tapimmune-logo

Robin McCallum manages all aspects of CMC Operations for TapImmune’s cancer vaccine programs.

 


Thank you, Robin, for taking part in this Q&A.

First off, what are “CMC operations”, and how do they impact clinical trials and the drug development process?

RM: CMC stands for Chemistry Manufacturing and Controls.  CMC operations come into play when drugs emerge from the drug discovery and lead optimization phases of drug development and enter the IND-enabling, preclinical phase.  An IND is an Investigational New Drug.  CMC is maintained as a drug goes through the clinical phase (Phase I, II, and III) of drug development and throughout the life cycle of the drug as it is approved by a regulatory agency (e.g., FDA, EMEA) and marketed.

CMC encompasses the nature of the drug, its manufacturing process, and the manner in which the manufacturing process is shown to be in control.  Some of the critical elements of CMC include:

  • how and where a drug is manufactured
  • what control procedures are in place to ensure reproducibility in the manufacturing process
  • what control procedures are there to maintain drug quality and consistency
  • what critical quality attributes (CQA) have been identified and characterized for the drug
  • are the CQAs appropriate for the drug and its phase of development
  • how stable is the drug
  • is the drug manufactured in an appropriate dosage form

Appropriate CMCs are essential to ensuring that drugs supplied to support human clinical trials are safe and tolerable, and will become more rigorous as a drug goes through early-stage clinical trials (Phase I and II) into late-stage clinical trials (Phase III).


What prior biotech and drug development experience do you bring to TapImmune?

RM: I bring more than 12 years of experience in biotechnology and pharmaceutical development to TapImmune.  This include broad experience in most areas of drug development and manufacturing, including research & development, process development, scale-up, GMP manufacturing, analytical method development, qualification, and validation, quality control testing, and quality assurance.  My particular expertise is in pharmaceutical and biopharmaceutical process development, GMP manufacturing, and analytical methods.

I also work closely with a technical consultant who has more than 25 years of experience and expertise in process development, analytical methods, formulation and dosage form design; technology transfer to GMP operations, GMP manufacturing, regulatory submissions and quality assurance with a broad range of drug types including  small organic molecules, peptides and proteins, biologics, and combination products.


Does the FDA require documentation of a company’s CMC operations as part of the drug development process?

RM: Absolutely!  Submission of an IND for first-in-human clinical trials (Phase I) requires submission of a CMC section as part of that IND to the FDA.  The agency is chiefly concerned that a drug administered to humans has been manufactured and characterized in an appropriate and consistent manner, and meets quality standards.  CMC along with preclinical and toxicology studies in animals ensures that any drug advanced to Phase I clinical trials is as safe as possible.


How do CMC operations change as drug development goes from phase I, into phase II, and beyond?

RM: CMC is one of the links connecting early non-clinical or toxicology batches (Engineering runs) to clinical batches and eventually commercial batches if the drug is deemed safe and efficacious, and is approved by the FDA or other regulatory agency.  The requirements for CMC expand and become more rigorous as the drug moves along the clinical development pathway toward commercialization.

At the Phase I stage, safety is the primary concern.  Typically, the drug lot that supplies this early stage trial will meet basic quality requirements; however, the manufacturing process is usually not yet optimized for yield, purity, efficiency, scalability, etc.  Further, the formulation is adequate for the dosage form and route of administration, but is not the optimal or final formulation.  Typically only one non-GMP lot (Engineering lot) and one GMP lot (clinical lot) has been manufactured; therefore, there is not adequate, statistically significant data on lot to lot variability and consistency.  Moreover, analytical methods if not performed as per compendia, have been minimally developed and qualified (method-dependent) to meet Phase I requirements, but have not been optimized and validated.  Broad, tentative specifications for CQAs are established and some tests simply have “report results”.  Also, although overall product purity and impurity has been quantified, individual specific impurities and related substances have not been identified and characterized.  Lastly, only about 1-3 months of stability data from the clinical lot will be available by the time the drug is dosed in the first patient for the first-in-man trial.  This is all acceptable from a regulatory standpoint for a Phase I drug lot.

At the Phase II stage where both drug safety and efficacy are concerns, the manufacturing and formulation process will typically be refined and improved although not optimized to the final process.  There is also usually a scale-up of the manufacturing process at this stage though not yet close to commercial scale.  The CQAs for the product will be better defined and characterized.  More stability data has been generated (12 months+) using stability-indicating methods, at multiple temperatures.  Many firms elect to finalize and validate analytical methods at this stage.

At the Phase III stage (drug safety, efficacy, and consistency), the manufacturing process is optimized to be robust, reproducible, and scalable to commercial scale with fully established in-process controls. This will be the commercial process by and large.  Using fully tested raw materials, at least three consistency batches are manufactured as part of process validation.  These batches are often used for NDA or BLA filings to regulatory agencies.  Analytical and microbiological methods are completed validated, CQAs are fully defined and characterized, and final specifications are set.  The physical, chemical, and biological properties of the drug are fully characterized. Process impurities are fully identified, defined, and quantified.  Stability data from multiple clinical or GMP lots is available and stress testing has been completed.  Also, container closure integrity testing is completed for sterile products.


I’ve read that in order to gain a competitive clinical edge, some companies may look to do the minimum amount of CMC work required while still maintaining an acceptable level of control, as required by the industry. How do CMC operations managers like yourself balance the need to keep costs down while maintaining a high level of quality required by the industry?

RM: In the competitive industry of pharmaceuticals, companies will always seek to accelerate drug development, with first-in-man trials being a critical milestone.  Whether large or small, any pharmaceutical company will have to balance three important and inter-related factors:  time, cost, and quality.  Fortunately, the FDA has defined certain basic CMC requirements for drug that supply first-in-man studies with safety being the main concern.  In some ways, the need to meet those basic requirement for safety in Phase I trials (derived in part from quality in CMC) will predefine the minimum amount of time any CMC operations manager will need to spend on the development, GMP manufacturing, and characterization of the first clinical lot.  Therefore, that mitigates some of the corporate pressures for accelerating what will be an already aggressive timeline and reducing an already streamlined budget for drug development.  TapImmune is committed to product quality and patient safety first, and we will not compromise that in favor of a faster timeline or lower cost.  Those who sacrifice quality often end up losing quite a bit more money and time in the long run.


How long does the process take of manufacturing TapImmune vaccines?

RM: The process to manufacture TapImmune’s vaccine can be broken up into two main parts:  I) manufacturing of the peptide Drug Substances or Active Pharmaceutical Ingredients (APIs) and II) manufacturing of the Drug Product or vaccine.  Part I consists of the synthesis, cleavage, and purification of the individual peptide Drug Substances (5 peptides) and this process typically takes 2-3 months depending on the peptide.  Part II consists of the formulation, filtration, vialing, and lyophilization of the Drug Product, and typically takes 1 week for manufacturing operations.  Pre-manufacturing activities such as batch record prep, etc. and post-manufacturing activities such as quality control testing will add around 1 month each.  Overall, it takes around 4 months to manufacture and fully release TapImmune’s vaccines for clinical use.


Once the vaccines are created, where are they sent to? Do you have any clinical sites in the country? If so, where?

RM: Once the vaccines are manufactured, tested, and released, they are stored at our manufacturing vendor for clinical distribution via clinical drug couriers.  At this time, all of TapImmune’s clinical sites are located in the USA in a number of states across the northeast, southeast, south, and midwest:  Florida, Kansas, Michigan, New Jersey, New York, Maryland, Missouri, Ohio, Tennessee, and Texas.


For more information on TapImune see:

Video: A Vaccine That Could Prevent Certain Breast, Ovarian, and Lung Cancers

TapImmune Investor Fact Sheet

TapImmune Reaches 50% Patient Enrollment Benchmark in Phase 2 Study of Novel T-Cell Vaccine Targeting Triple-Negative Breast Cancer

TapImmune Press Releases

U.S. Department of Defense Funds Phase II Trial of TapImmune Breast Cancer Vaccine  source: Breast Cancer News

Doctor Developing Vaccine That Would Prevent Breast, Ovarian, and Certain Lung Cancers source: WOKV News

TapImmune Improves T-cell Vaccine Ahead of Phase II Trials source: BioPharma Reporter

 


CannaRoyalty Marc Lustig

tapimmune-logoTapImmune (TPIV) is developing immunotherapies for a variety of cancers designed to target both tumors and metastatic disease. The company’s next-generation technology has been engineered to overcome the deficiencies of earlier cancer vaccine approaches and has the potential to be a powerful standalone therapy or part of a leading combination regimen by complementing other approved or development-stage immunotherapeutics (i.e. checkpoint inhibitors). The company’s off-the-shelf vaccines boost patients’ immune systems to comprehensively stimulate both killer T-cells and helper T-cells to destroy cancer cells.

TapImmune is advancing two clinical stage T-cell vaccine candidates in multiple Phase II and Phase Ib/IIa clinical trials for treating ovarian and breast cancers, including programs in ovarian cancer that will benefit from FDA Fast Track and Orphan Disease Designation. The company is working in collaboration with industry and clinical leaders including Mayo Clinic, Memorial Sloan Kettering Cancer Center, and AstraZeneca.


On May 1st, TapImmune announced Richard Kenney, MD, FACP, was joining TapImmune to lead the Clinical Development Program. Dr. Kenney will manage TapImmune’s ongoing and planned clinical programs for its next-generation T-cell vaccine candidates, which currently include multiple Phase 2 trials in advanced breast and ovarian cancer.

Richard Kenney

Prior to joining TapImmune, Dr. Kenney served as Principal Medical Advisor and Chief Medical Officer of Immune Design Corp, where he established and led the clinical development, pharmacovigilance and regulatory affairs groups to advance the development and commercialization of the company’s cancer prime-boost immunotherapeutic and vaccines.  Previously, Dr. Kenney served as Chief Medical Officer of Crucell Holland, BV, where he directed clinical development of a broad platform of vaccines. He also served as Senior Vice President, Clinical Development for Vical Incorporated, where he led the clinical development of DNA vaccines for cancer immunotherapy and infectious diseases. Dr. Kenney held key positions in vaccine development at GSK Biologicals from 2005 to 2009, most recently as Senior Director of Global Clinical R&D, Vaccines for Viral Diseases. He earned his M.D. degree at Harvard Medical School, completed his residency in Internal Medicine at Duke University Medical Center, and a fellowship in Infectious Diseases at the National Institute of Allergy and Infectious Diseases.

 


MR: Congratulations on your new position as Medical Director for TapImmune.
What are your responsibilities in this role?

RK: I am responsible for the clinical development of our products. Once a compound is shown to be promising in the research lab, it needs to be tested in human trials that show its safety and effectiveness. Few patients are exposed at first, when the risks are not fully known. When it is clear that more patients can be tested, larger populations are used to show whether a benefit can be expected from that product in various indications. I manage the design of future trials and help with the operational aspects of ongoing trial oversight.


MR: What prior experience do you have with clinical development programs in immunotherapy that will expedite TapImmune’s T-cell vaccine candidates as they progress through clinical trials?

RK: My career has been focused on the induction of immunity in human populations, using vaccines for infectious diseases as well as for different tumors. I have experience in both the clinical and regulatory aspects of moving a product through development in small and large projects. Much of my work has focused on the use of adjuvants, which can enhance the immune response, particularly when used in a prime-boost approach.


MR: I’m sure you could choose from any number of attractive T-cell immunotherapy companies to work with. What attracted you to TapImmune?

RK: It’s a combination of the people and the products. TapImmune is led by and employs a good group of hard-working people who are experienced in their various roles. The vaccines being developed have been shown to be safe and immunogenic and now need further work to demonstrate efficacy. We have an opportunity to use the latest scientific hypotheses to study novel combinations and are working with some of the nations’ best clinical investigators to generate robust approaches.


MR: In what way(s) is T-cell immunotherapy superior to other cancer therapies?

RK: Traditional chemotherapy is designed to kill cells directly and usually causes rapid shrinkage of the tumor. Unfortunately, that comes at a great cost in terms of the side effects on normal tissues and the cancer often becomes resistant and returns. Your immune system has been working to protect you from cancers since before you were born. Tapping into that protection by generating a targeted immune response where that system has broken down may be a better way to fight the growth of tumors and is usually much less toxic.


MR: TapImmune has multiple clinical trials underway primarily focused on aggressive breast and ovarian cancers. Would you provide an overview of these trials- where they are currently, what collaborative partnerships are involved, and the benefits of the FDA Fast Track designation where it has been granted?

RK: TapImmune has two main products in clinical trials. TPIV200, the folate receptor-alpha peptide vaccine, is in several Phase 2 trials looking at safety and immunogenicity in breast cancer and at efficacy in ovarian cancer. While the peptide vaccine itself is adjuvanted with GM-CSF, we are using the product alone, in combination with low-dose cyclophosphamide as an immunostimulant, or in combination with durvalumab, a checkpoint inhibitor of PD-L1, in collaboration with Memorial Sloan Kettering Cancer Center. Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Fast Track designation has been granted for TPIV200 for maintenance therapy in subjects with platinum-sensitive advanced ovarian cancer, so we have more opportunity to work closely with FDA to resolve issues along the way.

The other vaccine, which has been called TPIV100, has 4 peptides directed against HER2/neu. We recently updated that product by adding a fifth peptide to enhance the immune response and now call the vaccine TPIV110. One of the clinical studies using TPIV100 will evaluate an early stage of breast cancer called DCIS before surgery. The other will study more advanced patients with triple-negative breast cancer (TNBC) starting later this year. Both studies are being done in collaboration with the Mayo Clinic and the Department of Defense.


MR: In addition to the T-cell vaccine development, TapImmune is working on PolyStart™, a DNA vector technology. Would you explain what “DNA vector technology” means and what the potential applications are for PolyStart™?

RK: DNA vectors have been used to generate immune responses against infectious diseases and cancers in humans for many years. Basically, we can use the gene to let the body make the protein that is required to generate an effective immune response. DNA vaccines engage different parts of the immune system that can complement the way tumors are being attacked. PolyStart is a technology that greatly augments the amount of protein that can be generated inside the cell, which should induce a more robust immune response. We can use this approach by itself or in combination with the peptide vaccines to boost the overall immune response and thereby enhance efficacy. Thus, PolyStart can be used to target any number of infectious diseases or can be studied along with our vaccines for breast and ovarian cancer.


MR: What clinical development milestones can investors in TapImmune look forward to over the next 6-12 months?

RK: We should see the data from the Phase 1 trial of the TPIV200 folate receptor-alpha vaccine published within the next few months and the ongoing Phase 1b/2 trial at MSKCC has a decision point for continuation that will be available late this summer. The Phase 2 trial in TNBC has an interim look at safety and immunogenicity by the end of the year and it should be fully enrolled by the end of the year. The preliminary efficacy trial in ovarian cancer is just starting to enroll – those results will take more time to mature as it is a larger trial, although an interim analysis is planned for late 2018. In addition, we expect to see the Mayo trials of the TPIV100 HER2/neu vaccine starting later this year. Finally, we will be amending that IND later this year for our own sponsored study in Her2neu breast cancer using TPIV110. This is an active period for TapImmune and our collaborators that will lead to multiple readouts over the next two years.


More About TapImmune:

Video: A Vaccine That Could Prevent Certain Breast, Ovarian, and Lung Cancers

TapImmune Investor Fact Sheet

TapImmune Press Releases

U.S. Department of Defense Funds Phase II Trial of TapImmune Breast Cancer Vaccine  source: Breast Cancer News

Doctor Developing Vaccine That Would Prevent Breast, Ovarian, and Certain Lung Cancers source: WOKV News

TapImmune Improves T-cell Vaccine Ahead of Phase II Trials source: BioPharma Reporter


richard kenney

 

 

Terms of use, disclosure, disclaimer

TapImmune (TPIV) is advancing two Phase II studies that are funded by ~$17 million in non-dilutive grants from the U.S. Department of Defense.

In total, the company has 4 different Phase II studies underway and is planning to submit an Investigational New Drug (IND) Application with the FDA for another breast cancer vaccine this year.

Due to the unmet medical needs targeted by TapImmune’s T-cell vaccines as well as promising Phase I results, the FDA has granted Fast Track designation in two of the studies, providing an expedited review to facilitate development of the vaccines.

Additionally, TapImmune recently added Richard Kenney, MD, FACP, as Medical Director for the Company to lead the clinical development program. Dr. Kenney brings deep clinical development and FDA process experience to the Company as it continues to develop T-cell cancer vaccines that aggressively target breast and ovarian tumors.


Shares outstanding: 8.4 million
Closing Price 5/8/2017: $3.69
Market cap: $31 million
Total Cash (mrq) $8 million
Cash/Share (mrq) $0.93
Debt (mrq) 5k
Current Ratio (mrq) 4.6

 

tapimmune-logoTapImmune (TPIV) is developing immunotherapies for a variety of cancers that are designed to target both tumors and metastatic disease. The company’s next-generation technology is designed to overcome the deficiencies of earlier cancer vaccine approaches and has the potential to be a powerful standalone therapy or part of a leading combination regimen by complementing other approved or development-stage immunotherapeutics (i.e. checkpoint inhibitors). The company’s off-the-shelf vaccines boost patients’ immune systems to comprehensively stimulate both killer T-cells and helper T-cells to destroy cancer cells.

 

TapImmune web site


Full Funding for Phase II of TapImmune’s HER21-targeted T-cell vaccine

The U.S. Department of Defense (DoD) awarded Mayo Clinic researchers $3.7 million to conduct a Phase II trial of TapImmune’s HER21-targeted T-cell vaccine in women with the breast cancer known as ductal carcinoma in situ (DCIS). Her2neu is overexpressed in about 30% of all breast cancer patients, amounting to approximately 220,00 patients per year.

See press release: TapImmune Announces Fully Funded Phase 2 Clinical Study of HER2-Targeted Vaccine in Early Breast Cancer.

The 40 to 45 women who will be enrolled in the study will receive the TPIV 110 vaccine six weeks before surgery to remove the tumor.

This is TapImmune’s second T-cell vaccine candidate to be tested in a DoD-funded Phase II study at Mayo Clinic, and it marks TapImmune’s expansion into a second breast cancer indication. In addition to ongoing and planned Phase 2 studies of TapImmune’s lead TPIV 200 vaccine for treating triple-negative breast cancer, this new study of HER2neu vaccine in DCIS has the potential to validate the Company’s novel approach to establishing lasting immunity against breast cancer and precancerous lesions.

TapImmune’s new T-cell vaccine targeting HER2 consists of five carefully selected HER2 antigens that do the best job of activating HER2-directed T-cells. The mix is expected to cover a significantly larger patient population than the HER2-targeted therapy Herceptin (trastuzumab). TPIV 110 is expected to cover 90 percent of HER2-positive cancers, versus Herceptin’s 15-20 percent. TPIV 110 is also expected to remain effective for longer periods.

To date, the U.S. department of Defense has awarded approximately $17 million towards research using TapImmune’s targeted T-cell vaccines.

Additionally, investors should note that TapImmune has world-class sponsors and collaborators including AstraZeneca (AZN), Memorial Sloan Kettering Cancer Center, and Mayo Clinic. The caliber of these sponsors and partners speaks volumes about the potential for breakthrough research in the cancer immunotherapy space by TapImmune.


Dr. Richard Kenney Taking Clinical Development to the Next Stage

The addition of Dr. Kenney to the team as Medical Director at TapImmune validates the Company’s technology and recent progress, and is a milestone for the Company. Dr. Kenney is superbly qualified to lead the clinical development programs TapImmune is advancing.

  • M.D. from Harvard Medical School
  • Residency at Duke University Medical Center
  • Fellowship at the National Institute of Allergy and Infectious Diseases
  • Served as Principal Medical Advisor and Chief Medical Officer of Immune Design Corp, (Nasdaq: IMDZ), where he established and led the clinical development, pharmacovigilance and regulatory affairs groups to advance the development and commercialization of the company’s cancer prime-boost immunotherapeutic and vaccines
  • Served as Chief Medical Officer of Crucell Holland, BV, (a division of Johnson & Johnson), where he directed clinical development of a broad platform of vaccines
  • Served as Senior Vice President, Clinical Development for Vical Incorporated, (Nasdaq: VICL), where he led the clinical development of DNA vaccines for cancer immunotherapy and infectious diseases
  • Held key positions in vaccine development at GSK Biologicals most recently as Senior Director of Global Clinical R&D, Vaccines for Viral Diseases

Regarding his new position at TapImmune, Dr. Kenney stated:

“I am delighted to assist TapImmune during this exciting time of growth as the company advances two of its T-cell vaccine candidates though multiple Phase 1b/2 and Phase 2 clinical trials.  Each of these novel vaccines are designed to address significant unmet needs for women with ovarian and breast cancer, where recurrence is high and prognosis can be very poor.  Having led the development of multiple vaccine programs and immunotherapies for cancer and infectious disease, I am eager to utilize my experience to drive successful clinical programs for TapImmune in collaboration with the Company’s top-tier clinical partners.” 

Attracting someone of Dr. Kenney’s caliber to TapImmune speaks volumes about the current and future potential of the Company’s T-cell immunotherapy programs. 


Beyond Treatment, to Actual Breast Cancer Prevention

TapImmune believes that if the trials of HER21-targeted T-cell vaccine go well, the vaccine could replace a combination of chemotherapy and surgery as a breast cancer treatment, and could also be used as a preventive vaccine to keep healthy women from developing breast cancer.


Video: “Vaccine could prevent breast, ovarian, lung cancer”

 


 

 

Video: A Vaccine That Could Prevent Certain Breast, Ovarian, and Lung Cancers

 


Four Phase II Immuno-Oncology Trials Underway with Top Tier Partners

TapImmune has four clinical trials now in phase II for treatment of ovarian and triple-negative breast cancers.

 

TapImmune Pipeline


  • Phase II Trial of TPIV 200 for Triple-Negative Breast Cancer with Fast Track designation from the FDA

About 15-20% of all breast cancers are found to be triple-negative (meaning the breast cancer cells tested negative for estrogen receptors, progesterone receptors, and HER2). This form of breast cancer does not respond to hormonal therapy (such as tamoxifen or aromatase inhibitors), or therapies that target HER2 receptors, such as Herceptin (chemical name: trastuzumab). Triple-negative breast cancer tends to be more aggressive with higher mortality rates than other breast cancers.

The open-label, 80 patient clinical trial by TapImmune is designed to evaluate dosing regimens, adjuvants, efficacy, and immune responses in women with triple-negative breast cancer. Key data from the trial is expected to be included in a future New Drug Application submission to the FDA for marketing clearance.

TapImmune announced a key clinical milestone in February, passing a planned safety review that was performed when enrollment had reached 25 percent benchmark (20/80 patients).

In the prior Phase I study of TPIV 200 at Mayo Clinic, 100% of patients demonstrated a T-Cell response lasting over 6 months and the drug was found to be safe and effective in treatment of both ovarian and breast cancers.  

This study has Fast Track designation from the FDA which provides an expedited review to facilitate development of the drug.  This designation is granted in studies that treat serious or life-threatening conditions and fill an unmet medical need.


  • Phase II Mayo Clinic Trial of TPIV 200 in Triple-Negative Breast Cancer Fully Funded by U.S. Department of Defense

This is a separate Phase II study of TPIV 200 for the treatment of triple-negative breast cancer, conducted by the Mayo Clinic and sponsored by the U.S. Department of Defense (DOD). The 280 patient study is being led by Dr. Keith Knutson of the Mayo Clinic in Jacksonville, Florida. Dr. Knutson is the inventor of the technology and an advisor to TapImmune.

$13.3 million worth of non-dilutive capital for trial.

While TapImmune is supplying doses of TPIV 200 for the trial, the remaining costs associated with conducting this study will be funded by a $13.3 million grant made by the DOD. This grant is a direct result of the very positive findings of the Phase I trial of TPIV 200 and validates TapImmune’s technology.


  • Phase II Trial at Memorial Sloan Kettering of TPIV 200 in Platinum-Resistant Ovarian Cancer in Collaboration with AstraZeneca on FDA Fast Track

Approximately 22,000 women were diagnosed with ovarian cancer in 2016 and an estimated 14,180 will die from the disease according to the American Cancer Society. Because ovarian cancer tends to be detected at a later stage of the disease, the five-year survival rate for ovarian cancer is 45%. Current treatment options are surgery, radiation and chemotherapy.

There is currently no FDA approved cancer vaccine available for ovarian cancer.

This is a Phase II study of TPIV 200 in ovarian cancer patients who are not responsive to platinum, (a commonly used chemotherapy for ovarian cancer), sponsored by Memorial Sloan Kettering Cancer Center in collaboration with AstraZeneca. The open-label study is designed to evaluate a combination therapy which includes TapImmune’s TPIV 200 T-cell vaccine and AstraZeneca’s checkpoint inhibitor, durvalumab.

Because these patients are unresponsive to platinum-based therapy and have failed chemotherapy, there are unfortunately, no real options left at the present time. If the combination therapy proves effective, it would address a critical unmet need.

TapImmune received the FDA’s Fast Track designation to develop TPIV 200 as a maintenance therapy in platinum-resistant ovarian cancer.

 


  • Phase II Trial in Platinum-Sensitive Ovarian Cancer 

TapImmune’s fourth Phase II trial utilizes TPIV 200 in ovarian cancer that is platinum-sensitive, and is being funded by the company. This study is an 80-patient double-blind placebo controlled study designed to examine the potential benefits of using the company’s lead product candidate TPIV 200 in combination with standard of care chemotherapy.

The study has Fast Track designation from the FDA and TPIV 200 has orphan drug status for ovarian cancer.

In the January press release announcing the launch of this Phase II trial, Dr. John Bonfiglio, President and COO of TapImmune explained:

“The opening of this study represents the fulfillment of a major 2016 milestone. We now have three clinical studies utilizing TPIV 200 with approvals to enroll patients. A fourth study in triple-negative breast cancer sponsored by the Mayo clinic with a $13.3M grant from the Department of Defense is scheduled to begin shortly. We believe the depth of these clinical programs will give us an excellent understanding of how this exciting T-cell therapy can potentially be used in the treatment of both triple-negative breast and ovarian cancers.”


Preclinical Development of  PolyStart™ Next Generation T-Cell Vaccine

PolyStart is a unique antigen expression system that ‘elevates’ the expression, and consequently the processing and presentation of desired antigenic peptide(s) for the stimulation of T-killer and/or T-helper cells to recognize and kill target cells. This novel vaccine technology platform creates a four-fold or greater increase in presentation of any antigen, giving it unlimited application in oncology and infectious diseases. This allows TapImmune to not only leverage the technology for its own vaccine candidates, but also generates additional value for the platform via licensing to third parties.

In February of this year, TapImmune expanded its patent on the PolyStart Platform for use in next-generation T-cell vaccines. Glynn Wilson, Chairman and CEO of TapImmune stated that:

“This patent significantly enhances our IP position for our PolyStart platform, further positioning TapImmune as a leader in the development of next-generation vaccines for cancer. The allowed claims cover enhanced expression of class I and class II HER2 antigens, enabling us to create future vaccines that should elicit robust and long-lasting T-cell immune responses against HER2/neu+ cancers with enhanced potency. While we focus on advancing our multiple Phase 2 clinical programs in ovarian and breast cancer, we expect to continue developing PolyStart to be used synergistically with our peptide-based vaccines as well as potentially monetized through licensing or partnership with other vaccine developers in oncology and infectious disease applications.”

PolyStart creates a 4 (FOUR) fold or more increase in antigen presentation.  The increased cell surface presentation increases activated Helper and/or long-lived Killer T-cell populations that then effectively seek out and work to destroy a patient’s cancer cells.

PolyStart enhances immune responses in patients not only for cancer drugs but for infectious disease and other products. TapImmune believes PolyStart has unlimited application in oncology and infectious diseases not only in the Company’s own platforms, but that it can be applied to many others via licensing.


The Bottom Line

TapImmune has multiple phase II trials underway in the development of novel vaccines for the aggressive treatment of refractory breast and ovarian cancers. The Company’s technology is validated by research grants awarded by the U.S. Department of Defense totaling some $17 million, and by top research partnerships and collaborations with Mayo Clinic, AstraZeneca, and Memorial Sloan Kettering Cancer Center.

TapImmune has added a world-class Medical Director in Dr. Richard Kenney to lead clinical development programs. His extensive experience in both clinical trials and the commercialization of oncology drugs is a huge asset for the Company.

TapImmune’s current market capitalization of just $31 million is a gross understatement of the value of this innovative, exciting, and potentially game-changing company. I’ll be providing updates on TapImmune in the weeks ahead.


See also: TapImmune Fact Sheet

Drug Trials Heating Up In The Breast and Ovarian Cancer Treatment Space

TapImmune in biotech and other media

 


DRIO

 

 

Terms of use/disclosure/disclaimer

 

DarioHealth Corp. (DRIO) picked at $3.86 (see 2/21/17 report), and  MassRoots Inc. (MSRT) picked at .81. (see 3/16/2017 report) have significant news out this morning.

 


dariohealth-logoDarioHealth Launches Insurance Coverage Option for U.S. Consumers

This morning, DarioHealth announced that it is now offering a 3rd party insurance coverage option for U.S. consumers who want to have their DarioHealth products reimbursed by insurance.

According to the press release, DarioHealth has signed strategic alliance agreements with partners across the U.S. who will be able to verify insurance coverage benefits, and if approved, will supply and bill the customer’s insurance for their Dario™ Blood Glucose Monitoring System and test strip supplies. During DarioHealth’s pilot phase of this insurance coverage option, partners were able to verify benefits for customers covered by Aetna and various Blue Cross Blue Shield plans.

 

Erez Raphael, Chairman and CEO of DarioHealth, stated:

“We are extremely excited with this new opportunity and will continue seeking out partnerships to expand our insurance coverage reach. Our customers asked about this, and we are happy to be able to provide this option to them. Many of these customers are already paying significant out of pocket cost for a variety of healthcare needs, so lowering their financial burden is tremendously gratifying and a big win for everyone in our community.”


Until now, U.S.-based customers paid out of pocket for DarioHealth’s products. Despite that fact, DRIO grew sales by 172% during Q4 of last year, with 67% of quarterly revenues derived from recurring sales of test strips and other consumables.

Insurance coverage is a major win for DRIO and should rapidly accelerate growth in the Company’s major market, the U.S.


About DarioHealth Corp.

DarioHealth Corp. is a leading global digital health company serving tens of thousands of users with dynamic mobile health solutions. We believe people deserve the best tools to manage their treatment, and harnessing big data, we have developed a unique way for our users to analyze and personalize their diabetes management. With our smart diabetes solution, users have direct access to track and monitor all facets of diabetes, without having the disease slow them down. The acclaimed Dario™ Blood Glucose Monitoring System all-in-one blood glucose meter and native smartphone app gives users an unrivaled method for self-diabetes management. DarioHealth is headquartered in Caesarea, Israel with a regional office in Burlington, Massachusetts. For more information, visit http://mydario.investorroom.com/.

 

See also:

DarioHealth February 2017 Investor Presentation

Rodman and Renshaw Report: DarioHealth BUY $12 PT

Joseph Gunnar & Co. Report: DarioHealth BUY $8 PT

 


massroots-logoMassRoots Launches New Website and Accelerates User Acquisition

On the heels of last week’s announcements that MassRoots has registered more than one million users on its platform (press release), and that Google Play has approved its mobile application for distribution to Android devices (press release), the Company has launched a new web site at MassRoots.com.

 

Powered by more than one million registered users, MassRoots enables consumers to rate products and strains based on their efficacy (i.e., effectiveness for treating ailments such back-pain or epilepsy) and then presents this information in easy-to-use formats for consumers to make educated purchasing decisions at their local dispensary. Businesses are able to leverage MassRoots by strategically advertising to consumers based on their preferences and tendencies.

MassRoots Chairman and CEO, Isaac Dietrich stated:

“MassRoots’ new website enables us to broaden our audience and more effectively monetize our users and web-traffic. We are already seeing hundreds of thousands of unique page views per month and are confident that the significant functionality and SEO improvements in MassRoots’ new website will enable us to accelerate our user and web-visitor growth. At the same time, we have greatly expanded the inventory and targeting options available to MassRoots’ advertisers, which will have an immediate and direct impact on our revenue.”

As the 4/20 holiday season rapidly approaches, MassRoots is committed to rapidly growing its market share of cannabis consumers and effectively monetizing them to further drive shareholder value.


About MassRoots


MassRoots is one of the largest technology platforms for the regulated cannabis industry. The Company’s mobile apps enable consumers to make educated cannabis purchasing decisions through community-driven reviews. MassRoots is proud to be affiliated with the leading businesses and organizations in the cannabis industry, including the ArcView Group and National Cannabis Industry Association. For more information, please visit MassRoots.com/Investors.

See also:

MassRoots in the media

MassRoots December 2016 Investor Update


DRIO

Disclaimer/Disclosure/Terms of Use


dariohealth-logoNasdaq-listed mHealth company, DarioHealth (DRIO), (web site) reported record Q4 and 2016 results after yesterday’s close.

 

2016 Highlights

  • Record revenues of $2.8 million, increased 241% compared to the full year 2015
  • Sequential quarterly revenue growth throughout the entire year
  • Direct-to-consumer model launched in U.S. with approximately 18,500 Dario™ Blood Glucose Monitoring System devices sold; accelerated in 2nd half of year with approximately 14,000 sold
  • Direct-to-consumer model launched in Australia and Canada
  • Nasdaq listing in March
  • Commenced investment discussions with OurCrowd Qure, an Israeli Digital Health Specialized Fund; subsequently closed in early 2017

Fourth Quarter Highlights

  • Record revenues of $838,000, increased 172% compared to the fourth quarter of 2015
  • Sequential quarterly revenue growth of 15% over third quarter of 2016
  • 67% of quarterly revenues derived from test strips and other consumables
  • Record 8,500 Dario™ Blood Glucose Monitoring System devices sold in the U.S.; 55% growth from third quarter of 2016
  • Consumable strips growth of 67% over third quarter of 2016
  • Nearly 95% of U.S. users have ordered test strips

According to the press release, DarioHealth expects sales to continue to accelerate in 2017 while reducing overall customer acquisition cost via:

  • execution of insurance reimbursement coverage options for U.S. consumers
  •  an increase in the percentage of higher-margin recurring consumable revenue
  • an expansion of the platform availability to include Android, which has been submitted to the FDA

 

Chairman and CEO of DarioHealth, Erez Raphael, commented,

“Our vision and focus allowed us to achieve a great deal over the last year, and has placed us in an advantageous position for further growth and market penetration for our Dario all-in-one smart glucose monitor and data platform. Our direct-to-consumer strategy in the U.S., launched mid-year, yielded the majority of our sales in this region, and continued to accelerate in the fourth quarter.

“We are encouraged by the fact we delivered on increased device sales, significant monthly user growth and established a predictable stream of high margin recurring subscription revenues from new customers. Furthermore, we are excited by the positive engagement we are achieving with our users, expect user growth to accelerate in 2017, and see revenue growth to continue in each sequential quarter, as it has grown until now.”


DarioHealth Conference Call Today, 9:00am ET

DarioHealth Corp. will hold a conference call today at 9am ET to discuss fourth quarter and full year 2016 results, as well as strategy and outlook for 2017.

  • The conference call will be hosted by Erez Raphael, Chief Executive Officer, and Zvi Ben-David, Chief Financial Officer.
  • The call can be accessed by dialing (866) 682-6100 or (862) 255-5401 and asking for the DarioHealth earnings conference call.
  • A live webcast of the call will also be available at: http://www.investorcalendar.com/IC/CEPage.asp?ID=175764

See also:

 DarioHealth February 2017 Investor Presentation

Rodman and Renshaw Report: DarioHealth BUY $12 PT

Joseph Gunnar & Co. Report: DarioHealth BUY $8 PT

 

About DarioHealth Corp.

DarioHealth is a leader in digital health self-management solutions. DarioHealth delivers the ability to combine and analyze consumer health data to personalize treatment and advance medical knowledge. Dario’s™ smart diabetes management solution is a platform for diabetes management that combines the Dario™ Blood Glucose Monitoring System all-in-one blood glucose meter, native smart phone app, website portal and a wide variety of treatment tools to support more proactive and better informed decisions by users living with diabetes, their doctors and healthcare systems.  Having recently launched in the largest market in the world for glucose monitoring, U.S. sales are expected to have a significant impact on revenues and gross margins. With marketing clearance in Europe and the U.S., the Dario iOS mobile app recently launched with reimbursement in the United Kingdom, Australia, Israel, Italy, and Canada, and has also launched in New Zealand, Netherlands, Italy, and Belgium.  For more information, visit http://mydario.investorroom.com/

 


DRIO

 

 


Terms of use/disclosures/disclaimer

  • TapImmune (TPIV) is proceeding on a total of four Phase II clinical trials in the development of a novel vaccine that aggressively attacks ovarian and breast cancers
  • In the earlier Phase I study of TPIV 200 at Mayo Clinic, 100% of patients demonstrated a T-Cell response lasting over 6 months and the drug was found to be safe and effective in treatment of both ovarian and breast cancers  
  • TPIV has collaborative partnerships with AstraZeneca (AZN), Memorial Sloan Kettering Cancer Center, and Mayo Clinic
  • TPIV received a $13.3 million grant from the U.S. Department of Defense which is fully funding a Phase II study of TPIV 200 in 280 patients with triple negative breast cancer being conducted at Mayo Clinic
  • TapImmune is well-funded and has no meaningful long term debt
  • TPIV has several positive forward drivers in coming weeks and months
  • With a Fast Track Designation and Orphan Drug Status under its wing, TapImmune is breaking down barriers at rapid speed and could very well have an up-and-coming commercial pipeline on its hands
  • TapImmune’s current market cap of just $36 million is a bargain given the company’s cash balance + $13.3 million grant from the U.S. government, + four Phase II studies in progress

tapimmune-logo

TapImmune, Inc. (web site) is a clinical-stage immune-oncology company specializing in the development of innovative technologies for the treatment of cancer and metastatic disease. The Company has made considerable clinical and financial progress over the last year, including the completion of positive Phase I clinical trials in breast and ovarian cancer at the Mayo Clinic, which showed that its TPV-100 and TPV-200 vaccines were safe and well tolerated, and demonstrated robust cellular immune responses in over 90% of evaluable patients. Since the results, TPIV has announced multiple Phase 2 clinical studies – and was also granted an Orphan Drug Designation and received fast track designation from the FDA for TPIV 200 in ovarian cancer.

 


Shares outstanding: 8.4 million
Closing Price 2/24/2017: $4.30
Market cap: $36 million
Total Cash (mrq) $9.6 million
Cash/Share (mrq) $1.14
Debt (mrq) 5k
Current Ratio (mrq) 4.40

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Four Phase II Immuno-Oncology Trials Underway with Top Tier Partners

Immuno-Oncology (or cancer immunotherapy) is a ground-breaking approach in the fight against aggressive cancer that uses the body’s own immune system to fight the disease. TapImmune has four clinical trials now in phase II for treatment of ovarian and triple-negative breast cancers.

Investors should note that TapImmune has world-class sponsors and collaborators in these trials, including AstraZeneca (AZN), Memorial Sloan Kettering Cancer Center, Mayo Clinic, and the U.S. Department of Defense. The caliber of these sponsors and partners speaks volumes about the potential for breakthrough research in the cancer immunotherapy space by TapImmune.

TapImmune Pipeline

 


  • Phase II Trial of TPIV 200 for Triple-Negative Breast Cancer with Fast Track designation from the FDA

About 15-20% of all breast cancers are found to be triple-negative (meaning the breast cancer cells tested negative for estrogen receptors, progesterone receptors, and HER2). This form of breast cancer does not respond to hormonal therapy (such as tamoxifen or aromatase inhibitors), or therapies that target HER2 receptors, such as Herceptin (chemical name: trastuzumab). Triple-negative breast cancer tends to be more aggressive with higher mortality rates than other breast cancers.

The open-label, 80 patient clinical trial by TapImmune is designed to evaluate dosing regimens, adjuvants, efficacy, and immune responses in women with triple-negative breast cancer. Key data from the trial is expected to be included in a future New Drug Application submission to the FDA for marketing clearance.

TapImmune announced a key clinical milestone earlier this month in passing a planned safety review that was performed when enrollment had reached 25 percent benchmark (20/80 patients).

In the prior Phase I study of TPIV 200 at Mayo Clinic, 100% of patients demonstrated a T-Cell response lasting over 6 months and the drug was found to be safe and effective in treatment of both ovarian and breast cancers.  

This study has Fast Track designation from the FDA which provides an expedited review to facilitate development of the drug.  This designation is granted in studies that treat serious or life-threatening conditions and fill an unmet medical need.


  • Phase II Mayo Clinic Trial of TPIV 200 in Triple-Negative Breast Cancer Fully Funded by U.S. Department of Defense

This is a separate Phase II study of TPIV 200 for the treatment of triple-negative breast cancer, conducted by the Mayo Clinic and sponsored by the U.S. Department of Defense (DOD). The 280 patient study is being led by Dr. Keith Knutson of the Mayo Clinic in Jacksonville, Florida. Dr. Knutson is the inventor of the technology and an advisor to TapImmune.

$13.3 million worth of non-dilutive capital for trial.

While TapImmune is supplying doses of TPIV 200 for the trial, the remaining costs associated with conducting this study will be funded by a $13.3 million grant made by the DOD. This grant is a direct result of the very positive findings of the Phase I trial of TPIV 200 and validates TamImmune’s technology.

This Phase II launch is expected to begin shortly, and the announcement should be a positive driver for TPIV shares.


  • Phase II Trial at Memorial Sloan Kettering of TPIV 200 in Platinum-Resistant Ovarian Cancer in Collaboration with AstraZeneca on FDA Fast Track

Approximately 22,000 women were diagnosed with ovarian cancer in 2016 and an estimated 14,180 will die from the disease according to the American Cancer Society. Because ovarian cancer tends to be detected at a later stage of the disease, the five-year survival rate for ovarian cancer is 45%. Current treatment options are surgery, radiation and chemotherapy.

There is currently no FDA approved cancer vaccine available for ovarian cancer.

This is a Phase II study of TPIV 200 in ovarian cancer patients who are not responsive to platinum, (a commonly used chemotherapy for ovarian cancer), sponsored by Memorial Sloan Kettering Cancer Center in collaboration with AstraZeneca. The open-label study is designed to evaluate a combination therapy which includes TapImmune’s TPIV 200 T-cell vaccine and AstraZeneca’s checkpoint inhibitor, durvalumab.

Because these patients are unresponsive to platinum-based therapy and have failed chemotherapy, there are unfortunately, no real options left at the present time. If the combination therapy proves effective, it would address a critical unmet need.

TapImmune received the FDA’s Fast Track designation to develop TPIV 200 as a maintenance therapy in platinum-resistant ovarian cancer.

On the Fast Track designation, Dr. Glynn Wilson, Chairman and CEO of TapImmune stated:

“We believe that the FDA’s decision to grant Fast Track designation to TPIV 200 for the treatment ovarian cancer significantly expedites our clinical development program. We believe TPIV 200 has the potential to improve outcomes for ovarian cancer patients for whom current treatment modalities offer a relative short time to recurrence and a poor overall prognosis.”


  • Phase II Trial in Platinum-Sensitive Ovarian Cancer 

TapImmune’s fourth Phase II trial utilizes TPIV 200 in ovarian cancer that is platinum-sensitive, and is being funded by the company. This study is an 80-patient double-blind placebo controlled study designed to examine the potential benefits of using the company’s lead product candidate TPIV 200 in combination with standard of care chemotherapy. The study has Fast Track designation from the FDA and TPIV 200 has orphan drug status for ovarian cancer.

In the January press release announcing the launch of this Phase II trial, Dr. John Bonfiglio, President and COO of TapImmune explained:

“The opening of this study represents the fulfillment of a major 2016 milestone. We now have three clinical studies utilizing TPIV 200 with approvals to enroll patients. A fourth study in triple-negative breast cancer sponsored by the Mayo clinic with a $13.3M grant from the Department of Defense is scheduled to begin shortly. We believe the depth of these clinical programs will give us an excellent understanding of how this exciting T-cell therapy can potentially be used in the treatment of both triple-negative breast and ovarian cancers.”


See video from last week on TPIV:

“Vaccine could prevent breast, ovarian, lung cancer”

 


 


TPIV 100, TPIV 110 Also in Pipeline

The Phase 1 trial of TPIV 100 in 22 patients demonstrated the drug was safe and well-tolerated. The trial also showed that 19 out of 20 patients showed robust T-cell responses to two antigens while 15 out of 20 patients responded to all four antigens. The immune responses in these patients were durable for months after their final treatment.

 

The Phase 1b/2a program for TPIV 110 is designed to examine this novel T-cell vaccine both as a stand-alone therapy as well as a combination therapy with other standard of care therapies and newer experimental therapies. TapImmune plans to initiate TPIV 110 trials in breast cancer in 2017. The strategy is to obtain positive Phase 2 data and then look for a partnership or collaboration to fund the rest of the commercialization for TPIV 110.

TapImmune TPIV 110

Existing treatments such as Herceptin and Parjeta target the Her2/neu receptor and can work well in controlling the disease. However, the patient’s tumor must have the Her2/neu receptor (~30%) and in addition have the receptor in high enough density to make the antibody effective (~18% of the 30%). This leaves a void where patients who have the receptor but are not eligible for antibody treatment are relegated to chemotherapy, radiation and surgery.

TapImmune’s investigational product TPIV 110 also targets Her2/neu by stimulating the body’s own immune system to attack cancer cells with the Her2/neu target.

TapImmune plans to file an IND (Investigational new Drug) application with the FDA this year for TPIV 110.

TapImmune TPIV 110 development plan

 


Positive Upcoming Drivers

TapImmune has multiple positive drivers going forward, including:

  • Participation in multiple oncology and biotech events in March and April
  • Launch of the Phase II trial of TPIV 200 at Mayo Clinic, fully funded by a U.S. Government grant of $13.3 million
  • Clinical data coming out of multiple Phase II trials of TPIV 200
  • IND announcement on TPIV 110 expected during Q1 this year
  • Initiation of the Phase 1b/2a studies using TPIV 110

Preclinical, A Next Generation T-Cell Vaccine: PolyStart

PolyStart is a unique antigen expression system that ‘elevates’ the expression, and consequently the processing and presentation of desired antigenic peptide(s) for the stimulation of T-killer and/or T-helper cells to recognize and kill target cells. This novel vaccine technology platform creates a four-fold or greater increase in presentation of any antigen, giving it unlimited application in oncology and infectious diseases. This allows TapImmune to not only leverage the technology for its own vaccine candidates, but also generates additional value for the platform via licensing to third parties.

In February of this year, TapImmune expanded its patent on the PolyStart Platform for use in next-generation T-cell vaccines. Glynn Wilson, Chairman and CEO of TapImmune stated that:

“This patent significantly enhances our IP position for our PolyStart platform, further positioning TapImmune as a leader in the development of next-generation vaccines for cancer. The allowed claims cover enhanced expression of class I and class II HER2 antigens, enabling us to create future vaccines that should elicit robust and long-lasting T-cell immune responses against HER2/neu+ cancers with enhanced potency. While we focus on advancing our multiple Phase 2 clinical programs in ovarian and breast cancer, we expect to continue developing PolyStart to be used synergistically with our peptide-based vaccines as well as potentially monetized through licensing or partnership with other vaccine developers in oncology and infectious disease applications.”

PolyStart creates a 4 (FOUR) fold or more increase in antigen presentation.  The increased cell surface presentation increases activated Helper and/or long-lived Killer T-cell populations that then effectively seek out and work to destroy a patient’s cancer cells.

PolyStart enhances immune responses in patients not only for cancer drugs but for infectious disease and other products. TapImmune believes PolyStart has unlimited application in oncology and infectious diseases not only in the Company’s own platforms, but that it can be applied to many others via licensing.

The data below is from an earlier study showing the increased presentation and subsequent KILLING of the targeted cell population.

 

 

tapimmune-polystart

Dr. Glynn Wilson, Chairman & CEO of TapImmune explains:

“We are very excited about this technology, as we believe it marks a next generation of T-cell vaccines. PolyStart has unlimited application in oncology and infectious diseases not only within TapImmune’s own platforms but it can be applied to many others via licensing. As we move forward in Phase 2 trials for TPIV 200, which targets folate receptor alpha, and TPIV 100/110 our Her2/neu product, we fully expect to develop PolyStart as both a stand-alone therapy and as a ‘boost strategy’ to be used synergistically with our peptide-based vaccines for breast and ovarian cancer.” 

Along with novel peptides and the PolyStart expression system, the TPIV vaccine platform can address multiple infectious diseases as well as pandemic and biodefense threats. TapImmune’s current Smallpox vaccine study at Mayo Clinic has already shown significant benefits over the current vaccine stockpile. It is naturally processed and peptide based, making it safer, longer lasting, cheaper and as effective (in animal studies) as the current product stockpile. The last DHHS contract for a smallpox vaccine stockpile was worth up to $2.8 billion.


Conclusion

TapImmune (TPIV) is at the forefront of the immuno-oncology space and has world-class collaborative partners in AstraZeneca (AZN), Memorial Sloan Kettering Cancer Center, and Mayo Clinic. The fact that the U.S. government has fully funded the Phase II trial of TPIV 200 for the treatment of triple-negative breast cancer validates the strong data obtained from the preceding Phase I trial. Additionally, the grant provides $13.3 million of non-dilutive funding for TapImmune’s research.

Given that TapImmune has a healthy cash balance of $9.6 million (mrq) and is receiving some $13.3 million in non-dilutive grants from the U.S. government, the market cap of $36 million seems extremely low- especially given the company has four different Phase II trials on progress for what could be a game-changing vaccine in the fight against cancer.

 


See also: TapImmune January 2017 Investor Presentation

Interview With TapImmune, Inc. (NASDAQ: TPIV) President And COO, Dr. John Bonfiglio (SmarterAnalyst- January, 2017)

TapImmune Developing Vaccines for Breast and Ovarian Cancer (Biosience Technology- December, 2016)

One Big Question: How close are we to a cancer vaccine? (NewAtlas- December, 2016)

Vaccine could prevent breast, ovarian, lung cancer (Fox News- February, 2017)


tapimmune -gary pic

 

 

Disclaimer/Disclosure/Terms of Use

 

 

 

  • Nothing advances share prices like the strong top and bottom line growth DarioHealth Corp. (DRIO) is experiencing
  • DRIO reported a whopping 282% growth in sales for the previous 9 month period ending last September
  • Expect a record Q4 and full 2016 results when DRIO reports next month,a strong catalyst to drive shares higher
  • FDA approval for the Android version of the DarioSmart Diabetes Management Solution is expected by mid-2017, another positive catalyst for the company
  • Near-term launch in Germany pending, further accelerating sales
  • Coming off a $5.1 million raise last month, DRIO has a strong balance sheet to continue rapid market penetration
  • DRIO has a unique business model in the Mobile Health (mHealth) space that helps customers better manage their diabetes, and that model, (along with the Company’s proprietary technology), is the driving force behind the growth

dariohealth-logo

DarioHealth Corp. (NASDAQ:DRIO), (web site), is a digital health company that develops and commercializes patented and proprietary technologies providing consumers with laboratory-testing capabilities using smart phones and other mobile devices.

Its flagship product is the Dario Smart Diabetes Management Solution, a mobile, real-time, cloud-based, diabetes management solution based on a multi-feature software application combined with Dario Smart Meter, a pocket-sized, blood glucose monitoring device.

DarioHealth Corp. has marketing clearance in Europe and the U.S. and the Dario iOS mobile app recently launched with reimbursement in the United Kingdom, Australia, Israel, Italy, and Canada. Additionally, DarioHealth has launched in New Zealand, the Netherlands, Italy, and Belgium.

The company is also pursuing patent applications in various jurisdictions covering the specific processes related to blood glucose level measurement, as well as various general methods of rapid tests of body fluids using mobile devices and cloud-based services. The company was formerly known as LabStyle Innovations Corp. and changed its name to DarioHealth Corp. in July 2016. The company was founded in 2011 and is headquartered in Caesarea, Israel.


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Share Information

Shares Outstanding: 7.3 million
Insider ownership: ~40%
Float: 2
.9 million
Closing Price 2/17/2017: $3.86
Market Capitalization: $28 million
Revenue/Share 0.51
Quarterly Revenue Growth (yoy) 167%

 


DarioHealth Corp. Experiencing Strong Top and Bottom Line Growth

Nothing drives share price appreciation more than strong fundamentals, something DarioHealth Corp. has in spades. DarioHealth grew sales by 282% during the first 3 quarters of last year as compared to the same period in 2015, from $515,000 to $1,965,000 (see SEC filing).  Moreover, loss/share was trimmed to (.31) from (.90) during Q3 of 2016 vs. the same period in 2015. This strong improvement in top and bottom line growth is no fluke- it’s due to several factors that set DRIO apart from competitors, factors that I’ll discuss below.

Record Q4 Report Pending

DarioHealth will be reporting Q4 and full year results in March, and indications are that Q4 will be a new record for the company. This is due in part to the launch of DarioHealth Blood Glucose Monitoring System in the U.S. market, a launch in its infancy that’s producing very substantial early results. On January 23rd, DRIO gave a peek at the upcoming Q4 results from the U.S. market launch, and the numbers are impressive:

  • More than 8,500 were sold in the U.S during Q4 alone, increasing market presence by 85% compared to the end of the third quarter
  • 18,500 Dario All-in-One Smart Glucose Meter devices were purchased in the U.S. alone during the company’s 2016 U.S. launch
  • Nearly 95% of U.S. users have ordered test strips
  • DarioHealth generates recurring revenue between $150-$500/user annually from sales of disposable monitoring strips

DRIO is the classic “razor-razorblade model” on steroids. FDA approval of Android version will increase market penetration + launch in Germany also pending.

By taking the lower end of annual recurring revenue/user of only $200 and the 95% U.S customer conversion rate to disposable test strip consumers (or approximately 17,500 of U.S. customers), DRIO is looking at $3.5 million in annual recurring sales from the U.S. market alone for 2017 ($200 x 17,500). Keep in mind this is using the lower end of the $150-$500 annual recurring revenue/customer range and includes just the U.S. market alone, where DRIO is still ramping up sales. It does not account for growth in multiple other markets, (including the United Kingdom, Australia, Israel, Italy, and Canada, New Zealand, the Netherlands, Italy, and Belgium), or Germany where DarioHealth has a launch pending.

DRIO also submitted the Android version of the Smart Diabetes Management System to the FDA and expects approval in Q1 or early Q2 of this year. There are approximately 107 million users of android devices in the U.S., so this is a noteworthy market for expansion.

Given the facts above, investors can look forward to a record Q4 and full year 2016 to be reported in the DRIO 10-K filing due in early March, followed closely by a record Q1 2017.


Recent Capital Raise Will Fuel Rapid Expansion and Strong Sales Growth

DarioHealth has a strong balance sheet with current assets of $5.6 million and current liabilities of $2 million for a healthy current ratio of 2.8. Keep in mind the balance sheet is from Q3 of 2016 and does not include the cash infusion of approximately $5 million in gross proceeds expected from the Company’s recent raise announced January 12, 2017.

The financing deal was led by OurCrowd Qure, a dedicated digital health fund that invested $2.5 million of the $5.1 million. OurCrowd Qure has been granted two board seats which will be selected and announced at a later date.

On the recent funding, Erez Raphael, Chairman and CEO of DarioHealth stated:

We have received great support and belief in our product, vision, and growth strategy from investors. With this funding, we will accelerate adoption of our innovative and user-friendly remote glucose monitor platform across current markets and also expand into new geographies, such as Germany, in 2017.”

 


Analyst Sees $8 Million in Sales for 2017 and $19 Million for 2018

Analyst Joseph Gunnar & Co has a well-researched report on DarioHealth you can read here. In the report you’ll find sales estimates of $2.9 million for 2016, $8 million for 2017, and $19 million for 2018. Using a reasonable metric of 4.5X sales, Joseph Gunner has an $8/share price target on DRIO shares.

DarioHealth (DRIO) Sales Growth Chart

Additionally, Rodman and Renshaw has a $12 price target on DRIO shares, using a net present value (NPV) model, and assuming just 6.6% diabetes market penetration and $400/year sales/user (includes hardware, strips, licensing, etc.)

DarioHealth - rodman valuation

 

Clearly, DarioHealth Corp. is on to something in the rapidly expanding mobile health space.


The Diabetes Management Market

Diabetes is the 7th leading cause of death in the United States according to the Centers for Disease Control. Moreover, it greatly increases the risk for heart disease, end-stage renal disease, blindness, amputation, and complications during pregnancy. It is a chronic medical condition that has increased in its numbers at a faster pace than most other chronic conditions. In 2015, the International Diabetes Federation estimated that more than 415 million people had been diagnosed with the disease, and that number is expected to balloon to 642 million by 2040.

The importance of carefully managing diabetes cannot be overstated. In a recent study by the National Institutes of Health, people with type 2 diabetes who intensively managed their blood sugar levels were found to have cut their risk of diabetic retinopathy in half. Multiple studies have shown that well managed blood sugar levels in diabetics dramatically reduces risk of complications including heart and blood vessel disease, nerve damage, and kidney disease as well.

Mayo Clinic puts it simply and directly:

“Controlling your blood sugar levels can help prevent these complications.”

And this is where DarioHealth Corp. comes in- with 12% of all global health expenditures spent on diabetes, having a real-time diabetes management solution that is practical and user-friendly while reducing risk of costly and life-threatening complications represents an urgently needed paradigm shift in the management of the disease.


Moving the Market from “Monitoring” to “Management” is Driving Growth

The company’s focus on helping consumers manage and not just monitor diabetes is why sales are skyrocketing. Investors should understand that DarioHealth Corp. is not simply a diabetes monitoring or blood sugar measurement device company. Dario is a pioneer in effective disease management solutions, and diabetes is the first, “low hanging fruit” the company is addressing.

Unlike traditional glucose meters offered by competitors, the Dario App provides:

  • Real-time, easy-to-access information
  • Test results automatically logged and synced in the cloud for physician access (no need to write in paper log books)
  • Data insights, analysis, and pattern recognition so users can easily understand why their personal blood glucose levels change and what changes them
  • Actionable alerts and reminders
  • Insulin dose tracking
  • Log of carbs and calories
  • Database showing carbohydrate counts of half a million foods
  • Users can even set extreme hypoglycemic result alerts to text message family member(s) with GPS tracking

DarioHealth also intends to increase penetration in both the direct to consumer market and to other businesses by offering diabetes management coaching services in the future. The company plans to reduce medical complications of employees with diabetes (and improve clinical outcomes, reduce sick time, reduce health care costs) by using a team of nurses and other health care professionals that will provide diabetes management coaching services.

The video below gives an overview of the DarioHealth Smart Diabetes Management System in action.

 

 

The DarioHealth Smart Diabetes Management System includes a sleek, accurate, all-in-one Smart Meter combined with a robust, real-time mobile app that allows users to record their data: blood glucose measurements, carbs & insulin intake, and physical activity. Users can view, analyze, list and compare all of this valuable information and share it with family and medical staff.

 


DarioHealth is the only diabetes management system that includes all of the features below:

 

dariohealth-features

 


Innovative B2C Sales Model = High Margins and Rapid Sales Growth

Going beyond technological innovation in disease management, DarioHealth Corp. has an innovative approach to sales. The company is using a direct business to consumer sales approach with a strong presence on social media. DarioHealth is creating demand directly from the consumer, skipping the middlemen, and generating high margins.

Ultimately, DarioHealth intends to dramatically ramp revenue by expanding the company’s diabetes management solution beyond individual consumers to include businesses by offering a cost effective mobile health solution for employees with diabetes. DarioHealth plans to reduce medical complications of employees with diabetes (and improve clinical outcomes, reduce sick time, reduce health care costs) by using a team of nurses and other health care professionals to provide diabetes management coaching services. This is a huge, untapped market for Dario to penetrate with an early mover advantage.


Conclusion

DarioHealth is a pioneer in the digital health space, addressing a global market of > 400 million diabetics with patented technology that can help them better manage their disease and reduce expensive and life-threatening complications in a cost-effective manner.

With sales just beginning to dramatically increase following last year’s U.S. launch and the enormous market the Diabetes Management System addresses, the current low market capitalization of DarioHealth ($28 million) is not likely to last. To date, the company has been focused on the successful launch of the system itself, including FDA and other regulatory hurdles, obtaining patent protections, and regularly upgrading the software based on user feedback. During my conversation with management it was clear the company intends to begin doing much more in terms of investor awareness and investor relations, including taking steps to increase institutional awareness and participation in the company in 2017.

Relative to other digital health data solutions, both retail and institutional investors should find DRIO shares attractive at a $28 million market cap, especially given the “hockey-stick” growth curve the company is experiencing.

Fundamentals matter, and as a result DRIO shares shares should have a very strong showing in 2017 as the company rapidly expands revenues and is introduced to a larger investor base. 

Look for a record Q4 report in early March, followed up by another new record for Q1 2017, a launch in Germany, and FDA approval of the Android version as positive catalysts for near term share price appreciation.


DarioHealth - gary siggy

 

 

Supplemental: DarioHealth February 2017 Investor Presentation

Rodman and Renshaw Report: DarioHealth BUY $12 PT

Joseph Gunnar & Co. Report: DarioHealth BUY $8 PT


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DRIO stock

 

Nasdaq listed DarioHealth Corp. (DRIO) is pioneering the future of disease management and mobile health by providing consumers with laboratory-testing capabilities using smart phones and other mobile devices. Dario’s™ smart diabetes management solution is a platform for diabetes management that combines the Dario™ Blood Glucose Monitoring System all-in-one blood glucose meter, native smart phone app, website portal and a wide variety of treatment tools to support more proactive and better informed decisions by users living with diabetes, their doctors and healthcare systems.


In news today, (DarioHealth Ends a Successful Diabetes Awareness Month) DarioHealth Corp. (DRIO) announced the company added over 4,000 new sign-ups using their cost-effective, direct-to-consumer model.

 

Erez Raphael, DarioHealth’s Chief Executive Officer stated:

“During Diabetes Awareness Month, we welcomed thousands of new registrants. In the U.S. alone, we had over 4,000 new sign-ups. Our primary goal is to give members of our DarioHealth community the best user experience possible to deal with their diabetes. It is extremely encouraging and inspiring when we receive positive feedback. This is the ultimate vote of confidence and the results from Diabetes Awareness Month echo this. We continue to build on our success as we head towards 2017 and beyond.”

 

Leveraging the razor/razor blade model, the average consumer will use $300 of strips at 75% grow margins…part of the reason why the company turned a gross profit in Q3…and why adding 4,000 sign-ups for the month of November in the U.S. alone is significant.

Sales grew 166% last quarter, and it looks as management is delivering on stated guidance for “market penetration and user growth to accelerate in the fourth quarter”


For more on DRIO read our initial article: DarioHealth: Digital Disease Management Pioneer Experiencing Dramatic Growth

DarioHealth BUY Recommendation w $12 price target from Rodman and Renshaw

DarioHealth Corp. November 2016 Investor Presentation


DRIO stock - gary

 

 

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dariohealth-logo

Nasdaq listed DarioHealth Corp. (DRIO) is pioneering the future of disease management by providing consumers with laboratory-testing capabilities using smart phones and other mobile devices.

The company’s flagship product, the Dario Smart Diabetes Management Solution, is a patented, mobile, real-time, cloud-based, diabetes management solution based on a multi-feature software application combined with Dario Smart Meter, a pocket-sized, blood glucose monitoring device.

Leveraging the razor/razor blade model, the average consumer will use $300 of strips at 75% grow margins…part of the reason why the company turned a gross profit in Q3.

In Q3 2016, sales grew 166%, the company recorded a gross profit, and management expects “market penetration and user growth to accelerate in the fourth quarter.”

DarioHealth Corp. has built a digital disease management platform that is used in 7 different countries and growing, is cost effective for consumers, is readily scalable at minimal additional cost, and which can be expanded into other disease management areas beyond diabetes.


 

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Share Information

Shares Outstanding: 5.7 million
Insider ownership: ~40%
Float:
3.9 million
Closing Price 11/28/2016: $3.02
Market Capitalization: $17.3 million


The Diabetes Management Market

Diabetes is the 7th leading cause of death in the United States according to the Centers for Disease Control. Moreover, it greatly increases the risk for heart disease, end-stage renal disease, blindness, amputation, and complications during pregnancy.

It is a chronic medical condition that has increased in its numbers at a faster pace than most other chronic conditions. In 2015, the International Diabetes Federation estimated that more than 415 million people had been diagnosed with the disease, and that number is expected to balloon to 642 million by 2040.

The importance of carefully managing diabetes cannot be overstated. In a recent study by the National Institutes of Health, people with type 2 diabetes who intensively managed their blood sugar levels were found to have cut their risk of diabetic retinopathy in half. Multiple studies have shown that well managed blood sugar levels in diabetics dramatically reduces risk of complications including heart and blood vessel disease, nerve damage, and kidney disease as well.

Mayo Clinic puts it simply and directly:

“Controlling your blood sugar levels can help prevent these complications.”

And this is where DarioHealth Corp. comes in. With 12% of all global health expenditures spent on diabetes, having a real-time diabetes management solution that is practical and user-friendly while reducing risk of costly and life-threatening complications represents an urgently needed paradigm shift in the management of the disease.


Moving the Market from “Monitoring” to “Management”

Investors should understand that DarioHealth Corp. is not simply a diabetes monitoring device company. Dario is a pioneer in effective disease management solutions, and diabetes is the first, “low hanging fruit” the company is addressing.

The Dario App provides:

  • Real-time, easy-to-access information
  • Results are automatically logged and synced in the cloud for physician access (no need to write in paper log books)
  • Data insights, analysis, and pattern recognition so users can easily understand why their personal blood glucose levels change and what changes them
  • Actionable alerts and reminders
  • Insulin dose tracking
  • Log of carbs and calories
  • Database showing carbohydrate counts of half a million foods
  • Users can even set extreme hypoglycemic result alerts to text message family member(s) with GPS tracking

DarioHealth also intends to increase penetration in both the direct to consumer market and to other businesses by offering diabetes management coaching services in the future. The company plans to reduce medical complications of employees with diabetes (and improve clinical outcomes, reduce sick time, reduce health care costs) by using a team of nurses and other health care professionals that will provide diabetes management coaching services.

The video below gives an overview of the DarioHealth Smart Diabetes Management System in action.

 

 

The DarioHealth Smart Diabetes Management System includes a sleek, accurate, all-in-one Smart Meter combined with a robust, real-time mobile app that allows users to record their data: blood glucose measurements, carbs & insulin intake, and physical activity. Users can view, analyze, list and compare all of this valuable information and share it with family and medical staff.

 


DarioHealth is the only diabetes management system that includes all of the features below:

 

dariohealth-features

 


Innovative B2C Sales Model = High Margins and Rapid Sales Growth

Beyond the technological innovation in disease management, DarioHealth Corp. has an innovative approach to sales. The company is using a direct business to consumer sales approach with a strong presence on social media. With numerous ads like this (Special Offer for Diabetes Awareness Month: FREE METER), DarioHealth is creating demand directly from the consumer, skipping the middlemen, and generating high margins.

Razor/Razor Blade Business Model

In the diabetes lifestyle management revenue stream, the average user will use $300 worth of strips per year at 75% gross margin.

The model is working. 

DarioHealth Corp. launched the B2C sales model in the UK in Q1 of last year, then expanded sales to Australia, Canada, and Italy within 12 months. The company entered the U.S market in March of this year.

Sales growth is in a strong uptrend as seen in the chart below:

dariohealth-revenue-growth

In Q3 2016, sales increased by 166% vs. the year ago period. Other highlights from a very impressive quarter include:

  • Record revenues of $728,000
  • Gross profit of $76,000 in the third quarter
  • 75% of quarterly revenues derived from test strips and other consumables
  • More than 5,500 Dario all-in-one smart glucose meter devices were purchased directly by U.S. customers during the third quarter; globally about 8,500 were sold during the quarter
  • About 70% of strips sales in the U.S. during the quarter were under the subscription plan
  • Direct-to-consumer model launched in Australia and in Canada
  • Ramped up inventory to $1.1 million in order to support further market penetration

DarioHealth Corp. CEO, Erez Raphael, stated:

“During the third quarter, we continued to advance our direct-to-consumer strategy in the U.S., increased device sales, delivered significant monthly user growth and established a predictable stream of high margin recurring subscription revenues from new customers. We are encouraged by the positive engagement we are achieving with new users and expect market penetration and user growth to accelerate in the fourth quarter. Our active community of users and subscribers is growing every day which is bringing positive changes to people with diabetes, and disrupting the digital, mHealth and lifestyle market.”

and

“We have the right product and the right strategy to succeed in these efforts and look forward to the opportunities ahead of us. The predictable nature of these subscription revenues will provide us greater visibility in 2017 and serve as the foundation for our long-term growth.”

Sound fiscal management has improved the balance sheet over the prior year, and DarioHealth now has cash of ~ $1.50/share on hand (see 10-Q).

$ in thousands Period Ending 9/30/16 Period Ending 12/31/15
Cash $3,339 $2,671
Total Assets $6,696 $5,077
Total Liabilities $2,336 $6,657
Shareholders’ Equity (deficit) $4,360 $(1,580)

Growth in 2017 and Beyond

At present, DarioHealth has only has FDA approval for the Diabetes Management System on Apple devices in the U.S. The company has submitted the Android version of the system to the FDA and expects approval in Q1 or early Q2 of next year. There are approximately 107 million users of android devices in the U.S., so this is a noteworthy market for expansion. Additionally, DarioHealth will be offering more user applications and expanding into new geographic territories in the coming year.

Ultimately, DarioHealth intends to dramatically ramp revenue by expanding the company’s diabetes management solution beyond individual consumers to include businesses, by offering a cost effective mobile health solution for employees with diabetes. DarioHealth plans to reduce medical complications of employees with diabetes (and improve clinical outcomes, reduce sick time, reduce health care costs) by using a team of nurses and other health care professionals to provide diabetes management coaching services. This is a huge, untapped market for Dario to penetrate with an early mover advantage.


Valuation

DarioHealth is a pioneer in the digital health space, addressing a global market of > 400 million diabetics with patented technology that can help them better manage their disease and reduce expensive and life-threatening complications in a cost-effective manner.

With sales just beginning to dramatically increase following last year’s launch and the enormous market the Diabetes Management System addresses, the current low market capitalization of DarioHealth ($17 million) is not likely to last. To date, the company has been focused on the successful launch of the system itself, including FDA and other regulatory hurdles, obtaining patent protections, and regularly upgrading the software based on user feedback. During my conversation with management earlier this week it was clear the company intends to begin doing much more in terms of investor awareness and investor relations, including taking steps to increase institutional awareness and participation in the company.

Given the overall market growth, the innovative, high-growth user platform, the business model, marketing capabilities, and new market opportunities, DarioHealth is likely to deliver a “hockey-stick growth” chart in the year ahead.

Rodman and Renshaw has a $12 price target on DRIO shares, using a net present value (NPV) model, and assuming just 6.6% diabetes market penetration and $400/year sales/user (includes hardware, strips, licensing, etc.)

DarioHealth - rodman valuation

Joseph Gunnar & Co. uses a price/sales model peer group comparison, and has an $8 price target on DRIO Shares. This is 4.5x 2018 revenue estimates and multiple is in line with the peer group average.

Relative to other digital health data solutions, both retail and institutional investors should love DRIO shares here at a $17 million market cap. Consider Fitbit (NYSE: FIT) at a $2.2 billion market cap, or 23X EPS, and MyFitnessPal, acquired by Under Armour (NYSE:UA) for $475 million.

Fundamentals matter, and we think DarioHealth (DRIO) shares will have a very strong showing in 2017 as the company rapidly expands users, revenues, and is introduced to a larger investor base.


DarioHealth - gary siggy

 

 

Supplemental: DarioHealth November 2016 Investor Presentation

Rodman and Renshaw Report: DarioHealth BUY $12 PT

Joseph Gunnar & Co. Report: DarioHealth BUY $8 PT


See: Terms of use/disclosures/disclaimer

medovex-logo-blue-e1421779719549Medovex Corporation (MDVX) (web site) develops medical devices primarily in the in the United States and Europe. It offers DenerveX device for the treatment of conditions resulting from the degeneration of joints in the spine, which cause back pain. The company serves healthcare providers, physicians, and third-party payors. Medovex Corporation is headquartered in Atlanta, Georgia.

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MDVX at a glance:

Shares Outstanding: 14 million
Insider Ownership: 38%
Float: 8 million
Closing Price 11/01/2016: $1.66
Market Capitalization: 23 million


Multi-Billion Dollar Market Opportunity

Osteoarthritis (OA) is the most common form of arthritis, affecting 27 million people in the United States and The Centers for Disease Control and Prevention lists low back pain as the second most common cause of disability in US adults. With the advancing age of the population and obesity epidemic, the prevalence of OA is also increasing:

  • By 2030, 20% of Americans or about 70 million people age 65 and older, will be at risk for osteoarthritis
  • Fifty percent of people age 65 and older already exhibit evidence of osteoarthritis in at least one joint

Osteoarthritis of the spine, known as spondylosis, is a degenerative disorder that can cause loss of normal spinal structure and function. Aging is the primary cause. Spondylosis can affect the cervical, thoracic and/or lumbar regions of the spine, and may involve intervertebral discs and facet joints, which can lead to disc degeneration, bone spurs, pinched nerves, and an enlargement or overgrowth of bone that narrows the central and nerve root canals, causing impaired function and pain. When spondylosis worsens, it may progress to spinal stenosis, a narrowing of spaces in the spine, which results in pressure on the spinal cord and/or nerve roots.

A related condition, degenerative spondylolisthesis (slippage of one vertebra over another) is caused by osteoarthritis of the facet joints. Most commonly, it involves the L4 slipping over the L5 vertebra, and is also related to aging, most frequently affecting people age 50 and older. Symptoms may include pain in the low back, thighs, and/or legs, muscle spasms, weakness, and/or tight hamstring muscles.

medovex-facet-joint

 

Approximately 31% of chronic low back pain is attributed to the facet joints, small stabilizing joints located between and behind adjacent vertebrae. Facet joints are in almost constant motion with the spine and quite commonly simply wear out or become degenerated in many patients. When facet joints become worn or torn the cartilage may become thin or disappear and there may be a reaction of the bone of the joint underneath producing overgrowth of bone spurs and an enlargement of the joints.

Chronic back pain caused by facet joint arthritis is a multi-billion dollar market opportunity that currently has no effective, long term/permanent solution.  

 

 


Temporary Relief vs. Permanent Solution

Current treatment for chronic back pain caused by facet joint arthritis includes medications for pain relief, spinal injections, and radio frequency (RF) ablation.

medovex-treatment-options-chronic-back-pain

Unfortunately for the many individuals suffering from chronic back pain due to facet joint osteoarthritis, these options are not permanent solutions.


Permanent Solution from Medovex

medovex-chronic-back-pain-relief

The DenerveX™ System developed by MDVX provides long-lasting relief from pain associated with facet joint syndrome.

medovex-denervex

Using a two-step procedure of facet joint capsular tissue removal and RF Ablation with the DenerveX™ System, MDVX demonstrated positive outcomes via a study of 174 patients:

  • A total of 77%, 73%, and 68% of patients with cervical, thoracic, or lumbar disease, respectively, showed at least 50% improvement in pain at 3 year follow-up
  • The majority of patients achieved a 75% to 100% improvement (VAS pain score) at 3 year follow up
  • Overall, 76%, 60%, and 75% of patients with cervical, thoracic, or lumbar facet disease, respectively, had at least a 50% improvement in Oswestry Disability Index (ODI) scoring
  • Most patients experienced a 75%-100% improvement at 3 year follow up

(see: Endoscopic Facet Debridement for the treatment of facet arthritic pain – a novel new technique)

 

 

 


DenerveX™ System Represents Immense Savings for Patients and Health Care System*

medovex-health-care-savings

 

*Estimates are for a 3 year period


medovex-generator

 

medovex-kit


CE Mark Approval in Europe Pending

MDVX management stated in a conference call yesterday (11/1/2016) that CE Mark approval in the European Union is expected in the first half of 2017, and that their recent presence at the EuroSpine 2016 Tradeshow in Berlin was very rewarding.

Medovex President and COO, Patrick Kullmann, recently stated:

“We conducted meetings and demonstrations with at least six potentially strategic companies that could open the door to future collaboration for distribution, investment, co-future development of future generations of the technology or even potential acquisition. Many of the spine surgeons and pain relief physicians visiting the booth stated that the DenerveX Design is very elegant, and represents a very new and creative approach in treating pain associated with the Facet Joint Syndrome. Their clear appreciation for our different approach in performing a new procedure by way of a posterior capsulectomy of the facet joint, compared to the less effective standard radio frequency ablation (Rhizotomy), gives us cause for continued cautious optimism going forward.”

Medovex has opened a European distribution service center, and already has a Diagnosis-Related Group (DRG) designation in Europe. The DRG designation is a very positive milestone for MDVX as it terms of future billing for DenerveX™ System treatment and reimbursement. 


EU/Worldwide DenerveX™ System Commercialization

Investors should expect positive and frequent updates as MDVX moves along the commercialization timeline below:

medovex-product-launch


High Insider Buying/Ownership

As the saying goes, there are many reasons why insiders might sell a stock, but there’s only one reason why they buy it.

medovex-insider-buying

Source: Nasdaq.com


MDVX Investment Highlights

  • Founded by Steve Gorlin (Entremed, Medicis, Medivation, MiMedx) and James Andrews MD (world renowned orthopedic surgeon)
  • Experienced and proven management team and board of directors
  • High insider ownership (38%)
  • Huge, highly opportunistic market opportunity
  • Scalable high growth, recurring revenue model with strong margins and clean balance sheet
  • Intellectual property portfolio (300 claims)
  • Anticipated CE marking first half 2017 with already established international distribution
  • Positive news flow over the coming weeks and months as company begins commercialization and revenue generation

Best wishes for profitable investing!

Medovex corp gary

 

 

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