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Sunday, May 4, 2008

Prepping Robots to Perform Surgery


WHAT do you call a surgeon who operates without scalpels, stitching tools or a powerful headlamp to light the patient’s insides? A better doctor, according to a growing number of surgeons who prefer to hand over much of the blood-and-guts portion of their work to medical robots controlled from computer consoles.

Many urologists performing prostate surgery view the precise, tremor-free movements of a robot as the best way to spare nerves crucial to bladder control and sexual potency. A robot’s ability to deftly handle small tools may lead to a less invasive procedure and faster recovery for a patient. Robots also can protect surgeons from physical stress and exposure to X-rays that may force them into premature retirement.

A generation ago, the debate in medicine was whether robotics would ever play a role. Today, robots are a fast-growing, diversifying $1 billion segment of the medical device industry. And Wall Street has just two questions for the industry: How far is this going, and how fast?

There are no simple answers, of course, but it is remarkable how often Frederic H. Moll comes up in any discussion.

Dr. Moll, 56, is a soft-spoken man who can look uncomfortable on stage. Yet his role in founding Intuitive Surgical, the company that now dominates the field, and his current involvement with three other robotics companies, has kept him in the sights of investors, health care providers and fellow entrepreneurs.

He’s now best known as chief executive of Hansen Medical, a publicly traded robotics company focused on minimally invasive cardiac care. But he’s also an investor in and a board member of Mako Surgical, an orthopedics robotics company that recently went public, and he is a co-founder and chairman of Restoration Robotics, a start-up company focused on cosmetic surgery.

“Anyone who meets Fred will remember him,” says Maurice R. Ferré, the chief executive of Mako, which makes a drill that shuts off if a knee surgeon starts removing too much bone. “He will cut you off to ask technical questions and drives right to what’s important. A lot of people are looking at the Mako story because Fred’s involved.”

Despite Wall Street’s growing fondness for medical robotics companies, plenty of health care providers and insurers are cautious. They’re looking for more evidence that robotics improves outcomes for patients at a cost hospitals can absorb. Many still wonder whether it is more about marketing than medical progress.

Winifred Hayes, chief executive of Hayes Inc., a health care technology consulting firm in Lansdale, Pa., says that most clinical data doesn’t support contentions that patients fare better with robotic surgery. Most hospitals and clinics are losing money or making poor returns on their robots, she says.

“The real story is that this is a technology that has been disseminated fairly widely prematurely,” she says.

Even so, interest in robotics remains strong, and the arc of Dr. Moll’s own career has landed him at the intersection of tussles between business and medicine.

His parents were both pediatricians, and he sailed through medical school. But during his surgical residency at the Virginia Mason Medical Center in Seattle in the early 1980s, he found the ailments of patients less compelling than the shortcomings of the tools that surgeons used to treat them.

“I was struck by the size of the incision and injury created just to get inside the body,” Dr. Moll says. “It felt antiquated.”

So he obtained a leave of absence to study whether the long slender cutting tools he had seen gynecologists use in sterilization surgery on women could be adapted to gall bladder removal.

“We saved the spot for 10 years, but he never came back,” said Dr. John A. Ryan Jr., then head of the surgical training at Virginia Mason.

Indeed, Dr. Moll had left Seattle for Silicon Valley, where he spent the next decade creating and selling two medical equipment businesses while getting a graduate degree in management at Stanford. He walked away from the two deals with about $7.5 million. That was modest by the standards of, say, Paul Allen and Bill Gates, the Microsoft founders who were his schoolmates at the exclusive Lakeside School in Seattle in the early 1970s, but Dr. Moll had found his calling.

He says his immersion in the entrepreneurial life cost him his marriage; he remembers once telling his wife he was so busy he couldn’t talk to her for a month. But it also set him on a course to become a pioneer in the emerging field of medical robotics.

ROBOTS revolutionized manufacturing during the 1980s, on the back of advances in computing, motion controls and software design.

Visionaries like Dr. Richard M. Satava, who oversaw federally funded medical robotics research at the time, predicted that robots would eventually be able to operate as precisely as the world’s greatest surgeons and far more tirelessly, perhaps even in remote locations, through satellite links.

A project that Dr. Satava’s group financed to build a remotely controlled medical robot for the battlefield caught Dr. Moll’s eye in 1994.

Dr. Moll saw scant commercial potential for long-distance surgery, but he became convinced that the technology, being developed by SRI International, a nonprofit contract research firm in Palo Alto, Calif., could be adapted to make routine surgery much less invasive in the hands of civilian surgeons.

He took the idea to his employer, Guidant, a medical device company. Guidant decided that robotic surgery was too futuristic and too risky, so Dr. Moll rounded up backers, resigned, and in 1995, founded Intuitive Surgical.

A competitor, Computer Motion, had a head start using technology developed for the space program. But Intuitive Surgical had an experienced management team headed by Lonnie M. Smith. Mr. Smith was recruited from Hillenbrand Industries, where he oversaw health care companies, to become chief executive in 1997, leaving Dr. Moll to concentrate on strategic development.

Intuitive went public in 2000 at $9 a share. (Dr. Moll’s stake at the time was worth roughly $13.5 million, and he still owns a significant number of shares.) In 2003, it acquired Computer Motion, eliminating both patent wars and the competing design. Since then, soaring sales and profits have laid to rest any Wall Street doubts that robots could be commercially successful.

The company earned $144.5 million last year on sales of $600.8 million. Based on first-quarter results that were better than expected, Intuitive forecasts that sales will grow 42 percent this year, to $853.2 million. Its stock, which traded at $42.42 three years ago, closed Friday at $290.03 a share.

The company prospered by proving that robots could deftly handle rigid surgical tools like scalpels and sewing needles through small incisions in a patient’s skin. In prostate surgery, it is rapidly becoming unusual for a urologist to operate without using one of Intuitive’s da Vinci robots, which sell for $1.3 million, on average. Each also generates hundreds of thousands of dollars more in annual revenue from service contracts and attachments that must be replaced after each procedure. Intuitive is now marketing the da Vinci to other specialists, including gynecologists and heart surgeons.

Intuitive’s success has not put to rest questions about how many hospitals and clinics can afford robots. The da Vinci and the CyberKnife, a precision radiation robot from Accuray to treat tumors, are featured in hospital ads to attract patients, but it is hard for hospitals to get extra reimbursement from insurers for using them.

However, hospitals that have been leaders in adopting robotic technology say they are content to just break even for now, because the investment is partly about attracting surgeons who want to be leaders in research and training.

“If you are looking at the future, it’s hard to envision a hospital not offering robotics,” said Robert Glenning, chief financial officer at the Hackensack University Medical Center in New Jersey, which has bought five da Vinci’s and has a sixth on loan from Intuitive Surgical that is used to train visiting doctors.

DR. MOLL left Intuitive in 2002 to pursue a more ambitious concept at Hansen Medical: robots that manipulate the tips of thin, flexible catheters that doctors insert deep in the heart. If he succeeds, the Sensei robotic systems from Hansen, costing about $675,000, may become the go-to tools for treating many circulatory problems.

Relations between the two companies were rocky in the first year because of disagreements over the breadth of Intuitive’s patents. Eventually, the two signed an intellectual property agreement that gives Intuitive a 3 percent royalty on Hansen sales. With Intuitive expanding into cardiac care, the two may eventually collide in some procedures.

Doctors who use catheters generally gain access to the circulatory system through a small incision in the major veins that run through the thigh or arm. Both the makers of rigid tools and the catheter companies are competing in another fast-developing field of “scarless” therapy involving operations performed through the urinary tract and other natural openings.

Dr. Moll is betting that flexible tools like those that work with the Sensei will dominate as this movement matures. He took a team of four Hansen employees to India last summer for a series of surgeries testing whether kidney stones could be removed by using a robotic catheter. Dr. Inderbir S. Gill, a urologist from the Cleveland Clinic who led the research, said that Dr. Moll had followed every case for four days.

“He was at the console like a mother hen even though he wasn’t allowed to touch it,” said Dr. Gill, who received stock in Hansen for work on the research and is planning a clinical trial.

Like Intuitive in its early days, Hansen faces a competitor that got an earlier start. Stereotaxis, based in St. Louis, makes the Niobe, a robot that generates magnetic fields around the patient. By manipulating the magnetic field from Niobe’s computer, doctors can manage the movements inside the patient of its customized magnetic catheters.

The Sensei manipulates a Hansen catheter called Artisan, a hollow sheath through which doctors can deploy smaller catheters. Sensei and Artisan were approved by federal regulators last May for use with catheters that map electrical activity in the heart. While mapping is currently the only job for which Hansen can actively market the Sensei, the robot’s real focus is to combine mapping with minimally invasive treatments to halt electrical short circuits in the heart that cause it to beat abnormally.

Fans include Dr. Davendra Mehta, chief arrhythmia specialist at Mount Sinai Medical Center, who last fall became the first doctor in New York City to order a Sensei. “This is like power steering versus conventional steering,” said Dr. Mehta during a recent procedure.

Using the robot also lets Dr. Mehta avoid spending up to five hours a day wearing a lead vest to limit his exposure to the X-rays when monitoring the catheter’s location in a patient.

THE potential appeal of the Sensei may be obvious. But with just 23 systems installed at the end of March, the competition from Stereotaxis and doubts among many health care providers about whether robots are worth the expense, Dr. Moll has plenty of obstacles ahead.

Still, he and his team members took Hansen public in November 2006, and received approval from regulators in Europe and the United States to market the Sensei. In April, Hansen raised $39.4 million in a secondary stock offering despite Wall Street’s gloomy outlook on the economy. Hansen also has an agreement with St. Jude Medical, the heart device company that is a leader in 3-D heart mapping systems, for co-marketing of technologies.

Dr. Moll said Hansen, based in Mountain View, Calif., should become profitable by the end of next year, two and a half years sooner than Intuitive crossed that threshold. Hansen’s volatile stock, which hit a peak of $39.32 in October before tumbling to $13.48 in March, now trades at $18.54 a share after the company reported better-than-expected first-quarter results on Thursday. Hansen sold eight new robots in the quarter, producing revenue of $6.2 million, and operating losses narrowed.

Even while juggling all of this, Dr. Moll is serving as chairman of Restoration Robotics, a start-up he has financed that aims to apply robotics to hair replacement surgeries for bald men.

Dr. Moll says robotics will ultimately advance on still other fronts, largely because it can help doctors of varying ability perform at the level of the world’s top surgeons.

“The public has no idea of the extent of difference between top surgeons and bad ones,” he said. “Robots are good at going where they are supposed to, remembering where they are and stopping when required.”

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