An independent quality assurance study of the five clinical BSD-2000-3D/MR systems has been published in the International Journal of Hyperthermia by H. Mulder et al. The intent of the study was to validate the accuracy and consistency of the deep heating focus and electronic steering of this system. The study test results concluded, on these five separate systems, that “the Pyrexar Medical BSD2000-3D MR compatible applicator provides robust and reproducible heating.“ The study found that the heating characteristics were reproducible within a 95% confidence interval of 0.4˚C. Based on these evaluations, the applicator was approved for clinical use. This study further made it clear that these BSD-2000 systems provide deep selective heating focus to the center of the body equivalent phantom along with the electronic steering precision.
• Applicator provides robust reproducible heating • 95% confidence interval of 0.4˚C • Selective heating focus with electronic steering precision • 5 MR-based Hyperthermia Systems already Installed
Why is this important?
1) It shows that our systems design and manufacturing is solid, even in the most sophisticated products; 2) When designing a multi-hospital, multi-country clinical study, there is hardware reliance; and 3) The research community continues to invest its time in system validation, necessary to maintain standards that industry should follow.
About the BSD-2000 3D/MR
Pyrexar Medical manufactures the most advanced hyperthermia treatment systems in the world. The model BSD-2000-3D/MR has the capability to focus radiated RF power to deep sites in the body with 3D electronic steering. A further unique advancement of this configuration is that it has been integrated with magnetic resonance imaging (MRI) which has been adapted to display non-invasive temperature change images during the elevated temperature treatments. This unique system provides image guided thermal therapy of deep tumors within the patient’s body.
This excellent quality assurance study is important to our goal of assuring high quality hyperthermia cancer treatments and to allow for results of clinical studies, at various centers around the world, to be combined in future clinical research.
We have made some updates to the Pyrexar Medical website, both in style and performance. Our goal is to promote hyperthermia as a premier adjunct cancer treatment, and to make valuable clinical data and product information readily available.
New features include:
A new way to explore our product features
An updated interactive map to find the closest available treatment centers
Clinical data on hyperthermia with links to abstracts
Clinical studies that used Pyrexar products
We hope you will take a moment and explore the website. Your feedback is important and appreciated.
Other program notes:
We will be exhibiting at this year's ASTRO in San Antonio October 21-23. If you are planning to attend, please stop by booth #1942 and see some of our new products for 2019 on display.
Hyperthermia is reemerging on to the cancer treatment stage. There is growing acceptance of hyperthermia's role as a radiosensitizer, its effectiveness when used with chemotherapy, and maybe its most important role, in immunomodulation.
Pyrexar Medical receives requests to introduce our hyperthermia systems into new countries every month. In 2015, we were selling in 9 countries, three years later the count has grown to well over 36 countries. But the road is long from introduction to sale and is often drawn-out with regulatory filings, physician education, toward eventual acceptance. That is why we are so thankful for physicians like Dr. Gi-Ming Lai, Director of the Wan Fang Cancer Center, and his team at the Taipei Municipal Wan Fang Hospital, part of the Taipei Medical University in Taiwan.
The clinical data for hyperthermia, and specifically the BSD-2000 Deep Regional Hyperthermia system, is very impressive. But potential customers often want to see a device in a treatment environment to understand workflow and treatment planning. So when a new distributor from the region requested to visit a reference site, we reached out to our partner network and Linden Bioscience of Taiwan answered the call.
"Wan Fang is a well respected center in Taiwan, and Dr. Lai's experience with hyperthermia is unparalleled in the region" says Tainang Huang, president of Linden Bioscience. "They have a well-outfitted radiation oncology department and a strong team in medical oncology under Dr. Lai's direction". Wan Fang was the first JCI accredited hospital in Taiwan. The 730 bed facility has more than 350 full-time physicians, and over 2000 additional staff members. Because it is affiliated with Taipei Medical University, many doctors in training from the university complete internships at Wan Fang.
We believe with solid partnerships and a willingness to share knowledge, hyperthermia will continue to grow and serve cancer patients around the globe.
ASTRO's 60th Annual Meeting is the premier radiation oncology scientific event in the world and draws more than 11,000 attendees each year. This years exhibits will be held October 21-23th at the at the Henry B. Gonzalez Convention Center in downtown San Antonio, Texas (USA). Look for us in booth #1942.
We look forward to seeing you at the show. For more information visit the ASTRO website.
Pyrexar has signed with Kamol Sukosol Electric Company (KEC) to distribute Pyrexar's line of hyperthermia systems in Thailand. For over twenty years KEC has been supplying hospitals and clinics around the country with machinery vital in the fight against cancer. Their talented and well-trained sales and service group have started the process of introducing radiative phased array hyperthermia to their customers. Please join us in welcoming KEC to the Pyrexar family. We are fortunate to have such an excellent organization on our team.
We were in Thailand in June to meet with Daranee Clapp, Executive VP of KEC, and her team to pitch the Pyrexar hyperthermia solution to several Bangkok area hospitals. Below are a few photos of our visit.
Kamol Sukosol Electric Company Background
KEC traces its roots back to 1939 when its president, Mr Kamol Sukosol, started the trading business with a shipment of twelve G.E. radio sets from the United States. Before too long the company grew to have 22 showrooms in Bangkok and its surrounding provinces. Less than a decade later, the company become G.E’s sole distributor in Thailand. With each passing year, new product lines were added and KEC’s scope of activities spread from household appliances to electrical and engineering equipment, air conditioning, motor vehicles, manufacturing and, most importantly, healthcare. The company has a fascinating success story. You can read more here.
Pyrexar Medical was invited to participate in the Hanoi 2018 - Investment and Development Cooperation event. This year's event included twenty four MoUs (Memoranda of Understanding) and investment certificates at a total value of 270 trillion VND (approx. $12 billion USD). During the ceremony, Pyrexar received an award from the ministry of heath and signed an agreement to deliver hyperthermia systems to government hospitals this year.
Around 1,500 representatives, including leaders of the government, ministries, international organizations and hundreds of investors and businesses were in attendance. The conference is a chance for the Capital to meet domestic and foreign investors, representatives of embassies, and international organizations, to attract more domestic and foreign investments in Hanoi and the rest of the country.
A special thank you to our new distributor for Vietnam, Cambodia and Laos, Thai Thinh Medical of Hanoi City, for making this opportunity happen. The result; Pyrexar successfully signed agreements for placement of two BSD-500 Superficial Hyperthermia systems, a BSD-2000 Deep Regional Hyperthermia system and our newest BSD-2000 3D/MR Image Guided Thermal Therapy system to Hanoi High Tech and Digestive Center at St. Paul's Hospital and VinMec International Hospital, in Hanoi.
Society of Thermal Medicine (STM) Annual conference held at the Westin La Paloma Resort in Tucson Arizona. Average daily temperature was 100˚F
Pyrexar displayed some new applicators for the BSD-2000 3D/MR, as well as an upgrade (touch monitor / software / temperature box) for the BSD-2000 family
The Sigma 30/MR is a MR compatible applicator for treating limbs and pediatric patients. The new design fits into the MRI table tray and can shift left and right for patient comfort. Like the Sigma Eye/MR it is removable allowing for general imaging use.
Martin Wadepohl of Senewald Medizintechnik presented "MR Thermometry: New Scanners - New Challenges" at the Modeling, Monitoring, Measuring and Computation section
(L to R) James Snider, MD, Jason Molitoris, MD, PhD, Emily Kowalski, MD, Jill Remick. MD, Zeljko Vujaskovic, MD. PhD - University of Maryland's radiation oncology group was in full force at the STM. Great presentations on hyperthermia!
STM (Society of Thermal Medicine) Conference in Tucson, AZ
Over 100 presentations on thermal technologies and research
Hyperthermia = New business - Discover how hyperthermia increases the bottom line
New Pyrexar Applicators on display
Did I mention it was 103˚F in May
We just returned from a week-long STM conference in Tucson, Arizona (May 7-10, 2018). The theme of the meeting was "Temperature Matters". The thermometer reached 103˚F with a relative humidity of 5%... and "YES" it mattered!
There were over 100 presentations on thermal effect, including radiative hyperthermia, MR-guided thermal therapy, nano particles, HIFU, HIPEC, laser interstitial thermal therapy, immunology, cryotherapy and radio-biology. The common thread among all hyperthermia applications is that it is a valuable therapy in the treatment of cancer. But without financial rational and support, none of these technologies will reach the patient.
Hyperthermia = New business
We all care about results, but reimbursement is what gives you the ability to continue treating patients. That is why we wanted to highlight one presentation that stood out in our mind - "The Impact of Hyperthermia Therapy on Patient Referrals and Patterns of Care within a Radiation Oncology Department" by Dr. J. Remek from the University of Maryland Department of Radiation. In summary, actual reimbursement for a single hyperthermia treatment was less important than the additional services that a hyperthermia patient brings to the practice. Dr. Remek tallied all of the billable services rendered at the University of Maryland associated with its BSD-500 Superficial/Interstitial Hyperthermia System in the radiation oncology department (U of M is installing a BSD-2000 in their Proton Center). Of their sampling of patients who received hyperthermia, the additional radiation, imaging and care services increased their revenue stream by 15%-19%. Their reasoning is that new patients, referred from outside the hospitals network, increase billable services that they would not have received if they did not offer hyperthermia.
The STM conference is a intimate show, with 150-200 participants. Pyrexar sponsors the show, not to find customers, but as an effort to support hyperthermia research and the STM organization. We still like to show off what we have been up to and our small 10ft booth was packed with lots of new stuff.
Our backdrop is an image of the new BSD-2000 3D/MR installed in Grosshardern University Hospital, Munich, Germany. It represents a significant advancement in Image Guided Thermal Therapy. [Currently available in select EU countries]
Elevated on a stand on the left is the Sigma Eye/MR applicator, (internally we call the Universal). The Universal code name represent the ability to quickly deploy our applicator onto any MR table with a form factor that will fit most, newer MRI systems. Previously, we would build a custom gantry for each MR model requiring significant engineering and time. Now hyperthermia can be provided in the active MRI, then removed quickly for traditional imaging. [Currently available in select EU countries]
On the table to the left is the brand new Sigma 30/MR applicator. This applicator is often used to treat Soft Tissue Sarcoma of the limbs. Just in time for the JAMA release of the long term STS phase III clinical study recently published in JAMA. The 30cm bore applicator has also been used in pediatric cases of germ cell tumors. [Currently available in select EU countries]
Next on the table is a new innovation for existing BSD-2000 users. We have a new large screen touch monitor and upgraded control software. The software has the same ability to monitor and control the heat zone, but the user interface has been formatted to more user-friendly.
In front of the screen is the new temperature box. Repackaged to be user-friendly and less obtrusive, the temperature box features improved probe connectors and a probe calibration well similar to the BSD-500. Instead of a water bath, the user inserts the end of the probe into the well and initiates calibration. Quick and easy.
Last but not least..... Sorry we can not talk about the last item. We are currently in development of a new device. If you attend the ESHO show this week, you may get a closer look.
We had the honor to introduce Pyrexar Medical's line of hyperthermia equipment and present the benefits of hyperthermia in the treatment of cancer, to a VIP delegation from Vietnam last week. The presentation was held in Portland, Oregon while the group was in the US to investigate the latest medical device technologies. Participants included the Vice President and Vice Chairman of Ủy ban nhân dân thành phố Hà Nội representing the Peoples's Committee of the Hanoi Government and representatives from VinMec International Hospital, and Hanoi High Tech and Digestive Center at St. Paul's Hospital in Hanoi.
Vietnam has one of south-east Asia's fastest-growing economies and continues to improve and expand its medical services to care for its citizens. With a population of 93 million, cancer treatment is a priority. The top five most frequent new cancers cases in Vietnam are the liver (17.6 %s), lung (17.5 %), stomach (11.4%), breast (8.9%) and colorectum (7% ) . As hyperthermia re-emerges as a viable therapy, especially with data supporting immune response, the country's medical community is taking notice.
Pyrexar is currently in final negotiations with Dang Tran Dung, CEO of Thai Thinh Medicine, to represent our line of superficial and deep regional hyperthermia products in Vietnam. We hope to start the regulatory process with the Ministry of Health within the next 90 days.
Pyrexar traveled to Kuwait to address physicians at the Kuwait Cancer Control Center (KCCC). Founded in 1968, the KCCC is affiliated with the Kuwait Ministry of Health and is dedicated to provide Cancer Care across the State of Kuwait. The center utilizes all available resources to serve cancer patients with a wide selection of treatment modalities. We hope to see hyperthermia as a featured treatment option this year.
Ahmed El Ghamry, Business Unit Manager, MedVision | Mark Falkowski, CEO - Pyrexar Medical | Ali Rabie, Senior Product Specialist, MedVision at the GUG Exhibit
International Conference on Genitourinary & Gynecological Cancers - Kuwait Conference April 14-16
Salwa Sabah Al-Ahmad presentation hall at the Marina Hotel
Salwa Sabah Al-Ahmad Theater & Hall in Kuwait City
While there, we joined our Middle East distribution partner Medvision at their booth at the GUG-KC (Genitourinary & Gyneclogical Cancers Kuwait Conference) held at the Salwa Sabah Al-Ahmad Theatre. The booth was visited by Dr. Mustafa Redah, Co-Minister of Health; Dr. Kholoud Al Ali, head of the KCCC; and Dr. Al Saleh, head of Radiation Oncology at KCCC. The group was very impressed by the new technologies Pyrexar has pioneered and the benefits of hyperthermia in the treatment of cancer.
A special thanks to the Medvision team for their generous hospitality during the event.
There are only a few weeks to go until the ESHO Meeting in Berlin and it is not too late to register via ESHO Congress website, if you have not already done so. We asked Dr. Pirus Ghadjar (ESHO 2018 Congress Organization) to outline the main highlights of the event.
Since the hyperthermia department at the Charité Universitätsmedizin in Berlin is one of the nine centers that contributed to the long-term results of the EORTC 62961-ESHO 95 trial recently published in JAMA Oncology Journal, we also asked Dr. Ghadjar some
more detailed questions about the trial. You will find his answers below.The hyperthermia systems used in the trial were provided by BSD/Pyrexar Medical, so we are pleased to point out that as a Diamond Sponsor of the ESHO Meeting, we are holding a Lunch Symposium on May 17 on “Pyrexar Innovations 2018”.
DR. GHADJAR ABOUT - ESHO 2018
Dr. Ghadjar, could you please summarize the highlights of the ESHO 2018 program? I am pleased to say that the program of this year’s ESHO is very interesting and includes several highlights. For instance, the "abdominal tumor" session providing information on the latest treatment for pancreatic cancer and liver tumors and the use of hyperthermia to improve current treatment standards for abdominal tumors. The session on "MR-guided thermal therapies and applications" will summarize recent developments in MR thermometry as well as MR-based heat treatments. Another highlight -- among others -- will be the session on "Immune effects of hyperthermia and novel drug combinations" where the combination of hyperthermia and checkpoint inhibitors will be discussed.
The 2018 ESHO program also includes a one-day nurse/radiation therapist symposium, as well as a Patient Information Day, which will be held in German.
INTERVIEW DR. GHADJAR JAMA ONCOLOGY JOURNAL PUBLICATION
1. The EORTC 62961-ESHO 95 Trial was completed in November 2006. Why is JAMA Oncology only reporting now and what is the significance?
Long term data of the EORTC 62961-ESHO 95 trial comparing neoadjuvant chemotherapy vs. neoadjuvant regional hyperthermia plus chemotherapy for patients with localized high-risk soft tissue sarcoma was published by Issels et al. in February 2018 based on a median follow-up of 11.3 years. The recruitment of the total number of 341 patients was conducted from July 1997 to November 2006. The database for this analysis was closed in December 2014. The long follow-up duration is necessary to analyze potential differences in the secondary trial endpoint of overall survival. The significance of the results is that the addition of regional hyperthermia did not only improve local progression-free survival but also significantly improved overall survival as compared to neoadjuvant chemotherapy alone.
2. But why has it taken so long to publish the results?
Issels et al. closely analyzed their data after the database was closed. Due to the unique and convincing data, the manuscript was then submitted to high-impact medical journals and the process of manuscript review, re-submission and revision took time until the manuscript was accepted for publication by JAMA Oncology.
3. Is it true the study was prematurely halted? Were there negative results?
No, the predefined analysis plan as stated in the trial protocol was followed. The early trial results were published in Lancet Oncology in 2010, reporting that the primary trial endpoint local progression-free survival was significantly improved by neoadjuvant regional hyperthermia plus chemotherapy vs. neoadjuvant chemotherapy alone based on a median follow-up of 34 months. As the primary trial endpoint was significantly improved (as far back as 2010) the trial had to be regarded as a positive one. In 2010 the follow-up duration was not sufficient to detect potential differences in overall survival. Eight years later this has changed, and a significant overall survival benefit could be detected in favor of regional hyperthermia.
Great opportunity to view the International Journal of Hyperthermia for free. Volume 34, Issue 2 has been set to "free access" until May 30th, 2018.
Issue highlights editorials and reviews on the role of thermal therapy with infectious diseases. If you want access to all of the issues of the IJH, the most cost efficient way to become an STM or ESHO member. Membership provides additional cost benefits to the corresponding conferences, but it also helps build and promote hyperthermia research and treatment expansion throught the world.
A friendly reminder that the main Hyperthermia conference events in the US, Europe and ASIA, (STM, ESHO, ACHO) are right around the corner. These conferences are a gathering of the best in hyperthermia research and an excellent resource for those interested in the field of thermal oncology.
The 35th Annual Meeting of the Society for Thermal Medicine, 32nd Annual Meeting of the European Society for Hyperthermic Oncology and 7th Annual Asia Conference of Hyperthermic Oncology will provide an arena for presentations of latest data, concepts, and breakthroughs in our ever-expanding understanding of thermal medicine in the context of engineering, physics, materials science, and biology.
Keynote and Plenary speakers will highlight the extensive connections between physics, information science, biology, imaging, and the thermal state.
Who Should Attend?
Researchers in the field of thermal oncology
Clinicians, new to the field, who would like to talk with experts
Clinicians who want to expand their thermal oncology program
Medical Students that want to understand how hyperthermia may impact the future of medicine.
Pyrexar Distributors who want to expand their working knowledge of hyperthermia
Under the organization of the European Society of Hyperthermic Oncology the study was conducted in 9 centers located in Germany, Norway, Austria and the United States using the BSD-2000 Deep Regional Hyperthermia System. This study enrolled 365 soft tissue sarcoma patients (18-70 years old) that were matched and entered into a double blind study. One group received neoadjuvant chemotherapy consisting of doxorubicin, ifosfamide, and etoposide [CT] treatment and the other group received the same chemotherapy along with a course of hyperthermia [HT].
For non-clinicians, we have done our best to provide the salient points in the above info-graphic. The full article can be found on the JAMA website here.
We feel that the results are astonishing. The HEADLINE:chemotherapy plus hyperthermia equals better results and extended life. #heatmatters
In our efforts to bring hyperthermia cancer treatment to the world, we are welcoming three new distribution, sales and service companies covering 13 countries.
MedVision, a division of SADITA Holdings Group, is well known in the areas of cardiology, cardiac surgery and peripheral intervention products. The company will be representing Pyrexar Medical in their home country of Kuwait, as well as, Qatar, Bahrain, Saudi Arabia, Lebanon, Jordan, Egypt, UAE, Oman, Iraq & Iran. This represents a major expansion in the Middle East for Pyrexar and we are looking forward to growing with them.
Tema Sinergie is based in Faenza, Italy in the coastal province of Ravenna. The company's motto is "high tech, high care" and they have certainly been living up to that vision. Tema specializes in nuclear medicine, radiotherapy, uro-oncology, barrier solution technology and medical physics. The group has been serving the country's need for medical products for over 30 years. Hyperthermia is an excellent extension of their product line and we are excited to have them on our team.
Meyra Medicine and Health Products, will be bringing Pyrexar Medical's hyperthermia product line to Turkey. Meyra, which translates to "shining star" is headquartered outside the coastal city of Izmir in the town of Kemalpasa, Turkey. In addition to sales and service support of hyperthermia, the company is also involved in ultrasound imaging products and proton therapy systems. Turkey is an emerging market economy with a healthy medical technology sector.
Please join us in welcoming our new members to the Pyrexar team.