We are proud to announce the signing of Finggal Link Co. Ltd, headquartered in Tokyo, as our new distributor in Japan. Through the combined efforts of Mr. Masaaki Inoue of Advanced Medical and the regulatory group at Finggal Link, we hope to reinvigorate the product line in Japan.
In the 1980's and 1990's, there were approximately twenty BSD-1000 units installed in Japan. The BSD-1000 is the predecessor to the products we have today. In 1993, the sales distributor for Japan was disolved, leaving a product registration void that was never re-established. With this new effort, we hope to introduce the new Pyrexar product line and revive the use of hyperthermia for the treatment of cancer in Japan.
Masaaki Nagone-CEO, Finggal Link; Mark Falkowski - CEO, Pyrexar Medical; Kenji Hirayama - Director, Int'l Affairs and RA/QA, Finggal Link Dr. Tetsuya Furukawa - Director, Medical Division, at Finggal Link, will head the clinical education efforts at major hospitals throughout the country. A special thanks to Dr. Hayes and the thermal oncology team at Gamma West Cancer Services in Salt Lake City for allowing Dr. Furukawa to observe a Head and Neck Brachytherapy and Hyperthermia treatment at the St. Mark's location. Gamma West is a great asset to the medical community in Utah, and throughout the intermountain region, providing lifesaving and life changing procedures for cancer patients.
Masakki Innoue - Advanced Medical Systems; Dr. John Hayes - Gamma West Cancer Services; Paul Turner - Pyrexar Medical; Dr. Tetsuya Furukawa - Finggal Link
We want to acknowledge all the speakers for their participation at First International Conference of the Polish Society for Hyperthermic Oncology. It was an amazing event. Special thanks to the dedicated team at HT systems for creating such a dynamic conference and for re-energizing hyperthermia in Poland. And to the co-sponsors of the event for their support of the meeting. Pyrexar Medical strives to support hyperthermia (the treatment of cancer with heat) education and research around the globe.
Distribution Partner HT Systems
Dariusz Droś, CEO of HT Systems and Mark Falkowski, CEO of Pyrexar Medical
Meeting Well Attended
A large group of researchers and clinicians attended the event at the Hotel Rezydencja Luxury, Piekary Slaskie, Poland
HT Systems is the exclusive distributor of Pyrexar Medical Hyperthermia Systems in Poland
BSD-2000 Scale Model
HT Systems commissioned a 1/3 scale model of the BSD-2000 Sigma Base with the Sigma Ellipse Applicator
The lectures were professionally recorded and are in the editing process. The PTHO has started a Youtube Channel which will be hosting the video presentations of the speakers listed below.
Prof. Niloy R. Datta, MD, DNB, CCST (CH)
"Overview of meta-analysis clinical trials in head neck cancers / recurrent breast tumours / locally advanced cancer cervix" [Language: English]
Senior Consultant and Head, Radiation Oncology Research Programme, Centre of Radiation Oncology KSA-KSB, Kantonsspital Aarau AG, Aarau, Switzerland
Dr. Sc. Hana Dobsicek Trefna,PhD (S)
"Quality assurance in hyperthermia treatments" [Lecture: English]
Assistant professor in the Biomedical electromagnetics research group and an expert in systems and focusing algorithms for microwave hyperthermia treatment of deep-seated tumors. Her work aims at the clinical introduction of hyperthermia in Sweden, developing a UWB hyperthermia system for treatment of Head and Neck tumors and exploring the possibility of hyperthermia treatment of brain tumors in children.
Dr. med. Boris Hübenthal, MD, PhD (CH)
"Case Reports from the Center of Integrative Oncology ZIO Zurich" [Language: Polish]
Medical Director of the Center of Integrative Oncology ZIO in Zürich Switzerland, Chairman of the European society for integrative oncology ESIO eV. Principle investigator of the database project www.bestcase-oncology.com
Prof. Rolf Issels, MD, PhD (D)
"Up-date on clinical trials combining regional hyperthermia with chemotherapy" presented at the PTHO Confrence " [Language: English]
Head of the Clinical Cooperation Group Hyperthermia Researcher at the Helmholtz Zentrum München Deutsches Forschungszentrum für Gesundheit und Umwelt (GmbH)
Dr. Jacek Kabut, MD, PhD (PL)
"The treatment of bladder cancer combined with regional hyperthermia - case report" [Language: Polish]
Specialist of Internal Medicine and Oncology. Chief Assistant of the Oncology Department in the Regional Specialist Hospital in Rybnik. Oncology consultant in the Regional Hospital of Pulmonary Diseases in Wodzisław-Śląski Wilchwach. Member of the Polish Society for Clinical Oncology, Polish Society for Experimental and Clinical Immunology and of Polish Society for Hyperthermic Oncology.
Dr. Dorota Kazberuk, MD (PL)
"Deep tissue hyperthermia in oncological gynaecology in Białystok Cancer Center" [Language: Polish]
Radiation Oncologist in the Radiation and Brachytherapy Department and Brachytherapy Coordinator of the Białystok Cancer Centre. Member of the supervisory committee of the Polish Brachytherapy Society (PTB). Regional Branch President of the Polish Oncology Society of Podlasie.
Prof. Wiesław Kozak, PhD (PL)
"Fever Biology" [language: Polish]
Full Professor at the Nicolaus Copernicus University in Toruń, Poland, former Dean of Biology and Environmental Sciences, Head of Immunology Department
Dr. Andrzej Kukiełka, MD, PhD (PL)
"Rescue brachytherapy combined with interstitial hyperthermia in local relapse of prostate cancer after radical radiation therapy - prospective study phase II - current state of research" [Language: Polish; Slides: English]
Radiation Oncologist in NU-MED Cancer Diagnostics and Therapy Centre in Zamość Member of European Society of Hyperthermic Oncology (ESHO) Member of the Review Panel of the Polish Brachytherapy Society (PTB)
Prof. Urszula Mazurek, MD, PhD (PL)
"Heat shock proteins in hyperthermia applied in oncology" [Language: Polish; Slides: English]
Head of Department of Molecular Biology at the Silesian University of Medicine, Member of Scientific Committee in the Biotechnology Center of the Silesian University of Technology.
Dr. Med. Michal Niksa
"Operation of the BSD-2000. Experiences made in Cancer Centre of Białystok". [language: Polish]
A member of the Department of Radiotherapy with the Brachytherapy Department of the Białystok Cancer Center
Dr. markus Notter, MD, PhD (CH)
"Low dose re-irradiation & hyperthermia in extended local recurrent breast cancer : perspectives and challenges" [Language: English]
Radiation oncologist in the Lindenhofspital in Bern (CH), vice-president of the Berne Foundation against Cancer (Ligue Bernoise Contre le Cancer), member of the board of the Swiss Cancer League.
Prof. Elisabeth Repasky, MD, PhD (USA)
"Temperature Matters: Chasing an elusive evidence-based rationale for hyperthermia in the cancer clinic" [Language: English]
Professor of Oncology, William Huebsch Professor of Immunology and Program Leader for the Cell Stress and Biophysical Therapies Program at Roswell Park Cancer Institute in Buffalo, NY.
Dr. Wacław Śmiertka, MD, PhD (PL)
"Recommendations of PTHO for use of hyperthermia in selected cancer diseases" [Language: Polish; Slides: English]
Gynaecologic Oncologist in Warsaw Cancer Institute
Dr. Bartosz Urbański, MD, PhD (PL)
"The oncologic hyperthermia" presented during the conference of PTHO" [Language: Polish]
Radiation Oncologist in Great-Poland Cancer Institute, Poznan
Dr. Jacoba van der Zee, PhD (NL)
"Results of randomized trials comparing treatments with or without hyperthermia" [Language: English]
Researcher in the field of Hyperthermia at the Dept. of Radiation Oncology, Erasmus University Rotterdam, Rotterdam
Prof. Gerard C. van Rhoon, PhD, (NL)
"Current Technology for Hyperthermia Treatment" [Language: English]
Professor in Erasmus MC Cancer Institute, head of Hyperthermia Unit, president of the European Society for Hyperthermic Oncology (ESHO)
Dr. rer. nat. Alexander von Ardenne, Dipl.-Phys. (D)
"Non-oncological hyperthermia and a new immunological road to attack cancer" presented during the conference of PTHO" [Language: English]
Head of the "Von Ardenne Institute of Applied Medical Research GmbH"
Prof. Zeljko Vujaskovic, MD, PhD (USA)
"Hyperthermia and Immunotherapy in Cancer Treatment: Rational and Clinical Directions" [Language: English]
Professor at the University of Maryland School of Medicine, USA. Head of the Division of Translational Radiation Sciences in the Department of Radiation Oncology
Prof. Holger Wehner, MD, PhD (D)
"Extreme whole body hyperthermia: risks and opportunities" [Language: English]
President of German Hyperthermia Society. Medical director in the Gisunt Klinik - Integrative Medicine and International Hyperthermia Centre. Specialist for hyperthermia since 30 years.
We are excited to announce the commissioning of a BSD-2000 3D/MR "Universal" System at Grosshardern University Hospital in Munich Germany.
LMU (Ludwig Maximilians University of Munich in Großhadern) has been a pioneer in cancer treatment with hyperthermia. The hospital has treated over 15,000 patient treatments with hyperthermia, many of them with Soft Tissue Sarcoma tumors. This facility was part of a phase III clinical study which illuminated the long-term survival benefits of adding hyperthermia to chemotherapy. LMU is also at the center of the HEAT (Hyperthermia European Adjuvant Trial) study, a randomized, dual-arm trial for pancreatic cancer using chemotherapy plus hyperthermia.
The BSD-2000 3D/MR uses MR imaging to visualize temperature in the treatment area. MR images are taken during the hyperthermia treatment and proprietary software creates a three-dimensional (non-diagnostic) representation of the heating zone in the body. With this information, the operator can easily adjust the heating zone in 3 dimensions to ensure that the tumor area receives the maximum thermal dose. Above is an excellent product video produced by Sennewald Medizintechnik GmbH, the innovators of the SigmaVision software and Pyrexar’s distributor in Germany.
The Sigma Eye MR applicator uses the existing MR patient support table and can be removed and stored when not in use, leaving the MR free for general imaging. The complete system package includes a Dodek 12-channel RF amplifier (positioned in the equipment room), the Sigma Eye MR applicator, a water circulation system that provides temperature-controlled deionized water to the applicator bolus (seen in blue), an 8-channel motor-controlled temperature box (used to verify thermal accuracy during treatment), and a computer system with control software.
The BSD-2000 3D/MR fits most 1.5 Tesla, 60cm bore (or greater) MRI systems on the market. Our system runs at 100MHz providing deep regional hyperthermia to any depth in the body. The applicator is capable of treating up to 95 percentile patient size based on available world data.
The technology used in capacitive hyperthermia has changed very little since its invention in 1916, and its future is in question. The advent of computerized controls and motorized applicator arm has done little to change the way energy flows between electrodes, nor has it improved treatment outcomes. The replacement of wet cotton rags, for current connection, with a water bolus is probably the only real advancement forward of this aging technology. Issues like the inability to steer or shape the heating zone, the inability to increase focus or accuracy, may never be solved.
Q: What are three things Capacitive Hyperthermia and the Pop-up Toaster have in common? (answer at the bottom)
The future of hyperthermia is in Phased Array Radio Frequency. Phased Array RF is a superior heating method, according to a recent study “A comparison of the heating characteristics of capacitive and radiative superficial hyperthermia” by Kok and Crezee. The ability to focus, steer and size the heating zone, monitor and maintain zone temperature, use numerical modeling for treatment planning, is all part of this advancing technology. There is a reason that there are so few positive phase III studies using capacitive systems, the heating method is difficult to quantify. The introduction of non-invasive thermometry using MRI has created a new interest in hyperthermia. These advancements are giving researchers new tools and clinicians more resources to help cancer patients. The chances for a positive cancer outcome is simply getting better.
Capacitive Heating has several flaws.
Fat layer power absorption. Capacitive heating applies 10 times more power per cubic centimeter in surface fat than in tissues below the fat layer, such as tumors. This leads to significant patient discomfort and pain during treatments. The power absorbed within a 1 cm surface fat layer is equivalent the same power distributed over the next 10 cm of tissue. If you administered 200 watts of power, 100 watts would be stuck in the fat layer generating a hot spot, the remainder of the energy ( only 10 watts per cm) is spread over the next 10 cm in depth. Certainly not enough energy to heat a tumor. How many of your patients have more than 1 cm fat layer? Check out the world obesity figures.
Field Shape. It is very difficult to create an accurate treatment plan when you can not control field shape. Capacitive RF heating fields diverge as they penetrate in the body unless the high water content pathways are constrained by low water tissues such as bone structures of the pelvis. The only control of the shape of the heating pattern is by the placement and sizes of the electrodes used.
No Future as an Image Guided Therapy. Although temperature sensors are available as an option (although rarely used) on capacitive hyperthermia systems, there is no ability to respond to the distribution of heating during a treatment. The operator can change the amplitude of the RF power and the temperature of the electrode cooling bolus. This limits the possible benefit of invasive or non-invasive thermometry methods. Although one could build a system that would fit inside an MRI, the operator would only be able to turn the power up or down. There would be no ability to guide the treatment zone to the target area. It would be like driving a car that only had an accelerator, but no steering wheel.
Is your product Hyperthermia? In the U.S. the term "bait and switch" refers to companies that attract you with features and benefits of one product only to try to sell you an inferior product when you arrive. One manufacturer of capacitive systems does such a poor job delivering a thermal dose that they must “bait” the customer with well-known hyperthermia studies only to “switch” technologies with unproven claims that fractal frequency kills cancer cells. 30 years of hyperthermia research, 17 phase III clinical studies and hundreds of peer-reviewed clinical studies agree the active effects are due to temperature, not frequency modulation.
When presenting Pyrexar technology to a customer, you are offering a future.
Statement: Phased Array Radio Frequency systems are generally more expensive. Reason: The axiom "you get what you pay for" plays well here. You are paying for superior equipment proven by years of published data and tens of thousands of patient treatments.
Statement: Phased Array Radio Frequency systems require more training to treat patients. Reason: We wish it could be a push of a button like a chest X-ray, but effective results require proper treatment planning and simulation, similar to a Linear Accelerator, for vastly superior patient outcomes.
Statement: Phased Array Radio Frequency has a future. Reason: Continuing research and the advancement of software, a simple update can make your existing system work better and better.
Question: If you or your loved one was diagnosed with cancer, which technology would you choose? Maybe good enough, or the proven best.
The answer to the Quiz Question: They were both invented 100 years ago, the technology has advanced little in 100 years, and Capacitive Hyperthermia technology nowhere to go.
Pyrexar welcomed Dr. Joon Kim, Chief of the Medical Clinic at Oasis Medical Care Hospital for a site visit in Salt Lake City, Utah. Dr. Kim specializes in treating cancer with hyperthermia. Accompanying the doctor was Pyrexar's South Korea distributors, Harris Maeng of Hanbeam Technologies and Michael Cha, CEO of Ivy-Lab. The group observed Dr. Hayes perform brachytherapy and hyperthermia on a recurrent ovarian tumor patient at the St. Mark's location of Gamma West Cancer Services. There is a lot of positive and innovative outcomes both in patient recovery and reimbursement which I will discuss in a future post.
Harris Maeng (Hanbeam), Dr. Joon Kim (Oasis), Mark Falkowski (Pyrexar), Michael Cha (Ivy Lab), Drew Wilkens (Pyrexar)
ASTRO 2017 Trade Show in San Diego
An extremely busy three days in San Diego for the 59th Annual American Society of Therapeutic Radiation Oncology Meeting. Attendance was approximately 11,000 and we had a great response at the booth. The president of Dalian Orientech (Pyrexar’s Mainland China distributor), Mrs. Shuzhi Wang, brought a large contingent of physicians for an in-booth presentation of the newly updated BSD-2000/3D/MR. In addition, Dr. Zeljko Vujaskovic shared a presentation on the clinical benefits of hyperthermia in the treatment of cancer and how the University of Maryland School of Medicine has integrated thermal oncology in their practice. Other visitors included South Korea distributors, Hanbeam Technologies along with their newest marketing and sales partner Ivy-Lab, Finggal Link from Japan and Sennewald Medizintechnik representing Europe and Russia. The star of the show, as always, was "Virtual CTO" Paul Turner. Not only was he available on the show floor to share his vast knowledge in his autonomous robot form, he was also available for selfies.
JCA - Japan Cancer Association
This year the BSD-500 returned to Japan. Hyperthermia has been a well-accepted therapy in Japan for the last three decades. From 1984-1992, eighteen BSD-500’s were shipped to the island nation. Soon after, the Japanese Government funded the development of their own Capacitive Hyperthermia system the Thermotron RF. After a brief unveiling at the Japan Cancer Association Conference in Yokohama, and with the help of Dr. Taro Sirakawa of Tough Idenshi Meneki Clinic, the BSD-500 will now be available to treat patients once again.
In our last blog Taiwan Partners and Water, we introduced you to AMES Medical from Taiwan. The group was inadvertently labeled as representing South Korea. Our apologies to Stephen, Johnson and Andy for the mistake.
Ames Medical Team - Andy Hsu, Johnson Chen, Mark Falkowski (Pyrexar), Steven Shih
We had two visits last week, one friendly and one not so friendly.
The very friendly visitor was from Ames Medical, our newest sales and marketing group in Taiwan. Steven, Johnson, and Andy spent the week with us for sales and technical training on the Pyrexar product line. They have some excellent ideas on how to penetrate the Taiwan market and have put together a well thought out strategic sales plan.
Andy Hsu, Johnson Chen, Mark Falkowski, Steven Shih
During the visit, Steven wanted to see what it felt like to be a patient in the BSD-2000, so we put him on the patient sling inside both the Sigma 60 and Sigma Ellipse applicator and filled the bolus with water. (we left the power off). He remarked that being surrounded by the bolus was both comfortable and comforting. He mentioned cancer patients in Taiwan were afraid to move around while receiving hyperthermia treatment. We hypothesize that may be a belief left over from the importance of not moving during radiotherapy. We assured him that the heat zone on the BSD-2000 was large enough that casual movement would not affect therapeutic outcomes.
On Friday, as we were about to send our visitors home, a water main under the building a few doors down broke. What started as a puddle, turned into a torrent and headed to our building. It was all hands on deck, including the Ames Team. We all grabbed brooms and created makeshift water dams and attempted to push the water out as fast as it came in. We managed to quickly get everything off the floor. After 2 hours, the fire department turned off the water and we started to put everything back together. We appreciate the help from our new sales partners, along with the enthusiasm they bring to hyperthermia and the treatment of cancer.
REMINDER: We will be exhibiting at ASTRO 2017 in San Diego starting this Sunday. Look for us at booth #646
This year the PTHO invited more than 20 speakers, prominent scientists, experts in hyperthermia, from many different countries. Besides polish speakers, you will have the opportunity to hear the lectures of guests from the USA, Holland, Switzerland, Germany, Russia, and China. The main topic of the Conference will cover hyperthermia trends in the treatment of cancer. The conference goal is to present the standard procedures of combining hyperthermia with radiation therapy, chemotherapy and other systemic treatments. One of the sessions will be dedicated to the biology of fever and to the immunological effects of hyperthermia.
The conference will be held on October 20-21st, 2017 in Piekary Slaskie, Poland at the beautiful, and award winning, Hotel Rezydencja Luxury.
Who should go? If you are a thermal oncologist or someone looking to understand how hyperthermia can be used as part of a comprehensive cancer treatment program, this conference touches on all of the topics. Pyrexar will have on display its new BSD-2000 3D/MR applicator which features live 3D non-invasive temperature mapping utilizing MRI guidance for accurate heat placement. A complete program is available on the PTHO website (www.konferencja2017.ptho.pl/programme)
Representing Pyrexar at the event will be CEO, Mark Falkowski and our local distributor Darius Dros and his team from HT Systems. Conference Admission and Hotel prices are extremely affordable, especially for the caliber of speakers and international contacts you will meet. Register before September 19th and save 25%. Registration and information available on the PTHO website.
Pyrexar is proud to welcome Kirloskar Technologies to its distributor network. Kirloskar Technologies, popularly known as KTPL, is part of the 100 year old, multi-billion dollar conglomerate, the Kirloskar Group.
Kirloskar has been a successful healthcare enterprise for more than two decades, offering a multi-disciplinary product portfolio catering to the fields of Cardiac Surgery, Interventional Radiology, Interventional Cardiology, Neurosurgery, Nuclear Medicine, Oncology, Radiography, Vascular Surgery, Minimal Invasive Surgery and Plastic & Reconstructive Surgery.
According to cancerindex.org, more than 1 million people were diagnosed with cancer in India in 2012. Cancer death rates stand at 680,000 each year. The National Cancer Registry puts breast cancer as the most common cancer for women in India, with cervical cancer in second. It is estimated that for every two women newly diagnosed with breast cancer, one dies. Every 8 minutes, a woman dies of cervical cancer. The good news is that hyperthermia is a highly effective adjunct treatment of both breast cancer and cervical cancers.
India represents a significant expansion into Asia for Pyrexar. India accounts for one-sixth of the world population, 10 times greater than the population of the United states. Kirloskar believes that Pyrexar’s hyperthermia line is an excellent companion to their radiotherapy product offering and the therapy will play an important role treatment of cancer in the country. There are some real advocates for hyperthermia in the region. We believe these influencers can help bring awareness and acceptance of the technology to cancers centers throughout India.
Healthcare spending in China has been increasing over the past few years and China is now the second largest healthcare market in the world. Pyrexar has been represented in China by our trading partner Orientech Dalian for the last 10 years. Ever since the name and address change from BSD Medical to Pyrexar, we have been working with the Chinese regulatory agencies to re-register the product for export to the country. Bureaucracy can take its toll on market presence, especially in the growing field of hyperthermia.
Mrs. Wang, President (Orientech); Bob Depalma, VP Regulatory (Pyrexar); Dr. Wu Dengbin, VP Oncology Ansteel; Mark Falkowski, CEO (Pyrexar); Dr. Zhou Tong (Ansteel); Dr. Zhu Xu (Ansteel)
So we took a trip to China to review our regulatory progress and meet with potential customers for our hyperthermia products. As we have experienced in the past, Orientech is a very generous host, treating us very well on each leg of our journey. After some internal discussions with our distributors, we believe we have a direction to alleviate the regulatory blocks so products will again be available in China.
Orientech invited us to present our hyperthermia line to key prospects in the area. The first stop was the Ansteel Group Hospital, a large facility in the Tiedong District of Anshan in the Liaoning Province. The Ansteel Group facility houses centers for Cancer, Genetic Detection, Immunotherapy, and Radiation Oncology. Our next stop was Dalian Municipal Central Hospital in the Shahekou District of Dalian in the Liaoning Province. Dalian Municipal has received many accolades including “top 20 best service hospitals” and “most reliable hospital in the province”.
After successfully met presentations, not only were the hospitals very excited and receptive about adding hyperthermia to their cancer treatment services, but preferred the newly updated, top of the line, Image Guided Thermal System, the BSD-2000 3D/MR. According to Mrs. Wang, president of Oreintech, there are more than half a dozen hospitals in region looking at the new MRI based system. Now I feel a bit embarrassed teasing the new product without supporting product information. Our first commercial installation of the newly updated product is being signed off this week in Munich, Germany, and we will bring you more details very soon.
Pyrexar was invited to present its hyperthermia line to the leading oncologists in the KSA (Kingdom of Saudi Arabia) last week. The meeting was organized by the Saudi Cancer Foundation (SCF) with cooperation from the Al Afandi Medical Group. The SCF was formed to increase cancer awareness and inform the public about the importance of early detection and advancements in cancer treatment.
Even though cancer incidence is lower than world average in Saudi Arabia, colorectal cancer, prostate cancer, non-hodgkins lymphoma and lung cancer ranks highest in incidence for the population of 27 million. The country is looking to improve healthcare outcomes and is exploring the benefits of hyperthermia in the treatment of cancer.
Attending via Skype was Mark Falkowski, CEO of Pyrexar Medical. Mr. Falkowski presented Pyrexar's recent achievements in the advancement of radio frequency delivered hyperthermia. RF phased array hyperthermia is well established in its ability to deliver power both to superficial (surface cancers within 4 cm) and deep regional (any depth in the body), to heat tissue to targeted temperatures of 43˚C. A recent study by the University of Amsterdam, “A comparison of the heating characteristics of capacitive and radiative superficial hyperthermia, (Kok and Crezee, 2017) proved that radiative RF, the method used in Pyrexar Medical's BSD-500, is far superior to systems that use capacitive heating methods (i.e. Oncotherm, Celcius 42).
Also presenting was Dr. Mark Hurwitz of Thomas Jefferson University Hospital. Dr. Hurwitz is a widely recognized leader in the fields of thermal medicine and genitourinary oncology, and previously served as Director of Regional Program Development for the Department of Radiation Oncology at the Dana-Farber/Brigham and Women’s Cancer Center, A long time clinician, researcher and hyperthermia expert, Dr. Hurwitz presented clinical results and discussed hyperthermia’s role in the treatment of cancer. A special thanks to the Al Afandi Medical group, Pyrexar's representative in the region, as well as Mira Sirotic of Alltranix in the organization of the event.
Pyrexar Medical has completed product registration and regulatory requirements with the KSA and is preparing to place hyperthermia systems in the kingdom.
Hyperthermia, well known as a radiosensitizer for cancer treatment, has found its way into South Korea’s leading cancer centers. The country, with a population over 50 million, has the third highest cancer rate among women and ranks 8th in the world overall. In addition to treating cancers of the pelvic region with the Pyrexar BSD-2000 Deep Regional Hyperthermia system, physicians have also found profound value in hyperthermia as a palliative treatment. Prescribing hyperthermia to relieve cancer-related pain and increase patient mobility is being used in convalescent centers throughout the country.
(left to right) James Kim, Bob DePalma, Brian Bay, Mark Falkowski
The BSD-2000 units are getting quite a workout in centers throughout South Koreas. Some facilities are reporting 8 to 10 treatments a day, every day, generating an estimated 200 patient treatments a month.
During a recent trip to Asia, Pyrexar CEO, Mark Falkowski met with Hanbeam Technologies president, Brian Bay and his team in Seoul, Korea. Hanbeam is a Pyrexar sales leader and has placed 11 BSD-2000 Deep Regional units in the country in the last 12 months. Currently Hanbeam is waiting regulatory approval from the KFDA to import the BSD-500 Superficial Hyperthermia system into the region.
Hanbeam continues to promote hyperthermia with a major presentation in Seoul this month, inviting well-known hyperthermia expert Dr. Jacoba van der Zee from Erasmus University in The Netherlands. Dr. van der zee has authored many clinical papers and several landmark hyperthermia studies. Her extensive clinical experience in treating a range of cancers using hyperthermia makes her a well-spring of knowledge in a country that is embracing the technology.
This years STM (Society of Thermal Medicine) conference was a great success. The 3 day event was held at the beautiful CasaMagna Marriot Resort in Cancun, Mexico. The society strives to promote new discoveries in thermal biology, physics/engineering and medicine. Each year they come together to present their ideas in this forum.
Dr. Rolf Issels, Ludwig-Maximilians-University of Munich, included an update on the long term survival benefit of adding hyperthermia to chemotherapy for soft tissue sarcoma in the Phase III randomized clinical trial. Data demonstrates a more than doubling the overall survival time. Chemotherapy averaging 6.2 years vs. 15.4 years when adding hyperthermia. Treatments were performed using the Pyrexar BSD-2000.
Dr. Jacoba Van der Zee, Erasmus University, gave a very good talk reviewing 55 hyperthermia randomized trials including 5,099 patients showing the significant effectiveness of HT. Significant benefit was found in 19 of 27 trials when adding hyperthermia to radiation therapy, 9 of 11 trials when adding HT to chemotherapy, and in 7 of 10 trials by adding HT to both radiation plus chemotherapy. Concluding, “These results indicate that hyperthermia is a universal and effective modifier of radiotherapy and/or chemotherapy in malignant tumors.”
Dr. Elizabeth Repasky, Roswell Cancer Center, presented a plenary lecture describing the many ways that elevated temperature and physical stresses can stimulate immune responses.
Dr. Hana Trefna, Chalmers University of Technology, presented efforts to release in this summer a new ESHO QA guideline to support the growing interest and application of interstitially applied hyperthermia with Brachytherapy.
Dr. Ruediger Wessalowski, University of Dusseldorf, reported the success in treating pediatric ovarian germ cell tumors with hyperthermia and chemotherapy using the Pyrexar BSD-2000 system. This study included 22 patients. The overall survival in this patient population with an unfavorable prognosis was 71% (95% CI 46-86). This concluded: “A multi-modality therapy including regional hyperthermia according to the Hyper-PEI protocol has led to long-term remission in the majority of patients with advanced refractory or recurrent ovarian germ cell tumors.”
Dr. Niloy Datta, Kantonspital Aarau AG, presented a systemic review and meta-analysis of HT and RT in locally recurrent breast cancer which was also published in 2016. This review report included 34 clinical studies that included 2110 patients. The conclusion of the met-analysis is “Thermoradiotherpay (HTRT) enhances the likelihood of complete response rates in locally recurrent breast carcinomas (LRBTCs) over radiation therapy alone by 22% with minimal acute and late morbidities. For even those previously irradiated, re-irradiation with hyperthermia provides a loco-regional control in two-thirds of the patients. HTRT could therefore be considered as an effective and safe palliative treatment option for LRBCs.”
Dr. James Snider, University of Maryland, reported treatments for 87 patients treated with the Pyrexar BSD-500. Of this group 3 patients were treated by a pencil beam scanning proton therapy method showing the feasibility of combining hyperthermia with proton therapy.
Dr. Arpit Chabra, University of Maryland, reported on the use of the Pyrexar BSD-500 hyperthermia as an external thermal therapy (ETT) method with external beam radiotherapy (EBRT) in treating non-melanoma skin cancers on 6 patients. The conclusion stated: “This data tends to support strong consideration of using ETT concurrently with EBRT in this setting. “
Gerard Van Rhoon, Phd, Erasmus MC Cancer Institute, was presented with the 28th J. Eugene Robinson award presented annually to an investigator who has made outstanding contributions to the field of hyperthermic oncology.
Mark W. Dewhirst, Phd, Duke University, was presented with the George M Hahn award presented every other year to an investigator whose research has contributed in a significant way to new clinical applications in thermal therapy.
Thanks for STM president Robert Ivkov, Johns Hopkins University School of Medicine, and team for putting on an amazing event.
In the follow-up fifth installment of the ABC story, we see hyperthermia cancer treatment take a foothold in Utah. Gamma West Cancer Services, serving the Intermountain West starts its own thermal oncology group. We hear about their early success with the treatment and their plans to expand the service. If you missed the previous Part 1 • Part 2 • Part 3 • Part 4 you can use the links.
Last year, ABC4 traveled to New Orleans to learn about hyperthermia: a cancer treatment that kills harmful cells with heat. We explored its use throughout the world, but found that hyperthermia was not being used in the Intermountain West.
But now, it is.
“Cancer's not a neat word for anybody,” says Terrance Faber.
Faber was diagnosed with stage four prostate cancer one year ago.
“You know, I have aggressive cancer...and whatever we can do to combat that. And hyperthermia apparently is one really big help,” Faber continues.
And now he has that option right here in Salt Lake City. Gamma West Cancer Services is the first facility in Utah to use hyperthermia treatment.
Dr. John Hayes,the president of Gamma West, says “We have invested space, equipment, personnel...and we would like to become a regional center of excellence for hyperthermia.”
Hayes explained that there is clinical data which shows a benefit when you add hyperthermia to an already prescribed radiation treatment, especially in recurrent cancers.
So, when Faber’s cancer came back, Dr. Hayes added hyperthermia to Faber’s treatment plan.
Dr. Hayes says it works like this: the heat causes more blood to flow into the tissue. That brings more oxygen to the tumor cells trapped inside scar tissue. This makes radiation more effective.
Mr. Faber has plenty of scar tissue from previous treatments.
Our crew was there for Faber’s first hyperthermia treatment.
“Because he's had prior treatment, we're going to give a treatment with extra power, and let's say umph, to get rid of all this cancer,” Dr. Hayes explains.
Hyperthermia treatments have been around for more than three decades. Just last year, we at Good4Utah showed you how it's being used in Europe. However, many facilities in the U.S. still aren't using it. Many of these places say there is not enough peer-reviewed research yet to prove, or disprove, its effectiveness.
But Dr. Hayes disagrees.
“With hyperthermia, we have decades old data, with 15 randomized controlled clinical trials showing a benefit.”
Dr. Hayes says it typically only takes a few days to see a tumor visibly shrink after being treated with hyperthermia.
Both Dr. Hayes and Mr. Faber are optimistic about the future.
“I'm real excited about the way things are going. I'm feeling real good,” says Faber.
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.
Temperature Probes & Monitoring
SAR based tumor temp.
Phase III published clinical studies HT+RT
Made in the USA
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.”
The Pyrexar Blog is an Opinion Editorial written by Drew Wilkens, Vice President of Digital Content Marketing. We strive to provide factual information and rebuttal or corrections are welcome. Please send your comments to email@example.com