According to a new market report published by Credence Research (http://dtn.fm/FV2Gi) entitled ‘Head Mounted Display (HMD) (Defense, Consumer, Industrial, Healthcare, Public Safety, and Other Verticals) Market – Growth, Share, Opportunities, Competitive Analysis, and Forecast 2015 – 2022’, the head mounted display market is expected to expand at a compound annual growth rate of just below 50% between 2015 and 2022.

The report explains that this significant growth has been largely attributed to the declining prices of microdisplays, coupled with the high demand for lightweight wearable computing devices. Because of this decline in prices, manufacturers are now able to penetrate into the consumer market, offering more affordable products.

eMagin Corp. (NYSE MKT: EMAN), a company dedicated to developing and delivering head-worn systems for law enforcement, military, entertainment, and medical applications, among others, is set to capitalize on this growing industry thanks to its ability to develop and deliver high-quality, high-resolution, cutting-edge displays to its customers.

Earlier this week, the company was a big mover, with a rise in shares of more than 9% on March 7, 2017. According to the Nasdaq website (http://dtn.fm/YhZ6q), “The move came on solid volume with far more shares changing hands than in a normal session. This breaks the recent trend of the company, as the stock is now trading above the volatile price range of $2.10 to $2.30 in the past one-month time frame.” The company’s stock price escalated, climbing to $2.45 per share in Friday morning trading.

On March 8, the Daily Quint reported that Bessemer Group, Inc. had acquired over 76,000 new shares of eMagin stock worth approximately $164,000 (http://dtn.fm/9QusN). Not only this, Fiscal Standard (http://dtn.fm/l8xRG) reported that H. C. Wainright and Craig Hallum began coverage on the company, with both issuing it a ‘Buy’ rating. Craig Hallum gave eMagin a target share price of $6.

eMagin is the first and leading manufacturer of active matrix OLED-on-silicon microdisplays. In addition to the company’s focus on the security, defense, medical, and industrial markets, eMagin has now entered into the consumer market with its Z800 3DVisor, which was described as the “the best 3D goggles we’ve ever tested” by Maximum PC (http://dtn.fm/zyV67).

For more information, visit www.eMagin.com

Singlepoint, Inc. (OTC: SING), a publicly traded holding company based in Arizona, has been highlighted as one to look out for in the cannabis space, according to InsiderFinancial.com (http://dtn.fm/3zGnN). The company, through its SingleSeed subsidiary, provides business services to cannabis businesses, including marketing, point of sale and more.

Because of the company’s nature, and its ability to fill a very challenging gap in the marijuana industry, Singlepoint is on a climb as the industry continues to flourish in the United States. This has been reflected in its stock price, which at the time of InsiderFinancial’s coverage had shown a 560% appreciation in approximately 12 weeks.

In addition to its substantial stock rise, earlier this year Singlepoint announced that it has raised more than $600,000, and it is looking to secure up to $1 million. Singlepoint has also made reference to its strategic acquisition activities.

During an interview with Donald Baillargeon from Money TV (http://dtn.fm/e27Za), CEO Greg Lambrecht explained that the companies Singlepoint is looking to acquire are those that are part of the cannabis industry, but that do not in any way touch the plant itself. This acquisition strategy allows Singlepoint to continue expanding without getting into trouble with any state or federal laws.

According to InsiderFinancial, the acquisition announcement relates to a company called Convectium, which has invented a mechanism that fills over 100 oil cartridges in just 30 seconds. Because of the high demand for this type of infrastructural technology, Singlepoint is expected to close this acquisition in the very near future.

According to Lambrecht and InsiderFinancial, Singlepoint’s key goals are to close its acquisition of Convectium, look for more acquisitions to close in the future, and continue to raise money for the company. With a market cap that has grown from just $5 million to over $40 million, and a significant amount of attention from new investors and other third parties, analysts believe that Singlepoint will continue to show signs of growth for the foreseeable future.

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

Let us hear your thoughts: Singlepoint, Inc. Message Board

At the recently held Conference on Retroviruses and Opportunistic Infections at the Washington State Convention Center in Seattle, details of clinical trial results presented by CytoDyn Inc. (OTCQB: CYDY) for its monoclonal antibody, PRO 140, were well received. The UK-based charity, NAM Aidsmap, known for its pioneering work in providing information on HIV/AIDS therapies, hailed the poster presentations on monoclonal antibodies such as PRO 140, noting the promise they hold as long-acting therapies for HIV/AIDS patients with limited treatment options due to drug resistance (http://nnw.fm/dFPp2). PRO 140’s efficacy has already offered hope to a number of HIV positive patients in a series of clinical trials. On behalf of CytoDyn, Dr. Kush Dhody of Amarex Clinical Research presented, in a well-attended special themed discussion, the latest results from the extension study of a Phase IIb trial of PRO 140 as a single agent maintenance therapy for people who had achieved viral suppression on standard combination antiretroviral therapy (ART) and wanted to switch to a treatment with fewer side effects to improve their quality of life and provide simpler compliance.

Antibodies are produced by the body as a first line of defense against pathogens such as viruses and bacteria. Each antibody is uniquely developed to combat a particular antigen, which it then counters by flagging the intruder as such, to be destroyed by microphages, or by neutralizing it. Monoclonal antibodies are artificially produced antibodies that have been cloned from one cell, hence the term “monoclonal”. Being clones, antibodies produced from one cell are identical, and this means that large numbers of a specific antibody can be produced to fight the unique antigens associated with a pathogen.

This characteristic of selectively targeting a pathogen has given antibodies the moniker ‘magic bullets’, since they attack the disease-carrying cells without harming the host. The term was first proposed by German physician Paul Ehrlich, whose insights into the operation of these immunological mechanisms earned him the Nobel Prize in 1908.

PRO 140 is considered one of the most advanced experimental monoclonal antibodies for HIV treatment and has been used in more than 140 HIV positive 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 has been designated a “fast track” product candidate by the FDA.

If approved for commercialization, PRO 140 could face a $20 billion U.S. HIV therapeutics market that is plagued with a number of ills, including difficult dosing schedules, resistance to currently used drugs, and, worst of all, the debilitating toxicity of standard highly active antiretroviral therapy (HAART). PRO 140 has been shown to address the weaknesses of HAART with no serious side effects, hardly any toxicity and no drug resistance when self-administered as a dose-a-week subcutaneous injection. Despite advances in the prevention and treatment of HIV/AIDS, the scourge still afflicts ‘more than 1.2 million people in the U.S.’, according to the Centers for Disease Control and Prevention (http://nnw.fm/b5LWn). With PRO 140, CytoDyn is offering the hope of a longer and richer lifespan to many of those.

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

SolarWindow Technologies, Inc. (OTCQB: WNDW), on February 7, 2017, was named as a winner in the 2017 BIG Innovations Awards presented by the Business Intelligence Group (http://dtn.fm/Nb3Yd), an organization of business executives who utilize a proprietary formula to recognize superior performance. The company is a technology firm that develops transparent, electricity-generating coatings for windows on tall towers. Its product was one of only four named a ‘shining star’ of innovation and a Chairman’s Choice winner.

The coatings supplied by SolarWindow Technologies, Inc. have the potential to turn a skyscraper into a ‘clean power generator’, the company announced. Its veneers can generate electricity using either natural or artificial light, in shaded areas, and even reflected and diffused light. They can be applied to all sides of a tall building, and they’re capable of realizing electricity savings of up to 50% annually, the company said, noting that it could return a one-year financial payback. This potential return was validated by independent engineering studies, according to SolarWindow.

The coatings are designed to produce electricity through transparent and organic photovoltaic (PV) coatings applied to the glass and flexible plastic for applications to tall buildings. As a result, normally passive windows are transformed into electricity producers. The potential one-year payback has been seen on a 50-story building. The company’s technology can also provide more than 15 times the environmental benefits of a conventional solar rooftop PV system.

In a news release, Maria Jimenez, chief operating officer of the Business Intelligence Group, said, “We are thrilled to be honoring SolarWindow as they are leading by example and making real progress on improving the daily lives of so many.”

John A. Conklin, president and CEO of SolarWindow, added, “We are honored to be recognized by this distinguished panel of business leaders for our work in developing possibly the biggest single breakthrough in clean energy — converting the solar rays of the sun into electricity on skyscrapers the world over.”

For more information, visit www.SolarWindow.com

Advanced Medical Isotope Corporation (OTC: ADMD), a late-stage radiation oncology-focused medical device company, has developed a real power play portfolio in the radiotherapy segment of the cancer treatment market, a niche set to hit $11.3 billion on its own by 2025 globally, growing at an estimated 6.7 percent CAGR. Brachytherapy, or placing radioactive implants directly on or into cancerous tissue, is a component of this sector; however, brachytherapy hasn’t seen the kind of traction historically that an innovator like ADMD stands poised to wrest out of it. The brachytherapy market ran about $705 million in 2015 and consisted of a 60/40 mix between HDR/LDR (high- and low-dose radiation) or pulsed therapies on the one hand, and microsphere brachytherapy on the other.

A Market Ripe for Disruption

Even with somewhat innovative developments like microspheres helping to drive growth estimates of some eight percent CAGR for the overall brachytherapy space, and projections of $2 billion by 2030, only ten or so companies currently dominate this heavily consolidated space. Most microsphere solutions pose migration risk, require pretreatment of the patient (which only somewhat mitigates the migration problem), and carry similar risks to other radiotherapies when it comes to the overall impact to surrounding healthy tissues. Microspheres are also typically quite limited in terms of what types of cancers/tissue systems they can effectively address, with liver cancer treatments like Australian company Sirtex’s (OTC: SXMDF) SIR-Spheres® being the obvious analogy.

This is where a company like ADMD really stands out from the competition with its Yttrium-90 (Y-90) based radiotherapy solutions, such as the Y-90 RadioGel™ device (ruled a medical device by the FDA in 2013) which is a highly localized direct delivery technology that is injected into the tumor. Y-90 RadioGel delivers an exceptional therapeutic ratio (high degree of dose delivered to cancer tissues, relative to impact on normal tissues) thanks to Y-90’s short-range, which effectively delimits radiation impact to surrounding tissues. RadioGel promises to offer a superior therapeutic profile compared to existing solutions in the brachytherapy segment, even innovations such as Y-90 microspheres that pose significant migration risks, and thus still carry the standard risk to normal surrounding tissues.

Unlike more expensive brachytherapy industry standard isotopes such as Cesium-131, Iodine-125, or Palladium-103 (which primarily emit auger x-rays of an infinite path length, use complex/costly delivery systems, and have a half-life ranging from 9.7 to 60 days), Yttrium-90 has a very short path length of only 4mm, a half-life of just 2.7 days, and is considerably less expensive/more accessible. This means Y-90 solutions are much safer to handle for healthcare professionals, treatment times are sizably reduced, and huge cost savings can find their way to the consumer. Perhaps most importantly though, is the earlier point about how Y-90 RadioGel is not limited to a handful of tumor/cancer types, as is the case with most microsphere or seed-based brachytherapy products.

Tech Portfolio Coverage Hints at Upper Limit Potential

Not content to rest on the laurels of a brachytherapy device like RadioGel, which obliterates the migration problem and has shown in studies that greater than 99 percent of the radiation stays in the tumor, the company has also developed a new approach to so-called permanent seed brachytherapy as well. ADMD’s Y-90 Fast-Resorbable Polymer Seeds (which contain RadioGel), unlike the industry standard glass or titanium seeds (which are packed with radioactive material and then injected to the tumor site), are fully resorbable/biodegradable and leave no casing behind.

The contrast couldn’t be more apparent between these proprietary polymer seeds containing RadioGel, and standard permanent seed therapy in the typical use scenario of prostate cancer. The RadioGel-containing polymer seeds are administered via a minimally invasive procedure that only requires small-gauge needles, whereas the standard permanent seed therapy uses up to 30 large needles, which inject seeds whose casings are left behind. Put yourself in the shoes of a patient for even five seconds and the contrast becomes glaringly obvious.

ADMD has even developed a Y-90 Polymer Topical Paste product engineered for direct application to tissues after a tumor resection, where it works hard to kill off any residual tumor cells that got missed during the surgery. This is an important product due to the constant fear of cancer recurrence, which has been a PR black-eye for the oncology community, and is indeed quite devastating to brave cancer survivors. Going through all the cost, suffering, and difficulties of cancer treatment, only to have the cancer come back, is a living nightmare that is all too common among cancer patients.

The short-range beta radiation emitted by Y-90 particles offers such high therapeutic index possibilities that the products ADMD has developed could even help to gradually reshape the standards of care within the broader cancer treatment market. And brachytherapy, one of the oldest known approaches to radiotherapy, could see a big, big resurgence. The company has exclusively licensed the Y-90 polymer composite tech (which was developed at Pacific Northwest National Laboratory) from the legendary Battelle Memorial Institute, one of the top government/commercial research institutes in the world.

ADMD is On the March, Pet Oncology is the Spear Tip

The company achieved an important milestone in late February 2017 with its fourth letter in a series of communications with the FDA, wherein the company identifies skin cancer (basal cell and squamous) as the primary indication via which RadioGel will be pushed towards FDA submittal and commercialization. An excellent choice given the laborious complexities of skin cancer surgeries and their post-op complications. These issues are particularly vexing for elderly patients, who have skin that is usually significantly thinner and much less robust.

With some 3.3 million or more skin cancer patients in the U.S. alone, many of whom have more than one tumor, it is reasonable to assert that the superior therapeutic profile of ADMD’s RadioGel could see the product rapidly become the indication of choice preferred by both patients and healthcare professionals alike. Looking at the technology portfolio here and the broad range of cancer types that can be treated using ADMD’s products, it should be tantalizing to investors just how much of the roughly $113 billion global cancer therapy market the company could eventually gobble up. Particularly when one considers the 7.4 percent CAGR projections for the industry as a whole through 2021. Post-commercialization, once the word about this technology really starts getting out to consumers, ADMD could be sitting on a gold mine.

The company also released a key letter to shareholders in February, mapping the new and streamlined path forward to FDA submission, which also contained a more formal introduction of new management appointed at the end of 2016. It included the appointment of a new CEO by the Board of Directors, Dr. Michael Korenko, and the appointment of Dr. Carlton Cadwell as Chairman. It’s a serious move by ADMD to show the FDA that they are not only listening, but taking guidance as gospel.

As a prominent indicator of just how aggressive the company really is about commercialization, one need only look at its emphasis on the veterinary oncology market. This is something of an open trade secret these days in biopharma: if you want to rapid-prototype your way into human use as a novel medical device developer, on-ramp via the pet market (if you are lucky enough to be able to).

Advanced Medical Isotope Corporation’s wholly-owned IsoPet Solutions subsidiary just announced late last year in October that the first animal, a cat, had received initial treatment with the pet version of the Y-90 RadioGel. This study will generate important data and help to advance the product towards commercialization in the veterinary market, paving the way for longer-term human use approval by the FDA. This is an exciting forward vector for the company, given the Trump administration’s vow in February to massively overhaul the FDA, with an emphasis on speeding up the pace at which new drugs come to market.

Looking at just the veterinary oncology market we have a winning proposition with ADMD’s Y-90 tech portfolio, given that roughly half of all dogs and around one third of all cats will be diagnosed with cancer in their lifetime. There are around 85.8 million cats and 77.8 million dogs in the country and we now live in an age where pets are essentially bonafide members of the family. The preceding statistic should color the likely much broader incident rate of undiagnosed cancers in cats and dogs, and throw light on the comparatively much cheaper/effective radiotherapy solutions ADMD is developing. Cancer is the leading cause of mortality in cats and dogs alike, with the average radiation treatment for dogs currently costing from around $5,000 to $7,000.

People love their pets but that is a hefty price tag for the average consumer. IsoPet Solutions could place effective pet cancer treatment for a broad range of caner types well within comfortable striking distance for millions of average consumer households. Ask around, comprehensive cancer treatment for pets is simply not doable for most people today, as the average pet owner simply cannot afford to shell out that kind of capital, even for a cherished pet whom they consider a genuine member of the family. The PR upside for ADMD on this subject alone basically writes itself. As an investor, one can just imagine the publicity boon from being able to make such a boast to pet owners, as having an effective/affordable cancer treatment to save the lives of their cats and dogs.

The proven efficacy of radioisotopes for melting cancer in a localized fashion, further hyper-localized and made safer by the company in terms of impact to surrounding tissues, is an easy sell. ADMD is a very interesting play in the oncology space with some serious potential due to broad spectrum applicability of the tech, and is currently trading near the bottom of the 52-week range ($0.07 to $1.00) at approximately $0.15/share.

To take a closer look, visit https://www.isotopeworld.com and http://www.isopetsolutions.com

ProBility Media Corp. (OTCQB: PBYA), based in Houston, TX, is an EdTech Company that is building the first full service training and career advancement brand for the skilled trades. Through both acquisitions and organic growth, ProBility is executing a disruptive strategy of defragmenting the market place of disparate companies servicing fifteen vertical categories in over sixty skilled trades. ProBility has positioned itself as a key industrial training resource for individuals, small- and medium-size businesses as well as enterprise customers offering consistent high-quality training services and materials for education, testing, and career advancement.

Through its Electrical Training Division, the company has become the biggest wholesaler of electrical codes and test preparation materials in the U.S., while its Construction Training Division is one of the largest certification providers in the country, with programs in 22 states, and continuing to grow. The company serves corporate accounts and government buyers, and also offers advisory services for companies of all sizes.

Companies currently under the ProBility Media conglomerate include:

• Brown Technical Media Corp. – An online web business with multiple micro web sites featuring training materials and codes and standards sought by engineers, construction workers, scientists and other tradesmen in a wide variety of fields.
• Brown Technical Publications – A proprietary publishing business generating copyrighted training materials for engineers, construction workers, scientists and other tradesman in a wide variety of fields.
• 1ExamPrep – E-Learning, education and exam preparation for contractors via the cheapest, fastest and most effective exam prep school in the industry instituting our 4-point proven learning system.
• National Electrical Wholesale Providers – In the business of distributing wholesale industrial, commercial and residential training materials including HVAC, plumbing and electrical.

ProBility’s technology platform features virtual reality training for the crane business to be expanded into other industries, online subscription services for enterprise level companies, and recurring revenue streams. In addition, the company is already beginning to explore international expansion options, supported by the fact that other countries have adopted U.S. based codes, and have used U.S. training services.

The company’s acquisition strategy targets operations that service engineering firms, electrical contractors, fabricators, plumbing contractors, pipe fitters, riggers, QC firms, and additional vocational industries.

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

Oil and gas company stocks have taken a beating as oil prices have tumbled from a peak of over $100 in 2014 to around $50 a barrel today. This fall in prices crippled many exploration and production companies. Down from its peak of nearly $20 per share in 2014, Ring Energy, Inc. (NYSE MKT: REI) is still in a better position than most. Unlike other drillers, Ring Energy isn’t highly leveraged and has comparatively low production costs.

Ring Energy has stated that it could operate profitably under $60 per barrel, and the majority of the company’s crude production is based in the Permian Basin, which has fewer bottlenecks than the Bakken Formation. In its January 9, 2017, press release, the company reported “net production for the fourth quarter of 2016 was approximately 240,000 BOEs (Barrel of Oil Equivalent), as compared to net production of 218,500 BOEs for the same quarter in 2015, an approximate 10% increase, and net production of 209,000 for the third quarter of 2016, an approximate 15% increase… For the twelve months ended December 31, 2016, net production was approximately 865,500 BOE, as compared to 742,070 for the twelve months ended December 31, 2015, an approximate 16% increase.” The company’s low production costs and the increase in production has correlated into its share price more than doubling over the last year.

Ring Energy’s exploration and production interests focus primarily on Texas and Kansas. The company’s drilling operations target the Central Basin Platform in Andrews and Gaines Counties, Texas, and the Delaware Basin in Reeves and Culberson Counties, Texas. The company has proved reserves of approximately 24 million BOE.

Oil has certainly been on a ride the last few years, but it’s still an essential commodity that will continue to drive the world economy. Ring Energy has weathered the oil price collapse. Any further increase in oil prices, combined with the company’s cost cutting and increased production, should provide both topline and bottom line lift in the coming quarters.

For more information, visit www.RingEnergy.com

Less than two weeks after making a presentation at the SeeThruEquity Conference in Miami Beach, SeeThruEquity increased its price target for ChineseInvestors.com (OTCQB: CIIX) to $3.75. The previous price target for CIIX, issued in October 2016, was $2.05. SeeThruEquity delivers unbiased and unpaid for equity research for publicly traded companies with market capitalizations of less than $1 billion. The increased target price reflects the added potential from legal cannabis initiatives taken by ChineseInvestors.com. Though in the early stages of penetrating the legal cannabis market, ChineseInvestors.com has demonstrated prior success with its profitable investment in Medicine Man Technologies, generating $2.3 million in proceeds from stock sales of Medicine Man in 2016.

Traditionally, ChineseInvestors.com has delivered a broad range of products, services, and information for the Chinese speaking population, estimated at 1.2 billion people worldwide. The company provides real-time market commentary, analysis, and educational services in the Chinese language, and it offers several types of subscription-based services. Founded in 1999, the company is headquartered in Los Angeles with offices in New York City and Shanghai, China. ChineseInvestors.com also offers consultation services to private companies seeking to go public, as well as advertising and public relations services.

With a focus on value-added opportunities, the company has recently expanded into retail and online sales of cannabidiol (CBD) products. CBD is considered to have a broad range of potential medical applications, including the treatment of epilepsy. With multiple anecdotal claims of CDB efficacy in treating epilepsy, Great Britain-based GW Pharmaceuticals is seeking FDA approval to market a liquid formulation of pure plant-derived CBD. Clinical reports show CBD is devoid of the euphoric side effects associated with THC. ChineseInvestors.com markets CBD products to the Chinese people through its website, www.ChineseCBDoil.com.

Although early in market penetration, ChineseInvestors.com is among the very first to capitalize on selling CBD products to 1.2 billion Chinese people. The company has previously exhibited the ability to identify and execute upon opportunity. Given its track record, it should come as no surprise if CIIX succeeds in this new venue and, subsequently, achieves SeeThruEquity’s price target.

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

Monaker Group, Inc. (OTCQB: MKGI) will present at the ROTH Conference on March 15, 2017. The 29th annual conference will be held March 13-15 in Dana Point, California, at the Ritz-Carlton. Monaker Group is a multi-tiered technology travel company targeting the high-end tourism market, the alternative lodging rental (ALR) industry, and business/leisure travelers.

Bill Kerby, chairman and CEO, will present on March 15 at noon, when he is expected to discuss the company’s all-in-one site that includes a real-time booking engine for ALR, conventional travel and specialized tours. Omar Jimenez, company CFO, and Richard Marshall, director of corporate development, will also be present.

The presentation will be rebroadcast on the company’s website and will be broadcast live at http://wsw.com/webcast/roth31/mkgi. Kerby, Jimenez, and Marshall will be available for meetings throughout the conference for institutional and individual investors. Meetings can be pre-scheduled through email at OneOnOneRequests@roth.com.

Hundreds of companies are scheduled to make presentations at the ROTH Conference, as well as to participate in question sessions and direct and small group meetings.

ROTH Capital Partners, LLC, is a privately-held investment bank based in Newport Beach, California, that’s focused on emerging companies.

Monaker Group operates the NextTrip.com website, which offers rich content and a library of some 15,000 hours of video that assist travelers in their search for travel destinations and tours. The booking engine offers users the choice of conventional travel, ALR, or specialized tours prepared by a subsidiary of the company. The company has targeted several demographics, and it sees the potential growth of the ALR market, especially for travelers who seek challenging and adventurous trips. Monaker is also focused on business travelers who wish to add additional days for personal travel. Monaker Group aims to capitalize on ALR’s current status as one of the fastest growing sectors of the travel industry.

For more information, refer to www.MonakerGroup.com

The Female Health Company / Veru Healthcare (NASDAQ:FHCO) has established for itself an extremely robust footing in the global public health sector via its hormone-free, latex-free FC2 Female Condom, the only FDA-approved female condom in a market forecast to deliver nine percent plus CAGR over the next five years. The Americas, EMEA and APAC regions alone amount to roughly half a billion plus in revenues already, according to Technavio, and while the Americas’ female condom market accounts for nearly half of the global sum, China and India will most likely drive APAC to out-pace all other regions in terms of growth by a margin of a full one percent or more.

Having originally been founded back in the ’80s during the height of the AIDS epidemic, The Female Health Company’s clear vision of bringing a best-of-breed dual protection product for women to the public health table has now fully blossomed into one of the true frontline weapons in an ongoing struggle against both unwanted pregnancy and the spread of STD/STI (sexually-transmitted disease/infection). An ingenious example of design, the FC2 utilizes a non-latex nitrile sheath that is not only safe to use with oil or water-based lubricants, it also offers increased pleasure potential for both parties, as the material warms from body heat, and possesses a very natural feel. The FC2 also offers a higher rate of protection against unwanted pregnancy and sexually transmitted infection compared to male condoms, meaning that dual-use scenarios where both solutions are deployed often result in a strong additive relationship, leading to a higher overall rate of protected sex among populations.

Empowering women in 144 countries around the world with its FC2 product, FHCO’s combined two decades plus of extensive field experience doing education and distribution programs across the globe has earned the company impeccable credentials within the industry. Whether we are talking about big multilateral entities such as USAID and UNFPA, various national ministries of health, or the key NGOs whose confidence is often the deciding factor between massive contracts or relegation to obscurity. The Female Health Company offers free sexual and reproductive health training materials, as well as FC2 usage training materials, to providers and healthcare professionals via its website (from the same curricula used in FHCO’s worldwide education programs).

Q1 unit sales of the FC2 this year were on par with 2016’s first quarter at around 6.3 million, when you pull out the 9.1 million units attributable to the extraordinarily large Brazil Ministry of Health contract shipments that FHCO fulfilled last year. If you pull out related non-recurring acquisition-related costs and outlays for securing of vital IP, both the Q1 FY17 and FY16 financial data sets look quite good. The company also raked in a $2.8 million payment in early January from its exclusive Brazilian distributor Semina, and it has been informed that more payments on the $13.1 million outstanding ($7.8 million in 2016 invoices alone) are forthcoming for FY17. Quarter-to-quarter fluctuations are par for the course here and are related to timing and shipping of sizable orders, but the underlying fundamentals are solid, as is product throughput to end markets.

The overall success of the FC2 really primed FHCO for its transformational merger with Aspen Park Pharmaceuticals, Inc. (APP) late last year in October, which added a multi-faceted forward window to the company’s revenue profile in the form of APP’s attractive portfolio of men’s health-focused pharmaceuticals and consumer health indications. FHCO will be doing business as Veru Healthcare subsequent to the merger when it comes to pharmaceuticals for men’s and women’s health and oncology, as well as for consumer health and medical devices (as opposed to the division using the corporate name brand, The Female Health Company, which will oversee FC2 when it comes to the public health market). This distinct division, Veru Healthcare, will also deploy the company’s proprietary female condom as the FC2 Female Condom in the consumer health market and Female Disposable Contraceptive Device (FC2) in the U.S. prescription market.

President and CEO of FHCO, Mitchell Steiner, MD, certainly projected confidence about the company’s revenue growth-initiating merger last month, when FHCO released its Q1 FY17 financials, and noted of FC2 that it was “without equal” when it comes to contraceptive products for women who want to defend against both pregnancy and STDs. With HIV/AIDS still the top killer of women aged 15 to 44 globally, and around 80 percent of cases occurring via heterosexual transmission, the sheer utility of a product like the FC2, which can be inserted anywhere from hours or just minutes in advance of sexual intercourse, is unquestionable, particularly in at-risk populations like sex workers, where the existence of a female-use driven, dual-protectant product like the FC2 can potentially work wonders. Research has even shown substantial indirect healthcare cost benefits to the implementation of female condom programs, with two to three times return multiples on every dollar invested in countries such as Cameroon and Nigeria.

Solid financials and a healthy logistical footprint, as essentially a preferred provider in the public health/female condom market, amply supports FHCO’s expansion/growth strategy, and it is noteworthy how shrewd a move this is from a PR standpoint for a company already so well established in women’s health. Branching out boldly into pharmaceuticals with a focus on men’s health through Veru Healthcare is marketing gold, and with such IP-reinforced, exciting sexual health products for men as PREBOOST® in the pipeline (an OTC-available, convenient, discreet, medicated individual wipe designed to curb premature ejaculation), serious multi-pronged revenue growth may be on the near horizon for FHCO.

A disposable, pre-moistened wipe that employs a highly effective yet safe topical anesthetic, PREBOOST was designed by Clinical Professor of Urology and Reproductive Medicine at New York Presbyterian Hospital/Weill Medical College of Cornell University Dr. Fisch to solve application problems associated with industry-standard creams and sprays, while simultaneously providing powerful, yet subtle, skin desensitization. Available in easy to carry single-use packets, roughly the size of an individually-wrapped condom, PREBOOST is easy to apply without mess, and it doesn’t interfere with the pleasure from an orgasm.

The company has already sought Orphan Drug status from the FDA for its MSS-722, a patented and proprietary treatment for male infertility that would be the first orally-available option for such indications to come to market (only currently FDA-approved standard is HCG/FSH injections). The company is in a very good position here as the Trump administration moves to speed up the new drug approval process, and MSS-722 can effectively piggyback on extant clinical and nonclinical data for CLOMID (clomiphene citrate) tablets, which are currently being used as first line therapy in 90 percent of idiopathic (having an unknown pathogenesis, or spontaneous origin) infertile men. With a nice guidance follow up late last year in December to the company’s earlier pre-IND meetings with the FDA, FHCO is now gearing up for Phase 2 clinical trials of MSS-722 and expects an NDA filing sometime in 2019.

Another near-term viability (NDA expected this year) indication picked up under the merger is Tamsulosin DRS, a delayed-release sachet, novel oral powder-like formulation targeting Benign Prostatic Hyperplasia (BPH), which is set to hit $4.9 billion by 2024, according to research and consulting firm GlobalData, over which time the space will cook along at an impressive 8.23 percent CAGR. Tamsulosin DRS contains the same API (active pharmaceutical ingredient) as Tamsulosin hydrochloride, developed by Astellas (OTC: ALPMY; ALPMF) and typically marketed in the U.S. under the trade name FLOMAX®, for BPH, or enlarged prostate. A new formulation here by FHCO would knock directly on the front door of the roughly $3.5 billion domestic generic/FLOMAX market, as well as address the broader $4.5 billion (QuintilesIMS) U.S. BPH alpha blocker space. The development strategy here should seem familiar to readers, as FHCO can once again utilize extant safety and efficacy data (in this case FLOMAX data), in order to significantly benefit shareholders.

Also in the pipeline from FHCO’s Veru Healthcare division are APP-944 for hot flashes in men undergoing prostate cancer hormone therapy, which would be the first approved oral drug in this area (NDA expected in 2020), and two more oral drugs slated to NDA in 2022, APP-111/APP-112. The first of these, APP-111, is a third line hormonal therapy for advanced prostate cancer with phase 1 studies planned to take place in 2018. This will lead directly to an IND filing and APP-112 studies in gout (the most common form of inflammatory arthritis in men) the following year.

FHCO is making all the right moves to wrangle a revenue growth herd through the Veru Healthcare portfolio, and this growth strategy seems to have been marvelously handcrafted by management. Moreover, the company has recently executed a series of key appointments in support of its growth strategy, from the most recent tapping of 20-year veteran analytical chemist Matthew C. Gosnell, Ph.D. for the Senior V.P. of Manufacturing role, to the appointment in January of sales and marketing heavyweight Brian J. Groch (who has over three decades in pharma and biotech) as the company’s new CCO.

To learn more, visit www.veruhealthcare.com or www.fc2femalecondom.com