BSD Medical is Now Pyrexar Medical

The complete line of BSD Hyperthermia products are availble thru Pyrexar Medical

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.

finggal link signingMasaaki 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 introduction 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.

Finggal link at gamma westMasakki 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

BSD-2000 Scale Model
HT Systems commissioned a 1/3 scale model of the BSD-2000 Sigma Base with the Sigma Ellipse Applicator

Pyrexar Represented
HT Systems is the exclusive distributor of Pyrexar Medical Hyperthermia Systems in Poland

Meeting Well Attended
A large group of researchers and clinicians attended the event at the Hotel Rezydencja Luxury, Piekary Slaskie, Poland

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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.

Speaker Video Lecture Background
Prof. Niloy R. Datta, MD, DNB, CCST (CH) Play Video "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) Play Video "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) Play Video "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) Play Video "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) Play Video "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) Play Video "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) Play Video "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) Play Video  "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) Play Video "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 Play Video "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) Play Video "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) Play Video "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) Play Video "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) Play Video "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) Play Video "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) Play Video "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) Play Video  "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) Play Video "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) Play Video "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.

montage for munich

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.

Scheduled release for sale - April 2018.

 


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.

Toasters

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.

  1. 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.

  2. 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.

  3. 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.

  4. 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.