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Stock Market & Financial Investment News

News Breaks
May 1, 2014
06:58 EDTHTWRHeartWare issues voluntary device correction for HeartWare batteries
HeartWare issued a voluntary Urgent Medical Device Correction related to all HeartWare Ventricular Assist System batteries, product codes 1650 and 1650-DE. In letters to clinicians and patients, the company reports an observed increase in complaints related to earlier-than-expected battery depletion and routine battery handling. HeartWare is providing information to assist patients and clinicians in monitoring battery performance, recognizing abnormal behaviors and reinforcing proper power management. Premature or unrecognized deterioration of battery capacity or lapses in recommended power management pose a risk to the patient and, although rare, may result in serious injury or death. If a battery shows abnormal behavior, patients are instructed to stop using that battery and contact their VAD Coordinator for a replacement. No deaths have been reported to HeartWare that were directly related to a faulty battery. However, between January 1, 2011 and March 31, three deaths were reported that were potentially related to power source management. Of those, two patient deaths occurred after both sources of power were simultaneously disconnected; the third patient had batteries that far exceeded their expected useful life. A fourth death was originally reported as possibly related to power management, but was later determined to be more likely related to an accidental disconnection of the driveline. Clinicians and patients are encouraged to review the correction letters and the Patient Manual to ensure proper power management.
News For HTWR From The Last 14 Days
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September 3, 2015
09:42 EDTHTWRLeerink medical supplies/devices analyst holds analyst/industry conference call
Medical Supplies & Devices Analyst Antalffy, along with St. Paul's Hospital & Vancouver General Hospital Cardiac Transplant Program Surgical Director, Dr. Anson Cheung, and San Rafaele Hospital Cardiac Catheterization Lab & Vascular Interventions, Dr. Antonio Colombo, assess Valtech's pipeline and potential market opportunity on an Analyst/Industry conference call to be held on September 3 at 12:30 pm.
09:36 EDTHTWRLeerink medical supplies/devices analyst holds analyst/industry conference call
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September 2, 2015
13:21 EDTHTWRHeartWare plunges after Valtech deal sparks downgrades
Shares of HeartWare (HTWR) have plunged after the company's acquisition of cardiac device maker Valtech, with multiple analysts struggling to find any particularly strong rationale for the deal. WHAT'S NEW: Raymond James' Jayson Bedford downgraded HeartWare to Market Perform from Outperform after the company announced Tuesday night that it agreed to acquire Valtech Cardio, an Israeli-based company focusing on heart valve devices. Bedford said he was "surprised" by the size of the deal, noting that the all-stock transaction is valued at roughly $430M and will see Valtech owning roughly 22% of HeartWare upon closing. The acquisition is simply not what Bedford "envisioned" for the company, said the analyst. His prior investment thesis was based upon HeartWare's potential to dominate the ventricular assist device market, an idea "validated" by St. Jude's (STJ) pending acquisition of Thoratec (THOR), said Bedford. That thesis has now been disrupted by last night's early-stage asset buy at a "steep price," raising the overall execution risk of HeartWare, the analyst tells investors. WHAT'S NOTABLE: HeartWare was also hit with a downgrade to Neutral by BTIG, with the research firm emphasizing that the transaction will bring significant dilution to the company's existing shareholders. Northland's Suraj Kalia was even more bearish this morning, saying that the acquisition "does not make sense," coming at an "astronomical" multiple for an asset with "no obvious complementarity" and different domain expertise. Valtech's Cardioband CE study involved just 45 patients and only 40% of those were followed up at twelve months, said Kalia, who contended that the study does not present an accurate picture of clinical viability. Heartware will have to invest "significantly" to get Valtech's technology through U.S. trials, said the analyst, and entering the transcatheter mitral valve repair market will also bring new competition in the form of Edwards (EW), Medtronic (MDT), Boston Scientific (BSX), St. Jude and Abbott (ABT). PRICE ACTION: Shares of HeartWare have dropped more than 19% in intraday trading to $65.98, dipping below their 52-week low in the process.
12:22 EDTHTWROn The Fly: Top stock stories at midday
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10:00 EDTHTWROn The Fly: Analyst Downgrade Summary
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07:53 EDTHTWRHeartWare downgraded to Market Perform from Outperform at Raymond James
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07:36 EDTHTWRHeartWare downgraded to Neutral from Buy at BTIG
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September 1, 2015
16:21 EDTHTWRHeartWare agrees to acquire Valtech Cardio
HeartWare announced that it has entered into a definitive agreement to acquire Valtech Cardio. According to the terms of the agreement, Valtech shareholders will receive an up-front consideration of 4.4M shares of HeartWare common stock; 800,000 shares of HeartWare common stock, contingent upon CE Mark approval for Cardioband; and 700,000 shares of HeartWare common stock upon the earlier of first-in-man implants for either Cardioband tricuspid or CardioValve. The transaction also includes warrants to purchase 850,000 shares of HeartWare common stock at an exercise price of $83.73 per share exercisable upon attainment of $75M in net sales of Valtech products, and an earn-out payment of $375M, upon attainment of $450M of net sales of Valtech products. This transaction was approved by the boards of HeartWare and Valtech, with holders of more than 70% of Valtech's shares having signed support agreements committing to the transaction. The transaction is subject to regulatory approvals, as well as HeartWare stockholder and Valtech shareholder approvals. The closing of the transaction is expected in late 2015.

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