Category Archives: Stocks to Watch

DelMar Pharmaceuticals (NASDAQ: DMPI) Given a ‘Buy’ Rating and $16 Price Target by Aegis Capital

January 13, 2017

Biotechnology company DelMar Pharmaceuticals (NASDAQ: DMPI) has been given a ‘Buy’ rating by Aegis Capital Corp. and a $16 price target (http://dtn.fm/jZlI7). The company was trading at $3.29 on January 11, 2016. To reach that price target, Aegis, in its initiation of coverage, said that it applied a 15x multiple after estimating the company’s 2022 EPS at $3.93, then discounting it by 30%.

DelMar Pharmaceuticals has been developing its lead product candidate, VAL-083, as a chemotherapy for cancer. Specifically, VAL-083 would be used in the treatment of glioblastoma multiforme (GBM), the most common form of a fatal and aggressive brain cancer. VAL-083 is a very different drug from other cancer medications. It avoids the repair activities that enable tumor cells to impede the impact of chemotherapy.

As a result, DelMar has an upcoming phase III trial in refractory GBM and two additional phase II studies anticipated to begin this year. VAL-083 will also be tested in the treatment of solid tumors and lung cancer, with phase I and II trials anticipated in 2017, the report stated. The report was signed by Robert LeBoyer, research analyst at Aegis, who added that Aegis expects DelMar Pharmaceuticals “to be driven” by these trials.

In its report, Aegis said that the phase III study is expected in late 1Q17 and should take place at major medicine centers, aiding enrollment. Further, it said that the Food & Drug Administration (FDA) believes that only one phase III study will be required for VAL-083, following its assessment of the results of completed phase I and II studies.

In 2016, DelMar completed its phase I/II trials of VAL-083, the report stated, and then met with the FDA. The FDA agreed that only one phase III trial would be necessary, because the company would then use a 505(b)(2) regulatory pathway. Aegis notes that this was a ‘significant development’, which may mean phase III results as early as 2019 ahead of approval in 2020.

On January 9, 2017, DelMar Pharmaceuticals received an increase in funding of up to CDN$413,000 from the National Research Council of Canada Industrial Research Assistance Program (NCR-IRAP) to support ongoing research of VAL-083 (http://dtn.fm/iWzk2). In conjunction with the BC Cancer Agency, Vancouver Prostate Centre and the University of British Columbia, research will continue, DelMar Pharmaceuticals announced.

“We are very pleased with NCR-IRAP’s continued support of our non-clinical research of our lead product candidate VAL-083,” Jeffrey Bacha, chairman and CEO of DelMar Pharmaceuticals, noted in the news release.

In its most recent 10-Q filing, DelMar Pharmaceuticals reported cash and cash equivalents of $4,799,033 (http://dtn.fm/5qecY). For the quarter ended June 30, 2016, the company reported to the SEC that it had raised $7.2 million from the sale of convertible preferred stock.

For more information, visit www.DelMarPharma.com

MassRoots, Inc. (MSRT) Achieves Incredible Growth in 2016

MassRoots, Inc. (OTCQB: MSRT), a company offering cannabis enthusiasts the chance to share their cannabis content while staying connected with news and the latest legislation regarding the drug through a specialized social media platform and iOS application, has shown significant growth in the rapidly developing cannabis industry.

According to a SeeThruEquity update (http://dtn.fm/Y0Har), MassRoots achieved phenomenal growth in 2016, with revenue reaching $794,621 during the first three quarters of 2016, compared to just $63,982 during the same period of the previous year. This performance was attributed to the company’s ability to monetize its users, which increased by 1,140% as compared to the first three quarters of 2015.

The company now has a fan base of over 900,000 users and plans to introduce a range of new features to its platform, fully indexing the network’s public content on Google for search engine optimization purposes. Earlier this week, MassRoots launched an update to its iOS mobile application (http://dtn.fm/W8YeE), which is currently available through the App store. New features include geo-targeted advertisements, in-depth strain and product pages, and revamped reporting and content screening mechanisms.

In addition, MassRoots kicked off 2017 by achieving its strongest cash position in corporate history following the reception of $2 million in proceeds from the exercise of warrants (http://dtn.fm/bUC0G). According to CEO Isaac Dietrich, this capital infusion will allow MassRoots to continue building momentum in the industry. Dietrich has set an intermediate goal of reaching revenue levels similar to industry leaders such as Weedmaps and Leafly, which generated more than $25 million and $15 million in 2016 sales, respectively.

MassRoots’ substantial 2016 growth seems to be widely supported by strong industry trends. With eight states having legalized the recreational use of marijuana, MassRoots is positioned for growth, anticipating an increase in users from a number of states. Currently, the company receives three-quarters of its revenue from California and Colorado, but new markets are expected to emerge.

MassRoots also recently acquired DDDigtal, known as Whaxy, a menu management and online ordering platform for licensed cannabis businesses. In a news release announcing the acquisition (http://dtn.fm/zLsj0), Isaac Dietrich commented, “This acquisition, when completed, will expand MassRoots’ offerings to include a full suite of dispensary software solutions – online ordering, marketing, and real-time inventory management — for cannabis businesses”.

For more information, visit www.MassRoots.com

ChineseInvestors.com, Inc. (CIIX) Offers Unique Path to Global Chinese Investor and Consumer Market

January 12, 2017

Founded in 1999, and with offices in the U.S. and China, ChineseInvestors.com, Inc. (OTCQB: CIIX) acts as a growing Chinese-language investment information and services conduit to the global Chinese investor community. Primarily through its websites, the company provides different levels of investment information, both free and via subscription, including information on the U.S. market and foreign currencies, covering sectors as well as companies, real-time market news and analysis, quotes, charts, and research tools. The company is led by chairman and CEO Warren Wang, COO Brett Roper, CFO Paul Dickman, and Director James Toreson.

The company’s stated mission is to ‘educate and empower individual investors to make their own financial decisions and to achieve their financial goals at any time or place’. Its focus is on what is called the ‘ChineseInvestors Method’, a combination of technical tools, a disciplined investing process, and personalized instruction. It’s an approach that the company’s leadership team hopes to establish as the most widely recognized and used system for educated investing.

In addition, the company offers consulting services to private companies seeking to become public companies, along with advertising and public relations support. Among other things, this provides a unique opportunity for growing companies to reach the large and diverse Chinese investment community, both in the U.S. and globally.

Recently, the company announced (http://dtn.fm/JhZ83) plans to launch the world’s first online cannabidiol (CBD) health products store in the Chinese language, using the domain name of www.ChineseCBDoil.com. Through an agreement with a ‘well-known’ CBD health brand, CIIX will be able to retail nutritional CBD supplements, through both physical and online channels, to the Asian market. China alone has nearly 10 million epilepsy patients, with CBD oil seen as a desired treatment option.

For more information, visit the company’s website at http://www.chinesefn.com/english/indexen.asp

Cytosorbents Corp. (NASDAQ: CTSO) Expected to Announce Doubling in Sales for 2016

January 11, 2017

Cytosorbents Corp. (NASDAQ: CTSO), a critical care-focused immunotherapy company engaged in the research, development, and commercialization of medical devices, most prominently its platform blood purification technology that incorporates a proprietary adsorbent polymer technology, recently pre-announced unaudited results (http://dtn.fm/bKG3F) for fiscal 2016 ahead of its Form 10-K filing.

Cytosorbents expects to announce between $8.1 and $8.3 million in Cytosorb sales for the whole of 2016. This equates to more than double the total from the previous year. Cytosorb is the company’s flagship product, a blood filter that helps treat deadly inflammation in critically-ill and cardiac surgery patients across the globe.

In addition to this, the company predicts product sales for the fourth quarter of 2016 to range between $2.5 and $2.7 million, compared to just $1.5 million during the fourth quarter of 2015. This will take Cytosorbents to its sixth consecutive quarter reporting record sales, with the result representing a 20% increase as compared to the third quarter of 2016.

Cytosorbents Corp. had its ‘Buy’ rating reaffirmed by equities and research analysts at HC Wainwright, B. Riley, Maxim Group, Brean Capital, and Aegis Capital Corp., all according to Daily Quint (http://dtn.fm/80qqY). Currently, the consensus target price for the company is $15.05 per share. Not only this, Advisor Group, Inc. raised its position in Cytosorbents’ stock by over 1% during the third quarter, giving it ownership of 1.20% of the company’s stock worth over $1.9 million. To view the latest Aegis update, visit http://dtn.fm/YMJf3.

Cytosorbents Corp. also announced that it is expanding its partnership with Fresenius Medical Care (FMC) (http://dtn.fm/biF1L), the world’s largest dialysis company, increasing the commitment to a three-year renewal and a guaranteed minimum order of Cytosorb. The expansion also includes the addition of a new co-marketing agreement for worldwide Cytosorb markets.

For more information, visit www.Cytosorbents.com

Aegis Restates ‘Buy’ Rating on Shares of Rosetta Genomics Ltd. (NASDAQ: ROSG)

Rosetta Genomics, Ltd. (NASDAQ: ROSG), a company in the business of developing and commercializing MicroRNA-based and other molecular diagnostics, recently had its ‘Buy’ rating restated by Aegis Capital Corp. (http://dtn.fm/l0Yk0) with a price target of $3.50 per share. This was based on Aegis’ 2017 revenue estimate of $17.7 million with a multiple of 4X. The company update was released after Rosetta Genomics Ltd. announced a new collaboration to determine biomarkers that can predict response to Opdivo, a PD-1 immunotherapy.

In addition to the above, Aegis Capital Corp. announced expectations for Rosetta Genomics’ cash deliverables to be over $9 million by the end of this year after the company completed a financing with stock and convertible debentures of approximately $5 million. This is accompanied by the fact that Rosetta Genomics continues to expand its portfolio of diagnostic tests through collaborations, allowing it to grow its business and expand its client base.

The company reported an increase in revenue from $2.3 million in 1H15 to $5 million during the first six months of 2016. This has been put down to a growing demand for RosettaGX Reveal for thyroid, for which revenues were expected to reach approximately $1.5 million by the end of September 30, 2016, according to the report. Not only this, total expenses were lower than Aegis’ estimates, showcasing the company’s ability to efficiently manage its cash.

Since Aegis initiated coverage on Rosetta Genomics, the company has grown from a single diagnostic to a portfolio covering solid tumors, urology, and thyroid cancer. Aegis estimates the company’s product revenue to be $10.8 million for the full year with allowance for variations in revenue recognition and COGS, which is currently estimated at 85% of the revenue level seen in previous quarters.

Aside from the company’s ability to continue to make progress in product development, sales growth, and financial advancements, Aegis expects Rosetta to continue to increase its sales and customer base. According to Community Financial News (http://dtn.fm/xES6P), institutional investor Morgan Stanley recently increased its stake in Rosetta Genomics Ltd. by 15%, giving it ownership of just under 338,000 shares of the company’s stock. Hedge funds and institutional investors now own just below 4.3% of the company’s stock.

For more information, visit www.RosettaGx.com

Trevena, Inc. (NASDAQ: TRVN) Completes Phase 3 Apollo Trials for Oliceridine, Says Athena Study on Track

Trevena, Inc. (NASDAQ: TRVN), a clinical stage biopharmaceutical company, on January 4 announced it had completed enrollment for its Phase 3 Apollo Pivotal Efficacy Trials of oliceridine for moderate to severe pain.

Oliceridine (TRV 130) is Trevena’s lead product candidate. It was deemed “a breakthrough therapy by the U.S. Food and Drug Administration,” based on the results of earlier clinical trials, the company said (http://dtn.fm/5zmYr).

“We are pleased to have completed enrollment in these important studies and to confirm that the Apollo trials remain on schedule to report top-line results in the first quarter of 2017,” Maxine Gowen, Ph.D., chief executive officer of Trevena, stated in a news release. “We look forward to sharing these data when they become available.”

Trevena expects that, compared to morphine and placebo, these results will show that oliceridine shows tolerability, safety and efficacy. Additionally, Trevena announced that patient enrollment for its Phase 3 Athena safety study is on track.

The company noted plans to file a New Drug Application (NDA) for oliceridine with the U.S. Food & Drug Administration in the second half of this year.

Trevena also has a portfolio, in the early stages, of more drug discovery programs. The company has also discovered additional drugs, such as TRV027 for acute heart failure, TRV734 for pain and TRV250 for migraine.

In its 10-Q Securities and Exchange Commission filing for November 2016, Trevena reported revenues of $3.75 million for the nine-month period ended September 30, 2016 (http://dtn.fm/hf4AH). By comparison, its revenue was $4.375 million for the same period a year earlier.

In an 8-K filing on January 4, 2017, Trevena reported that its net cash on hand should fund its operations until at least March 31, 2018. The company had cash equivalents, cash and marketable securities of $110.6 million as of December 31, 2016, the report said (http://dtn.fm/6OjhM).

Earlier this month, Aegis Capital Corp. gave Trevena a ‘Buy’ rating and a target price of $14 per share (http://dtn.fm/exE4N). Differ Yang, Ph.D., research analyst, said that the target price was determined through a DCF analysis. Aegis set a seven-time multiple of the 2022 EBITDA of $168 million. Yang said Aegis further assumed a clinical success probability of 70% for Trevena’s phase III program.

The company’s share price was $6.49 at market close on January 10, 2017, and its 52-week range was $10.00 – $3.76.

For more information, visit the company’s website at www.Trevena.com

Jaguar Animal Health, Inc. (NASDAQ: JAGX) Given Company Update by Aegis Capital Corp.

January 10, 2017

Jaguar Animal Health, Inc. (NASDAQ: JAGX), a company in the business of developing and commercializing gastrointestinal products for companion animals, horses, and production animals, recently had its company outlook updated by Aegis Capital Corp. (http://dtn.fm/Phj8l). The company has been offered a ‘Buy’ rating with a price target of $10 per share. The company update was announced after JAGX made several decisions that Aegis believes could improve the outlook for the company.

The company, which is committed to identifying animal health market opportunities to develop products specific to various species, announced that it has proposed a business combination with its parent company, Napo Therapeutics, Inc., to form a single entity. This, combined with Napo’s recent reacquisition of anti-diarrhea drug crofelemer from Valeant Pharmaceuticals (NYSE: VRX), will consolidate all human and animal health operations into one company.

In addition to the above, Jaguar Animal Health, Inc. recently announced a product distribution agreement with Henry Schein, Inc. (NASDAQ: HSIC) for Neonorm Foal, a form of crofelemer used to treat newborn horses with diarrhea. This agreement will allow crofelemer to be distributed more widely thanks to Schein’s Animal Health Division, which has a client base of 26,000 veterinary professionals. Not only will the product be distributed across all segments of the U.S. equine market, but Jaguar will also be given more time to focus its efforts on developing new therapeutics.

Aegis Capital Corp. is not the only research analyst showing an interest in Jaguar Animal Health, Inc. Most recently, the company received a consensus ‘Buy’ rating, with one equity research analyst rating the stock with a ‘Buy’ recommendation and another with a ‘Strong Buy’ recommendation. According to the Cerbat Gem Market News and Analysis (http://dtn.fm/6roMM), Zacks Investment Research has assigned JAGX an industry rank of 64 out of 265, and brokers have set a price objective of $6.50 for the following 12 months. As of close of market January 9, 2016, Jaguar was trading at $0.66 per share.

For more information, visit www.JaguarAnimalHealth.com

Bovie Medical Corporation (BVX) CEO to Present at Biotech Showcase 2017

January 6, 2017

Earlier this week, Bovie Medical Corporation (NYSE MKT: BVX), a leading developer of medical devices and supplies, announced its plans to participate in the 9th Annual Biotech Showcase Conference, which is set to take place at the Hilton San Francisco Union Square from January 9-11. Robert L. Gershon, the company’s chief executive officer, is scheduled to present to investors at 11:00 am PST on Tuesday, January 10. Planned talking points include Bovie Medical’s recent activities, as well as the company’s innovative J-Plasma® surgical instrument. Additionally, Gershon is expected to present at Medtech Showcase at the Parc 55 San Francisco Hotel in Union Square on Wednesday, January 11 at 10:30 am PST.

To learn more about Biotech Showcase 2017, visit http://nnw.fm/I1blo

Bovie Medical – named for the inventor of modern electrosurgery, Dr. William T. Bovie – leverages a portfolio of proprietary technology and expertise spanning the design, development and manufacture of electrosurgical equipment to create advanced energy devices that it markets around the globe. The company maintains a number of well-respected brands, including Bovie®, Aaron®, IDS™ and ICON™, in addition to marketing its products through private labels.

J-Plasma® is Bovie Medical’s leading product. A plasma-based surgical product for cutting and coagulation, J-Plasma® combines the unique properties of cold helium plasma with RF energy to give surgeons greater precision, minimal invasiveness and an absence of potentially dangerous conductive currents through patients during surgery. To date, the product has been used successfully in a wide array of surgical procedures, such as capsular scoring, wound debridement and scar revision. J-Plasma® is still in the early stages of commercialization, according to the company’s website, but Bovie Medical believes that it has the potential to become a “transformational product for surgeons.”

In August 2016, the market potential of J-Plasma® was reaffirmed when a portion of the J-Plasma® platform was recognized as an “Innovation of the Year” by The Society of Laparoendoscopic Surgeons for the third consecutive year. The Precise 360™ hand piece, which received this year’s distinction, features an angled and rotating tip that allows surgeons to access structures that are difficult to reach with a straight laparoscopic device. In 2014, the J-Plasma® product line received the same distinction, and, in 2015, the title was given to the Bovie Ultimate™ Operating Room Generator, which combines J-Plasma® technology with the highest wattage monopolar and bipolar electrosurgical generator.

For more information, visit www.BovieMedical.com

CytoDyn Inc. (CYDY) Set to Host Conference Call on January 5, 2017

January 4, 2017

In a news release issued late Tuesday, CytoDyn Inc. (OTCQB: CYDY), a biotechnology company focused on the development of new antibody therapies for combatting human immunodeficiency virus (HIV) infection, announced that its management team will be hosting an investment community conference call on Thursday, January 5, 2017, at 4:00 pm EST.

The call is expected to feature an update on developments related to CytoDyn’s clinical and regulatory programs. The company will also be posting to its website (www.CytoDyn.com) a “Letter to Shareholders and Friends” from Nader Pourhassan Ph.D., president and CEO of CytoDyn. This letter, which will also be made available tomorrow, is expected to include a review of the company’s recent progress as well as insight into CytoDyn’s goals and milestones for the coming year.

To participate in tomorrow’s conference call, investors should dial 877-407-2986 (U.S./Canada) or 201-378-4916 (international). Alternatively, a live audio webcast may also be accessed under the Investors section/IR Calendar of CytoDyn’s corporate website. The company encourages web participants to visit its website at least 15 minutes prior to the start of the call in order to register and install any necessary software.

For those unable to attend the live call, the audio webcast will be archived for 60 days on CytoDyn’s corporate website. A replay of the conference call will also be made available until March 5, 2017. To access this replay, interested parties may dial 877-660-6853 (U.S./Canada) or 201-612-7415 (international); Conference ID: 13652328.

Tomorrow’s conference call comes less than a month after CytoDyn announced the treatment of the first several patients in its ongoing Phase 3 clinical trial of PRO 140 as a single-agent maintenance therapy in virally suppressed subjects with HIV. The new trial, which Pourhassan called “nearly a duplicate of [CytoDyn’s] Phase 2b monotherapy trial with an additional objective of investigating why some R5 patients did not respond to this therapy as well as others,” is likely to “provide essential data to support the continued clinical and regulatory advancement of PRO 140.”

Notably, data from this Phase 3 trial is expected to be submitted as part of CytoDyn’s upcoming Biologics License Application (BLA) for PRO 140 as a combination therapy with the current standard-of-care, highly active antiretroviral therapy (HAART). In addition to providing potential cost savings, this dual use of clinical data will facilitate “the fastest path to regulatory approval which is an expected submission of the rolling BLA in 2017,” according to Pourhassan.

For more information, visit www.CytoDyn.com

My Size, Inc. (NASDAQ: MYSZ) Measuring App in the Spotlight Following Partnership with Fashion Retailer Trucco

January 3, 2017

One of the biggest problems facing ecommerce – online fashion retailers, in particular – is high return rates due to the fact that purchased products aren’t always a good fit. This can apply to all kinds of items, but clothing leads the way with more than 50 percent of online purchases being returned to the vendor due to sizing or quality issues. Israel-based company My Size, Inc. (NASDAQ: MYSZ) is intent on solving this problem once and for all via an innovative suite of high-precision measurement applications that can be used in a variety of markets.

Using a unique measurement technology based on several patent-pending algorithms that calculate measurements in novel ways, the company has developed various apps designed to help users determine the correct size of virtually any everyday object, as well as their bodies and clothing. One of the most popular My Size apps is designed to help shoppers always get the right fit, no matter what kind of size charts online vendors are using. The MySizeID app utilizes smartphone sensors to determine a user’s personal measurements, which can then be stored in a secure online profile and used for any new purchase.

The app will soon become available worldwide as a direct result of a new partnership between My Size and renowned high-end fashion retailer Trucco. Based in Spain, Trucco has more than 30 years of experience in the apparel industry and is present in 20+ countries all around the globe, including markets in Europe, Asia and South America. Under the deal, the My Size measurement app will become available to Trucco’s online and offline customers beginning this spring, coinciding with the launch of a new collection. Until then, the app will undergo a testing period in the Trucco system. According to both Trucco and My Size representatives, the highly-accurate app will help customers select the right size garments on the first try, which will ultimately help improve conversion rates and significantly reduce returns.

The application is very easy to use, My Size Chief Product Officer Billy Pardo explained in a news release. Customers are only required to wave their smartphones (with the installed app) over a piece of clothing that fits just the way they like it. The app will instantly calculate the exact measurements, and the Trucco system will then recommend which size the customer should purchase, making the entire online shopping experience easier and fun, all while minimizing the risk of wasting time and money on items that are not the right fit.

In addition to the exposure it will receive due to the Trucco partnership, My Size is expected to make a strong showing at the Consumer Electronics Show (CES) in Las Vegas this month. The company will showcase its products at the Israeli Pavilion during CES 2017, with a program that will include a press conference on January 5, a market launch, contests and demonstrations. Additionally, My Size will exhibit its applications at the ShowStoppers press reception, which is also scheduled for January 5 at this year’s CES.

For more information, visit www.MySizeID.com

PixarBio Corporation (PXRB) Takes the Addiction out of Painkillers with NeuroRelease™

December 27, 2016

Remedies for pain have progressed beyond the one recommended in Shakespeare’s Romeo and Juliet, where the renowned playwright wrote, “One pain is lessened by another; catch some new infection… and the poison of the old one will die.” Today, a variety of treatment options are available to the sufferer. Alas, many of these come bundled with pernicious side effects and the risk of addiction, making the remedy, in the long term, worse than the ailment. With NeuroRelease™, Cambridge, Massachusetts-based PixarBio Corporation (OTCQX: PXRB) is offering the possibility of release not only from pain but also from dependence on painkillers.

Pain is a ubiquitous phenomenon that pervades our lives from cradle to grave. We bear its lesser manifestations with a grimace or a smile, but, in many instances, analgesics are needed to free us from the greatest torments. For centuries, extracts from opium, derived from the poppy plant, have served that purpose. Perhaps, the most significant of these extracts or alkoloids is morphine, named after Morpheus, the Greek god of dreams.

Morphine, in one form or another, has been used to ease pain since it was isolated from raw opium in 1805. Before that time, a number of preparations, such as laudanum, a solution of opium in alcohol, were employed as painkillers. Morphine is, however, treacherously addictive. Its use during the American Civil War turned large numbers of wounded veterans into addicts. This spurred the search for less addictive analgesics and the employment of weaker opiates such as codeine, which was widely used, at one time, in cough medications.

The quest for less addictive opiates, ironically, led to the discovery of more addictive ones. The German chemist, Felix Hoffman, developed heroin while working in the pharmaceutical research department of what is now Bayer AG. Bayer actually manufactured and sold bottles of heroin medicine in the first decade of the twentieth century (http://dtn.fm/Fw8dD).

In 1909, the U.S. Congress passed the Smoking Opium Exclusion Act, which banned the importation, possession and use of ‘smoking opium’. The statute still allowed for the use of opium-based ‘medications’, however. It was actually the first federal law banning the non-medical use of a substance.

Since that time, a number of FDA-approved drugs have made their appearance, including Vicodin in 1984, OxyContin in 1995 and Percocet in 1999. These are, essentially, all synthetic opiates and, like their natural cousins, are just as addictive. As a result, opioid addiction has mushroomed into a national crisis. The U.S. Department of Health and Human Services (HHS) (http://dtn.fm/2qeUg) has stated that “more people died from drug overdoses in 2014 than in any year on record, and the majority of drug overdose deaths (more than six out of ten) involved an opioid.”

This frightening scenario makes PixarBio’s NeuroRelease™ a welcome addition to the analgesic arsenal. NeuroRelease™ is a morphine replacement, non-addictive pain platform for the surgical and hospital setting, for the battlefield, and for the alleviation of acute and chronic pain in general. The first product FDA approval for the platform is expected to be a 14-day post-surgical pain treatment, and the company anticipates commercial approval for this indication in late 2018.

PixarBio is a specialty pharmaceutical and biotech company focused on pre-clinical and clinical commercial development of novel neurological drug delivery systems for post-operative pain. The company researches and develops targeted delivery systems for drugs, devices, or biologics to treat pain, epilepsy, Parkinson’s disease, and spinal cord injury. Its lead product platform, NeuroRelease™, has achieved sustained therapeutic release of non-opiate drugs for post-operative, acute and chronic pain in pre-clinical models.

For more information, visit www.PixarBio.com

FTE Networks, Inc. (FTNW) is Enabling the Connection

December 23, 2016

In less than a decade, we’ve seen multiple networks spring up that are now connecting hundreds of millions of people. The largest one, Facebook, surpassed an astounding one billion users earlier this year as it advanced on its mission to “connect the world”. Facebook, as well as other networks sharing the same goal, is achieving great success by connecting more and more people every day. However, they can’t do that alone.

FTE Networks (OTCQX: FTNW) lives by the mission of “enabling the connection” that is allowing so many businesses to thrive in today’s globally connected environment. The company provides end-to-end network infrastructure solutions and focuses primarily on the burgeoning technology & communications networks industries. Current customers and target markets include tier 1 & 2 carriers, network infrastructure providers, OEMs, major ISPs and government.

When you consider just a few of the latest statistics, it becomes clear how much this company’s services are needed. Today, there are approximately 7.3 billion people, 3.4 billion internet users, and 2.3 billion active social media users. And all those numbers are growing. Networks will soon need to have the capacity to connect hundreds of millions of new people, and significant constraints or delays won’t be acceptable.

FTE Networks’ strategy includes optimizing its customer base through strategic partnerships, expanding recurring revenue with high margins, pursuing continuous improvement, leveraging innovative technology and expertise, deploying a world-class managed network services platform and capturing new growth opportunities on an ongoing basis. The strategy is clearly working well, with 19 locations across the country, favorable growth characteristics, and continued momentum heading into 2017.

Looking back over 2016, revenue increased significantly, and the final total is expected to be 50% greater than what was generated in 2015. There have also been tremendous gains in gross profits, with the third quarter bringing in $1.4 million, which is a 159% increase from the same period last year. Additionally, gross margins were improved from 14% to 37% year-over-year, and the company achieved positive income from operations.

In a recent news release, Chairman and SEO Michael Palleschi stated that not only will the company finish strong this year, but it is anticipated that the company will continue to drive incremental growth quarter-over-quarter throughout 2017 and beyond. As we enter 2017, FTE Networks will focus on pursuing accretive growth opportunities through mergers and acquisitions that are expected to solidify its position as a leader in the infrastructure solutions business segments, while also accelerating the launch of its exciting Managed Services platform.

With a track record of success already established, this is a company you will want to keep on your radar screen.

For more information, visit www.FTENet.com

Biotricity, Inc. (BTCY) – A Modern Technology Company for Medical and Consumer Markets

Modern technological advancements are permeating all facets of society and industry and encouraging remote interactions from anywhere and at anytime. In the realm of education, we have seen a rise in the offering of massive open online courses (MOOCs) aimed at unlimited student participation and open access via the web. In the financial services arena, we have seen the rapid growth of technology-driven companies enabling mobile payments and value-added transactional services via e-commerce sites and point-of-sale solutions. It was only a matter of time before we began looking more closely at how the latest developments in technology are influencing the medical field and the way doctors care for patients.

On December 20, 2017, only days before the dawn of the coming new year, SeeThruEquity – an independent equity research firm focused on small cap and micro cap public companies – brought this medical consideration to the general public when it issued a press release (http://dtn.fm/ky37V) highlighting its initiation of coverage on Biotricity, Inc. (OTCQB: BTCY). SeeThruEquity estimated a 12-month price target of $4.20 for the company.

Biotricity is an emerging medical technology company that is focused on preventative health solutions. The company concentrates on developing and delivering remote patient monitoring and connected health solutions for disease management and lifestyle improvement in both diagnostic and post-diagnostic settings. With an eye toward putting health management into the hands of the patient, the company uses proprietary technology to develop cutting-edge solutions that empower the self-management of critical and chronic conditions and ease the rising burden on the health care system.

At present, Biotricity is directing its lead product, Bioflux, toward the monitoring of cardiovascular disease (CVD). With Bioflux, the company has designed a wearable mobile device and echocardiogram (ECG) system that boosts a doctor’s ability to monitor and diagnose CVD. Bioflux allows doctors to detect CVD or coronary heart diseases while also serving as an ambulatory monitor capable of identifying arrhythmias; acting as a remote mobile cardiac telemetry diagnostic monitor; and communicating ECG data via a built-in cellular radio in real-time. As a result, Biotricity’s management team is pursuing a 510(k) regulatory pathway for Bioflux and expecting to receive clearance to market the device in the first quarter of 2017.

In the future, the company intends to look beyond Bioflux at other sectors that present opportunities for long-term growth. For example, Biotricity intends to launch its Biolife health and lifestyle solution for the chronic illness side of the consumer market in 2017, aiming it at those individuals with high risks of CVD or who are already diagnosed with it. The Biolife solution consists of a clinical-grade heart monitor that reads ECG data or heart rhythms, as well as respiration, calories, temperature, physical activity and more. Additionally, the company plans to introduce products that target sleep apnea, fetal ECG monitoring, and diabetes monitoring to the wider healthcare market, as these three medical areas represent multi-billion dollar opportunities, if the company successfully executes its plan.

For more information, visit www.Biotricity.com

CytoDyn Inc. (CYDY) Announces Engagement of NetworkNewsWire for Corporate Communications Solutions

December 22, 2016

CytoDyn Inc. (OTCQB: CYDY), a biotechnology company focused on the development of new antibody therapies for combating human immunodeficiency virus (HIV) infection and other diseases, announced this morning that it has engaged the expertise of NetworkNewsWire (“NNW”), a multifaceted financial news and publishing company that delivers a new generation of social communication solutions, news aggregation and syndication, and enhanced news release services. NNW’s strategies help public and private organizations find their voice and build market visibility via social media and a rapidly expanding distribution network of well over 5,000 key syndication outlets.

“Maintaining strong communication with CytoDyn shareholders is highly important as we pursue regulatory approval of PRO 140, our leading monoclonal antibody for HIV infection,” Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn, stated in this morning’s news release. “As we focus on our ongoing Phase 3 clinical trial with PRO 140, NNW will work behind the scenes and use its vast network to keep existing and potential investors up-to-date on our progress.”

As part of the Client-Partner relationship with CytoDyn, NNW will leverage its investor-based Brand Network of partners, various newsletters, social media channels, blogs, and other outreach tools to generate greater brand awareness for the company.

“Though tremendously invaluable, communication strategies are an often overlooked aspect of business for many biotech and biopharma companies,” Sherri Franklin, director of Content Marketing for NNW, added in the release. “CytoDyn, however, is taking a proactive approach in making sure the investment community is aware of its progress. We look forward to working with this exciting company as it addresses a significant global concern and advances its clinical development of monoclonal antibodies for treatment of HIV infection.”

For more information, visit www.CytoDyn.com

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CytoDyn Inc. (CYDY) Targets HIV as its Lead Product, PRO 140, Enters Phase 3 Clinical Development

December 20, 2016

CytoDyn Inc. (OTCQB: CYDY) is entering a Phase 3 clinical trial with its leading product candidate, PRO 140, and the Washington-based biotech is showing a lot of progress nearing major milestones. PRO 140 is a viral-entry inhibitor, a new class of HIV/AIDS therapies that work by blocking the entry of the human immunodeficiency virus (HIV) to healthy cells. PRO 140 is presently at the Phase 3 clinical trial stage. For the millions worldwide with HIV/AIDS, PRO 140 could offer the promise of a more robust bodyguard from further viral insult with potentially fewer side effects and hardly any toxicity.

HIV, like many other dangerous viruses, has a formidable ability to reproduce itself. The virus will invade an immune system cell and employ that cell’s reproductive machinery to make copies of itself, often killing the host cell in the process. New viral particles then emerge from the host and go on to infect other cells.

Many of the current AIDS therapies slow HIV replication by inhibiting viral enzymes within cells already affected by HIV. However, a new class of drugs, known as viral entry inhibitors, is designed to protect healthy cells from HIV infection by blocking early steps in the viral life cycle.

HIV infection occurs when the virus gains entry to two ‘doorways’ or receptors on the cell surface. These are the CD4 receptor and the co-receptor CCR5. The GP120 protein of HIV first attaches to the CD4 receptor on the cell membrane and then is able to bind to the co-receptor CCR5. At that point, the chips are down. The membranes of the virus and the immune cell fuse, and genetic material from HIV enters the cell.

PRO 140 works by attaching to the same portion of the CCR5 co-receptor to which HIV normally binds. The PRO 140 monoclonal antibodies physically block the HIV from attaching to the CCR5 co-receptor and arrest the completion of the second step in the entry process. The HIV is, consequently, rendered ineffective.

The approach taken by PRO 140 has a distinct advantage over other therapies. The normal function of CCR5 is to bind chemokines, molecules that regulate inflammation. Other HIV drugs that target CCR5 interact with the pocket of the receptor and thereby inhibit binding of both HIV and chemokines, which may have a number of adverse consequences because of the disruption of the chemokine inflammatory response. However, PRO 140 blocks HIV yet permits normal chemokine binding leading to potentially less side effects.

Early clinical testing indicates that PRO 140’s half-life contributes to the masking of CCR5 receptors for up to two months. Thus, infrequent dosing with PRO 140 may be possible compared to small molecule drugs, which require daily dosing.

In addition, being an antibody and not a synthetic drug means that PRO 140 will, most likely, have fewer issues with toxicity. Previous short and long-term trials have shown that PRO 140 is less likely to induce the development of resistant viruses.

Earlier this month, CytoDyn Inc. announced that several patients had been treated in the first single-agent maintenance therapy, Phase 3 (instead of today’s standard of care of at least three agents) in virally suppressed subjects with HIV. PRO 140 is considered one of the most advanced experimental monoclonal antibodies for HIV treatment and has been used in more than 140 HIV-infected patients in placebo controlled and open label FDA-approved clinical trials. The drug has been the subject of seven clinical trials, each demonstrating efficacy by significantly reducing or controlling HIV viral load in human test patients and being designated a “fast track” product candidate by the FDA.

CytoDyn is a biotechnology company focused on the clinical development and commercialization of humanized monoclonal antibodies for the treatment and prevention of human immunodeficiency virus infection.

For more information, visit www.CytoDyn.com

CytoDyn Inc. (CYDY) is “One to Watch”

December 19, 2016

CytoDyn Inc. (OTCQB: CYDY) is a Vancouver, Washington-based biotechnology company engaged in the clinical development and potential commercialization of humanized monoclonal antibodies for the treatment and prevention of Human Immunodeficiency Virus (HIV) infection.

Monoclonal antibodies – soluble proteins produced by the body in response to infections from bacteria, viruses and other pathogens – have become one of the fastest expanding opportunities in the biotech/pharma sector. CytoDyn’s lead drug candidate is PRO 140, one of the leading monoclonal antibodies under development for HIV infection.

PRO 140 belongs to a new class of HIV/AIDS therapeutics intended to protect healthy cells from viral infection. The candidate has been used in more than 200 HIV-infected patients in placebo-controlled and open label FDA-approved clinical trials; has been the subject of seven clinical trials, each demonstrating efficacy by significantly reducing or controlling HIV viral load in human test subjects; and is designated a “fast track” product candidate by the FDA.

The PRO 140 antibody appears to be a powerful antiviral agent leading to potentially hardly any side effects or toxicity and less frequent dosing requirements, as compared to daily drug therapies currently in use. CytoDyn has received FDA clearance for and currently has two Phase 3 clinical trials underway. The company’s first Phase 3 trial is a pivotal trial with PRO 140 in combination with current standard-of-care antiretroviral therapy (ART) for highly treatment-experienced patients with HIV. This 25-week trial involves only 30 patients with a primary endpoint of just one week of efficacy and the company expects to report primary endpoint results as early as the first quarter of 2017.

The company’s other Phase 3 trial is with PRO 140 as a single-agent maintenance therapy in virally suppressed subjects with HIV. This multicenter, open-label trial is now enrolling 300 patients prequalified with CCR5-tropic HIV-1 infection who are clinically stable on standard-of-care highly active antiretroviral therapy (HAART). The objective of the trial is to assess the efficacy, safety and tolerability of PRO 140 as a long-acting, single-agent maintenance therapy for the chronic suppression of HIV. Patients enrolled in the trial will be shifted from daily HAART regimens to weekly PRO 140 subcutaneous injections for 48 weeks. This trial protocol is nearly a duplicate of the Phase 2b monotherapy trial, which is ongoing with an extension study that supports a group of patients who have maintained viral suppression for over two years and is continuing.

Additionally, the company has underway a Phase 2 trial to evaluate PRO 140 for Graft vs. Host Disease (GvHD) in a 100-day study involving 60 patients. GvHD is a life-threatening complication for cancer patients undergoing stem cell transplants. This trial will evaluate the safety and efficacy of PRO 140 for prophylaxis of acute GvHD in patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) undergoing allogeneic stem-cell transplantation.

CytoDyn operates under the guidance of a highly qualified management team and advisors with experience in a wide range of complementary skillsets, including business development, mechanical engineering, life sciences and biotech, manufacturing and clinical development, IP asset development, biologics, antibody drug conjugates, engineered tissue therapeutics, small molecule and radiopharmaceutical drugs and more. Additionally, CytoDyn has established relationships with world-class HIV experts who advise on the company’s trial designs.

For more information, visit www.CytoDyn.com

Rennova Health, Inc. (NASDAQ: RNVA) Creating the Next Generation of Health Care

Rennova Health, Inc. (NASDAQ: RNVA, RNVAX), a vertically integrated public holding company serving the health care sector, focuses on offering comprehensive single-source solutions to health care providers ranging from diagnostic laboratory testing to technology solutions, revenue cycle management and financial and billing services. With a declared goal of creating efficient, innovative and empowering solutions, the company is dedicated to putting the needs of health care providers and their patients at the center of everything it does.

The company’s single-source solutions are designed to help health care providers increase operational efficiency and obtain added value, with the purpose of ultimately supporting better treatment outcomes, increasing patient care efficiency and optimizing revenue streams. Available individually or as a package, these industry-leading supportive software and diagnostics solutions and services work together to empower customers and help shape the next generation of health care.

The diagnostics testing solutions include highly complex clinical, toxicology and esoteric laboratory services, offered via Rennova Health’s subsidiary, Medytox Diagnostics, and its five labs located strategically across the country. These laboratories offer specialized services of urine drug testing for prescription medication, abuse drugs and pain medication, as well as toxicology, clinical chemistry, hematology, serology, immunology and esoteric testing services such as neurotransmitter tests. The testing and sampling process uses the company’s proprietary StableSpot™ methodology.

The company currently has an active customer base with 139 clients and possesses Medicaid licenses in a total of 28 states. Also part of its clinical lab operations segment, Rennova Health recently initiated the acquisition of various assets of a rural clinical access hospital that filed for Chapter 11 bankruptcy. The acquisition process is to be completed early next year, with the hospital and its laboratory likely back in operation in the third quarter of 2017. Another major acquisition the company plans is that of Genomics, Inc., a biomedical diagnostics company that offers personalized medicine via DNA-guided management. Genomics uses a patented combination of genes and a proprietary platform that correlates gene and physiological variability to come up with ideal medication for pain, diabetes, mental illness and heart disease.

Another essential component of Rennova’s comprehensive solutions offering is health care technology. The company’s integrated software solutions include both specialized applications and simplified technologies for electronic health records, an advanced laboratory information management system and a reporting application designed to help streamline diagnostic laboratory testing, as well as information solutions for precision oncology. The company launched an electronic health records service in the substance abuse sector in the last quarter of 2015 and currently has approximately 100 EHR clients across all verticals.

As for revenue cycle management services, Rennova’s in-house medical billing services solution, Medical Billing Choices, offers a customer-centered workflow designed to minimize errors, streamline customers’ billing cycles and maximize cash flow by expediting tasks such as insurance eligibility checks, claims submissions, and payment collecting. The company launched a specialized medical billing division for substance abuse facilities in the third quarter of the year and currently has approximately 20 facilities as customers.

Rennova also offers financial service solutions to health care providers, designed to help them maintain positive cash flows and overcome any income gaps cause by slow-to-pay customers. From special loans collaterized by accounts receivable to acquisitions of qualifying accounts receivable at a discounted rate, the company offers a wealth of financial solutions tailored to every customer.

For 2017 as well as long term, Rennova Health has plans to create and maintain a sustainable relationship with its customers, to grow revenue and provide added value to its shareholders by increasing and diversifying its diagnostics business, offering improved supportive software solutions and exploring new ways to improve provider and patient outcomes for various diagnostics, including cancer and diabetes. The company’s main target markets at the moment are pain management and drug and alcohol rehabilitation.

For more information, visit www.RennovaHealth.com

PharmaCyte Biotech, Inc. (PMCB) Pre-IND Meeting with FDA Makes ATM Funding Possible

December 16, 2016

For California-based PharmaCyte Biotech, Inc. (OTCQB: PMCB), a light at the end of the pipeline tunnel has become visible as one piece of good news follows another. The approval by the FDA to entertain a Pre-Investigational New Drug (Pre-IND) submission from the company sent PMCB stock soaring to triple its pre-approval value. The resulting market cap made PharmaCyte ‘primarily eligible’ to register securities for sale in an at-the-market (ATM) offering, which it now plans to do through Chardan Capital.

To make an ATM offering requires that the issuer be eligible, on a primary basis, to use a shelf registration statement on Form S-3. The Form S-3 filing initiates an equity distribution program under which, from time to time, ATM offerings can be made. Each ATM offering is a drawdown from the related shelf registration securities offering.

ATM offerings have a number of advantages. They typically cost less than traditional follow-on offerings, particularly since they are executed without high profile, expensive road shows. They also give an issuer the flexibility to determine the timing and size of any share sale, while allowing shares to ‘trickle’ into the market in a way that does not adversely affect the stock price.

PharmaCyte is now primarily eligible to use Form S-3 to offer securities, on its own behalf, for cash on an unlimited basis in ATM offerings, since the aggregate market value of its voting and non-voting common equity held by non-affiliates (i.e., the public float) is at least $75 million. The company intends to use funds received from the ATM offerings to advance the clinical trial process of its signature live-cell encapsulation technology, Cell-in-a-Box®.

PharmaCyte will be submitting a full Pre-IND package of information to the FDA that will set out essential elements of its planned Investigational New Drug (IND) application. After which, the FDA will review PharmaCyte’s manufacturing, preclinical pharmacology and toxicology, and clinical trial plans for the company’s therapy to treat locally advanced pancreatic cancer (LAPC). On successful completion of the review, PharmaCyte will be able to proceed with enrolment of the first clinical trial.

PharmaCyte’s clinical trial for LAPC is designed to meet a clear unmet medical need for those whose cancer no longer responds after 4-6 months of treatment with the combination of Abraxane® and gemcitabine. The trial will be open-label and multi-site in nature, with sites in the U.S. and Europe. Patients with LAPC will be randomized equally into two groups. One group will receive gemcitabine chemotherapy alone, and the other will receive PharmaCyte’s pancreatic cancer therapy. In addition to comparing the anticancer activity and safety of the two therapies, a major aspect of the trial will be to determine if, and how well, PharmaCyte’s therapy can shrink inoperable tumors so that they may become operable.

To work on its novel technology, Cell-in-a-Box®, PharmaCyte has assembled a respected team of oncologists that includes leading pancreatic cancer expert Dr. Daniel Von Hoff from Translational Drug Development (TD2) (http://www.td2inc.com), Dr. Manuel Hidalgo from Harvard Medical School, and Dr. Matthias Löhr from the Karolinska Institute in Stockholm, Sweden.

PharmaCyte Biotech is a clinical stage biotechnology company developing therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as Cell-in-a-Box®. The Cell-in-a-Box® therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or anti-carcinogenic form.

These encapsulated cells are implanted as close to the patient’s cancerous tumor as possible. Once implanted, a chemotherapy drug that is normally activated in the liver (ifosfamide) is given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to the location of the implanted encapsulated cells.

When the ifosfamide comes in contact with the encapsulated cells, they act as an artificial liver and activate the chemotherapy drug at the source of the cancer. This targeted chemotherapy has proven effective and safe to use in past clinical trials and results in no side effects.

For more information, visit www.pharmacyte.com

Higher Price Target for Ocera Therapeutics (NASDAQ: OCRX) as Hepatic Encephalopathy Treatment Study Moves Forward

An innovative potential treatment for hepatic encephalopathy created by Ocera Therapeutics, Inc. (NASDAQ: OCRX) is a unique product on an under-served market, and if clinical trials are successful, it could become a major source of success and profitability for the company, according to an Aegis Capital Corp. report (http://dtn.fm/J0h97) released on December 8. The report reiterates a ‘Buy’ rating for Ocera and recommends a higher stock price target of $8, compared to the $2.1 at the time of the analysis.

The Aegis report was released a day after Ocera announced completion of enrollment in its phase 2B trials for lead product candidate OCR-002 – an acute treatment for hepatic encephalopathy and hyperammonemia in patients with acute liver injury, acute liver failure and liver cirrhosis. The phase 2B study, called STOP-HE, will evaluate the safety, efficacy and tolerability of OCR-002 (Ornithine Phenylacetate) in hospitalized patients suffering from hepatic encephalopathy. The study enrolls a total of 230 subjects, which will be administered either OCR-002 or a placebo intravenously for five days. Based on their degree of liver impairment, patients will be given various doses of the drug, ranging from 10 to 20 grams over a 24-hour period.

Top-line data are due in the first quarter of 2017, which Aegis experts expect will be a share inflection point for the company. The study’s primary goal is to archive a meaningful clinical improvement in hepatic encephalopathy symptoms, so as to keep OCR-002 on track to potentially becoming a first-line, foundational therapy of choice for patients with this condition, on a market with significant unmet medical needs. Hepatic encephalopathy is a progressive complication of liver failure of cirrhosis which is marked by partial cognitive impairment including disorientation, confusion and impaired motor skills, while more severe forms can lead to coma and even the patient’s death.

According to the Agis report, there are currently only two hepatic encephalopathy products on the market, with others in development. Lactulose is a first-line therapy that has the largest market share at the moment, while Rifaximin is a second-line therapy. But Aegis analysts believe that OCR-002 has great potential and can take a significant market share, being unique in several respects: it has a unique mechanism of action as an ammonia scavenger, it is the only drug that can be administered intravenously and it has the potential to significantly shorten hospital stays.

If the phase 2B trial is successful, OCR-002 could reach approximately 170,000 patients that have hepatic encephalopathy and require hospitalization. Aegis analysts expect the therapy to achieve at least 22 percent market share and yield revenues of approximately $150 million. Ocera is also developing an oral formulation of the drug for chronic use, with the goal of preventing hepatic encephalopathy recurrences. The oral formulation was not included in the Aegis analysis, but it may indeed help provide an even larger share of the market.

As for potential risks for investors as identified in the report, these include typical manufacturing, commercialization, research and development, and regulatory risks that generally result from investing in pharmaceutical companies. The analysis also points out a series of specific risks of investing into Ocera, such as relying on the success of OCR-002, the company’s liquidity and high volatility.

For more information, visit the company’s website at www.ocerainc.com

NuVasive, Inc.’s (NASDAQ: NUVA) Speed of Innovation and Absolute Responsiveness form the Backbone of its Rapid Growth

December 15, 2016

How does a start-up venture capital-backed company grow its revenues to nearly a billion dollars in the global spine industry in less than two decades? By developing a competitive advantage in Speed of Innovation® and Absolute Responsiveness®, two concepts that have made NuVasive, Inc. (NASDAQ: NUVA) the number three company in the spine industry with over 90 products in its portfolio, including lumbar, thoracic, and cervical applications; neuromonitoring services; and biologics solutions.

The global spinal implants and surgical devices market ‘is expected to reach USD 17.27 Billion by 2021, growing at a CAGR of 5.3% from 2016 to 2021’, according to a press release from MarketsandMarkets (http://dtn.fm/uHV0W). Increasing longevity and the resulting larger elderly population means more spinal disorders, such as herniated discs, degenerative disc disease, spondylolisthesis, prolapsed intervertebral discs, and spinal stenosis. In addition, the development of minimally invasive surgical (MIS) procedures is leading to wider adoption of technologically advanced spinal implants.

MIS is NuVasive’s forte. The company is best known for developing the eXtreme Lateral Interbody Fusion® (XLIF) procedure, a minimally disruptive procedure that allows spine surgeons to have direct access to the intervertebral disc space (the “joint” of the spine) from the side of the body, as opposed to the front or back. The XLIF procedure is just one of the company’s many innovative procedures, which have redefined spine surgery and opened doors to treat pathologies not previously treated with minimal disruption.

NuVasive has also developed a revolutionary nerve avoidance monitoring system (NVJJB™ /M5®) designed to help ensure nerve and spinal cord safety – this unique and advanced technology may help reduce the incidence of injury to neural elements during spinal procedures by providing real-time feedback and notifying surgeons immediately of any neurological insult. Additionally, NuVasive offers a portfolio of biologics products to help in the bone healing process.

A recent report from Aegis Capital (http://dtn.fm/H1sQC) suggests that NuVasive’s rapid growth is far from over. The company has been steadily paring manufacturing inefficiencies. As a consequence, gross profit has hovered around 75 percent. Other operating margin improvements are expected from economies of scope as the marketing offering expands and economies of scale form an increasingly larger international footprint. Aegis sees “900bp of operating improvements to come, which will continue to drive value.”

In a fast growing industry (2–3% p.a.), NuVasive, focused on developing minimally disruptive surgical products and procedures for the spine, is a fast growing company (2-3x faster than the overall market). The drivers of growth are its ‘expanding platform of offerings, adapting a holistic approach with regards to its sales effort, and increased Integrated Global Alignment (iGA) integration which allows better planning for deformity and saves cost.’

Alignment is one of three important factors to be considered when spine surgery is being contemplated. In cases of spondylolisthesis, for example, the first concern is usually decompression of the nerves to ease any pain or discomfort the patient may be experiencing. In many instances, this means removing the disc or other offending piece from the spine. The resulting space is, typically, filled by bone graft or a synthetic substance in a procedure known as lumbar interbody fusion (LIF). At this point, alignment procedures to straighten the spine may be implemented.

NuVasive, which has a presence in over 30 countries and employs more than 1,600 people globally, had revenues of $811 million in 2015. A 17 percent increase to $953 million is expected this year. Aegis has initiated coverage with a ‘Buy’ rating and a price target of $72.00. The stock, trading on the NASDAQ under the symbol NUVA, is currently around $67.00.

For more information, visit www.nuvasive.com

Nano Dimension Ltd. (NASDAQ: NNDM) Revolutionizing the Way Electronics are Made with 3D Printing

Nano Dimension Ltd. (NASDAQ: NNDM) is the holding company for Nano Dimension Technology Ltd., a company in the business of researching, developing, and manufacturing three-dimensional (3D) printers for printed circuit boards (PCBs). The company also develops nano ink materials and other products for electronics. NNDM has the vision of revolutionizing the way electronics are made with 3D printing by using 3D printers for multilayer PCBs, along with advanced nanotechnology-based conductive and dielectric inks.

Since the beginning of last year, Nano Dimension has won the Europe 2015 Award for Best Development in 3D Printing Equipment, the Gartner ‘Cool Vendor’ in 3D Printing 2016, and the TÜV SÜD Innovation 2016 award. NNDM is equipped with an experienced managerial team with a long background in the technology and 3D printing spaces, and the company is well-positioned to capitalize on the PCB prototyping industry, which is currently worth approximately $70 billion.

With the launch of its new DragonFly 2020 3D Printer to select beta customers in the U.S., Israel, and Germany, during the third and fourth quarters of this year, Nano Dimension Ltd. is expected to make sales on a more commercial level as early as 2017. The printer, which comes with specialized 3D software as well as conductive and dielectric inks, has now received attention from over 2,500 entities currently on the information waitlist. In addition, more than 30 NDAs have been signed to enable the collaboration and evaluation of this equipment.

With its new printer, Nano Dimension Ltd. plans to provide its clients with more advanced solutions than ever before while tapping into additional markets. Through the DragonFly 2020 3D Printer, Nano Dimension expects to meet the needs of additional market segments by offering faster solutions that print larger objects from a broader materials portfolio with functional inks.

According to The Daily Quint (http://dtn.fm/j5xiP), Nano Dimension has been the topic of conversation for several research analysts firms, receiving a consensus ‘Buy’ rating from five investment analysts with a consensus average price target of $12.60 per share. At close of market on December 13, 2016, the company’s shares were sold at an individual price of $6.05. NNDM’s market capitalization currently stands at $46.96 million.

For more information, visit www.nano-di.com

Hope for HIV Patients as Cytodyn Inc. (CYDY) Therapy Proves Efficacy during Clinical Trials

PRO 140, an innovative new therapy for HIV patients developed by Cytodyn Inc. (OTCQB: CYDY), is currently undergoing phase 3 clinical trials, having been administered to several patients, according to a company press release (http://dtn.fm/F40vr). No other details were provided about the initial results of phase 3 trials, but a separate report said actor Charlie Sheen is one of the subjects and that he has achieved undetectable viral load after taking PRO 140.

Sheen, who revealed his HIV status in November last year, has been a part of the study for eight months and is receiving weekly injections of the drug, the report said. The phase 3 study is looking into PRO 140’s safety and effectiveness in HIV patients and is being administered without any other HIV medication to determine whether it alone is enough to fight HIV and help subjects achieve an undetectable viral load.

Cytodyn, a biotech company that focuses on the development of innovative antibody therapies against the human immunodeficiency virus and other diseases, has not officially commented on the Daily Mail report. In a press release this week, however, it announced that several patients have already been treated with PRO 140 as part of the phase 3, multicenter clinical trial which will enroll a total of 300 subjects. All the patients included in the study have CCR5-tropic HIV-1 infection and are clinically stable, being on highly active antiretroviral therapy up to one week after the enrollment.

During the phase 3 trial, the subjects will receive only PRO 140 in the form of subcutaneous injections for 48 weeks to determine whether the product candidate is safe and efficient as a single-agent maintenance therapy for chronic suppression of HIV. PRO 140 is a fully humanized monoclonal antibody that specifically targets the CCR5 entry receptor on CD4 cells, which HIV targets and takes over. The proprietary therapy fights HIV by blocking this entry point and preventing the virus from infecting healthy cells.

CytoDyn CEO and President Nader Pourhassan, Ph.D. said his company expects the monotherapy trial to yield significant results and provide sufficient data to support further clinical and regulatory advancement of the treatment. He explained that the phase 3 trial is nearly a duplicate of the phase 2b trial that ended last year, with an additional objective of determining why some R5 patients are not responding to the therapy as well as others. Out of 15 subjects who continued the trial in the extension arm and received weekly PRO 140 injections in phase 2b trials, 10 maintained an undetectable viral load for more than two years, while four others did not report any changes in their HIV infection. The last patient moved away and could not be monitored.

Pourhassan is confident that the phase 3 trial findings will help determine which patients can achieve long-term HIV suppression and ultimately secure label expansion for PRO 140 as a single agent therapy, given it has low toxicity and virtually no side effects. PRO 140 only targets HIV patients with the R5 strain, Pourhassan added. This strain currently accounts for about 70 percent of HIV infections and 90 percent of newly-diagnosed cases in the United States.

For more information, visit www.cytodyn.com

MediWound Ltd. (MDWD) Receives Consensus Analysts Rating of ‘Buy’

December 9, 2016

MediWound Ltd. (NASDAQ: MDWD) is a biopharmaceutical company in the business of developing, manufacturing, and globally commercializing products that treat severe burns and wounds. In 2012, MediWound’s innovative drug, NexoBrid™, a burn and wound eschar removal agent, was approved by the European Medicines Agency (EMA) via a centralized procedure. The drug was given orphan indication for removal of dead and damaged skin in adults with burns that are deep partial and full thickness thermal burns.

NexoBrid™ was launched throughout Europe and is now being used in patients with hospitalized burns and wounds. MediWound has initiated phase III clinical trials on NexoBrid™ in the U.S. and pediatric study. The company also has two other products in its pipeline: EscharEx, which is in its phase II study and is for use in patients with chronic wounds, and MWPC003, which is about to enter its phase I study and is for use in patients with connective tissues disorders.

In November of this year, MediWound Ltd. announced third quarter 2016 financial results for the three- and nine-month periods ended September 30, 2016. The company reported revenue for the quarter of $518,000, compared to just over $100,000 for the same quarter of 2015. This was put down to the growing sales of NexoBrid™. The nine-month period results showed total revenue of $1.1 million, compared to $0.3 million for the same nine-month period of the previous year. MDWD will be spending the remainder of 2016 investing primarily in sales and marketing activities relating to the further adoption of NexoBrid™ in Europe.

Aegis Capital Corp. (http://dtn.fm/l63Bn) initiated coverage on MediWound Ltd., giving the company a ‘Buy’ rating with a price target of $11 per share. This rating was given based on the fact that the company has made significant progress in the area of wound debridement. According to the report, MDWD’s NexoBrid™ is showing significantly faster, more selective, safer, and more cost efficient results compared to current treatments. The report also highlights the possibility for the company to integrate into the chronic wound care market with EscharEx and markets relating to connective tissue disorders with its pipeline product MWPC003.

Despite Zacks Investment Research lowering the company’s status from a ‘Buy’ rating to a ‘Hold’ rating, six other research analysts have given MDWD a ‘Buy’ rating, and Wells Fargo & Co. offered MediWound an ‘Outperform’ rating with a price target on the stock of $14. The company has a consensus ‘Buy’ rating with a consensus price target of $13.25, all according to Cerbat Gem Market News and Analysis (http://dtn.fm/Ch85p).

Institutional investors and hedge funds are now said to own over 27% of MediWound shares, after Migdal Insurance & Finance Holdings, Wells Fargo & Company MN, and Oppenheimer & Co. bought new positions in the company’s stock. Wellington Management Group LLP and United Services Automobile Association also increased their positions in MediWound. As of this writing, the company has a market cap of $107.17 million, with an enterprise value at $84.15 million, and shares currently selling at around $4.90 per share.

For more information, visit the company’s website at www.mediwound.com

Globus Medical, Inc. (GMED) Class A Stock Sees Significant Volume Spike Moving Into 2017

As an eventful year for Globus Medical, Inc. (NYSE: GMED) is nearing an end, the leading medical device company experienced a substantial surge in trading volume on December 06. Equities.com (http://dtn.fm/Rab1C) noted a 1.3% gain of Globus Medical, Inc. Class A stock, closing at $23.31. The stock, which averages a daily volume of 1.11 million shares over the last month, captured the attention of numerous institutional investors and analysts when a surge of 11.57 million shares traded hands on 28,116 trades. The article states, “Generally speaking, when a stock experiences a sudden spike in trading volume, it may be seen as a bullish signal for investors. An increase in volume means more market awareness for the company, potentially setting up a more meaningful move in stock price.”

Increased awareness has been building for the medical device company during 2016, including the unveiling of its investigational robotics system Excelsius at the 2016 North American Spine Society (NASS) meeting held in late October. Per articles from MassDevice.com (http://dtn.fm/Of7Fc), and Becker’s Spine Review (http://dtn.fm/9t2Mm), Globus Medical expressed its anticipation of an approval and launch of the platform in early to mid-2017 to investment bank Leerink Partners. The MassDevice.com article also states that Leerink spoke with surgeons who were very interested in a trial of the platform as it becomes available. This adds credence to the company’s position as one of the “three main players” in the burgeoning surgical robotics industry (http://dtn.fm/u9oeH), citing recent commentary from the Medical Device and Diagnostic Industry website. MDDI mentions that surgical robots are only used in roughly 5% of spine procedures today, but that a survey by RBC Capital Markets indicates the potential for rapid adoption growth.

This potential for mass adoption has also been noted by financial analysis firm, Aegis Capital (http://dtn.fm/s1Rhi), in a report from November 30th that preceded Tuesday’s surge in trading activity. The firm set a $31 target price that was achieved, in part, by Globus Medical’s promising pipeline of emerging technologies, namely the robotics platform and trauma. The report calls attention to the system’s ability to serve as a competitor to Medtronic’s O-Arm with Stealth Station navigation. Those systems, which do not include robotic assistance, retail for more than $1 million, placing Globus Medical in a position to charge a premium on its own systems, as they incorporate full feature navigation. As a result, the company believes the customers of the roughly 900 O-Arms installed worldwide to be prospective customers and early adopters. Globus Medical intends to demonstrate, through clinical studies, the system’s time and money-saving benefits, as well as the added layer of predictability and accuracy it affords.

Headquartered in Audubon, Pennsylvania, Globus Medical, Inc. is a leading musculoskeletal implant manufacturer with the singular focus of advancing spinal surgery through the development of innovative engineering and technology. To date, Globus Medical has developed and released more than 150 spine products.

For additional information, visit www.GlobusMedical.com

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