A Decade of Discovery
The pace of medtech innovation since 2003 has turned the industry into an
unrecognizable version of its former self.
Michael Barbella • Managing Editor
The cycle of rejection was almost surreal. Mark Gelfand and Howard R. Levin, M.D., knew their idea would be a hard sell in Silicon Valley, but they never expected their funding
stump to be so demoralizing. For weeks in the spring of 2003, the
outspoken New Yorkers earnestly but futilely pitched their invention to the Barons of Sand Hill Road; with each visit, the duo
hoped that somebody—anybody—would recognize the enormous potential of their idea. Usually though, the meetings ended
badly, with venture capitalists calling the pair’s blood pressure
treatment device“crazy” or simply too risky.
“Everyone and their grandmother pissed on us,” Gelfand told
Fast Company Magazine.
Not everyone. Hanson S. Gifford III, CEO of Menlo Park,
Calif.-based The Foundry LLC (a medical device incubator), was
intrigued by the pair’s invention, particularly with research that
showed a relationship between the removal of renal nerves and
improvements in cardiovascular health. After weeks of dead ends,
Gelfand and Levin finally had found an investor who recognized
the revolutionary nature of their invention.
In Gifford, the pair also found a partner who appreciated their
unconventional approach to medical innovation. Most of Gelfand
and Levin’s ideas are based on the theory of evolutionary lag—
a belief that the Western world’s most prevalent maladies (
hypertension, heart disease, diabetes, sleep apnea) are caused by a
nervous system stuck in prehistoric mode. Our sensory apparatus
was programmed during the Paleolithic Era, when“fight-or-flight”
responses were crucial to survival. While the world has grown
considerably safer over the last 2.6 million years (
environmentalists might argue otherwise), the primitive part of our nervous system—otherwise known as the“sympathetic” branch—still evokes
a“fight-or-flight”response to perceived dangers (hence, a quickening pulse, blood pressure spike or adrenaline surge).
Millions of years ago, such responses were critical to survival.
But danger no longer lurks in the minutiae of daily existence,
where basic tasks like gathering food or finding shelter often
were lethal undertakings. Modern hazards are burrowed inside
computer screens, cell phones and television sets, but the blurred
senses and clouded judgment they evoke is hardly a match for
the tribal warfare and wild animal attacks that imperiled the lives
of primeval humans.
A safer world is a better world, obviously, but the lack of acute
peril can cause the nervous system’s“sympathetic”branch to prime
the body for non-existent threats. Gelfand and Levin blame the
improper response on malfunctioning sensors such as renal nerves,
which send faulty signals to the brain. They contend that blocking
those faulty sensory signals can restore order to our out-of-whack
“sympathetic” system and even help prevent chronic disease.
“We decided the most interesting way to hack into the [sym-pathetic] system is to mess with information that the beast receives,” Gelfand, an engineer, explained to Fast Company.
Gelfand and Levin’s idea builds upon mid-20th century research that show the removal of certain nerve chains near the kidney dramatically can affect the way the body expels fluids or the
brain regulates blood pressure. Serious cases of hypertension, in
fact, often were treated surgically until the 1970s by removing certain nerves to reduce symptoms. The procedure worked but was
risky, exposing patients to serious and potentially lethal side effects
(mainly respiratory difficulties and the inability to perspire).
Gelfand and Levin conduct an enormous amount of historical
research during their innovative process. The pair regularly visits
medical libraries throughout the nation to find clues that may
lead them to their next Big Idea.
Though their historical research on renal nerve removal and
its impact on cardiovascular health failed to impress the Silicon Valley investment community of 2003, it piqued the interest
of Gifford and his partners enough to assume development of
the project. By 2007, human clinical trials showed the new treatment—otherwise known as renal denervation—could lower
blood pressure far more efficiently than any single drug therapy,
with relatively few significant side effects. Such promising results
eventually prompted Medtronic Inc. to purchase the technology
in 2010 for $800 million.