Shares of NewCardio and MannKind surprise investors on Thursday 01-14-10 |
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| By Mary Davila |
| Friday, 15 January 2010 02:03 |
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 Below is a list of the companies that made news in the health care sector on Thursday , January 14, 2010.NewCardio, Inc., (OTC BB: NWCI) a cardiac diagnostic technology provider, announced today that on January 12, 2010, it received notice of allowance for U.S. patent 7,647,093, titled "Apparatus and method for cordless recording and telecommunication transmission of three special ECG leads and their processing," from the U.S. Patent and Trademark Office. This represents the core patent for CardioBip™ and, in conjunction with the two encouraging validation studies announced on January 5, 2010, validates the CardioBip technology, positioning NewCardio as an emerging leader in remote cardiac monitoring. The CardioBip™ is a unique, hand held device that offers the solution to the problem of urgent ECG telemonitoring, capable of providing truly comprehensive and accurate ECG data that is being transmitted wirelessly. CardioBip™ is unique due to its extreme ease of use, as it employs only three integrated electrodes, combined with the ability to generate a standard 12 lead ECG recording. The absence of any cables and integrated nature of its electrodes offers the potential for an integration with popular hand held PDA platforms. NewCardio, Inc., CEO, Branislav Vajdic, Ph.D., said, "This patent strengthens our intellectual property protection creating a significant barrier to entry for a competing device. We believe the CardioBip technology fills an important technological and diagnostic void, enabling not only rhythm diagnosis, but also detection of ischemic ECG changes and precise reconstruction of atrial activity. At present there is no convenient and reliable method for remote monitoring and detection of either ischemic events or derangements of atrial electrical activity, but this patent and the two recently completed validation studies indicate that the CardioBip may potentially fill this need. This patent protects the core technology underlying the CardioBip. The patent comes immediately following the encouraging results from two validation studies, which confirmed CardioBip's ability to record, reconstruct and transmit an accurate, high-resolution 12-lead ECG. NewCardio is committed to advancing the widely accepted 12-lead ECG to deliver innovation to the cardiac sciences. We are gratified by the U.S. Patent and Trademark Office's grant of patent rights and pleased that they approved all 33 claims." Shares were up in early morning trading on this news. Later in the day, a story here on BioMedReports by M.E. Garza reported that rumors of a company buyout were circulating. Garza stated that shares could rise to over $10.00 on such an event. BioMedReports will continue to monitor the situation and will issue additional alerts as the story develops. MannKind Corp (NASDAQ: MNKD) shares continued to trade higher as investors anticipate the U.S. Food and Drug Administration to approve its experimental inhaled insulin device., the company's CEO said on Tuesday during a presentation at the JP Morgan healthcare conference that approval could come "within days" of inspecting a manufacturing plant that supplies the insulin. The company reported on Monday the U.S. Food and Drug Administration would delay a ruling on whether to approve the product, called Afrezza, until it completed the inspection of third-party manufacturing facilities. "My guess is an action letter will come within days of the inspection," MannKind CEO Alfred Mann said during a presentation at the JP Morgan healthcare conference. "We have nothing from our side that's due."Mann went on to say that the FDA has so far inspected one of the two N.V. Organon manufacturing plants that produce the insulin used in Afrezza. Shares have been climbing all week from the mid $8.00 range to just over $10.00 on Thursday. In other news Thursday: Bionovo, Inc. (NASDAQ: BNVI) announced today the publication of their results from its phase 1B clinical trial of Bezielle (BZL101) for metastatic breast cancer. The results of the study are available online in Breast Cancer Research and Treatment and demonstrate that Bezielle continues to be safe and well tolerated with clinical evidence of anticancer activity in a heavily pretreated population of women diagnosed with metastatic breast cancer. Preliminary results from this study were released previously by the Company. Boston Scientific Corporation (NYSE: BSX) After the bell today announced that the first patient has been enrolled in a clinical trial to evaluate its WallFlex® Biliary RX Fully Covered Stent for the treatment of benign bile duct strictures. This multi-center, prospective study plans to enroll 187 patients at 11 centers(1) worldwide over the next 18 months. The first patient was enrolled by Professor Horst Neuhaus at the Evangelisches Krankenhaus in Dusseldorf, Germany. Cardiovascular Systems Inc (NASDAQ:CSII) today received conditional IDE approval for ORBIT II coronary clinical trial (CSII) 4.37 : Co announces it has received FDA conditional Investigational Device Exemption approval to evaluate the safety and effectiveness of its Diamondback 360 System in the treatment of calcified coronary lesions. With this conditional approval, CSI is authorized to begin its pivotal trial, ORBIT II, in early 2010 and initially enroll up to 100 patients at as many as 50 U.S. sites. Shares were up almost 10% on the news. Cerus Corporation (NASDAQ:CERS) announced today that INTERCEPT-treated platelet components were found to be effective for patient support following extended six and seven day storage in a clinical study conducted at four sites in Europe. These data further confirm the safety and therapeutic efficacy of platelets treated with the INTERCEPT Blood System, a pathogen inactivation treatment designed to protect against transfusion-transmitted diseases. Shares climbed $.26 to close at $2.23 on the day. EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) earlier in the day announced today the departure of Michael Chen, the Company’s former Vice President of Global Business Development. Mr. Chen served EpiCept in this capacity since May 2006. After the bell the company announced that a previously authorized 1-for-3 reverse stock split of its common stock has been consummated and will be in effect at the start of trading on Friday, January 15, 2010 on a 1-for-3 split-adjusted basis. The Company’s shares will trade under the symbol EPCTD for 20 business days and will, after such 20-business day period, revert back to the current trading symbol of EPCT EnteroMedics Inc. (NASDAQ: ETRM), Shares had a wild ride on Thursday. The stock opened nearly 50% higher and were up almost 80% in early morning trading as the developer of medical devices using neuroblocking technology to treat obesity and other gastrointestinal disorders, today announced clinical results from two studies of VBLOC® vagal blocking therapy, including additional data from its EMPOWER™ study in obesity and interim clinical results from its ongoing VBLOC-DM2 ENABLE (DM2) study in diabetes using the next-generation rechargeable (RC) device. For all studies, the Maestro® System continues to meet its safety goals, with no therapy-related serious adverse events reported across the various study populations. Shares rocketed on the news. Then, later in the day the company announced It had entered into a definitive agreement with institutional investors to sell 7,438,299 of common shares in a "registered direct" offering, at a price of $0.65 per share, for gross proceeds of $4,834,894, before deducting placement agent fees and estimated offering expenses. Shares were cut in half after this news, and shares wound up closing down more than 10% on the day. Luna Innovations Incorporated (NASDAQ: LUNA), a company focusing on sensing, instrumentation and nanotechnology, announced today that it has received notification from The NASDAQ Stock Market LLC indicating that the Company timely demonstrated compliance with all requirements for initial listing on The NASDAQ Capital Market upon its emergence from bankruptcy, as required by the NASDAQ Listing Rules and the December 28, 2009 decision of The NASDAQ Listing Qualifications Panel. BiomedReports is not paid or compensated to report news and developments about publicly traded companies. Full disclosure can be read in the About Us Section Add this page to your favorite Social Bookmarking websites            |
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