margin in Medical Technology

FDA Requires Additional Information on DORIBAX for Treatment of Hospital-Acquired Pneumonia

... of NP, including VAP. The committee did not agree that the non-inferiority margin for the DORIBAX NP trials was appropriately justified, nor did it agree on the appropriate margin for NP trials in general. J&JPRD is confident in the NP data submitted and ...

DATATRAK International Reports First Quarter Results for 2008

... a basic and diluted basis in the first quarter of 2007. The gross profit margin for the first quarter was 55% compared to 62% for the same period a year ago. The decline in gross profit margin was a result of the 41% decrease in revenue partially offset by a 30% ...

Nabi Biopharmaceuticals Announces Second Quarter 2007 Financial Results

... of products sold 11,680 14,366 26,487 28,882 Gross margin 9,193 6,008 18,134 11,009 Selling, ... $ 20,873 $ 20,374 $ 44,621 $ 39,891 Gross margin (loss): Nabi Biologics $ 9,192 $ 5,649 $ 18,245 $ ...

Medigus and Tower Semiconductor Announce World's Smallest Medical Video Camera Based on Advanced CMOS Image Sensor

... camera. Our extraordinary sensor design capabilities, along with best in class pixel performance, have allowed us to get into this very high margin market which will be sustainable for many years." About Medigus Ltd. Medigus is a medical device company specializes in developing ...

Proteolix, Inc. Drug Candidate, PR-957, Prevents Disease Progression in Rheumatoid Arthritis Models by Selective Inhibition of the Immunoproteasome

... Molineaux, Ph.D., Chief Scientific Officer at Proteolix. "This selective inhibition of the immunoproteasome results in an increased therapeutic margin compared to that achieved with non-selective proteasome inhibitors, and can have dramatic impact on the inflammatory response without risking broad ...

Osteotech Completes Enrollment for DuraTech(TM) BioRegeneration Matrix Clinical Trial

... impact of competitive products and services, the availability of sufficient quantities of suitable donated tissue and the success of cost control and margin improvement efforts. Certain of these factors are detailed from time to time in the Company's periodic reports filed with the Securities and Exchange ...

New Poll Finds Disease Prevention is Top Priority for Americans in Health Reform

... by Greenberg Quinlan Rosner Research and Public Opinion Strategies from May 7 to 12, 2009, and is available at www.healthyamericans.org . The margin of error was +/- 3.1 percent. Trust for America's Health is a non-profit, non-partisan organization dedicated to saving lives by protecting the ...

AFRESA(R) Phase 3 Pulmonary Function Safety Data in Patients with Diabetes Presented at ADA

... along with nondiabetic subjects (n=145). The main study end-point was change from baseline in pre-bronchodilator FEV(1) at 2 years (non inferiority margin of 50 ml/year). Secondary endpoints included change from baseline in other PFT parameters (forced vital capacity, total lung capacity, and carbon ...

Freezing Kidney Cancer: Hot Treatment Should Be New Gold Standard for Destroying Small Tumors

... tumor. The tumor is then thawed by replacing the argon with helium. The procedure consists of two freezing and one thawing cycle, seeking a frozen margin beyond the tumor edge to ensure death of the entire tumor. After the cryoprobe is removed, a small bandage is placed over the skin puncture site. ...

ImQuest Submits Investigational New Product Application to the Food and Drug Administration to Initiate HIV Therapeutic Clinical Trials with IQP-0410

... with IQP-0410 therapy. Preclinical pharmacokinetic and toxicology studies have demonstrated the potential for once per day dosing and a high safety margin for the compound. IQP-0410 has been found to inhibit HIV replication at sub-nanomolar concentration levels and to have highly significant activity ...

Osteotech Initiates Pivotal Clinical Trial for DuraTech(TM) BioRegeneration Matrix

... impact of competitive products and services, the availability of sufficient quantities of suitable donated tissue and the success of cost control and margin improvement efforts. Certain of these factors are detailed from time to time in the Company's periodic reports filed with the Securities and Exchange ...

Thoratec Says Interim Data Analysis Demonstrates Statistical Superiority for the HeartMate II(R) in Destination Therapy Trial

... for our products, customer and physician acceptance of Thoratec products, changes in the mix of existing markets for our products and related gross margin for such product sales, the results of enrollment in and timing of clinical trials, including the HeartMate II, the effects of FDA regulatory ...

Data From Investigational Use of PROCRIT(R) (Epoetin alfa) Presented at American Society of Nephrology Annual Meeting

... regimens were statistically non-inferior to the TIW regimen (lower limits of 95 percent confidence intervals [CIs] within the non-inferiority margin of -1 g/dL). The percent of subjects with Hb exceeding 11.9 g/dL during the first 22 weeks of treatment was higher in the TIW group (86.2 percent) ...

deCODE Files IND for DG071, a Novel PDE4 Modulator Being Developed for Alzheimer's and Other Cognitive Disorders

... or impaired. In animal models, DG071 has been shown to significantly improve learning and long- and short-term memory at doses that offer a wide margin for safety and tolerability. The compound has the potential to eliminate the nausea that limits the utility of previous PDE4 inhibitors. deCODE plans ...

QuatRx Pharmaceuticals Announces Additional Data From Phase 3 Study for Ophena(TM) (Ospemifene Tablets) Showing Improvements in Clinical Symptoms of Vulvovaginal Atrophy

... showed that after 12 weeks of treatment, the mean scores for common clinical signs of vaginal atrophy were decreased by a statistically significant margin in the Ophena(TM) groups when compared with placebo. These positive effects of Ophena(TM) were already evident at week 4, as the mean scores of all ...

Velos Set to Clear 50 Percent Market Penetration of Large U.S. Clinical Research Sites by Year End

... the past few years and now includes 21 Top 25* U.S. centers. Clinical and Translational Science Award (CTSA) winners have chosen Velos by a wide margin versus all other vendors combined. Velos eResearch customers receive 47 percent of extramural clinical research funding from the National Institutes ...

Pharmasset Reports Preliminary Results of a 4-week Combination Study of R7128 for the Treatment of Chronic Hepatitis C

... Medical Officer, stated, "This result indicates that it is unnecessary to carry the 1500 mg dose forward, since the 1000mg dose may provide a greater margin of safety over longer treatment periods without sacrificing efficacy. Even at the dose of 500mg, R7128 in combination with SOC has demonstrated a ...

Genta Incorporated Announces Fourth Quarter and Year End 2007 Financial Results and Corporate Highlights

... - net $ 267 $ 117 $ 580 $ 708 Cost of goods sold 22 29 90 108 Gross margin 245 88 490 600 Operating expenses: Research and development 1,247 6,164 13,491 ...

Trius Initiates U.S. Phase I Trial for its Oxazolidinone Antibacterial Drug, TR-701

... clinical trial our goal is to demonstrate the potential of TR-701 to provide patients and clinicians with more convenient dosing and a broader safety margin than the current standard of care," stated Jeffrey Stein, Ph.D., President and CEO of Trius Therapeutics. "TR-701's potential for once-daily ...

Genta Incorporated Announces Third Quarter 2007 Financial Results

... - net $115 $145 $314 $591 Cost of goods sold 20 41 68 79 Gross margin 95 104 246 512 Operating expenses: Research and development 4,763 8,514 12,244 ...

NicOx and Ferrer Present Promising Clinical and Preclinical Results in Dermatology

... an increasing burden on medical services. Furthermore, the clinical data on NCX 1022 suggest that nitric oxide donation may also improve the safety margin over current treatments. We will continue to work closely with Ferrer to bring our promising drug candidate into clinical trials." NicOx and Ferrer ...

Influenza is Leading Cause of Vaccine-Preventable Deaths for Kids; Despite CDC Recommendations, Moms Still Don't Vaccinate

... of what they would have been had the entire population of mothers with children under 10 years of age in the United States had been surveyed. The margin of error will be larger for sub- groupings of the survey population. (1) Childhood Influenza Immunization Coalition, "Key Messages," National ...

Aspirin Named 8th World Wonder by Majority of Americans

... Corporation conducted a survey on current wonders from March 30, 2007 through April 2, 2007 among 1,038 American consumers via telephone. The margin of error is +/- 3%. About Bayer Consumer Care The Consumer Care Division of Bayer HealthCare LLC, is headquartered in Morristown, N.J. Bayer's ...

Genta Incorporated Announces Second Quarter 2007 Financial Results and Corporate Highlights

... - net $105 $379 $199 $446 Cost of goods sold 26 22 48 38 Gross margin 79 357 151 408 Operating expenses: Research and development 4,099 8,637 7,481 ...

Northfield Laboratories Reports Results of Pivotal Phase III Trauma Study

... of mortality at 30 days after injury. The margin to assess noninferiority, using the upper ... endpoint requires the establishment of a relative margin around the control outcome. The margin to assess noninferiority in this study, using the ...

Ulcerative Colitis (UC) Sufferers Find UC Quite Disruptive to Many Aspects of Daily Life

... certified gastroenterologists in the U.S. Assuming no sample bias, the margin of error for the sample of 451 UC patients is +/- 5 percent; assuming no sample bias, the margin of error for a sample of 300 (the other surveys) is +/- 6 percent. For ...

Answerthink and LORENZ Life Sciences Group Announce Strategic Alliance for the SAP Life Science Industry

... our ability to attract and retain skilled employees, possible changes in collections of accounts receivable, risks of competition, price and margin trends, changes in general economic conditions and interest rates as well as other risks detailed in the Company's Annual Report on Form 10-K for the ...

CytRx Announces Clinical Results from Its Rising Multiple Dose Trial with Arimoclomol for ALS

... higher than those that have provided maximum therapeutic benefit in animals. Second, using less than the highest possible dose potentially provides a margin of safety for ALS patients. Finally, larger doses may not be practical in this population as the capsules could be too large for ALS patients who ...

Chi-Med Announces Positive Phase II Proof-of-Concept Data for HMPL-004 in Ulcerative Colitis

... over long-term use is common. The Directors believe that today’s result is highly important because it shows that HMPL-004 has a similar margin of effect yet offers a different mechanism of action and therefore provides a direct alternative to the current best standard of care. If ultimately ...

DOR BioPharma Announces Publication Describing Results of Its Multivalent Botulinum Toxin Vaccine BT-VACC

... Drug Advisory Committee ("ODAC") appointed by the FDA voted that the data supporting orBec® did not show substantial evidence of efficacy by a margin of 7 to 2 for the treatment of GI GVHD, although the FDA is not bound by ODAC's decision, the FDA may not consider orBec® approvable based upon ...

DOR BioPharma Announces Issuance of European Patent for Its Oral Multivalent Botulinum Toxin Vaccine BT-VACC

... Drug Advisory Committee ("ODAC") appointed by the FDA voted that the data supporting orBec® did not show substantial evidence of efficacy by a margin of 7 to 2 for the treatment of GI GVHD, although the FDA is not bound by ODAC's decision, the FDA may not consider orBec® approvable based upon ...

Phase 3 Results for Dabigatran Etexilate, an Investigational Oral Anticoagulant, Presented Today at the XXIst Congress of the International Society on Thrombosis and Haemostasis

... (enoxaparin 40 mg). The incidences of total VTE and all-cause mortality in both dabigatran dose groups were within the pre-specified non- inferiority margin of 7.7%. Safety was evaluated for 3,463 patients receiving study treatment. The incidences of major bleeding events were similar in all treatment ...