Boston Scientific has agreed to pay $716 million to Johnson & Johnson to settle 14 lawsuits related to patent disputes in the field of interventional cardiology. Both companies make products in that field that seek to be less invasive alternatives for patients with cardiovascular disease, who otherwise might be headed toward open-heart surgery.

Natick, MA-based Boston Scientific (NYSE: BSX), said the money for the settlement will come out of its existing cash reserves, which stood at $1.19 billion at the end of June, when the company issued its most recent quarterly report with the Securities and Exchange Commission. The legal disputes go at least as far back as 1997, according to company filings. Despite the size of the payment, Boston Scientific didn’t get rid of all its legal issues with one fell swoop.

“We are pleased we have been able to significantly reduce the amount of outstanding litigation we have with Johnson & Johnson,” said Ray Elliott, Boston Scientific’s CEO, in a statement. “We continue to work with them to resolve other outstanding matters.”

Boston Scientific has been bracing itself for a big legal payout for some time. The company accumulated $1.27 billion as of June 30 for its estimated legal payments, after it lost a court ruling this year to J&J for an estimated $237 million and a $50 million settlement payment to inventor Bruce Saffran. Both of those disputes were related to stent products.

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Tom Steinke says he founded San Diego’s Minnow Medical out of an abiding conviction of the limitations of the medical stent, a mesh tube inserted in arteries to help prop open clogged blood vessels.

Steinke came to this view after spending 20 years developing medical devices in the cardiovascular industry. His previous startup was San Diego-based Reva Medical, which he founded in 1998 around a novel slide-and-lock design for a metal stent that does not deform as it expands. Before that, he was a product group director for Medtronic, director of engineering for Sonotek, and a development engineer at Advanced Cardiovascular Systems, which became Guidant, the maker of heart pacemakers and defibrillators.

“I know the industry,” Steinke says. With a metal stent, he says, “you’re going to have an ongoing inflammation to a foreign body… Even a [stent with a] drug coating doesn’t last forever; eventually the coating dissolves.” As Denise has reported, drug-coated stents represented a major innovation for the industry, and one that caught Reva off-guard. As the industry shifted to drug-coated stents, Steinke helped Reva reinvent itself in 2003 by developing a bio-absorbable stent that fully dissolves over time.

By the end of 2003, though, Steinke had moved on.

Tom Steinke

He founded Minnow Medical that year, and tells me the company sprang from his “altruistic desire to improve health care for the masses.” Now, after six years of development, Steinke is working to commercialize the technology that sprang from his convictions.

Steinke tells me that during his first couple of years at Minnow, he searched for alternatives to vascular stents. The founder and CEO says he self-funded Minnow until he had identified a way to improve the medical device used in balloon angioplasty to treat arteries that have narrowed and hardened due to atherosclerotic disease, the build-up of waxy plaque along the inside walls of an artery. In the process, Steinke also focused on …Next Page »

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San Diego’s new West Wireless Health Institute today announced its first clinical research program, saying it will oversee randomized clinical trials of wireless heart monitoring technology developed by San Jose, CA-based Corventis.

The institute, which announced its presence less than three months ago, was established to advance healthcare by helping medical device makers and others developing new wireless technologies pass regulatory muster. Corventis has been developing remote cardiovascular monitoring technology. The multi-center trial will be supervised by Eric J. Topol, a cardiologist who is the institute’s chief medical officer. Topol also is the chief medical officer at Scripps Health in San Diego.

Topol told me in May that remotely monitoring patients diagnosed with congestive heart failure is one of the obvious applications in the convergence of healthcare and new wireless technologies. He says a recent study of Medicare cases found that 26.9 percent of the patients hospitalized for heart failure are readmitted within 30 days, at an overall cost to the health system of $10 billion a year.

In its statement, the institute says the ability to continuously monitor heart rhythm, respiratory rate, and other factors remotely poses an opportunity to markedly reduce the need for hospital readmissions among such patients. The institute’s collaboration with Corventis is intended to validate remote wireless monitoring technology in proactively managing heart failure patients and reducing hospital readmissions.

The institute’s announcement coincided with a keynote address that Topol is delivering today at the U.S. Capitol in Washington D.C. at a technology and policy forum on mHealth solutions hosted by CTIA, a wireless industry association.

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Jeff Carbeck walked away from a promising career in academia four years ago to co-found Arsenal Medical, to apply advances in materials science to the healthcare market. Carbeck and I talked last week about his work at Watertown, MA-based Arsenal (originally named WMR Biomedical), which Xconomy reported last week raised $8.2 million in a third round of venture capital. In addition to the advances in biomaterials development at the firm, we discussed his recent award of a fellowship with the New England Clean Energy Council.

Carbeck, who is also chief scientist at Cambridge, MA-based nanotech research firm Nano-Terra, is not as recognized in the Boston area as some of his Arsenal co-founders, such as Harvard’s George Whitesides or MIT inventor Bob Langer. Still, Carbeck is very much on the leading edge of translating discoveries in material science for use in medical products, clean technology, and a variety of other disciplines. (Nano-Terra, in fact, is open to tackling R&D challenges in multiple industries except for life sciences.)

He’s also one of the top chemical engineers to come out of the Harvard lab of Whitesides, the chairman and initial inventor at Nano-Terra. (Whitesides’ other protégés include North Bridge Venture Partners general partner Carmichael Roberts and John Rogers, a professor of chemical engineering at the University of Illinois Urbana-Champaign.)

At Arsenal, Carbeck oversees development of biomedical devices in the fields of cardiology and ophthalmology. He guarded some of the fine details of the products under development, but he shed new light on some of the problems they hope to solve.

The startup is developing devices with materials that can treat arterial disease at the molecular and cellular level—rather than simply dealing with the problem mechanically with an arterial stent to prop open clogged arteries. It’s also studying materials that could deliver drugs to different regions of the eye. The company is exploring multiple other medical uses for proprietary materials at the firm, he says. Interestingly, Arsenal was not founded around a specific technology, yet subsequent to its launch has developed its own materials and gained rights to other technologies from Langer’s lab at MIT as well as research institutions not affiliated with the firm.

“I guess I see the world through the eyes of a …Next Page »

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Ischemix, a Maynard, MA-based developer of drugs intended to prevent tissue damage that occurs after heart attacks and other cardiac events, says that it has appointed board member Robert “Duffy” DuFresne to be its new CEO. He will replace former chief executive Reinier Beeuwkes, who is remaining president and chairman of the company. By the middle of 2009, Ischemix expects to begin mid-stage clinical trials of its lead drug for preventing ischemia-reperfusion injury. Xconomy contributor David Stipp wrote last year that the drug, dubbed “CMX-2043,” could draw big drug companies to startup in search of rights to the treatment.

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Clinical Data, the Newton, MA-based maker of diagnostic tests, said today it has acquired Adenosine Therapeutics to expand its roster of drug candidates in cardiology, diabetes, inflammatory diseases, and sickle cell anemia. Clinical Data (NASDAQ: CLDA) agreed to pay $11 million in cash for the Charlottesville, VA-based Adenosine, and also entered into a $22 million, five-year promissory note and a separate $3.2 million, 32-month promissory note. Clinical Data also agreed to pay as much as $30 million more in cash if certain regulatory and commercial goals are met.

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Christmas has come in July for Pathway Medical Technologies. The privately-held maker of medical devices in Kirkland, WA, has won FDA approval to market its first product in the U.S., a drill that cuts and vacuums out blockages in leg arteries.

CEO Tom Clement had an antsy look on his face last Wednesday, like a kid waiting for Christmas morning. “We’re so close, I can taste it,” he said on a visit to his office. The FDA approval letter arrived two days later, Xconomy has learned.

It’s a remarkable turnaround story. Pathway ran out of cash and literally closed its doors in November 2004. It was re-born four months later when it stopped trying to treat the heart, and switched its focus to a less crowded market of companies that treat the legs. Pathway’s device, the Jetstream Atherectomy System, works the same way in either part of the anatomy. It’s a tiny stainless-steel drill mounted on a catheter that snakes inside clogged arteries, where it cuts up and vacuums out fatty buildups.

The approval means Pathway can now market its device specifically to doctors who treat peripheral artery disease. An estimated 8 to 12 million people in the fast-food loving U.S. have blockages in the legs, and about one-fourth have sought some sort of treatment, complaining of pain when they walk.

“This is one of the most exciting companies in medical technology in the country, much less just here in the region,” says David Auth, a director of Pathway and the former CEO of Heart Technology, a Redmond, WA-based company that developed a previous-generation device in the 1990s for drilling out heart blockages. The market for such a device? It “could easily top $150 million in annual sales,” Auth says. “If they execute well, they will easily top $200 million.”

Pathway’s FDA application was based on a study of 172 patients in Europe, which found that its device sliced through rock-hard calcium and squishier blockages without tearing or poking any holes in vessel walls. Three patients developed clots or debris that required treatment, which contributed to a serious adverse event rate of 2.9 percent. The effectiveness was eye-opening. Arteries of patients went from 89 percent blocked on average at the beginning of the study to 39 percent clogged after the Pathway device was used, according to data presented in October at the Transcatheter Cardiovascular Therapeutics conference in Washington D.C.

The arteries apparently stay open, too. After six months of follow-up, only about 14 percent of patients required a second procedure, Clement says, compared with about half of patients after traditional balloon angioplasty.

Pathway doesn’t plan to begin selling its device immediately, however. The company first needs …Next Page »

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The world’s leading pharmaceutical and medical device companies are going to be in town this week for a meeting known as Summer in Seattle, and they’re not just here to catch some scenery and sun.

The eighth annual conference, running Thursday through Sunday, is drawing 350 cardiologists, heart surgeons, radiologists, neurologists, and industry representatives from around the world to the Seattle Science Foundation to learn state-of-the-art techniques for treating diseased hearts. The list of sponsors, which runs 28 deep, says a lot about the importance of “thought leaders” who influence other doctors, and can therefore make or break a new technology. Natick, MA-based Boston Scientific (NYSE: BSX), Abbott Laboratories, Pfizer, and Medtronic will be in town, vying to get their products in the doctors’ hands.

Summer in Seattle has traditionally featured live surgeries demonstrating technologies, such as insertion of drug-coated stents to prop open clogged arteries. This year, doctors will also get an unusual amount of hands-on work with cadavers and pig hearts to test new minimally-invasive devices designed, for example, to fix heart valves, said Mark Reisman, director of Cardiovascular Research and Education at Swedish Medical Center, and the conference’s co-director.

“This is very powerful for the companies to have people with national prominence to demonstrate their technologies,” Reisman says.

A couple of receptions are planned at the swanky W Hotel in downtown Seattle, but the doctors have a fair bit of time at the end of the day for wining and dining on their own. They are encouraged to get out and enjoy the city, but in terms of extra-curriculars, “We leave that up to the individuals,” Reisman says. No doubt those individuals will be courted well after-hours by the folks who want them to bless their technologies.

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Summer in Seattle (SIS) focuses on the most pertinent and controversial issues in the field of cardiology, vascular, and neurovascular therapeutics. Utilizing small group formats to maximize interaction between faculty and attendees, SIS 2008 will feature concurrent four-hour educational sessions. These sessions will include didactic lectures, hands-on Cadaveric training and live case presentations transmitted simultaneously from several catheterization laboratories. All of these activities will take place at the state-of-the-art Seattle Science Foundation.

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Abiomed got a healthy boost this morning. The FDA cleared the company’s new heart pump for sale in the U.S., enabling it to potentially reach a market of about 14,000 interventional cardiologists. Shares of the Danvers, MA-based company (NASDAQ: ABMD) shot up 13 percent to $16.75 at 12:14 p.m. Eastern Standard time.

The Impella 2.5 Cardiac Assist Device, which is already approved in some 40 other companies, is designed to help very sick patients’ hearts keep blood circulating for short periods of time. The pump can move as much as 2.5 liters of blood a minute, and it cleared for use for up to six hours, the company said. Like standard heart-helping pumps it’s threaded into the heart through an artery in the leg, but the Impella is different because it can deliver more blood volume, and it unloads blood from the left ventricle, relieving stress on the heart.

The Impella costs $20,000 per disposable unit, and is reimbursed by Medicare, said Michael Minogue, the company’s chief executive officer, on a conference call this morning with analysts. He didn’t offer a specific sales forecast.

“This marks a great day for the company and for heart failure patients in the U.S.,” Minogue said.

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No doctors thwart the Reaper more often than cardiologists, who routinely pull heart-attack victims back from the brink with artery-opening procedures. But their god-like powers suddenly fade after coronary arteries are unblocked. In fact, much of the harm from heart attacks occurs at that point due to “reperfusion injury,” which occurs when blood flow is restored to oxygen-starved tissues—just when things are looking up, the phenomenon unleashes gusts of cell-trashing “oxygen free radicals” and induces deadly calcium overload within cells. The inexorable heart-muscle destruction that follows can give the Grim Guy the last laugh, leading to fatal second heart attacks within days or the prolonged agony of congestive heart failure. But now Maynard, MA-based Ischemix thinks it’s found a way to block much of the damage and prevent cardiac miracles from turning into Pyrrhic victories.

Ischemix says its experimental drug CMX-2043 has consistently reduced reperfusion injury by 30 to 40 percent in extensive, placebo-controlled rodent tests. You heard it here first: If the drug shows similar efficacy in people—a big if, given that dozens of promising drugs for reperfusion injury have failed—Ischemix will be transformed from one of the Boston area’s least-known biotechs into a Big Pharma mob scene as drug makers scramble to secure rights to the new medicine.

Heart researchers have struck out for over three decades trying to develop reperfusion-injury blockers. Indeed, all the flailing on the reperfusion front threatens to lead to “therapeutic nihilism” concerning the problem, according to a sweeping 2004 report on the problem by scientists at the National Institutes of Health. Arguably, reperfusion injury is already the dirty little secret in cardiology: Animal studies indicate that it causes up to 50 percent of the tissue damage after heart attacks. Further, the controlled blood-flow interruption during cardiac procedures, such as coronary artery bypass surgery, or CABG (pronounced “cabbage”), also can trigger reperfusion injury—that’s probably why some 13 percent of the 500,000 U.S. patients who undergo CABG each year suffer major complications within 30 days of their operations.

All this adds up to the kind of blockbuster potential that’s increasingly scarce in drug research. Ischemix’s first goal with CMX-2043 is to cut post-CABG complications, including potentially fatal heart-beat irregularities—that indication alone represents a $500 million “market opportunity,” says CEO Reinier Beeuwkes. Following a successful safety trial with CMX-2043 last year, the company plans to launch a “proof of principle” efficacy trial in CABG patients later this year. But the plan is contingent on whether the company can raise the $15 million it needs to fund the trial, he adds.

You’d think venture investors would already have perfused the startup’s coffers. But so far Ischemix has funded CMX-2043’s development with a mere $14 million supplied by Beeuwkes himself and Ischemix’s medical director, Geoffrey Clark. Before taking a flyer on Ischemix, the two co-founded Braintree Laboratories, a leading maker of “gastrointestinal lavage” products ingested before colonoscopies. A former heart researcher, Beeuwkes served on Harvard’s faculty in the 1970s, then went on to become director of renal and cardiovascular pharmacology at Smith Kline and French Laboratories, now part of GlaxoSmithKline, before founding Braintree.

Ischemix has purposely kept a low profile during CMX-2043’s initial development, compiling considerable data on the drug before trying to sell the story to outside investors, explains Beeuwkes. One reason is the long history of withered hopes in the effort to develop reperfusion-injury blockers—potential investors aren’t easily convinced that substantial progress is now finally in the offing. Ischemix also has had a special reason to keep quiet while building the case for its new drug: A few years ago, its predecessor company, CereMedix, made an ill-fated foray under previous management into the hype-ridden world of anti-aging dietary supplements, or “nutraceuticals,” whose snaky aura can be the kiss of death for an aspiring biotech trying to raise money from hard-headed VCs.

CereMedix sprang from research on antioxidants discovered by biologist Victor Shashoua, who co-founded the company in 1999 while associated with McLean Hospital in Belmont, MA. Shashoua had developed a suite of compounds with antioxidant properties that raised hopes of blocking the damage by free radicals that appears to be a central part of the aging process. CereMedix’s plan of developing an anti-aging nutraceutical proved untenable, however, and in late 2005 Beeuwkes, a long-time investor in the startup, stepped in as CEO to develop some of Shashoua’s compounds as reperfusion-injury blockers. Though retired, Shashoua still holds a stake in the company, and his son, a physician, serves on its board.

Renamed Ischemix, the company set about tinkering with the antioxidants to give them a second key property besides the power to mitigate the free-radical damage of reperfusion injury: the ability to block its cell-killing calcium overload. Veteran pharmaceutical chemist Steven Kates, Ischemix’s vice president of research, led the effort, which yielded a family of promising candidates, the best of which was CMX-2043. While details of the drug’s mechanism remain murky, says Beeuwkes, in rat studies it appears to exert, as hoped, a two-pronged defense against reperfusion injury—a novelty that might finally break the logjam in efforts to minimize the injury. In the Phase 1 safety trial in humans last year, says Beeuwkes, “even at the highest dose we used, we didn’t see adverse effects” that seemed related to the drug. Further, the doses ranged up to about five times “what we think we may need to work in CABG patients, based on our animal studies.”

With the promising data in hand, the company is now trying to get on venture capitalists’ and Big Pharma’s radars. It just launched a new website, and Beeuwkes recently began presenting at biotech meetings. “If you’d asked me for an interview a year ago, I’d have said ‘No, thank you,’” he says. “But now it’s time to put on the slippers and go to the ball.”

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