RE: WI Podiatrist Among First to Use PinPointe
FootLaser
From: Mark Wolpa, DPM
I replied to the ad for the PinPointe Laser
about two months ago and was as skeptical to
their claims as I was with ECSWT, EPF,
cryoablation, and the myriad of procedures that
are constantly introduced into the marketplace.
The study that they cited was a very small
patient population and only had a 6 month follow
up. I asked for the names of doctors who had
been performing the procedure the longest .
I knew three of them and when I called , my
first question was, does it work! No one said
that it cured onychomycosis, but what they did
say was that their follow-ups at 3 months and 6
months showed about a 80%-85% improvement,
their patients were pleased with the results and
it was the most successful treatment for mycotic
nails, to date, that they had seen Some
mentioned that they re did the procedure on some
cases, similar to placing a resistant patient on
a second round of Lamisil.
No not the 3-year randomized study that I would
love to see, but anecdotal information from
reliable sources that stimulated me to further
investigate the technology.
I since have started offering the procedure to
my patients and although it is too early for me
to report on its success(less than a month),
what I can say is that patients are "thrilled"
to have this as an alternative to treat their
fungal nails. I go overboard in explaining to
them that like all procedures, there is no
guarantee, I tell them the study to date is
promising, but is not long-term and they may be
in that group that does not show improvement.
To my surprise, 90% of them chose to have the
procedure performed. One patient told me "I've
tried everything and nothing has worked, I
understand there are no guarantees in life, but
I am excited to try something that finally makes
sense." Like all procedures, time will dictate
its place in our arsenal of treatments. I do
think it has potential and as my patient said, I
am excited to try a new technology that makes
sense.
Mark Wolpa, DPM, Lafayette, CA Mwolpa@ToeFood.com
I would first like to take this opportunity to
say thanks to Barry Block and PM News for
providing this very efficient communication
channel for our industry. I have been in
numerous industries in my career and I can say
as a matter of fact that this is one of the best
there is.
There are and have been many misquotes in the
press and I cannot speak to whether or not Chris
Milkie, DPM, was misquoted as stating “88% cure
rate” or not. Our first clinical trial showed
88% of patients improved with a single treatment
followed for 6 months. The results of that trial
have now been published and is available by e-
mailing me at: John@patholase.com
We have never claimed that this device and
procedure provides a “cure.” The PinPointe
FootLaser is a safe and effective way to treat
onychomycosis and its use results in clear nail
growth for patients in most cases. It has to be
used correctly and consistently to achieve best
results. Most patients will see a noticeable
improvement with a single or small number of
treatments. All providers and patients should
have the expectation that one or a small number
of procedures will be required to achieve best
clear nail growth. Obviously, as with any
medical device, the provider will exercise their
best medical discretion and obtain patient
consent to the procedure and cost in advance of
service provision.
Our clinical data is still being developed and
it is early. We have formally studied a small
patient population, though those familiar with
statistical power analysis will appreciate that
a small patient population (n-value) is needed
where the efficacy is very high. Where the
efficacy is very low (i.e. treated not very
distinguishable from untreated) a large n is
required. Most drug studies require very large n
numbers because their effects are low and due to
their systemic nature require a large n to
demonstrate safety.
Our power analysis showed that 19 subjects was
far more than adequate to demonstrate a p-value
< 0.0001 which is incredibly small, meaning that
the effect caused by the FootLaser procedure had
very high efficacy. One letter to PM News
stated that our research showed no
discrimination between treatment and no
treatment for culture results and notch
measurement which is true. Our culture results
were very mixed (as are all culture results
published in all studies done before us). This
demonstrates why we are using new analytical
techniques in our new trial, we will set a new
trial standard. The notch measurement was nearly
equal in treated vs. untreated which
demonstrates no significant change to the nail
growth between treated and untreated which is a
critical safety measure.
This is the first published study. We are now
embarking upon a very ambitious multi-site, 100+
patient, long-term follow-up study to
unequivocally demonstrate the safety and
efficacy of this revolutionary new technology.
The sites involved each have specific expertise
and offer unparalleled quality in clinical
research and respected publication. Two sites
have principal investigators who are very well
respected and published dermatologists with long
term clinical study expertise. Another site’s
principal investigator is a world renowned
general surgeon who has developed published
expertise in clinical trials in photomedicine.
Our final site principal investigator is one of
the most prolific onychomycosis clinical trial
podiatrists.
This new clinical trial is about to begin
recruiting patients across the country and
internationally (one site is in Canada). The
level of scientific rigor and methods of
analysis embodied in this trial will set the bar
for future onychomycosis trials.
The PinPointe FootLaser in addition to being
cleared by the FDA, has the first and only
European equivalent medical device clearance for
the safe and effective treatment of
onychomycosis (CE Mark) based upon the same
published study attached. Despite the solid
science upon which everything PinPointe (and its
parent company PathoLase, Inc.) base its
business decisions, we are all looking for and
requiring a higher level of evidence and quality
of clinical trial data.
Given the state of current evidence available to
providers, the PinPointe FootLaser is only
appropriate for those that are visionary
leaders in the podiatric community. We fully
expect that providers who are interested and
become involved today are those that understand
where the science and data are and where it is
going. They are the visionary pioneers of the
industry that are taking advantage of
technological developments to propel their
practices to new heights while leading the
industry.
We are planning long-term on having only the top
10% of podiatric practices as contracted
providers. In the near-term we are limiting this
number much further and are already close to
closing out numerous major metro markets for
2009. With better than 50 providers in 18
states, we are seeing a groundswell of provider
feedback for those that have been practicing
this procedure long enough. As you all know, it
takes a few months for even a small distal
lesion to grow out due to toenail growth rates.
For some, it may take as long as 18 months to
see a fully involved toenail grow out. At 3 and
4 months, our providers have documented evidence
of unsurpassed efficacy with no adverse events.
Most of our providers are finding this to be
podiatry’s best new technology with the biggest
potential for increasing value, differentiating
practices and simultaneously satisfying
patients. Additionally, as a cash paid
procedure, this is proving to be very profitable
for providers while greatly enhancing cash
flow.
While not all providers have succeeded (less
than a handful have not) the rest are thriving
even in the current economic state. Currently,
we are limiting our marketing to podiatry for
numerous reasons, one of which is that it is the
specialty that deals with this disease. We also
feel that since dentists have teeth whitening
and veneers, ophthalmologists have LASIK,
plastic surgeons have breast Implants and
liposuction and dermatologists have hair removal
and Botox, podiatrists can now have and will
enthusiastically develop their PinPointe
FootLaser practices.
John Strisower, Chief Executive Officer,
PathoLase, Inc./PinPointe FootLaser,
John@patholase.com
