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 the 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 radiofrequency 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 fifth follow-up 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 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 that 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 oomph, 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 really 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 demonstrate 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 essentially 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 methods 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). The 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 through 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 overheating of the fat tissues of the surface by limiting the radio frequency power from their capacitive electrodes. Technology speaks for they don't heat, hoping to rely on their claimed non-thermal effects for the treatment.
The 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.”
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 year's meeting will be held April 29th through 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.
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. 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 radiosensitivity, 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. Also, it 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 in 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. The 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, the applicator can be stored for a typical MRI imaging workflow.
RSNA Chicago is approaching fast. Our booth just shipped out this afternoon. Below are pictures of our booth mock-up we use to help us plan the event. We are offering a sneak peek 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.
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 the heat is applied to tumor cells.
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.
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.
This year our CTO, Paul Turner, arrived at the American Society for Therapeutic Radiology and Oncology exhibition via a shipping crate. Our ability to communicate the highly significant 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 by merely taking controls remotely of our onsite robot. "We use this technology in our office every day," 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."
Not only was Paul available for meetings and to answer questions, he often posed for photographs during the show.
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 essential to physicians, but it's all about the RVUs.
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.
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 has 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 facility's geographic radius 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.
Saturday 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 oncologists, physicists, and therapists from around the globe. This year we had a beautiful in-line space across the aisle 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.
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.
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.
Group 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 primary healthcare for all citizens. Although it possesses its 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 necessary treatment to fight cancer in China. Pyrexar continues its expanse into China with the assistance of our long-time distributor Dalian Orientech Co., Ltd.
Researchers are combining traditional cancer treatment therapies to increase a patient's chance of surviving cancer. Even a few percentage points in tumor response can represent a significant benefit in saving 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.