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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