“Fantastic Presentation given by James Carroll.
Very comprehensive Presentation and I finally understood what is going on with the Light Therapy. Thank you again and I am following your progress.
Great demonstration of the device and an interesting group of people.”
Occupational Health Nurse
Barbara has suffered from chronic pain for 2 years, so much that she couldn’t lie on her back. After her fifth visit using NovoTHOR Photobiomodulation Pod at Total You Health her pain and brain fog has gone. For now, she is coming in every 2 weeks for maintenance and to keep it that way. Barbara is off all medications and feeling wonderful.
Barbara P took some time to sit down with Jess to tell us about her AMAZING results from using the NovoTHOR bed. Since what she had was chronic, it took a few sessions, but she is SO HAPPY she stuck with it!!! Hear it for yourself …
Over the past year Courtney Runyon has had to undergo lots of chemo treatments, she suffered with nerve damage and stiffness in her hands, and felt she had aged 5 or 10 years due to this. As a side benefit with just over a month of using the NovoTHOR at XscapePain, her skin has improved so much as well as getting pain and stress relief. Courtney says the NovoTHOR is her happy place.
SEATTLE, Oct. 1, 2019 /PRNewswire/ — LumiThera Inc., a commercial stage medical device company delivering photobiomodulation (PBM) treatment for ocular disorders and disease, today announced it has begun enrolling patients in a multi-center United States clinical study in dry Age-Related Macular Degeneration (AMD) patients.
The randomized, multi-center study called LIGHTSITE III enrolled and treated the first patient at Cumberland Valley Retina in Hagerstown, Maryland. The United States study is being conducted in leading retinal centers throughout the United States. The study will enroll approximately 100 patients suffering from dry AMD and treat them over the course of two years. In addition to demonstrating safety, key efficacy endpoints include visual acuity, contrast sensitivity and reduction of drusen deposits.
In February, the company announced that the National Institute of Health and the division of the National Eye Institute was providing a $2.5M grant to partially support the U.S. study.
“This is an exciting opportunity to establish a potential new treatment for dry AMD patients” remarked Allen Hu, M.D. (Principal Investigator, Cumberland Valley Retina Consultants). “The previous work with PBM has been very promising. Our center has been involved in many drug studies with the wet form of AMD, but this study critically provides an important medical device treatment for the majority of patients with intermediate dry AMD and limited options.”
LumiThera has already obtained a CE mark authorization to commercialize the Valeda™ Light Delivery System in the European Economic Area for the treatment of dry AMD. The separate LIGHTSITE II study is an ongoing post-marketing study with top retinal centers in key European countries and was initiated earlier in the year.
“The LIGHTSITE III study has engaged eight top U.S. retinal centers to evaluate the Valeda,” stated Eleonora Lad, M.D., Ph.D. (Principal Investigator, Duke University). “We are now actively screening patients and will be measuring multiple vision outcome measures. The Duke Imaging Center with Dr. Glenn Jaffe will also be evaluating retina images for all study centers involved to determine if we are improving the health of the eye during the course of the trial. This is a major study that will establish a novel treatment for these elderly patients and could have a big impact on their quality of life.”
“We have two multi-center trials currently underway, one in Europe and one in the U.S.,” stated Clark Tedford, Ph.D., President and CEO. The data from these trials will be used to further support our commercialization efforts and global regulatory submissions. We have enlisted top private retinal and University centers in the U.S. for the LIGHTSITE III trial and if successful, the study would allow an important treatment choice in the prevention of vision loss for patients here.”
About LumiThera Inc.
LumiThera is a commercial-stage medical device company focused on treating people affected by ocular disorders and diseases including dry AMD, a leading cause of blindness in adults over 65. The company is a leader in the use of PBM for treatment of acute and chronic ocular diseases and disorders. The company is developing the office-based Valeda Light Delivery System to be used by eye care specialists as medical treatments.
The Valeda Light Delivery System has been granted authorization to use the CE Mark by an EU Notified Body as required for commercial use in the European Economic Area only. Valeda is not approved for use by the Food & Drug Administration (FDA) in the USA.
U.S. CONGRESSIONAL BRIEFING. Ending Opioid Use – Washington DC
James Carroll presented evidence to Congress on the effectiveness of PBM for treating pain and where it can be used in place of opioids. Prof. Praveen Arany explained how and why it works, and Annette Quinn RN gave her first hand experience in treating over 854 patients with Oral Mucositis.
A hundred million adults in the United States are affected by chronic pain and $600 billion a year is spent on in health care, direct health care costs and lost productivity because of pain.
49,000 people from opioids in 2017, 19,000 of which were from prescribed opioids for pain relief.
We believe that Photobiomodulation therapy can help reduce the prescribing of opioid medication for pain relief and we wish to draw attention to the Congress and health care policymakers, NIH and CMS, about this potentially valuable tool.
This 15 minute video starts with an overview of Photobiomodulation and low level light therapy. Later in the presentation James introduces the Lumithera treatment for Dry Age related Macular Degeneration (AMD).
The paper “High-intensity versus low-level laser therapy in the treatment of patients with knee osteoarthritis: a randomized controlled trial” Kheshie et al 2014 pitches the 3B BTL laser against the HIRO class IV “High intensity” laser. The results appear to show that the HIRO class IV “High intensity laser” was more effective than the “Low Level Laser”. HOWEVER, the HIRO class IV “High intensity” laser was delivered over a large area (not adequately defined but approx 100cm2 by my estimation) so the intensity was actually very low (about 13mW/cm2 which is less than most LED systems), and the 3B BTL “Low Level Laser” was actually very high (4 x 200mW small, high intensity beams) and were held stationary on the patella for over half an hour, YES, HALF AN HOUR IN ONE SPOT! This is insane.
This paper leads people to think that the class IV Hiro laser was more effective because it was higher intensity when in fact the beam distribution meant the average intensity distribution was low (13mW/cm2). The 3B laser was not so effective because it was held stationary such that it would cause an overdose. If the 3B laser treatment had been delivered in using same scanning technique as the class IV then they would likely have achieved the same result. (I am not a fan of scanning because you can never be sure how much energy you have delivered to an area, better to use a low intensity device and hold it still in my view).
This paper misdirects the reader towards favouring class IV lasers rather than 3b or LED by misinforming the reader.
The title of last months PMLS editorial was Low Level Laser Therapy (LLLT) and World Association for Laser Therapy (WALT) Dosage Recommendations. Written by the Scientific Secretary Prof. Jan Bjordal. He describes how far we have come and the importance of the WALT dosage recommendations. No abstract is available for editorials so I have prepared one for you below. Continue reading →
A paper titled ”The Effectiveness of Therapeutic Class IV (10 W) Laser Treatment for Epicondylitis” [ref] showed that 10 Watt Class IV laser (mixed 8W 970nm, 2W 810) was successful in reducing pain and improving function in an RCT with 15 patients, and that there was good statistical significance at 6 months following a course of 6 treatments.
The claim by class IV laser manufacturers is that class IV lasers are better (faster, deeper and more effective) than Class 3b and LED systems. Conversely the 3B laser and LED manufacturers argue that less power density is more effective because delivering energy too quickly can overdose tissues and class IV lasers might burn the skin.
Throughout this paper there are marketing messages claiming the advantages of shorter treatment times than low power LLLT systems and of course the title shouts “10 Watt Class IV laser” just in case the reader is in any doubt that more power is what you need.
Regular readers of this column know my obsession with irradiation parameters, particularly dose rate effects (W/cm2) and will not be surprised to learn that I deconstruced the irradiation parameters used in this trial . Surprise, surprise they were the same low irradiance levels typically used by 3B lasers and LED systems, if not less and the treatment time was longer too.
Yes, it was a 10 Watt laser and yes, 3,000 joules was delivered, however it had a large beam area and treatment was delivered over (45cm2) in a “painting fashion”. The fluence (dose) was 6.6 Joules/cm2 and the power density was a tiny 22mW/cm2, consequently treatment time was a hefty 5 mins.
The average irradiance was not disclosed in the paper and the reader is directed to think that more power is quicker.
P.S. research trials with 3B lasers are typically 30 seconds to 3 mins and our recommended treatment is 1 min with a large LED cluster to the lateral epicondyle and 30 seconds for any related trigger points.
The Treatment Protocol Library is available only to THOR Customers and/or people who have attended a THOR training course in the last 3 years. All treatments are based on our four step method which includes treatment of the injury, trigger points, lymphatics and nerve roots.
Take a look to see how it works and let us know what you think.
“Wonderful workshop! I enjoyed learning about the research that has gone into THOR and the continuing research and development on the process and products in general. I am convinced of the THOR Laser’s value. I also have a much better understanding of the protocol – I needed the ‘why’ for the steps and now I have it. Thank you.”
Nicci Robinson a “super athlete” client of XscapePain uses and recommends NovoTHOR to not only address pain, but to also use as a booster to her athletic performance as well as a significant recovery modality!