Just under a year ago, Pyrexar purchased the hyperthermia device group from Perseon Medical (formerly BSD Medical). As part of the original purchase agreement, Perseon acquired 19.9% of our company along with royalties on future sales of the BSD-2000, our flagship product. Royalties alone were estimated at $4 million over the next three years.
Today, we purchased that ownership back!
Pyrexar is whole again and continuing to grow and move forward. Every single department in the company has made incredible strides in efficiency, productivity and expansion. The details may not be an interesting read, but they go along way to make Pyrexar a very successful business case study.
Here are some highlights!
New Distribution - Added nine new international distribution companies to our channel with several more in negotiation bringing our sales coverage to 31 countries
Revamped Manufacturing Workflow - We increased the speed of our manufacturing process by 600%.
Regulatory Process - Added TFDA (Taiwan FDA), KFDA (Korean FDA), TUV Rheinland and RoHs compliance to our process.
Engineering Updates - Manufacturing processes are being re-engineered to be more efficient and cost effective. Plus, we are well into a product road-map of new and exciting thermal therapy products
These improvements, along with a laundry list of incremental achievements, makes the company more organized, cost efficient, proactive and flexible.
Thank you for helping us continue the work that brings life-saving hyperthermia to cancer patients around the world.
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 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 positively affect the people of that region.
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 own 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 6 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 6 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 bring a great enthusiasm for hyperthermia as a front 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 an amazing show located in an amazing 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 article titled “Hyperthermia and radiotherapy in the management of head and neck cancers: A systematic review and meta-analysis” finds level 1 evidence of the efficacy of HTRT (Hyperthermia + Radiotherapy) over RT (Radiotherapy alone) in the treatment of Head and Neck Cancers.
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 6 studies evaluated the benefit of Hyperthermia as an adjunct treatment had an overall benefit ratio of 1.6.
The evidence that Hyperthermia is an important 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 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.
Resources: Fever and the thermal regulation of immunity: the immune system feels the heat; Sharon S. Evans,Elizabeth A. Repasky& Daniel T. Fisher
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.
Lessons Learned from XRT/Hyperthermia
Wednesday 1:55-2:10 PM | VSIO41-03 | S405AB
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
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.
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.