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A young and savvy, yet experienced and accomplished investments mogul since ‘01, Michael has amassed a fortune as a private self investor. Recently starting his own successful blog and turning it in to a corporation — MiV Investments Inc. (http://www.stockshaven.com/), a company offering... More
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  • Technical Breakout Alert Issued for CytRx (NASDAQ:CYTR)

    Miv Investments Inc. has initiated an independent bullish technical trading alert for 11/23/09 on CytRx Corporation (NASDAQ:CYTR). Shares of the company finished trading during 11/20/09 at $1.14 per share, up 20.18% from the opening bell on heavy buying pressure. As of 11/18/09, the biopharmaceutical company announced plans to initiate an open-label, multinational Phase 2 clinical trial with its doxorubicin prodrug INNO-206 as a second-line treatment in patients with advanced gastric (stomach) cancer.

    CytRx President and CEO Steven A. Kriegsman said, “This planned clinical trial is a key step forward in our plans to build a commercial oncology franchise for CytRx. We have studied the oncology market in solid tumors and believe that stomach cancer represents a major market and an unmet medical problem worldwide. We have also been encouraged by exciting animal data for INNO-206 in a broad array of cancer indications, and are hopeful that this carefully-designed study will bring hope to the sufferers of advanced gastric cancer.”

    Rumours are also swirling that the popular biopharma news-portal BioMedReports.com has contacted the company, and news is pending on what could be a turning point for shareholders. An announcement could come as early as this week, many investors have long been awaiting news on the Tamibarotene, Acute Promyelocytic Leukemia pivotal phase II trial.

     

    About CytRx Corporation

    CytRx Corporation is a biopharmaceutical research and development company engaged in the development of high-value human therapeutics. The CytRx drug development pipeline includes programs in clinical development for cancer indications, including tamibarotene in a clinical trial for the treatment of acute promyelocytic leukemia (APL). In addition, CytRx is developing two drug candidates based on its industry-leading molecular chaperone technology, which aims to repair or degrade misfolded proteins associated with disease. CytRx also maintains a 36% equity interest in publicly traded RXi Pharmaceuticals, Inc. (NASDAQ:RXII). For more information on the Company, visit www.cytrx.com.

    Product Pipeline

    CytRx Corporation’s oncology pipeline includes three clinical-stage drug candidates in various stages of development, including:

    Tamibarotene (formerly known as TM-411, TOS-80T, Am-80, and INNO-507) is an orally available, rationally designed, synthetic retinoid compound which was designed to potentially avoid toxic side effects by binding to its molecular target more selectively than all trans-retinoic acid (ATRA), the current first line treatment for APL. There is a Special Protocol Assessment (SPA) in place with the FDA for a Phase 2 registration clinical trial, known as STAR-1, which is evaluating the efficacy and safety of tamibarotene as a third-line treatment for APL. The STAR-1 trial is ongoing and currently includes seven clinical sites in the U.S.  CytRx recently reported that, of the 11 patients enrolled in the STAR-1 trial to date, 5 patients, or 45%, achieved a morphologic leukemia-free state, or MLFS.  Of those, two patients have achieved durable complete response and one has achieved morphologic leukemia-free state, or MLFS, but withdrew from the trial to receive a bone marrow transplant before the durable complete response could be confirmed. One patient achieved a complete response, but did not maintain MLFS for the required 28 days to be considered a durable complete response. Another patient achieved a durable MLFS, but did not have the necessary increases in blood cells to be considered a durable complete response. CytRx holds the North American and European rights to tamibarotene as a treatment for APL.

    The FDA has granted Orphan Drug Designation for APL and Fast Track Designation for the use of tamibarotene in patients with relapsed or refractory APL following treatment with all-trans retinoic acid (ATRA) and arsenic trioxide. In addition, tamibarotene has been granted orphan medicinal product status by the European Medicines Agency for the treatment of APL.  The efficacy of orally-administered tamibarotene was demonstrated in two Phase 2 studies conducted in Japan in a total of 63 Japanese subjects with APL. The overall complete response rate in these subjects was 60%. In subjects experiencing their first relapse, the overall complete response rate was 81%.

    APL is diagnosed in approximately 1,500 new patients in the United States annually. The near-term market opportunity for CytRx’s tamibarotene in refractory APL in the U.S. alone is estimated to approach $20 million per year – with the market opportunity for an expanded label including refractory, maintenance and front-line therapy increasing to $150 million in potential recurring revenue in the U.S. and Europe. There are currently no approved third-line treatment options for refractory APL patients.

    Tamibarotene has also showed statistically significant anti-tumor activity in animal trial for multiple myeloma, an incurable malignant tumor of the plasma cells of bone marrow. CytRx  retains an option to expand its licenses for the use of tamibarotene in other fields in oncology, including multiple myeloma, myelodysplastic syndrome and certain solid tumors in the U.S., and multiple myeloma, myelodysplastic syndromes and solid tumors other than hepatocellular carcinoma in Europe.

    INNO-206 (formerly DOXO-EMCH) is a prodrug of the commonly prescribed chemotherapeutic doxorubicin and was designed to reduce adverse events by controlling release and preferentially targeting the tumor. In a Phase 1 study, doses were administered at up to six times the standard dosing of doxorubicin without an increase in observed side effects over those historically seen with doxorubicin. Objective clinical responses were seen in patients with sarcoma, breast and lung cancers. In addition, the Company has announced that INNO-206 has demonstrated statistically significant results in animal models of breast cancer,  pancreatic cancer and ovarian cancer. The Company is evaluating options for a Phase 2 protocol with the FDA.

    INNO-406 (formerly known as NS-187) is a potent, orally available, rationally designed, dual Bcr-Abl and Lyn-kinase inhibitor that is currently being planned as a third line treatment for patients with Chronic Myeloid Leukemia (CML) or certain forms of Acute Myeloid Leukemia (AML) that are refractory or intolerant of other approved treatments. In November 2008, CytRx announced that bafetinib demonstrated clinical responses in patients with CML in an international Phase I dose-ranging clinical trial conducted in patients with CML and other leukemias that have a certain mutation called the Philadelphia Chromosome (Ph+) and are intolerant of or resistant to Gleevec and, in some cases, second-line tyrosine kinase inhibitors such as dasatiniband nilotinib). INNO-406 has been granted Orphan Drug Status for the treatment of Philadelphia chromosome-positive (Ph+) CML by the FDA.

    CytRx Oncology Expertise

    Collectively, CytRx’s management and its Board of Directors have brought numerous oncology drugs to market. The senior managers and directors of CytRx who hold significant oncology experience include: Joseph Rubinfeld, Ph.D., a director since July 2002 and world-renowned expert in the field of oncology, who was one of the four initial founders of Amgen, Inc.; Max Link, Ph.D., Chairman of the Company’s Board of Directors since 1996, who served for a number of years as Chairman and CEO of Sandoz Pharma and also serves as a director of Alexion Pharmaceuticals, Inc., Celsion Corporation and Discovery Laboratories, Inc.; Daniel Levitt, M.D., Ph.D., Chief Medical Officer, who served as president of Protein Design Labs, as global leader of oncology drug development at Sandoz Pharmaceuticals and as director of clinical oncology at Hoffmann-LaRoche; and Jack R. Barber, Ph.D., Chief Scientific Officer, who has significant R&D experience in oncology at Immusol and Viagene, where Dr. Barber most recently served as Head of Oncology.

    Technical Analysis

    Taking a look at the 6 month chart, we notice the 0.85 and 1.2 price per share points to hold significant independent values. Throughout this time, the stock has spent time consolidating in between these levels, and thus creating some very significant support and resistance levels. What most new investors should be interested in is the 0.85 support level, which has held two times before, thus creating a level of confidence and safety, should the stock begin to see a downtrend in the short-term. However, most new investors are looking for a technical breakout, and thus stock seems to have all the makings for it. Strong volume, similar to that of mid-end June and early September, both of which saw the stock jump to the pivotal 1.2 price per share level. The MACD and EMA have been experiencing a golden cross since the beginning of November, and the RSI is shooting upwards towards the critical 70 marker. Should the RSI break this point, a re-test of 1.72 (52 week high) could be experienced. The important variable that needs to remain constant is the heavy volume, or in particular, buying pressure.

    Disclosure: Long CYTR
    Tags: CYTR
    Nov 23 09:03 am | Link | Comment!
  • Bullish Technical Breakout Alert for Soligenix (OTC:SNGX.OB)

    Miv Investments Inc. has initiated an independent bullish technical trading alert for 11/11/09 on Soligenix, Inc. (OTC:SNGX.OB). Shares of the company finished the day at $0.220, up 15.79% from the opening bell on heavy buying pressure. The turning point in the price resulted from two heavy orders of 778,980 at $0.75, and 790,000 at $0.18, which signalled the start of a run up in price.

    Soligenix’s lead product orBec® represents a first-of-its-kind oral, locally acting therapy tailored to treat the gastrointestinal (GI) manifestation of Graft-versus-Host disease GVHD (GVHD), the organ system where GVHD is most frequently encountered and highly problematic. orBec® is currently being evaluated in a randomized, double-blind, placebo-controlled Phase 2 clinical trial for the prevention of acute GVHD after allogeneic hematopoietic cell transplantation (HCT) with myeloablative conditioning regimens.

    The company anticipates completing phase II and releasing news on their findings for orBec’s ability to prevent GVHD by year end.

    For more information regarding Soligenix’s current and future operations, visit the full Rodman & Renshaw recap here.

     

    About Soligenix, Inc.

    Soligenix, Inc. (Soligenix), formerly known as DOR BioPharma, Inc., is a late-stage biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents. Soligenix’s lead product, orBec® (oral beclomethasone dipropionate or BDP), is a potent, locally acting corticosteroid being developed for the treatment of GI GVHD, a common and potentially life-threatening complication of hematopoietic cell transplantation. orBec® is currently the subject of a confirmatory Phase 3 clinical trial for the treatment of acute GI GVHD and an NIH-supported, Phase 2, randomized, double-blind, placebo-controlled trial in the prevention of acute GVHD. Soligenix also expects to begin an NIH-supported Phase 1/2 clinical trial of SGX201 in radiation enteritis in the second half of 2009. Additionally, Soligenix has a Lipid Polymer Micelle (LPM(TM)) drug delivery technology for the oral delivery of leuprolide for the treatment of prostate cancer and endometriosis.

    Through its Biodefense Division, Soligenix is developing biomedical countermeasures pursuant to the Project BioShield Act of 2004. Soligenix’s lead biodefense product in development is a recombinant subunit vaccine called RiVax(TM) which is designed to protect against the lethal effects of exposure to ricin toxin. RiVax(TM) has been shown to be well tolerated and immunogenic in a Phase 1 clinical trial in normal volunteers. RiVax(TM) will also be the subject of a recent $9.4 million NIH grant received by the Company supporting development of new heat stable vaccines.

    Technical Chart Analysis

    http://www.profitspi.com/stock-chart-str.aspx?id=SNGX&ca=1409609992

    Soligenix’s stock seems to have bounced off the strong $0.18 support level set way back in June. Looking at the 6 month chart, we notice that the RSI still has an oversold representation, recently reaching the 30 point, where there seems to be strong sentiment for a buy signal. The current daily chart seems highly comparable to that of mid September, when the RSI was at a similar point which then bounced upwards to above the 70 line, causing the price to increase from $0.20 to $0.30. We also notice similar volume buys to that of mid September. The MACD and EMA trend lines have entered into the initial stages of a possible golden cross formation. What should be more noticeable for investors is the fact that the golden cross has happened 3 times before during the past 6 months, never failing, thus seems primed to happen once again in the next couple of days. Don’t be too surprised to see the $0.30 resistance being tested once again shortly. For more information on the golden cross formation, visit this link here.

    Disclosure: Long SNGX
    Nov 11 04:14 am | Link | Comment!
  • Bullish Technical Breakout Alerts (NASDAQ:NCOC), (OTC:BIEL.OB)

    Miv Investments Inc. has initiated an independent bullish technical trading alert for 11/10/09 on National Coal Corp. (NASDAQ:NCOC) and BioElectronics Corp. (OTC:BIEL.OB). BioElectronics Corp. gained tremendous buying pressure leading into market close, and National Coal Corp. saw its shares rise 7.62% within after hours trading on high volume.



    About National Coal Corp.

    National Coal Corp. is engaged in mining, processing and selling bituminous steam coal from mines located in East Tennessee and North Alabama and, until March 31, 2008, in Southeast Kentucky. The Company owns the coal mineral rights to approximately 65,000 acres of land and leases the rights to approximately 17,700 additional acres excluding the Southeast Kentucky properties, known as Straight Creek, sold on March 31, 2008. As of December 31, 2008, its mining complexes included three active and two inactive underground mines, one underground mine in the development stage, one inactive and six active surface mines, and one highwall mine. In addition, it had two preparation plants and two unit train loading facilities in Tennessee served by the Norfolk Southern (NS) railroad. It holds seven permits that allow it to open new or re-open existing mines close to its operations. As of December 31, 2008, it controlled approximately 40.8 million estimated recoverable tons of coal reserves.


    Recent News Regarding the Coal Industry


    Coal prices are indeed destined to go higher as they follow the rise of ‘coal currencies’ such as Australian Dollar (AUD), South African Rand (ZAR) and Columbian Peso (COP). Strong emerging market demand is also pushing up prices although it may be limited by abundant stocks on coal producing countries.

    The BofA Merrill Lynch Global Report on energy pointed out that many “oil currencies” including UAE Dirhams (AED) and Saudi Arabian Riyal (SAR) are pegged to the US dollar, but coal exporters tend to keep a free float therefore currencies linked to coal have outperformed both their emerging market and G-10 peers. Source found here


    Recent National Coal Corp. Q3 Results


    * Third quarter revenues from Tennessee operations increased 19.0% to $22.1million, up from $18.6 million during the
    year-ago quarter.

    * Tons of coal sold increased 5.9% to 286,447 tons up from 270,515 tons during the year-ago quarter.

    * The average price per ton increased 15.2% to $75.00 from $65.08 in the same year-ago quarter.

    * For the nine months ended September 30, 2009, net cash flows provided by operating activities improved and are reported
    at $6.6 million, versus a negative $3.6 million during the year-ago period.

    National Coal Corp. (Nasdaq: NCOC), a Central and Southern Appalachian coal producer, reports that for the three months ended September 30, 2009, it achieved total revenues of $22.1 million based primarily on the sale of 286,447 tons of coal. In the same prior-year period, National Coal generated revenues of $18.6 million primarily through the sale of 270,515 tons of coal. Source found here

    Considering they have 40.8 million estimated recoverable tons of coal reserves, these revenues should increase as they further their technological development, and thus achieve a more efficiency.

    Technical Chart Analysis

    http://www.profitspi.com/stock-chart-str.aspx?id=NCOC&ca=1536628479
    We can see from the chart that the RSI is beginning to what it seems is a rebound, causing an ascention from the 50 on its way to the 70 where it has reached in the $1.3-1.5 range. As well, the MACD and EMA are shaping up for a short-term cross, thus creating a bullish signal. There was a recent sell off post Q3 earnings which should subdue within the next couple of days, and as well there is heavy short interest of 1.57% or 447,300 of the total float with an estimated average of 0.7 days to cover as per shortsqueeze.com’s report. The company also saw its average volume being surpassed today, going from 538,000 to 689,588, an increase of 22%.

     


    About BioElectronics Corp.


    BioElectronics Corporation (BioElectronics) designs, develops and markets a variety of drug-free, anti-inflammatory patches for a range of medical indications. The Company’s patch products, which are marketed under the name ActiPatch Therapy, deliver pulsed electromagnetic field therapy, an anti-inflammatory and pain relief therapy. The ActiPatch Therapy products combine a miniaturized microchip, power source and antenna in a soft, flexible outer envelope. When applied to the body, these devices deliver a pulsed radio frequency signal into the body on a 27 megahertz (MHz) frequency wave that induces a low frequency electromagnetic field to damaged cell tissue.

    MiV Investments Inc. has profiled the company before, to view it please follow this link: http://www.stockshaven.com/bioelectronics-corp-otcbiel-a-doubled-edged-sword/

    Recent Company Achievements

    Company Achievements

    *All data and information used is courtesy of BioElectronics Investor Overview

    The dermal patch delivery system creates a multitude of new product opportunities for chronic and acute inflammatory conditions. The market potential is estimated at $10 billion or 400 million incidents worldwide. The distinctive value proposition of ActiPatch is the delivery of drug-free therapy that reduces pain and inflammation and accelerates healing by 30% to 50% when compared with the present standard methods of patient care. The current major applications are:

    • Medical Surgeries
    • Chronic Wounds
    • Oral Surgeries
    • Sprains and Strains
    • Lower Back Pain
    • Chronic Repetitive Stress Injuries, Heel Pain, Carpal Tunnel, Bursitis, etc.

    Below is a list of the Company’s accomplishments to date.

    • United States Food and Drug Administration market clearance
    • Canadian market approval for relief of pain in muscosketal complaints in both medical and over-the-counter markets
    • CE Mark (European Common Market) Certification for the medical and retail over-the-counter markets
    • ISO Certification
    • Chosen as “One of 9 Medical Breakthroughs That May Change Your Life” by MedicalHeadway.com
    • 15+ domestic independent sales agents
    • 20+ International distributors with additional agreements in place or awaiting regulatory approvals
    • A medical research agreement with the David Genecov, MD, Dallas Medical Center, a leading medical researcher to supervise and write manuscripts for four studies, plantar fascitis (heel pain), ankle sprains, breast augmentations, and cesarean sections.
    • Canadian retail product line launched in June of 2008, actively interviewing distribution partners throughout the rest of the world.
    • A solid intellectual property portfolio covering both the product design and the pulse signature.
    • A 3-year pipeline of new products for treatment of sports injuries, bone fractures, chronic injuries, chronic wounds, skin conditions, arthritis and post-operative care.
    • Product now available online to the consumer market via multiple websites in several countries.
    • Projected annual sales in 2008 of over $2,000,000.

    Technical Chart Analysis

    http://www.profitspi.com/stock-chart-str.aspx?id=BIEL&ca=1089242657

    The RSI has reached nearly a one year low at 33.25, being highly oversold and shorted, and this should overturn soon. MACD and EMA lines have been bilinear for quite sometime, and it is not going to be long before they see a cross, leading to a jump in price as seen in early to mid September. As FDA deadlines near, BIEL should also see a jump in volume, which was down against the average on 11/09/09.

    Disclosure: Long NCOC and BIEL
    ———–

    By reading MiV Investments Inc. company profiles you agree to the disclaimer, and thereby will not hold Michael Vlaicu accountable for any transactions or decisions you make. It is up to you to do your own due diligence.

    MiV Investments Inc. is not paid, compensated or in any way incentivized to report news and developments about publicly traded companies, unless otherwise stated.

    Tags: NCOC, BIEL.OB
    Nov 09 11:30 pm | Link | Comment!
  • Burning the Calories with CardioCor (PINK:CDOI.PK)
    CARDIO INFRARED TECHNOLOGIES INC.

    (Public, PINK:CDOI.PK)

    http://cardio-cor.com/

    MiV Investments Inc. has initiated independent research coverage on Cardio Infrared Techs Inc, a company that looks to profit as America’s negative habbits and lifestyles begin to catch up to them. Their phase II Clinical trials are set to be completed by 4Q09, and it couldn’t come at a better time as obesity levels reach new heights. During the past 20 years there has been a dramatic increase in the United States. In 2008, only one state (Colorado) had a prevalence of obesity less than 20%. Thirty-two states had a prevalence equal to or greater than 25%; six of these states (Alabama, Mississippi, Oklahoma, South Carolina, Tennessee, and West Virginia ) had a prevalence of obesity equal to or greater than 30%. Their lead product, CardioCor, involves fusing a bike and infrared together, in order to create a fat burning oven which trumps anything else in the market. It uses 2800 Watts of Infrared, and thus burns calories up to 10 times faster than that of traditional exercise.

    Marketdata projects 6.0% annual growth for the total U.S. weight loss market, to $68.7 billion by 2010, with growth rates for individual market segments ranging from zero to 16% per year.

     

    About Cardio Infrared Technologies, Inc.

    Cardio Infrared Technologies, Inc. is a technology and marketing company, which is focused on developing the revolutionary and evolutionary process of combining exercise equipment with medical benefits that go far beyond the normal benefits of standard exercise equipment. Cardio Infrared Technologies, Inc. is committed to continue to market this equipment to the exercise and medical markets and to aggressively expand the market to every country around the world. The equipment has already been featured on “Good Morning America” and “The View.” Cardio Infrared Technologies, Inc. also has an aggressive growth plan that includes acquisitions and development of innovative new equipment and programs in the exercise and medical industries.

    CardioCor Product Benefits
    Losing weight is synonymous with losing toxins

    When your body is overloaded with toxins, whether it is from the contaminants in the food we eat, the air we breathe or the water we drink, your body’s metabolism slows down. This sluggishness and lack of energy causes your body to create more fat cells to store the excess toxins, establishing a vicious cycle that  can help bring to a halt.

    Retained toxins are key in the accelerated aging process

    The pounds of toxins and waste that overload the elimination systems of the body will cause your body to prematurely age and develop chronic diseases. This is reversible! By applying infrared heat in a controlled environment to the skin, the largest organ of elimination in the body, we can help the body rid itself of poisons and pollutants. It has been recorded that in deep perspiration, the body excretes 85% water and 15% toxic waste.
    Live to a ripe old age with energy and vitality

    By unburdening your body form the built up toxins and poisons that clog your organs, tissues, blood, muscles, fat and cells, you will also rejuvenate your spiritual and emotional vitality. A cleaner body will engender a livelier spirit and a true love of life well into your older years. Being able to feel alive and vibrant every day is truly a blessing.

    A 40-minute session 3 times a week will provide you with:

    Sweat Therapy that will increase your calorie burn up to 10 times the normal rate to aid in weight and inch loss. Increased blood circulation, and increased core temperature are key factors in moving the toxins out of your body. Infrared penetrates the body up to 3 inches because the body is 70% water. This fact allows the body to absorb the energy from the infrared as it would absorb the energy of the sun. The absorption of this energy helps to increase the core temperature of the body and the detoxification that it promotes. As a mood booster, infrared can’t be beat. You will enjoy an overall feeling of well-being, starting with your very first session. Light therapy has long been used to aid in depression and respite from the doldrums and gloom of the winter and the effects of SAD.  Increased circulation will help promote collagen production and give you a super deep cleansing effect. You will see a noticeable improvement in skin texture and obvious scars through the use of infrared. Detoxify your body with regular infrared exposure and reap the benefits of natural good health.  Natural therapists confirm that sweating is a great way to remove toxins, using infrared heat offers this benefit at a comfortable temperature.?Infrared has been documented as aiding in the pain management and recuperation of sports injuries, arthritis and more.

    Key Weight Loss Market Statistics

    • Marketdata estimates that the total U.S. weight loss market was worth $55.4 billion in 2006. The market should reach $58.7 billion this year and $68.7 bill. by 2010 (see attachment, table).
    • Retail meal replacements were hit hard by the low-carb craze, but have shown signs of growing once again. We estimate that sales were $1.17 billion in 2006.
    • OTC diet pills market is in turmoil as the FTC fines marketers $25 million and many brands fight for market share and tinker with non-ephedra ingredients.
    • In 2006, 68% of dieters preferred a diet program they could access from home/online/by phone, and 56% want a plan based on regular (not diet) food.
    • Bariatric surgeries reached record levels of 177,000 in 2006, representing a $4.4 billion market. However, major insurers still don’t cover these surgeries and growth slowed to only 4%. More obese Americans are having the procedure done in Latin America, where the cost is substantially less.
    • Diet food home delivery grows into an $800 million market segment, fueled by NutriSystem, Jenny Direct, Medifast and a few dozen others. Not all companies provide national delivery. Many only cater to local markets in Los Angeles, Chicago or New York, delivering premium priced gourmet fresh food. The average monthly cost for consumers is $725.
    • Diet soft drinks Diet sodas’ share of all soft drinks has risen to 29.5%, almost the historical peak, and this is forecast to rise to 31%. This segment was worth $19 billion in 2006.
    • Diet drugs The prescription $459 million diet drugs market did grow somewhat in 2006, but still awaits the FDA’s approval of Rimonabant (Acomplia).
    • Market leaders Weight Watchers ($1.2 bill.), NutriSystem ($568 mill.), LA Weight Loss ($500 mill.), Jenny Craig ($462 mill.), Slim-Fast ($310 mill.), Herbalife ($271 mill. ” U.S. diet prods. sales).

    Experienced Management

    Wayne K. Bailey, CEO

    Wayne has spent his life as a CEO and CFO of various corporations, both private and public that had a competitive edge over the competition.  Wayne spent 3 years as the CFO of a Publicly traded mortgage bank.  For 12 years Wayne was part of a group that acquired manufacturing companies in the Aerospace, water, wood, steel, plastic, circuit board and other manufacturing and distribution business. In the mid 1970’s Wayne founded and was the CEO of a private plastic company that developed the process to thermoform PET plastic and became part of the development group of Eastman Chemical for PET products.
    A decade ago, Wayne fought hard against the established medical protocol of the day as he lost the battle to save his daughter from small cell ovarian cancer and to institute a more holistic, direct and focused methodology to bring his daughter back. As expected, his input was rejected as the time, but is now one of the accepted treatments for this dreadful, fateful disease. As a result, over the last decade, Wayne has focused his energies toward educating his friends and associates toward a more holistic, healthy lifestyle through nutritional supplements and detoxification. It is as a result of this quest that Wayne decided to bring the CardioCor to the U.S. and begin the process of teaching people the overall dangers of the toxins in our environment and how to safely remove them.

    Elle Reinhardt, M.B.A., T.N.D.

    Elle’s background includes her early years as an educator and encompasses a career in interior design and construction before her inevitable confrontation with the allopathic medical community several years ago. After a year and a half of remaining undiagnosed for a medical problem by her doctors, Elle diagnosed herself through a serendipitous newspaper article and the internet. She then proceeded to heal herself and return to school to achieve her Doctorate in Naturopathy at Clayton College of Natural Health, Birmingham, AL.
    She has focused the rest of her life towards educating others as to the ways of achieving and maintaining homeostasis. Her passion and focus are education through whole food nutrition, cleansing and detoxification to aid her clients in achieving a vibrant longevity. Elle is also a Board Certified Reflexologist.  Elle joined forces with Wayne Bailey in the CardioCor endeavor to bring to America the gift of a focused cardio-infrared program that is unlike anything available in the United States today.

    CAROL ANGLIN, NATIONAL SALES DIRECTOR

    Carol joined the Cardio-Cor team in November 2006.  Carol started working with Cardio Infrared Technologies, Inc doing cold calls in the Utah market. Carol quickly completed sales of two units by the end of 2006. In 2007 she was doing cold calls on a nationwide basis developing sales leads and sales first on the East Coast and then on the West Coast. Carol has become a very valuable member of the Cardio-Cor  sales and management team.   The training she has received and the first hand observations of the results obtained by the people using the Cardio-Cor has given her a unique perspective that has added to the mounting sales momentum of Cardio Infrared Technologies, Inc. Carol was part of the team that attended the Anti-Aging show in December 2007 and was given the responsibility for the sales leads generated from that show and most of the leads generated from the other shows in 2007. Carol has aggressively followed up on the leads generated by these shows, which as resulted in many sales that may have been missed if not for her diligence. Carol Anglin comes to Cardio Infrared Technologies, Inc. with over 25 years of sales experience which includes selling photography, Tanning equipment and Time Shares.  Carol has won several awards in the Time Share industry for most valuable employee and for record numbers of leads generated. Carol comes to Cardio Infrared Technologies, Inc. from a desire to help people gain a healthier more natural way of improving their bodies.  Carol’s son Scott died of bone cancer at age 20 which led her to a quest to find other alternative ways to keep the body in a natural healthy state of being.”

    Refocusing the Company

    The company first brought the Unit to the United States two years ago under the name Cellubike, so named by the Italian manufactures, which only recognized the beauty benefits of the Bike. Over the past 40 years, the intrinsic value of Infrared has blossomed into a multi-billion dollar beauty industry in Europe, where, typically, most beauty innovations are discovered. As our knowledge and experience with this amazing product grew, our clients and we quickly realized that the results being experienced were nothing short of astounding. Yes, the beauty benefits were still there such as weight loss, inch loss, diminishing of cellulite, and building of collagen in the skin. But, just as importantly, the body was detoxifying and promoting even better results through loss of toxins. Many clients experienced the reduction, if not total disappearance, of chronic conditions such as fibromyalgia, arthritis, colitis, bursitis and pain from sports injuries that had plagued them for years as you can read in the Testimonials. Others were surprised as scars diminished, recovery from strokes was accelerated and eczema conditions were relieved. With this exciting new information we felt it was imperative to relaunch this amazing device in a new light. We found it fitting that the new name incorporates all aspects of its capabilities, thus highlighting the medical benefits. Hence the CardioCor emerged, reflecting not only the Cardio benefits, but also, the benefits of increasing the body’s core temperature and boosting the client’s metabolism!

    Company News

    Cardio Cor Announces $400K in New Orders for Cardio Cor and Cardio Cor IITM

    LAS VEGAS, NV–(Marketwire – October 30, 2009) – Cardio Infrared Technologies, Inc. ( PINKSHEETS: CDOI) www.cardio-cor.com, a leading Health and Wellness technology and marketing company, announced today that it has received orders from a new Florida-based client for two of the Commercial Cardio Cor bikes and six Personal Cardio Cor II™ bikes.

    Wayne Bailey, President and CEO of Cardio Infrared Technologies, Inc., stated: “A new customer in Florida has ordered two Cardio Cor units for immediate delivery and six Cardio Cor II units for delivery as soon as they are available in first quarter 2010. The sales revenue of this order exceeds $100,000. We have also taken orders from customers in San Francisco, CA, Palm Springs, CA, Hollywood, CA, Palm Beach, FL, New York, NY, Salt Lake City, UT, Atlanta, GA and Atlantic City, New Jersey for the new Cardio Cor II™. The orders placed now total well over $300,000. It is understood that additional orders will be received soon and will result in the new production capacity being sold out for the first three months of 2010 production. Additional demand for the Cardio Cor II™ will be generated at the “Anti Aging Show “coming in Las Vegas mid December.”
    New customers are being told to get their orders in now or they will be on a waiting list that takes them to mid year 2010.

    Cardio Infrared Tech Announces New Infrared Lights for the Cardio-Cor II

    LAS VEGAS, NV–(Marketwire – October 21, 2009) – Cardio Infrared Technologies, Inc. ( PINKSHEETS: CDOI) www.cardio-cor.com, a leading Health and Wellness technology and marketing company, announced today newly developed infrared lights for the Cardio-Cor II personal Exercycle.

    Wayne Bailey, President and CEO of Cardio Infrared Technologies, Inc., stated: “The new infrared lights will now power the Cardio-Cor II. The new lights were developed specifically for Cardio Infrared Technologies and the new Cardio-Cor II personal Exercycle. The new lights are the product of recent innovation in bulb design and technology that provide for a smaller bulb but retains all the benefits of the previous larger bulb. The new 100-watt bulb is only one inch in diameter and four inches long and is extremely energy efficient. The older bulbs are five inches in length and five inches in diameter. The light array in the Cardio-Cor II is now only two inches thick instead of the nine inches as on the original Cardio-Cor. This innovation allows for a much smaller, super compact Exercycle. Cardio Infrared Technologies, Inc. will use the new lights in all new products. These new lights will allow Cardio-Cor to develop a wide range of compact products that couple the use of infrared and exercise. Cardio Infrared Tech remains committed to develop and/or acquire improved infrared technologies for the benefits of our customers and stockholders.”
    The new personal Cardio-Cor II Exercycle is being well received in all beta market tests and is expected to dramatically improve sales in 2010.

    Cardio Infrared Technologies, Inc. Announces Reduction in the Amount of Authorized Stock

    HENDERSON, NV–(Marketwire – 10/23/09) – Cardio Infrared Technologies, Inc. (Pinksheets:CDOINews) (www.cardio-cor.com) today announced that its Board of Directors has authorized a reduction of the authorized shares from 5,000,000 to 1,500,000.
    “The Board took the action to reduce the amount of authorized stock to more accurately reflect the capitalization of the company. This lower authorized is a one third reduction in the authorized shares for the company. The board believes that this reduction in authorized shares will facilitate the company’s ability to attract companies for acquisition and expansions. The company currently has 47,181,495 shares issued with 4,714,172 free trading shares currently issued and outstanding,” said Wayne Bailey, Chief Executive Officer of Cardio Infrared Technologies, Inc. “We continue to pursue our acquisition and growth plan and believe this 1/3 drop in authorized will facilitate our financial plans for the company.”

    Cardio Infrared Phase II Clinical Trials to be Completed This Year

    LAS VEGAS, Oct. 5, 2009 (GLOBE NEWSWIRE) — Cardio Infrared Technologies, Inc. (Pink Sheets:CDOINews) (www.cardio-cor.com), a leading Health and Wellness technology and marketing company, announced today that the clinical trials being conducted in Pennsylvania completed Phase I earlier this year and demonstrated the efficacy portion of the trials. Phase II, which has been underway for 6 months, has been testing the effects on Detoxification and will be available by the end of this year.

    Wayne Bailey, President and CEO of Cardio Infrared Technologies, Inc., stated: “The second phase of the clinical trials are within two months of completion. The expanded number of people involved in the second phase is providing a tremendous amount of additional information and data on the Cardio-Cor system. The results from the expanded Phase II are reported to be superior to those released in the first phase and additional levels of study are showing amazing results according to the community of patients involved. The expanded basis of the second phase of the study is concerned not only with weight and inch loss but also on detoxification and the tested results of infrared on the body. The report on the second phase is scheduled to be completed before the Las Vegas Anti-Aging show in December. The third phase of the Clinicals will be a comparison of the Cardio-Cor ExerBike vs. a treadmill which will document the additional benefits of using the Cardio-Cor over any other type of exercise equipment available to the public.”

    The clinical trials that were completed in Italy will also be released within the next three months. The Clinicals from Italy were completed using Italian guidelines, not FDA standards. They show vast weight, inch and cellulite loss. They also address detoxification and many of the other issues that our Phase II study is now addressing. The release of the additional studies will add validity to the technology and products of Cardio Infrared Technologies.

    Disclosure: Long CDOI
    ———–

    By reading MiV Investments Inc. company profiles you agree to the disclaimer, and thereby will not hold Michael Vlaicu accountable for any transactions or decisions you make. It is up to you to do your own due diligence.

    MiV Investments Inc. is not paid, compensated or in any way incentivized to report news and developments about publicly traded companies, unless otherwise stated.

    Nov 04 08:19 am | Link | Comment!
  • Awaiting IND Targetting a Twenty-Eight Billion Dollar Market (OTC:ACTC.OB)
    Advanced Cell Technology, Inc.

    (Public, OTC:ACTC.OB)

    MiV Investments Inc. has initiated independent research coverage on Advanced Cell Technology Inc. (OTC:ACTC.OB), which is anticipating a filing of an investigational new drug (IND) application which takes on a 28B Age-related macular degeneration (AMD) market, with over 30 million people affected by the disease. The company expects to file the IND prior to the end of Q409. Macular degeneration is a medical condition usually of older adults that results in a loss of vision in the center of the visual field (the macula) because of damage to the retina. It occurs in “dry” and “wet” forms. It is a major cause of visual impairment in the elderly (>50 years). Macular degeneration can make it difficult or impossible to read or recognize faces, although enough peripheral vision remains to allow other activities of daily life. There is no other existing therapeutic treatments which regenrate the lost cells, leaving 90% of Age-related macular degeneration (AMD) patients with dry variety as an unmet need. This condition affects more than 15% of elders aged 75 and above, leaving it as one of the top threats to an elder’s health. The company has also taken major strides, recently moving from the PINK sheets, to the OTC bulletin and sufficing the qualifications needed to be pink sheets compliant. Technicals on the company’s stock have also been highly bullish as of late, sitting at a nine month price low, all the while anticipating news on what could be the beginning of a revolutionary new drug.


    The company is in preparation of its first IND filing with the Food and Drug Administration for its retinal pigment epithelium (RPE) cell program for the treatment of various eye diseases. The Company noted that in the next few weeks, it will be completing the preclinical work necessary for filing the IND. To date, no adverse events have occurred in testing. The results will be part of the submission which Advanced Cell expects to submit to the FDA prior to the end of the year.   “We are very pleased with the long-term safety and efficacy data,” said Dr. Robert Lanza, ACT’s Chief Scientific Officer. “We have carried out pre-clinical studies using these cells in multiple animal models, and to-date have not seen any teratoma formation or untoward pathological reactions. We are optimistic that human embryonic stem cells (hESCs) will serve as a potentially safe and inexhaustible source of RPE for the treatment of a range of macular degenerative diseases.”   Existing therapies only treat the condition and do not regenerate cells of the macula that have been damaged. Plus, existing therapies only treat wet AMD, not dry AMD, leaving a significant unmet need for an effective treatment for the 90% of AMD patients who have the dry variety. The company expects to file an IND for its RPE program by end of 2009.

    About Advanced Cell Technology, Inc.

    Advanced Cell Technology, Inc. is a biotechnology company focused on developing and commercializing human embryonic and adult stem cell technology in the field of regenerative medicine. The Company has acquired, developed and maintain a portfolio of patents and patent applications that form the base for its research and development efforts in the area of embryonic and adult stem cell research. The Company’s technology base, in combination with its know-how, provides an advantage and will facilitate the successful development and commercialization of products for use in treatment of an array of chronic degenerative diseases and in regenerative repair of acute disease, such as trauma, myocardial infarction and burns. The Company’s embryonic stem (ES) cell research programs are divided into three core categories: cellular reprogramming, reduced complexity program, and stem cell differentiation.

    Worldwide Recognition

    Dr. Robert Lanza, its Chief Scientific Officer, was featured on Deepak Chopra’s Wellness XM Radio and Barbara Walters 20/20 special.  The shows focused on Dr. Lanza’s research at ACTC and his new book “Biocentrism.”  SIRIUS XM Stars Channel is the flagship satellite talk station featuring unique and diverse programs, including Deepak Chopra and broadcasting legend Barbara Walters, among others. It has a listenership of approximately 9 million people.

    Chopra is a prolific author of over fifty-five books on topics ranging from health to consciousness and quantum mechanics, and was heralded by Time Magazine as one of the top heroes and icons of the century.  On his show, Lanza discusses the cutting edge of regenerative medicine, including ACTC’s efforts to use stem cells to treat blindness, vascular damage, and heart disease.  ACTC hopes to file at least one application with the FDA this year to begin human clinical trials using retinal pigment epithelium (RPE) cells to treat macular degeneration and other retinal degenerative diseases.

    Lanza and Chopra also discuss “Biocentrism,” and how life and consciousness are the keys to understanding the true nature of the universe.   “We think life is an accident of physics,” explains Lanza.  “But a long list of experiments suggests just the opposite.  Amazingly, if you add life to the
    equation, you can explain some of the biggest puzzles of science. ”

    Deepak Chopra stated, “Having interviewed some of the most brilliant minds in the scientific world, I found Dr. Robert Lanza’s insights into the nature of consciousness original and exciting.  His theory of biocentrism is consistent with the most ancient wisdom traditions of the world which says that consciousness conceives, governs, and becomes a physical world.  It is the ground of our Being in which both subjective and objective reality come into existence.  I hope to have Dr. Lanza continue this conversation on Sirius XM satellite radio in the future.”

    “We believe that Dr. Lanza has contributed significantly to the understanding of the key role stem cells play in the field of regenerative medicine,” said William M. Caldwell IV, Chairman and CEO of ACTC.  “Through his scientific leadership the field is on the verge of therapeutically validating a new platform for regenerative medicine.” Source found here

    Retinal Pigmented Epithelial Cell Program

    Advanced Cell Technology is currently focused on using its proprietary technologies to generate stable cell lines including retinal pigment epithelium (RPE) cells for the treatment of diseases of the eye, including macular degeneration, which represents a $28 billion dollar market. Age-related macular degeneration (AMD) affects more than 30 million people worldwide and is the leading cause of blindness in people over 60 years of age in the United States. AMD is a disorder that affects the macula of the eye that causes decreased visual acuity and possible loss of central vision. The prevalence of AMD begins to increase after the age of 50. Approximately 15% of people over 75 years of age have the condition.

    Positive Clinical Trials

    ACT demonstrated the ability to rescue visual function in rats through implantations of RPE cells derived from human embryonic stem cells. In collaboration with Raymond Lund at the University of Utah, the company performed RPE transplantation into sub-retinal space of rats that naturally become blind in several weeks due to RPE degeneration and photoreceptor death. In the experiments conducted by the company, the rats were injected with embryonic stem-RPE cells into the sub-retinal space of the eye at 21 days after their birth — an age at which photoreceptor degeneration has not yet occurred. As control measures, some rats received injections of cell culture medium alone or were not injected at all. Subsequently, tests for visual function were performed at 60 and 90 days after birth — times at which loss of photoreceptor cell has produced characteristic vision deficits. The results represented a major breakthrough. The injected RPE cells grew normally without forming teratomas. Soon, the rats were able to follow lights with their eyes and attained approximately 70% of the spatial acuity of a normal, healthy rat. Necropsy revealed that the eyes had grown layers of the retinal cells. The experiment demonstrated that animals receiving the human embryonic stem cell-derived RPE cells performed significantly better than medium-only treated (50% improvement), or untreated (100% improvement) controls in visual performance. In addition, the human embryonic stem cell-derived RPE cells did not appear to cause any side effects in the animals. The research was published in Cloning and Stem Cells and was also referenced in Scientific American. Source found here

    Understanding Advanced Cell’s Position

    Market Opportunity: Age related macular degeneration (AMD) represents a “tremendous” market opportunity given the size of the patient population and the lack of treatment alternatives. Diseases of the eye affect more than 30 M people worldwide and represent a $20+B market.

    • Existing therapies only treat the condition and are not curative but palliative and do not regenerate cells of the macula that have been damaged.  Additionally, existing therapies only treat Wet AMD not Dry AMD hence leaving a significant unmet need for an effective treatment for the 90% of AMD patients who have the dry variety,
    • AMD is a common eye disease that leads to deterioration of the macula which is the central area of the retina in the back of the eye, the paper-thin tissue where light-sensitive cells send visual signals to the brain.  In particular, sharp, clear, “straight ahead” vision is processed by the macula.  Injury to the macula results in the formation of blind spots and blurred or distorted vision.  When the macula becomes damaged, many daily activities such as driving and reading become increasingly difficulty,
    • AMD most often affects individuals over 50 years of age.  There are two forms of macular degeneration: dry macular degeneration or wet macular degeneration.  Dry AMD takes place when the light-sensitive cells in the macula slowly break down, gradually blurring central vision in the affected eye.  As dry AMD gets worse, the patient may see a blurred spot in the center of their vision.  As the disorder progresses, and less of the macula functions, central vision is gradually lost in the affected eye.  The most common symptom of dry AMD is slightly blurred vision.  The affected individual may need more light for reading and other tasks,

    Wet AMD occurs when abnormal blood vessels behind the retina start to grow under the macula.  As the dry form worsens, some people begin to have abnormal blood vessels growing behind the macula.  These new blood vessels tend to be very fragile and often leak blood and fluid (hence ‘wet’ macular degeneration).  The blood and fluid raise the macula from its normal place at the back of the eye.  Damage to the macula occurs rapidly.  With wet AMD, loss of central vision can occur quickly.  Wet AMD is also known as advanced AMD.  It does not have stages like dry AMD.  The wet form is diagnosed in approximately 10 percent of cases; however, it results in 90% of the visual impairment and is considered advanced AMD (there is no early or intermediate stage of wet AMD).  Wet AMD is always preceded by the dry form of the disease.

    Investment Highlights

    • Currently ACT is finalizing preclinical studies for the bio-distribution of our therapeutic program addressing Retinal Degeneration (i.e. AMD or macular degeneration in the eye) and has completed GLP Safety Studies and long-term efficacy studies for the RPE therapy with positive results.
    • The Company expects spiking studies for the RPE product to be finished in the second half of 2009. ACT expects to file the RPE program IND by the end of 2009.
    • Working on acquiring funding for Phase II clinical trials for the Company’s Myoblast program, an autologous (meaning “one’s own”) adult stem cell therapy for treating cardiac disease. Historically the Myoblast program successfully completed several Phase I clinical trials.
    • Published positive results from HG program demonstrating hemangioblasts’ ability to repair vascular damage in animals. Therapy could be effective for treatment of blood and cardiovascular diseases. Anticipates filing an IND in 2010.
    • Made progress in macular degeneration indication by reporting positive data for RPE cell animal study. Entered into collaboration with Casey Eye Institute for preclinical trials. Completed Pre-IND meeting with FDA. Expects to file IND in 2009.
    • Developed and demonstrated technique to generate embryonic stems that maintain developmental potential of the embryo and therefore has potential to shift the ethical debate. Announced hESC lines created without destroying an embryo in multiple studies.
    • Owns or licenses over 380 patents and patent applications related to stem cell therapy.
    • Large Target Market: Regenerative Medicine has potential to treat diseases of the eye, blood disorders, heart disease, neurodegenerative diseases, liver disease, diabetes, and others.
    • Led by experienced management team and scientific experts including CEO William Caldwell, Chief Scientific Officer Robert Lanza M.D., VP of Regulatory Ed Mickunas, Senior Director of Manufacturing Roger Gay PhD and Director of Operations Rita Parker.

    Growing Legislative Support

    • CA Prop. 71 provides $3.0 billion in funding over 10 years for stem cell research, with preference given to research that is ineligible for NIH funding.
    • Other states (e.g., NJ, CT, FL, IL, MD, NY, MA, and MO) have passed or proposed similar initiatives.
    • Political landscape moving in positive direction for stem cell industry starting with President Obama new embryonic stem cell directive initiated January 2009. Source found here

    FDA News

    *Information via BioMedReports’ FDA Calendar

    Highly Experienced Leadership

    Read this article regarding ACTC’s Chief Scientific Officer within Discover Magazine.

    “Whether defying the dean of the University of Pennsylvania Schl. of Medicine so he could publish a book on world health or challenging the titans of cosmology, Robert Lanza has never followed the script. It’s no wonder, then, that this renegade doctor would lead the charge into medicine’s most controversial turf: the creation of cloned embryos for therapy and the engineering of spare human parts.”

    William M. Caldwell, IV

    Chairman and CEO

    William CaldwellMr. William Caldwell serves as Chairman and Chief Executive Officer of the Company and has a 30-year management career working with emerging technologies and restructuring distressed corporate environments. During his career, he has served in senior executive positions both in marketing and finance. He has worked with Booz Allen and Hamilton; the Flying Tiger Line Inc.; Van Vorst Industries; and Kidder Peabody. He started a firm specializing in corporate financial and strategy planning, which was instrumental in restructuring over $1.0 billion of debt for over twenty companies and partnerships. He was a pioneer in the satellite radio auctions as president of Digital Satellite Broadcasting Corporation; assisted in the financing, and became president and ultimately CEO in the restructuring of CAIS Internet. He has advised corporations, both public and private, in technology, telecommunications, retailing, real estate, hospitality, publishing, and transportation. He received his B.A. degree from the University of Southern California and was a Multinational Enterprise Fellow at the Wharton Graduate School of Finance. He serves as a director of Lee Pharmaceuticals (LPHM.PK) and King Koil Franchising Corp.


    Robert Lanza, M.D.

    Chief Scientific Officer

    Dr. Robert LanzaDr. Lanza joined ACT in 1999. Dr. Lanza has over 25 years of research and industrial experience in the area of stem cells and regenerative medicine. From 1990 to 1998, he was Director of Transplantation Biology at BioHybrid Technologies, Inc., and is currently an Adjunct Professor at the Institute for Regenerative Medicine, Wake Forest University School of Medicine. He has several hundred scientific publications and patents, and has authored/edited 20 books, including the “Handbook of Stem Cells” (as Editor-in-Chief), Principles of Tissue Engineering, XENO, the Yearbook of Cell & Tissue Transplantation, and One World: The Health & Survival of the Human Species in the 21st Century (as editor, with forewords by C. Everett Koop and former President Jimmy Carter). He is a former Fulbright Scholar, and studied as a student in the laboratory of Richard Hynes (MIT), Jonas Salk (The Salk Institute), and Nobel laureates Gerald Edelman (Rockefeller University) and Rodney Porter (Oxford University). He also worked closely (and coauthored a series of papers) with the late Harvard psychologist B.F. Skinner and heart transplant pioneer Christiaan Barnard. Dr. Lanza received his B.A. and M.D. Degrees from the University of Pennsylvania, where he was both a University Scholar and Benjamin Franklin Scholar.


    Edmund Mickunas

    Vice President of Regulatory

    Mr. Mickunas, a recent addition to the ACT team, is the Company’s Vice President of Regulatory. Mr. Mickunas is in charge of spearheading the company’s effort to translate its cutting edge research into FDA approved therapies ready for clinical trials. Mr. Mickunas is working with Dr. Robert Lanza and ACT’s Development Team to finalize and submit the IND for the RPE program to the FDA. Mr. Mickunas brings 28 years of experience from a number of disciplines including biotechnology, medical device and pharmaceuticals. He has worked in preclinical program development, clinical affairs, regulatory affairs/compliance and quality assurance, and has worked closely with all disciplines involved in product development. Prior to joining Advanced Cell, Mr. Mickunas was Executive Director, Regulatory Affairs and Quality Assurance for Applied Genetic Technologies Corporation, a privately held gene therapy and genomics-focused biotech company. Mr. Mickunas was previously Senior Director of Regulatory Affairs and Compliance for Control Delivery Systems, Inc., where he managed the submissions of IND filings, among other responsibilities. He also held senior regulatory positions at Bioheart, Inc., Cytomed and Del Laboratories. He received his B.S. and pursued graduate studies in human biochemistry at Fairleigh Dickinson University, as well as a Masters Degree from Fairfield University.


    Roger Gay, Ph.D

    Senior Director of Manufacturing

    Dr. Gay serves as Advanced Cell’s Senior Director of Manufacturing. Dr. Gay is responsible for Process Development and Clinical Manufacturing at Advanced Cell. For the past 28 years, he has been involved in clinical manufacturing and product development at a number of biotechnology companies specializing in cell-based products and services including Organogenesis, Diacrin, Genvec and Mytogen. He has extensive experience directing and leading product development and clinical trial manufacturing for cellular products having planned and executed R&D programs leading to market introduction of first-ever products for two biotechnology companies prior to joining Advanced Cell. He received a Ph.D. in biochemistry from the University of Rochester in 1980 and was a post-doctoral fellow at Harvard Medical School.


    Rita Parker

    Director of Operations

    With Advanced Cell since 2005, Ms. Parker brings a 20 year career in management to her role as the Company’s Director of Operations. A native of Massachusetts, she has held senior positions in marketing and operational management, focusing on paving the way for local businesses to expand their geographical footprint and increasing their technological and productive capabilities by introducing new and efficient information technology products and systems; a few of these companies include Digital Equipment Corporation, Computer Devices, and Banyan Systems, Inc.

    External News Affecting Advanced Cell

    Judge Throws Out Stem Cell Lawsuit

    by Jocelyn Kaiser

    A federal judge has rejected a lawsuit challenging the Obama Administration’s policy lifting restrictions on using federal funds to study human embryonic stem cells. Christian groups had sued the National Institutes of Health in August, arguing on behalf of themselves and embryos that NIH’s stem cell guidelines violate a ban on using federal funds to create or destroy human embryos. According to Bloomberg,  U.S. District Court Judge Royce Lamberth ruled yesterday in Washington, D.C., that the groups had no standing because the U.S. Supreme Court has found that embryos are not persons under the law, and the unborn have no constitutional right to life. The AP’s story says the judge also rejected the argument that the guidelines would reduce the number of embryos available for adoption. http://blogs.sciencemag.org/scienceinsider/2009/10/judge-throws-ou.html

    Recent Company News

    Advanced Cell Technology, Inc.’s Shares To Trade On Over-the-Counter Bulletin Board
    Tuesday, 6 Oct 2009 07:40am EDT

    Advanced Cell Technology, Inc. announced that effective immediately the Company’s shares will be traded on the Over-the-Counter Bulletin Board under its previous ticker symbol ACTC. The Company is now fully reporting and up-to-date with all of its filing requirements. The Company`s stock had previously traded on the Pink Sheets.

    Advanced Cell Technology, Inc. Completing Pre-Clinical Activities In Preparation For IND Filing
    Tuesday, 22 Sep 2009 11:28am EDT

    Advanced Cell Technology, Inc. announced an update on pre-clinical activities in preparation of its first IND filing with the Food and Drug Administration for its retinal pigment epithelium (RPE) cell program for the treatment of various eye diseases. In the next few weeks, the Company will be completing the preclinical work necessary for filing the IND. To date, no adverse events have occurred in testing. The results will be part of the submission which Advanced Cell expects to submit to the FDA prior to the end of the year.

    Advanced Cell Technology, Inc. and Collaborators At The Casey Eye Institute Present Promising Data Supporting Safety and Efficacy of Stem Cell Therapy to Combat Retinal Disease
    Friday, 12 Jun 2009 09:39am EDT

    Advanced Cell Technology, Inc. and its collaborators at OHSU reported the long-term safety and efficacy of human embryonic stem cell (hESC)-derived retinal pigment epithelium (RPE) produced under manufacturing conditions suitable for human clinical trials. Two important early potential hESC applications are the use of RPE for the treatment of age-related macular degeneration and Stargardt disease, an untreatable form of eye disease that leads to early-onset blindness. The research, which appears online ahead of print in the journal Stem Cells, shows long-term functional rescue using hESC-derived cells in both the RCS rat and Elov14 mouse, animal models of retinal degeneration and Stargardt, respectively. The cells survived transplantation for prolonged periods (>220 days) and sustained visual function without tumor formation or untoward pathological reactions. Near-normal functional rescue was also achieved in the `Stargardt` mouse. To further address safety concerns, a study was carried out in the NIH III immune deficient mouse model. Long-term data (spanning the life of the animals) revealed no evidence of tumor formation after transplantation.

    Advanced Cell Technology, Inc. Prepares IND Filing with the Capability to Produce Stem Cell Lines without the Destruction of the Embryo
    Thursday, 12 Mar 2009 08:00am EDT

    Advanced Cell Technology, Inc. announced that it is finalizing preparations to file an IND in the second half of this year with the Food and Drug Administration for the Company’s retinal pigment epithelium (RPE) cell program for the treatment of diseases of the eye. It has available the only technology that can today produce stem cell lines without the destruction of the embryo. While President Obama recently issued an Executive Order that authorizes expanded federal funding for research using stem cells produced by destroying human embryos, the decision remains controversial as some believe that the Government should not fund the ongoing destruction of human embryos. In the coming months Congress will be debating altering or eliminating the Dickey Wicker Amendment which is at the core of this controversy. Advanced Cell Technology`s stem cell platform offers a compromise on this issue, as described in peer review scientific journals published over the past several years. Over 3000 healthy children have undergone the medical procedure, PGD, which is at the core of ACTC`s technology.

    Overall Sentiment & Technical Analysis ( Click chart to enlarge )


    For the past six months, ACTC has moved within a very dependable price channel shown in Blue lines on the chart.  The channel was defined by a 193% gain in price back in May to June of this year.  Since then, the price has been waiting for the bottom trend-line of the price channel to catch up (consolidation). It appears this has finally happened. The stock has found the bottom trend-line of the channel where the big move back in May started.  That move started with a run in price that quickly made it to the middle trend-line (dashed Blue line) around .18 cents. The conditions are classically bullish as the daily 100 SMA (Orange line) is above the 200 SMA (Yellow line).  As the buyers assume control of this stock, the price should easily find the 100 SMA around .15 cents.  With growing volume (gray bars), the stock could quickly move back to the middle trend-line and likely back up into the upper half of the price channel.  Of course, news can trump everything and any FDA action would probably send this stock well above the top trend-line. It’s good to keep in the back of your mind that the price has already tested the top trend-line twice this year and we have seen numerous times that the third time is the charm to finally break out.

    Disclosure: Long ACTC
    ———–

    By reading MiV Investments Inc. company profiles you agree to the disclaimer, and thereby will not hold Michael Vlaicu accountable for any transactions or decisions you make. It is up to you to do your own due diligence.

    MiV Investments Inc. is not paid, compensated or in any way incentivized to report news and developments about publicly traded companies, unless otherwise stated.

    Tags: ACTC
    Nov 02 09:03 am | Link | Comment!
  • Empowering Alternative Renewable Energy from Disposable Waste (PINK:WTWO.PK)

    W2 ENERGY, Inc.

    (PINK:WTWO.PK)

    MiV Investments initiates an independent company profile on W2 Energy, Inc. (PINK:WTWO.PK), which looks to breakthrough within a $23B bio-fuel industry, as a successful alternative renewable energy company amongst worldwide rising oil and energy prices. since the dawn of technological advancements, the world has relied on the burning of fossil fuels in order to generate sufficiency and reliability for our energy needs. Most fossil fuels are formed from the remains of long-dead creatures and plants. Buried over the course of hundreds of millions of years, these carbon-based deposits have been converted by heat and pressure over time into such combustible substances as crude oil, coal, natural gas, oil shales and tar sands. While this has proven to be a cost effective method within the short-run, at current rates, the world uses fossil fuels 100,000 times faster than they can form. The time for alternative renewable energy to emerge from its shackles as a viable and feasible source has long been overdue. World oil demand is set to rise in 2010, as the price per barrel should see $80. Furthermore, the Minister for Natural Resources, Mines and Energy Stephen Robertson has been advised by the independent Queensland Competition Authority (QCA) of their decision to increase electricity prices by 11.82% for the 2009/10 financial year. The reason oil prices would likely rise in early 2010, is due to the outlined production cuts by the OPEC crude producers’ cartel since last year. OPEC members, which pump 40 per cent of the world’s oil, agreed in late 2008 to remove a massive 4.2 million barrels of daily output from the market as it sought to prop up crumbling prices. The cartel’s official daily output quota has stood at 24.84 million barrels per day since January but analysts say that compliance with the cuts has slipped over recent months to less than 70 per cent. Amongst these difficulties, lies the opportunities for W2 Energy, as it has the ability convert the syngas into hydrocarbon liquids (ultra low sulfer diesel, JP8 jet fuel, and/or gasoline). According to David Freund, Vice-President of Business Development, they have been developing this technology for over 9 years and now feel it is the optimal time to let it shine for the rest of the world to witness.

    Currently, bio-fuels are capturing about $23 billion of the $1.3 trillion spent each year to power our cars, trucks, airplanes, trains and ships. That’s just two percent of the market with an astounding 98 percent upside. One Brazilian company planning to spend $54 billion on this new fuel by 2010, estimating that the bio-fuel market is set to grow by an estimated 1000%.

    About W2 Energy, Inc.

    W2 Energy designs mass-to-energy plants which convert feedstocks into syngas, using patented low temperature highly efficient non-thermal plasma-based reactor technology. This allows the plant to run at a low cost and a profit.The Future of Energy - From Fossil to Plasma

    Patented gas-to-liquid catalysts convert the syngas into hydrocarbon liquids (ultra low sulfer diesel, JP8 jet fuel, and/or gasoline. W2’s patented true rotary steam engine (See the “SteamRay” in motion) converts excess heat generated into electricity. The electricity can be sold to the grid, and can supply all the plant’s power requirements. Learn more about the W2 Energy technology.

    The following feedstocks can be converted.

    • coal
    • battery waste
    • municipal solid waste
    • agricultural waste
    • human and animal waste
    • tires and plastics
    • medical waste
    W2 Energy has completed final testing of its first SEGS (Small Electrical Generating System) system. SEGS Photos. Also, the SunFilter Algae Reactor designed for the production of bio-fuel and the sequestration of greenhouse gasses, is now ready for commercial scale applications. SunFilter Photos.

    W2 Solar is the solar power subsidiary of W2 Energy.

    Visit www.w2solar.com for more information.

    Technology

    W2 Energy, Inc. - Green TechnologyW2’s mass-to-energy technology can convert any hydrocarbon feedstock (including coal, municipal solid waste, agricultural waste and sewage) into electricity and liquid fuel (gasoline, JP8 jet fuel and ultra low sulfur diesel). Our technology filters out the harmful by-products such as hydrochloric acid, and makes additional fuel out of the greenhouse gases (carbon dioxide and nitrogen oxides).

    One 4 ton per day system including the NT Plasmatron gasifier, the Steam Ray steam engine, the SunFilter algae reactor and the SmartFuel gas-to-liquid reactor, can fit on a single 45-foot tractor trailer bed.

    The W2 Energy technology is modular and scalable. Once proven at 4 tons per day, it can be deployed in plants processing 10,000 tons per day or more of any hydrocarbon feedstock.

    Other W2 technologies include:

    PAG (Plasma Assisted Gassifier) mass to energy reactor

    SEGS (Small Energy Generating Systems)

    Recent Headlines
    Maryland has decided that it is better to turn its garbage into energy than to keep pouring it into landfills. The Mayor Craig A. Moe and City Council of Laurel, Maryland are excited about the opportunity to convert a costly trash problem into green energy products. With landfills reaching capacity and trash disposition becoming increasingly more expensive, this is a partnership that will not only save some of the City’s limited resources, but contribute to a cleaner environment.
    “This is an amazing opportunity for W2 Energy to prove out its technology,” says David Freund, Vice-President of Business Development for W2. “We have been developing this technology for the last 9 years and now it is time to let it shine.”

    TORONTO–(Marketwire – 10/15/09) – W2 Energy, Inc., a developer of mass-to-energy technology, and Toxco, Inc., one of the world’s leading battery recyclers, announce they have entered into a joint venture in which W2 Energy will take approximately 600 tons yearly of carbon cake and plastics generated in Toxco’s battery recycling plant in British Columbia and will convert that battery waste into electricity and ultra low sulfur diesel.

    he algae for fuel market is a quickly growing market. Recently Exxon announced on CNN and through commercials that it is beginning to develop algae production for the production of fuel in the US. W2 Energy has already developed the technology and expects to have several production units in the Caribbean by the middle of 2010.The significant number of sun hours in the Caribbean are ideal for the production of biofuel using the the W2 Energy Sunfilter bioreactor. The Company expects that the algae to biofuel program in the Caribbean will be a great success.

    TORONTO–(Marketwire – 10/07/09) – W2 Energy Inc., a developer of green energy, is pleased to announce that it will be able to offer the coal industry a viable alternative for disposal of coal ash or coal fines, that will result in the production of diesel to reduce costs while cleaning up coal fines at the power generating sites. Forty eight percent (48%) of all power generated in the United States is generated through coal burning power plants. During a television show called “60 Minutes” on October 4, 2009, there was a segment showing that there is a new problem emerging as a result of generating power using coal. During the generation of electricity at coal burning power plants, coal ash or coal fines are produced.

    The first phase will be the completion of 20 Sunfilter units. This phase of the plant has an expected completion date of mid October. The Company will immediately begin construction of the second phase which will be the addition of another 30 Sunfilter units.

    The Company anticipates that the plant, once all phases are operational will produce up to 500 gallons of fuel per day. Several companies are advertising that they are attempting to develop this technology to convert Algae to Diesel. W2 Energy has already developed the technology and is demonstrating to the industry that it works by establishing its own unit for demonstration purposes and cash flow.

    W2 Energy’s marketing partner held multiple meetings starting from September 7 to September 14 with representatives from 5 companies and 1 government official.

    W2 Energy recently announced that it had received a sample of high quality coal that will be processed in W2 Energy’s NT Plasmatron non thermal plasma reactor. All test data results will be the focus at the second meeting.

    W2 Energy’s plasma technology incorporated with its SteamRay Steam Engine, its Multi-Fuel Gas-to-Liquid Reactor along with its Sunfilter allows coal to be processed in a closed loops system, producing Synthetic Fuel, Electricity and sequester the greenhouse gasses to produce algae.

    TORONTO, Sept. 14 /PRNewswire-FirstCall/ – W2 Energy, Inc., a green energy company, is pleased to announce that it has received significant samples of high quality coal from a major Pennsylvania coal producer. W2 Energy will be using the Pennsylvania coal to show the industry that its technology will make 100% clean fuel plus electricity from the Pennsylvania coal.

    TORONTO–(Marketwire – 09/08/09) – W2 Energy, Inc., a developer of green energy, continues to take a very aggressive approach to expanding its product line. Garbage is like gold. Gold is considered the only real currency that can retain value. But gold reserves are becoming depleted worldwide. Garbage is in fact a renewable resource that maintains its value like gold and is never depleted. Garbage reserves continue to increase and are a huge benefit to anyone with a W2 Energy plant. Ultimately it is a very strong currency, when you have a W2 Energy waste to energy plant, because W2 Energy has the technology that works. The products produced by the W2 Energy plants will always be in demand. The W2 Energy Plant cleans up the environment and reduces CO2 emissions because it is a closed system. W2 Energy develops products that are targeted at small scale, low cost energy solutions that are affordable while protecting the environment. Large scale projects create huge environmental footsteps with high risk and high cost. No one knows for sure if the benefits of large scale projects out weigh the negative effects.

    TORONTO–(Marketwire – 09/02/09) – W2 Energy, Inc., is pleased to announce that based on the latest information released related to its Algae to Diesel Project using the NT Plasmatron, it has generated significant interest internationally. Several very interested parties have asked for information about costs and yields of the W2 Energy facility being built in Guelph, Ontario. The marketing team is meeting with these parties in Miami, Florida the week of September 7, 2009 to discuss commitments for the system. As well as getting paid for the systems, W2 Energy will receive a royalty from each barrel of diesel produced. Using the W2 Energy technology and equipment, the cost to set up the facility is reasonable and the paybacks substantial.

    TORONTO–(Marketwire – 08/31/09) – W2 Energy Inc., a developer of green energy, is pleased to announce that it has begun to take delivery of materials to begin construction of the Algae plant previously announced on August 13, 2009. The construction of the Algae plant is the first step in W2 Energy becoming vertically integrated. The Algae plant is expected to be completed and in full production by the end of 2009. W2 Energy currently markets its waste to energy plants to third parties, and now the company will use its own technology and equipment to produce diesel for resale. The Company is very confident that it can produce the algae-diesel at 1/3 of the cost of those companies making bio-diesel by using its technology and catalytic methods, rather than methanol, catalyst and heat.

    Experienced Management
    Michael McLaren – President, CEO, Director

    Michael McLaren has been in the high technology industry for 20 years his past experience includes a number of Military and government projects in high-energy physics, advanced robotics and weapon design. Mr. McLaren has been with W2 Energy since its inception and prior to that was with General Cybernetics since 1998 which was a division of World Wise Technologies Inc. Mr. McLaren has a Masters Degree in Science, Masters Degree in Business from University of British Columbia.

    David Freund -Vice President of Business Development

    After studying architecture at the University of Virginia in the 1980’s, Mr Freund began his alternative energy career at Kelbaugh & Lee, one of the world’s leading passive solar architecture firms. At Casa Blocka, Ltd., in St. Croix, Mr. Freund raised venture capital for the manufacturer of energy-efficient building materials. As an entrepreneur Mr. Freund established DSF Public Relations, a public relations firm, and The Energy Tree Group, a firm that promoted and raised capital for green businesses and projects. David Freund also has been named president of W2 Energy’s solar division.

    Sigmund Phillipe Friberg – Director

    Sigmund Phillipe Friberg earned a Masters Degree in Economics from University of Copenhagen in 1979. From 1990 to 2001, Mr. Friberg served as the Chief Financial Officer with André Group, a company established in 1877 and was one of the world’s big 5 in grain trading. From 2001 until the present, Mr. Friberg served as a financial & administrative consultant for various Swiss financial and trading companies, and an independent economic adviser for insurance, investment and real estate financing.

    Pierre Besuchet – Director

    Mr. Besuchet is a seasoned director of the company. He is a private Swiss banker and fund manager located in Geneva. In 1983 he founded an asset management company for private clients and has worked at that company since that date through the present. He is a director of Faisal Finance SA by Dar al-Maal Islami S.A, Switzerland, Indufina SA, Switzerland, Valor Invest Ltd, Virgin Islands, W2 Energy Inc, Ontario since 1994, Lundin Mining Vancouver since 1990 and Orko Silver. Mr. Besuchet attended the High Commercial School in Lausanne – Switzerland and the American Institute of Banking in New York.

    Technical Analysis ( Click chart to enlarge )


    WTWO has spent almost three months consolidating after a significant gain in price back at the beginning of August and now appears ready to climb again. The August gain expanded the price channel back to levels that had been in control over a year ago.  Typically, one doubles the height of the previous channel and this indicates the new channel (Blue lines on the chart) reaches up to .046 cents at the top trend-line.  The previous top trend-line is now the middle trend-line (Blue dashed line) and today the price clearly exceeded this line and turned this level into support.  This move is backed-up by a strong increase in volume over the past two days.  Now, the stock seems to be headed for the upper levels of the current channel and beyond.  The sellers appear to have lost control and the buyers have gained the momentum.  All this positive sentiment is backed by the standard bullish signal of the daily 100 SMA (Orange line) moving above the daily 200 SMA (Yellow line) back in July.  The bullish signal is further strengthened by both these moving averages currently trending up.  It’s good to keep in mind that the price has reached well above the top trend-line, trading up to .20 cents just last year (over a 680% increase from today’s closing price).

    Overall Sentiment

    With oil and energy prices projected to increase in 2010, as well as into the foreseeable future — alternative renewable energy companies will continue to receive increased transparency. Entering a $23B bio-fuels industry, W2 Energy should prosper based on its ability convert the syngas into hydrocarbon liquids (ultra low sulfer diesel, JP8 jet fuel, and/or gasoline). According to the 6/11/09 10-Q, total assets increased by $494,314 from December 31, 2008 to March 31, 2009, mostly due in part as a result of equipment purchases during the quarter. Any upcoming news regarding the partnership with Toxco to turn old batteries into energy, or the partnership with Maryland to turn garbage into clean energy, should spark a renewed interest in the company as investors await monetary compensation for the company’s efforts.

    Disclosure: Long WTWO
    ———–

    By reading MiV Investments Inc. company profiles you agree to the disclaimer, and thereby will not hold Michael Vlaicu accountable for any transactions or decisions you make. It is up to you to do your own due diligence.

    MiV Investments Inc. is not paid, compensated or in any way incentivized to report news and developments about publicly traded companies, unless otherwise stated.

    Oct 27 08:36 am | Link | Comment!
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