The Wall Street Journal just published an article on Hyperthermia’s resurgence in the medical scene. Although the article lacks to mention some of the amazing 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 spot light. READ THE ARTICLE
The article mentions some studies in the 90’s where outcomes were not as stellar as they are today. This may be due to early lab built equipment and poor 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 important 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 a wonderful cancer fighting device. Heating the cancerous tumors to fever temperatures (42-42˚C) appears to unmask cancer from the bodies immune system. We will see results of this ongoing research and study of the immunological effect in the near future.
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 seemed 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 amazing benefits that hyperthermia had to offer.
In addition to the wealth of business opportunities, medical and technical students had the opportunity 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 thru Thursday Dec. 3rd.
Since this is a really big 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, PhD 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, PhD 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 complimentary interactions between hyperthermia and radiotherapy that increase cell killing. 2) Understand 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 radiotherapy 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 important 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 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 really great 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 new video “One More Year”. If you have not had a chance to see it, its 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 deeply interested. It is evident that the pathway to success is to continue sharing the message: Thermal Therapy Works.
The main event at this years show appeared to be Proton Therapy, whose massive $200 million dollar systems were the technological stars. Proton therapy is the pinpiont 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 potential make their system work better, they were shocked and intrigued. To us it seemed like a “no brainier”. 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 in the near future.
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. 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 delivers 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 fork lift 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 session 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 the 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 kinda 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, 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, the process 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 hand picked; 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 just 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 awesome 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 greater 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 a great 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 really good at this. It has been just under 5 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 at ESHO (European Society of Hyperthermic Oncology) in Switzerland. Launched a website, assembled a talented sales organization, implemented a 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.
My father died 23 years ago today from Non-Hodgkins Lymphoma. He was 59. He did not drink or smoke and seemed to live a life in general good health. His illness and death caught the family off guard.
Cancer does that. It hides from us, it steals from us. I reflect on how much his cancer took away from my family. His grandchildren, all graduated from college now, lived their life without his presence. His friends, neighbors, co-workers, customers, lived their lives void of the help, wisdom and passion that he had to share.
The anniversary of is death stirred me to visit the NIH (National Institutes of Heath) PubMed website and type “hyperthermia” and “non-hodgkins lymphoma” into the search bar. Two studies popped up showing positive clinical response treating with hyperthermia back in 1996. study 1study 2
I was surprised at the result. Part of me reflected, “maybe the doctors could have done more”, or “did I miss an opportunity to find a better treatment”. I take a bit of solace that in 1992, our “great age of information” was still six years away. Google search did not exist.
Now, there is certainly no excuse to be uninformed. If you, your family member or friend have cancer, search “hyperthermia cancer”. You don’t have to be an advocate, just be informed. Find out what the research says about how hyperthermia benefits cancer therapies. If you have your own story about hyperthermia, please share it.
Surviving cancer is not just about you. It is about those of us left behind.
Our immune system has mechanisms in place for detecting and destroying cancer cells. A form of a triggered self-destruct instruction set that tells the cell to stop duplicating and disassemble itself into reusable components.
So, if we know the body can fight off disease and infection, why does it allow cancer cells to survive and grow?
The simplest explanation is that the immune system does not see these rogue cells. The cancerous tumor uses the biological equivalent of a Jedi mind trick to mask themselves from the immune system. “These are not the cancer cells you are looking for”. The culprit, according to the researchers at National Jewish Health, is a lipid secreted by the cancer tumor called LPA (lsyophosphatidic acid). LPA binds to receptors in cancer killing T cells and makes the tumor invisible.
What if we could make all cancer cells visible to the body’s immune system?
That is what researchers want to do, and they may have found a solution in hyperthermia. It has been shown that when tumor cells are heated up to “fever temperature” (around 41-43˚ C) using hyperthermia, the tumor cells essentially light up to the body’s anti-tumor immune response. It is also believed that once a specific type of cancer cell is identified to the immune system, that information is telegraphed through the body revealing and attacking those cancer cells growing elsewhere. So treating a cancer in one part of the body may trigger an immune response everywhere.
Early Evidence Shows Positive Data for Hyperthermia Drug
It may not be nano-robots yet, but hyperthermia triggered smart release drugs are definitely here to stay. Celsion, maker of the chemotherapy drug ThermoDox, announced data from its Phase 2 DIGNITY trial for recurrent chest wall (RCW) breast cancer. The early results, available from their recent press release, show that every patient in the trial experienced a clinical benefit.
ThermoDox is one of several heat-activated nanoparticle liposomal encapsulated drugs arriving on the market. Like traditional chemotherapy, the encapsulated drug is delivered through the blood stream to all parts of the body. The difference is that drug is only released when it reaches the tumor and nowhere else. It does this using a hyperthermic response mechanism. Patients receive localized hyperthermia treatments to heat the tumor to 42˚C (108˚F). The hyperthermia treatment begins to shrink and sensitizes the tumor to chemotherapy. When the drug reaches the “thermal zone” (40˚C or greater), it opens up the encapsulation releasing the chemo on target.
Doing this not only makes sure that enough therapeutic drug gets delivered to the cancer, but also protects the rest of the body from the harmful side effects of traditional chemotherapy delivery. The remainder of the unused drugs gets flushed through the body naturally. I have linked the Celsion webpage that has a great video demonstrating the process.
At it’s annual scientific meeting in Zurich, Switzerland June 24-26, 2015, the European Society of Hyperthermic Oncology (ESHO) bestowed its highest honor, the 30th annual ESHO-Pyrexar Award, on Jan Vrba, PhD. Dr. Vrba is Professor and Chairman, Department of Electromagnetic Fields, Faculty of Electrical Engineering, Czech Technical University (CTU), Prague. The ESHO-Pyrexar Award is awarded annually for outstanding contributions to hyperthermic oncology, education and scientific achievement. Prof. Vrba received his PhD in Communications Technology from the CTU in 1976. He rose through the academic ranks to become full professor and department chairman in 1993, the position he still holds. He has held many prestigious academic appointments at the CTU including membership on the Scientific Board 1994-97, serving as Vice-Rector from 1994-97 and as Chancellor from 2000-2002.
Prof. Vrba’s research efforts have concentrated on the interaction between electromagnetic fields and biological systems most notably the medical application of microwaves, specifically the design of microwave applicators for inducing hyperthermia for cancer treatment.Prof. Vrba has published well over 100 scientific papers.
An indication of the respect held by his scientific colleagues is that Prof. Vrba has been the Congress Chairman of a number of prominent international scientific meetings including: The Annual Meeting of ESHO in Prague in 2007; the Progress in Electromagnetic Research Symposium (PIERS) in Prague in 2007; the Microwave and Radioelectronics Week (MAREW) in Prague in 2008; the Int. Symp. on Microwave & Optical Technology (ISMOT) in Prague in 2011 and again the PIERS meeting in Prague to be held July 5-10, 2015. The PIERS meeting will attract over 2,000 attendees.