After passing the rigorous clearance process with the TFDA (Taiwan Food and Drug Administration), a Pyrexar BSD-2000 Deep Regional Hyperthermia system is now installed and treating patients at MacKay Memorial Hospital in New Taipei City, Taiwan. On-site to provide hands-on training, and treat the first series of patients, was a well-respected physician and researcher Dr. Jacobi van der Zee from Erasmus University Hospital-Daniel den Hoed Cancer Center Rotterdam, The Netherlands. Dr. van der Zee is recognized as a world leader in hyperthermia with a long list of published papers and clinical studies.
The news quickly reached nearby hospitals creating lines of doctors and clinicians daily to see the new device in action. Integral to bringing this life-saving treatment to Taiwan was the team from Lindenbiotech and its president Tainang Huang, Ph.D. “Having this first installation on the island is important to the health and wellbeing of the people of Taiwan,” says Dr. Huang “Cancer is a very serious threat to our population which now exceeds 23 million and effects 1 in every 223 people”.
We are hopeful that this first of several installations planned for Taiwan this year will begin to affect the people of that region positively.
Our distributor in Spain invited Mark Falkowski, CEO of Pyrexar, to participate in a conference sponsored by the Spanish Societies of Radiation Oncology (SEOR) Hyperthermia Group. Oncologists from the area converged in Málaga, Spain, to talk about a new type of adjunct cancer treatment. They gathered to learn about the positive clinical trials and growing success that surrounds a specific type of thermal therapy, rf (radio frequency) hyperthermia. Energy is directed deep into the body then focused and steered by adjusting wave frequency and amplitude, resulting in targeted “fever” temperature (41-42C) at the tumor site. Heat sensitizes and improves blood flow at the tumor site, which, in turn, increases the amount of chemotherapy that reaches inside the tumor. Blood flow also brings oxygen to these hypoxic (without oxygen) cancer tumors, increasing the effectiveness of radiation therapy. Phase 3 clinical studies demonstrate that hyperthermia, along with chemotherapy or radiotherapy, increases tumor control of up to 300% when compared to radiotherapy or chemotherapy alone.
Thanks to regional groups like the SEOR and companies like Magna Medic, this newest cancer fighter will be available in the near future. “Facilities, like Clínica Ruber Internacional (Madrid), Vithas Xanit International Hospital (Málaga), Instituto Valenciano de Oncología (Valencia) and Centro Médico Teknon (Barcelona)” are the types of progressive institutions that look for cancer treatment innovations,” says Felix Navarro, Medical Physicist at the Magna Clinic Marbella, “We are very experienced with hyperthermia in our clinic, and we look forward to sharing our successes with the country.”
In preparation for the expected technology growth in hyperthermia cancer treatment sector, Magna Medic has signed a six year, $3 million (USD) distribution contract with hyperthermia device maker Pyrexar Medical. “We are excited to see cancer patients get the treatment they deserve,” says Mark Falkowski, Pyrexar CEO, “and we could not find a more capable partner than Magna Medic.”
We had a great week in Dubai at the Arab Health show. Dubai is the most populous city in the United Arab Emirates (UAE), located on the southeast coast of the Persian Gulf and is one of the seven emirates that make up the country. The 2016 exhibition showcased more than 4,000 companies exhibiting their latest innovations to more than 130,000 healthcare professionals attending from 163 countries.
A special thanks to our newly signed distributor, AB Care Medical, out of Egypt. This agreement represents a $3 million commitment to the hyperthermia product line over the next six years. AB Care was founded with a resolute purpose that is to represent prominent manufacturers to influence the Egyptian market and be its leaders. It has offices in Cairo, Alexandria, Mansour, and Assiut.
AB Care provided a last-minute opportunity to bring the Pyrexar message into their booth. They are very knowledgeable and experienced in the medical device market and deliver a great enthusiasm for hyperthermia as a first-line cancer treatment. To learn more about our new partners, visit their website at www.ab-care.com
Pyrexar continues to build a strong presence in the middle east. With the addition of Egypt, we now have representation in Azerbaijan, Iraq, Iran, Kuwait, Oman, Qatar, Saudi Arabia, Turkey, and the UAE. It was a fantastic show located in an incredible city, and we will be back next year.
Published last month in the International Journal of Hyperthermia, N. Datta, S.Rogers, S.G. Ordonez, E. Puric and S. Bodis review and analyze ~30 years of studies conducted to evaluate the outcome of controlled clinical trials in head and neck cancers (HNCs) using hyperthermia and radiotherapy versus radiotherapy alone.
The most recent study in 2014 by Wen et provided data demonstrating that HT+RT was one and half times more effective than RT alone. Of the six studies evaluated the benefit of Hyperthermia as an adjunct treatment had an overall benefit ratio of 1.6.
The evidence that Hyperthermia is a vital cancer treatment therapy continues to grow. Adding heat to radiation therapy, chemotherapy, and immunotherapy shrinks tumors and increases sensitivity to traditional cancer therapies without adding toxicity. Thermal Therapy Works!
The Wall Street Journal just published an article on Hyperthermia’s resurgence in the medical scene. Although the report lacks to mention some of the fantastic results that this therapy produces in cervical, bladder, pancreatic, melanoma, ovarian, breast, esophageal, prostate, and head/neck cancers (to name a few), it at minimum brings hyperthermia back in the spotlight. READ THE ARTICLE
The article mentions some studies in the ’90s where outcomes were not as stellar as they are today. This may be due to early lab built equipment, and inadequate protocols had much to do with that data. Today, with our BSD-500 Superficial/Interstitial and BSD-2000 Deep Regional systems at the center of many critical phase III medical trials, results can be 2 to 3 times greater when adding hyperthermia to chemotherapy and radiotherapy.
Immunology is the real story here. The body is an efficient cancer-fighting device. Heating the cancerous tumors to fever temperatures (42-42˚C) appears to unmask cancer from the body's immune system. We will see the results of this ongoing research and study of the immunological effect soon.
This year the Radiological Society of North America (RSNA) held in Chicago attracted an estimated 55,0000 medical professionals from around the world. Wandering through the maze of displays by medical device manufacturers were an army of international distributors looking for something new.
“Something new” seemed to be the theme of the five-day event, and hyperthermia appeared to fit the bill. The show provided a personal introduction and interaction platform that no brochure, website, or email can reproduce. Key players from Europe, Asia, South America, and the Middle East passed through the booth to learn about the fantastic benefits that hyperthermia had to offer.
In addition to the wealth of business opportunities, medical and technical students had the chance to see and touch the equipment with which they may one day participate. As the only representative company for this particular therapy at the show, we felt great privilege in participating in the educational process.
Overall the show was a great success. Some incredible business relationships were formed, and some big deals solidified. But you will need to wait a bit before we can reveal that news.
This year the Radiological Society of North America (RSNA) will hold its annual meeting in Chicago, marking the organization's 100th anniversary. The RSNA is the world's largest annual medical meeting, with attendance estimated at 55,000 people. The five-day event includes two large exhibition halls presenting medical device products and a full schedule of presentations and education. The program starts Sunday, Nov 29th, and runs through Thursday, Dec. 3rd.
Since this is a massive show, I have included a map Link to help you find us. Our booth, #6563, is located in the far end of North Building, Hall B, just past the end of the Philips booth and directly across from North Cafe.
In addition to our booth and sales team, you may be interested in a lecture by Mark Dewhirst, DVM, Ph.D. from Duke University Medical Center. "Lessons Learned from XRT/Hyperthermia | VISIO41-03” will discuss how hyperthermia compliments the ability of radiotherapy to kill cancer cells include a review of the more than a dozen positive phase III cancer trials; and provide new insights on how hyperthermia affects the process of DNA damage repair.
PARTICIPANTS: Mark W. Dewhirst, DVM, Ph.D. durham, NC (Presenter) Stockholder, Celsion Corporation Research Grant, Biomimetix Corporation Research Grant, Johnson & Johnson Consultant, Nevro Corp Consultant, Merck KGaA Consultant, Siva Corporation
LEARNING OBJECTIVES 1) Understand the complementary interactions between hyperthermia and radiotherapy that increase cell killing. 2) Understand the importance of measuring temperature during heating and methods for how this is accomplished. 3) Be able to articulate how hyperthermia affects tumor physiology and how these effects influence treatment responses.
ABSTRACT There are more than a dozen positive phase III trials showing that hyperthermia can increase local tumor control when it is combined with radiotherapy. Such trials include head and neck cancer, cervix cancer, GBM, esophageal cancer, and chest wall recurrences of breast cancer. It has been known for more than two decades that hyperthermia augments the cytotoxicity of radiotherapy. Basic tenants underlying this interaction include proof that hyperthermia inhibits DNA damage repair. Hyperthermia has complimentary cytotoxicity with radiation in different parts of the cell cycle.
Further, hyperthermia can increase tumor perfusion, thereby increasing oxygen delivery; lack of oxygen is a source of relative resistance to radiotherapy. In recent years, however, new insights have been made into how these two treatment modalities interact. These insights come from 1) innovative clinical trials involving functional imaging and genomics, and 2) examination of how hyperthermia affects the process of DNA damage repair. These developments point the way toward new methods to further therapeutic gain by taking advantage of cellular responses to these therapies.
This year’s “Workshop on Hadron Therapy” was hosted by the Mesoamerican Center for Theoretical Physics (MCTP) and FIMENUTEP (Nuclear and Medical Physics Proton Therapy) in Tuxtla Gutierrez in the state of Chiapas, Mexico. The three-day summit brought together experts from around the world to discuss the benefits and implementation of proton therapy in the treatment of cancer. Presenters included the Mayo Clinic, University Hospital of Geneva, John Hopkins School of Medicine, and Benemérita Universidad Autónoma de Puebla (BUAP).
Mark Falkowski, CEO at Pyrexar Medical, was invited as the industry leader in thermal therapy medical devices to present the topic “Hyperthermia for Proton Therapy.” Interest in the combined therapy was piqued by a paper published in 2014 by N. Datta entitled, “Could hyperthermia with proton therapy mimic carbon ion therapy?” This research is essential as it postulates that not only could adding hyperthermia to proton therapy increase the effectiveness but also potentially mimic the superior results of carbon ion therapy without the magnitude of higher systems cost.
Currently, there is a multi-institutional phase I/II clinical trial with concomitant local hyperthermia and proton beam radiotherapy at the Kantonsspital Aarau in Switzerland. Hyperthermia is a well-known sensitizer of cancer tumors, increasing tumor response, and increasing effective dose in radiation therapy. Researchers have measured increases in tumor control and complete response in many cancers when adding hyperthermia to chemotherapy and traditional radiotherapy. The new study is designed to measure the effective downstaging of soft tissue sarcoma tumors when adding hyperthermia to proton therapy.
The Hadron Therapy Workshop provided another opportunity to share the hyperthermia message with medical experts, staff, and university researchers focused on increasing the effectiveness of cancer treatments. Pyrexar Medical continues to ask the question, “If there is a pain-free, harm-free way to increase cancer survival rates, why not choose to use it?”
We just finished up a week in San Antonio, Texas, at the ASTRO (American Society of Therapeutic Radiation Oncologist) annual meeting. We were surrounded by all of the big device manufacturers like Accuray, Philips, Elekta, Siemens, Varian, Iba, and Hitachi, with their massive show displays towering above us. But our modest, elegantly appointed show booth still seemed to shine brightly. Although not in a prime spot (next to the restroom), we had a really high traffic. Maybe it was the restroom? Or maybe that our sales and marketing group did a great job out in front, prepping for the event. Either way, it was a big success.
Our show team included Rex Harmon and Mark Kidd for Pyrexar Team USA; Dr. Gerhard Sennewald and Martin Wadpohle from Sennewald Medizintechnik out of Germany; Mira Sirotic representing the team at ORB Healthcare. Paul Turner, Chief Technology Officer, was there answering any and all questions hyperthermic, plus Drew Wilkens in Marketing and Mark Falkowski, Pyrexar CEO, who was taking names and making deals. It was an extremely fast-paced show, continually busy with a long list of new potential clients. We also passed around our latest video, “One More Year.” If you have not had a chance to see the video, it is worth a look.
What we learned
We were not surprised that very few booth visitors knew about our product and how it increases outcomes. But after explaining the benefits of heating the cancer tumor, before or after radiation therapy, and sharing the clinical evidence, everyone seemed to be genuinely interested. The pathway to success is to continue sharing the message: Thermal Therapy Works.
The main event at this year's show appeared to be Proton Therapy, whose massive $200 million systems were the technological stars. Proton therapy is the pinpoint distribution of proton particles targeted at a tumor. It offers less damage to healthy tissues as the energy passes through the body than conventional x-ray radiation therapy. When clinicians heard that adding hyperthermia to their program could potentially make their system work better, they were shocked and intrigued. To us, it seemed like a “no brainer.” Adding our system would cost less the one half of one percent (0.005) to the total investment. If it means better results for the patient, why wouldn't every proton therapy system have a deep regional hyperthermia unit in each suite? Expect to see the combination of proton therapy and hyperthermia available soon.
We also want to recognize the team back in Salt Lake City for getting us to the show and supporting the sales efforts. In the middle of a very aggressive product build and ongoing new product development, everyone helped put together the resources we needed for a successful show. It looks like we will be participating in the ASTRO show again next year in Boston. (watch the One More Year video to find out why that location is a bit ironic).
If you missed us at ASTRO, please be sure to visit our booth (#6563) in Chicago at the RSNA, Nov 29th-Dec. 4th.
Amazon.com might someday be delivering your packages by a tiny drone, but when Pyrexar provides to a customer site, we use a crane. Delivery by crane is not our usual methodology, but when a brand new BSD-2000 arrived at the Healer's Care Center in Busan, South Korea, we headed off script for installation. At just under 9ft long, the Deep Regional Hyperthermia system was clearly not going to fit in a 5ft by 5ft freight elevator the cancer center had to offer.
But for a country of 49 million people in an area half the size of the state of Kentucky (pop. 4.4 million), tall buildings and tight accommodations are nothing new.
The engineers did not blink; they brought in a crane, created a lifting platform, and prepared the unit to be elevated high above the sidewalk. Some cover panels were removed, and anything that might get caught during the lift was secured to the system. A forklift delivered the system to a lifting platform at the end of a boom crane, and the crane lifted the 700 lb treatment base to a ninth-floor window. Workers removed the hallway window, transitioned the base to a scaffolding-like structure and down to the floor.
In no time, the system base joined its slightly smaller system components and was sitting in a brand new treatment room where successful installation and systems training sessions followed. A special thanks to the crew at the Healer's Care Center along with the team from HanBeam Technologies for their great effort. The new system is now successfully treating patients with cancer patients with the benefits of hyperthermia.
So next time someone brags about getting a pizza via drone, tell them about Pyrexar cancer treatment systems with crane delivery.
Pyrexar is proud to welcome a new distributor to the fight against cancer, Magna Medic Systems. Magna is headquartered just outside the city of Málaga on the Southern coast of Spain. We first met Elie Helou, General Manager, and Félix Navarro, Medical Physicist, at the annual European Society of Hyperthermic Oncology (ESHO) conference in Zurich, Switzerland. Their team was on a mission to bring hyperthermia to the forefront of Spain's oncology community and while at the conference sift through the competitive offerings to find the best fit. After hearing Pyrexar's presentation of the company's direction, along with the stream positive result findings from thermal therapy researchers from around the world, the group chose Pyrexar.
In addition to being an ESHO partner, Magna Medic is the driving force behind the creation of the thermal oncology working group of SEOR (Spanish Society of Radiation Oncology). SEOR is a group of 60 oncologists looking to improve cancer treatment outcomes with the latest in cancer-fighting technologies. Together they are building a thermal oncology training and education program that will span the country.
Magna joins long-time distributors, Sennewald Medizintechnik (Germany) and Orientech (China), along with newly added Linden Biosciences (Taiwan), HanBeam Technologies (Korea), ORB Global (UK), ORB Darou (Iran), ProCoss (Japan). BON FCZ (Middle East) and ORB Enerji (Central Asia). We look forward to working closely with the Magna team and plan to visit their facilities and tour the country. I have never been to Spain, but I kind of like their music. (Those under 40 may not catch the Three Dog Night reference, but if you want to see my 1970's high school fashion influence, here is a link, enjoy.)
On April 11, 2015, I posted my blog for the first time. We had just set up the office in a portion of the old BSD Medical building, and we seem to be moving at the speed of light. It was our first week in business, and I complained about the lack of staplers. Start-ups are awesome.
Five months later, we just moved into our expanded headquarters not too far down the road — lots of room for manufacturing and new space for research and development. The additional room is not the news; how we are putting it to work is the real story. It used to take 120 days to build a hyperthermia system, and now we do it in 30 days. We did not hire an army of technicians; what changed was the workflow. Not only is everyone on the team accountable, but the process also has transparency. New MRP/ERP system, a CRM tied to marketing automation, project management, and a new CAD system, everything in the cloud. Essentially, I can tell you where the sales lead was generated to when the customer site will install and all the steps in-between. (from my phone). Technology is pretty awesome.
But technology is not what got us to this point, that has everything to do with team and leadership. Mark Falkowski, our CEO, is a seasoned "turn-around" veteran. We were all handpicked; Sales, Regulatory, Manufacturing, Engineering, Finance, and Marketing, because we knew what needed to be done, and we did it. We all trust in Mark's vision, and he trusts our ability; that recipe works. Not saying I have not been worked harder than anytime in my career, but all of our efforts are starting to show. Teamwork is awesome.
But the truly remarkable part is that every time a new product goes out that door, someone with cancer is going to be helped. From here on out, it is a numbers game. The more systems that go out the door, the higher the number of people who will have access to this cancer treatment therapy. That my friends is a great reason to get up and go to work. To everyone reading this... thermal therapy works. Please share the news.
South Korea has the eighth highest cancer rate in the world (the US ranks sixth). Tracking cancer statistics in the country is the KCCR (Korea Central Cancer Registry), a nationwide hospital-based cancer registry established by the Ministry of Health and Welfare. According to the KCCR, stomach and colorectal cancer are some of the highest incidence of cancer among men and women in the country. This is an excellent opportunity for hyperthermia to make a positive impact on the citizens of South Korea.
After meeting Korea's strict regulatory standards, two new BSD-2000 Deep Regional Hyperthermia systems landed in South Korea. Pyrexar’s Field Service Manager, Ray Lauritzen, was onsite for installation and training. Joined by local distributor HanBeam Technology, the first unit was successfully installed and ready for operation at the newly opened Healer’s Care Hospital in the city of Busan. The second installation is scheduled for this week at the YCH Cancer Hospital in Seoul. Both oncology groups were looking forward to treating patients with the new systems.
Pyrexar team has finished the second BSD-2000 for shipment to South Korea today. After successfully navigating the regulatory hurdles of the KGMP, Korea Good Manufacturing Practices (see press release), and a successful build process, we are moving forward. I want to thank all the management and staff for pitching in and getting assembly and testing done before the end of the month. We are scheduled to start building our next two BSD-500 and two BSD-2000 in September. We are on pace for a great first year.
I don't want to be too self-congratulatory, but our team is good at this. It has been just under five months since we started Pyrexar, and the pace has been phenomenal. We connected with the BSD-2000/500 installed base to understand what they needed. We built a product road map that included upgrades and new products. We wowed them at STM (Society of Thermal Medicine) in Orlando and ESHO (European Society of Hyperthermic Oncology) in Switzerland. Launched a website, assembled a talented sales organization, implemented an MRP, untangled our regulatory status, plus secured distribution contracts with China, South Korea, Taiwan, UK, Turkey, Japan, Germany, Iraq, Iran, Saudi Arabia, and the UAE.
We did it all with trust, cooperation, and teamwork. Congratulations to all.