Hyperthermia Blog

What's New, What's News, What's Happening

enfrdehija

Data does not Lie, Oncotherm... well??

We have recently heard a few stories from doctors who have purchased Oncotherm systems. When asked why they did not choose the industry standard, Pyrexar Medical, for their hyperthermic cancer treatment center, their answers revealed some sly misinformation.  The statements below are hearsay, and we presume that the anecdotal information was represented to physicians during the equipment sales process. We have provided statement ratings to help you separate fact from fiction.

Statement: Google "Oncothermia" and you will see plenty of published data that it works.

tom pantsonfireThis is very misleading. In the medical field, published data refers to peer reviewed studies published in reputable medical journals. So we did our own research and typed "oncothermia" into the search bar of the journals listed below. The results compare the number of articles referencing "hyperthermia" vs number of articles referencing "oncothermia". The data spoke.

Peer Reviewed Medical Journal  "hyperthermia"  "oncothermia"
International Journal of Hyperthermia 1985 1
European Journal of Cancer 960 1
The Lancet 484 0
International Journal of Cancer 367 0
British Journal of Cancer 343 0
Journal of Clinical Oncology 227 0
International Journal of Oncology 153 1
Oncology Reports 132 0
The Journal of the American Medical Association 80 0
European Society of Radiotherapy and Oncology 79 0
Cancer Immunology, Immunotherapy 52 0
International Journal of Medical Science 37 0
CA: A Cancer Journal for Clinicians 33 0
Journal of the National Cancer Institute 32 0
Japanese Journal of Clinical Oncology 30 0
Prostate Cancer and Prostatic Diseases 10 0
Journal of Clinical Investigation 8 0
Cancer Medicine 7 0
Society for Endocrinology 7 0
Cancer Epidemiology, Biomarkers & Prevention 3 0

If you go to the American Cancer Society website and type “oncothermia”... Sorry, no matches were found...  But it gets worse, type "oncothermia" into Google and among the findings, you get an NIH abstract "Current Status of Oncothermia Therapy for Lung Cancer" by Andras Szasz,PhD . The paper uses HT studies as the foundation that hyperthermia works, but then introduces oncothermia as a false equivalent. Under the Clinical Evidence section it states that no clinical results can be provided, instead just observations through case studies. Szasz is the founder of Oncotherm and is the author of the majority of the claims found on the internet.

Statement: Pyrexar is only FDA approved for Cervical cancer and superficial tumors of Melanoma and Sarcoma.

tom falseIn fact the BSD-500 Superficial/Interstitial system is approved for most indications.  It has well documented success in superficial lesions like recurrent chest wall tumors, soft tissue sarcoma and melanoma. The BSD-500 Hyperthermia System is indicated for use alone or in conjunction with radiation therapy in the palliative management of certain solid surface and subsurface malignant tumors (i.e., melanoma, squamous- or basal-cell carcinoma, adencarcinoma, or sarcoma) that are progressive or recurrent despite conventional therapy. Because its interstitial capabilities are designed for brachytherapy, it has the ability to treat along side any brachytherapy treatment. This makes the BSD-500 is a very effective system. In the U.S. the BSD-2000 is FDA HDE approved for Cervical cancer, but that restriction is changing.

Statement: Pyrexar Systems requires a temperature probe to be inserted into the tumor under imaging guidance.

tom falseThat is very old data. Although a physician could choose to place a temperature probe directly into the tumor, it would be an extremely rare case, not a common practice, aside from Brachytherapy where a catheter is already inserted into the tumor for radiation. We use that existing path for both temperature probes and rf antenna placement. Pyrexar equipment can track up to 8 temperature probes with a temperature resolution of ± .2˚C (per ESHO guidelines), and are commonly taped to the surface for superficial tumors or placed near deep tumors through the natural orifices using closed tip catheters. Physicians can easily place probes using their knowledge of physiology without the need for image guidance.

Statement: With Oncothermia you don’t need to use temperature probes.

tom mostlytrueThis is absolutely true, but for the wrong reason. Oncotherm claims that the heat component is not the therapeutic effect on the tumor, even though they continually reference hyperthermia (heat) clinical studies. The Oncotherm system is generally not capable of elevating tumor tissues to therapeutic temperature where probes would provide necessary data and system control.  Instead they promote an unsubstantiated belief that frequency waves effect the tumor at the cellular level. This is alarming as there is no clinical evidence of this “effect”. Doubly alarming is that Oncotherm is convincing physicians to use this equipment on their patients with cancer.

Statement: FDA approval is not that important unless you sell in the US.

tom mostlyfalseFDA approval is the gold standard around the world.  It is very difficult to get because it requires claims to be based on supporting factual evidence.  Even though not required for sales outside the US (there are no Oncotherm systems operating legally in the US) the global medical community acknowledges this labeling and the gravity of its certification. In addition to being Made in America, Pyrexar also has CE, TUV, ISO 13485, RoHs and KFDA approvals. (CFDA and TFDA re-certification pending due to our address change)

Statement: The recent Amsterdam study shows the radiative heating method (used by Pyrexar) was superior in heating versus all capacitive heating systems, but is not user friendly.

tom truetom falseThe study showed the radiated source heating was superior (read previous post) in the Pyrexar Superficial system but that has nothing to do with user friendly.  Pyrexar systems now come standard with a 24” monitor, a new improved applicator support arm, simple temperature thermal well sensor calibration and a redesigned user friendly touch screen interface, plus many other time saving and simplification features. The features that are most accessed by the RT are icon driven and right up front. All of the more advanced controls and treatment simulators are still active and can be easily pulled up on the screen for more advanced user adjustments.  The software tracks input from the temperature probes and continuously makes power adjustments to hold the tumor at target temperatures.

So don't fall for it. 17 Phase III studies show its about Heat, not Hype.

Study Shows Capacitve Heating the Poor Choice

New Study shows that Radiated Hyperthermia is superior to Capacitive Hyperthermia in the Treatment of Superficial Cancerous Tumors. Clinical data demonstrates that adding superficial hyperthermia treatment to radiation in the treatment of Recurrent Chest Wall Tumors (breast cancer) and malignant melanoma can double* the complete response (tumor eliminated) rate. Add Hyperthermia, Your chances of beating cancer DOUBLES!

The downside, not everyone who claims to offer hyperthermia can deliver this potentially life saving benefit.  It essential comes down to two heat delivery methodologies; Capacitive vs Radiated Electromagnetic Fields. In a recent comparison study at the Department of Radiation Oncology at the University of Amsterdam, researchers H.P. Kok and J. Crezee compare hyperthermia systems made by Pyrexar, ALBA, Oncotherm, Celcius 42 and Thermotron. SPOILER ALERT: Pyrexar’s BSD-500 Superficial Hyperthermia system is the only one among the systems tested to earn FDA Approval.

Feature Radiated Microwave Capacitive
Pyrexar Oncotherm Celcius 42 Thermotron
FDA Approved YES NO NO NO
Temperature Probes & Monitoring YES NO NO YES
SAR based tumor temp. YES NO YES YES
Phase III published clinical studies HT+RT YES NO NO NO
Made in the USA YES NO NO NO


Pyrexar uses radiated microwave / radio frequency to pass energy into the body and absorbed by the tissue as heat. This heat delivery can be measured and compared using a numerical value called a SAR (Specific Absorption Rate). Primary benefit of choosing a hyperthermia system using frequency radiated field is that the energy can be transmitted from the antenna to the cancer tumor without getting stuck in the fat layer.  Capacitive heating techniques used in Oncotherm, Celsius 42 and Thermotron have difficulty passing thru the fat layer.  This often results in the super-heating of the fat layer, causing patient discomfort and blocking the tumor from receiving a therapeutic dose of heat.

Capacitive systems often claim they heat, just not where it will do the patient the most good if there is superficial fat over the tumor.  More fatty tissue in the treatment area equals poor results.  Oncotherm claims they avoid over heating of the fat tissues of the surface by limiting the radio frequency power from their capacitive electrodes .  Technology speak for they don't heat, hoping to rely on their claimed non-thermal effects for the treatment. 

Conclusion from the report, “This study showed that radiative hyperthermia yields more favorable SAR and temperature distributions for superficial tumor locations, compared with capacitive heating, especially within heterogeneous tissues. With radiative heating, higher tumor temperatures can be achieved without inducing treatment limiting hot spots, which will benefit clinical outcome.”

View the entire report “A comparison of the heating characteristics of capacitive and radiative superficial hyperthermia” in the International Journal of Hyperthermia, 2017.

* statement based on published Phase III Clinical Studies

Join Us at the 34th Annual STM

Please join us at the 34th Annual Meeting of the Society for Thermal Medicine in Cancun, Mexico. I know some of you are still experiencing winter, so enticing you with ocean water temperatures of 81˚F would be unfair.  But supporting and participating in the advancement of the hyperthermia industry is a good thing.

This years meeting will be held April 29th thru May 2nd at the CasaMagna Marriott Cancún Resort.  The 2017 Program Chair is Robert Ivkov from the Department of Radiation Oncology at Johns Hopkins University School of Medicine.  You can register for the conference at the STM website, thermaltherapy.org. The full conference program is available here.

The conference is shaping up to feature an outstanding line-up of the world’s thought leaders and prominent researchers presenting cutting-edge developments in biology, physics, engineering, and clinical applications of thermal medicine. Our CTO, long time STM member and industry expert, Paul Turner will be in attendance.  Jason Ellsworth, our VP of Engineering, will be a featured speaker at the event. And as the company CEO, I will be available to field any questions about the direction Pyrexar is taking to expand the global market.

In addition to being an event gold sponsor, Pyrexar has invited several hyperthermia luminaries from the ESHO (European Society of Hyperthermic Oncology). Dr. Niloy Datta, Dr. Rolf Issels and Dr. Jacoba Van der Zee will be there to speak at the event and share their experiences.

 

stm cancun

The Future of Radiation Therapy in Peril

With the increased attention worldwide on immunotherapy, the future of radiation therapy as a monotherapy is at risk of losing ground as the standard of care. In order to fight radio-resistant tumor types, oncologists are reaching for treatment solutions that can close the performance gap of existing therapies to increase tumor control. Monotherapy treatments, like radiation therapy, are being pushed aside by dual-therapy treatment programs. So what can be done to increase radio sensitivity, reduce toxicity and improve outcomes?

RF hyperthermia is one such dual-therapy technology that is leading the charge. Hyperthermia is an ideal adjunct therapy for radiation resistant tumors. Focused energy applied to the tumor site (targeting tumor heating of 41 C) is a highly effective radio-sensitizer. In addition, provides this heightened benefit with little to no-toxic effect to the patient.

  • Known benefits of hyperthermia include:
  • Increased oxygenation of the tumor site.
  • Inhibits DNA repair.
  • Assist in cell death during cellular s-phase.
  • Increases in effective Gy dose by as much as 150 percent.

Phase III clinical studies have shown dramatic improvement of tumor control and long-term patient survival by adding RF hyperthermia. Targeted heating within four hours before or after radiation therapy can increase the radiosensitivity of the cancer tumor. The benefit of increased oxygenation of the tumor site can remain for up to 24 hours.

The Pyrexar family of highly reliable, deep regional and superficial/interstitial hyperthermia systems are based on 30 years of product development and tens of thousands of patient treatments. Pyrexar cancer treatment devices use radio frequency to deliver focused energy to the tumor site. This technology allows for superior heating of most soft tissue tumors, provides temperature mapping and treatment zone control, with emphasis on patient comfort.

At this year’s RSNA trade show in Chicago, Pyrexar will be introducing the next step in image guided thermal therapy, the newly redesigned BSD-2000 3D/MR. The benefit of the 3D/MR system is that it allows the oncologist and therapist to accurately visualize tumor and treatment zone temperatures using the MRI.

The new applicator, designed to fit the majority of tesla 1.5 systems, surrounds the patient’s body in the approximate area of the tumor. The patient and applicator are transported inside the MRI. The initial MRI image records the proton resonance frequency image using known baseline temperatures. As the system begins to heat the tumor area, subsequent images are taken. Software calculates the temperature dependent image changes and builds a 3-D temperature map of the tumor and surrounding tissue. Having live temperature data provides the operator easy retargeting, via control software, to ensure the tumor is within the treatment zone and has reached prescribed temperature and coverage. After treatment, applicator can be stored for normal MRI imaging workflow.

RSNA Trade Show Booth Mock-up

RSNA Chicago is approaching fast.  Our booth just shipped out this afternoon. Below are pictures of our booth mock-up we use to help use plan the event.  We are offering a sneak peak of our new BSD-2000 3D/MR Applicator at the show.  Everyone on the team has been working hard all year for this achievement. We will be sharing specifics of the product and our first installation in Germany, later this month.

If you are planning on attending the show, please stop by booth #3257 and be the first to see the new product.  For more details, visit our events page. If you would like to make an appointment with our CEO and our team, please use the form link.

Booth 1

Booth 2

Booth 3

Booth 4

Booth 5

World's Largest Hospital Supporting Hyperthermia

A high-point of the show was an impromptu presentation by Dr. Daoke Yang on the advances of hyperthermia in China.  Dr. Yang is the head of oncology for the First Affiliated Hospital of Zhengzhou University. Dr. Yang presented clinical data to support the benefits of hyperthermia as an adjunct to chemotherapy and radiotherapy. And explained in great detail, the triggered immune response when heat is applied to tumor cells.

dr yang presentation

First Affiliated Hospital of Zhengzhou University is the largest hospital in the world. With over 10,000 beds (after the hospital's latest expansion opening Q1 2017), the hospital is not only the largest in the world, but nearly three times larger than the world’s second largest hospital in Belgrade, Serbia.

zhangzhou university

A special thanks to Mrs. Wang, president of Orientech Dalian, for orchestrating the visit. We are expecting to place several Pyrexar Hyperthermia systems in ZhengZhou early next year.

Robots Invade ASTRO 2016

paul robot 4paul robot 2

This year our CTO, Paul Turner, arrived to the American Society for Therapeutic Radiology and Oncology exhibition via a shipping crate.  Our ability to communicate the highly important contribution that Pyrexar hyperthermia systems provide to cancer treatment takes a team.  So how do you bring your entire team to Boston in a fiscally responsible way?  You do it virtually, with a virtual presence robot. Our entire staff at our Salt Lake City headquarters was available to answer attendee questions simply by taking controls remotely of our onsite robot.  "We use this technology in our office everyday" says Mark Falkowski, CEO of Pyrexar, "having control of your virtual presence in the office is different from a Skype meeting, it gives you the autonomy to go just about anywhere".

paul robot 3paul robot 1

Not only was Paul available for meetings and to answer questions, he often posed for photographs during the show.

ASTRO, Hyperthermia and RVUs

Our first day at ASTRO 2016 (American Society for Therapeutic Radiology and Oncology) was a very successful one.  We had the opportunity to present our technology and to field questions from attendees of the conference.  One theme that continued throughout the day was hyperthermia reimbursement. What we learned; patient outcomes were still very important to physicians, but its all about the RVUs.

astro skybridge

Doctors’ time and energy are not always measured in lives saved, and patient wellness. Now they need to devote part of their busy days on managing RVUs. Relative Value Units are a measure of value used in the United States Medicare reimbursement formula for physician services.  RVUs are part of the system Medicare uses to decide how much it will reimburse physicians for each of the 9,000-plus services and procedures covered under its Physician Fee Schedule, and which are assigned current procedural terminology (CPT) code numbers. A well patient visit, for example, would be assigned a lower RVU than an invasive surgical procedure.

astro crowds

Hyperthermia is a non-invasive treatment that increases the patients chances of beating cancer. How does Hyperthermia play in the RVU system? What we learned is that hospitals and cancer centers need to be competitive to attract new patients. Although it is been clinically proven that hyperthermia treatment improves cancer outcomes, it is not in every hospital and cancer center.  And limited resource creates higher demand. Centers need to attract patients outside of the facilities geographic radius in order to stay in business.

“Speaking with our Pyrexar installed base in the US, we are finding patients are requesting hyperthermia and traveling outside their local cancer centers to receive treatment” says Mark Kidd, VP Sales at Pyrexar. “Bringing in patients by offering the latest in cancer technology means more revenue for the center..

ASTRO 2016 Setup Day

ASTRO beforeSaturday was set-up day for Pyrexar at the ASTRO 2016. The exhibition, held at the Boston Convention Center, is expected to draw 10,000 radiation oncologist, physicist and therapists from around the globe. This year we had a nice in-line space across the isle from one of our customers, 21st Century Oncology.  Their Fort Meyers, FL location uses a BSD-500 Superficial/Interstitial Hyperthermia System to treat a variety of cancers including recurrent chest wall tumors and melanoma.

astro cratesastro open crates

Crates arrived on time and the booth will be ready to go for Sunday’s exhibition opening. Watch for tomorrow's blog to see the booth.

As American as Baseballs and "Apple" Pie

On September 5th, the United States observed Labor Day.  This national holiday honors the creation of the labor movement and is dedicated to the social and economic achievements of American workers.

Even though iconic brands like Apple, Levi and Rawlings (the official baseball of the MLB is made in Costa Rica) are no longer manufactured in the U.S.A, the U.S. is still a manufacturing powerhouse. Especially when it comes to providing the world with advanced medical devices. According to the International Monetary fund, the U.S. exports a whopping $85 billion in medical devices. Although some brands have moved their manufacturing overseas, “Made In America” is still very sought after when it comes to medicine.

dalian sfogroup photo includes members from Dalian Orientech, Dalian Municipal Central Hospital and Pyrexar Medical.

That is why it was not surprising that when representatives from Dalian Municipal Central Hospital in China were ready to invest in new medical technologies, they came to the U.S. to do some shopping.  China is the second largest medical device market in the world. In addition to having the world’s largest population, the Chinese government has invested heavily in healthcare infrastructure with basic healthcare for all citizens. Although it possesses its own medical device industry, it often looks to the United States for advanced technology products.

Dr. Wang, president of Dalian Municipal Central Hospital, met with Pyrexar CEO, Mark Falkowski to talk about hyperthermia as a vital treatment to fight cancer in China.  Pyrexar continues it expanse into China with the assistance of our long time distributor Dalian Orientech Co.,Ltd.

 

HT+RT Beats CT+RT in Advanced Cervical Cancer

Researchers are combining traditional cancer treatment therapies in order to increase a patients chance of surviving cancer.  Even a few percentage points in tumor response can represent a significant benefit in saving of a life. Dr. Niloy Datta. from Kantonsspital Aarau AG,Switzerland, presented his recently published meta-analysis paper at a conference held at the Scientific-Research Institute of Oncology, St. Petersburg, Russia.

In the analysis Dr. Datta compared results for treating advanced cancer of the cervix using combination therapies.  When comparing Chemotherapy with Radiotherapy (CTRT) versus radiation alone, the odds benefit of complete tumor response was 1.43.  When comparing Hyperthermia with Radiotherapy (HTRT) versus radiation alone, the odds of complete tumor response to 2.68.

Hyperthermia plus Radiation therapy provided superior outcomes without the increase in acute toxicity found with Chemotherapy.

Go to minute 25:00 on the presentation to see the overall Odds and risk ratios presented.

The paper was published August 12th, 2016 in the International Journal of Hyperthermia, Hyperthermia and radiotherapy with or without chemotherapy in locally advanced cervical cancer: a systematic review with conventional and network meta-analyses. Niloy R. Datta, Susanne Rogers, Dirk Klingbiel, Silvia Gómez, Emsad Puric & Stephan Bodis

Visit Pyrexar at RSNA 2016 Chicago, Booth 3276

We would like you to join us for the RSNA 102nd Scientific Assembly & Annual Meeting in Chicago.  RSNA (Radiological Society of North America) is the premier radiological show in the world, with more than 435 educational courses, 1,728 scientific paper presentations, and 659 exhibitors.

RSNA 2016 convenes radiology professionals from around the globe to gather knowledge through educational courses, explore the latest innovations presented by technical exhibitors, discover groundbreaking research from scientific paper presentations, and participate in networking opportunities.

The exhibits run Sunday thru Thursday, November 27th - December 1st. From the main entrance of the South Hall A, find your way to the back of the hall, next to the BISTRO food court.  Look for booth 3276.  Click the map for the full listing.

RSNA 2016, McCormick Place, Chicago Convention Center, Nov. 27th - Dec. 1st

RSNA 2016 floor map

 

If you would like to reserve some time in advance with one of our experts, submit the link form and we will confirm your appointment time. We look forward to seeing you there.

 

 

 

Pyrexar Super User Receives Award for Hyperthermia Research

DR. Zeljko VujaskovicZeljko Vujaskovic , MD, PhD, a hyperthermia proponent and Pyrexar Hyperthermia systems “super user”, was presented with the J. Eugene Robinson Award. The award is presented annually to those how have made outstanding contributions to hyperthermic oncology. Dr. Vujaskovic, a professor of radiation oncology at the University of Maryland School of Medicine and the director of the Division of Translational Radiation Sciences at the University, is the twenty seventh recipient of this honor.

There has been a resurgence in focus int the field of Thermal Oncology in the past year.  Many researchers are looking at hyperthermia as an effective immune system activator. Not only boosting the effect dose of radiation and increasing the effectiveness of drug delivery, but as a way to keep cancer from returning to those patients who have already battled the disease.

Dr. Vujaskovic was recently a featured speaker at this years Pyrexar Day. His complete presentation is available for review below.

Where is the Evidence that Hyperthermia Works?

If you want irrefutable proof that hyperthermia works, visit the US National Library of Medicine's website PubMed.gov, a division of the National Institute of Health (NIH).  PubMed is a repository of over 26 million citations for biomedical literature.  Using the search bar, type in “hyperthermia cancer treatment” and you will find over 25,000 results.

Too many results than most of us would find useful, so we narrowed down the list.  The link below contains completed randomized trials using hyperthermia as an adjunct to radiation therapy and chemotherapy over the last 30 years.  The studies reveal a higher tumor response when hyperthermia is added over chemotherapy and/or radiotherapy alone.  Several of the studies use Pyrexar Medical equipment or lab built equipment using the same or similar radio frequency energy delivery system.

abstract table

So the next time someone challenges you with “where is the evidence that hyperthermia works?”, just send them to evidence.pyrexar.com and let them read it for themselves.