In my previous article on MabVax Therapeutics (MBVX) last week, “MabVax Therapeutics (MBVX): Promising Early Results in Treatment of Pancreatic Cancer“, I wrote about a near term positive driver in the upcoming release (expected  this month) of data from the Phase I trial of lead drug development candidates MVT-5873 (Therapeutic Agent Study) and MVT-2163 (Imaging Study).

In this article, I’ll share other considerations that make MBVX shares a compelling and STRONG BUY.

These include:

• Recent NASDAQ uplisting
• Cash position/no near term stock offering/dilution needed
• Noteworthy investments from Dr. Phillip Frost and OPKO health (OPK)
• Development pipeline
• Strength of management team
• Strong chart technical indicators

MabVax Therapeutics (MBVX) Share Information

Shares outstanding: 5.6 million
Approximate float: 3.8 million
Close on 9/6/16: $5.30
Market cap: ~ 29.7 million

MabVax Therapeutics uplisted from the over-the-counter market to the Nasdaq Capital Market, effective August 17th. While the benefits of this uplisting are known to most investors, they bear repeating.

The listing opens MabVax Therapeutics up to an entire market of institutional investors that previously could not buy the shares. Some institutions won’t touch a stock trading below $5/share, regardless of the exchange. With MBVX trading at/near that $5 point, and an update on Phase I trials of two lead drug candidates, expect that participation to increase as more institutions discover the stock. It’s not hyperbole to say that pancreatic cancer pharmaceuticals are typically blockbuster drugs, and as MabVax progresses lead candidates in the FDA trials, institutional participation should ramp considerably. Additionally, there are many retail investors who won’t touch a stock trading under $5 as well.

The Nasdaq Capital Market requires higher standards of  corporate governance and transparency to be in place for listed companies, another obvious benefit for shareholders. The bottom line here is that the Nasdaq Capital Market listing is very positive for MabVax Therapeutics and shareholders going forward, and buying shortly after the uplisting, (as in right now), is just plain good old fashioned common sense investing.

MBVX is Well Capitalized Following Recent Raise

Pharma and biotech stocks are cash-intensive and the need for a near term capital raises is a consideration. Buying shares after a recent raise is often the best way to avoid a dramatic drop in share price, plus unwanted dilution.

Fortunately, MabVax just completed a capital raise of $9.4 million and (from my discussion with management) the company now has access to approximately $16 million in cash. The present cash burn is about $1 million/month, so chances of near-term dilution are slim to none. This is a time when I love to buy biotech and pharma stocks! I hate surprises and dilution…who doesn’t?

Noteworthy Investments from Dr. Phillip Frost

As many reading this are aware, Dr. Phillip Frost is a well known and highly respected biotech investor. Often referred to as “the Warren Buffett of biotech”, his investments in MBVX shares began back in April, 2015, See: “MabVax Therapeutics Catches Eye of Billionaire Investor Dr. Phillip Frost and OPKO Health“.

Dr. Frost and $5B market cap OPKO Health (OPK) added shares of MBVX in the just-completed capital raise. If you peruse the SEC filings from April 2015-present, you’ll discover that Dr. Frost and OPKO Health now have an approximate 15% stake in MabVax Therapeutics. As a shareholder of MBVX myself, I like that.

Ability to Develop Multiple Blockbuster Drugs with HuMab-1 Antibody

Due to the properties of MabVax’s HuMab-5B1 antibody, drug development is not limited to a single cancer type. The 5B1 antibody has demonstrated high specificity and affinity, and has shown potent cancer cell killing capacity and efficacy in animal models of pancreatic, colon and small cell lung cancers.

The antigen the antibody targets is expressed on more than 90% of pancreatic cancers making the antibody potentially broadly applicable to most patients suffering from this type of cancer.

HuMab-5B1 was derived from a patient vaccinated with MabVax vaccine licensed from MSKCC

• Patients repeatedly vaccinated to drive immune response against cancer antigen
• Patient samples obtained at maximal response
• HuMab-5B1 chosen because of optimal characteristics
• Patient outcomes
  – Seven Stage IV patients vaccinated in 4Q08 and six are still alive (median: 197 weeks post-vaccination)
  – Patient from whom derived the HuMab-5B1 antibody remained disease free at 5+ years

The HuMab-5B1 antibody has ideal characteristics that enable development of a broad commercial platform of cancer drugs:

Due to the positive characteristics of MabVax’s HuMab-5B1 listed above, the drug pipeline in chart below and collaborations with Memorial Sloan Kettering Cancer Center, the NIH, Heidelberg Pharma, and Rockefeller University could be just the beginning:

Early Results Beat Blockbuster Drug Paclitaxel (Taxol) in Small Cell Lung Cancer

Early studies from the MVT-5873 trial, (which management will be giving an update on in September), show that doses of 25mg/kg and 50mg/kg of MVT-5873 resulted in a greater slowing of tumor growth than 10mg/kg of Paclitaxel alone.

Moreover, the combination of MVT-5873 with Paclitaxel demonstrated a strong synergistic effect on Paclitaxel alone in slowing lung cancer tumors.

• Keep in mind that because MVT-5873 is based on MabVax’s HuMab-5B1, side effects to date have been benign/minimal.
• Also keep in mind Paclitaxel remains a widely prescribed chemotherapy drug and the market capitalization of MBVX is a mere $29.7 million today.

Early Results also Show Much Greater Slowing of Tumor Growth when Combined with Current Standard of Care Drugs for Metastatic Pancreatic Cancer

Strong Patent Moat

The major claims of patents awarded to MabVax Therapeutics to date cover composition of the vaccine, methods of treatment, chemical modification of antigens, and synthesis.

11 issued patents and 3 pending applications in the U.S.
– Issued patents covering monovalent and polyvalent vaccines, methods of manufacture,
methods of use
– 2 pending applications covering monoclonal antibodies
14 international patents and 3 pending applications
– Issued patents covering monovalent and polyvalent vaccines, methods of manufacture,
methods of use
– 2 pending applications covering monoclonal antibodies
Orphan drug designation available for vaccine and antibody products
– Received U.S. FDA ODD in Sept 2014 for neuroblastoma vaccine

Highly Skilled, Veteran Management Team with Extensive Drug Development and Commercialization Experience

The management team’s experience in drug development, joint ventures, and drug commercialization/product launches adds exceptional value that will be realized by more institutions as the company continues to be discovered on the Nasdaq Capital Market.

Founder and CEO, J. David Hansen
David Hansen has more than 30 years of industry experience as a biopharmaceutical industry executive, having held senior management roles in both private start-up companies as well as small to mid-sized public companies. His senior level experience includes executive management, finance and accounting, corporate development, sales and marketing. During his career, Mr. Hansen has executed a wide variety of in and out licensing agreements, research and development collaborations, joint ventures, divestitures, and acquisitions. Mr. Hansen has expertise in the therapeutic areas of immunology, oncology, and infectious disease. Mr. Hansen gained executive management experience at several life sciences companies prior to co-founding MabVax Therapeutics that make him particularly suited for his leadership role. He was a corporate officer of Avanir Pharmaceuticals where he held the titles of Vice President of Commercial Development, Senior Vice President of Corporate Development, and President and Chief Operations Officer of the Avanir Subsidiary Xenerex Biosciences. Prior to Avanir, Mr. Hansen served in multiple roles at Dura Pharmaceuticals including National Sales Director, Director of Marketing, and Director of Business Development. He has additional management experience with Merck & Co. (Schering-Plough), Key Pharmaceuticals, and Bristol Myers Squibb.

Co-founder and Chief Science Officer, Philip Livingston, M.D.
Philip Livingston received his MD degree from Harvard Medical School and was Professor of Medicine in the Joan and Sanford Weill Medical College at Cornell University and Attending Physician and Member in Memorial Sloan-Kettering Cancer Center (MSKCC) where he treated melanoma patients and ran the Cancer Vaccinology Laboratory research lab for over 30 years until his retirement from MSKCC October 1, 2011. Dr. Livingston’s research focused on: identification of suitable targets for immunotherapy of a variety of cancers, construction of polyvalent conjugate vaccines specifically designed to augment antibody responses against these targets, and identification of optimal immunological adjuvants to further augment the potency of these vaccines. He has over 150 publications and 4 issued and 3 pending patents concerning cancer vaccines.

Co-founder and Vice President of Antibody Discovery, Wolfgang Scholz
Wolfgang W. Scholz, Ph.D. has extensive drug discovery experience in multiple therapeutic categories and has collaborated with major pharmaceutical companies on several projects. He was Senior Director at Avanir Pharmaceuticals, where he led research and development efforts for 8 years, and was a co-founder of Xenerex Biosciences, a subsidiary owned by Avanir Pharmaceuticals. Under his leadership, the antibody discovery group at Xenerex developed human monoclonal antibodies to multiple infectious disease targets using in vitro and SCID mouse technologies, and one antibody (AVP-21D9) was successfully out-licensed and recently passed Phase I safety testing. Prior to Avanir, Dr. Scholz held positions with increasing responsibilities at Tanabe Research Laboratories. Dr. Scholz is the principal investigator on multiple National Cancer Institute grants received by MabVax totaling almost $5 million. Dr. Scholz is an inventor on three pending and three issued antibody patents, three issued small molecule patents, and author on thirty-four peer-reviewed publications. Dr. Scholz earned his Ph.D. in Microbiology and Immunology from the University of Kiel, Germany in 1985 and completed his postdoctoral training at The Scripps Research Institute, La Jolla.

Vice President and Chief Business Officer, Paul F. Resnick
Dr. Resnick has an M.D. from The Medical College of Wisconsin and an MBA from The Wharton School of the University of Pennsylvania, and recently joined MabVax Therapeutics in April of this year. Prior to joining MabVax, Dr. Resnick was Senior Vice President, Business Development for Juventas Therapeutics, where he was responsible for business and commercial strategy and working with executive management overseeing corporate clinical development, and financial and business strategies. From January 2008 to January 2012 he was Vice President, Business Development for Intellikine, Inc. (acquired by Takeda Pharmaceuticals), responsible for managing alliances and leading the business development strategy that resulted in securing an acquisition by Takeda Pharmaceuticals. Dr. Resnick also held Senior Director positions for Worldwide Business Development, and for Strategic Alliances, at Pfizer Inc., where he was responsible for networking with leaders from biotechnology companies, universities, and research institutions to gain early insights into emerging technologies, and for leading technical and business diligence, negotiations, and alliance management of science and technology initiatives for Pfizer’s Biotechnology and Bio-innovation Center. Prior to Pfizer Dr. Resnick held Director and Senior Director positions at Rinat Neuroscience (acquired by Pfizer), Intermune, Inc. and Roche Pharmaceuticals.

Executive VP of Research and Development, Paul W. Maffuid, Ph.D.
Dr. Maffuid’s management experience includes global pharmaceutical organizations, developing biotechnology companies and contract development and manufacturing organizations. His senior level management experience includes leadership for product development, manufacturing and drug disposition. Throughout his career, Dr. Maffuid’s organizations were integral for research and development activities and represented by regulatory filings for biopharmaceuticals and small molecule therapeutics indicated for oncology, diabetes, CNS disorders and obesity. Dr. Maffuid served as Executive Vice President, Pharma Operations for AAIPharma Services Corporation and was a member of the Executive Team that transformed a declining business into a leading provider of integrated drug development services. His responsibilities included formulation, manufacturing, and analytical services for clients developing biologic and small molecule therapeutics. Prior to joining AAIPharma he was the founder and President of Biopharmalogics, Inc. a consulting company supporting the development of pharmaceutical products from 2008 to 2011. Earlier in his career Dr. Maffuid was Senior Vice President of Operations at Irvine Pharmaceutical Services, Inc., and Vice President of Pharmaceutical Development for Arena Pharmaceuticals. While at Arena Pharmaceuticals Dr. Maffuid was a member of the executive management team, was responsible for drug product and drug disposition research and development operations, and led the design and construction of a cGMP compliant pilot manufacturing facility. Dr. Maffuid’s management experience also includes Amylin Pharmaceuticals, Magellan Laboratories and Glaxo Research Institute (currently GSK).

Chief Financial Officer, Gregory P. Hanson
Gregory P. Hanson, CMA, has over 30 years serving as CFO/financial executive of both public and private biotech and hi tech companies. From January 2008 to February 2014 Mr. Hanson was Managing Director of First Cornerstone, a board and management advisory service to companies and executives in the areas of international corporate development, financing strategies, commercialization of technologies and products, and M&A advisory service. Since November 2009, Mr. Hanson has served as Advisory Board Member of Menon International, Inc. involved in commercialization of biosensor devices and assays, and renewable products. Since October 2011, Mr. Hanson has served on the Life Sciences Advisory Board of Brinson Patrick Securities, a boutique investment bank. He also serves as mentor and confidential advisor to several other tech and life sciences companies. Mr. Hanson is Past-President and 9-year Member of the Board of Directors of San Diego Financial Executives International (FEI), and a member of the Capital Formation Committee at BIOCOM since 2011.  Mr. Hanson served as Senior Vice President of Brinson Patrick Securities, where he opened up the San Diego branch and introduced at-the-market financing strategies to public life sciences companies. Prior to Brinson Patrick Securities, Mr. Hanson served as Senior Vice President and Chief Financial Officer of Mast Therapeutics (MSTX—NYSE MKT), and prior to Mast Therapeutics was Vice President and CFO, Chief Accounting Officer, Compliance Officer and Corporate Secretary of Avanir Pharmaceuticals, Inc. (acquired by Otsuka Holdings Co., Ltd.), the developer of the cold sore product Abreva™, and Neudexta™, for the treatment of Pseudobulbar Affect, a central nervous system disorder. During the course of his career, Mr. Hanson has completed approximately $1 billion in financing, licensing and partnering arrangements. Mr. Hanson was a founding and 6-year member of the Small Business Advisory Committee to the Financial Accounting Standards Board, and has spoken at various national conferences, industry organizations and panels on financing strategy and mergers and acquisitions, and twice spoken to the SEC’s Committee on Improvements to Financial Reporting. He has an MBA with distinction from the University of Michigan, and a BS in Mechanical Engineering from Kansas State University.

Chart Technicals

The MBVX chart looks strong here, with a notable increase in volume since the NASDAQ uplisting, accompanied by a rise in share price as recent lows bounced off the uptrend line.

Keep in mind many institutions can not buy stocks trading below $5/share.  As MBVX continues to close above $5/share, investors can expect an increase in institutional participation.

Review of Near Term Forward Drivers

In addition to increased institutional participation following the Nasdaq uplist and low float (3.8 million shares), there are several positive drivers that should push MBVX shares higher during the remainder of 2016.  These are:

• MVT-5873 (for treatment of pancreatic cancer) and MVT-2163 (a companion diagnostic) interim program milestones expected this month (with full Phase I readout mid-2017)
• Plans to file IND for radioimmunotherapy program Q4 2016
• Presentation and meetings with investors at the 18th annual Rodman & Renshaw Global Investment Conference in NYC 9/11-9/13/2016 (see brochure)

Conclusion

MBVX is a compelling buy here due to:

• Recent NASDAQ uplisting leading to increased institutional and retail investor awareness and participation
• Cash position/no near term stock offering/dilution needed
• Noteworthy, repeat investments from Dr. Phillip Frost and OPKO health (OPK) for an approximate 15% stake in company to date
• Strong drug development pipeline using HuMab-5B1
• Strength of management team
• Strong chart technicals
• Near term positive drivers
• Low float + tiny market cap ($28 million) with blockbuster pancreatic cancer drug development potential

I’ll be attending the Rodman and Renshaw conference in NY next week.  I look forward to meeting management of MabVax Therapeutics, and sharing more near term positive developments with subscribers!

Supplemental: August, 2016 Investor Presentation

Best wishes for profitable investing!

Disclosure/Disclaimer/Terms of Use

Part I of II: Expect Near Term Positive News on Lead Product Candidates from MBVX

MabVax Therapeutics (MBVX) Share Information

Shares outstanding: 5.6 million
Approximate float: 3.8 million
Current Price: $4.90
Market cap: ~ 28 million

Repeat investments from Dr. Phillip Frost and OPKO Health (OPK) began in April 2015 and account for an approximate 15% stake in MabVax

Pancreatic cancers are extremely complex and, unfortunately, highly lethal.  According to the American Cancer Society the one-year relative survival rate is 20% and the five-year rate is 7% for all stages of pancreatic cancer combined. The 5-year survival rate for patients with metastatic pancreatic cancer is approximately 1 (one) percent.  This is a horrific disease in which survivability for the vast majority of patients is measured in weeks and months.

However, an area of research in pancreatic cancer treatment that shows initial and growing promise is in the development of immuno-oncology and cancer vaccines.  The American Cancer Society notes that:

“Immune therapies attempt to boost a person’s immune system or give them ready-made components of an immune system to attack cancer cells. Some studies of these treatments have shown promising results.”

and

“Several types of vaccines for boosting the body’s immune response to pancreatic cancer cells are being tested in clinical trials. Unlike vaccines against infections like measles or mumps, these vaccines are designed to help treat, not prevent, pancreatic cancer. One possible advantage of these types of treatments is that they tend to have very limited side effects. At this time, vaccines are available only in clinical trials.”

MabVax Therapeutics (web site) has shown early, promising results in clinical trials of immuno-oncology products developed from the human immune response to cancer, with an emphasis on pancreatic cancer.

Additionally, MabVax has:

• an attractive, multi-pronged drug development pipeline
• wide and expanding patent moat
• recent (August 17th) NASDAQ uplisting 
• low float (3.8 million shares)
• significant and recurring investments from Dr. Phillip Frost and OPKO Health, Inc.
• including recent capital raise, (closed August 22), MabVax Therapeutics can access $16M cash with a burn rate of ~ $1M/month
• positive near term drivers- early data from promising Phase 1 studies of lead product candidates expected within 5 weeks

MabVax Therapeutics Holdings, Inc., a clinical-stage biopharmaceutical company, engages in the discovery, development, and commercialization of proprietary human monoclonal antibody products and vaccines for the diagnosis and treatment of various cancers. It has a pipeline of human monoclonal antibody products based on the protective immune responses generated by patients who have been immunized against targeted cancers. The company generates its pipeline of antibody-based product candidates from patients who have been vaccinated with propriety vaccines licensed from Memorial Sloan-Kettering Cancer Center (MSKCC). Its lead cancer vaccines targeting recurrent sarcoma and ovarian cancer are in proof of concept Phase II multi-center clinical trials. The company’s product candidates include 5B1 antibody program, 5B1 imaging program, and 5B1 antibody drug conjugate, which targets an antigen over expressed on metastatic pancreatic, colon, stomach, ovarian, breast, and small cell lung cancers. It also develops follow-on antibody products, including 1B7 and 31F9 antibody programs to the antigen GD2, which is over expressed on sarcoma, melanoma, and neuroblastoma. The company has collaboration agreement with Heidelberg Pharma GmbH, as well as a research collaboration agreement with Rockefeller University’s Laboratory of Molecular Genetics and Immunology. MabVax Therapeutics Holdings, Inc. was founded in 2006 and is based in San Diego, California.

Lead Product Candidates MVT-5873 (Therapeutic Agent) and MVT 2163 (Imaging Agent)

MVT-5873 (Therapeutic Agent Study)

The Phase I trial is evaluating the safety, tolerability and pharmacokinetics of MVT-5873 as a single agent or in combination with the current standard of care chemotherapy regimen in subjects with metastatic pancreatic cancer. The first group of patients will be enrolled in a traditional dose escalation regimen to assess safety, the pharmacokinetics and determine the optimal dose of the antibody. A second group of patients will establish the safety and optimized dose of the antibody when administered with a standard of care chemotherapy as a first line therapy for the treatment of patients with advanced cancer.

On March 21, 2016, MabVax announced the initiation of the Phase 1 trial of MVT-5873 in patients with pancreatic cancer. This is an open label, multi-center, dose escalation clinical trial with patient enrollment initiated at three clinical trial sites: Memorial Sloan Kettering Cancer Center (MSK) in New York as well as two sites within the Sarah Cannon Research Institutes network at the Tennessee Oncology site in Nashville, TN, and Sarah Cannon Research Institute at Florida Cancer Specialists in Sarasota, FL.

The initial cohort of patients will be treated with 1, 3, 6 or 10 mg/kg of MVT-5873 to determine the MTD. This dose will then be utilized in an expansion cohort of approximately 10 subjects to examine additional safety and PK parameters. For the combination study, the first cohort will be treated with one dose below the MTD with escalation up to the MTD. This dose will then be utilized in an expansion study where MVT-5873 will be administered alongside the standard of care chemotherapeutic agent gemcitabine.

See ClinicalTrials.gov for in-depth study information.

Positive Early Results Hinted at in 10-Q Filing on 8/11/16: 

On page 24 of the 10-Q filing for the quarter ending June 30, 2016, MabVax Therapeutics disclosed (in relation to MVT-5873) that:

“Of the nine patients who have been dosed to date, five have been treated for three or more months and investigator observations have noted stable disease for a subset of those patients. We are continuing to escalate the drug dose to assess safety and reach an MTD and anticipate initiating the second portion of the trial where our drug is dosed in combination with chemotherapy in the fourth quarter of this year.  We expect to have the preliminary results of this clinical trial later in the third quarter in 2016.”

Now, a “stable disease for a subset of those patients” (with late-stage, metastatic pancreatic cancer) is an extraordinary and strongly positive near term driver.  Expect a press release on these exciting early results by end of the current quarter…within the next 5 weeks based on the SEC filing. 

MVT-2163 (Imaging Study)

As a bit of background, part of the reason pancreatic cancers are so lethal is because they typically cause no symptoms, or (at best) vague symptoms in the earlier stages. As a result, the diagnosis of pancreatic cancer is most often made at a very late, metastatic, stage IV disease.

Widespread screening, (analogous to mammograms for breast cancer or colonoscopy for colon cancer), is not practical for this less common cancer. However, improved diagnostic imaging tests can be extremely useful in high-risk groups, such as those with a strong family history of pancreatic cancer.

Simply put, the earlier this devastating  disease can be identified and aggressively managed, the better the chance for survival. Because of this, MabVax Therapeutics received a $1.75 Million contract for development of the HuMab-5B1/MVT-2163 Imaging Agent from the National Institutes of Health (NIH).

The Phase I clinical trial for MVT-2163 (see ClinicalTrials.gov)  was initiated in the second quarter of 2016 at Memorial Sloan Kettering Cancer Center for the Company’s new generation fully human immuno-PET imaging agent. In this Phase I trial, the safety, pharmacokinetics and biodistribution of MVT-2163 is being evaluated in patients with pancreatic and other CA19-9 positive cancers. The trial will determine the ideal dose and conditions for an optimal PET scan image.

MVT-2163 has demonstrated high-resolution images of tumors in xenograft animal models, potentially making it an important new tool to aid in the diagnosis, monitoring and assessment of patients with pancreatic cancer and an attractive companion diagnostic for the MVT-5873 therapeutic product.

Like the early results from the MVT-5873 study, MabVax Therapeutics plans to provide an update on MVT-2163 in the near term according to the August 11th 10-Q filing which states:

“Investigator observations showed scans potentially highlighting smaller metastatic sites not seen on standard CT scans.  These results are preliminary and require more patients to confirm.  We expect to have the preliminary results of this clinical trial later in the third quarter 2016”

Clearly there are exciting times ahead for investors in MabVax Therapeutics, and more significantly, some cause for optimism in the future treatment of pancreatic cancer.

I’ll be sharing part 2 of the MabVax Therapeutics investment thesis later this week.

See also: June 2016 Investor Presentation

See Disclosure/Disclaimer/Terms of Use

3D printing stocks are in rally mode following respectable results from industry leader 3D Systems (DDD).

Adjusted earnings of $0.12 per share were almost double what the street expectations were, and I’m sure there some short covering involved in the 19% move higher to top $14.50/share.

In the release, CEO Vyomesh Joshi stated:

“We were pleased with continued strong demand for our healthcare solutions and software as well as increased materials sales into advanced industrial and healthcare applications” 

It’s noteworthy that DDD is seeing the greatest revenue driver in the medical applications (including materials and software) space- and this is an established trend.

The 3D printing medical devices market (consisting of 3D printing equipment, materials, and services & software) is poised to grow at a CAGR of 25.3% from 2015 to 2020, and to reach USD 2.13 Billion by 2020 according to MarketsandMarkets.

Future Player in 3D Printing Medical Device Market

This may be a future player in the 3D printing medical applications space that’s as-yet unknown…

Take a look at Amedica Corporation (web site) ticker, AMDA

Amedica is commercializing silicon nitride ceramics as a biomaterial platform.

The AMDA market cap is just $15M with about $19.5M in sales last year for a P/S under 1

and…

The company is the first to 3D print Silicon Nitride for medical applications/joint replacement market.

see:  Silicon nitride plus robocasting equals a new approach to medical applications

Amedica is also waiting to hear from the FDA on a Composite Interbody Spinal Device utilizing silicon nitride. A decision from the FDA should be announced within the next two weeks according to this press release in June. Obviously a positive announcement from the FDA should be a strong catalyst for a move higher.

Beyond the pending FDA decision on the company’s interbody spinal device, Amedica Corporation is definitely “one to watch” if you are a 3D printing investor and are looking for a future player in the high-growth medical applications space of 3D printing.

Best wishes for profitable investing!

Disclosure: I am long shares of AMDA. I have not been paid by any person or company for this update.

Shares outstanding: 21.02 million
Price on date of publication: $5.06
Market cap: $ 106.36 million
Insider ownership: 29%
Float: 12.45 million
Institutional ownership: 4%

Goldman Sachs research believes that augmented reality (AR) and virtual reality (VR) have potential to become the next big computing platform and that AR/VR will become an $80 billion industry by 2025.  Forrester research estimates that enterprise customers will adopt 400,000 smart glasses in 2016 alone.  In 2015 the industry witnessed smart glass pilot program across a production line, but over the second half of 2016 commercial rollouts will expand and encompass an entire factory.  Google brought the hype to the industry in 2014 with the introduction of Google Glass, but one company’s smart glasses have outperformed Google Glass time in and time again in the enterprise field where it matters most.

The company that outperformed Google Glass in the enterprise field with its first generation augmented reality smart glasses was Vuzix (VUZI).  Vuzix has sold thousands of smart glasses to enterprise customers over the past few years and the company is planning a commercial rollout of its next generation smart glasses this summer.  Vuzix’s second generation smart glasses (M300) were developed based on the feedback from thousands of users.  The M300 smart glasses will continue to expand the performance gap between Vuzix’s smart glasses and the competition within the enterprise marketplace.

Market Overview: Enterprise Adoption of Augmented Reality Smart Glasses Will Be Massive

• “Over 14 million US workers will use smart glasses by 2025” – Forrester

• “8 % of all US workers will use smart glasses in their jobs by 2025” – Forrester

• “Augmented reality is expected to generate $80 billion in revenue (excluding hardware) by 2020 and become the backbone of immersive journalism where readers can experience a story and be part of it.” – Manatt Digital Media

• “Enterprises will spend over $30 billion on smart glasses hardware through 2025” – Forrester

• “You’ll start seeing them (smart glasses) used on a much larger scale than they were in 2015: Moving from one line to the whole factory, or from one factory to the whole bullpen of factories that support a process” – APX Labs via Washington Post

Forrester estimates that enterprise customers will adopt 400,000 smart glasses in 2016, with the total adoption of smart glasses expected to reach 14.4 million by 2025. The 2025 estimate assumes that 8% of US workers will wear smart glasses as part of their jobs.  New smart glass device unit sales are expected to make up a majority of unit sales through 2021 until sales of replacement units eclipse new units.

Forrester identified 264 jobs in the US that are most likely to benefit from smart glasses including the most jobs such as technician, repairer, operator and nurses.  Other jobs that are less common that made the list include museum curators and surgeons.  GE’s aviation engineers use APX Labs’ skylight software and smart glasses to power real-time, first person collaboration.  General maintenance and repair workers are expected to adopt a large number of smart glasses.

Forrester interviewed 13 vendor and user companies to compile its most recent report on enterprise smart glasses.  Vuzix works closely with more than half of the companies referenced in Forrester’s industry report including Intel, Boeing, General Electric, APX Labs, Atheer, Kopin and Salesforce.

Boeing, Airbus and General Electric are early users of smart glasses and have active smart glass pilot programs with Vuzix.  General Electric is expected to do a large commercial rollout of smart glasses in 2016 based on commentary provided by APX Labs in a November 2015 interview with Tech Crunch.

Vuzix partners with key software developers including APX Labs, Atheer and Salesforce, which are developing software to support the deployment of enterprise smart glasses.  These key relationships are yet another key confirmation why Vuzix is a leader amongst leaders in the augmented marketplace.

In addition to the companies named in the Forrester report Vuzix has partnerships with SAP, Lenovo, XOeye, Pristine Labs, AMA, NTT Data, HP, IBM, Augmate, Sony, AirWatch as well as several other around the globe.  Vuzix is also working closely with key smart glass integration partners including Accenture, who specializes in effective implementation of large-scale mobile technology deployments for clients such as Airbus.

Overview

Vuzix Corporation (VUZI) is an award winning, leading developer and supplier of smart glasses and video eyewear products in the consumer, enterprise and industrial markets.  The company has won 20 Consumer Electronics Show Innovations awards and holds over 40 patents and 23 additional patents pending along with numerous IP licenses in the Video Eyewear field.

The major shareholders of Vuzix are the founding management team and Intel Corporation, which collectively own approximately 40% of Vuzix Corporation.  Intel Corporation invested $24.8 million in Vuzix in January 2015 and owns 24% of the company.  Founded in 1997, Vuzix is a NASDAQ listed company with offices in Rochester, NY, Oxford, UK and Tokyo, Japan.

Shares outstanding: 21.02 million
Recent price: $5.06
Market cap: $ 106.36 million
Insider ownership: 29%
Float: 12.45 million
Institutional ownership: 4%

The Next Big Thing: Augmented Reality

Augmented reality is often times referred to as mixed reality, superimposes information or images on top of the real world through glass or a display of a device.  Virtual reality on the other hand provides a view of computer-generated scenes and is totally immersive. Augmented reality allows users to see what’s going on around us, whereas virtual reality users are restricted to a small area.  This is one of the prime reasons why augmented reality will have a more immediate practical applications for business according to a BBC News interview with industry leaders published earlier this year.

Google’s Glass project brought an incredible amount of media attention to the smart glass industry and augmented reality.  However, Google learned quickly that the company’s smart glass design was ill suited for consumers so the company decides to market the product to enterprise customers.  Enterprise customers were excited to have a hardware offering that could improve efficiencies and drive up productivity in manufacturing, warehouses for order picking and receiving as well remotely supporting service technicians.

Unfortunately for Google the company’s experiment to serve enterprise customers with a consumer designed product resembled a square peg being jammed into a round hole.  Google’s customers were left with a disappointing taste in their mouth and yearned for  augmented reality hardware offering that could deliver on Google’s initial promises.

In January 2015 Google announced that the company ended the sale of Google Glass under its explorer program. Google’s smart glass product simply didn’t live up to expectations.  The battery life was exceptionally short lived, the processor suffered from overheating due to inadequate tech specifications and to make matters worse the head worn device shorted out frequently from perspiration.   Google Glass failed to deliver real-time video stream, which makes any attempt at remotely delivering field service advice nearly impossible.

Google cared about its enterprise customers and instead of bailing on those customers Google picked up the phone and called the leading augmented reality manufacturer in the marketplace.  The industry leader that was on the other end of the phone call from Google was Vuzix, a company that was founded in 1997 in Rochester, NY that has been building a foundation in optics and wearable displays for nearly 20 years.

Vuzix introduced the M100 smart glasses in 2013, which were dubbed as the “first true competitor to Google Glass” by the Examiner.  Enterprise customers learned just a few years later that Vuzix’s M100 smart glasses were not simply a competitor to Google Glass, but the augmented reality hardware device that Google itself would recommend to its customers.

Vuzix has sold thousands of M100 smart glasses across a variety of industries including warehousing, logistics, biopharma, oil & gas as well as telemedicine industries since 2013.  Vuzix has worked with hundreds of companies that have evaluated the company’s smart glasses and provided critical feedback and user experiences.  Vuzix listened to the feedback provided by the company’s vast and diverse customer base, which led to the design of the M300 smart glasses.

Vuzix’s M300 smart glasses will address critical and necessary feedback from customers that will increase the value proposition for enterprise customers.  The ergonomic design of the M300 results in a sturdier, tougher and lighter device versus the first generation M100 smart glasses.

The M300 will feature a hot swappable battery that allows users to swap out an existing battery with a fully charged battery without skipping a beat.   The M300 will be waterproof, which is critical for the HVAC and other industries that may encounter wet environments.  Vuzix partnered with a leading US based Tier-1 contract manufacturer (Jabil Circuit) to produce the M300 smart glasses. The M300 will list for $1,499 or an increase of $500 over its predecessor the M100.

The M300 is set for commercial launch over the summer and industry researchers are expecting enterprise smart glass demand to hit full stride over the second half of 2016.  Vuzix’s known customer list includes DHL, General Electric, Airbus, Boeing, Tesla, Daimler, Volkswagen, Bosch, Bechtle and many more.  In total Vuzix has well over 100 customers including over 40 of the Fortune 100 companies.

A Close Look Into Vuzix’s Current Products and Pipeline

Vuzix M100 smart glasses for enterprise customers will soon be replaced by the M300, which is an all-around more impressive device in terms of design, functionality, features and component upgrades.  The “M” in front of Vuzix products stands for monocular and any product that begins with a “B” is a binocular based product.  The M300 will be the hit of the year for Vuzix beginning this summer, but the company’s current product offerings and pipeline does not end there.

iWear Video Headphones:

Vuzix currently generates limited revenue from sales of its iWear video headphones, which are immersive headphones best suited for gamers, drone owners, medical/dental facilities and other markets around the globe.  The iWear video headphones sell for $499 and the iWear’s direct competitor is the Avegant Glyph.  Vuzix encountered some manufacturing and supplier quality issues over Q4 2015 and the first half of 2016.  However, over the next month the company is expecting to reach full production levels.  The company recently launched an initiative with market leading companies such as GoPro to enhance iWear sales opportunities.

M3000 Smart Glasses

Vuzix is currently working on the company’s first waveguide based product for enterprise customers.  The M3000 features all of the advantages of the M300, but utilizes the latest optics to deliver a 1.4mm thin see-through display that will enable more advanced AR applications.  The M3000 is expected to begin shipping in the fall of 2016, shortly after the commercial launch of the M300.

VidWear B3000 Series Sunglasses

Vuzix is working on augmented reality sunglasses that resemble fashion-based sunglasses for enterprise customers and prosumers.  The VidWear B3000 waveguide sunglasses blend fashion and technology and is expected to be one of the world’s first sunglasses with integrated video.  The B3000 allows for full see-through capabilities in fashion glasses.  The B3000 VidWear products are targeted for introduction into the marketplace sometime in 2017.

The AR3000 waveguide augmented reality sunglasses will be Vuzix’s first binocular augmented reality smart glasses viewer.  These sunglasses are expected to feature two HD cameras with one for gesture support.  The wearer will be able to reach out and manipulate 3-D objects overlaid in the real world.  The AR3000 is being developed to provided advanced operator support for enterprise, industrial and medical uses.

Waveguides and Display Engines

Vuzix holds over 40 patents and 23 additional patents pending along with numerous IP licenses in the Video Eyewear field.  Vuzix has developed waveguide displays that use complex displays engines to enable image and video viewing through a microscopic display.  Vuzix is now producing display engines at the diameter of a large pencil with optical displays that are as thin as reading glasses.

During the FY 15 Q4 conference call Vuzix indicated that the company is actively sharing the company’s new waveguides and display engines with the public.  The display engines are mini projectors built into the wearable displays that beam an image into the waveguide displays for users to view.  Vuzix generated over $200,000 of revenue from waveguide sales to Intel in Q3.

The Tier-1 customers that Vuzix is working with are believed to be on par with the likes of Apple, Samsung and LG, which are all actively pursuing, augmented reality smart glasses for the consumer marketplace.  Other PC OEM manufacturers including HP and Dell are anticipated to enter the consumer augmented reality marketplace as well.

The augmented reality arms race occurring behind closed doors to introduce consumer centric smart glasses is in full swing.  The arrival of the first generation of smart glasses for consumers will hit the market within the next 6 to 18 months and Vuzix is well positioned to be a key player within the consumer smart glass marketplace.

Why Intel Corporation Invested $24.8m in Vuzix

In January 2015 Intel Corporation invested $24.8m (30% stake that currently sits at 24%) in Vuzix to advance Vuzix’s waveguides for fashion based wearable display products for the consumer marketplace.  Intel’s investment provided Vuzix with the financial resources to build a 30,000 square foot manufacturing facility to manufacture waveguides for the company’s next-generation wearable display products as well as the company’s strategic partners.

Intel has been providing silicon expertise for Vuzix behind closed doors for Vuzix’s next generation augmented reality smart glasses.  Intel and Vuzix are also working together on a secret augmented reality project led by Intel.  In December 2014, Intel partnered with Luxottica, the owner of Oakley fashion sunglasses on a collaborative research project to bring fashionable smart glasses to consumers.

The Wall Street Journal reported in March 2016 that Intel was developing an augmented reality wearable headset. According to the Wall Street Journal Intel’s augmented reality wearable headset is a reference design that will ultimately end up white labeled and sold through a leading OEM.

According to a recent SEC filing Vuzix has supplied Intel (a related party) with over $200,000 worth of waveguides that are believed to be inside of Intel’s augmented reality smart glasses reference.  Vuzix’s waveguides are super thin (1.4mm thick), high quality, relatively inexpensive compared to competitive offerings and ideally positioned for fashion based consumer smart glasses.

Intel has acquired a handful of augmented reality companies and technologies over the past two years.  Intel’s acquisitions and investments in augmented reality exceed $500m and are closing in on $1 billion.  Intel typically collaborates with a company and acquires them or makes and initial investment and acquires the company within a 24-month period.  Intel’s initial $24.8 million investment in Vuzix occurred 16 months ago, which makes Vuzix a potential takeover target within the next 6 to 12 months.

Management Team

Paul J. Travers, CEO, President and Director (Holds 2.55 million shares or 12.1% of shares outstanding)

Paul J. Travers was the founder of Vuzix and has served as the President and Chief Executive Officer since 1997 and as a member of the board of directors since November 1997. Prior to the formation of Vuzix, Mr. Travers founded both e-Tek Labs, Inc. and Forte Technologies Inc. He has been a driving force behind the development of our products for the consumer market. With more than 25 years of experience in the consumer electronics field, and 15 years of experience in the virtual reality and virtual display fields, he is a nationally recognized industry expert. He holds an Associate degree in engineering science from Canton, ATC and a Bachelor of Science degree in electrical and computer engineering from Clarkson University.

Grant Russell, CFO, Executive Vice President, Treasurer and Director (Holds 0.9 milion shares or 4.2% of shares outstanding)

Grant Russell has served as the Chief Financial Officer since 2000 and as a member of the board of directors since April 2009. From 1997 to 2004, Mr. Russell developed and subsequently sold a successful software firm and a new concept computer store and cyber café. In 1984, he co-founded Advanced Gravis Computer (Gravis), which, under his leadership as President, grew to become the world’s largest PC and Macintosh joystick manufacturer with sales of $44,000,000 worldwide and 220 employees. Gravis was listed on NASDAQ and the Toronto Stock Exchange. In September 1996, Gravis was acquired by a US-based Fortune 100 company in a successful public tender offer. Mr. Russell holds a Bachelor of Commerce degree in Finance from the University of British Columbia and is both a US Certified Public Accountant and a Canadian Chartered Accountant.

Key Stakeholders

Intel Corporation investing $24.8 million in January 2015 and currently owns 24% of Vuzix Corporation.  Intel has an option to secure two Vuzix corporate board seats and also has the right of first refusal to match any strategic investment made by another company in Vuzix.

Analyst Research

Vuzix is current covered by two sell-side analysts Chardan and H.C. Wainright with an average rating of buy and a price target of $10.00. Both sell-side analysts expect revenue FY17 revenue to double compared to FY16 due to new product rollouts commencing in FY16.

Chardan maintains a buy recommendation for Vuzix and a $10.00 per share price target.  Chardan’s price target is based on 10-12 times Q4 2017 revenue run rate of $19 million.

H.C. Wainright maintains a buy recommendation for Vuzix and a $10.00 per share price target.  H.C. Wainright’s price target was based on a DCF analysis to arrive at a $10.00 price target.

Why We Are Watching Vuzix Closely

Vuzix is well positioned for a major uptick in business activity in the second half of 2016 driven by the commercial launch of the M300 smart glasses.  Vuzix is working closely with Intel on a secret project focused on consumer fashion based smart glasses that provides additional upside for investors. Vuzix’s product pipeline is market leading and extensive, which positions the company for rapid market penetration and growth for years to come. Vuzix (VUZI) shares are trading at an incredible discount to fair value and now might be a good time to take a closer look at Vuzix, a market leader that has all the markings of being The Next Big Thing in Augmented Reality.

Get profit-generating, actionable information on great small and microcap stocks like VUZI for free. Subscribe now!

Disclosure: Receipt of $10,000 from an unrelated third party

While I’ll still be writing about 3D printing stocks in the future, there are some great non-3D printing stocks out there that I would like to share on occasion.

At my sister site (MicrocapResearch.com), I focus on small and microcap stocks with strong, near term positive catalysts that drive share prices significantly higher over a period of days-weeks.

During 2015, the average pick at MicrocapResearch gained just over 100% in the days-weeks following articles I wrote…all featuring companies with near term catalysts.

My March pick was Oasmia Pharmaceutical (OASM). See article: Oasmia Pharmaceutical (OASM): Grossly Undervalued + Multiple Near Term Catalysts = Strong BUY).

OASM shares closed at $2.96 on the day of my article (March 7th) and closed yesterday at $4.70, for a gain of 58.8 % in just under a month.

Here’s what’s next: American Brewing Company (ABRW) at .40/share

ABRW has a clean balance sheet and turned cash flow positive in their most recently reported quarter. It’s a great high growth story in a booming healthy beverage market with a great product that has attracted an industry leader (who could go anywhere) to take over as the new CEO.  I think ABRW could be one of the best performing stocks of 2016 based on forward growth.

So if you missed out on the 58% gain with OASM, check out my new pick, American Brewing Company (ABRW).

Read:  American Brewing Company (ABRW) Revamps for High Growth in Booming Functional Beverage Market

Best wishes for profitable trading!

New York-based Graphene 3D Lab, (TSXV: GGG and OTCQB: GPHBF), has released a shareholder update, reviewing the significant events of 2015 and the busy year ahead in 2016. Somewhat hidden away in the company’s investor presentation (page 10) is guidance for sales to grow to +$5 million this year.

Shares issues & outstanding: 49.4 million

The shareholder update is below.

Graphene 3D Lab fuses basic materials research and product development in graphene and other innovative materials with a commitment to the technologies surrounding advanced composites. With the acquisition of Graphene Labs, in an all share arrangement, Graphene 3D Lab has two main lines of business:

1. The production of research grade graphene and other nanomaterials for corporate, university and government research labs.
2. Rapid commercialization of 3D Printing technologies including graphene infused polymer filaments and other functional filaments

Industrial Materials Division

We are delighted to announce a third line of business, the Industrial Materials Division, to be devoted to development of high volume graphene-infused polymers for the automotive, robotics, drone, aerospace and military industries.

As a critical step in this direction, we have finalized installation and testing of a state of the art twin-screw extruder manufactured by Thermo Fisher. This specialized equipment allows Graphene 3D to create advanced composite materials with exceptional accuracy in shorter working times. The extruder will help to incorporate graphene into materials that well suited for industrial production of new or existing products that are lighter, stronger, and more flexible than their current commercial counterparts. The company is now able to respond faster to the increased demand we are seeing from manufacturers who wish to partner with us.

ll three of these business lines are closely tied to each of the others and we are developing the capacity to innovate and commercialize products by applying our company’s rapidly expanding knowledge base. The past year has been spent developing new product lines, expanding our production capacity and integrating Graphene Labs into the 3D Lab business. At each stage of our development as an innovative materials company, we are securing Intellectual Property which we believe will be critical to the future of materials science and 3D printing.

Graphene Laboratories, Inc. Acquisition

The acquisition of Graphene Laboratories has given Graphene 3D Lab and its products exposure to thousands of the leading researchers in the graphene and nanomaterials field. We are confident this will increase sales and put our innovative products in the hands of leading edge scientists and technologists.

Acquiring Graphene Labs has brought us approximately one million dollars per year in revenue from sales of graphene and other nanomaterials. It has also brought us exposure to the over 10,000 clients Graphene Labs has developed since 2009. These include nearly every Fortune 500 tech company and major research university. Some notable clients are NASA, HP, Ford Motor Co., GE, Apple, Xerox, Samsung, Harvard University, IBM, MIT, Yale, and Stanford University. Being in touch with some of the world’s leading materials scientists and having Graphene Lab’s track record of success makes product introduction much more straightforward and gives us insight into where the materials industry is heading.

Through Graphene Labs’ website, Graphene Supermarket (www.graphene-supermarket.com), we offer a wide array of Graphene related products in the form of solutions, powders, and films—all of which yield impressive profit margins. Sales from the Supermarket are usually to researchers at the beginning stages of projects. As the project progresses larger quantities of our products are required and through our well established relationship, our company is in the perfect position to fulfill this order.

Production of Materials for 3D Printing

In 2015, we invested heavily in production equipment establishing our fully operational production line. Our first filament product, a 3D printable graphene conductor, is now established in the market. Our recent release of new magnetic and nylon filaments demonstrates our capacity to manufacture many specialized filament products. We expect to put out several more filaments with innovative properties in the upcoming months as we continue to increase our customer base. Our upgraded extrusion lines and increased production capacity will improve the profit margins on 3D printing products. In house production gives 3D Lab significant advantages in the specialty filament market. We can produce on demand, control quality and, where warranted, accept custom orders. Maintaining our own production capacity allows us to make proprietary filaments without exposing our IP or trade secrets.

Industrial Scale Graphene Production

As a materials company, Graphene 3D Lab is committed to manufacturing products with significant added value. To achieve high volume production of composites, it is essential to have a solid supply of high quality graphene material. In the last two years the company has developed a unique approach to produce graphene nanoplatelets based on separating the graphene platelets from natural graphite feedstock. We anticipate an increased demand for our graphene composite materials for 3D printing and other applications. To satisfy the demand we need to scale up the production of graphene nanoplatelets. Our graphene production method could be fully automated and run continuously. Once completed, our production facility is anticipated to be producing tens of kilograms of graphene per day. With this technology, we fully control the supply chain: from basic materials to final graphene enabled products.

We thank you for your continued interest and support.

On behalf of the management,

Elena Polyakova
co-CEO

Perhaps most importantly, Graphene 3D Lab is also giving guidance to “Grow company revenue to +$5 million” by the end of 2016″ 

see full Q1,2016 investor presentation.

slide 10:

With 49.4 million shares issued and outstanding, the market cap of Graphene 3D Lab is $16 million USD.

Given the dramatic sales growth expected this year, I am extremely bullish on the stock and believe it is the best stock in the 3D printing space to buy now.

Disclosure: I am long shares of Graphene 3D Lab. I was not paid by any company or person for this article.

BioSig Technologies, Inc. (web site) is a medical device company with proprietary, patent-pending technology which addresses a well-documented, yet unsolved problem in the rapidly growing $3 billion electrophysiology (EP) marketplace. The company has a unique platform to minimize noise and artifacts from cardiac recordings during electrophysiology studies and ablation. Its product under development includes PURE (Precise Uninterrupted Real-time evaluation of Electrograms) EP system, a surface electrocardiogram and intracardiac multichannel recording and analysis system that acquires, processes, and displays electrocardiogram and electrograms required during electrophysiology studies and ablation procedures. The company is also developing a library of software tools that are designed to be configured to fit the needs of electrophysiologists in various settings and/or for arrhythmia treatments.

BioSig Technologies was founded in 2009 and is headquartered in Minneapolis, Minnesota.

Share Structure

Shares outstanding: 17 million
Recent price: $1.29
Market cap: $ 21.9 million
Insider ownership: 50%
Float: 6 million

With a novel product nearing commercialization which addresses a need in the global cardiology market, BioSig Technologies became public by filing an S-1 registration statement for an IPO, and began trading in November of 2014. Insiders have been buying shares regularly, (see recent transactions), and the process of uplisting to NASDAQ has begun. Uplisting to NASDAQ is projected to be completed in “early 2016“.

The Electrophysiology Market

Cardiac arrhythmias (abnormal heart rhythms) are a common problem. It’s estimated that between 3 and 6 million patients in the U.S. alone have atrial fibrillation, the most frequently seen cardiac arrhythmia. If left untreated, atrial fibrillation can cause chronic fatigue, heart failure, or even a stroke. More than 750,000 hospitalizations occur each year because of atrial fibrillation and the condition contributes to an estimated 130,000 deaths annually. Unfortunately, the death rate from this abnormal heart rhythm as the primary or a contributing cause of death has been rising for more than two decades according to the CDC. Atrial fibrillation costs the United States about $6 billion each year, and the medical costs for people who have the rhythm disturbance are about $8,705/year. Other, more serious cardiac arrhythmias include ventricular tachycardia and ventricular fibrillation, where the lower heart chambers just quiver and the heart doesn’t pump any blood, causing cardiac arrest and sudden death.

An electrophysiology study (or EP study) is a diagnostic procedure performed to locate and map out where an arrhythmia such as atrial fibrillation is coming from within the heart’s conduction system. Cardiologists who specialize in heart rhythm abnormalities are called electrophysiologists, and they use EP studies to determine if a patient needs medicine, a pacemaker, cardiac ablation surgery, or an implanted cardioverter defibrillator.

The addressable market also includes cardiac ablation, an invasive procedure performed to correct abnormal heart rhythms by terminating a faulty electrical pathway(s) from microscopic sections of the heart.  Cardiac ablation is used when pharmaceutical options to treat rhythm problems have failed and has a 90% success rate of curing cardiac rhythm abnormalities according to The American Heart Association.

Still in its infancy, the EP device market is seeing significant growth as more physicians become experienced in EP study and cardiac ablation techniques, increasing numbers of hospitals purchase supportive equipment, and patient outcomes improve.

The global EP market is estimated to grow at a significant CAGR of 10.3% from 2014 to 2019, making it one of the fastest growing medical device segments. Once found in only large metropolitan areas, EP labs are becoming commonplace in small and mid-sized cities throughout the U.S. as America’s baby boomers continue to age. While about half of the EP labs in the world are currently located in the U.S., hospitals in Canada, South America, Europe and Asia are rapidly adopting the technology.

The product BioSig Technologies is on the verge of commercializing addresses both the EP study (electrical mapping and diagnostic) branch of the market, and the cardiac ablation (definitive treatment) branch of the market.

The Problem of Noise and Artifact in EP Studies and Cardiac Ablations

Prior to my investing career, I was directly involved in EP studies and cardiac ablations as the manager of a coronary care unit and later as director of intensive care in a large hospital system in Florida. I can speak with firsthand knowledge that a persistent challenge in EP studies and cardiac ablation procedures is the presence of what is called “noise” or “artifact” encountered while recording the electrical activity of the heart. This signal noise can be caused by electrical interference coming from other equipment in the room, the patient’s own minute, involuntary muscle contractions, offset signals produced by the electrodes themselves, and artifact signals produced by the interaction of body fluids and the electrode gel.

To date there is no complete solution for eliminating noise and artifact, and signal processing in the EP lab remains a challenge. This is where BioSig Technologies comes in, with what may be the perfect solution for dealing with noise and artifact in the EP lab.

The Solution from BioSig Technologies

With 7.5 years of development, BioSig has a system unlike anything else on the market to correct the problem of noise and artifact in the EP lab. The PURE ( Precise, Uninterrupted, Real-time evaluations of Electrograms) EP System was developed using proprietary technology that (among other advances) converts the analog to digital signal at 2-3X the sampling rate of the most precise and advanced EP equipment now available. During proof of concept testing, the electrocardiogram and intracardiac signals produced by the PURE EP System were shown to have less baseline wander, noise and artifacts compared to signals displayed on other recording systems.

BioSig conducted a series of preclinical studies in 2015 at the Mayo Clinic in Rochester, Minnesota and engineering studies at UCLA. The main objective of the studies was to demonstrate the superior clinical potential of PURE EP which is not currently obtainable with present recording systems. BioSig will publish the results of these studies at industry conferences and peer reviewed journals early this year.

The PURE EP System gives electrophysiologists information and data that is unobtainable from any other EP device today, including:

• proprietary hardware and dramatically improved signal processing capabilities
• ability to open multiple review windows
• assisting in clinical decision making in real-time
• maximizing ablation efficacy & minimizing need for repeat procedures
• shorter and & simplified EP procedures

Today’s health care system is extremely focused on improving patient outcomes, minimizing complications and repeat procedures, (which in turn decreases length of stay).  Management believes that the PURE EP System will contribute to an increase in the number of successful ablation procedures performed in each electrophysiology lab thereby substantially raising the value of the platform among EP labs.

The length of time to perform an ablation can vary widely, but is typically 3-6 hours.  In addition to the patient’s particular rhythm disturbance, ablation procedure time is dependent upon how quickly and thoroughly the electrophysiologist can reproduce the rhythm disturbance in the lab, and then to “ablate”, or destroy the offending electrical pathway that is causing the rhythm disturbance. To eliminate the atrial fibrillation for example, a typical patient requires between 150 and 250 different micro areas to be cauterized!  The PURE EP System shortens the “reset” time between each micro-cauterization by more rapidly acquiring a clean rhythm signal with zero noise or artifact. With a reduction in ablation procedure times, EP lab efficiency and turnover are improved, thereby driving demand from hospitals and electrophysiologists.

In the near term, BioSig plans to file with the FDA for 510(k) clearance, (new medical device premarket notification), which management believes will be granted in 2016. In a December shareholder letter  Kenneth Londoner, (Chairman), and Greg Cash (President and CEO) stated:

“Management is actively preparing for the commercial launch of PURE EP…and will do everything possible to drive timelines as aggressively as possible without compromising quality and regulatory rigor.”

Full scale commercialization is projected for early 2017.

Proven Management Team Collaborating With World–Renowned Testing Centers

BioSig has an experienced, proven management team and a scientific advisory board that’s second to none in the areas of cardiology and electrophysiology.

BioSig Technologies is collaborating with several of the nation’s most prestigious cardiac arrhythmia centers including:

• Texas Cardiac Arrhythmia Institute
• UCLA Cardiac Arrhythmia Center
• U.H. Case Medical Center in Cleveland
• William Beaumont Hospital in Michigan
• Mount Sinai Medical Center in NY
• Mayo Clinic in Minnesota

Conclusion

BioSig Technologies has multiple upcoming catalysts that will increase awareness of the company in the medical and investor communities. These catalysts include:

• Q2 2016 NASDAQ Uplisting
• Mayo Clinic Peer Review Cardiology Journal Q2 2016
• Engineering Journal Feb/March 2016
• Heart Rhythm Society May 2016
• Sell Side Research/Conferences
• FDA 510(k) Submission Q4 2016

The company has a proprietary, patent pending device that addresses an unmet need in the high growth electrophysiology market.

With the stock market off to such a rough start in 2016, many individual investors along with institutions will be looking for defensive positions in health care and medical device stocks.
A near-term uplisting to NASDAQ should drive increased investor awareness and institutional participation.

As a result we believe taking a position in BSGM shares soon is the “Buy Low” part of the buy low/sell high equation.

See also: February 2016 Investor Presentation

See Dislaimer/Terms of Use

Disclosure:  receipt of of $20,000 from Star Media LLC.

3D Printing Will Rock the World is now available for purchase here on Amazon  just in time for Santa, and the Kindle version will be available soon.

The book is an excellent read for any investor in the space and I highly recommend it.

I’ve had the pleasure of hearing the author, John Hornick, speak at multiple 3D printing conferences, and his knowledge of the industry and trends is encyclopedic. John Hornick has been widely published and is the only IP attorney selected by the National Academies to participate in the US Comptroller General Forum on Additive Manufacturing (which was the basis of a report to the US Congress), and is a juror for the International Additive Manufacturing Award.

3D Printing Will Rock the World is a book about technological innovation and business, and how 3D printers will change the world in many ways.  It will interest:

• the business reader who wants to know how 3D printing may affect manufacturing, product design, where things are made, the jobs market, how companies do business, and how it may be misused
• the general reader and average consumer who is curious about 3D printing, especially parents, whose kids will help drive the adoption of this technology
• Makers, who already believe that 3D printers will help change the world
• potential investors, who want to learn about this technology and its potential

Industry leaders have this to say about 3D Printing Will Rock the World:

“A lucid and comprehensive account of the burgeoning field of 3D printing—the technologies, and their implications. Hornick makes a compelling case for why this technology can’t be ignored. A must-read for anyone who wants to see beyond the horizon.”—Hod Lipson, coauthor, Fabricated: The New World of 3D Printing

“Hornick explores an exciting possible future where 3D printing has changed the way we design, make, and interact with the world. This book is a great compendium of 3D printing as it is today and what it may become tomorrow.”—Michael Weinberg, former vice president, Public Knowledge/General Counsel, Shapeways

“Hornick has written a terrific and much needed guide and explanation on the uses and possibilities of 3D Printing.”—Alan Meckler, Meckler Media, producer of Inside 3D Printing Conferences and Trade Shows

“John has assembled a comprehensive assessment of this rapidly growing technology and offers rare insight into how 3D printing is redefining what can be designed and manufactured, spawning new products and markets that we have yet to imagine.”—Ed Morris, vice president and director, America Makes—The National Additive Manufacturing Innovation Institute

Full of real-world examples based on extensive research, illustrated, and with over 600 endnotes, 3D Printing Will Rock the World explains where this technology stands today and where it is going, and how everything will change when you can make anything.

Simply put, 3D Printing Will Rock the World will make you a better informed investor in the 3D printing space while guiding you through the present realities and future potential of the technology. 

In news this morning, Graphene 3D Lab (TSXV: GGG, OTCQB: GPHBF) announced that the company has entered into a R&D agreement with a Fortune 500 Manufacturer for multi-phased deliverables over the course of the next 12 months.

Today’s press release notes that:

“For competitive reasons and pursuant to confidentially clauses contained with the Agreement, neither specific research objectives nor the identity of the Agreement partner can be publicly disclosed. Upon successful completion of the research phase, and subject to approval by the U.S. Food & Drug Administration, the developed materials will become a part of a consumer retail product.”

CEO of Graphene 3D Lab, Daneol Styeolyarov, explained:

“Our lab team will assist our partner to understand, handle and integrate graphene into future manufacturing. We are not just replacing other additives with graphene, we are working jointly with our partners to elevate the potential of their products. Product expertise from our partners, graphene expertise from our lab – the results is new products that can do more than before.”

Co-CEO Elana Ployakova added that the company expects graphene to become a common ingredient in large-scale manufacturing, and the agreement announced today will likely be a common first-step for traditional manufactures.

Graphene 3D Lab also announced the recent availability of Graphene Flex Foam, which has potential to be an excellent substrate candidate in the manufacture of electrodes of lithium-ion batteries as well as wearable and flexible electronics.

More information on Graphene 3D Lab:

• Graphene 3D Lab web site
• Innovations in Material Science Bring Functional Filaments to Market (by Dr. Daniel Stolyarov, CEO, Graphene 3D Lab)
• Conductive graphene filaments on sale at BlackMagic3D.com
• Investor Presentation
• 3D Printed Battery Demo

Follow me on Twitter: @3DPrintingStock

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Disclosure: I am long shares of Graphene 3D Lab. See additional disclosure in “The Best 3D Printing Stock to Buy Now is Graphene 3D Lab (GGG.V)”

Disclaimer: Opinions expressed are my own and should not be considered investment advice nor an invitation to buy or sell shares of any company mentioned on this site. Investors should perform their own due diligence and consult with a Registered Investment Advisor prior to making any investment decision. See sidebar for full disclaimer.

Prototyping circuit boards has historically been a long and expensive process, requiring external manufacturers to print circuit boards on a client’s behalf. Now, Dr. Jeff Casey from Rockfield Research Inc. shows what he has accomplished using Graphene 3D Lab’s flagship conductive filament: a 3D printed three layer circuit board. 

Jeff Casey was able to 3D print the circuit board directly in his facilities, using only Conductive Graphene Filament, standard filament, a dual-head 3D printer, and a few additional components. Check out his creation by watching the video below!

Now applications like this are probably why Graphene 3D Lab had to double production capacity several months ago.

When I first wrote about Graphene 3D Lab on August 11, 2014, I explained why I thought it was “The Best 3D Printing Stock to Buy Now.”

Over a year later, shares are down slightly from their 8/11/2014 close of .70, but have outperformed other 3D printing stocks through the entire period by a wide margin.

 Beyond R&D… Significant Revenue

While Graphene 3D Lab remains in R&D, see 3D Printed Battery Patent Application, revenue production will be ramping quickly do to the recent acquisition of Graphene Laboratories, (see news), which generated over $1million in revenue last year and was cash flow positive with no debt.

To put that into perspective, 3D bioprinting company Organovo (ONVO) reported $571,000 in revenue for the year ending March 31, 2015 and has a market cap of $330 million, while Graphene 3D Lab has a market cap under $30 million. Obviously the two companies operate in vastly different areas of the 3D printing space, and aren’t true “comps” as a result…but I think it does drive home the point that when Graphene 3D Lab begins reporting revenue from the acquisition, shares are likely to get some attention.

Lastly, no other company has the commercial production capacity of electrically conductive, graphene enhanced filaments that Graphene 3D Lab has- making Graphene 3D Lab a first mover in this new and exciting space in 3D printing.

Exciting times ahead!

More information on Graphene 3D Lab:

• Graphene 3D Lab web site
• Innovations in Material Science Bring Functional Filaments to Market (by Dr. Daniel Stolyarov, CEO, Graphene 3D Lab)
• Why The Future of 3D Printing is in Multi-Material Printing
• Conductive graphene filaments on sale at BlackMagic3D.com
• Investor Presentation
• 3D Printed Battery Demo

Follow me on Twitter: @3DPrintingStock

Subscribe to 3DPrintingStocks.com for free (box in left upper corner of page) to get news, articles, interviews, and actionable information on 3D printing stocks delivered to your inbox.

Disclosure: I am long shares of Graphene 3D Lab. See additional disclosure in “The Best 3D Printing Stock to Buy Now is Graphene 3D Lab (GGG.V)”

Disclaimer: Opinions expressed are my own and should not be considered investment advice nor an invitation to buy or sell shares of any company mentioned on this site. Investors should perform their own due diligence and consult with a Registered Investment Advisor prior to making any investment decision. See sidebar for full disclaimer.