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  • Skyline Medical (SKLN), Nothing But Blue Skys Ahead For This Revolutionary Device Maker

    When the U.S. Food and Drug Administration recalled two models of the Stryker liquid waste management systems last year after two patient deaths and other patient injuries due to providers applying high-flow, high-suction vacuums to passive chest drains using the system, hospitals were faced with the daunting task of looking for alternatives to deal with the unpleasant issue of liquid medical waste.

    Enter Skyline Medical's Streamway Liquid Waste Management System:

    BenefitsThe STREAMWAY System:
    • Virtually eliminates handling of surgical fluids by providing automated collection, measurement and disposal
    • Increases safety for staff and patients by reducing exposure risk
    • Cuts overhead expenses by eliminating costly canisters, handling and disposal
    • Boosts operative efficiency by delivering uninterrupted performance
    • Improves staff utilization by decreasing time for set-up and cleanup, and freeing valuable floor space near surgical areas.
    How It Works

    Fluid Management SystemOperative fluid is suctioned directly from the surgical field into the STREAMWAY System, which automatically measures and records volume before it disposes of the fluid directly into a facility's existing plumbing system. Cleaning the STREAMWAY System is easy-simply detach the procedure filter, connect our proprietary cleaning solution, and activate the clean cycle on the touch screen.

    Fluid Management Systems - STREAMWAY System

    Skyline has a new name, (formerly BioDrain Medical) and a new CEO, Josh Kornberg whose looks to be taking the Company to the next level. An advisory board was also formed last year which is comprised of top doctors and a healthcare executive with ties to one of the largest purchasing groups in the country HCA. The business model is to not only to sell the Streamway System but to also sell a one time cleaning solution and filter that hospitals will use with each surgery ( i.e. "razor blade model".) The Company estimates that there are approximately 50,000 operating rooms in the US with a total number of procedures performed of around 70m. If Skyline can penetrate just 5-10% of this market, their high gross margin (80%) recurring revenue model will generate substantial earnings.

    It appears that the Company's efforts are starting to be realized :

    • Revenues were $107,835 and $386,418 for Q3 and first nine months of 2013, up more than 108% and 289% compared to Q3 and first nine months of 2012;
    • More than 50 purchase orders were received in Q3 2013 for Skyline's improved STREAMWAY System, scheduled for delivery in Q4 and beyond;
    • Company strengthened balance sheet through conversion of all convertible notes;
    • Company entered Virginia market with multi-unit purchase from Ambulatory Surgical Center;
    • Skyline expanded its presence in Florida with multiple unit sale to a major hospital;
    • Increased sales force to support national and international rollout of STREAMWAY System;
    • National ambulatory surgical center chain client doubles initial Q2 2013 order fully replacing Skyline competitor; and

    "Now that the technological modifications of our STREAMWAY System are complete, we will prepare for mass production and be able to fulfill a large backlog of purchase orders currently in our pipeline. These orders represent approximately $2 million in revenue of which approximately $1 million will be recurring on an annualized basis. We will begin to recognize these revenues immediately as they will impact our financial results starting over the next two quarters." Kornberg, 11/14/2013

    Skyline Medical Expands Early Access to Its Revolutionary Fluid Waste Management System Through Attainia partnership:

    "Skyline's STREAMWAY® System will be included in the world's most widely used healthcare equipment planning and budgeting software Our partnership with Attainia will increase awareness among healthcare organizations worldwide that they have an alternative to the antiquated, high-risk fluid disposal methods they've been using for years," said Josh Kornberg, CEO of Skyline Medical, formerly BioDrain Medical. "The patented STREAMWAY System is the first truly closed system designed specifically for medical applications, where safety simply cannot be compromised. Our system is a one-piece, wall-mounted unit that connects directly to a facility's plumbing system to minimize human intervention, provide unlimited capacity, and eliminate the cost and environmental waste of canisters," Kornberg explained. "By working closely with clinical teams and architect partners in the early stages, we can ensure a seamless and successful installation." Skyline Medical chose Attainia because it's the industry leader in healthcare equipment planning. "Currently, more than 2,000 active healthcare projects are being planned using Attainia software systems, totaling more than $30 billion," Kornberg said. "As a leading provider for healthcare planning, Attainia was a logical choice for our new alternative solution to fluid waste management."

    Skyline recently raised over $2m in a private placement in which the CEO put his money where his mouth is. The Company will use the proceeds from the sale of the Securities to expand its sales and installation efforts and for general working capital purposes. Skyline Medical will also use this capital to help fulfill the purchase orders of STREAMWAY Systems ready for placement in hospitals and surgical centers, as well as anticipated installations to occur in the first half of 2014 as a result of expected trials. "This private placement provides us with the growth capital necessary to expand our sales force and meet the demand we are seeing from healthcare facilities and hospital groups for our STREAMWAY System," stated, Josh Kornberg, CEO of Skyline Medical.

    Technically the chart is in the lower risk basing zone and appears to be setting up a nice bottoming pattern in preparation for what I believe will be a big move in 2014. First major resistance is at 30c, a break of that with volume will bring a move towards the September highs of 47c. I fully expect a break of that level once this Company gets discovered with a move towards $1.00 as more major hospitals switch to the Streamway System.

    2014 should be a transformative year for Skyline. The Company appears poised to execute on their recurring revenue business model and ramp up the sales of the Streamway System to a mass scale level. This is already represented by the current $2m in backlog of orders that should substantially increase with the recent Attainia partnership in place. In addition, many hospitals and surgery centers will need to replace the Stryker Neptune System to due the Class I recall. The Streamway System is at the right place at the right time.

    Patient investors should benefit significantly from purchases of the stock at around this level as Skyline has recently raised $2m to fuel future growth and the Company should see extremely high profits margins on dramatically ramping revenues during 2014.

    Disclosure: I am long SKLN. I wrote this article myself, this is NOT investment advice, it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with Skyline Medical SEE FULL DISCLOSURE BELOW

    Disclosure: I am long SKLN.

    Tags: SKLN, Biotech
    Feb 18 9:37 AM | Link | Comment!
  • Adamis Pharmaceuticals, (ADMP) Undiscovered Gem Set To Soar In 2014

    On August 1, 2013, Adamis Pharmaceuticals, (OTCQB:ADMP) entered into an agreement, paying $3m to initially license and with an additional closing payment fully acquire from 3M Company certain intellectual property and assets relating to 3M's Taper Dry Powder Inhaler technology under development for the treatment of asthma and chronic obstructive pulmonary disease. On December 27, Adamis filed an 8k showing that they made the additional and final payment of $7M to 3M and that ownership of the assets and intellectual property were transferred to the Company. With this closing, Adamis now has rights to a dry powder inhaler that combines a patient-friendly design with active aerosolization to provide effective delivery of drug in a multi-dose and will attack Glaxo's (NYSE:GSK) $8 billion a year Advair franchise.

    3M's Taper Dry Powder Inhaler

    • Can be used with single or combination drugs
    • Virtually eliminates need for complex powder treatments or lactose in most formulations
    • Holds up to 120 doses in convenient pocket sized design
    • API dose range up to 1 milligram
    • Protects against moisture ingress
    • Utilizes patented 3M breath actuated technology for simple open, inhale, close functionality
    • Integrates dose counter to ensure patients know how many doses remain
    APC-5000 - Dry Powder Inhaler ***NEW PRODUCT***

    APC-5000 is Adamis' first product using the Taper Dry Powder Inhalation (DPI) technology that the Company has exclusively licensed, and with additional payment, fully acquire from 3M Drug Delivery Systems. The Taper DPI is a patented pre-metered device that Adamis expects will have a number of advantageous features when compared to competing DPI products including: greater efficiency, less dependence on the individual's inspiratory flow rate (due to the aerosolization energy inherent in the device), no need for excipients in most formulations, capability of delivering up to 120 doses (a two month supply), moisture protection, and ease of use. In addition, the device has been designed to reduce the likelihood of delivering a double dose.

    Addressable Market ~$4.0 billion

    According to IMS Health data, the global asthma and COPD prescription market is more than $34 billion and is averaging 7% growth per year. Also according to IMS, annual sales of the AdvairDiskus® are currently in excess of $5 billion in the United States and $8 billion globally.

    FDA Guidance clears path for Advair generics

    In September, the US Food and Drug Administration (FDA) has published draft guidance on generic copies of combination drugs for respiratory diseases which could hasten generic competition to GlaxoSmithKline's (GSK) big-selling Advair brand. The FDA's new draft guidance provides a simplified framework for companies trying to develop generics of Advair as well as other combination inhaled medicines such as AstraZeneca's Symbicort (budesonide/formoterol), also a blockbuster with sales of $3bn-a-year. The FDA laid out the kind of scientific studies generic companies need to submit to be considered for approval. The new clarity means generics could potentially hit the market by 2016 or 2017, analysts said, though some cautioned that the complexity of producing an exact copy could still delay generics to a later date.

    Dr. Dennis J. Carlo, President and CEO Adamis stated, "There are a limited number of companies that have the capability to develop this type of novel inhalation drug delivery technology, and 3M is considered one of the leaders. To date, there is no low cost alternative to Advair. We believe that the exclusive license and acquisition of the 3M Taper DPI technology provides Adamis with a blockbuster opportunity in the branded generic asthma/COPD market, where even a small market share could generate a very large potential return on investment for Adamis shareholders. This technology strengthens the Company's respiratory product pipeline and has the potential to provide solid growth for Adamis for years to come and I believe the acquisition of this pivotal technology could be a transforming event for our company. This acquisition is consistent with one of the objectives outlined in my recent letter to shareholders in a press release dated May 3, 2013."

    Adamis Specialty Pharmaceuticals Product Pipeline

    (click to enlarge)

    ProductsEpinephrine Pre-filled Syringe (PFS) - single dose

    The Epinephrine Pre-filled Syringe (PFS) (Epinephrine Injection USP 1:1000, 0.3mg Pre-Filled Single Dose Syringe) will compete as a simpler, more intuitive, low cost therapeutic alternative to epinephrine auto injectors like the well-known brand EpiPen® in the anaphylaxis market. The Company's New Drug Application to the FDA for marketing approval of the product is completed and ready to be filed.

    Addressable Market ~ $800 million

    In the U.S., an estimated 5% of the population suffers from insect sting anaphylaxis, up to 6% are latex sensitive and up to 1.5% of adults and 5% of children under three years of age experience food related anaphylaxis. The number of prescriptions has grown annually as the risk of anaphylaxis has been more widely understood. Adamis also intends to introduce the Epinephrine PFS world-wide through licensing agreements.

    TeloB-VAX: Prostate Cancer Telomerase Vaccine

    Adamis Pharmaceuticals TeloB-VAX vaccine is composed of the patients' own circulating B lymphocytes harboring a unique patented engineered plasmid DNA. The transfection procedure is "spontaneous", requiring no facilitating molecules or devices. After 60 minutes of incubation with the plasmid, the cells can be re-infused back into the patient. In studies conducted to date, TeloB-VAX cancer vaccine induces a potent cellular immune response against the first truly common cancer antigen, the telomerase reverse transcriptase (TERT).

    Telomerase is an enzyme that adds DNA sequence repeats (e.g., "TTAGGG") to the 3' end of DNA strands in the telomere regions of chromosomes at every cell division. Telomerase confers the immortality trait that converts normal cells into cancer cells and prevents the erosion of telomeres and end-to-end chromosomal fusion. As such, telomerase is over-expressed in the vast majority of differentiated cancer cell types. Importantly, telomerase is also necessary for self-renewal of cancer stem cells and cancer cell progenitors. Based on the foregoing, TERT is an antigen expressed in both differentiated and progenitor cancer cells making vaccination against TERT a potentially effective measure to induce an immune response against cancer cells at both stages of differentiation.

    If successfully developed, Adamis believes the technology offers certain significant advantages over the existing FDA approved vaccine, Provenge. Some of the advantages include: 1) prolonged antigen presentation by B cells (5 days) as compared to the short presentation time by dendritic cells (12 hours), 2) a unique patented technology using a universal cancer antigen (marker) that is increased in approximately 85% of all tumors, 3) induces an immune response after a single injection, 4) no need for complicated culture procedures (easy to manufacture), 5) much fewer steps, and 6) lower cost.

    If future clinical trials are successful, TeloB-VAX may very well be called a "universal cancer vaccine" that could induce immunity against multiple cancer types as well as targeting the specific cancer stem cell.

    Upcoming Catalysts:

    • Focusing on submitting our single dose epinephrine syringe for regulatory approval and sale next year
    • Completing the manufacture of our Beclomethasone-HFA product to initiate Phase III studies in asthma and COPD
    • Finalizing our allergic rhinitis product development in order to initiate Phase III clinical trials
    • Acquiring or in-licensing an established product or technology that, following regulatory marketing approvals, will compete in large (multi-billion dollar) product markets and will be synergistic with our existing assets. (Done)
    • Completing our Phase I prostate cancer drug trial
    • Finalizing the activities necessary to begin a Phase I/II trial for our second prostate compound
    • Initiating a Phase II prostate cancer vaccine trial for TeloB-VAX.

    Conclusions:

    On December 13, Adamis completed an uplisting to the NASDAQ and announced the pricing of an underwritten public offering of 3,720,000 shares of common stock at an offering price of $5.95 per share, the Company also completed a 1-17 reverse split. In addition to paying off the $7m to 3M Company for the Taper Dry Powder Inhaler Technology, Adamis intends to use the remaining net proceeds to fund the filing and launch of the Epinephrine PFS product candidate and fund clinical trials.

    As I have outlined above, in addition to APC-5000, using the just acquired Taper Dry Powder Inhalation (DPI) technology addressing a $4b market , Adamis has a very deep pipeline that addresses multi-billion dollar markets. With just a $64m market cap, small public float and many significant near term catalysts, Adamis appears to be extremely undervalued. Once this tiny biotech is discovered, we could see a dramatic share price appreciation in 2014 which would reflect the true value of the Company and its current pipeline.

    Disclosure: I am long OTCQB:ADMP.

    Tags: ADMP, Biotech
    Dec 30 7:54 AM | Link | Comment!
  • Advaxis (ADXS): Uplisting Should Expand Valuation By 300%

    Yesterday Advaxis (NASDAQ:ADXS), a next generation immunotherapy biotech company, announced the pricing of its public offering of 5.7m shares at an offering price of $4.00, with estimated proceeds of $23m. The shares are being uplisted and will start trading today on the NASDAQ. Aegis Capital was the sole acting book-running manager. Coincidentally, Aegis also ran the book for Cancer Genetics (NASDAQ:CGIX), which uplisted on August 14th and it went on a spectacular run from $9 to nearly $23. The completed uplisting to the NASDAQ is a major catalyst and I expect the stock to respond in a big way over the short term.

    Another potential big near term catalyst is that Advaxis will be presenting three abstracts at the Society for Immunotherapy of Cancer November 8-10th:

    The abstract titled "Listeria monocytogenes (Lm)-LLO immunotherapies reduce the immunosuppressive activity of myeloid-derived suppressor cells and regulatory T cells in the tumor microenvironment" has been selected for oral presentation during the session, "Tumor Microenvironment and Innate Cells Recognition" on November 8, 2013 from 9:40 AM to 12:00 PM. Anu Wallecha, Ph.D., Director of Research and Development at Advaxis, will report on the localized effects of Lm-LLO immunotherapies on the tumor microenvironment in preclinical studies using transplantable mouse models.

    The abstract titled "ADXS11-001 immunotherapy targeting HPV-E7: Updated survival and safety data from a Phase 2 study in Indian women with recurrent/refractory cervical cancer" has been selected for poster presentation during the Vaccine session. Robert Petit, Ph.D., Chief Scientific Officer of Advaxis, will present final 18-month survival and updated safety data from the ongoing trial.

    The abstract titled "Biomarker identification in serum samples from patients with recurrent cervical cancer treated with ADXS11-001 immunotherapy" has been selected for poster presentation during the session "Biomarkers and Immunoscoring". Poonam Molli, Ph.D., Senior Scientist at Advaxis, will report on the correlation of changes in cytokine and chemokine levels pre- and post-dosing with ADXS11-001 from the Phase 2 study in Indian women with recurrent/refractory cervical cancer.

    "The three presentations of Advaxis data at SITC reflect our growing understanding of the unique attributes of the Advaxis platform technology for immunotherapies. Dr. Wallecha's presentation will highlight the ability of Lm-LLO immunotherapy to counteract immune suppressor cells that enable persistence of the tumor. We will report final 18-month survival and final tumor response data from our 110 patient Phase 2 study in India in women with recurrent cervical cancer. Dr. Molli's presentation will illustrate the remarkable immune stimulation that occurs in patients after treatment with ADXS11-001. Together, these data paint a picture of an immunotherapy that has a strong positive impact on the immune system while at the same time counteracting immune suppression in the tumor microenvironment that can lead to apparent prolonged survival and objective tumor responses from a single immunotherapeutic agent," commented Dr. Petit.

    (click to enlarge)

    Advaxis has all the ingredients for a nice short term momentum run: reverse split, uplisting, tiny market cap and float, plenty of cash to fund ADXS-HPV phase 3 trials and key near term clinical data presentations. I anticipate that ADXS has near term appreciation potential back to its recent September highs of near $11.

    Disclosure: I am long ADXS.

    Tags: Biotech
    Oct 17 9:45 AM | Link | Comment!
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