We're into the heart of earnings season, and several of the medical device industry's biggest players have already reported quarterly results. Johnson & Johnson (NYSE: JNJ ) led off among the biggest players, with fellow diversified health care firm Abbott Labs (NYSE: ABT ) and more concentrated company St. Jude Medical (NYSE: STJ ) following suit last week.
In that time, a few key trends have stood out that investors should take note of ��particularly before Boston Scientific's (NYSE: BSX ) earnings emerge this Thursday. Fool contributor Dan Carroll and health care analyst Max Macaluso discuss how the above companies fared this earnings season, and if the trends we've seen will come to shape Boston Scientific's earnings as well later this week.
Is bigger really better?
Involved in everything from baby powder to biotech, Johnson & Johnson's critics are convinced that the company is spread way too thin. If you want to know if J&J is nothing but a bloated corporate whale -- or a well-diversified giant that's perfect for your portfolio -- check out The Fool's new premium report outlining the Johnson & Johnson story in terms that any investor can understand. Claim your copy by clicking here now.�
Best Semiconductor Companies To Own For 2015: Myriad Genetics Inc (MYGN)
Myriad Genetics, Inc. (Myriad) is a molecular diagnostic company. The Company is focused on developing and marketing predictive medicine, personalized medicine and prognostic medicine tests. It performs all of its molecular diagnostic testing and analysis in its own reference laboratories. These technologies include the cornerstone technologies of biomarker discovery, high-throughput deoxyribo nucleuc acid (DNA) sequencing, ribo nucleic acid (RNA) expression and multiplex protein analysis. The Company uses this information to guide the development of new molecular diagnostic tests that are designed to assess an individual's risk for developing disease later in life (predictive medicine), identify a patient's likelihood of responding to drug therapy and guide a patient's dosing to ensure optimal treatment (personalized medicine), or assess a patient's risk of disease progression and disease recurrence (prognostic medicine).
As of June 30, 2012, the Company had launched nine commercial molecular diagnostic tests. The Company markets these tests through its own approximate 385-person sales force in the United States. The Company also markets its BRACAnalysis, COLARIS, and COLARIS AP tests through its own European sales force and have entered into marketing collaborations with other organizations in selected Latin American, European and Asian countries. The Company also generates revenue by providing companion diagnostic services to the pharmaceutical, and biotechnology industries and medical research institutions utilizing its multiplexed immunoassay technology.
Molecular Diagnostic Tests
The Company's molecular diagnostic tests are designed to analyze genes, their mutations, expression levels and proteins to assess an individual's risk for developing disease later in life, determine a patient's likelihood of responding to a particular drug, assess a patient's risk of disease progression and disease recurrence and measure a patient's exposure to drug therapy to ensu! re optimal dosing and reduced drug toxicity. The Company's BRACAnalysis test is a analysis of the BRCA1 and BRCA2 genes for assessing a woman's risk of developing hereditary breast and ovarian cancer. BRACAnalysis accounted for 81.7% of the Company's total revenue during the fiscal year ended June 30, 2012. Its The Company's COLARIS test is an analysis of the MLH1, MSH2, MSH6 and PMS2 genes for assessing a person's risk of developing colorectal cancer or uterine cancer.
The Company's COLARIS AP test detects mutations in the APC and MYH genes, which cause a colon polyp-forming syndrome known as Familial Adenomatous Polyposis (FAP), a more common variation of the syndrome known as attenuated FAP, and the MYH-associated polyposis signature (MAP). The Company's MELARIS test analyzes mutations in the p16 gene to determine genetic susceptibility to malignant melanoma. The Company's OnDose test is a nanoparticle immunoassay that is designed to assist oncologists in optimizing 5-FU (fluorouracil) anti-cancer drug therapy in colon cancer patients on an individualized basis. The Company's PANEXIA test is a comprehensive analysis of the PALB2 and BRCA2 genes for assessing a person's risk of developing pancreatic cancer later in life. The Company's PREZEON test is an immunohistochemistry test that analyzes the PTEN gene and assesses loss of PTEN function in many cancer types.
The Company's Prolaris test is a 46-gene molecular diagnostic assay that assesses whether a patient is likely to have a slow growing, indolent form of prostate cancer that can be safely monitored through active surveillance, or a more aggressive form of the disease that would warrant aggressive intervention, such as a radical prostatectomy or radiation therapy. The Company's TheraGuide 5-FU test analyzes mutations in the DPYD gene and variations in the TYMS gene to assess patient risk of toxicity to 5-FU (fluorouracil) anti-cancer drug therapy.
Companion Diagnostic Services and Other Revenue
! Through M! yriad RBM Inc., the Company provides biomarker discovery and companion diagnostic services to the pharmaceutical, biotechnology, and medical researches industries utilizing its multiplexed immunoassay technology. The Company's technology enables the Company to screen large sets of clinical samples from both diseased and non-diseased populations against the Company's menu of biomarkers. The Company's companion diagnostic services consist of Multi-Analyte Profile (MAP), Multiplexed Immunoassay Kits and TruCulture.
The Company has compiled a library of over 550 individual human and rodent immunoassays for use in its multi-analyte profile (MAP) testing services. The Company has also developed RodentMAP, a panel for use in pre-clinical animal studies and OncologyMAP, which measures cancer-related proteins to assists researchers accelerate the pace of discovery, validation and translation of cancer biomarkers for early detection, patient stratification and therapeutic monitoring. The Company has developed multiplexed immunoassay kits that enable its customers to leverage its technology services with their in-house capabilities. The Company's internally developed multiplexed immunoassay kits include all of the components necessary for a customer to perform a test on their own Luminex instrument. TruCulture is a simple, self-contained whole blood culture that can be deployed to clinical sites around the world for acquiring cell culture data without specialized facilities or training.
Advisors' Opinion:- [By Dan Radovsky]
Myriad Genetics (NASDAQ: MYGN ) , almost one month after a landmark ruling in the U.S. Supreme Court both undermined and supported the company's claim of patents for the BRCA1 and BRCA2 genes, has filed suit against a company it says has infringed on those patents.
Top Medical Stocks To Buy Right Now: Compugen Ltd.(CGEN)
Compugen Ltd. operates as a drug and diagnostic discovery company based on computer-based discovery capabilities to predict and select novel product candidates. Through in silico prediction and selection, the resulting novel molecules are synthesized and validated utilizing traditional in vitro and in vivo experimental procedures. The company provides these validated product candidates to pharmaceutical, biotech, and diagnostic companies under licensing and other commercialization arrangements. Its research and discovery efforts are focused primarily on therapeutic proteins and peptides, and monoclonal antibodies, and primarily in the fields of immunology and oncology. Its therapeutic peptide and protein related platforms include Protein Family Members Discovery Platform, Protein-Protein Interaction Blockers, GPCR Therapeutic Peptide Ligands, Disease-Associated Conformation Blockers, Intracellular Drug Delivery, Viral Peptides, and Splice Variant based Therapeutic Proteins . The company?s monoclonal antibody related platforms comprise Monoclonal Antibody Targets. Its other therapeutic and diagnostic platforms consist of Nucleic-Acid Disease Markers, Protein Disease Markers, Nucleic-Acid Preclinical Toxicity Markers, Non-SNP Drug Response Markers, and New Indications. Its therapeutic peptide and protein product candidates comprise CGEN-15001, a novel protein for the treatment of autoimmune disorders; CGEN-25017, a novel peptide antagonist of the Angiopoietin/Tie-2 pathway; CGEN-855, a peptide agonist of the FPRL1 GPCR receptor; CGEN-856 and CGEN-857, which are MAS GPCR peptide agonists; CGEN-25007, an antagonist of the gp96 protein; and CGEN-25009, a peptide of the LGR7 receptor. The company also offers monoclonal antibody target product candidates, including CGEN-671, a drug for multiple epithelial tumors; CGEN-928, a drug for multiple myeloma; and CGEN-15001T, a novel B7/CD28 family member. Compugen Ltd. was founded in 1993 and is based in Te l Aviv, Israel.
Advisors' Opinion:- [By Lisa Levin]
Compugen (NASDAQ: CGEN) climbed 3.54% to $11.86 after Jefferies initiated coverage on the stock with a Buy rating and a $17.00 price target.
Posted-In: market moversNews Intraday Update Markets Movers
- [By Sean Williams]
On Monday, small-cap biotechnology company Compugen (NASDAQ: CGEN ) gave investors something to cheer about when it announced a collaboration and licensing agreement with Bayer for two of its antibody-based immunotherapies. The deal could be worth as much as $540 million for Compugen and gives the company $10 million upfront, as well as the potential for $30 million more in milestone payments during preclinical trials. The two companies will co-develop these drugs, with Bayer getting worldwide rights upon commercialization (though Compugen would still receive a mid- to high-single-digit royalty). This is great news for Compugen, as it solves the problem of seeking out a partner later, helps reduce its clinical testing costs, and staves off the need to dilute shareholders with a secondary offering to raise cash. Shares added 44% this week.
Top Medical Stocks To Buy Right Now: Sucampo Pharmaceuticals Inc (SCMP)
Sucampo Pharmaceuticals, Inc., incorporated on December 9, 2008, is a global biopharmaceutical company focused on research, discovery, development and commercialization of drugs based on ion channel activators known as prostones. The Company�� prostone-based compounds target the ClC-2 and big potassium (BK), ion channels. It is focused on developing prostones to treat gastrointestinal, ophthalmic, neurologic, and oncology-based inflammatory disorders, and is also considering other therapeutic applications of its drug technology. The Company�� products include AMITIZA (lubiprostone) and RESCULA (unoprostone isopropyl).
AMITIZA
The Company�� AMITIZA is being marketed in the United States for three gastrointestinal indications under a license agreement, or the Takeda Agreement, with Takeda Pharmaceutical Company Limited, or Takeda. The three gastrointestinal indications include chronic idiopathic constipation (CIC), in adults, irritable bowel syndrome with constipation (IBS-C), in adult women, and opioid-induced constipation (OIC), in adult patients with chronic, non-cancer pain. AMITIZA for OIC received approval from the United States Food and Drug Administration (FDA), in April 2013. In Japan, AMITIZA is marketed under a license, commercialization and supply agreement, or the Abbott Agreement, with Abbott Japan Co. Ltd. (Abbott), for the gastrointestinal indication of chronic constipation (CC), excluding constipation caused by organic diseases. In Switzerland, the Company is marketing AMITIZA.
RESCULA
The Company holds license agreements for RESCULA in the United States and Canada and the rest of the world, with the exception of Japan, Korea, Taiwan and the People�� Republic of China. The Company is commercializing RESCULA (unoprostone isopropyl ophthalmic solution) 0.15% for the lowering of intraocular pressure (IOP), in patients with open-angle glaucoma or ocular hypertension in the United States. RESCULA may be used as an agent or concomit! antly with other topical ophthalmic drug products to lower intraocular pressure. RESCULA is a BK channel activator and has a different mechanism of action than other IOP lowering agents on the market.
Advisors' Opinion:- [By Roberto Pedone]
Another under-$10 stock that's starting to trend within range of triggering a major breakout trade is Sucampo Pharmaceuticals (SCMP), which is engaged in the discovery, development and commercialization of proprietary drugs based on prostones, and other novel drug technologies. This stock is off to a decent start in 2013, with shares up by 26%.
If you take a look at the chart for Sucampo Pharmaceuticals, you'll notice that this stock has been downtrending badly for the last four months, with shares dumping hard from its high of $10.48 to its recent low of $5.40 a share. During that downtrend, shares of SCMP have been consistently making lower highs and lower lows, which is bearish technical price action. That said, the downside volatility for SCMP looks to be over in the short-term since the stock has started to reverse its downtrend and enter an uptrend. That reverse is quickly pushing shares of SCMP within range of triggering a major breakout trade above a key downtrend line.
Traders should now look for long-biased trades in SCMP if it manages to break out above some near-term overhead resistance levels at $6.33 to $6.66 a share with high volume. Look for a sustained move or close above those levels with volume that hits near or above its three-month average action of 115,383 shares. If that breakout triggers soon, then SCMP will set up to re-test or possibly take out its next major overhead resistance levels at $7.09 to $7.67 a share. Any high-volume move above those levels will then give SCMP a chance to tag $8 to $9 a share.
Traders can look to buy SCMP off weakness to anticipate that breakout and simply use a stop that sits right below some key near-term support levels at $5.58 to $5.40 a share. One can also buy SCMP off strength once it clears those breakout levels with volume and then simply use a stop that sits a comfortable percentage from your entry point.
- [By James Brumley]
Still, for the nimble who know when to get out, OREX is one of the few cheap stocks worth a closer look.
Sucampo Pharmaceuticals (SCMP)Finally, though the price of $7.60 clearly qualifies it as one pf the cheapest of the cheap stocks out there in the pharmaceutical world, that’s not the reason Sucampo Pharmaceuticals (SCMP) may be worth a look here. It’s the 30% slide we’ve seen SCMP stock suffer since peaking in mid-January. It’s not a pullback that’s bound to go unchallenged by the bulls.
Top Medical Stocks To Buy Right Now: Atossa Genetics Inc (ATOS)
Atossa Genetics Inc., incorporated on April 30, 2009, is a development-stage healthcare company focused on the prevention of breast cancer through the commercialization of diagnostic tests that can detect precursors to breast cancer, and through the research, development, and ultimate commercialization of treatments for pre-cancerous lesions. The Company�� diagnostic tests consist of medical devices cleared by the Food and Drug Administration (FDA), which can collect fluid samples from the breast milk ducts, where over 95% of breast cancers arise. During the fiscal year ended September 30, 2012, the tests that the Company offered and that are in development consist of ForeCYTE, ArgusCYTE, FullCYTE and NextCYTE. In September 2012, the Company acquired all of the assets of Acueity.
The ForeCYTE Breast Health Test provides personalized information about the 10-year and lifetime risk of breast cancer for women between ages 18 and 73. The ArgusCYTE Breast Health Test provides information to help inform breast cancer treatment options and to help monitor potential recurrence. The FullCYTE Breast Health Test is designed to assess the individual breast ducts for pre-cancerous changes in women previously identified to be at high risk for breast cancer. The NextCYTE Breast Cancer Test is designed to profile breast cancer specimens for prediction of treatment outcomes and distant recurrence in women newly diagnosed with breast cancer. MASCT, Oxy-MASCT, and its name and logo are the trademarks. ForeCYTE, FullCYTE, NextCYTE, and ArgusCYTE are its service marks.
Advisors' Opinion:- [By James E. Brumley]
I have little doubt that what I'm about to say could inflame some fans and followers of Atossa Genetics Inc. (NASDAQ:ATOS). But, I wouldn't be doing my job if I didn't call 'em like I see 'em. So, here goes. ATOS is on the verge of a substantial meltdown. It's possible the stock could circumvent this pullback, but the odds don't favor it.
- [By John Kell]
Atossa Genetics Inc.(ATOS) is planning to offer shares and warrants to raise proceeds for general corporate purposes including the development of the company’s breast health testing products. Shares slumped 20% to $2.56 premarket.
- [By Virginia Harrison]
The other big Olympic sponsors are Visa (V, Fortune 500), Samsung (SSNLF), Panasonic (PCRFF), General Electric (GE, Fortune 500), Dow Chemical (DOW, Fortune 500), Procter & Gamble (PG, Fortune 500), Omega (OCFN) and Atos (ATOS). They're staying tight-lipped about the issue in public but a senior official at the International Olympic Committee said this month that several had raised concerns about how the law could affect the Games.
- [By Rebecca McClay]
Atossa Genetics Inc. (Nasdaq: ATOS) shares are up about 6% in midday trading due to a cancer breakthrough it plans to showcase this weekend...
Atossa will exhibit its ForeCYTE Breast Health Test at the 2013 Breast Cancer Symposium in San Francisco, CA, which starts Saturday.
Top Medical Stocks To Buy Right Now: Vocera Communications Inc (VCRA)
Vocera Communications, Inc. (Vocera), incorporated on February 16, 2000, is a provider of mobile communication solutions. The Company�� solutions consist of its Voice Communication, Messaging and Care Transition solutions. Its Voice Communication solution, which includes a communication badge and a software platform, enables users to connect with other hospital staff. The Company�� Messaging solution delivers text messages and alerts directly to and from smartphones. Its Care Transition solution is a voice and text-based software application that captures, manages and monitors patient information when responsibility for the patient is transferred or handed-off from one caregiver to another, or when the patient is discharged from the hospital. Users can communicate with others using the Vocera communication badge or through Vocera Connect client applications available for BlackBerry, iPhone and Android smartphones, as well as Cisco wireless Internet protocol (IP) phones and other mobile devices. In January 2014, Vocera Communications Inc announced the acquisition of mVisum.
Communication solution can also be integrated with nurse call and other clinical systems to alert hospital workers to patient needs. The Company�� solutions are deployed in over 800 hospitals and healthcare facilities, including hospital systems, hospitals, and clinics, surgery centers and aged-care facilities. During the year ended December 31, 2011, the Company had shipped over 400,000 communication badges to its customers. The Company outsources the manufacturing of its products. Vocera offers a range of services, including clinical workflow design, wireless assessment, solution configuration, training and project management. It also provides a classroom-based curriculum for systems administrators, information technology professionals and clinical educators. The Company provides around-the-clock technical support to its customers through its support centers in San Jose, California, and Reading, United Kingdom.!
Voice Communication solution
The Company�� Voice Communication solution consists of a software platform that connects communication devices, including its hands-free, wearable, voice-controlled communication badges, Vocera-branded smartphones and third-party mobile devices that use its software applications to become part of the Vocera system. The system transforms the way mobile workers communicate by enabling them to connect with the right person simply by the name, function or group name of the person they want to reach, often while remaining at the point-of-care. Its system responds to over 100 voice commands.
Vocera�� Voice Communication solution is a software platform that runs on its customers��Windows-based servers. In addition, it controls the calling and messaging functions of the mobile client devices and maintains profiles for users and groups that enable customization of workflow patterns for each customer. The Company�� communication badge is a wearable device that operates over customers��wireless fidelity (Wi-Fi) networks. The badge is worn clipped to a shirt or on a lanyard. It can be used to conduct hands-free communication. It enables two-way voice conversations without the need to remember a phone number or use a handset. Its badge also incorporates automatic diagnostic mechanisms that feed data on wireless network performance back to the software platform for reporting and diagnosis of problems. In October 2011, it introduced the Vocera B3000 badge. In 2012, the Company added Cisco wireless IP phones to the list of mobile devices it supports.
Messaging solution
The Company�� Messaging solution delivers text messages, alerts and other information, directly to and from smartphones. Its solution consists of a software platform and client applications that run on BlackBerry, iPhone or Android devices. Its Messaging solution includes a range of client applications, including Alert, Chat and Commander.
Care! Transition Solution
The Company�� platform, which includes modules for patient transfers, shift changes, physician sign-outs and patient and family information exchanges, allows hospitals to standardize and monitor patient hand-offs. Its Care Transition solution can be deployed through either a hosted software-as-a-service model or as a server-on-site model and has been deployed by over 120 hospitals.
The Company competes with Cisco Systems, Ascom and Polycom.
Advisors' Opinion:- [By gurujx]
Vocera Communications Inc (VCRA) Reached the 3-year Low of $12.33
The prices of Vocera Communications Inc (VCRA) shares have declined to close to the 3-year low of $12.33, which is 64.4% off the 3-year high of $32.97.
- [By Evan Niu, CFA]
What: Shares of Vocera Communications (NYSE: VCRA ) have gotten slaughtered by 38% today after the company reported earnings.
So what: Revenue in the first quarter came in at $22.4 million, which translated into a non-GAAP net loss of $0.07 per share. Both figures were significantly worse than the $24.3 million in revenue and $0.02 per share adjusted loss that the Street was expecting. CEO Bob Zollars conceded that management was disappointed with the results.
- [By Victor Selva]
On Dec.24, Mario Gabelli, the Chairman and Chief Executive Officer of GAMCO Investors, Inc. added Communications Systems Inc. (JCS) at an average price of $11.05 and currently holds 330,172 shares of the stock. It was the 5th time he added the stock during this year, which makes me feel that he is betting in favor of a positive future for the consumption of network capacity.
Recommendations of the Board
Communications Systems is engaged in the manufacture and sale of modular connecting and wiring devices for voice and data communications, digital subscriber line filters, and structured wiring systems, and through its Transition Networks business unit in the manufacture of media and rate conversion products for telecommunications networks.
Few months ago the firm announced�a series of actions to increase revenues and improve profitability. The first change was to operate as a holding company, monitoring and supporting all the business units: Suttle, Transition Networks (TN) unit and JDL Technologies. With this ��ew format�� each unit will operate with a high degree of autonomy. This will result in the reduction of labor costs, the emphasizing of accountability in the units as well as better recognition of performance. "While difficult decisions for the Board, we believe the changes we have taken to restructure our parent company as a holding company and to focus on individual business unit performance is in the best interest of our shareholders and will increase shareholder value" said Curtis A. Sampson, the Company's Board Chair and Interim CEO. Furthermore, strategic investments in the TN unit such as marketing, sales and product development will boost revenues in the future.
Severe Warning Signs
Not all are good news, we found three severe warning signs issued by GuruFocus: Piotroski F-Score of 2 is low, which usually implies poor business operation; revenue has been in decline over the past 3 years and operating margin has been in 5-year
Top Medical Stocks To Buy Right Now: Hemispherx Biopharma Inc (HEB)
Hemispherx Biopharma, Inc. (Hemispherx) is a specialty pharmaceutical company engaged in the clinical development of new drugs therapies based on natural immune system enhancing technologies for the treatment of viral and immune based chronic disorders. Hemispherx focuses on two core pharmaceutical technology platforms Ampligen and Alferon N Injection.The commercial focus for Ampligen includes application as a treatment for Chronic Fatigue Syndrome (CFS) and as an influenza vaccine enhancer (adjuvant) for both therapeutic and preventative vaccine development. Alferon N Injection is a United States Food and Drug Administration (FDA) approved product with an indication for refractory or recurring genital warts. Alferon LDO (Low Dose Oral) is a formulation under development targeting influenza. It has three subsidiaries BioPro Corp., BioAegean Corp., and Core BioTech Corp. The Company's foreign subsidiary is Hemispherx Biopharma Europe N.V./S.A.
Ampligen
Ampligen is an experimental drug, which is undergoing clinical development for the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Over 1,000 patients have participated in the Ampligen clinical trials representing the administration of more than 90,000 doses of this drug. The Company is also engaged in ongoing, experimental studies assessing the efficacy of Ampligen against influenza viruses.
Alferon N Injection
Alferon N Injection is the registered trademark for the Company's injectable formulation of natural alpha interferon. Interferons are a group of proteins produced and secreted by cells to combat diseases. The Company's natural alpha interferon is produced from human white blood cells. Alferon N Injection [Interferon alfa-n3 (human leukocyte derived)] is a highly purified, natural-source, glycosylated, multi-species alpha interferon product.
Alferon LDO (Low Dose Oral)
Alferon LDO [Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived)]! is an experimental low-dose, oral liquid formulation of Natural Alpha Interferon and like Alferon N Injection should not cause antibody formation, which is a problem with recombinant interferon. It is an experimental immunotherapeutic that works by stimulating an immune cascade response in the cells of the mouth and throat, enabling it to bolster systemic immune response through the entire body by absorption through the oral mucosa.
The Company competes with Pfizer, GlaxoSmithKline, Merck, AstraZeneca, Baxter International, Fletcher/CSI, AVANT Immunotherapeutics, AVI BioPharma and Genta.
Advisors' Opinion:- [By MONEYMORNING]
Hemispherix Biopharma Inc. (NYSE: HEB) is a specialty pharmaceutical company. It engages in the clinical development of new drug therapies based on natural immune system enhancing technologies and targets the treatment of viral and immune-based clinical disorders. The Philadelphia, Pa.-headquartered company gained widespread attention over the last several months for its work on flu research. Its flagship products include Alferon N Injection, approved by the FDA for a category of sexually transmitted disease infection. Experimental treatments include Ampligen and Oragens, in development stages for the potential treatment of global viral diseases and disorders of the immune system including human papilloma virus, human immunodeficiency virus, chronic fatigue syndrome, hepatitis, and influenza. Shares have traded as low as $0.18 and as high as $0.55 over the last year. At last check, shares were changing hands around $0.50 on volume of 2 million shares.
Top Medical Stocks To Buy Right Now: StemCells Inc (STEM)
StemCells, Inc. (StemCells), incorporated in August 1988, is engaged in the research, development, and commercialization of stem cell therapeutics and related tools and technologies for academia and industry. The Company is focused on developing and commercializing stem and progenitor cells as the basis for therapeutics and therapies, and cells and related tools and technologies to enable stem cell-based research and drug discovery and development. The Company�� primary research and development efforts are focused on identifying and developing stem and progenitor cells as potential therapeutic agents. The Company has two therapeutic product development programs, including its CNS Program, which is developing applications for HuCNS-SC cells, its human neural stem cell product candidate, and its Liver Program, which is characterizing the Company�� human liver cells as a therapeutic product.
CNS Program
The Company in its CNS Program, is in clinical development with its HuCNS-SC cells for a range of disorders of the central nervous system. The CNS includes the brain, spinal cord and eye. In February 2012, the Company had completed a Phase I clinical trial in Pelizeaus-Merzbacher Disease (PMD), a fatal myelination disorder in the brain.
The Company�� CNS Program is focused on developing clinical applications, in which transplanting HuCNS-SC cells protect or restore organ function of the patient before such function is irreversibly damaged or lost due to disease progression. The Company�� initial target indications are PMD, and more generally, diseases in which deficient myelination plays a central role, such as cerebral palsy or multiple sclerosis; spinal cord injury, disorders in which retinal degeneration plays a central role, such as age-related macular degeneration or retinitis pigmentosa. The Company�� product candidate, HuCNS-SC cells, is a purified and expanded composition of normal human neural stem cells. Its HuCNS-SC cells can be directly transp! lanted.
Liver Program
Liver stem or progenitor cells offer an alternative treatment for liver diseases. A liver cellular therapy or cell-based therapeutic provide or support liver function in patients with liver disease. The Company held a portfolio of issued and allowed patents in the liver field, which cover the isolation and use of both hLEC cells and the isolated subset, as well as the composition of the cells themselves.
The Company�� range of cell culture products, which are sold under the SC Proven brand, includes iSTEM, GS1-R, GS2-M, RHB-A, RHB-Basal, NDiff N2, and NDiff N2B27. Its iSTEM is a serum-free, feeder-free medium that maintains mouse embryonic stem cells in their pluripotent ground state by using selective small molecule inhibitors to block the pathways, which induce differentiation. RHB-A is a defined, serum-free culture medium for the selective culture of human and mouse neural stem cells and their maintenance and expansion as adherent cell populations. RHB-Basal is a defined, serum-free basal medium. When supplemented with specific growth factors, this media is formulated for the propagation and differentiation of adherent neural stem cells. RHB-Basal can also be tailored to specific-cell type requirements by the addition of customer preferred supplements.
The Company�� NDiff N2 is a defined serum-free scell culture supplement for the derivation, maintenance, expansion and/or differentiation of human and mouse embryonic stem (ES) cells and tissue-derived neural stem cells supplement. Its NDiff N2-AF is a serum-free and animal component-free version of NDiff N2. Its NDiff N2B27 is a defined, serum-free medium for the differentiation of mouse embryonic stem cells to neural cell types. NDiff N27-AF is a serum-free and animal component-free version of NDiff N27. Its GS1-R is a serum-free media formulation shown to enable the derivation and long-term maintenance of true, germline competent rat embryonic stem cells without the add! ition of ! cytokines or growth factors. Its GS2-M is a defined, serum- and feeder-free medium for the derivation and long-term maintenance of true, germline competent mouse iPS cells.
The Company also markets a number of antibody reagents for use in cell detection, isolation and characterization. These reagents are also under the SC Proven brand and it includes STEM24, STEM101, STEM121 and STEM123. Its STEM24 is a human antibody that recognizes human CD24, also known as heat stable antigen (HSA), a glycoprotein expressed on the surface of many human cell types, including immature human hematopoietic cells, peripheral blood lymphocytes, erythrocytes and many human carcinomas. Its CD24 is also a marker of human neural differentiation. Its STEM101 is a human-specific mouse antibody that recognizes the Ku80 protein found in human nuclei. Its STEM121 is a human-specific mouse antibody that recognizes a cytoplasmic protein of human cells. Its STEM123 is a human-specific mouse antibody that recognizes human glial fibrillary acidic protein (GFAP).
The Company�� Other products marketed under SC Proven include total cell genomic DNA (gDNA), RNA and protein lysate reagents purified from homogenous stem cell populations for intra-comparative studies, such as Epigenetic fingerprinting, Southern, Western and Northern blots, PCR, RT-PCR and microarrays. This range of purified stem cell line lysates includes mouse embryonic stem (ES) cells propagated in SC Proven 2i inhibitor-based GS2-M media and mouse ES cell-derived and fetal tissue-derived neural stem (NS) cells propagated in SC Proven RHB-A media.
Advisors' Opinion:- [By James E. Brumley]
When an investor thinks of spinal-related stem cell stocks, usually a name like Neuralstem, Inc (NYSEMKT: CUR) or StemCells Inc (NASDAQ: STEM) comes to mind. And well they should. STEM has logged some amazing breakthroughs in the field of spinal cord repair, while CUR has done the same. Not all back problems are spinal cord related though. In fact, most back problems - and therefore the most opportunity - are bone and disc related problems. That's where a young gun like BioRestorative Therapies (OTCBB: BRTX) can step in and make stem cell waves. BRTX has developed an approach to rejuvenate and revive failing spinal discs, potentially ending pain for millions of back-pain sufferers, and circumventing expensive spinal surgeries that are in increasing burden on insurance companies.
- [By Garrett Cook]
Healthcare shares gained 0.81 percent in the US market on Friday. Top gainers in the sector included Shire plc (NASDAQ: SHPG), StemCells (NASDAQ: STEM), and Flamel Technologies SA (NASDAQ: FLML).
- [By Garrett Cook]
Healthcare shares gained 0.81 percent in the US market on Friday. Top gainers in the sector included Shire plc (NASDAQ: SHPG), StemCells (NASDAQ: STEM), and Flamel Technologies SA (NASDAQ: FLML).
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