Fresenius Medical Care AG (FME) fell the most in more than four years in Frankfurt after the U.S. government proposed cutting payments to kidney dialysis center operators by 9.4 percent next year.
The shares dropped as much as 10 percent, the biggest intraday decline since October 2008. The stock was down 9.7 percent at 49.18 euros as of 9:11 a.m.
Much of the $1 billion reduction in payments is the result of a federal budget-balancing agreement. That deal targeted overspending on anemia drugs such as Amgen Inc. (AMGN)�� Epogen and Aranesp for patients in Medicare, the U.S. health plan for the elderly and disabled.
The U.S. government will consider phasing in the reduction over more than one year, the Health and Human Services Department said yesterday in a regulatory filing, citing concerns it may ��mpact beneficiary access to care.��The proposal is subject to public comment and may change before taking effect.
��his is a very dramatic cut,��Robert Sepucha, Bad Homburg, Germany-based Fresenius�� senior vice president for government affairs in the U.S., said by telephone. ��e��e concerned it would push dialysis clinics under the cost of care, which is not the right thing for Medicare to be doing.��
5 Best Railroad Stocks To Invest In 2016: Cell Therapeutics Inc (CTIC)
Cell Therapeutics, Inc. (CTI), incorporated in 1991, develops, acquires and commercializes treatments for cancer. The Company�� research, development, acquisition and in-licensing activities concentrate on identifying and developing new ways to treat cancer. As of December 31, 2011, CTI focused its efforts on Pixuvri (pixantrone dimaleate) (Pixuvri), OPAXIO (paclitaxel poliglumex) (OPAXIO), tosedostat, brostallicin and bisplatinates. As of December 31, 2011, it developed Pixuvri, an anthracycline derivative for the treatment of hematologic malignancies and solid tumors. Another late-stage drug candidate of the Company, OPAXIO, is being studied as a potential maintenance therapy for women with advanced stage ovarian cancer, who achieve a complete remission following first-line therapy with paclitaxel and carboplatin. As of December 31, 2011, it also developed tosedostat in collaboration with Chroma Therapeutics, Ltd. (Chroma). On May 31, 2012, CTI completed its acquisition gaining worldwide rights to S*BIO Pte Ltd.'s (S*BIO) pacritinib.
Pixuvri
As of December 31, 2011, the Company developed Pixuvri, an aza-anthracenedione derivative, for the treatment of non-Hodgkin�� lymphoma (NHL), and various other hematologic malignancies, and solid tumors. Pixuvri was studied in the Company�� EXTEND, or PIX301, clinical trial, which was a phase III single-agent trial of Pixuvri for patients with relapsed, refractory aggressive NHL who received two or more prior therapies and who were sensitive to treatment with anthracyclines. On September 28, 2011, CTI announced that a second independent radiology assessment of response and progression endpoint data from its PIX301 clinical trial of Pixuvri was achieved with statistical significance. The results of the EXTEND trial met its primary endpoint and showed that patients randomized to treatment with Pixuvri achieved a significantly higher rate of confirmed and unconfirmed complete response compared to patients treated with standard chem! otherapy had a significantly increased overall response rate and experienced a statistically significant improvement in median progression free survival. Pixuvri had predictable and manageable toxicities when administered at the proposed dose and schedule in the EXTEND clinical trial in heavily pre-treated patients. In March 2011, the Company initiated the PIX-R trial to study Pixuvri in combination with rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Pixuvri has also been studied in patients with HER2-negative metastatic breast cancer who have tumor progression after at least two, but not more than three, prior chemotherapy regimens. In the second quarter of 2010, the NCCTG opened this phase II study for enrollment. The study is closed to accrual and results are expected to be reported by the NCCTG later in 2012.
OPAXIO
OPAXIO is the Company�� biologically-enhanced chemotherapeutic agent that links paclitaxel to a biodegradable polyglutamate polymer, resulting in a new chemical entity. As of December 31, 2011, the Company focused its development of OPAXIO on ovarian, brain, esophageal, head and neck cancer. OPAXIO was designed to improve the delivery of paclitaxel to tumor tissue while protecting normal tissue from toxic side effects. In November 2010, results were presented by the Brown University Oncology Group from a phase II trial of OPAXIO combined with temozolomide (TMZ), and radiotherapy in patients with newly-diagnosed, high-grade gliomas, a type of brain cancer. The trial demonstrated a high rate of complete and partial responses and a high rate of six month progression free survival (PFS). Based on these results, the Brown University Oncology Group has initiated a randomized, multicenter, phase II study of OPAXIO and standard radiotherapy versus TMZ and radiotherapy for newly diagnosed patients with glioblastoma with an active gene termed MGMT that reduces responsiveness to TMZ. A phase I/II study of OPAXIO combined with radi! otherapy ! and cisplatin was initiated by SUNY Upstate Medical University, in patients with locally advanced head and neck cancer.
Tosedostat
In March 2011, the Company entered into a co-development and license agreement with Chroma Therapeutics, Ltd. (Chroma), providing the Company with marketing and co-development rights to Chroma�� drug candidate, tosedostat, in North, Central and South America. Tosedostat is an oral, aminopeptidase inhibitor that has demonstrated anti-tumor responses in blood related cancers and solid tumors in phase I-II clinical trials. Interim results from the phase II OPAL study of tosedostat in elderly patients with relapsed or refractory acute myeloid leukemia (AML) showed that once-daily, oral doses of tosedostat had predictable and manageable toxicities and results demonstrated response rates, including a high-response rate among patients who received prior hypomethylating agents, which are used to treat myelodysplastic syndrome (MDS), a precursor of AML.
Brostallicin
As of December 31, 2011, the Company developed brostallicin through its wholly owned subsidiary, Systems Medicine LLC, which holds rights to use, develop, import and export brostallicin. Brostallicin is a synthetic deoxyribonucleic acid (DNA) minor groove binding agent that has demonstrated anti-tumor activity and a favorable safety profile in clinical trials, in which more than 230 patients have been treated as of December 31, 2011. The Company uses a genomic-based platform to guide the development of brostallicin. A phase II study of brostallicin in relapsed, refractory soft tissue sarcoma met its predefined activity and safety hurdles and resulted in a first-line phase II clinical trial study that was conducted by the European Organization for Research and Treatment of Cancer (EORTC).
The Company competes with Bristol-Myers Squibb Company, Sanofi-Aventis, Pfizer, Roche Group, Genentech, Inc., Astellas Pharma, Eli Lilly and Company, Celgene, Telik, I! nc., TEVA! Pharmaceuticals Industries Ltd. and PharmaMar.
Advisors' Opinion:- [By John Udovich]
The start of 2014 shows that biotech is still a hot area with the sector along with small cap biotech stocks like AMAG Pharmaceuticals, Inc (NASDAQ: AMAG), Mast Therapeutics Inc (NYSEMKT: MSTX), Cell Therapeutics Inc (NASDAQ: CTIC), Imprimis Pharmaceuticals Inc (NASDAQ: IMMY) and TNI BioTech (OTCMKTS: TNIB) producing news or returns�plus Auspex Pharmaceuticals (NASDAQ: ASPX), Cara Therapeutics (NASDAQ: CARA), Egalet (NASDAQ: EGLT), Flexion Therapeutics (NASDAQ: FLXN) and Ultragenyx Pharmaceutical (NASDAQ: RARE) are among the (many�� planned biotech IPOs that have recently been announced publicly:
- [By MONEYMORNING]
Cell Therapeutics Inc. (Nasdaq: CTIC), based in Seattle, Wash., acquires, develops, and commercializes treatments for cancers, including non-Hodgkin's leukemia and ovarian, neck, and brain cancers. The company just announced it has completed patient enrollment in clinical trials for an investigational agent to be used as a maintenance therapy in ovarian cancer patients. The trial is being conducted by the Gynecologic Oncology Group, one of the National Cancer Institute's funded research groups. Roth Capital recently reiterated a "Buy" rating on the stock and raised its price target from $6 to $7. Roth believes the company's treatment for leukemia, Pacritinib, is effectively evolving. Additionally, the investment firm sees potential in CTIC's Tosedostat, which deprives tumor cells of the amino acid building blocks needed to make proteins necessary for tumor cell survival. Shares rose 2% Tuesday to $3.52 on volume of 6 million shares.
- [By Bryan Murphy]
If you're reading this, then odds are you already know that the last two weeks (not even a full two weeks) have been more fruitful for Cell Therapeutics Inc. (NASDAQ:CTIC) shareholders than the prior two years have been - the stock's up 28% since last Thursday. And, odds are you already know why. The question most of you are asking now is, can CTIC actually keep climbing at this pace, or even keep climbing at any pace? The answer is "yes", though floating that answer almost inherently requires a deeper explanation.
- [By Sean Williams]
Cell Therapeutics (NASDAQ: CTIC )
Certainly no discussion of companies with large accumulated deficits would be complete without discussing a biotechnology company. It's perfectly understandable to see a biotech, especially a clinical-stage one, run with an accumulated deficit, as it takes time and money to build up a drug pipeline. However, after multiple complete response letters (the equivalent of a rejection) by the Food and Drug Administration and years without an approved drug, Cell Therapeutics racked up an astounding $1.83 billion in accumulated deficits through the end of fiscal 2012. By comparison, that's nearly 56 times larger than its shareholder equity.�
Top 10 Medical Companies To Watch For 2015: Cambridge Heart Inc (CAMH)
Cambridge Heart, Inc., incorporated on January 16, 1990, is engaged in the research, development and commercialization of products for the non-invasive diagnosis of cardiac disease. The Company's products incorporate its technology for the measurement of Microvolt T-Wave Alternans (MTWA). The MTWA Test is conducted by elevating the patient's heart rate through exercise as performed on a treadmill similar to a stress test, pharmacologic agents, or pacing with electrical pulses.
The Company's products, including its first generation HearTwave System and second generation HearTwave II System, CH 2000 Cardiac Stress Test System, MTWA original equipment manufacturer (OEM) Module (MTWA Module) and Micro-V Alternans Sensors have received 510(k) clearance from the United States Food and Drug Administration (FDA) for sale in the United States. The Company's products have also received the Conformite Europeenne (CE) mark for sale in Europe. The Company's first generation HearTwave System, CH 2000 Cardiac Stress Test System and the HearTwave II System have been approved for sale by the Japanese Ministry of Health Labor and Welfare.
The Company's 510(k) clearance allows the Company's MTWA Test to be used to test patients with known, suspected, or at risk of ventricular tachyarrhythmia and/or sudden cardiac arrest, and allows the claim that its MTWA Test is predictive of those events. The MTWA Module is designed to work with existing cardiac stress test platforms distributed by other manufacturers as an add-on module to enable MTWA testing to be performed using the Company's Micro-V Alternans Sensors.
The Company's HearTwave II System, which has replaced the Company's original HearTwave System, is used to perform both MTWA testing and standard cardiac stress testing. In addition to MTWA measurement, the Company's HearTwave II System is a cardiac diagnostic system designed to support a range of customized protocols for the conduct of cardiac exercise stress testing. The Comp! any's Micro-V Alternans Sensors are single patient use, multi-segment electrodes. The Company's CH2000 is a cardiac diagnostic system designed to support a range of customized protocols for the conduct and measurement of cardiac exercise stress testing.
The Company competes with GE Medical Systems.
Advisors' Opinion:- [By Peter Graham]
Last Friday, small cap stocks Cambridge Heart, Inc (OTCMKTS: CAMH), Abby Inc (OTCMKTS: ABBY) and Grillit Inc (OTCMKTS: GRLT) surged 176.92%, 71.2% and 24.07%, respectively. Of course, that was last week and today is a new trading week. So what should investors and traders alike be prepared for this week with these three small caps? Here is a closer look to help you decide on an investing or trading strategy:
Cambridge Heart, Inc (OTCMKTS: CAMH) Recently Changed Its BoardSmall cap Cambridge Heart, Inc is a healthcare company engaged in the research, development and commercialization of products for the non-invasive diagnosis of cardiac disease. On Friday, Cambridge Heart, Inc surged 176.92% to $0.018 for a market cap of $1.80 million plus CAMH is up 20% since the start of the year and down 86.1% over the past five years according to Google Finance.
Top 10 Medical Companies To Watch For 2015: PTC Therapeutics Inc (PTCT)
PTC Therapeutics, Inc., incorporated on March 31, 1998 , is a biopharmaceutical company focused on the discovery and development of orally administered, small-molecule drugs that target post-transcriptional control processes. The Company�� lead product candidate includes ataluren, which is used for the treatment of patients with genetic disorders that arise from a type of genetic mutation known as a nonsense mutation. Ataluren is in late stage clinical development for the treatment of Duchenne muscular dystrophy caused by nonsense mutations (nmDMD) and cystic fibrosis caused by nonsense mutations (nmCF).
Ataluren is orally administered small-molecule compound that targets nonsense mutations. The Company is engaged in the development of ataluren for the treatment of genetic disorders in, which a nonsense mutation is the cause of the disease. Genetic tests are available for many genetic disorders, including Duchenne muscular dystrophy and cystic fibrosis, to determine if the underlying cause is a nonsense mutation. The EMA has designated ataluren as an orphan medicinal product for the treatment of nmDMD and nmCF. During the year ended December 31, 2012, the Phase III clinical trial completed. The Company�� Ataluren clinical trials in patients with nonsense mutation genetic disorders include Ataluren for nmDMD: Phase 2b clinical trial complete; Confirmatory Phase III clinical trial initiated, and Ataluren for nmCF: Phase III trial completed.
Advisors' Opinion:- [By WWW.DAILYFINANCE.COM] Records fell on Wall Street Friday as another solid report on housing lifted the market for the second day in a row. There's a three-day weekend coming up -- something that often prompts investor caution -- but the gains were broad-based even though volume was fairly light. The VIX, which measures volatility, fell to its lowest level this year. The Dow Jones industrial average (^DJI) gained 63 points, the Nasdaq composite (^IXIC) rose 31, and the Standard & Poor's 500 index (^GPSC) added 8, topping the record high set last week. The Dow Transportation average also raced to an all-time high, lifted by airline stocks. United (UAL) soared more than 4 percent; Delta (DAL) gained more than 1 percent and Southwest (LUV) gained 2 percent. Southwest is at an all-time high, up 79 percent from a year ago. New home sales bounced back with a better than expected 6.4 percent increase last month. Lennar (LEN) and D.R. Horton (DHI) both rose 4 percent. Pulte (PHM), Beazer (BZH) and Hovnanian (HOV) also solid posted gains. Earnings continue to drive retail stocks. Gap (GPS) edged higher even though net fell. Foot Locker (FL) gained 1½ percent after topping expectations. GameStop (GME) rose 4 percent. Its net rose, helped by the rollout last year of new Xbox and PlayStation consoles. Zumiez (ZUMZ) rose 5½ percent on an earnings beat. But Aeropostale (ARO) tumbled 24 percent. Its loss widened and sales declined. The retailer continues to struggle with teen fashion trends. Also on the earnings front, TiVo (TIVO) rose 2 percent as it swung to a profit from a year ago loss. It also reported an increase in the number of subscribers. Hewlett-Packard (HPQ) rose 6 percent on news the company plans to eliminate up to 16,000 additional workers in an effort to cut costs. And several stocks extended big moves from yesterday. Best Buy (BBY) rose more than 3 percent for the second straight day after earnings beat expectations. Isis Pharmaceuticals (ISIS) jumped
- [By John Kell]
PTC Therapeutics Inc.(PTCT) said the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a negative opinion on the biopharmaceutical company’s marketing authorization application for its muscular dystrophy treatment. Shares slumped 21% to $20.60 in premarket trading.
Top 10 Medical Companies To Watch For 2015: 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 Bryan Murphy]
You know, it's fun to be right about a particular stock, but at the same time, it's miserable if you didn't have the guts to actually act on the idea. That's my tale of woe with Atossa Genetics Inc. (NASDAQ:ATOS). On Monday of this week I was singing its praises, explaining how the chart suggested ATOS was on the verge of a breakout. But, I also suggested waiting for shares to take that one final confirming step.... a move above the 100-day moving average line. Now I wish I hadn't been so picky.
- [By Roberto Pedone]
One stock that's starting to push within range of triggering a big breakout trade is Apple (ATOS), which is involved in the prevention of breast cancer through the commercialization of diagnostic medical devices and laboratory developed tests that can detect precursors to breast cancer. This stock is off to a decent start in 2013, with shares up 24%.
If you take a look at the chart for Atossa Genetics, you'll notice that this stock has been starting to uptrend over the last month, with shares moving higher from its low of $4.22 to its recent high of $5.08 a share. During that uptrend, shares of ATOS have been making mostly higher lows and higher highs, which is bullish technical price action. That move has now pushed shares of ATOS within range of triggering a big breakout trade above a key downtrend line that dates back to May.
Traders should now look for long-biased trades in ATOS if it manages to break out above some key overhead resistance levels at $5.08 a share with high volume. Look for a sustained move or close above that level with volume that hits near or above its three-month average volume of 74,575 shares. If that breakout hits soon, then ATOS will set up to re-test or possibly take out its next major overhead resistance levels at $5.60 to $6.23 a share. Any high-volume move above $6.23 will then put $7 to $7.50 into range for shares of ATOS.
Traders can look to buy ATOS off any weakness to anticipate that breakout and simply use a stop that sits right below some key near-term support levels at $4.42 or at $4.22 a share. One could also buy ATOS off strength once it takes out $5.08 a share with volume and then simply use a stop that sits a comfortable percentage from your entry point.
- [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.
Top 10 Medical Companies To Watch For 2015: OncoMed Pharmaceuticals Inc (OMED)
OncoMed Pharmaceuticals, Inc. (OncoMed) incorporated on July 19, 2004, is a clinical development-stage biopharmaceutical company. The Company focuses on discovering and developing monoclonal antibody therapeutics targeting cancer stem cells (CSCs). It utilizes its technologies to identify, isolate and evaluate CSCs; identify and/or validate multiple potential targets and pathways critical to CSC self-renewal and differentiation; and develop targeted antibody and other protein-based therapeutics that are designed to modulate these CSC targets and inhibit the growth of CSCs. The Company's anti-cancer therapeutics include anti-DLL4 (demcizumab, OMP-21M18), Anti-DLL4/Anti-VEGF Bispecific, and Anti-Notch2/3 (OMP-59R5), Anti-Notch1 (OMP-52M51, Anti-Fzd7, Fzd8-Fc, RSPO-LGR.
Anti-DLL4 (demcizumab, OMP-21M18) is a humanized monoclonal antibody that inhibits Delta Like Ligand 4 (DLL4) in the Notch signaling pathway. The Company has completed a single-agent Phase Ia trial in advanced solid tumor patients. The Company focuses on conducting two Phase Ib combination trials of demcizumab. Anti-DLL4/anti-VEGF bispecific is a monoclonal antibody that targets and inhibits both DLL4 and vascular endothelial growth factor ( VEGF). VEGF is the target of Avastin. Anti-Notch2/3 (OMP-59R5) is a human monoclonal antibody that targets the Notch2 and Notch3 receptors.
Anti-Notch1 OMP-52M51 is a humanized monoclonal antibody targeted to the Notch1 receptor. Anti-Fzd7 OMP-18R5 is a human monoclonal antibody identified by screening against the Frizzled7 receptor (Fzd7) that binds a conserved epitope on five Frizzled receptors and inhibits Wnt signaling. OMP-18R5 is in a Phase I single-agent trial in advanced solid tumor patients. Fzd8-Fc OMP-54F28 is a fusion protein based on a truncated form of the Frizzled8 receptor ( Fzd8). RSPO-LGR ligands signal through the LGR receptor family.
The Company utilizes several robust technologies for the discovery and optimization of its antibody and protein-bas! ed therapeutics, including multiple proprietary technologies. Its antibody technologies include Mammalian Display Technology, Bispecific Antibody Technology, Hybridoma Technology. Mammalian Display Technology utilizes flow cytometry to isolate mammalian cells expressing antibodies on the cell surface with desired characteristics from large libraries of candidate antibodies. Bispecific Antibody Technology is used to generate its anti-DLL4/anti-VEGF antibody. Hybridoma Technology is used for isolating antibodies from mice, including multiplex single-cell screening techniques.
Advisors' Opinion:- [By WWW.DAILYFINANCE.COM] Stocks ended a mini-losing streak on Friday, led by upbeat news from Intel (INTC). The Dow Jones industrial average (^DJI) rose 41 points, after sliding more than 200 over the previous two days. The Nasdaq composite (^IXIC) gained 13 and the Standard & Poor's 500 index (^GPSC) added 6 points. Those modest gains did little to trim the loss for the week. The major averages posted their biggest weekly declines in more than two months. Intel is a component of all three big indexes, and it jumped 7 percent after raising its revenue guidance for the current quarter. The company sees stronger business demand for PCs than it previously expected. Intel shares are up 23 percent over the past six months. The Intel news had a ripple effect. Computer maker Hewlett-Packard (HPQ) rose more than 5 percent and Microsoft (MSFT) gained 1½ percent. Part of the increased demand Intel points to is tied to corporate buyers who need to replace their Windows XP machines, because Microsoft has stopped providing technical support for that platform. But Apple (AAPL) lost more than 1 percent. The stock is down since its 7-for-1 stock split took effect on Monday. There were two other big stories that had some legs beyond the companies directly involved. Open Table (OPEN) agreed to be acquired by Priceline (PCLN) for $2.6 billion. Open Table, which provides restaurant reservations, jumped 48 percent. Other online service providers rode the coattails of that deal. Yelp (YELP) gained 14 percent and Groupon (GRPN) gained 4 percent. In the retail arena, Express (EXPR) jumped 21 percent after a private equity firm took a 9.9 percent stake in the teen retailer and indicated it may make a buyout offer. That gave a boost to Aeropostale (ARO) and American Eagle (AEO), which both rose more than 2 percent. Abercrombie & Fitch (ANF) gained 1½. Elsewhere, International Game Technology (IGT) gained 10½ percent on a Reuters report that a bidding war could erupt for
- [By Stephen Quickel]
Recently, too, Celgene has formed a strategic partnership with OncoMed (OMED) to develop up to six anti-cancer stem-cell antibodies.
Celgene itself has posted four successive quarters of revenue growth, which is expected to lift annual sales from $5.5 to $6.4 billion for calendar 2013, and to $7.5 billion in 2014. Despite its expanding size, earnings per share are projected to grow by 23.2% a year, by 28 Street analysts following its stock.
- [By Jake L'Ecuyer]
Equities Trading UP
OncoMed Pharmaceuticals (NASDAQ: OMED) shot up 8.62 percent to $30.09 after the company initiated Phase 1B trial of WNT-parthway-target antibody. Jefferies lifted the price target on the stock from $27 to $46.
Top 10 Medical Companies To Watch For 2015: MiMedx Group Inc (MDXG)
MiMedx Group, Inc. (MiMedx), incorporated on February 28, 2008, is an integrated developer, manufacturer and marketer of regenerative biomaterial products processed from human amniotic membrane. The Company�� biomaterial platform technologies include the device technologies HydroFix and CollaFix, and tissue technologies, AmnioFix and EpiFix. Its tissue technologies are processed from human amniotic membrane that is derived from the donated placentas. Through the Company�� donor program, mothers delivering full-term caesarian births can elect in advance of delivery to donate the placenta in lieu of having it discarded as medical waste. MiMedx processes the human amniotic membrane utilizing its Purion Process to produce a manipulated implant for homologous use. MiMedx is the supplier of amniotic tissue, having supplied over 100,000 implants to distributors and other equipment manufacturers (OEMs) for application in the Wound Care, Surgical, Sports Medicine, Ophthalmic and Dental sectors of healthcare.
The Company has three platform technologies. Its largest addressable market is in chronic wound care consisting of diabetic, venous and pressure ulcers. On January 5, 2011, the Company acquired all of the outstanding equity interests in Surgical Biologics, LLC. Located in Kennesaw, Georgia, Surgical Biologics develops allografts and other products processed from human amniotic membrane that can be used for a range of medical applications, including ocular surface repair, gum repair, wound care, nerve and tendon repair, spine repair, burn treatment, and many other types of procedures that require the repair of a patient�� integumental (native) tissue. Surgical Biologics has developed a specialized process for the processing of amniotic membrane to produce a manipulated allograft for homologous use.
AmnioFix and EpiFix
MiMedx is the supplier of allografts processed from amniotic tissue, having supplied over 70,000 allografts to date for application in the Ophthalm! ic, Orthopedic, Dental, Spinal and Wound Care segments of healthcare. Its amnion products, AmnioFix and EpiFix, are processed from human tissue. The AmnioFix and EpiFix allografts can be used for a range of procedures, including ocular surface repair, gingival recession repair, wound care, burns, and many other types of procedures for the repair of a patient�� integumental (native) tissue. Its AmnioFix technology also is used as a graft to reduce the amount of scar tissue formation, provide a local anti-inflammatory and help with the soft tissue healing of the area. EpiFix offers a range of wound healing and wound care options. Much of the clinical usage of EpiFix has been for wound care patients suffering from diabetic ulcers, pressure ulcers, vein circulation ulcers, or artery circulation ulcers.
CollaFix
The Company�� CollaFix technology combines a means of creating fibers from soluble collagen and a specialized cross-linking process. MiMedx utilizes two separate cross-linking technologies for various applications. Initial laboratory and animal testing shows that the cross-linked collagen fibers produce a biocompatible, and durable construct that can be transformed into surgical meshes intended to treat a number of orthopedic soft-tissue trauma and disease disorders.
HydroFix
The Company licenses rights to a polyvinyl alcohol (PVA) polymer, which is a water-based biomaterial that can be manufactured with a range of mechanical properties, including those that appear to mimic closely the mechanical and physical properties of natural, healthy human tissue. This hydrogel has been used in other orthopedic and general surgery device applications, and it has demonstrated biocompatibility and durability inside the human body. It has a similar version of the product for the European market called HydroFix Spine Shield. The device is classified as a post-surgical adhesion inhibiting barrier and is used in specific spine surgeries. In December the original! HydroFix! Spine Shield (for Anterior use Class IIb in Europe) was renamed to be HydroFix Anterior Shield.
The Company competes with W.L. Gore & Associates, Inc. and Stryker.
Advisors' Opinion:- [By Garrett Cook]
MiMedx Group (NASDAQ: MDXG) shares were also up, gaining 12.10 percent to $7.04 after the company reported Q2 earnings of $0.00 per share on revenue of $25.60 million and raised its FY14 sales outlook.
- [By Rich Smith]
MiMedx Group (NASDAQ: MDXG ) ,�announced�Monday that results from a randomized controlled trial for its EpiFix wound-care allograft have been published in the International Wound Journal.�
The clinical trial included patients with diabetic foot ulcers of at least four weeks' duration without infection, having adequate blood supply. Patients were broken into two groups, one receiving standard care alone, the other standard care plus EpiFix. After four and six weeks of treatment, the overall healing rate of patients treated with EpiFix was 77% and 92%, respectively, whereas standard care healed 0% and 8% of the wounds, respectively. The rate of healing with EpiFix exceeded that of standard treatment as well.
According to the World Health Organization, diabetes will affect 366 million people worldwide -- up from 171 million in 2000.�Approximately 25% of diabetics will develop a chronic non-healing ulcer over their lifetime.�Diabetic foot ulcers�occur in 15% of all patients with diabetes and precede 84% of all lower leg amputations.
EpiFix makes use of dehydrated human amniotic membrane to heal these ulcers. At room�temperature, EpiFix can have a shelf life of five years and retains the properties of the natural membrane.�Although there are similar, competing products on the market, the superior performance of�EpiFix compared with rival products (not yet proven by published studies) could help to make the company a market leader in the treatment of diabetic foot ulcers. - [By Bryan Murphy]
It may not be as big as NuVasive, Inc. (NASDAQ:NUVA), and it might not be as sexy as MiMedx Group Inc. (NASDAQ:MDXG). But, Bacterin International Holdings Inc. (NYSEMKT:BONE) offers something to investors that MDXG and NUVA don't - can't - right now... a distinct opportunity for a lot of upside in a short amount of time.
Top 10 Medical Companies To Watch For 2015: Sirona Dental Systems Inc (SIRO)
Sirona Dental Systems, Inc. (Sirona), incorporated on April 25, 1997, and its subsidiaries is a manufacturer of dental equipment, and is focused on developing, manufacturing and marketing solutions for dentists around the world. The Company operates in four segments: Dental CAD/CAM Systems, Imaging Systems, Treatment Centers and Instruments. The Company markets its products globally to dental practices, clinics and laboratories through an international network of distributors. The dental distributors supply both dental equipment and consumables, and have regular contact with the ultimate end-users. In addition, the Company also distributes its products through its own sales and services infrastructure.
Dental CAD / CAM Systems
Dental CAD/CAM Systems address the dental restorations, which includes several types of restorations, such as inlays, onlays, veneers, crowns, bridges, copings and bridge frameworks made from ceramic, metal or composite blocks. Sirona's CEramic REConstruction (CEREC) system is an in-office application that enables dentists to produce high quality restorations from ceramic material and insert them into the patient's mouth during a single appointment. The CEREC system consists of an imaging unit and a milling unit. The imaging unit scans the damaged area, captures the image of the tooth or teeth requiring restoration and proposes the specifications for the restoration. The milling unit then mills the ceramic restoration to the required specifications based upon the captured image and the dentist's design specifications.
Sirona offers a service contract on its CEREC product, which includes software updates and upgrades and maintenance on software-related hardware. In addition to CEREC, Sirona also offers CAD/CAM products for dental laboratories, including the inLab restoration fabrication system and the extra-oral inEos scanner. These products are designed to improve efficiency and reduce costs for the dental lab. The inLab system scans the ! models received from the dentists and then mills ceramic or composite block restorations, such as crown copings and bridge frameworks to the specifications of the captured image.
Imaging Systems
Imaging Systems comprise a broad range of systems for diagnostic imaging in the dental practice. Sirona has developed a comprehensive range of imaging systems for two dimensional (2D) or three dimensional (3D), panoramic and intra-oral applications. Intra-oral x-ray systems use image-capture sensor devices, which are inserted into the mouth behind the diagnostic area, and take images of one or two teeth. Panoramic x-ray systems produce images of the entire jaw structure by means of an x-ray tube and an image capture device, which rotates around the head.
Treatment Centers
Treatment Centers consists of a range of products from basic dentist chairs to chair-based units with integrated diagnostic, hygiene and ergonomic functionalities, as well as specialist centers used in preventative treatment and for training purposes. Sirona offers specifically configured products to meet the preferences of dentists within each region in which it operates. Sirona's treatment center configurations and system integration are designed to enhance productivity by creating a seamless workflow within the dental practice.
Instruments
Sirona offers a range of instruments, including handheld and power-operated handpieces for cavity preparation, endodontics, periodontology and prophylaxis, which are regularly updated and improved. The instruments are supplemented by multi-function tips, supply and suction hoses, as well as care and hygiene systems for instrument preparation. Sirona's instruments are often sold as packages in combination with treatment centers.
Advisors' Opinion:- [By John Udovich]
Yesterday, small cap dental stock BIOLASE Inc (NASDAQ: BIOL) surged 17.69% after announcing it had received a license from the Health Canada-Medical Device Bureau to sell its EPIC dental soft-tissue diode laser systems throughout Canada, meaning its worth taking a closer look at the stock along with the performance of mid cap dental stocks like Sirona Dental Systems, Inc (NASDAQ: SIRO), DENTSPLY International Inc (NASDAQ: XRAY) and Align Technology, Inc (NASDAQ: ALGN).
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