Sunshine Heart Completes AU Portion of Placement

05 September 2011 - Two-part financing strategy supporting C-Pulse® Heart Assist System - Sunshine Heart, Inc. (ASX: SHC), announced it has entered into definitive agreements with institutional and high net worth investors to sell approximately 55.8 million shares of common stock in a private placement totaling $2.2 million. This completes the Australasian portion of the Company’s financing plan, as previously announced and approved by shareholders at its General Meeting on July 18, 2011. Proceeds from the placement will be used to support the U.S. pivotal trial and the continued development of the C-Pulse® Heart Assist System.

Terms of the placement are identical to the first tranche, which closed on July 27, 2011. Investors also receive warrants to purchase 3 shares of common stock for every ten shares purchased, at an exercise price of $0.056 per share (4-year term). RBS Morgans was the exclusive Australian placement agent for the transaction.

“As we progress to our next important stage of development, we are expanding our investor base in North America. Australasian investors have been included in the placement on the same terms and conditions. The Board and the management team very much appreciate the continuing support from our long-standing shareholders who participated in this financing, including our largest shareholder, CM Capital. We are very encouraged by the quality of new investors joining the registry. This is an exciting time for Sunshine Heart, and this financing is an essential part of our accelerating development,” said Dave Rosa, Sunshine Heart’s Chief Executive Officer.

The Company has shareholder approval to issue up to an additional 170.6 million shares on the same terms until September 16, 2011, the cut-off date agreed with participants in the first tranche of the placement. Thus far, $6.8 million has been raised.

About the C-Pulse Heart Assist System

C-Pulse Heart Assist System utilizes an extra-aortic approach to proven intra-aortic balloon counter pulsation technology to assist the left ventricle by reducing the workload required to pump blood throughout the body, while increasing blood flow to the coronary arteries. Operating outside the patient’s bloodstream, the novel extra-aortic approach of the C-Pulse technology offers greater flexibility allowing patients to disconnect as necessary or desired... [PDF] Sunshine Heart's Press Release -

MAQUET Cardiovascular : FDA 510(k) Clearance and CE Mark for Its New SENSATION PLUS™ Intra-Aortic Balloon Catheter

Sept. 20, 2011 -- MAQUET Cardiovascular, a leading provider of cardiovascular technologies, announced today that it has received both 510(k) clearance from the U.S. Food & Drug Administration (FDA) and CE mark approval from the British Standards Institution (BSi) for its new SENSATION PLUS™ 50cc 8 Fr. intra-aortic balloon catheter. The new SENSATION PLUS intra-aortic balloon (IAB) catheter is the first 50cc 8 Fr. IAB catheter to combine fiber optic signal acquisition with greater hemodynamic support compared to a standard 40cc IAB catheter.

"Clinicians have been asking for an IAB that combines all of the benefits of fiber optic technology; faster initiation of therapy, easier patient management and a crisp, clean arterial pressure wave form with increased hemodynamic support," said Deb Joseph, Vice President, Marketing and Clinical Services. "We believe that the new, state-of-the art SENSATION PLUS™ intra-aortic balloon catheter meets these needs and will enable clinicians to provide patients with improved care."

The new 50cc 8Fr. SENSATION PLUS IAB catheter provides greater patient support, comfort and ease of use than any IAB catheter MAQUET has ever offered. SENSATION PLUS incorporates fiber optic signal acquisition and provides 25 percent more blood volume displacement than standard 40cc IAB catheters, allowing for improved unloading and better augmentation. This new IAB catheter also comes with two Stat Lock® IAB stabilization devices which allow the catheter to be secured to the patient's leg without sutures. This is more comfortable for patients and eliminates the risk of suture needle sticks for clinicians when initiating counterpulsation support. The new IAB catheter will be available for sale in October... [PDF] MAQUET's Press Release -

Ono Pharmaceutical : License Agreement with Servier for Ivabradine

September 14, 2011 - Ono Pharmaceutical Co., Ltd. (Osaka, Japan) announced that it has entered into a license agreement with LES LABORATOIRES SERVIER (Suresnes, France) to exclusively develop and commercialize in Japan Ivabradine (generic name) which is on the overseas market* for the treatment of stable angina and currently under review by European Medicines Agency (EMA) of marketing approval application for the additional indication of chronic heart failure (CHF). Ono will pay to Servier 20 million euros as an upfront payment of the agreement and thereafter milestone payments based on development stage. In addition, Ono will also pay sales-based milestone payments upon achievement of projected sales.

In CHF, heart cannot pump out enough blood to satisfy oxygen requirement in major organs due to decreased cardiac function. That leads to congestion in lungs or systemic venous which cause various systemic symptoms including dyspnea and sense of exhaustion and daily lives of patients are therefore impaired. It is known that life prognosis of CHF patients are very poor and also that, while higher heart ratemay be increased in order to compensate for low cardiac output, this increase is detrimental in the long term. In fact, it is reported that higher heart rate has been associated with poor prognosis... [PDF] Ono Pharmaceutical's Press Release -

Advanced Circulatory Systems : NIH-Funded Study Demonstrates That Patients Receiving New CPR Devices (ResQPOD and ResQPUMP) and Cooling Have Improved Long-Term Brain Function Following Cardiac Arrest

Sept. 6, 2011 - Advanced Circulatory Systems Inc. (ACSI) announced results from a large, NIH-funded clinical trial comparing standard cardiopulmonary resuscitation (CPR) to a new method of CPR that provides greater protection to the heart and brain when the heart stops beating (cardiac arrest).

Their new device combination, called the ResQCPR™ System, combines an active compression decompression CPR (ACD-CPR) device, called the ResQPump™, and an impedance threshold device (ITD), called the ResQPOD®.

Additional results from the ResQTrial study have now demonstrated that when the ResQCPR System was used together with therapeutic hypothermia, there was a six-fold increase in the percentage of patients who improved from poor neurologic function at hospital discharge to good neurologic function at 90 days, when compared to standard CPR with hypothermia.

"The striking improvement in patients treated with the ResQCPR System and hypothermia demonstrates the important synergy between the two technologies. These findings provide a new way to significantly decrease the number of patients with poor long-term neurological function, especially when the ResQCPR System is applied early during cardiac arrest," ... [PDF] Advanced Circulatory Systems' Press Release -

nContact : CE Mark Approval of its Generation 4 "EPi-Sense(TM)" Epicardial Ablation System

August 18, 2011 - First Multi-disciplinary, All-in-One Tool that Enables Epicardial Ablation, Mapping and Navigation for the Treatment of Cardiac Arrhythmias - nContact, Inc. (nContact), the leading innovator in epicardial ablation devices and techniques, announces it has received CE Mark approval for the "EPi-Sense(TM) Guided Coagulation Device with VisiTrax®" for the treatment of cardiac arrhythmias, including atrial fibrillation. The EPi-Sense features first-of-its kind epicardial sensing electrodes designed to allow both electrophysiologists (EP) and cardiothoracic surgeons to map and navigate the epicardium and locate areas for linear epicardial ablation. John Funkhouser, CEO, nContact, Inc., said, "The CE Mark approval of the EPi-Sense System, our 4th generation of coagulation devices, marks yet another milestone in our commitment to improve and evolve epicardial ablation tools and techniques for better access to the heart. Our goal is to create a new standard of care for treating cardiac arrhythmias. We believe epicardial ablation is critical to better clinical outcomes, and the new 'hybrid' device is designed for use by both EPs and surgeons." EPi-Sense further enhances the advantages of the Convergent Procedure, a closed chest, endoscopic technique enabled by nContact's Numeris® Coagulation System with Visitrax®. The primary procedure advantages include visible access to the posterior of the atrium through a trans-diaphragmatic pericardial window (eliminating the need for chest incisions, ports, lung deflation or heart dissections), and the ability to create visible, non-conductive, linear lesions on a beating heart. With the new EPi-Sense device, EP mapping systems can locate the EPi-Sense ablation device in real time... [PDF] nContact's Press Release -