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Transdermal Stimulation

Unique devices
developed to stimulate lymph system
An Australian company has developed a range of transdermal
stimulation devices using unique technology. Trials have shown they have
a remarkable therapeutic effect on many conditions linked to the health
of the soft tissue layer and the efficiency of the lymphatic system.
Middle East Health speaks to Norm Taylor, Executive Director of
LymphoGenics about the product and the unique technology.
Middle East Health: Can you
give MEH readers a brief
history of LymphoGenics?
When was it set up? Why was
it established? Where is it
based?
Norm Taylor: LymphoGenics
Pty Ltd is a subsidiary of VibraQ Corporation Pty Ltd.
VibraQ developed the
world’s first Planetary Electric
Motor and commenced
research into applying the
technology into the healthcare
and other sectors in 2002. The
technology is ‘platform technology’
– in other words it can
be applied across many industries
in a large variety of applications
– however, the first
area in which it will be commercialised is in the
healthcare sector.
On the back of some very
good clinical trial results, LymphoGenics was established
in 2007 as the entity through
which the VibraQ group would
commercialise the technology
with applications in the
healthcare sector.
The company is currently
based in Perth, Western
Australia however, it is considering relocating in the
near future to be closer to its
key markets.
MEH: What are LymphoGenics’ key product?
NT: LymphoGenic’s key products
are therapeutic devices for
the wellness and healthcare
sectors. The devices draw on
the core technology’s unique
programmability features to
generate differing forms of
Dynamic Transdermal
Stimulation to treat a range of
conditions that are linked to
the health of the soft tissue
layer and the efficiency of the
lymphatic system.

The first product is a
consumer product – the DTS
Personal. This product has one
complex tissue stimulation
pattern with the patient
controlling both intensity and
frequency.
The second product is a
professional clinical product –
the DTS Professional
The clinical product is a more
sophisticated product than the
consumer device. This product
will be sold to therapy clinics
(for example physiotherapy),
health clubs and day spas. It will
contain two or three choices of
complex tissue stimulation
patterns in addition to full variability
of intensity and
frequency and will provide for
patient treatment history to
be retained as well as other
features relevant for the therapist
setting.
The future product pipeline
will also include: a large clinical/
hospital device – the DTS
Clinical;
A fully adjustable prototype
device has been built to facilitate
intensive 360° Dynamic Transdermal Stimulation (DTS)
Therapy of either an arm or a
leg. This device is particularly
relevant for people suffering
from conditions like
lymphoedema, a side effect of
cancer treatment.
MEH: You mention that the
device works by stimulating
the soft tissue. What is the soft
tissue layer?
NT: The application of transdermal
stimulation to treat
symptoms of soft tissue disorder
is a relatively new field of
research. The human body is
potentially covered with a soft
tissue layer extending 1-5cm from the epidermis through to
the muscles, organs and encapsulates
the subcutaneous tissue
layer. This soft tissue layer
holds the key to many health
and wellness issues and is
fundamental in the removal of
metabolic waste products via
the lymphatic system and is
also the stimulus for triggering
an immune system response to
invading bacteria and infections.
This soft tissue layer
reacts to injury resulting in a
painful inflammatory response
and starts a cascading of chemical
signals between metabolic
cells and the venous system.
Soft tissue trauma is evident
by swelling or persistent oedemas in limbs, hands and
feet. Trauma and swelling
produces a painful response
from both the group III and IV
nerve fibres which reduces a
persons’ function, range of
motion and quality of life.
Persistent oedemas are often
found in lymphoedema and if
left untreated can result in the
formation fibrotic regions in
areas of the subcutaneous layer.
Fibrosis results in persistent
pain, reduced lymphatic clearance
and poor capillary flow
which all exacerbate the
health of the soft tissue matrix.
The strategic focus for the
company is to provide world
class, clinically evidenced
wellness products for both the
home consumer markets for
management of aches and
pains and for the professional
healthcare provider for adjunct
integration into their patient’s
treatment programme.
MEH: Can you explain in
more detail how the device
works?
NT: In order to appreciate and
understand the affects of our
technology it is important to
understand the physiology of
the lymphatic system. The most
confounding examples of a
malfunctioning lymphatic
system can be found in post
cancer survivors who develop lymphoedema as a result of a
damaged or impaired lymphatic
system due to surgery or radiotherapy.
This often leads to high
protein concentration in the
interstitial tissue spaces which
causes an osmotically
sequestered fluid accumulation
to the region. Efficient removal
of the accumulated proteins is a
very important part of a healthy
functioning lymphatic system
and the fundamental target of
our research.
LymphoGenics’ technology
stimulates the entry of lymph
materials, particularly macromolecules
and proteinaceous
fluids into the lymphatic
lumen region. This is achieved
by rhythmically varying the
interstitial tissue pressures
acting upon the junctions of
the endothelial cells. The
highly tuned DTS Therapy has
the benefit of encouraging the
endothelial junctions to open
widely to entrain large protein
molecules and lymphocytes
into the lymph capillaries for
subsequent transport along the
pulsatile lymphangion system.
The DTS also resonates the
tissue matrix with both a
fundamental stimulation
frequency along with a
multiple of sweeping harmonic
frequencies which act to reverberate
the smaller portions of
the soft tissue matrix to influence
the movement and the
transduction of chemical
signalling of inflammatory cells
such as neutrophils,
macrophages, lymphocytes and
free radicals. The oscillating
pressure waves also act upon
the lymph collectors to help
move the lymph fluid along
the lymphatic network and
back to the circulatory system.
MEH: Are there any sideeffects?
NT: The devices are non invasive
and have not shown any
adverse side effects in trials.
They are very safe to use. MEH: Can you give an
outline of some of the clinical
trials / case studies that have
been carried out to show the
efficacy of the device?
NT: Clinical trials and case
studies to date have concentrated
on two conditions:
Lymphoedema; and Delayed
Onset Muscle Soreness.
Clinical evaluations are a
continuing focus for the
company and to date we have
undertaken the following
studies, which are as yet unpublished.
However, study reports
are available on request.
The following studies have
been carried out:
● Pilot study using Clinical
Model on lymphoedema at
Flinders University School
of Medicine, South Australia
● Comparative and cross over
pilot study using Clinical
Model on lymphoedema at
Flinders University School
of Medicine, South Australia
● Study of home based treatment
using Portable Model
for lymphoedema – in
progress at the Mount
Hospital, Western Australia
● Study of Delayed Onset
Muscle Soreness in healthy
subjects at Edith Cowan
University, Western Australia
With regards lymphoedema,
we have conducted two clinical
trials on lymphoedema
sufferers at the Flinders
University School of Medicine
in Adelaide, Australia using
the large clinical device which,
whilst it is not one of the
initial products about to be
launched, has demonstrated
the safety and efficacy of
Dynamic Transdermal Stimulation
Therapy. Importantly, the
trials also demonstrated that
the form of soft tissue stimulation
was very important. These
trials were conducted by
Professor Neil Piller,
Australia’s leading expert in
lymphoedema.
One trial looked at the
immediate effects of the treatment
using two different forms
of proprietary pattern stimulations.
The material difference
in outcomes confirmed that
the type of stimulation applied
matters and it is not a matter of
applying any form of tissue
stimulation.
The other clinical trial
looked at the effect of a
sequence of four daily intensive
treatments and compared
this to the current ‘gold standard’
of treatment for lymphoedema, which is
manual lymphatic drainage or
“MLD”. At the end of the
week Dynamic Transdermal
Stimulation Therapy achieved
a 30% greater reduction in the
average size of the oedema
compared to MLD. Importantly
this trial also showed that
wearing compression bandaging,
which patients hate to
do but are generally advised
they should, actually reduced
the beneficial effect of DTS
Therapy. This outcome is
consistent with our understanding
of the effect DTS
Therapy is having with the
lymphatic system.
You should appreciate that
the above results were
obtained with significantly less
treatment time compared to the
Manual Lymphatic Drainage
results and were achieved
without any attempt to optimise
treatment protocols – this is an
area for future studies.
In this same clinical trial
patients subjective assessment
of a range of key quality of life
issues were recorded. Two of
the most significant issues for
the quality of life of lymphoedema sufferers are the
hardness of the affected limb
and the limited range of movement
they had. DTS Therapy
has been shown to have a
material beneficial impact for
sufferers in these areas.
We haven’t sought to have these clinical trial results
published in medical journals.
However Professor Neil Piller
who headed up the trials has
presented the outcomes at a
number of leading industry
conferences in the USA, Asia,
Europe and Australia.
With regards Delayed Onset
Muscle Soreness, we conducted
a clinical trial into the efficacy
of DTS Therapy to alleviate
delayed onset muscle soreness
(DOMS) at the Edith Cowan
University in Western
Australia. The results of this
trial, which concluded in
January 2008, were outstanding.
DTS Therapy is now the only
clinically proven medical device
to be effective on DOMS.
We are expecting the results
of this trial to be published
later this year in a prestigious
international sports medicine
journal.
The key outcomes were:
● Significantly reduced peak
pain levels
● Faster recovery period
● Improved range of motion
● Significant analgesic effect
The trial results can be summarised in the following
two graphs:
The graph below shows the
mean pain score (VAS – red
bar) for the control group
which follows a typical
scenario for a person suffering
from DOMS: pain peaking 2
days after exercise and then a
steady decline back to base
levels between day 6 and day 7.

For the DTS Therapy treatment
group, pain levels peaked
at day 1 and returned to
starting levels around day 4.
This is very important for elite
athletes where recovery is a
critical element of their
routine. The quicker and
better the recovery from one
activity point the sooner
athletes can start preparing for
the next outing.

The study also showed a significant
analgesic effect immediately
following treatment as shown in
the graph above:
The graph above illustrates
the immediate pain reduction
from the treatment group
following DTS Therapy.
These findings (the pain
reduction) are consistent with
the subjective feedback we have
received from lymphoedema
sufferers and gives us confidence
that pain management from a
range of causes or ‘triggers’ is
going to be a significant area
that we target in the future.
MEH: How does the device
work mechanically?
NT: The Planetary Transducer
(“PT”) converts electrical
energy directly into a high
frequency, non-rotational
oscillating motion of a contact
head. Electronics and software
enable the transducer to
output a myriad of complex,
multiple harmonic waveforms
which stimulate the soft tissue
matrix via the epidermis.
The technology can produce
all of the above waveforms in the
one machine with complete
dynamic control over the
displacement and frequency of
the output stimulus. The transducer
is capable of switching
between a broad range of waveforms
allowing for a myriad of
harmonics to be delivered
through to the subcutaneous
tissue layer. The unique functionality
of this technology was
confirmed when the first patent
for the transducer was granted
unopposed in the United States
of America. Since then the
patent portfolio has been
expanded considerably to form
an integral part of the company’s commercialisation strategy. This
type of motion cannot currently
be replicated by any competing
product in the world.
MEH: Can you explain in
more detail the workings of the
patented planetary transducer?
NT: The patented Planetary
Transducer converts electrical
energy directly into non rotational
oscillatory motion and is
electronically controlled to
deliver dynamic motion in
either figure eight, circular, elliptical, star formations or any
complex geometric pattern.
The energy transfer within this
technology is controlled
through power electronics and
is therefore capable of
producing many different forms
of stimulus responses. The technology
is designed in a manner
to deliver a two dimensional
planar motion and utilises the
fundamental principle of transverse
flux where a current
carrying conductor within a
magnetic field produces thrust.
Oscillatory motion is produced
through the electronic control
of the currents and their
phasing relationship.
MEH: Is the device commercially
available?
NT: No devices are commercially
available as yet. A
number of prototypes have
been built for use in clinical
trials. The next stage in the commercialisation process is to
transfer to manufacturing and
the company is currently
seeking to raise capital for this
purpose. We anticipate that it
will take about 12 months from
the time this capital raising is
completed for the product to
be commercially available. An
important component of this
capital raising is the appointment
of distributors and we are
currently seeking expressions
of interest from distributors in
the Middle East.
We have held some preliminary
discussions with potential
distributors to confirm interest
in this region some time ago
and are about to launch a more
formal process to appoint
distributors for our products in
the Middle East. We are keen
to hear from any distributors
that service the healthcare
sector that may be interested
in our products.
MEH: Where will the device
be manufactured?
NT: Manufacturing and assembly
is currently planned to be
conducted in China. We are
well advanced in our discussions
with an experienced group to
undertake this role for us.
MEH: Which certifications
does the device have?
NT: All products will be
manufactured to CE classifications
and international standards
for safety and quality.
MEH: From a commercial
perspective, which markets
are you looking at initially?
NT: Our first products will
target the sports medicine
(exercise recovery), pain
management and wellness
sectors. Once we get established
we will push into more
mainstream medical device
applications for conditions like lymphoedema, diabetic oedemas,
wound healing and cosmetic
body contouring.
MEH: What will the device cost?
NT: We expect the consumer
product to retail for US$400 to
$600. We anticipate that the
clinical product will retail for
$3,000 to $4,000.


Date
of upload: 29th September 2008
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