Boston Scientific’s (NYSE:BSX) got a busy road ahead, with regulatory approvals and market launches in the works for products in some of its hottest business divisions.
During a conference held in Marlborough, Mass., today, incoming CEO Michael Mahoney – currently listed as president – detailed the outlook for 7 of the company’s up-and-coming divisions, including for the newly acquired Cameron Health subcutaneous ICD and the highly competitive renal denervation market.
Mahoney described the timeline as a "high-level strategy of gaining share in our core business, expanding globally, moving into some smart adjacencies that are growing quickly that leveraging our strength, and also cost productivity."
Alair asthma treatment – 20 countries and 200 sites by the end of the year
Boston Scientific’s Alair bronchial thermoplasty system, which provides relief for patients with persistent asthma, was the star of today’s presentation.
The Alair system already has CE Mark approval in the European Union and FDA approval for the U.S. (since March), and Mahoney predicted that the worldwide market for bronchial thermoplasty will hit $1 billion by 2020.
The Alair system delivers precise thermal energy to lung tissue via bronchoscope to reduce excessively smooth muscle, decreasing the airways’ ability to constrict.
The procedure won reimbursement from the Centers for Medicare & Medicaid Services at the start of this year.
Cameron S-ICD – FDA approval in 1st half of 2013
Boston Scientific on Friday closed its $1.35 billion buyout of Cameron Health, and with it the only subcutaneous implantable cardioverter eon the world market. Cameron’s S-ICD won CE Mark approval in the European Union in 2009, and Boston Scientific expects FDA approval and U.S. launch in 2013, Mahoney said today.
"We target this market at about $750 million for the subcutaneous ICD," Mahoney told attendees. "It truly is a very unique, novel device in healthcare. We’re very excited about exercising that option and closing that deal, and we anticipate FDA approval hopefully in the 1st half of 2013."
Clinical trial data debuted at the Heart Rhythm Society meeting in Boston last month found that the S-ICD system had comparable safety and effectiveness to traditional ICDs in treating life-threatening ventricular arrhythmias. The device is awaiting final word from the FDA, having won a positive vote from the federal watchdog agency’s advisory committee in April.
Renal denervation – 1st human use in Q3 2012
Boston Scientific is looking to stay apace with rivals in the highly competitive renal denervation market, which is currently led by pure-play device maker Medtronic (NYSE:MDT) and cross-town rival St. Jude Medical (NYSE:STJ).
BSX expects 1st human use in the 3rd quarter of 2012 for its RDN renal denervation system as treatment for resistant hypertension, predicting CE Mark approval and European commercialization in 2013. Mahoney pegged the renal denervation market at around $3 billion worldwide by 2020.
Medtronic’s Symplicity is already on the road to FDA review with clinical trials approved last summer in the U.S. St. Jude’s Enlightn, the 1st to use multiple electrodes, won CE Mark approval last month in the European Union.
Boston Scientific has "a number of organic programs currently taking place to enter the hypertension market," Mahoney says, and the company expects U.S. trials in 2014.
Transcatheter aortic valves – CE Mark in second half of 2013
Boston Scientific’s Lotus transcatheter aortic valve system
designed to minimize valve leakage post-implant, should win CE Mark approval in the European Union in the second half of 2013, at which point the company expects to launch a the device in Europe.
The company acquired the Lotus system in 2011 with the $450 million buyout of Sadra Medical, and Mahoney pegged the market at about $3 billion by 2020.
BSX implanted the 1st 11 patients with its Lotus TAVI system in Australia in the Reprise I trial, which was unveiled earlier this year, and the Reprise II trial, which will be used to support a bid for CE Mark approval, should close enrollment in the 1st half of 2013.
"We believe there are some unique feature benefits of this in terms of retrievability, and it also leverages our commercial sales force that we have around the world," Mahoney said.
The company is a few steps behind rivals Edwards Lifesciences (NYSE:EW) and Medtronic, which already have devices on the market.
Edwards’ Sapien landed FDA clearance in November 2011 for treatments of patients too sick to undergo open-heart surgery. Medtronic’s CoreValve TAVI system won CE Mark approval in the European Union in March 2007, and is expected to hit the U.S. market in 2014.
Synergy partially resorbable drug-eluting stents – CE Mark in late 2012
Boston Scientific’s next-generation Synergy drug eluting stents with a resorbable drug and polymer coating, may win CE Mark approval in the European Union as early as this year.
"This is a product that will have a 3 month drug-elution time, where after the 3 months both the drug and the polymer are gone which will leave the benefit of the long-sustaining bare-metal stent," Mahoney said. "We believe this platform combined with our Promus Element Plus platform will really position us, Boston Scientific, to have 2 leading platforms in the market to gain share in that business."
The company expects full European commercial launch in the second half of 2013, and will begin its Evolve II U.S. trials possibly as early as the 2nd half of this year. Market approval in the U.S. and Japan will likely come in 2016, according to BSX.
Mahoney pegged the global market at more than $4 billion by 2020.
Watchman left atrial appendage closure device – FDA approval and U.S. launch in 2013
Boston Scientific’s Watchman heart implant, designed to trap blood clots, is slated for FDA approval and U.S. launch in 2013.
The Watchman device may be an important tool for preventing stroke in high-risk atrial fibrillation patients, according to research unveiled at the Hearth Rhythm Society meeting in Boston last month.
The device already has CE Mark and is on the market in Europe.
"This is about a half-billion dollar market where Boston Scientific will be the leader in this business, leveraging our current channel with electrophysiologists," Mahoney said.
