tag:blogger.com,1999:blog-28174911898648272932024-03-28T19:30:25.131-07:00Heart DiseasesUnknownnoreply@blogger.comBlogger101125tag:blogger.com,1999:blog-2817491189864827293.post-89539042764866274372024-02-12T09:28:00.000-08:002024-02-12T09:28:37.637-08:00Venus Medtech VenusP-Valve transcatheter pulmonic valve replacement system granted Health Canada approval<p><i>Hangzhou, China, Jan. 31, 2024</i> --<a href="https://www.venusmedtech.com/" rel="nofollow" target="_blank">Venus Medtech (02500. HK)</a>, a leading provider of integrated solutions for transcatheter structural heart valvular therapies in China, announced today that, VenusP-Valve, the company's in-house developed innovative transcatheter pulmonic valve replacement (TPVR) system, cleared approval from Health Canada.</p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgDYOkZbKclPULV9k0rretrT-Wq1U9loDN4O-XTUY1OZRyrPGny4fXHj0ALpzoUKAXHxUkklBpT3jftFVDoFJ5CADJR0fWrBzdUD3CxuqG7LpUf5uzK2547tvaWFQaeyJNSUiuN7owV8cNJv6WGaqce3VSWHtj2Y4kW4A31osC78Ul_-2oO5xqZuXQ7nUhc/s214/venus%20medtech%202024.PNG" style="margin-left: 1em; margin-right: 1em;"><img alt="Venus Medtech" border="0" data-original-height="58" data-original-width="214" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgDYOkZbKclPULV9k0rretrT-Wq1U9loDN4O-XTUY1OZRyrPGny4fXHj0ALpzoUKAXHxUkklBpT3jftFVDoFJ5CADJR0fWrBzdUD3CxuqG7LpUf5uzK2547tvaWFQaeyJNSUiuN7owV8cNJv6WGaqce3VSWHtj2Y4kW4A31osC78Ul_-2oO5xqZuXQ7nUhc/s16000/venus%20medtech%202024.PNG" /></a></div><p style="text-align: left;">As the first self-expanding TPVR product approved in China and Europe, VenusP-Valve carries remarkable clinical value. Uniquely designed with both flared ends, the product ensures the blood flow of branchial artery with bare stents at the outflow end. It provides a stable multi-point anchoring system and enables easy delivery, with no need for pre-stenting before the procedure. Available in a variety of specifications with extensive applicability, VenusP-Valve is able to meet the needs of 85% of patients in the case of large RVOT.</p><p>"VenusP-Valve is able to eliminate pulmonary regurgitation in a wide range of anatomies," said Prof. Lee Benson, Director of Cardiac Diagnostic and Interventional Unit at the Hospital for Sick Children in Toronto, Canada. "Available in different sizes and specifications, the product offers extensive applicability to meet the clinical needs of a larger pulmonary regurgitation patient population."</p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjM-TeRsMp1zLU8V6XAq6o0Kd_x-LKpk6PPNpQRRBSqfRgPmf-FekSi-tUwHseUjO-meJOGPTmyhfmPPaxPJ2TeJcj3l_sQKAN-BPYd5RIyPh8ecxXWuekHfB8P5EqyuogGl87p6vOXmKywa3fQ0-rMK9LvrIgj0eIt5ODaa71-1wF-yr_ZzdhE3MV0L2kC/s650/VenusP-Valve%20System.PNG" style="margin-left: 1em; margin-right: 1em;"><img alt="VenusP-Valve System" border="0" data-original-height="361" data-original-width="650" height="178" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjM-TeRsMp1zLU8V6XAq6o0Kd_x-LKpk6PPNpQRRBSqfRgPmf-FekSi-tUwHseUjO-meJOGPTmyhfmPPaxPJ2TeJcj3l_sQKAN-BPYd5RIyPh8ecxXWuekHfB8P5EqyuogGl87p6vOXmKywa3fQ0-rMK9LvrIgj0eIt5ODaa71-1wF-yr_ZzdhE3MV0L2kC/w320-h178/VenusP-Valve%20System.PNG" width="320" /></a></div><p style="text-align: left;">Clinical data reveals that VenusP-Valve demonstrates safety and efficacy on par with similar products, and excels in aspects such as rates of reintervention and arrhythmia. According to three-year follow-up data of the European clinical trial, the success rate for TPVR with VenusP-Valve is 100%. All-cause mortality and reintervention rates were zero. In addition, no moderate or severe pulmonary regurgitation was observed. Paravalvular leakage and tricuspid regurgitation were mild or below in 96.87% of subjects.The data suggest excellent performance, robust safety and reliability, and drastic and steady improvements in patients' cardiac function.</p><p>As the company's international flagship product, VenusP-Valve received CE marking under the Medical Devices Regulation (MDR) on April 8th, 2022, becoming the first Class III implantable cardiovascular device approved under the new MDR. In 2023, after receiving Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA), VenusP-Valve gained its first ethical approval in the territory, setting the stage for the VenusP-Valve PROTEUS pivotal clinical trial. More recently, the U.S. Centers for Medicare & Medicaid Services (CMS) also granted coverage approval for the PROTEUS study... <i><span style="font-size: x-small;"><a href="https://www.venusmedtech.com/index.php/content-850" rel="nofollow" target="_blank">Venus Medtech's Press Release</a></span></i> -</p>Unknownnoreply@blogger.comtag:blogger.com,1999:blog-2817491189864827293.post-32376497670499785832024-02-07T01:02:00.000-08:002024-02-07T01:02:39.788-08:00Sirius Therapeutics Begins Phase 1 Clinical Trial of Next-Generation, Long-Acting Factor XI siRNA Anticoagulant for Treatment of Thromboembolic Disorders<p>Sirius Therapeutics Begins Phase 1 Clinical Trial of Next-Generation, Long-Acting Factor XI siRNA Anticoagulant for Treatment of Thromboembolic Disorders</p><p><i>SAN DIEGO, CA & SHANGHAI, February 2nd 2024 </i>- <a href="https://www.siriusrna.com/" rel="nofollow" target="_blank">Sirius Therapeutics</a>, announced it has dosed the first subject in a Phase 1, first-in-human clinical trial in Australia of SRSD107 on January 30th 2024, its next generation siRNA therapeutic targeting coagulation Factor XI (FXI), for the prevention and treatment of thromboembolic disorders. SRSD107 is the second clinical candidate in the company’s portfolio of next generation siRNA therapeutics to treat cardiovascular diseases. The company recently began clinical trials of SRSD101 in China for the treatment of dyslipidemia following IND clearance from the China National Medical Products Administration.<span style="text-align: center;"> </span></p><p style="text-align: center;"></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg2zJ-ovkMLY6klFXBBd3E6fArkQ9mlItvbYujrZhQzpZwg7oM3Usud63Ysi1r2nPIrdd5mlFADHzCFjzkUe8wO589LR0wd12nyP1TpfIw2MutWpMNWxy-f891LPJIYYc_Z58KHwwgpNZnS-z3PBNojM2C-C05DLYfjwjZdjpVlaz0jbvBZfy6FSgjwv35N/s207/sirius%20therapeutics%202024.PNG" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img alt="Sirius Therapeutics" border="0" data-original-height="90" data-original-width="207" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg2zJ-ovkMLY6klFXBBd3E6fArkQ9mlItvbYujrZhQzpZwg7oM3Usud63Ysi1r2nPIrdd5mlFADHzCFjzkUe8wO589LR0wd12nyP1TpfIw2MutWpMNWxy-f891LPJIYYc_Z58KHwwgpNZnS-z3PBNojM2C-C05DLYfjwjZdjpVlaz0jbvBZfy6FSgjwv35N/s16000/sirius%20therapeutics%202024.PNG" /></a></div><div style="text-align: left;">“This trial is based on in vivo studies that demonstrated a nearly 100% reduction of FXI levels for up to 6 months, without bleeding events, after a single subcutaneous dose,” said Dr. Qunsheng Ji, Sirius Therapeutics’ Chief Executive Officer. “The trial will provide an opportunity to evaluate SRSD107’s potential as a differentiated therapeutic for these common disorders globally.”</div><p></p><p>The SRSD107 Phase 1 study, which is being conducted in healthy volunteers in Australia, will evaluate SRSD107’s safety, tolerability, pharmacokinetics, and pharmacodynamics at single ascending doses and multiple ascending doses... <a href="https://www.siriusrna.com/html/companynews/59.html" rel="nofollow" target="_blank"><i><span style="font-size: x-small;">Sirius Therapeutics' Press Release</span></i></a> -</p><div><br /></div>Unknownnoreply@blogger.comtag:blogger.com,1999:blog-2817491189864827293.post-25034456067285445492024-01-23T07:22:00.000-08:002024-01-23T07:30:57.723-08:00 Sensydia Completes Fifth Study for Heart-Sound AI<p><i>Completion of this 50-subject study is a key milestone on the path to delivering the first device for non-invasive and accurate measurement of pulmonary pressure</i></p><p><i>Los Angeles, CA – January 16, 2024</i> – Non-invasive cardiac assessment company <a href="https://www.sensydia.com/" rel="nofollow" target="_blank">Sensydia</a> announced that it has completed its 50-subject development study at the University of Minnesota (UMN). This study was conducted at UMN to collect data for its innovative AI-powered, non-invasive <a href="https://www.sensydia.com/tech" rel="nofollow" target="_blank">Cardiac Performance System (CPS)</a> that uses heart sound analysis to enable earlier detection and more effective therapy guidance for patients suffering from heart failure and pulmonary hypertension. </p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjdtyJamdL8RgCbUDth84cRfVDEU_HunZTkCRdHKCaxDmNZD_paX3mGcT6PqgGHdOIN_ASx1f1GLxPL999xv9d2e2ngwHv8KAGNBVsKpaIJ2yiInDyaUTzy7hudCiwRFTgKAwuknUsvhBOYhBVKJov1BYjonunmUXm0TbAH94Cb_1GNzDn3pOUhU403OLIg/s253/sensydia%202024.PNG" style="margin-left: 1em; margin-right: 1em;"><img alt="Sensydia" border="0" data-original-height="59" data-original-width="253" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjdtyJamdL8RgCbUDth84cRfVDEU_HunZTkCRdHKCaxDmNZD_paX3mGcT6PqgGHdOIN_ASx1f1GLxPL999xv9d2e2ngwHv8KAGNBVsKpaIJ2yiInDyaUTzy7hudCiwRFTgKAwuknUsvhBOYhBVKJov1BYjonunmUXm0TbAH94Cb_1GNzDn3pOUhU403OLIg/s16000/sensydia%202024.PNG" /></a></div><p style="text-align: left;">Sensydia is developing the CPS platform, which uses ultra-sensitive biosensors to provide clinicians with rapid, non-invasive measurement of ejection fraction, cardiac output, pulmonary artery pressure, and pulmonary capillary wedge pressure in a handheld device. Knowledge of these parameters is critical when caring for individuals with heart failure and pulmonary hypertension. To obtain these measurements today, patients must undergo echocardiography and invasive right heart catheterization, which are resource intensive, restricted to medical facilities, and only provide snapshot data. In contrast, CPS measurements are fast, safe, may be repeated as frequently as indicated, and can be performed essentially anywhere with minimal training. </p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhktM8oRvcXHQMLq-rkVzq7yI4BjAEXtWQXpAqSAUNvzDJIW6a9oLImfWfM5r-QQqqgt9OXj-loBgEsBOiX9SUTr_95fWxgaUVJULXGTml2E9L-EsT2J0NV4roRu3ijTyS3sG6Kxeeh_l5G_wEZV6qppM0HMkflIFXWmRjwlNE2RZJKDRnq7kJyxJmInZLb/s762/sensydia%20cps%20cardiac%20performance%20system.PNG" style="margin-left: 1em; margin-right: 1em;"><img alt="Sensydia’s Cardiac Performance System (CPS)" border="0" data-original-height="491" data-original-width="762" height="206" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhktM8oRvcXHQMLq-rkVzq7yI4BjAEXtWQXpAqSAUNvzDJIW6a9oLImfWfM5r-QQqqgt9OXj-loBgEsBOiX9SUTr_95fWxgaUVJULXGTml2E9L-EsT2J0NV4roRu3ijTyS3sG6Kxeeh_l5G_wEZV6qppM0HMkflIFXWmRjwlNE2RZJKDRnq7kJyxJmInZLb/w320-h206/sensydia%20cps%20cardiac%20performance%20system.PNG" width="320" /></a></div><p style="text-align: left;">"This is Sensydia’s fifth successful study, and we will continue to collect data across leading cardiac care institutions to improve the performance and utility of the artificial intelligence algorithms that power our breakthrough CPS platform," said Anthony Arnold, President and CEO of Sensydia. “We’re working to overcome today’s barriers in acquiring vital hemodynamic measures for monitoring and managing cardiac patients, and we appreciate the participation of cardiologists and staff at University of Minnesota in working toward this goal.” </p><p>“The CPS platform shows promise as a non-invasive alternative to routine echocardiography and right-heart catheterization. It has the potential to positively impact the way patients with heart failure are monitored, managed, and ultimately to improve clinical outcomes,” said Tamas Alexy, MD, Associate Professor of Medicine and Principal Investigator, UMN Medical School. “These measurements are essential in the diagnosis and ongoing management of patients with heart failure as well as pulmonary hypertension. We are pleased to help evaluate Sensydia’s platform utilizing acoustic sensing technology and advanced AI algorithms, reducing the need for repeat echocardiograms and invasive hemodynamic assessments.”... <i><span style="font-size: x-small;"><a href="https://www.sensydia.com/post/umn-50-study" rel="nofollow" target="_blank">Sensydia’s Press Release</a></span></i> -</p>Unknownnoreply@blogger.comtag:blogger.com,1999:blog-2817491189864827293.post-23630911106039469912024-01-15T09:47:00.000-08:002024-01-15T09:47:15.133-08:00Orchestra BioMed Announces Initiation of BACKBEAT Pivotal Study of AVIM Therapy in Hypertensive Pacemaker Patients<p><b>Orchestra BioMed and Medtronic, Inc., have an exclusive strategic collaboration for development and commercialization of AVIM therapy for hypertensive pacemaker population, which is estimated to be more than 750,000 patients annually worldwide</b></p><p><i>NEW HOPE, Pa., Jan. 08, 2024</i> -- <a href="https://www.orchestrabiomed.com/" rel="nofollow" target="_blank">Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”)</a>, a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced the first patient was randomized in the BACKBEAT pivotal study in late December 2023. The BACKBEAT pivotal study will evaluate the efficacy and safety of atrioventricular interval modulation (“AVIM”) therapy (also known as BackBeat CNT™), for the treatment of pacemaker-indicated patients with uncontrolled hypertension despite the use of antihypertensive medications.</p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhblnkBDe69ZxIwq1nLyxbBixeohP6aDcGXCQJPSB4tsgKcnoWk115Y247Pw9oMyK8qJrk3jiJeVkbR-CC3NVM0YP-9qm_MhVCeG-bIk13IQn_57GjwUv-EyoVKmagSwGPL7062vqGZm44x_gumJdCdn5nJA09CzWYzxe9r4YqIaLofQQOzloLmzDs-OHIY/s290/orchestra%20biomed%202024.PNG" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img alt="Orchestra BioMed" border="0" data-original-height="102" data-original-width="290" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhblnkBDe69ZxIwq1nLyxbBixeohP6aDcGXCQJPSB4tsgKcnoWk115Y247Pw9oMyK8qJrk3jiJeVkbR-CC3NVM0YP-9qm_MhVCeG-bIk13IQn_57GjwUv-EyoVKmagSwGPL7062vqGZm44x_gumJdCdn5nJA09CzWYzxe9r4YqIaLofQQOzloLmzDs-OHIY/s16000/orchestra%20biomed%202024.PNG" /></a></div><p style="text-align: left;">AVIM therapy is an investigational patented bioelectronic therapy, administered using a standard dual-chamber pacemaker, designed to immediately, substantially and persistently reduce blood pressure. Orchestra BioMed and <a href="https://www.medtronic.com/us-en/index.html" rel="nofollow" target="_blank">Medtronic, Inc. (NYSE: MDT) (“Medtronic”)</a> formed a strategic collaboration for the development and commercialization of AVIM therapy for hypertensive pacemaker patients in July 2022. If approved, Medtronic will have exclusive global rights to commercialize AVIM-enabled pacing systems for this target population, and Orchestra BioMed will share in the revenues generated from Medtronic sales of the AVIM-enabled pacing systems.</p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjGATZVnqZAB6huNBBuk1-kuvmzD3HdQbAe49-92lzbs0CzUlrO2amPIhbW_CXC7FNNWmU_JtajJ6Kn2WM36JWtKEtWh9bxSwP_AvVb7DQmdZCXM9YzNEZIGhQLcpVe_UBSAtjseQegy_-EjxcoFCim78qyRto8mzfLyI5JraskeVTES8Q_jTblv6W6pQak/s195/Medtronic%202024.PNG" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img alt="Medtronic" border="0" data-original-height="54" data-original-width="195" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjGATZVnqZAB6huNBBuk1-kuvmzD3HdQbAe49-92lzbs0CzUlrO2amPIhbW_CXC7FNNWmU_JtajJ6Kn2WM36JWtKEtWh9bxSwP_AvVb7DQmdZCXM9YzNEZIGhQLcpVe_UBSAtjseQegy_-EjxcoFCim78qyRto8mzfLyI5JraskeVTES8Q_jTblv6W6pQak/s16000/Medtronic%202024.PNG" /></a></div><p style="text-align: left;">“Our collaboration with Orchestra BioMed will explore how cardiac pacing can go beyond management of bradycardia and conduction disease to treat hypertension as well,” said Robert C. Kowal, M.D., Ph.D., vice president and general manager of Cardiac Pacing Therapies within the Medtronic Cardiac Rhythm Management operating unit. “Our goal is to deliver the best possible outcomes for patients; this study will help us understand the potential role of AVIM therapy in treating hypertension, a major source of cardiovascular illness and a comorbidity in more than 70% of patients receiving pacing therapy.”</p><p>Suman Pasupuleti, M.D., from Citrus Cardiology Consultants, the first site to randomize a patient in the BACKBEAT pivotal study, commented: “Blood pressure management with currently available treatments is especially challenging in many elderly patients who also are prone to side effects from medications. This leaves a gap in the care of these patients and increases their risk for heart attack, stroke and heart failure progression. We are excited to be among the first to enroll patients in the BACKBEAT study, which will evaluate the efficacy and safety of this therapy in patients with high blood pressure who also need pacemakers.”</p><p>“We are thrilled to announce the initiation of the BACKBEAT pivotal study. This is an essential milestone as we evaluate how this therapy may benefit pacemaker patients who confront the mortality and morbidity risks of elevated blood pressure,” commented David Hochman, chairman, chief executive officer and founder of Orchestra BioMed. “We have activated multiple clinical sites and are screening patients in the U.S. and Europe. We are grateful to the clinical sites, our team and Medtronic for their dedication to finalizing all the study initiation deliverables. Most importantly, we are thankful to the patients who will participate in this landmark study.”</p><p>The BACKBEAT pivotal study is a global, multi-center, prospective, randomized, double-blind study investigating the efficacy and safety of AVIM therapy in patients who have recently undergone implantation of a Medtronic dual-chamber cardiac pacemaker and have uncontrolled hypertension despite the use of antihypertensive medications. Orchestra BioMed is actively screening patients for enrollment in the BACKBEAT pivotal study. Site activations are expected to continue throughout 2024 with a target of activating approximately 80 centers in the U.S. and Europe. The study will randomize approximately 500 patients 1:1 to AVIM therapy combined with continued medical therapy (treatment) or continued medical therapy and standard pacing alone (control). The study’s primary efficacy endpoint will determine at three months post-randomization whether AVIM-treated patients experience a statistically significant reduction in daily average blood pressure (mean 24-hour ambulatory systolic blood pressure or “aSBP”) as compared to control patients. The primary safety endpoint will determine at three months post-randomization whether AVIM-treated patients experience serious adverse device effects that are not anticipated with cardiac pacing. Double-blind follow up will continue through 12 months to enable the collection of additional clinical endpoints. All patients will be eligible to cross over upon completion of the 12-month blinded follow-up phase.</p><p>The BACKBEAT pivotal study investigational device exemption (“IDE”) was supported by encouraging results from MODERATO II, a prospective, multi-center, randomized, double-blind, pilot study of pacemaker patients with persistent hypertension conducted in Europe. MODERATO II showed that patients treated with AVIM therapy experienced net reductions of 8.1 mmHg in 24-hour aSBP and 12.3 mmHg in office systolic blood pressure (oSBP) at six months when compared to control patients. There were no major adverse cardiac events in the treatment group, compared to three events in three patients in the control group (0.0% vs. 14.3%).1</p><p>More information on the BACKBEAT pivotal study can be found at: <a href="https://clinicaltrials.gov/study/NCT06059638">https://clinicaltrials.gov/study/NCT06059638</a> - <a href="https://investors.orchestrabiomed.com/news-releases/news-release-details/orchestra-biomed-announces-initiation-backbeat-pivotal-study" rel="nofollow" target="_blank"><i><span style="font-size: x-small;">Orchestra BioMed's Press Release</span></i></a> -</p>Unknownnoreply@blogger.comtag:blogger.com,1999:blog-2817491189864827293.post-39411891000941416462024-01-05T03:30:00.000-08:002024-01-05T03:30:35.199-08:00Nanowear Announces FDA 510(k) Clearance for AI-enabled Continuous Blood Pressure Monitoring and Hypertension Diagnostic Management: SimpleSense-BP<p><i> NEW YORK, NY, January 4, 2024 </i>– <a href="https://www.nanowearinc.com/" rel="nofollow" target="_blank">Nanowear</a>, a leader in healthcare-at-home remote diagnostics, announced that its nanotechnology-enabled wearable and software platform, <a href="https://www.nanowearinc.com/simplesense" rel="nofollow" target="_blank">SimpleSense™</a>, has received FDA 510(k) clearance for a novel AI-enabled Software-as-a-Medical Device (SaMD). As the first non-invasive, cuffless, continuous blood pressure monitor, and diagnostic, SimpleSense-BP provides a transformational tool in clinical diagnostic management of hypertension and is additive to the wearable platform’s previously cleared cardiopulmonary diagnostics.</p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiGILlhEVGfIiLgCAigc9dJ8yLf_1w4HB9627RafVag4Rkf1fRRf75Yo01CNgpOrKFpqptC-WzLBJ-bXNp18ZcbcHnxxGjgXpLhfHlqOScOGt1Ex2E-kxoYcn-InMytQtk6rOtu6iMPHGjrb2CTa4U1lacGX0oqJy2unx1aLt6w8OO_2OnbmjerWy769DcA/s293/nanowear%202024.PNG" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="77" data-original-width="293" height="77" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiGILlhEVGfIiLgCAigc9dJ8yLf_1w4HB9627RafVag4Rkf1fRRf75Yo01CNgpOrKFpqptC-WzLBJ-bXNp18ZcbcHnxxGjgXpLhfHlqOScOGt1Ex2E-kxoYcn-InMytQtk6rOtu6iMPHGjrb2CTa4U1lacGX0oqJy2unx1aLt6w8OO_2OnbmjerWy769DcA/s1600/nanowear%202024.PNG" width="293" /></a></div><p style="text-align: left;">“This FDA clearance represents an exciting and differentiating moment for Nanowear. Accelerated by the pandemic, the market has been eagerly searching for reliable, clinical-grade wearable, and data service solutions that find product market fit with the following three attributes: at-home, utilizing AI, and a proven team that executes,” says Venk Varadan, CEO and Co-founder of Nanowear, emphasizing the company’s distinction as the world’s only nanotechnology-based embedded sensor platform fueling irreproducible AI algorithms. “This SaMD is just the first example of what our nanotechnology and AI is capable of, in understanding the individualized risk signatures and cardiopulmonary care pathways of each patient, materially enabling precision medicine.”</p><p>With its fourth FDA 510(k) clearance, alongside 13 awarded and 12 pending patents covering its nanotechnology, scaled nanosensor manufacturing, multi-parametric wearable, software platform, ingestion pipeline, and AI algorithms in a closed-loop ecosystem, Nanowear’s SimpleSenseTM is uniquely positioned in the market: the platform is indicated for use at-home, in healthcare facilities, and clinical research. The novel 4-decision tree algorithmic model, SimpleSense-BP, was tested in three study arms with both training and validation performed in independent geographies and demographic populations mirroring the most recent US census and generalizability to the entire hypertensive population. SimpleSense-BP is validated to track changes of > +/- 15mmHg systolic and +/- 10mmHg diastolic blood pressures over a continuous recording period across all classes of hypertension, via its wearable undergarment and AI platform. </p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEif6J-fxJmLXTu99FlhEJO2divDsIi-C82Nwce3VYhtJ4Lixj2Qd4ewZmuWlUptIWmCfLRuHL0nyYBDbWxjgQQ-mBjLQ5rQfASzemeXpn4g6s122h9DEprmq8zALAkoV9u0NE4eZro-2kxSbq1mcOF9dOGpCiyKmUiTmI1NfMwQbWei1aafxThNLmRV2Qnt/s119/namsa%202024.PNG" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="43" data-original-width="119" height="43" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEif6J-fxJmLXTu99FlhEJO2divDsIi-C82Nwce3VYhtJ4Lixj2Qd4ewZmuWlUptIWmCfLRuHL0nyYBDbWxjgQQ-mBjLQ5rQfASzemeXpn4g6s122h9DEprmq8zALAkoV9u0NE4eZro-2kxSbq1mcOF9dOGpCiyKmUiTmI1NfMwQbWei1aafxThNLmRV2Qnt/s1600/namsa%202024.PNG" width="119" /></a></div><p style="text-align: left;"><a href="https://namsa.com/" rel="nofollow" target="_blank">NAMSA</a>, the leading cardiovascular MedTech clinical research organization worldwide, sees Nanowear’s most recent clearance and indication for use as differentiating in customizing clinical research, a $50bn+ market with significant cost increases and requisite emphasis on real-world data reliability since the pandemic. “We often talk about whitecoat syndrome limiting our ability to understand the effect of therapeutics in blood pressure or other cardiopulmonary assessments. Whitecoat syndrome is just another word for ‘real-world’ living. Just as a patient’s blood pressure may be high in a 30 second reading due to whitecoat syndrome, the same patient may reduce their blood pressure by breathing calmly for five minutes before the 30 second reading. So, what are we actually learning about that individual patient or the therapeutic applied?” says NAMSA’s Chief Medical Officer, Ken Ouriel MD. “To date, existing healthcare wearables and software platforms are either restricted in scope and time; or are unreliable and unvalidated for what they can diagnose during ‘real-world’ conditions. Nanowear’s continuous device, software platform, and AI algorithms, can transform the way clinical research platforms operate. Efficiency, access, diversity, and standardization across geographies can be enhanced while significantly lowering trial costs. Importantly, sponsors would be able to receive clinically reliable and trended data driven insights; data from the real world; their patients’ homes, their workplace, and a myriad of other settings that comprise everyday life,” Dr. Ouriel concluded... <i><span style="font-size: x-small;"><a href="https://www.nanowearinc.com/releasejan2024" rel="nofollow" target="_blank">Nanowear's Press Release</a> -</span></i></p>Unknownnoreply@blogger.comtag:blogger.com,1999:blog-2817491189864827293.post-31897110129825857182023-12-21T00:53:00.000-08:002023-12-21T00:53:44.970-08:00Cadrenal Therapeutics Engages The Sage Group to Advance Tecarfarin's Late-Stage Development and Commercialization<p><i> PONTE VEDRA, Fla., Dec. 12, 2023</i> — <a href="https://www.cadrenal.com/" rel="nofollow" target="_blank">Cadrenal Therapeutics, Inc., (Nasdaq: CVKD)</a> a biopharmaceutical company developing <a href="https://www.cadrenal.com/tecarfarin/" rel="nofollow" target="_blank">tecarfarin</a>, a late-stage, novel, oral and reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes and deaths (due to blood clots in patients with certain orphan diseases), today announced an engagement with <a href="https://www.sagehealthcare.com/" rel="nofollow" target="_blank">The Sage Group</a> to assist the company in exploring strategic partnerships, co-development and licensing agreements for tecarfarin.</p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhbMAHuBzl_HBekizbNgIb9A_zpadCJa_thJDR9CnHMXC3yYmZCKUheXggDXBhAXmkbww-TnaNFjJsGqYrV7dHklUxY_vUmkEk9co9vteJVDdBXcmI6HNSDJgWtwMd4LpkPqjwQaGh6rvDweibDsGqc29bebhJiJWN3TvD7fJ1Ur-pVXkTKCcQI2LCVYVhm/s214/cadrenal%20therapeutics%20logo.PNG" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img alt="Cadrenal Therapeutics" border="0" data-original-height="62" data-original-width="214" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhbMAHuBzl_HBekizbNgIb9A_zpadCJa_thJDR9CnHMXC3yYmZCKUheXggDXBhAXmkbww-TnaNFjJsGqYrV7dHklUxY_vUmkEk9co9vteJVDdBXcmI6HNSDJgWtwMd4LpkPqjwQaGh6rvDweibDsGqc29bebhJiJWN3TvD7fJ1Ur-pVXkTKCcQI2LCVYVhm/s16000/cadrenal%20therapeutics%20logo.PNG" /></a></div><p style="text-align: left;">The Sage Group is a leader in providing strategic and transactional advice to healthcare and life science companies in the pharmaceutical, diagnostics, medical devices, biotech, regenerative medicine, and cell and gene therapy fields. This partnership will give Cadrenal access to The Sage Group’s clinical and regulatory expertise, capital resources, and network of contacts, including innovators and large pharma companies.</p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhnpYuVHfPx3W0masaW_Hfi9JJgohJWQrIgzIa9Z5D8k9054ZKDgk7IggcuIXghV5NESbkRsAiNTv60IePqlOHhiN0whP3JXb3v3rtwATT5WMWFbffJbZYCwQv1xdLzsz8-KWEqrm9EslAxJ4YTA0fqfSpIab4zE_hfF3Z8J3Xw_nPKbozgsJGKyGxlMFIQ/s251/the%20sage%20group%20logo.PNG" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img alt="The Sage Group" border="0" data-original-height="150" data-original-width="251" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhnpYuVHfPx3W0masaW_Hfi9JJgohJWQrIgzIa9Z5D8k9054ZKDgk7IggcuIXghV5NESbkRsAiNTv60IePqlOHhiN0whP3JXb3v3rtwATT5WMWFbffJbZYCwQv1xdLzsz8-KWEqrm9EslAxJ4YTA0fqfSpIab4zE_hfF3Z8J3Xw_nPKbozgsJGKyGxlMFIQ/s16000/the%20sage%20group%20logo.PNG" /></a></div><p style="text-align: left;">Tecarfarin is a novel chemical entity that provides stable anticoagulation to patients with certain orphan diseases, including End-Stage Kidney Disease (ESKD) with Atrial Fibrillation (AFib); Left Ventricular Assist Devices (LVADs); and Antiphospholipid Syndrome (APS). The currently available blood thinners, including warfarin, Pradaxa, Xarelto, Eliquis, and Savaysa, fail to achieve sufficiently stable anticoagulation in these patients and are not widely prescribed for these rare medical conditions. In recent advertisements for Eliquis, the narration specifically states, ‘Don’t take Eliquis if you have an artificial heart valve ‘ and ‘Eliquis is not for patients who have antiphospholipid syndrome (APS).’</p><p>Tecarfarin was designed to solve one of warfarin’s major problems, namely warfarin’s unreliable pharmacokinetic (PK) profile, due to its metabolism via the cytochrome P450 pathway. This pathway is responsible for the metabolism of many other drugs, resulting in drug-drug interactions that can lead to unstable anticoagulation. Tecarfarin was specifically designed to be metabolized via an alternate pathway, resulting in a more reliable, stable PK and anticoagulation, as evidenced in clinical trials in over 1,000 patients.</p><p>“Patients with certain orphan diseases, including ESKD with AFib, LVADs, and APS, suffer from a lack of options to achieve sufficiently stable anticoagulation,” said Quang Pham, CEO of Cadrenal. “With The Sage Group’s support, we look forward to identifying the right partner to help us advance clinical development globally in an effort to bring a much-needed blood thinner solution to the market for these underserved patients.”</p><p>Tecarfarin has been evaluated in eleven (11) human clinical trials and more than 1,000 individuals. In Phase 1, Phase 2, and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects and patients with chronic kidney disease.</p><p>The FDA has granted tecarfarin orphan drug and fast-track designations for ESKD with AFib. Cadrenal is also developing expanded regulatory strategies for LVAD and APS. Cadrenal estimates that in the treatment of these orphan diseases, the combined addressable market opportunity is in excess of US $2 billion per year in the U.S... <a href="https://www.cadrenal.com/cadrenal-therapeutics-engages-the-sage-group-to-advance-tecarfarins-late-stage-development-and-commercialization/" rel="nofollow" target="_blank"><i><span style="font-size: x-small;">Cadrenal Therapeutics' Press Release</span></i></a> -</p>Unknownnoreply@blogger.comtag:blogger.com,1999:blog-2817491189864827293.post-82686263663420962202023-11-09T01:09:00.004-08:002023-11-09T01:09:29.141-08:00Xenter Unveils Groundbreaking Investigational Dual Sensor Wireless GuideWire for Minimally Invasive TAVR Procedures at TCT 2023<p><b>Xenter Unveils Groundbreaking Investigational Dual Sensor Wireless GuideWire for Minimally Invasive TAVR Procedures at TCT 2023</b></p><p><b>Revolutionizing Data Collection in Cardiology with Proprietary Wireless Ecosystem</b></p><p><br /></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhxrDmenW57jdQiBLXQRpPJQiX45nqndKBZMUHQONWsfmhyphenhyphenuhx0_0J_L9FWK0m2kcgpJRO_sD38sfudj-vM5ptnm5osODybXNw8_iDP39BqEaMUKFXLBXamehHKFgUsx2Gc_L2Fm0ta_nWxwjQS2mMrTPMXnq_V3Jlf07gwMdGZm3LcVkZ1WlumjPXBHaNB/s474/device%20cardio%20de%20%20x%20e%20n%20t%20e%20r%202023.PNG" style="margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="187" data-original-width="474" height="126" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhxrDmenW57jdQiBLXQRpPJQiX45nqndKBZMUHQONWsfmhyphenhyphenuhx0_0J_L9FWK0m2kcgpJRO_sD38sfudj-vM5ptnm5osODybXNw8_iDP39BqEaMUKFXLBXamehHKFgUsx2Gc_L2Fm0ta_nWxwjQS2mMrTPMXnq_V3Jlf07gwMdGZm3LcVkZ1WlumjPXBHaNB/s320/device%20cardio%20de%20%20x%20e%20n%20t%20e%20r%202023.PNG" width="320" /></a></div><br /><p style="text-align: center;"><br /></p><p><i>Xenter introduced at TCT the first-of-its-kind wireless guidewire designed for use during transcatheter aortic valve replacement (TAVR) procedures that aims to collect an extensive range of crucial real-time data points to serve as an aortic regurgitation measurement (xAR™) and clinical decision support tool, significantly enhancing the prediction of para valvular leak (PVL) during TAVR.</i></p><p><br /></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg4wIcN9B2fXYJINmrgj2mG6pYkgRGnW-fRM7GRBNCLySSujvdL4WwBUoAO_ixEwITnCQprrTL6PJvXXJFkS675Vv_BgTK4C-LGfCzE96Ir3bh1xfAmwjoAbow9ME6h9G8xsY2rV72wTLaWUlrh0VQLYommQ-hcMzxTvqW17OHjSZo-kXonQ9LoZkKyCucS/s231/xenter%202023.PNG" style="margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="71" data-original-width="231" height="71" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg4wIcN9B2fXYJINmrgj2mG6pYkgRGnW-fRM7GRBNCLySSujvdL4WwBUoAO_ixEwITnCQprrTL6PJvXXJFkS675Vv_BgTK4C-LGfCzE96Ir3bh1xfAmwjoAbow9ME6h9G8xsY2rV72wTLaWUlrh0VQLYommQ-hcMzxTvqW17OHjSZo-kXonQ9LoZkKyCucS/s1600/xenter%202023.PNG" width="231" /></a></div><p style="text-align: center;"><span style="text-align: left;"><br /></span></p><p style="text-align: center;"><br /></p><p><i>November 08, 2023 - DRAPER, Utah--(BUSINESS WIRE)-</i>-<a href="https://xentermd.com/" rel="nofollow" target="_blank">Xenter, Inc. (Xenter.io)</a> announced the recent unveiling of its groundbreaking dual sensor investigational guidewire for TAVR procedures at the <a href="https://tct2023.crfconnect.com/" rel="nofollow" target="_blank">Transcatheter Cardiovascular Therapeutics (TCT) 2023 conference in San Francisco, CA</a>.</p><p style="text-align: center;"> <iframe allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share" allowfullscreen="" frameborder="0" height="315" src="https://www.youtube.com/embed/hngPI85LzPE?si=k1prF1DRGzjwpcvH&controls=0" title="YouTube video player" width="560"></iframe> </p><p>Xenter introduced the first-of-its-kind wireless guidewire designed for use during transcatheter aortic valve replacement (TAVR) procedures that aims to collect an extensive range of crucial real-time data points to serve as an aortic regurgitation measurement (xAR™) and clinical decision support tool, significantly enhancing the prediction of para valvular leak (PVL) during TAVR... <a href="https://www.businesswire.com/news/home/20231107778269/en" rel="nofollow" target="_blank">Xenter's Press Release</a> -</p>Unknownnoreply@blogger.comtag:blogger.com,1999:blog-2817491189864827293.post-69681610340986573962012-07-05T13:51:00.001-07:002012-07-05T13:53:11.419-07:00MicroMed Cardiovascular's HeartAssist 5™ Goes Wireless<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img alt="MicroMed Cardiovascular" border="0" height="32" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhoT2BijK5X7BrbqJUcU0VdIOyeD_qAgm2Dfvk-bc5CxDUjkxq0Ots_L9L-syH3Yj2jyJ36kfLwrFUntNXljyz74Be3yJ_nd86s5t0WCKweIXD114X2ltMVQBplnj0Ur21uHjZsgrY_a1sX/s200/MicroMed+Cardiovascular.png" width="200" /></a></div>
June 21, 2012 - <i>Breakthrough Technology Advances Remote Monitoring Capabilities of the HeartAssist 5® System to Wirelessly Report Data when Patients are on the Move</i> – <a href="http://www.micromedcv.com/">MicroMed Cardiovascular Inc.</a>, manufacturer of the HeartAssist 5™ Left Ventricular Assist Device (LVAD), recently integrated the capacity for continuous wireless monitoring into its Conquest Controller. The Conquest Controller release is pending approval by regulatory agencies.<br />
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This unprecedented innovation will allow continual remote monitoring of data from the Heart Assist 5 LVAD. As a result, clinicians, doctors and technicians will be informed automatically and in the background without requiring the patient to do anything or having to come in to the clinic or hospital facilities.<br />
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Prior to MicroMed’s implementation of the M2M technology, clinicians could only access device data when the patient physically plugged the HeartAssist 5 into MicroMed’s HeartAttendant™ so that data could be transmitted via a local internet connection. The internet solution provided useful data, but limited patient mobility, and meant data reporting could not be continuous... <a href="http://www.micromedcv.com/us/news-and-media-center/press-releases/69-micromed-cardiovasculars-heartassist-5-goes-wireless">MicroMed Cardiovascular's Press Release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-2817491189864827293.post-67328078172982857932012-05-18T06:44:00.004-07:002012-05-18T06:45:53.372-07:00Loma Vista Medical : CE mark for its TRUE Dilatation™ Balloon Valvuloplasty Catheter<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img alt="Loma Vista Medical" border="0" height="40" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgaFpFeEnCNq2DuM7roz4VzWSgu-BgaKtcySN6hZrQwtgxZVuc6XZm7v7cOw0RG3NJ4kA74A_cUhb-MCL3mfqLrbAL9TKTCvEJGbuHWSCBkW_eS9PLDdsh7jKVkMaRN1cBsbMEYrj1UdLeS/s200/Loma+Vista+Medical.jpg" width="200" /></a></div>
May 10, 2012 - <a href="http://lomavistamedical.com/">Loma Vista Medical (“LVM”)</a> announced that it has received CE mark for its TRUE Dilatation™ Balloon Valvuloplasty Catheter. The company has seen rapid adoption at major clinical centers and will be launching its initial product at next week’s <a href="http://www.europcr.com/">EuroPCR</a> congress in Paris (Booth #M22, Paris Convention Center Palais des Congrès).<br />
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Fabricated from tough, high-strength materials and designed to prevent the catastrophic failures seen with other heart valve dilatation balloons, the TRUE Dilatation Balloon is highly resistant to ruptures, punctures, and tears. Studies funded by the U.S. <a href="http://www.nhlbi.nih.gov/">National Heart, Lung and Blood Institute (NHBLI)</a> and others have reported a 10% to 17% failure rate in conventional balloons used in BAV (balloon aortic valvuloplasty) and TAVI (transcatheter aortic valve implantation) procedures... <a href="http://lomavistamedical.com/wp-content/uploads/2012/05/Loma_Vista_News-PCR_Launch.pdf">[PDF] Loma Vista Medical's Press Release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-2817491189864827293.post-12581517644354092242012-04-20T09:31:00.000-07:002012-04-20T09:31:19.013-07:00Quantum Genomics : initiation of a First-in-Human clinical study with QGC001, its lead compound for the treatment of hypertension<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img alt="Quantum Genomics" border="0" height="95" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjMzYdJxmqx_66qOeCG4ZMjMPwS-7AhGvuk4BYc3xuRZKAGaRzWw_b2FjQPISd_PoX0g8yTXssKBRVrX3PQhVy7wPgABYXqaorcpLI8tB4gmKlDouriGdFbNkDZXRGPrgJgL2aXbGJbuV7F/s200/Quantum+Genomics.png" width="200" /></a></div>
April 13th 2012 - <a href="http://www.quantum-genomics.com/">Quantum Genomics (NYSE Euronext Paris : MLQGC)</a>, following the approval from the French Agency for Safety of Health Products (AFSSAPS), announces the initiation of a phase I clinical study in healthy volunteers with its product QGC001. QGC001 is the first of a new class of drugs that is able to monitor high blood pressure by inhibiting the aminopeptidase A enzyme (APA) at the brain level.<br />
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Arterial hypertension affects an estimated 1 billion people worldwide (13 million people in France). Despite the availability of many antihypertensive drugs, 30% to 60% of patients diagnosed with hypertension do not have their blood pressure properly controlled by current medications for various reasons (49% in France ([1])). Moreover, the overall incidence of resistant hypertension to at least three antihypertensive drugs (including a diuretic) is estimatedaround 8% to 12% of the hypertensive population... <a href="http://www.quantum-genomics.com/news_read.php?txtid=33">Quantum Genomics' Press Release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-2817491189864827293.post-2086597870081509192012-04-03T09:32:00.002-07:002012-04-03T09:33:44.992-07:00HeartWare International Expands Intellectual Property and Technology Portfolio Through Definitive Agreement to Acquire World Heart Corporation for US$8 Million<div class="separator" style="clear: both; text-align: center;">
<a href="" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img alt="HeartWare International" border="0" height="31" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEia8bct9zJINyz88Zn6eTU4kg2d1Woe4XBOFVtXcDpFR6DWTSQOLTrs9s5rtnsYmdywKi2C7cyiBsV0Kc4ZY_SrhNPQgVz3H1xx1QkQOTnlhMagrggxkRXr23LLCFCvySfx4435XMI-rrmq/s200/HeartWare.gif" width="130" /></a></div>
March 29, 2012 - <a href="http://www.heartware.com.au/">HeartWare International, Inc. (Nasdaq:HTWR) (ASX:HIN)</a>, which develops and manufactures miniaturized ventricular assist devices, and <a href="http://www.worldheart.com/">World Heart Corporation (Nasdaq:WHRT)</a>, which has been engaged in the development of left ventricular assist devices, announced that they have entered into a definitive merger agreement under which HeartWare will acquire WorldHeart for consideration of US$8 million, which will be paid in shares of HeartWare common stock or cash, at HeartWare's election.<br />
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<a imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img alt="WorldHeart Corporation" border="0" height="76" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhph-UhAeGAB1sXeY1Nbu7Lcu1QuX4CyPc14dBdGto8GQun2q_FZYm2fAiLCZq0Vjl94ijyHPhKpQpm0HdryOHZyJKuIkooYUd2NSHKRvIb66caBdZkC1IYvILG3Q1n9nXc4BacKqqIMhg-/s200/WorldHeart+Corporation.jpg" width="200" /></a></div>
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"WorldHeart has been an important participant in the development of ventricular assist therapies for many years and has amassed over one hundred patents and patent applications. In line with our goal to be a leader in the VAD market for years to come, we believe that bolstering our patent portfolio and adding WorldHeart's technologies broadens our options for the future," said Doug Godshall, President and CEO of HeartWare. "While we are intensely focused on the FDA panel for our HVAD® System next month, and commencement of first-in-man studies for our MVAD® System mid-year, we look forward to integrating WorldHeart's technologies and members of its talented team into our research efforts."... <a href="http://ir.heartware.com/phoenix.zhtml?c=187755&p=irol-newsArticle&ID=1678382&highlight=">HeartWare International's Press Release</a> - <a href="http://investor.worldheart.com/releasedetail.cfm?ReleaseID=660495">WorldHeart Corporation's Press Release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-2817491189864827293.post-33864826178309828452012-03-20T09:40:00.000-07:002012-03-20T09:40:31.664-07:00Asahi Kasei : Agreement to Acquire ZOLL Medical<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img alt="Asahi Kasei" border="0" height="30" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi_D2g8lKBId3xtCvO21z42lcKQUL6WDvkdZngo6CPna32WNwtVfSlJq7gVhDOlkKcSXD1VWoPja4cohAbmLRy73HxhBxddAsEF4TAC2JqzjOUMhwuPNytd6vl7Jok-vIt-NTJMJCQn0KR6/s200/Asahi+Kasei.png" width="200" /></a></div>
March 12, 2012 - <i>Builds on existing relationship to drive global development of critical care businesses</i> –<br />
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<a href="http://www.asahi-kasei.co.jp/">Asahi Kasei Corporation (TSE1: 3407, hereinafter: Asahi Kasei)</a>, and <a href="http://www.zoll.com/">ZOLL Medical Corporation (NASDAQ GS: ZOLL, hereinafter: ZOLL)</a> jointly announced that Asahi Kasei, Japan’s leading diversified chemical manufacturer with businesses in the health care, chemicals & fibers, homes & construction materials, and electronics sectors, has entered into a definitive merger agreement with ZOLL, a manufacturer of resuscitation and critical care devices and related software solutions, pursuant to which Asahi Kasei will acquire ZOLL for approximately $2.21 billion. The transaction has been approved by the Boards of Directors of both companies.<br />
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<a imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img alt="ZOLL Medical" border="0" height="55" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh0B5zA2tJkCbttw1y_ZE8mZtAPadLkMxsvFCcxfK-do2cJOFFw9-5AG3N2H-dRi3zYZknswx2rxonnjaG3T5SLbvnDxRwuvz6sMnv2MVozGKwgLmkaFPF0cqhVRt9hCIAMH26ARLb0Ez4b/s200/zoll.png" width="200" /></a></div>
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Asahi Kasei, through a U.S. subsidiary, will make a cash tender offer to purchase all of the outstanding shares of ZOLL common stock for $93 per share. The purchase price represents a premium of 29.6% over ZOLL’s volume weighted average closing stock price over the 30 trading day period ended March 9, 2012, and a 23.8% premium over the closing price on March 9, 2012. The tender offer is expected to commence within 10 business days and will remain open for a minimum of 20 business days. Closing of the tender offer is subject to customary conditions, including receipt of applicable regulatory clearances and the minimum tender of at least two-thirds of the outstanding shares of ZOLL (on a fully diluted basis). The transaction is not subject to a financing condition. The ZOLL Board of Directors has recommended that ZOLL stockholders accept the offer and tender their shares into the offer when it is made. The transaction is expected to close in the second calendar quarter of 2012... <a href="http://www.asahi-kasei.co.jp/asahi/en/news/2011/e120312.html">Asahi Kasei's Press Release</a> - <a href="http://www.zoll.com/news-releases/2012/03/12/asahi-kasei-announces-agreement-to-acquire-zoll/">ZOLL Medical's Press Release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-2817491189864827293.post-88152491049584319572012-03-12T10:32:00.001-07:002012-03-12T10:32:39.322-07:00Boston Scientific to Acquire Cameron Health<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img alt="Boston Scientific" border="0" height="67" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhVFHfa0FT4u8RW5PE0BSPB372Gts60VKgFVvwIgPKiDHmZP0wBkPsMJ2Zf-uGAUznvus5ObJM3rmrBCGQZ-CUD55s-RmfTursCDmBmZLs0Ony0zhMb4_rzU_tkEGpDmIb1-VuAoQ-0eG1x/s200/Boston+Scientific+2012.gif" width="151" /></a></div>
March 8, 2012 - <i>Company gains first and only commercially available subcutaneous ICD technology to offer lifesaving therapy to patients at risk of sudden cardiac arrest</i> - <a href="http://www.bostonscientific.com/">Boston Scientific Corporation (NYSE: BSX)</a> announces the exercise of its option to acquire Cameron Health, Inc., a privately held company based in San Clemente, California. <a href="http://www.cameronhealth.com/">Cameron Health</a> has developed the world's first and only commercially available subcutaneous implantable cardioverter defibrillator – the S-ICD® System. Unlike conventional implantable cardioverter defibrillators (ICDs), which require thin, insulated wires (leads) to pass through the venous system and into the heart, the entire S-ICD System sits just below the skin and leaves the heart and blood vessels untouched. This one-of-a-kind technology has the potential to expand the reach of ICD therapy, offering physicians and appropriate patients a new alternative to traditional ICDs, while strengthening Boston Scientific's arrhythmia management portfolio.<br />
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<a imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img alt="Cameron Health" border="0" height="116" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgy7ExyOQVJGyDxMabVY-KI_FgpO8sE_OxpU4NZlkDKdUmlVpZEkgzbO1AQ-sxC58dCS14jVL3BW8ab4INcDjVtSRsyLB2D6u1RLl8uCQdgTzPH0sNhJpaBRu710GLLpdDjJcjHKPX0vG68/s200/Cameron+Health.jpg" width="198" /></a></div>
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The S-ICD System has received CE Mark and has been commercially available in select geographies, including several major European countries, since 2009. The system has been clinically evaluated in a variety of studies and has been implanted in more than 1,000 patients worldwide. Cameron Health received expedited review status and submitted its PMA application to the U.S. Food and Drug Administration (FDA) in December 2011. Boston Scientific anticipates FDA approval for the S-ICD System in the first half of 2013... <a href="http://bostonscientific.mediaroom.com/index.php?s=24889&item=124076">Boston Scientific's press Release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-2817491189864827293.post-84445652161009633622012-02-10T07:40:00.000-08:002012-02-10T07:40:47.699-08:00LIFEBRIDGE Medizintechnik : New ACCF/AHA/SCAI Guidelines with increased recommendations for the use of extracorporeal hemodynamic support in patients with cardiac or cardio-pulmonary failure.<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear:right; float:right; margin-left:1em; margin-bottom:1em"><img border="0" alt="LIFEBRIDGE Medizintechnik" height="61" width="176" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiIAxVqlLI5JQjCi5PiyeefpDLGrHbLK4FDJ5AVUofi7pPLXCv9h9WMgWP38vOAdEyn5FyaDJKnkG9fxRpWJ26Y6KHxEuRfxNmnpr2SQY5XV1SIlL6yoXLS4kgU6RZzZJpz3rGY8OjDneQF/s200/LIFEBRIDGE+Medizintechnik.png" /></a></div>
January 17, 2012 - <a href="http://www.lifebridge.de/">LIFEBRIDGE Medizintechnik AG</a> announces increased recommendations for hemodynamic support by guidelines for percutaneous coronary interventions (PCI). Issued by the <a href="http://www.cardiosource.org/">American College of Cardiology Foundation (ACCF)</a>, the <a href="http://www.heart.org/HEARTORG/">American Heart Association (AHA)</a> and the <a href="http://www.scai.org/">Society for Coronary Angiography and Interventions (SCAI)</a>, guidelines provide expanded recommendations for hemodynamic support in patients with cardiogenic shock, during high-risk PCIs and to stabilize emergent patients in hospitals without on-site cardiac surgery. The portable LIFEBRIDGEâ system, with its clinically proven capability to completely substitute cardiac function and oxygenate emergency patients, is the ideal cardiopulmonary support system for PCI centers to fulfill the updated guideline recommendations... <a href="http://www.lifebridge.de/english/media-room/press-releases/17012012-new-accf-aha-scai-guidelines-with-increased-recommendations-for-the-use-of-extracorporeal-hemodynamic-support-in-patients-with-cardiac-or-cardio-pulmonary-failure-kopie.html">LIFEBRIDGE Medizintechnik's Press Release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-2817491189864827293.post-81397581501563002642012-02-03T03:54:00.000-08:002012-02-03T03:54:58.660-08:00Cellartis : partner in CardioNet, an EU-project with the aim to develop novel therapeutic tools for identification of heart disease<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img alt="Cellartis" border="0" height="64" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjjdvxDDJI44oijS2cKF-GzOZHE8YiA4SwPNFtkUjKnoSDNJkcPG2rxhku8u-usucxT2eYz0IZNeAXkKk4p9tfNNU3eXTO3HaEf_lr5RBwB3A7X_3bc28oLBmTpAHWtsXAJ_dd-Br6EgcZa/s200/Cellartis.jpg" width="149" /></a></div>
JANUARY 23, 2012 - <i><a href="http://www.cellartis.com/">Cellartis</a> is a partner in CardioNet, an EU-project with the aim to develop novel therapeutic tools for identification of heart disease</i> -<br />
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Enabling functional recovery of the heart after myocardial infarction through cardiac regeneration and repair is a major goal of cardiovascular and regenerative medicine. The CardioNet network, coordinated by the Spanish National Centre for Cardiovascular Research (CNIC), aims at integrating knowledge from holistic molecular and cellular biology approaches in order to better understand the regulation of heart development, homeostasis, and disease. This knowledge will contribute to the identification of new targets and the development of novel therapeutic tools for heart disease. In order to achieve these aims, a diverse interdisciplinary set of partners has been assembled comprising 13 partners throughout Europe.<br />
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<a imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img alt="Cellectis stem cells" border="0" height="79" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgXoeGZ2Mv9n5cGOh5wr4lhIAOI4GKEyCmTYMTygfmfsUmddvOWKhE-l80shp2SD84HF9B3dUPzBLBeHiPyICry6OaAVxTGsuf6WYQ36u-f0PO_hd6G5LQHf5z78YYWmO0mZkCV6KyMHiEy/s200/Cellectis+stem+cells.jpg" width="179" /></a></div>
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About <a href="http://www.cellectis.com/">Cellectis</a> stem cells : Cellectis stem cells speeds up the development of stem cell technology in particular to find a robust and reproducible way of controlling stem cell production and differentiation. Through the sharing of knowledge and expertise developed by the the two companies forming Cellectis stem cells - Cellartis and Ectycell – Cellectis stem cells becomes a major, long-term and stable industrial player in the global marketplace... <a href="http://www.cellartis.com/news/news-archive/93-january-23rd-2012">Cellartis' Press Release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-2817491189864827293.post-20689839345346600322012-01-25T16:25:00.000-08:002012-01-25T16:26:01.769-08:00Ikaria : Global Registration Trial for Bioabsorbable Cardiac Matrix<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear:right; float:right; margin-left:1em; margin-bottom:1em"><img border="0" alt="Ikaria" height="51" width="163" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiUZJ0y5NXP0kDjLMTciHh-o42hNBKMpkkmiHHFl3oPmXUSbIMBlcGE1gyO_5MG8apX3phWkZcNZPERNJVArB_Cfh4-_IQnXexQKAbcffyEYKNQ5GbysKv1r6VNwwgfH_sR72wTlYEnI1bP/s200/IKARIA+2011.jpg" /></a></div>
Jan. 3, 2012 - <i>PRESERVATION I Investigates Novel Device for Cardiac Remodeling and Congestive Heart Failure</i> -<br />
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<a href="http://www.ikaria.com/">Ikaria, Inc.</a>, a critical care company focused on developing and commercializing innovative therapies for critically ill patients in the hospital and ICU settings, announced that it has commenced its global development program, the PRESERVATION I clinical trial, for its Bioabsorbable Cardiac Matrix (BCM). The CE Mark registration trial has commenced in Australia , and will be followed in Europe. The trial also is expected to commence in other countries, including Israel.<br />
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PRESERVATION stands for A Placebo Controlled, Multicenter, Randomized, Double-Blind Trial to Evaluate the Safety and Effectiveness of IK-5001 for the Prevention of Remodeling of the Ventricle and Congestive Heart Failure After Acute Myocardial Infarction.<br />
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BCM, also known as IK-5001, is being investigated to prevent ventricular remodeling and subsequent congestive heart failure (CHF) following acute myocardial infarction (AMI). Ventricular remodeling is the structural alteration of the damaged heart muscle that occurs following an acute heart attack. Once this damage occurs, the weakened heart muscle forces the rest of the heart to compensate. Under this extra workload, the heart muscle dilates, the walls of the heart thin, and the heart further remodels, thereby causing another cycle of dilation and overcompensation. The extra workload to the heart causes further structural damage and can lead to congestive heart failure... <a href="http://www.ikaria.com/media/news/press_2012-Jan3-BCM-Trial-Initiation.pdf">[PDF] Ikaria's Press Release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-2817491189864827293.post-3623185649778859412012-01-18T16:21:00.000-08:002012-01-18T16:21:31.673-08:00REVA : the RESTORE Clinical Trial First Human Implants With ReZolve(TM) Scaffold<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img alt="REVA Medical" border="0" height="65" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjKVStfUNWTwqh04xbIEb6Vu93EffTgIDKj-UuGFS3CSZm1ebCys9mbO9Nfy3aIO-bBjBILGFtxf5RBgRNn0wLiz8vJqJtRH_3xnneaNPrdv_XOBk0-w6bKmYfzT4C8ZJa193P2NJBohXx0/s200/REVA+Medical.jpg" width="160" /></a></div>
Dec. 21, 2011 - <a href="http://www.teamreva.com/">REVA Medical, Inc. (ASX:RVA) ("REVA" or the "Company")</a> is pleased to announce that it has initiated patient enrollment in a pilot clinical study designed to evaluate its ReZolve™ Bioresorbable Sirolimus-Eluting Coronary Scaffold. The RESTORE Trial (Pilot Study of the ReZolve Sirolimus-Eluting Bioresorbable Coronary Scaffold) will evaluate the safety and performance of ReZolve in 50 patients at multiple leading heart centers in Brazil and Europe.<br />
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ReZolve is a fully bioresorbable polymer scaffold designed to provide all of the proven benefits of a metal drug-eluting stent, with the advantage of dissolving from the body after it is no longer needed, leaving the patient free of a permanent implant.<br />
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The first patient implant was performed by the study's principal investigator, Dr. Alexandre Abizaid, Chief of Coronary Interventions at the Instituto Dante Pazzanese de Cardiologia in Sao Paulo, Brazil. Dr. Abizaid is a renowned interventional cardiologist and the institute is one of the world's leading heart centers.<br />
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"The procedure went very smoothly in a 90% occluded coronary artery utilizing standard practices that are used to implant conventional metallic stents around the world today. The REVA fully bioresorbable polymer scaffold deployed and became well-apposed against the artery wall and we were able to visualize the entire scaffold under standard x-ray imaging, which was very helpful," commented Dr. Abizaid. "While we will need to continue to gather data over the coming year to measure the safety and efficacy of this device, I was pleased with the outcome of today's procedure; the ReZolve scaffold delivered and deployed as designed." Dr. Abizaid also added, "Bioresorbable scaffolds represent an exciting new frontier to the treatment of coronary artery disease due to their potential to return the vessel to normal function after restoring blood flow. I am excited about the potential clinical benefits ReZolve may provide our patients and my team looks forward to enrolling additional patients in the RESTORE trial."... <i><a href="http://files.shareholder.com/downloads/ABEA-5JMECA/1605049527x0x530016/50275acb-cd90-4b8f-bc43-3feb7b8b7de0/RVA_News_2011_12_21_General_Releases.pdf">[PDF] REVA Medical's Press Release</a></i> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-2817491189864827293.post-15903347530048824782012-01-12T15:18:00.000-08:002012-01-12T15:18:26.117-08:00AtriCure's Synergy Ablation System : FDA Approval for the Treatment of Atrial Fibrillation<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img alt="AtriCure" border="0" height="41" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg8gFdWswPnXexar2zQfp5noDqPTNyLTw2xg_SjIWM0tOL76_HYUhpgs5C343tZdA1EfonRCQ62Sr5otXkrOsUJsuN3_LzTwWdXNdF8RtntLcd-00_IzhfRBUHmPjbg1bTB-VK4fpPDsLYt/s200/atricure.jpg" width="200" /></a></div>
Dec 16, 2011 - <i>First and Only System in the United States Approved to Treat Patients with Persistent and Long-Standing Persistent Atrial Fibrillation</i> -<br />
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<a href="http://www.atricure.com/">AtriCure, Inc. (Nasdaq: ATRC)</a>, a medical device company and a leader in cardiac surgical ablation systems and systems for the exclusion of the left atrial appendage, announced that the U.S. Food and Drug Administration (FDA) has approved AtriCure's Synergy Ablation System for the treatment of atrial fibrillation (AF). Specifically, the Synergy Ablation System has been approved for the treatment of patients with persistent and long-standing persistent AF during open-heart concomitant coronary artery bypass grafting and/or valve replacement or repair procedures. This is the first time a surgical ablation system has been approved for the treatment of AF and the first time any system, catheter or surgical, has been approved in the United States for the treatment of patients with persistent and long-standing persistent AF.<br />
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"This marks the achievement of a major milestone for AtriCure, the field of cardiac surgery, and the treatment of AF. The approval confirms the effectiveness of the Synergy Ablation System and recognizes the increasing need for the surgical treatment of AF," said David J. Drachman, President and Chief Executive Officer. "We look forward to educating physicians and patients on our surgical alternative for the treatment of AF, which we believe will raise awareness for a large number of AF patients that are currently being undertreated. Importantly, we would like to thank all of our partners who worked with us to achieve this approval, particularly the FDA, physicians and their patients who participated in the ABLATE trial. Additionally, I would like to recognize the efforts of the AtriCure team, who have worked tirelessly toward the successful achievement of this seminal milestone."...<a href="http://ir.atricure.com/phoenix.zhtml?c=189981&p=irol-newsArticle&ID=1640461&highlight=">AtriCure's Press Release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-2817491189864827293.post-15878166945816859462012-01-06T01:32:00.000-08:002012-01-06T05:32:10.200-08:00BioLineRx : Initiation of CE Mark Registration Trial for BCM (BL-1040), a Novel Medical Device for Prevention of Cardiac Remodeling Following Acute Myocardial Infarction<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img alt="BioLineRx" border="0" height="20" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhaS_Wcsd_IjVIQrmGHNo-Ass2a48bMqYHwjUNyUz1vNI8TlxS8jTyV0VagFkmhsukWvxmEqII4nniGsh1u1nssoFJPXLSSGOCM7EMil3kYhoVYTYGPRgVPtVJ28mb4SYv41-plWpQ8xnPG/s200/BIOLINERX.png" width="200" /></a></div>
January 3, 2011 - <a href="http://www.biolinerx.com/">BioLineRx(NASDAQ:BLRX; TASE:BLRX)</a>, a biopharmaceutical development company,
announced the commencement of the PRESERVATION I clinical trial, a CE
Mark registration trial of BCM (BL-1040), a novel medical device
intended for the prevention of cardiac remodeling following an acute
myocardial infarction (AMI). The trial has commenced in Australia,
will be followed in Europe, and is expected to commence in additional
countries, including Israel. Ikaria Inc., which acquired the license
for continuation of development and commercialization of BL-1040 from
BioLineRx in July 2009, is now leading BL-1040's clinical development
as Bioabsorbable Cardiac Matrix (BCM), previously named IK-5001.<br />
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<div style="margin-bottom: 0cm;">
PRESERVATION stands for A Placebo
Controlled, Multicenter, Randomized, Double-Blind Trial to Evaluate
the Safety and Effectiveness of IK-5001 for the Prevention of
Remodeling of the Ventricle and Congestive Heart Failure After Acute
Myocardial Infarction.
</div>
<div style="margin-bottom: 0cm;">
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<div style="margin-bottom: 0cm;">
PRESERVATION I aims to evaluate the
safety and effectiveness of BCM (BL-1040) for prevention of
ventricular remodeling and congestive heart failure when administered
following AMI. The trial is a placebo-controlled, randomized,
double-blind, multi-country and multi-center trial including
approximately 300 patients which are expected to be recruited across
45 sites. This includes approximately 50 Australian patients at 11
clinical trial sites. The BCM device will be administered to subjects
who had successful percutaneous coronary intervention with stent
placement after ST-segment elevation myocardial infarction (STEMI)
and they will then be monitored for six months... <a href="http://www.biolinerx.com/default.asp?pageid=16&itemid=102">BioLineRx's PressRelease</a> -</div>Unknownnoreply@blogger.comtag:blogger.com,1999:blog-2817491189864827293.post-69002899668843721152011-12-19T14:13:00.000-08:002011-12-19T14:13:57.689-08:00Mylan : Generic Version of Toprol-XL® Tablets<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img alt="Mylan Pharmaceuticals" border="0" height="37" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgM2m7EozMAn_znlNo5WrM6z1PlxWGGPDQJJESXACHN3OCZKJnem533DcS0YUxm2JEN_yzesmKDIIFk6XWGdzYc1XCrlgZVwclC7IiCFlgjeVrCy6J_V_9x6TIw6ReYWlEOTlL9PQ7bWmzp/s200/Mylan+Pharmaceuticals.gif" width="150" /></a></div>
Dec. 16, 2011 - <a href="http://www.mylan.com/">Mylan Inc. (Nasdaq: MYL)</a> announced that its subsidiary <a href="http://www.mylanpharms.com/">Mylan Pharmaceuticals Inc.</a> has received final approval from the <a href="http://www.fda.gov/">U.S. Food and Drug Administration (FDA)</a> for its Abbreviated New Drug Application (ANDA) for Metoprolol Succinate Extended-release (ER) Tablets USP, 25 mg, 50 mg, 100 mg, and 200 mg. This product is the generic version of <a href="http://www.astrazeneca.com/">AstraZeneca</a>'s Toprol-XL® Tablets, which are indicated for the treatment of hypertension.<br />
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Metoprolol Succinate ER Tablets had U.S. sales of approximately $1.18 billion for the 12 months ending Sept. 30, 2011, according to <a href="http://www.imshealth.com/">IMS Health</a>. Mylan's launch of this product is representative of the company's strength in continuing to bring difficult-to-formulate medicines to market.<br />
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Currently, Mylan has 166 ANDAs pending FDA approval representing $98.3 billion in annual sales, according to IMS Health. Forty-three of these pending ANDAs are potential first-to-file opportunities, representing $26.9 billion in annual brand sales, for the 12 months ending June 30, 2011, according to IMS Health... <a href="http://investor.mylan.com/releasedetail.cfm?ReleaseID=633996">Mylan's Press Release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-2817491189864827293.post-51102539669683166002011-11-28T11:28:00.001-08:002011-11-28T11:36:18.903-08:00Philips : HeartStart FR3 automated external defibrillator for professional responders treating victims of sudden cardiac arrest<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img alt="Philips Healthcare" border="0" height="43" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiYLcZCsQFIHMgALTCJur4ZjI20PSYqCXyYfLjFF34zzW-dvU7xWs26TCh5UtsHKKHuVkvx0YECS07Z1FFFwV5XP51RG9-RbujJTJMLm8HDS86SntBIsst1r4AuSCZLIMgbvWokIdmBN_sb/s200/philips.gif" width="162" /></a></div>
November 14, 2011 – <a href="http://www.healthcare.philips.com/">Royal Philips Electronics (NYSE: PHG, AEX: PHI)</a> introduced Philips HeartStart FR3 automated external defibrillator (AED) in the U.S. for professional responders who treat victims of sudden cardiac arrest (SCA). As the smallest and lightest professional-grade AED among leading global manufacturers, the HeartStart FR3 is Philips’ most advanced professional-grade AED. The rugged and reliable HeartStart FR3 is designed to help make lifesaving faster and easier for professional responders. The FR3 requires a prescription for use in the United States, and must be used under medical direction.<br />
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SCA is one of the leading causes of death in the United States, claiming nearly 300,000 lives each year. Defibrillation is recognized as the only definitive treatment for ventricular fibrillation, the abnormal heart rhythm most often associated with SCA. While cardiopulmonary resuscitation (CPR) may help prolong the window of survival, CPR alone cannot restore a normal cardiac rhythm. After 10 minutes without defibrillation, few attempts to resuscitate an SCA victim are successful.<br />
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Recognizing that time-to-therapy matters, the HeartStart FR3 significantly reduces deployment time by eliminating steps to help responders start delivery of the right therapy – CPR or defibrillation – on the patient faster. The FR3 automatically powers on when the Philips HeartStart FR3 carry case is opened1. The device also features easy to access, pre-connected peel and place pads that do not require opening a foil pouch. These unique features help speed therapy delivery... <a href="http://www.newscenter.philips.com/us_en/healthcare/news/press/2011/20111114_fr3.wpd">Royal Philips Electronics' Press Release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-2817491189864827293.post-50660582822231697452011-11-24T11:21:00.001-08:002011-11-24T11:27:25.833-08:00RegeneRx : Notice of Allowance on Two Cardiac-Related Patent Applications<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img alt="RegeneRx Biopharmaceuticals" border="0" height="60" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi7ksfgxV2Cn3ljFeYlXFsYDmOkVoQOimcoTjyLeUowrrzL5A7Ef77BKvvK011UTW6T6lz8GAAUP_z6c75gx0AnMma__NZuZUUQcnpvLK5WuSsNGZy-a2RQi_TTNi1fDWtF1YONuICO1QEQ/s200/regenerx.gif" width="200" /></a></div>
November 17, 2011 — <b>RegeneRx Receives Notice of Allowance on Two Cardiac-Related Patent Applications</b> -<br />
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<a href="http://www.regenerx.com/">RegeneRx Biopharmaceuticals, Inc. (OTC Bulletin Board: RGRX) (“the Company” or “RegeneRx”)</a> announced that the Company has been notified that two cardiac-related patents will be allowed in Australia and Mexico.<br />
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The Australian patent is for the treatment or prevention of damage due to heart failure and will expire in July, 2026.<br />
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The Mexican patent is for the treatment or prevention of damage caused by increased blood flow in the myocardium, commonly called reperfusion injury. It will expire in January, 2026.<br />
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RegeneRx has similar patents pending in numerous other countries, including in the U.S., Asia and Europe... <a href="http://www.regenerx.com/wt/page/pr_1321557969">RegeneRx Biopharmaceuticals' Press Release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-2817491189864827293.post-48920694109796226582011-11-16T14:40:00.001-08:002011-11-16T14:53:14.307-08:00STENTYS : Outstanding Interim Results of STENTYS International Clinical Study of 600 Heart Attack Patients<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img alt="STENTYS" border="0" height="62" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhcQ8gzXaYqXvQGpBifusoeuO9A_1uk-DUTY2fOOA9CB4MYCwCkZQo9wHSyTXDanRne0BGPI96IFQNQKX71wkUYu9aQI0q8JjapTvkPwBbRWkTLOYt1bDyNE1n5mt5Q_dnafOJGuEVfo6M4/s200/STENTYS+2011.jpg" width="200" /></a></div>
November 08, 2011 - PRINCETON, N.J. & PARIS - <i>Lower rate of adverse events for STENTYS Self-Apposing™ Stent compared to reported results of conventional stents</i> -<br />
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<a href="http://www.stentys.com/">STENTYS S.A. (STNT.PA)</a>, a medical technology company commercializing the world's first and only Self-Apposing™ Stent to treat Acute Myocardial Infarction (AMI), disclosed today data on 600 patients from its ongoing “APPOSITION III” international clinical study who underwent an examination 30 day after treatment of a severe heart attack.<br />
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“With only 2.4% of patients experiencing a Major Adverse Cardiac Event (MACE) at 30 days in the latest patient cohort compared to rates of over 5% in published landmark trials with conventional stents, these remarkable preliminary clinical results could challenge the existing gold standard of treating AMI patients with balloon-expandable stents,” said study investigator Dr. Robert Jan van Geuns, M.D., Ph.D., Thorax Center at Erasmus Medical Center, Rotterdam, the Netherlands.<br />
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“We believe that these impressive clinical results confirm the Self-Apposing™ technology as the best solution for treating heart attack patients, and will contribute to increase its adoption in routine practice,” said Gonzague Issenmann, CEO and co-founder of STENTYS.<br />
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The STENTYS Self-Apposing™ Stent represents a major breakthrough: it solves the stent sizing dilemma that cardiologists are confronted with when treating heart attack patients with conventional stents. It “fits snugly” into the contour of a blood vessel, and its shape and diameter adapt to the anatomic changes of the coronary arteries during the post-AMI phase, avoiding a major complication of all other conventional stents: malapposition... <a href="http://www.stentys.com/file_bdd/documents/1320767405_StentysCPAppoIIIvfENG.pdf">[PDF] STENTYS' Press Release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-2817491189864827293.post-1151267959063532522011-11-04T09:34:00.000-07:002011-11-04T09:35:16.757-07:00Emboline : to Debut Game-Changing Embolic Protection Technology for Percutaneous Heart Valve Procedures in San Francisco Next Week<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear:right; float:right; margin-left:1em; margin-bottom:1em"><img border="0" alt="Emboline" height="43" width="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhBMXTAvzdmM821YD0gsJQNhh6d-4sGAzNDiLuv23DGwjnlacJ_Fw8c2yZIBfc3VhqaTLxO4d6hA7RBgoCTpUdhrMHbQxBLpTIv6JLL7bwAKiZdPpibfNHuSVRNNJxc4vLjok10_V_ujg4Q/s200/emboline.jpg" /></a></div>
November 02, 2011 - <i>Emboline CAP™: new approach to eliminating aortic embolic risk, providing Complete Accessible Protection™ from cardiac procedural-related emboli</i> -<br />
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<a href="http://www.emboline.com/">Emboline, Inc.</a>, an emerging medical device company, will debut its game-changing embolic protection devices for percutaneous heart valve repair and replacement in San Francisco next week.<br />
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The Company is initially focused on developing its novel Emboline CAP™ device; a next-generation system intended to provide complete protection of the arterial bed (both the cerebrals and the aortic lumen) utilizing a uniquely ported design that maintains tool access through the filter.<br />
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In addition, Emboline is also developing Emboliner™, a simple-to-use, low profile system for protection of the cerebral vessels alone... <a href="http://www.emboline.com/Emboline_Launch_110111.pdf">[PDF] Emboline's Press Release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-2817491189864827293.post-74853707151290892542011-10-25T14:50:00.000-07:002011-10-25T14:52:11.926-07:00SORIN GROUP INVESTS IN ENOPACE BIOMEDICAL<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img alt="Enopace Biomedical" border="0" height="66" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi_JyoncN37Ljbn48-PAU8ggtV8Yp_nf2ImRRFynlfvr6GitMeP6PC1k1vn6qWT12JntJ5V51_8VXr-A7cmqzOy5nHKLRlhi9Q0mbdq9Hl9qc7GiJ30h61xHrZUJO_QtddBcoAUIYsrniBV/s200/Enopace+Biomedical.jpg" width="200" /></a></div>
October 17, 2011 - <b>SORIN GROUP INVESTS IN ENOPACE BIOMEDICAL, EARLY STAGE COMPANY FOCUSED ON INNOVATIVE SOLUTION FOR HEART FAILURE PATIENTS</b> -<br />
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<i>Investment will drive development of a unique interventional technology for the largest unmet clinical need in the cardiovascular field</i> –<br />
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<a href="http://www.sorin.com/">Sorin Group (Reuters Code: SORN.MI)</a>, a global medical device company and a leader in the treatment of cardiovascular diseases, announced a minority investment in <a href="http://www.enopace.com/">Enopace Biomedical</a>, an early-stage company focused on the development of a neuromodulation system to treat patients with congestive heart failure.<br />
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Enopace’s technology consists of a minimally invasive, implantable neurostimulator for heart failure patients that increases cardiac efficiency by reducing left ventricular workload. Sorin’s $7 million investment will finance the initial clinical studies of this technology as well as ongoing product development. Sorin Group joins Rainbow Medical as an investor in Enopace.<br />
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<a imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img alt="Sorin Group" border="0" height="28" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjx2HSAidQuOdzIC8TZUT2HNTFAXMYJzrLf_AoT3_2h5buxDG0W97xH0RzGRXbsRfjnA_mv2G7EVb-M_nkl0XxeAx3jo2MhkgffJvS9phDwMXUt0FWyJoHtHDoz1mPAGjGytqNTHtNItfcG/s200/sorin.jpg" width="107" /></a></div>
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Heart failure is the largest unmet clinical need, with the highest associated healthcare costs, in the cardiovascular world today. In Europe and in the United States around 15 million patients suffer from chronic heart failure. The United States healthcare system spends over $40 billion to treat these patients. CRT (cardiac resynchronization therapy) devices currently address part of the systolic heart failure population, but no approved therapies exist for diastolic patients. Neuromodulation systems represent a significant opportunity to expand the clinical indications for device-based heart failure therapy and, moreover, enhance the treatment for congestive heart failure patients... <a href="http://www.sorin.com/press-release/sorin-group-invests-enopace-biomedical-early-stage-company-focused-innovative-solution-heart-failure-patients">Sorin's Press Release</a> -Unknownnoreply@blogger.com