strong balance sheet, along with an opportunity to capitalize on potential operating synergies. When completed, the merger situated the company in a fundamentally improved position to realize financial growth through the utilization of a combined intellectual property portfolio featuring over 200 patents and patent application.

“This merger has created a company with a stronger position as a leader in optical technology and provides improved opportunities for accelerated growth,” My Chung, president and chief executive officer of Luna, stated in a news release. “We look forward to working with the talented team at API as we build a dynamic company with even greater potential.”

At the closing of the merger, API stockholders received shares of Luna common stock at a ratio of 0.31782 shares for each owned share of API common stock. According to a Luna news release, the merger received overwhelmingly positive response from shareholders of both companies. For prospective investors, the broadened industry presence of the combined company could provide a platform upon which to realize strong returns moving forward. Look for API and Luna to leverage their combined strengths in order to promote sustainable market growth in the years to come.

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LightPath Technologies, Inc. (LPTH) Strategically Positioned to Capitalize on Rising Demand for Infrared Components

LightPath Technologies, Inc. (NASDAQ: LPTH) is a recognized leader in optics and photonics solutions, serving blue chip customers in the industrial, defense, telecommunications, testing and measurement, and medical industries for over a quarter of a century. The company designs, manufactures and distributes a full range of optical and infrared (IR) components for direct sale to customers throughout North America and China, as well as through distributors and channel partners in Europe and the United States. LightPath’s current product offerings include molded glass aspheric lenses and assemblies, IR lenses and thermal imaging assemblies, fused fiber collimators and gradient index GRADIUM® lenses.

In recent weeks, LightPath has taken strides toward expanding its market share through the continued development and commercialization of its innovative IR product line. The potential applications for the company’s IR technology are plentiful – including small hand-held cameras for thermography, maintenance and security applications, in-process quality assurance monitoring, and medical sensing devices. In June, LightPath highlighted one pivotal application when it partnered with a leading supplier of integrated products and technologies to supply its proprietary IR molded optics for use in the manufacture of firefighting thermal imaging cameras. In total, the company’s IR products currently account for more than 10 percent of its consolidated annualized revenues.

“We are extremely excited by the growth in market opportunities of our infrared product line,” Jim Gaynor, president and chief executive offer of LightPath, stated in a news release. “The launch of our proprietary infrared product technologies positions us to participate in an estimated $3.5 billion global market… that will contribute to revenue growth for LightPath.”

During its fiscal quarter ending March 31, 2015, LightPath provided prospective investors with a preview of its massive market potential by posting strong financial results. In addition to recording a 193 percent year-over-year increase in revenue from the sales of IR products, the company realized a six percent year-over-year rise in overall revenue. These results helped LightPath record a net income for the period of approximately $90,000.

“We had an excellent fiscal 2015 third quarter that reflects the actions taken in the first half of the year to accelerate sales and improve our operating efficiency,” continued Gaynor. “We are benefitting from growth in both our precision molded optic product line and infrared product line and operational efficiencies to drive improved profitability.”

With growing demand for its IR product line leading the way, LightPath is in a strong strategic position to build upon its industry presence moving forward. For potential investors, the company’s recent financial growth could foreshadow an opportunity to capitalize on sustainable returns in the years to come.

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SofTech, Inc. (SOFT) Promoting Enhanced Productivity through Development of Innovative Product Lifecycle Management Solutions

SofTech, Inc. (OTCQB: SOFT) enhances customer productivity and promotes profitability through the development, marketing and distribution of computer software solutions for the product lifecycle management (PLM) industry. In particular, the company’s proprietary ProductCenter® PLM solution enables users to automate product data and lifecycle processes, allowing for streamlined management of product development from concept to commercialization and beyond. Currently, over 100,000 users benefit from SofTech’s innovative portfolio of software solutions and services, including employees of General Electric Company (GE), Goodrich, Honeywell (HON), AgustaWestland and the U.S. Army.

In recent months, SofTech has leveraged the marketability of its PLM solutions to record strong financial results. Despite a year-over-year decrease in total revenues following the sale of its CADRA product line, the company recorded a 20.5 percent year-over-year increase in ProductCenter revenue in the fiscal quarter ending February 28, 2015, as two of the company’s existing customers significantly escalated their usage of the product. Moving forward, SofTech will look to build on this progress by expanding its industry reach.

“The sale of the CADRA product line in 2014 provided the capital and the flexibility for us to make a significant current year investment in the development of a new PLM-based product aimed at the consumer market,” Joe Mullaney, chief executive officer of SofTech, stated in a news release. “We believe this product has the potential to get SofTech on a revenue growth path, an essential element of shareholder value enhancement.”

Through the continued expansion of its portfolio, SofTech could be in a strong position to capitalize on the growth of the PLM industry in the years to come. According to a report by Transparency Market Research, the global PLM market is expected to grow at a compound annual growth rate of 8.1 percent from 2015 to 2022, reaching a market value of more than $75.8 billion by the end of the period. Rising demand for product innovation and enhanced productivity are expected to dramatically increase the deployment of PLM solutions in non-traditional end-use sectors, including consumer products and retail.

With over 45 years of industry experience, SofTech is an established player in the expanding PLM industry. Look for the company to leverage this positioning in order to promote continued adoption of its ProductCenter solution and prepare for the commercial launch of its groundbreaking consumer market-centric product in the coming weeks.

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ContraVir Pharmaceuticals, Inc. (CTRV) Addressing Underserved Market Segments through Development of Advanced Product Candidates

ContraVir Pharmaceuticals, Inc. (NASDAQ: CTRV) is a biopharmaceutical company focused on the development of targeted antiviral therapies. The company’s leading product candidate, FV-100, is currently in phase III clinical development for the treatment of shingles, as well as for the prevention of debilitating shingles-associated pain known as post-herpetic neuralgia (PHN). Additionally, ContraVir’s product pipeline includes CMX157, which is scheduled to be evaluated in a phase II clinical study for the treatment of hepatitis B virus in the coming months.

While there are already antivirals approved to treat the viral infection underlying shingles, there are currently no approved antiviral therapies for the prevention of PGN. According to a report by the National Institute of Health, an estimated one million Americans suffer from shingles each year, and more than 65 percent of those individuals suffer from PHN for 30 days or more. In some cases, PHN symptoms can persist for well over two years if left untreated. Through the eventual commercialization of FV-100, ContraVir will gain access to this critically underserved market segment within the biopharmaceutical industry. In clinical trials, FV-100 demonstrated a clinically meaningful 37 percent reduction in the incidence of PHN versus the current standard of care.

In addition to FV-100, the company continues to make clinical progress with CMX157. In June, ContraVir took a major step in the development of CMX157 by partnering with the Baruch S. Blumberg Institute, the non-profit research sister organization of the Hepatitis B Foundation, to conduct a series of experiments with the company’s drug candidate. Specifically, these tests will focus on comparing the relative anti-hepatitis B activities of CMX157 with those of tenofovir, the current standard of care, in order to determine if the candidate has unique attributes not previously appreciated of other antiviral agents.

“The Blumberg Institute’s commitment to advancing new therapies for hepatitis B make them an ideal research and development vehicle for ContraVir,” James Sapirstein, chief executive officer of ContraVir, stated in a news release. “This association will help advance our CMX157 candidate and may further de-risk the development process going forward, as we prepare to enter phase II clinical studies.”

For prospective shareholders, ContraVir’s considerable developmental progress could foreshadow an opportunity to realize sustainable returns moving forward. Following its uplisting to the NASDAQ Capital Market earlier this year, the company is in a strong strategic position to capitalize on improved visibility in the coming months. Look for ContraVir to leverage the opportunities presented by this visibility in order to optimize market growth as it continues toward the commercialization of its advanced product pipeline.

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Neptune Technologies & Bioressources, Inc. (NEPT) Building Shareholder Value through Sustainable Krill Oil Production

Neptune Technologies & Bioressources, Inc. (NASDAQ: NEPT) is a biotechnology company focused on the development and commercialization of products derived from marine biomasses for the nutraceutical and pharmaceutical industries. Leveraging a patented extraction process, the company produces nutrient-rich oils from Antarctic krill, which provide the foundation for its business dealings. Following extraction, Neptune principally sells its krill oils under the NKO® brand through a network of distributors doing business in the U.S., European and Australian nutraceutical markets.

Since bringing its first krill oil product to market in 2003, Neptune has taken significant steps toward increasing its market share in the global nutraceutical industry. The company’s proprietary extraction process allows it to produce an oil with superior levels of EPA, DHA and antioxidants, as compared to other krill oils. As a result, NKO products provide broad, clinically proven support for a collection of health issues. In 2014, Neptune expanded on these benefits by introducing three condition-specific oil blends – including NKO Beat, NKO Focus and NKO Flex – specially formulated to support heart, brain and joint health, respectively.

Last year, Neptune set the stage for continued market growth by launching operations at its new manufacturing facility in Sherbrooke, Quebec. The company’s new plant provides it with the means to address manufacturing challenges unique to krill oil production, affording Neptune an opportunity to optimize operational efficiency while promoting sustainable financial growth. The new facility currently has an annual krill oil production capacity of 150 metric tons, and the company has indicated that expansion efforts could double this capacity in the future.

“Our business has a solid foundation, built on science, intellectual property and entrepreneurship,” Jim Hamilton, president and chief executive officer of Neptune, stated in a news release. “Our key priority is to optimize our plant’s utilization, while producing the industry benchmark krill oil, NKO.”

In the first quarter of 2015, Neptune built on its recent progress by recording strong financial results. In addition to realizing a 10 percent year-over-year increase in revenue for the period, the company made significant headway toward continued improvement by streamlining production processes. For prospective shareholders, these efforts could foreshadow an opportunity to realize considerable returns in the years to come. Look for Neptune to continue expanding its effective production capacity in line with increasing commercial demand moving forward.

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Tonix Pharmaceuticals Holding Corp. (TNXP) Addressing Underserved Therapeutic Indications with Three Ongoing Clinical Studies

Tonix Pharmaceuticals is a clinical-stage pharmaceutical company focused on the development of next-generation medications for disorders of the central nervous system. The company’s leading product candidate, Tonmya, is currently being evaluated in a phase III clinical study for the treatment of fibromyalgia, as well as a phase II clinical study for the treatment of post-traumatic stress disorder. Additionally, Tonix’s product pipeline includes TNX-201, which is currently being studied in a phase II proof-of-concept trial for the treatment of episodic tension-type headaches.

“Having three large, adequate and well-controlled clinical studies in high-value therapeutic indications simultaneously ongoing validates our business model of developing next generation medicines for significant unmet needs in a capital-efficient manner,” Dr. Seth Lederman, chairman and chief executive officer of Tonix, stated in a news release.

When commercialized for the treatment of fibromyalgia, Tonmya will give Tonix access to a large and relatively underserved market within the pharmaceutical industry. According to the Centers for Disease Control and Prevention, fibromyalgia affects an estimated five million Americans. Recent evidence suggests that poor sleep quality likely plays a fundamental role in the development and persistence of the disorder, which is characterized by chronic widespread pain and abnormal pain processing. Tonmya addresses this issue by performing as a low-dose sleep aid to improve quality of rest, effectively minimizing the effects of fibromyalgia symptoms. Top-line data from the company’s ongoing clinical study is expected in the second half of 2016.

In June, Tonix substantially increased its potential for short-term growth within the pharmaceutical industry by initiating its phase II study of TNX-201. Designed to establish efficacy and safety evidence to support future studies, the results of this trial could clear the way for the continued development of the first new prescription pharmaceutical approved to treat episodic tension-type headaches in more than 40 years.

“Approximately 75 million people in the U.S. suffer from frequent episodic tension-type headache, a condition that is estimated to be three times as prevalent as migraine,” continued Lederman. “If approved by the FDA, TNX-201 may become the only non-narcotic prescription medicine for episodic tension-type headache.”

Moving forward, Tonix’s promising product pipeline could provide a formidable platform for the company to realize tremendous market growth. For prospective shareholders, the company’s ongoing clinical trials and the immense market potential of its drug candidates combine to make Tonix an intriguing investment opportunity in the months to come.

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Sonus Networks, Inc. (SONS) Leveraging Innovative Technological Solutions to Increase Presence in Evolving Communications Industry

Sonus Networks enables and secures real-time communications that allow the world’s leading service providers and enterprises to embrace the next generation of session initiated protocol (SIP) and 4G/VoLTE solutions – including voice over IP (VoIP), video, instant messaging and online collaboration. With nearly two decades of industry experience, the company provides a complete portfolio of hardware-based and virtualized session border controllers (SBCs), diameter signaling controllers (DSCs), policy/routing servers and media and signaling gateways to customers in nearly 100 countries around the globe.

Since being founded in 1997, Sonus has increased its market presence by successfully evolving to meet the demands of the communications industry. In 2014, the company built on this proven strategy through the launch of its SBC 7000. Utilizing a transcoding firmware with nearly double the capacity of competitive systems, this purpose-built platform is capable of licensing up to 150,000 sessions for secure, reliable delivery of multimedia services in the world’s largest communications networks. Through the commercialization of this product, Sonus provides its clients with the means for streamlined expansion of operational capacity in order to effectively accommodate rapid customer growth.

“Service providers today are facing insatiable demand for multimedia communications applications – voice, video and data – and many of them are struggling with how to meet this demand,” David Tipping, vice president of Sonus, stated in a news release. “Sonus now offers a disruptive platform that resets service providers’ expectations for real-time dependent sessions with scale.”

This dedication to scale could pay dividends for Sonus in the future. According to a report by IBISWorld, VoIP has experienced massive growth over the past five years in both commercial and residential applications. From 2010 to 2015, the overall market recorded annual growth of 17.5 percent. Moving forward, increased network capacity will be essential, as the continued expansion of 4G data networks will likely propel accelerated adoption of real-time communication solutions in the years to come.

Despite recording mildly disappointing financial results in the first quarter of 2015, Sonus remains in a strong competitive position to capitalize on the inevitable technological shift of the communications industry. For prospective investors, the company’s persistent commitment to innovative technologies, along with its recent efforts to optimize its cost structure, could provide a platform to realize improved returns in the months ahead.

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