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News Breaks
July 21, 2014
08:15 EDTRMDITC rules redesigned APEX humidifier infringes ResMed patents
An ITC ruling issued Friday held that, despite a redesign of its iCH CPAP device, Taiwanese device manufacturer APEX continues to infringe ResMed patents in its humidification. The original ITC action filed by ResMed in March 2013 asserted patent infringement by four products: APEX iCH and XT Fit CPAP humidifiers, the WiZARD 220 full face mask, and the WiZARD 210 nasal mask. In July 2013, APEX agreed to entry of an order prohibiting it from infringing ResMed's patents. And as a result, APEX has been banned from selling infringing products in the United States. APEX then redesigned its products and sought a ruling that it had avoided ResMed's patents. In this new ruling, the full commission held that the APEX iCH humidifier continues to infringe. As a result, APEX should continue to be banned from selling the iCH humidifier in the United States. The redesigned APEX XT Fit was found not to infringe. But APEX's expert stated that the redesigned humidifiers compromised on functionality and performance. The redesigned WiZARD 220 full face mask which now has a fused elbow instead of the more desirable detachable elbow -- was found not to infringe on ResMed patents. Again, APEX's expert noted that the redesigned masks sacrificed functional advantages present in the ResMed products. Finally, APEX chose to withdraw its redesigned WiZARD 210 nasal mask from these proceedings, so the July 2013 order remains in place as to that product.
News For RMD From The Last 14 Days
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May 13, 2015
10:56 EDTRMDResMed declines sharply, levels to watch
Shares are trading close to the lows of the day at $54.95. At that price, next support is at $53.20. Resistance is at $56.65.
10:36 EDTRMDResMed pullback overdone on SERVE-HF missing endpoint, says Piper Jaffray
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10:01 EDTRMDOn The Fly: Analyst Downgrade Summary
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08:25 EDTRMDResMed downgraded to Neutral from Buy at BofA/Merrill
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05:39 EDTRMDResMed announces SERVE-HF study did not meet primary endpoint
ResMed announced that SERVE-HF, a multinational, multicenter, randomized controlled Phase III trial did not meet its primary endpoint. SERVE-HF was designed to assess whether the treatment of moderate to severe predominant central sleep apnea with Adaptive Servo-Ventilation therapy could reduce mortality and morbidity in patients with symptomatic chronic heart failure in addition to optimized medical care. The study did not show a statistically significant difference between patients randomized to ASV therapy and those in the control group in the primary endpoint of time to all-cause mortality or unplanned hospitalization for worsening heart failure. The results from SERVE-HF are preliminary and will be submitted for future publication after further analysis. A preliminary analysis of the data identified a statistically significant 2.5% absolute increased risk of cardiovascular mortality for those patients in the trial who received ASV therapy per year compared to those in the control group. In the study, the cardiovascular mortality rate in the ASV group was 10% per year compared to 7.5% per year in the control group. There were no issues associated with the performance of the ASV therapy device in the trial. ResMed is working with global regulatory authorities to proactively revise the labels and instructions for use for ResMed ASV devices to include a contraindication for people with symptomatic chronic heart failure. The company is also proactively informing healthcare providers, physicians, and patients of the cardiovascular safety signal observed in SERVE-HF.

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