InnerPulse: Bringing the Interventional Revolution to
CRM
By employing catheter-based technology, a rare cardiac
rhythm management start-up is looking to enable more
physicians to treat arrhythmias to increase the patient pool
and grow the overall electrophysiology device market.
by Stephen Levin
Cardiac rhythm management has historically been the
province of a small number of physicians, primarily
electrophysiologists (EPs).
Although available technologies have served EPs'
patients' needs, there has been a lack of innovation
enabling expansion of the market through alternative care
pathways.
Recent product innovations and important clinical trial
data have driven growth in EP procedures for certain
patients, but the market as a whole remains underserved.
A particular patient population—those who are at high
risk of suffering sudden cardiac arrest due to compromised
cardiac function—remain significantly undertreated, in part
because of lack of access to EPs, who are operating at near
capacity.
InnerPulse believes that developing a percutaneous
device and procedure will enable other physicians, including
interventional cardiologists, to treat more of these
patients, thereby also expanding the market for all CRM
devices.
One of the most significant ways in which the medical
device industry has been successful in improving both
clinical practice and patient care has been in the
development of catheter-based products that enable
physicians to percutaneously perform procedures that
previously required open surgery. This trend, toward what is
commonly called interventional medicine, has truly
revolutionized physician practice patterns, to the point of
creating a variety of new clinical specialties. The greatest
impact of these advances has been in cardiology, where
interventionalists now treat not only coronary vascular
disease patients in the cath lab, but peripheral and carotid
patients as well.
Although the plumbing side of cardiology has been changed
dramatically by interventional medicine, the electrical part
of that clinical area--cardiac rhythm management (CRM)—has
remained largely untouched by these developments. Implanting
defibrillators (ICDs) and pacemakers remain the
bread-and-butter procedures for electrophysiologists (EPs),
the primary physicians who treat electrical coronary
disorders, notwithstanding catheter-based advances such as
ablation procedures to treat atrial fibrillation (AF) and
other arrhythmias. But implanting these devices still
requires surgically forming an internal pocket to contain
the metal box in a patient's chest and often involves a
cut-down approach to the venous system to insert the wires
that extend into the heart.
Device inventor/entrepreneur Richard Stack, MD, himself
an interventional cardiologist, and fellow entrepreneur and
veteran industry executive William Starling, decided to
tackle the challenge of developing a catheter-based CRM
device through their incubator, Synecor
LLC
. Their goal was not simply to develop a
product platform for CRM devices that could be implanted
percutaneously; they decided to initially pursue a treatment
for a patient population that has been undertreated with
current devices—the so-called primary prevention market for
patients at risk of suffering sudden cardiac death (SCD).
A percutaneous approach to treating patients at risk for
SCD, Stack and Starling reasoned, could overcome a major
reason why this population is currently significantly
undertreated: their lack of access to the limited number of
EPs, whose priorities are often the secondary prevention
market, heart failure management, and AF. (Primary
prevention patients meet certain criteria as to their
heart's pumping ability, e.g., left ventricular ejection
fraction (LVEF), but they have not yet exhibited symptoms of
arrhythmias—and they typically don't until undergoing an
SCD—whereas secondary patients have either survived an
arrhythmic event or have had their arrhythmias diagnosed
through sophisticated testing.) Developing a percutaneous
device and procedure also meant that primary prevention
patients could be treated by most cardiologists, the very
physicians managing the vulnerable patient population,
thereby expanding not only the number of primary prevention
patients treated but also the existing secondary prevention
CRM market. Indeed, earlier intervention, in the primary
market, would bring in patients who, otherwise, wouldn't
have survived a sudden cardiac arrest and who would likely
be candidates for additional conventional CRM devices to
treat their underlying arrhythmias.
This is the high-risk strategy behind Synecor's formation
of InnerPulse
Inc.
(formerly known as Interventional Rhythm
Management [IRM]): develop a catheter-based CRM platform,
start with an ICD (which is more complex than a pacemaker),
and target a patient population that is largely beyond the
reach of current technology. "We could have gone for an
easier project, but it would have been more difficult
raising money, would have gotten lower valuations, and
wouldn't have gotten investors and employees as excited,"
Bill Starling explains. "So we decided to go for the home
run."
Of an Incubator Born
The genesis of InnerPulse was a brainstorming session at
Synecor in early 2003. Richard Stack recalls that several
people talked about personal experiences with family members
who had some type of EP device, all of whom found it
"surprisingly difficult to live with a large metal box under
their skin, particularly as they got older," he says. Stack
admits to being surprised at that reaction because "as a
physician, I hadn't thought that was of any consequence."
Because Synecor had significant experience developing
catheter-based products, the question that logically
followed was whether the incubator team could design an EP
device in a catheter form that could be inserted into the
venous circulation.
Before launching Synecor with Starling in 2000, Stack
played a significant role in developing interventional
cardiovascular technology for 20 years. As the head of the
interventional cardiology program at the Duke
University Medical Center
, Stack worked with
a variety of device companies, perhaps with none more
closely than balloon angioplasty pioneer Advanced
Cardiovascular Systems (ACS) and its successor, Guidant
Corp.
(the vascular business of which is now
a part of Abbott
Laboratories Inc.
, [20061007]
and its CRM business now belongs to Boston
Scientific Corp.
) [200510206]
(See "Richard Stack, MD: Filling the Cath Lab
Pipeline," IN VIVO, June 2006.) [2006800111]
It was through ACS that Stack met Starling roughly 25
years ago, when Starling served as the company's marketing
director and Stack as its chief technology consultant.
Starling left ACS 15 months after the company was acquired
by Eli
Lilly & Co.
in 1984 and went on to found
defibrillator pioneer Ventritex
Inc.
(now part of St.
Jude Medical Inc.
) He later spent much of the
1990s running Cardiac
Pathways Corp.
, an EP ablation start-up that
was acquired by Boston Scientific in 2001. [200110149]
Starling had left Cardiac Pathways a couple of years before
the acquisition and was considering a number of
opportunities when Bob Reiss, the former CEO of ACS, brought
him back together with Stack, who had talked about Duke's
interest in creating a technology and clinical center of
excellence along the lines of what was being done at the Stanford
University Medical Center
. Out of that
discussion came Synecor. (See "Synecor's Golden
Touch," IN VIVO, June 2006.) [2006800110]
Synecor's strategy is a large part of why a company such
as InnerPulse can embark on a strategy that most device
start-ups would consider too risky. Whereas most incubators
find that their biggest challenge is obtaining sustainable
financing, the success of Synecor's early deals has greatly
diminished that risk. Indeed, Synecor's reputation has been
based as much on its robust financings as on its innovative
technologies. (Synecor's Series A financing in December 2000
was done at "one of the highest pre-money valuations ever in
the medical device arena," according to Starling. In that
round, the incubator raised $10.5 million at a pre-money
valuation of $30 million from financial investors Frazier
Healthcare, Delphi Ventures, and Deutsche Bank Alex Brown,
and from corporate partners Guidant, General Electric
Medical Systems, and Becton
Dickinson & Co.
[200030870])
In six years, the incubator has launched four companies: two
cardiovascular (InnerPulse and BioStent, which was acquired
by Guidant), and two in gastroenterology (BaroSense
Inc.
and TransEnterix Inc.), and it
has two spine plays in the works.
The incubator's success to date reflects Richard Stack's
original vision for Synecor, which was to create an
organization that could provide everything that a device
start-up would need from generating new ideas to having
experienced engineers and state-of-the-art facilities for
prototyping and animal testing to, most importantly, being
able to provide the necessary financing. Synecor has
engineering facilities in Santa Rosa, CA (its West Coast
headquarters is in Portola Valley), and an animal research
facility at its Research Triangle Park, NC, location, and
the two are linked by advanced telecommunications
technology.
According to Stack, having this broad range of
capabilities within one organization enables Synecor to take
a new product idea through prototyping and preclinical
testing six to eight times faster than any other facility in
the US. "We are able to support good ideas with the
resources and funding they need to quickly reach
proof-of-concept and prototypes, so we can determine whether
the idea works or not, and if it doesn't, we kill it," he
says. Synecor allocates as much as $1 million to get a
project to the prototype stage and to conduct initial safety
studies to reach the point of making a go/no-go decision.
"Because of our broad capabilities, we can do more with $1
million than most start-ups and entrepreneurs," Stack says.
The success of Synecor's financings has enabled the
incubator not only to invest more money in companies at
earlier stages--so that, according to Starling, its Series A
rounds often look more like other start-ups' Series B
financings--but also allowed Stack and Starling to move in a
new direction for funding its companies. In May 2006, they
launched a captive venture fund called Synergy Life Science
Partners, based in Portola Valley, and headed by Stack,
Starling, and John Onopchenko, who was formerly with one of
Synecor's corporate investors, Johnson
& Johnson Development Corp.
(JJDC), the
venture arm of Johnson
& Johnson
. Indeed, as this article was
going to press, Synergy and another venture firm, Ascent
Biomedical Ventures, were finalizing the details of a deal
to acquire Frazier's and Delphi's interests in Synecor,
enhancing Stack and Starling's stakes in the incubator.
Synergy is in the process of raising its first fund,
expected to be around $150 million, which will likely invest
in the Series A rounds of Synecor's next few companies, as
well as InnerPulse's Series C financing, which the company
is currently raising.
Form Precedes Function
In Richard Stack's view, Synecor's unique perspective on
product innovation was as important to launching a high-risk
start-up like InnerPulse as the incubator's product
development and financing capabilities. "When we decide to
begin a new company, we absolutely ignore, for the most
part, the space as it exists today," he says. In the case of
InnerPulse, that meant that Starling and Stack did not
initially reach out to their colleagues in the CRM and EP
communities to get their perspectives on what attributes
they'd like to see in a next-generation ICD. "Every CRM
device you've ever heard of starts with a square box
implanted under the skin, so if you ask an EP to design
something new, that's where they'll start because that is
time zero for them," says Stack, who adds that the same is
true for the "Big Three" CRM companies "who think very much
within the existing paradigm because they have franchises to
protect." (See Exhibit 1.)
Instead, Synecor starts building ideas for new technology
and new companies from the patient's perspective. In the
case of InnerPulse, as noted, this process started with the
discussion of the complaints that founders' family members
had with EP devices. The common elements in Synecor's
companies are patient needs and large markets. "We look to
see what we can do in a large market that would benefit
patients and drive them to want to seek out this device from
their physicians," Stack adds. "I don't know of any other
group that uses this approach to create disruptive
technology."
In April of 2003, Bill Starling took the idea of
developing a catheter-based CRM device to two Synecor
engineers who had led the product development efforts at
Ventritex: Terry Ransbury, who became InnerPulse's VP of
R&D, and Steve Masson, who became its CTO. "The biggest
problem we had was getting the form factor to work with
conventional implantable batteries and capacitors," Starling
recalls. "That was a huge obstacle to overcome." Ransbury
and Masson's solution was to design a series of flexible
modules that were slightly smaller than the diameter of a
pencil that could be connected together to house the
workings of a device. Indeed, InnerPulse's president and
CEO, Dan Pelak, who joined the company in 2005, acknowledges
that a big part of the reason he accepted the job was that
he was so impressed with Ransbury and Masson and their
innovative design of the new system.
The batteries and capacitors for EP devices, however, are
designed to fit in forms closer to the size of a squarish
hockey puck not a pencil-sized catheter. For InnerPulse to
develop and test its new system, Stack and Starling had to
convince Wilson
Greatbatch Technologies Inc.
, the leading
supplier of batteries and capacitors for EP devices, that it
was in its interest, as well as InnerPulse's, to design and
manufacture these components in a completely new form to fit
the catheter-based design.
Making the case to Wilson Greatbatch wasn't easy:
Starling and Stack made five trips to Wilson Greatbatch's
headquarters near Buffalo, NY, between November of 2003 and
May of 2004, including one on Super Bowl Sunday. "Their CEO
eventually realized that for the company to remain the
majority share leader in the implantable battery business
for the CRM industry, they had to partner with us and make
this project a top priority," Starling says. Wilson
Greatbatch recognized that the three major EP companies—Medtronic
Inc.
, St. Jude, and now Boston Scientific
(with the Guidant acquisition)—were increasingly developing
internal battery and capacitor manufacturing capabilities,
thereby reducing the overall market size. "We showed Wilson
Greatbatch that they could be an important part of our
company if they made this project a priority, and we worked
out a deal so that if they delivered these components on
schedule, we would give them 5% of the company as a bonus,"
he explains. Wilson Greatbatch assigned its top battery and
capacitor engineers to the project and offered them
performance bonuses to complete the job on time, producing a
miniaturized battery with a five-year lifespan. "They
delivered everything on time in what turned out to be a
win-win for both parties," Starling notes.
Having acquired the necessary components to build the new
device, the next challenge was to design a system that could
be protected within the intellectual property (IP) landscape
in this space. At first, this, too, seemed to be a major
obstacle because the CRM industry is known to be a thicket
when it comes to IP, resulting in extensive litigation and
resulting cross-licensing agreements. InnerPulse's founders,
however, encountered a pleasant surprise. "When we did a
patent search, there was nothing in the public domain that
talked about an intravascular CRM system, so that was a
revelation," Starling recalls.
Dan Pelak points out that there are two components to
InnerPulse's IP strategy. "First, to make sure we have the
right to practice, we took a novel approach to developing
new technology by finding our way to this innovative
technology through studying expired CRM patents and weaving
our way through what is now off-patent," he explains.
InnerPulse then staked out what Pelak calls "a clear picket
fence" around what they consider to be its novel
technology—the intravascular defibrillator. To date, the
company has a total of 14 patents, either applied for or
issued, in this space. InnerPulse's IP portfolio also is
designed to protect the company's strategy of developing a
platform technology that can be used for other EP
applications, such as a pacing product that is being
designed to treat bradycardia patients (whose hearts beat
too slowly) that is likely to be InnerPulse's second
product.
A Large, Untreated Market
Armed with a viable product design and IP clearance,
funding the company was a start-up's dream. Not long before
Synecor started looking for venture funding for InnerPulse,
Guidant had acquired bioabsorbable stent start-up BioStent
from the incubator before any venture firms had the chance
to invest in it. That left VCs eager to fund Synecor's next
venture, which was InnerPulse in November of 2003.
"It didn't take more than a minute to get agreement with
our venture capital investors to fund InnerPulse at a very
high valuation," Bill Starling says, claiming that "it was
the highest Series A post-money valuation in device
history--$15.2 million at a $21 million pre-money, $36
million post-money." [200430920]
(The company's first-round investors were Delphi, Frazier,
and Guidant, which received an observer's board seat that
now belongs to Boston Scientific.) That was only exceeded by
InnerPulse's Series B round, which was done 18 months later,
when the company raised an additional $20 million at a
pre-money valuation of $130 million, and post-money
valuation of $150 million. (The B round included the
original investors plus JJDC, which received a board seat.)
The ease with which InnerPulse has been financed is due
in part to both Synecor's contribution in rapidly developing
the technology and the promise of the technology itself, but
it is due also to the attractiveness of the market that the
company's founders staked out for its initial product
offering: its PICD (percutaneous implantable cardioverter
defibrillator). The primary prevention CRM market is both
large, which is a Synecor prerequisite, and undertreated.
The primary prevention market is focused on the 450,000
people who die in the US each year from sudden cardiac
arrest. Often, these people have no history of heart
disease; their first symptoms—sudden cardiac arrest--are
those that cause their death. In that way, the SCD or
primary prevention market is distinguished from the
secondary prevention CRM market, which comprises patients
who have documented cardiac arrhythmias, generally either
ventricular tachycardia (VT or V-tach, where the heart beats
too quickly) or ventricular fibrillation (VF or V-fib, where
the heart beats in irregular flurries).
The secondary prevention market has historically been the
primary focus of the Big Three CRM companies, particularly
as they've turned their attention to the potentially
explosive cardiac resynchronization therapy (CRT) market,
which represents a major expansion of the secondary market.
The results of two major clinical trials, MADIT-II and
SCD-HeFT, reported in 2001 and 2004, respectively, showed
that implanting ICDs reduced incidents of SCD and was cost
effective in these two different patient populations.
MADIT-II included patients who had survived a myocardial
infarction (MI) and had left ventricular ejection fractions
of less than 30%, whereas SCD-HeFT's patient population was
heart failure patients categorized as either Class II or III
according to the New York Hospital Association (NYHA)
guidelines, who had LVEFs of less than 35%.
After much clamor by clinicians and industry, these trial
results triggered the issuance of guidelines recommending
the prophylactic use of ICDs for these patient populations
(including those without any prior arrhythmias) and caused
CMS to increase reimbursement for certain segments of these
patient groups. Indeed, this expansion of the ICD market,
combined with the increased interest in advanced CRM
technology, primarily ICDs featuring cardiac
resynchronization therapy (primarily to treat heart failure
patients), have jump-started what had been a market
accustomed to moderate, steady, single-digit growth and have
turned it into one of the hottest device segments with
growth rates in the mid-teens.
James Buck, InnerPulse's VP of sales and marketing,
estimates that the combined US ICD market for MADIT-II and
SCD-HeFT patients, which constitute the primary prevention
population, is around 1.16 million patients. (See Exhibit
2.)
.gif)
Yet, despite FDA approval and CMS reimbursement, only
approximately 20% of that potential patient population is
currently treated with ICDs. This despite the fact that
rapid defibrillation within seven to eight minutes of a
cardiac event is the only definitive treatment for SCD,
according to Dan Pelak. Even the increase in the placement
of automatic external defibrillators (AEDs) in public
places—an effort that Richard Stack aggressively promoted—is
having minimal impact in improving survival rates.
(Surviving patients generally do have ICDs implanted because
the SCD event typically results from some type of
arrhythmia.)
"I'm a big believer in the value of AEDs, but the truth
is that, in the case of sudden cardiac arrest, it's like
having a fire extinguisher on the wall when the house is
burning down," Stack points out. "You need it there, but the
problem is that the general public isn't really comfortable
yet with defibrillating somebody." Also, most people
experience sudden death either while they're asleep or just
walking around the house, not when they're in a public
place, he goes on. Adds Dan Pelak, "We've been successful in
putting AEDs in many public places, but they're really not
saving a lot of lives."
Bill Starling also believes that the recent CRM product
failures, such as those experienced with certain Guidant
devices, have further reduced the number of patients who
receive treatment, if only because they've made referring
physicians and their patients more anxious about the devices
generally speaking. "Many general practitioners and
internists typically do not refer patients for an ICD
implant until they show symptoms of having a ventricular
arrhythmia, and after Guidant's problems, these physicians
are even more reticent to make those referrals," he says.
A Question of Access
In Dan Pelak's view, one of the biggest reasons that the
ICD market is underpenetrated is because patients have only
limited access to this technology due to the small number of
physicians who are trained to implant CRM devices—currently,
EPs perform 85 to 90% of the procedures, with the rest being
done by a recently emerging subspecialty called implanting
cardiologists. "After MADIT-II and SCD-HeFT, we know that
many more patients should be receiving ICDs, so it's not an
approval issue, and we know that it's not a reimbursement
issue," says Pelak. "It's basically an access issue."
James Buck notes that although more than one million
people in the US qualify to receive ICDs under the MADIT-II
and SCD-HeFT guidelines, there are only around 1,800 EPs in
the US and a much smaller number of implanting
cardiologists. And the primary prevention market is not an
EP's primary patient focus, in part because industry has
been looking to drive adoption in other large market
segments.
"Over the same time period that the MADIT-II and SCD-HeFT
data have come out, the Big Three companies have really been
emphasizing the CRT opportunity, and that has been the major
focus of their product development and sales and marketing
initiatives," says Buck. "EPs are very motivated by those
efforts and by the fact that the CRT population is a
challenging population to treat."
Perhaps more so than most clinical specialties, EPs have
a penchant for treating the most complex cases, often
through procedures that can last several hours. Indeed, Buck
refers to them as "the intellectuals of cardiology."
Technology-hungry and savvy, EPs for years were forced to
construct homegrown tools to perform their procedures in the
absence of significant technology advances by the CRM
companies. Recent product innovations, including ICDs with
CRT capability and catheter-based ablation systems, have
expanded EPs' armamentarium, enabling them to more easily
treat complex arrhythmias such as AF. "If you give an EP a
choice between the challenge of ablating a complex AF
patient or implanting a primary prevention ICD, typically
they're going to want to perform the ablation, both because
of the degree of difficulty of the procedure and the fact
that they often will receive immediate feedback from that
patient, which is a good feeling for the physician," Buck
says. (Primary prevention patients, because they are
asymptomatic, do not notice any change in their conditions
following implantation of an ICD.)
Whereas several trends within the US are pushing EPs to
focus on secondary rather than primary prevention, outside
the US, a number of other trends have limited treatment of
SCD patients. In Europe, drug therapies are the primary
course of treatment, in part because of device reimbursement
limitations. And in Japan, Jim Buck points out that cultural
considerations about scarring following ICD implantation and
the protrusion of an ICD also limit adoption.
Practice Expansion = Market Expansion
Despite the obvious opportunities—the need to improve the
treatment of potential SCD patients and the underpenetration
of the primary prevention market by the large CRM
companies--Dan Pelak was skeptical regarding InnerPulse's
prospects when Stack and Starling first approached him about
heading the start-up, which was then still housed within
Synecor. In part, his skepticism stemmed from a career spent
largely at the CRM business of Medtronic where he was able
to see firsthand how the existing Big Three companies built
this business into what he calls "a comfortable oligopoly"
that few start-ups have even tried to crack.
Pelak had left Medtronic, where he was VP of US
cardiovascular marketing and the general manager of several
operating divisions, to lead wound healing company Closure
Medical Corp.
, which he successfully sold to
J&J in 2005 for $370 million. [200510042]
Pelak had recruited Buck to Closure Medical from St. Jude
Medical—the two had gotten to know each other as competitors
in the CRM market. As InnerPulse got ready to launch its
commercialization strategy, Buck then joined him there.
For both Pelak and Buck, the decision to join InnerPulse
was driven largely by conversations each had with Terry
Ransbury and Steve Masson that gave both a firsthand look at
InnerPulse's technology. The company's PICD system consists
of a series of pencil-thin modules that include batteries,
capacitors, and chips, which are connected together to a
length of 56 cm. The device is housed in a catheter that is
inserted into a patient's femoral vein over a guidewire in
the same manner as a balloon, stent, or any other
interventional cardiology device.
Under standard fluoroscopic guidance, the PICD is then
steered through the patient's vena cava and subclavian vein
where it is anchored with a proprietary stent. Because the
vena cava is one of the largest vessels in the body, the
PICD does not materially impact blood flow, occupying only
roughly 20% of the vessel. "When I first saw a demonstration
of this device, I thought, 'If they can pull this off, this
will be one of the most disruptive technologies the device
industry has ever seen,'" Pelak recalls.
As noted, unlike most other segments of the
cardiovascular industry, the CRM market has not recently
attracted many start-up companies, although start-ups played
a key role in early technology development in this space.
Indeed, if one goes back 20 years to the birth of
defibrillators, companies such as Ventritex, which Bill
Starling helped launch, were pioneers in developing new EP
devices.
The current dearth of CRM start-ups is the result of the
tremendous technology bases required to develop devices that
can compete with today's advanced ICDs. In addition, the
heavily litigated intellectual property landscape serves as
a significant barrier to entry for new companies, as do the
well-established marketing and distribution channel
relationships that the Big Three companies and their large
sales forces have with EP customers. (One recent CRM
start-up, Cameron
Health Inc.
, is also looking to develop a
device that cardiologists can implant. Boston Scientific
made an early investment in Cameron, but to complete the
Guidant acquisition, in which the CRM business was its
primary target, Boston relinquished its rights to acquire
the start-up. See "Cameron Health and the Revolution from
Below," IN VIVO, December 2003.) [2003800202]
InnerPulse's strategy from the start, however, has been
to avoid head-to-head competition with the major CRM
companies, and, rather, to develop a device aimed at
patients currently not treated by the large companies—in the
process, InnerPulse hopes, it will also expand the market
for existing EP devices. "By going after the primary
prevention patient, we see this not as competing with
existing technology, but as augmenting it, and having the
capability of significantly expanding the market for
standard ICDs," Pelak argues.
The company also does not believe it will be creating a
competitive situation between interventional cardiologists
and electrophysiologists by developing a procedure that can
be performed by both. Nor should the strategy cause a repeat
of the turf battles between interventionalists and surgeons
that emerged when angioplasty reduced the number of cardiac
bypass surgeries, or as has been replayed in the current
debate over the benefits of carotid stenting versus
endarterectomy surgery, say InnerPulse executives. The
reason: interventional approaches won't so much poach the
existing ICD market as identify a new one—primary prevention
patients, most of whom are currently not being treated.
"It's not like EPs are treating them now and our device will
enable cardiologists to take these patients away," Richard
Stack points out.
Indeed, InnerPulse argues that its PICD product is a
practice expansion opportunity for both EPs and
interventionalists. Unlike interventional tools in coronary
revascularization, the InnerPulse device is one that EPs can
easily use. Further, the patients whose lives are saved from
sudden cardiac death as a result of the device are people
who will be likely candidates for additional EP devices
because SCD is generally the first sign of a serious
arrhythmia. "These are all now going to be new patients
referred to the electrophysiologist, patients who were never
seen by anyone before," Stack notes.
"By putting this device in the hands of
interventionalists and giving them an easy 10-minute
procedure by which they can implant it using their
traditional skills and approach to minimize the learning
curve, we'll be able to keep these patients alive through
the arrhythmias they are likely to suffer but that would
otherwise never be diagnosed," Dan Pelak explains. He
acknowledges that it is likely that the PICD will not be the
only EP device these patients will need, but "if they don't
receive our device, unfortunately they may not be alive to
receive additional treatment."
No Legacy to Protect
Dan Pelak credits Synecor's capabilities with enabling
InnerPulse to progress along a much more rapid product
development path than the company would have had if it had
been a typical VC-backed venture. "All the work that Synecor
did took a lot of the risk out, and we're nearly ready to
begin implanting the device in humans," he says. The
incubator's resources also enabled InnerPulse to run fairly
lean; despite the need for a variety of advanced skill sets
in areas such as electronics, software, materials, and
catheters, the company only has 32 employees at its Research
Triangle Park, NC, location, not far from its original base
within Synecor.
Having worked through much of the technology risk, Pelak
believes InnerPulse is in a position to take advantage of
the CRM companies that have come before it and thereby
minimize much of the regulatory and reimbursement risk. "The
defibrillator regulatory pathway is well worn and
understood, so we don't have to re-invent the wheel in terms
of our clinical trials and regulatory requirements," he
explains. And reimbursement, too, is well-established.
Pelak believes InnerPulse will begin its first-in-man
studies at the end of 2007, and the company hopes to begin
selling the device in Europe by the end of 2008. The goal
for US commercialization is 2010.
InnerPulse's story is one of a company taking advantage
of both new and traditional paths to success in the device
industry. Clearly, the company has developed an exciting,
innovative new technology by taking products currently
nearly as large as a hockey puck and reducing them to a size
small enough to be placed in the vascular system through a
conventional catheter. At the same time, converting a
traditional open procedure to a percutaneous approach is a
well-established route to success in medical devices.
"Although the big companies have made great advances in
the defibrillator business," Dan Pelak acknowledges, "they
are constantly looking at things through the lens of their
legacy businesses. We can start with a blank piece of
paper." If InnerPulse is successful, it will demonstrate
another truism about device innovation, though one that has
been interestingly lacking in CRM development in recent
years: start-ups are the source of disruptive technologies,
not large companies with franchises to protect.
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