Healthcare Industry News: neuromodulation
News Release - August 19, 2013
St. Jude Medical Acquires EndosenseSt. Jude Medical adds ablation catheter with contact-force measurement to its industry-leading atrial fibrillation portfolio and accelerates U.S. timeline for AF ablation indication
ST. PAUL, Minn. & GENEVA--(Healthcare Sales & Marketing Network)--St. Jude Medical, Inc. (STJ), a global medical device company, today announced the acquisition of Endosense SA, a Switzerland-based company that has pioneered contact-force measurement in catheter ablation. The acquisition adds to the company’s leading electrophysiology portfolio and provides a robust platform for future product development.
St. Jude Medical has made an initial payment of approximately 159 million Swiss francs ($170 million USD) and acquired 100 percent of the outstanding equity of Endosense. The terms of the transaction also provide for an additional cash payment of up to 150 million Swiss francs ($161 million USD), which is contingent upon both the achievement and timing of a regulatory milestone. The company funded the initial payment using available cash from outside of the U.S. and expects to make any future payments using these same cash balances. Except for acquisition-related expenses, this acquisition does not impact St. Jude Medical’s outlook for 2013 consolidated earnings per share.
Endosense Force-Sensing Technology
Endosense developed the TactiCath irrigated ablation catheter to give physicians a real-time, objective measure of the force they apply to the heart wall during a catheter ablation procedure. Without contact-force data, physicians have to estimate the amount of force applied to the heart wall during an ablation. If too little force is applied, there is a risk of incomplete lesion formation that could result in AF recurrence, potentially requiring additional treatments. If too much force is applied, there is a risk of tissue injury, which can lead to serious procedure-related complications.
“Force sensing is a tremendous advancement in cardiac ablation that will potentially improve safety and efficacy, likely becoming a standard for all cardiac ablations,” said Dr. Vivek Reddy, professor of medicine and principal investigator in the TOCCASTAR trial at Mount Sinai Hospital, N.Y. “As the first and most studied force-sensing catheter on the market, TactiCath now provides St. Jude Medical with a best-in-class ablation catheter.”
There is a growing body of evidence to support the safety and effectiveness of contact-force ablation technology, including Endosense’s TOCCATA, EFFICAS I and EFFICAS II studies, which have collectively demonstrated safety and reduced rate of AF recurrence when contact force was used. TactiCath is CE Mark approved for atrial fibrillation (AF) and supra ventricular tachycardia (SVT) ablation. In addition, Endosense just completed its U.S. IDE trial – the TOCCASTAR trial – and plans to submit its pre-market approval application to the U.S. Food and Drug Administration (FDA) in support of a paroxysmal AF indication before the end of 2013.
"TactiCath offers important improvements over previous-generation ablation catheters,” said Prof. Dr. Karl-Heinz Kuck, director of cardiology at St. Georg Hospital in Hamburg, Germany. “While low contact force can lead to ineffective lesions, excessive contact force can cause safety concerns. The ability to more precisely measure this force improves procedural efficiency and provides increased confidence that an ablation will be effective in treating complex cardiac arrhythmias."
The acquisition of Endosense is highly complementary to the St. Jude Medical business. The Endosense force sensing technology provides a strong, patent-protected platform for future product development. Immediate opportunities to integrate this technology into other proprietary St. Jude Medical technologies include the potential to offer a MediGuide-enabled force-sensing ablation catheter and to incorporate force sensing data into the company’s EnSite Velocity™ Mapping System. In addition, St. Jude Medical’s global presence and geographic distribution scale can further strengthen and enhance Endosense’s international growth in a number of markets.
“The acquisition of Endosense further strengthens our industry-leading portfolio of products to treat patients with cardiac arrhythmias, and provides an opportunity to accelerate our market share capture in the $900 million global cardiac ablation catheter market,” said Frank J. Callaghan, president of the Cardiovascular and Ablation Technologies Division of St. Jude Medical. “This transaction significantly accelerates our timeline to providing an irrigated ablation catheter that incorporates force sensing in both international and U.S. markets, and has potential future applications across other St. Jude Medical technology platforms as well.”
In connection with this transaction, BofA Merrill Lynch is acting as financial advisor and Gibson, Dunn & Crutcher LLP and Homburger AG as legal advisors to St. Jude Medical. Perella Weinberg Partners is acting as financial advisor and Baker & McKenzie is acting as legal counsel to Endosense.
Founded in Geneva in 2003, Endosense is a medical technology company focused on improving the efficacy, safety and accessibility of catheter ablation for the treatment of cardiac arrhythmias. The company pioneered the use of Contact Force measurement in catheter ablation with the development of the TactiCath, the industry’s first force-sensing ablation catheter. Endosense is backed by Edmond de Rothschild Investment Partners, NeoMed Management, Gimv, VI Partners, Sectoral Asset Management, Ysios Capital Partners, Initiative Capital Romandie and NGN Capital. For more information, visit www.endosense.com.
About St. Jude Medical
St. Jude Medical is dedicated to transforming the treatment of some of the world’s most expensive, epidemic diseases. The company does this by developing cost-effective medical technologies that save and improve lives. Headquartered in St. Paul, Minn., St. Jude Medical has four major clinical focus areas that include cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company’s Annual Report on Form 10-K for the fiscal year ended December 29, 2012 and Quarterly Report on Form 10-Q for the fiscal quarter ended June 29, 2013. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
Source: St. Jude Medical
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