Pyrexar Medical Mission
We are revolutionizing cancer care by designing and producing advanced hyperthermia systems. We aim to harness the potent impact of controlled heat to amplify the effectiveness of cancer treatment. By leveraging the therapeutic power of controlled heat, the company seeks to enhance traditional therapies, offering patients advanced and effective options. Pyrexar Medical is committed to pioneering solutions and strives to redefine the landscape of cancer care for a brighter and healthier future.
Pyrexar Medical Corporation
Pyrexar develops, manufactures, and markets medical systems that deliver precision-focused radio frequency waves into diseased body sites, heating them to specified temperatures as required by various medical applications, particularly cancer therapies. The company is based in Salt Lake City, Utah. The Company's product line is Hyperthermia, also called thermal medicine. Its treatment systems have been used to treat thousands of patients worldwide. They have received many awards, including the Frost & Sullivan "Technology Innovation of the Year Award" for cancer therapy devices.
Hyperthermia delivers focused, therapeutic heating to solid cancerous tumors by targeting radiofrequency or microwave energy to the tumor site. Cancer cells have poor mechanisms for heat adaptation and are more vulnerable to heat-induced death than normal cells. The therapeutic effect on cancerous cells is first achieved through concentrating the cytotoxic effect, second through thermal injury, and third by stimulating the immune system. Clinical studies using the Company's Hyperthermia System in conjunction with radiation therapy have compared favorably on randomized tests with radiation-only and chemotherapy treatment (see appendix for clinical test results).
In April 2015, Pyrexar Medical Corp. was formed by acquiring the hyperthermia business and assets from BSD Medical Corp. with a small group of initial investors. Pyrexar Medical is now seeking growth capital investors. Pyrexar technology is currently state of the art in R.F. and microwave hyperthermia. It believes it is positioned to grow and transition Hyperthermia into the fourth pillar of the column for oncology treatment.
Cancer is a significant global issue, with 18.1 million new cases reported in 2020. The impact of cancer is even more pronounced when considering the 10 million deaths it caused, or one in six total deaths worldwide in 2020. By 2040, the number of cancer cases is projected to increase to 27.5 million and deaths to 16.3 million due to population growth and aging. Despite advancements in cancer treatment technology, survival rates remain concerning, with only 69% of cancer patients in the U.S. reaching the five-year survival milestone and 43-64% in the E.U. These statistics highlight the ongoing need for investment in cancer research and treatment options. The company's hyperthermia systems can be placed and used with the estimated worldwide installed base of approximately 7,500 linear accelerators and 2,500 brachytherapy systems. Compared to the $750,000 to $1.5 million for a LINAC radiotherapy system or the $20-$150 million proton therapy system, adding Hyperthermia is comparatively inexpensive and significantly boosts treatment outcomes. Recent studies have demonstrated the efficacy of using Hyperthermia in combination with chemotherapy and liposomal encapsulated pharmaceuticals, which has the potential to expand the market opportunities for this technology significantly. Phase I of the study is underway with drug carrier maker Thermosome using Pyrexar hyperthermia systems. Additionally, early research suggests a high likelihood of using Hyperthermia effectively with immunotherapy drugs. These advancements position Hyperthermia as a promising and growing market, providing significant opportunities for companies like Pyrexar at the forefront of this technology.
Pyrexar's target customers are clinics, hospitals, and institutions that offer cancer treatment services. The Company has a diverse sales strategy, focusing on key markets including China, South Korea, Taiwan, Germany, Netherlands, Switzerland, Poland, Turkey, the Middle East, Australia, New Zealand, and Indonesia. Other European markets and the United States. This diversified approach to sales and marketing allows Pyrexar to tap into a growing demand for cancer treatment solutions, providing a solid foundation for growth and expansion.
The current Pyrexar Team members are led by Mark Falkowski, who has four decades of experience in the capital equipment medical market. The team is leading experts in physics, engineering, regulatory and clinical affairs, and equipment manufacturing. Through exclusive licenses, Pyrexar's hyperthermia sales and servicing activities in Europe are predominantly led by "Dr. Sennewald Medizintechnik GmbH," Munich. The team currently consists of experienced scientists and sales reps. Sales and servicing are provided directly by distributors in China, Taiwan, South Korea, Spain, Turkey, UAE, Poland, Australia, New Zealand, and Indonesia.
Radiofrequency (R.F.) hyperthermia is a therapeutic modality that utilizes electromagnetic waves within the radiofrequency spectrum to elevate the temperature of targeted tissues for medical benefits, particularly in cancer treatment. This technology exploits the unique sensitivity of cancer cells to heat, aiming to induce controlled Hyperthermia (elevated temperature) in the affected area. The R.F. energy is delivered through specialized applicators or antennas near or inside the tumor site. These applicators emit R.F. waves that generate heat through energy absorption by water molecules in the targeted tissue. Since cancer cells are known to be more heat-sensitive than normal cells, the elevated temperature selectively damages or destroys cancerous cells while minimizing harm to surrounding healthy tissue. The rationale behind R.F. Hyperthermia lies in its ability to enhance the effectiveness of other cancer treatments, such as radiation therapy or chemotherapy. Elevated temperatures can increase blood flow to the tumor, improving the delivery of oxygen and anticancer drugs. Moreover, Hyperthermia can make cancer cells more susceptible to radiation, making the combined approach more potent than individual treatments. This synergistic effect has led to integrating R.F. Hyperthermia into comprehensive cancer treatment strategies, showcasing its potential as an adjunctive therapy to improve therapeutic outcomes and enhance the overall effectiveness of cancer care.
ALBA has a limited market presence with microwave and R.F. hyperthermia systems. Several other companies are marketing in Asia using old technology using capacitive coupling electrodes placed on the body.
Pyrexar's hyperthermia activities currently comprise a product range of two systems. The BSD-500 Superficial / Interstitial Hyperthermia System treats solid tumor cancers within 4cm of the skin surface or areas that can be accessed using inserted antennae combined with brachytherapy. The BSD-500 Hyperthermia System comes in variable versions, depending on the customer's requirements.
The BSD-500 Hyperthermia System is FDA-approved for use alone or in conjunction with radiation therapy in the palliative management of specific solid surface and subsurface malignant tumors (i.e., melanoma, squamous- or basal cell carcinoma, adenocarcinoma, or sarcoma) that are progressive or recurrent despite conventional therapy.
The BSD-2000 Hyperthermia System is used to treat certain deep cancers non-invasively. This system also comes in several versions, including models with three-dimensional steering of electromagnetic energy and models that can be integrated with magnetic resonance imaging or MRI.
The BSD-2000-3D Hyperthermia System adds three-dimensional steering of deep-focused energy, enabling additional electronic steering along the body's long axis. The BSD-2000-3D Hyperthermia System also delivers more precise heating to the tumor mass. As part of the international collaborative research efforts, sophisticated treatment planning software for the BSD-2000 Hyperthermia System (called Sigma HyperPlan) has also been developed by Dr. Sennewald to further enhance the Hyperthermia System treatment precision. The Company added the option of concurrent magnetic resonance imaging with the BSD-2000-3D/MR, which uses MRI to monitor the delivery of deep hyperthermia therapy. M.R. Hybrid treatment includes non-invasive temperature monitoring, a significant breakthrough in developing hyperthermic oncology primarily because it allows a non-invasive "online" view of hyperthermic temperature during treatment.
Pyrexar's objective is to increase margins in 2023 - 2024
Since the upgrade of the BSD-500, we have increased our distribution price by 30% since 2020. Our target price for distribution is $198,000 with a 53% margin. In that same period, the BSD-2000 increased by 21% to a total distribution margin of 52% by the end of 2023.
Product Redesign to improve margin and gain market share
Two major product development projects are underway to renovate the BSD-2000 system to improve aesthetics, update technology, and reduce costs. These projects will compound and result in a new modern treatment system with significantly improved margins.
The Computer, Control Console, Temperature Box, and Water Control system have been updated to the latest technology and streamlined designs and are complete.
Control Console | Temperature Box | Water Control
Cost Reduction: $16k (10%)
This project is 50% complete and paused because of the lack of resources. This project focuses on design simplification, supply chain control, and cost savings. Completion will also significantly improve order fulfillment time.
Cost Reduction: $25k (15%)
Timeline: 4 months to prototype, ten months to launch.
Integrated System with New Patient Support:
This third phase is the most impactful on the aesthetic appearance of the system and combines all of the previous projects. It may be run in parallel with the Amplifier Update project.
Present BSD-2000 New BSD-2000
Cost Reduction: $10k (6%)
Timeline: 6 months to prototype, 12 months to launch.
Total Cost Reduction: $51k (31%). We will target a 62% margin.
New Product Development: Hal. o NIR
Pyrexar systems can treat 85% of solid tumor cancer, including cervical, breast, pelvic, bladder, stomach, rectal, anal, vaginal, prostate, pancreas, melanoma, and soft tissue sarcoma. The next frontier is brain cancer. Using our existing base technology, engineers have created a head applicator capable of focusing and steering an energy zone 2.1 cm in diameter. The applicator has gone through extensive computer modeling and phantom testing. The next phase is to demonstrate the heating capability of an animal subject. The team at the University of Maryland is leading this endeavor. Once complete, we will begin phase I of the clinical study on humans. The overall survival rate for patients with brain cancer is low, around 5.6%, with a median survival of 6 months. We believe we can achieve increased results based on an invasive clinical study using Hyperthermia plus radiotherapy.
Beyond Brain Cancer:
The Hippocampus, the key to unlocking Alzheimer's Dementia
Once we prove our brain applicator on brain cancer, Pyrexar Medical will continue looking forward to a more effective treatment for Alzheimer's. We want to give dementia patients a new hope with Hyperthermia.
Alzheimer's dementia kills more people than Breast Cancer and Prostate Cancer combined. 59% of people worldwide incorrectly believe that Alzheimer's disease is a typical part of aging. Hyperthermia Therapy has the potential to stop this disease. We are now exploring the effects of heating the brain to hyperthermic higher temperatures to excite the brain's response to protect neuropathogenic pathways.
1. Stop or reverse dementia progress in Alzheimer's
2. Dementia and degenerative prevent/stall brain diseases
3. Parkinson's disease
The Pharmaceutical Industry has spent the last 14 years looking for a miracle drug, which has failed. The solution lies with heat shock proteins, something Hyperthermia does very well, and product possibilities with controlled brain heating to therapeutic temperatures.
Sales plan for the Hal. o
The plan is to test the Hal. o to provide clinical evidence of success with glioblastoma as the first study. It is already planned in several critical hospitals worldwide, in the United States, Europe, and Asia. Our first testing will be at the University of Maryland Cancer and Proton Center once we show clinical evidence of using the Hal. o on glioblastoma with radiation therapy to kill cancer, we will create a new division of Pyrexar called Hal. o. Pyrexar will then submit to a public offering by going into an IPO to raise funds to support the new Hal—o product development. We will not sell the Hal. o. We will provide a lease program based on patient studies per month. This would give continuing revenue for the company since we do not have consumable revenue for our exciting products. It would strengthen our revenue stream and provide an attractive entry into hospitals to provide Pyrexar therapy systems.
Clinical Evidence of Hyperthermia Results
A rich history of phase III clinical evidence showcases the advantages of combining Hyperthermia with cancer treatments. Pyrexar surpasses any commercial hyperthermia system in terms of published studies in leading medical journals globally, with over 100 peer-reviewed studies and thousands of solid tumor carcinoma patient treatments documented. For an organized summary by indications, see the appendix.
Pyrexar owns seven nonexpired patents in the United States related to specific components or technology of hyperthermia systems and four international patents [Europe].
n Since its founding, the Company has advanced technology while significantly reducing production costs. The immediate development pipeline includes the BSD-2000 and BSD-500 cost reduction and redesign, including new development of advanced software tools. Initiatives have included joint work with many notable cancer research centers in Europe and the United States. In past years, funding for their research efforts has been provided by such sources as the National Institutes of Health in the United States and significant European government agencies.
The recent transition in the European Union from MDD to MDR regulation has significantly affected the industry. Pyrexar has invested over $250k in regulatory and engineering resources over the past two years and is now on track to return to European sales fully certified to this new regulation within the next month.
Proven Product – The company has been established as a world leader and pioneer in hyperthermia cancer treatments. From 2015 through 2023, Pyrexar hyperthermia sold over 72 units in 8 countries. The company's products are backed by numerous clinical studies demonstrating the benefits of Hyperthermia.
Barriers to entry for new entrants are high. Established product lines, cancer therapies, approvals, know-how, and reputation in the industry are critical competitive factors. These companies have not received [FDA] approval to manufacture and sell hyperthermia therapy systems.
Strong Gross Margin – The Company realizes approximately 55% gross margin on the sale of each unit. The Company also provides ongoing service for its hyperthermia products, generating additional profitable revenues.
Potential in the USA –The first-generation BSD-500 product is FDA-approved. The Company's second-generation product, BSD-2000, is approved for marketing in the United States via a Humanitarian Device Exemption ("HDE").
Significant Contract Adoption in Asia – The Company has three exclusive Asian distributor agreements, one in Taiwan, one in South Korea, and one in China, outlining the potential purchase of 8 and 12 systems in fiscal 2023.
Klinikum Grosshadern der Universität München (Germany)
Universitätsklinikum Tübingen (Germany)
Universitätsklinikum Erlangen (Germany)
Universitätsklinikum Düsseldorf (Germany)
Ospedale Civile Maggiore (Italy)
Erasmus Medical Center Daniel Den Hoed Cancer Center (Netherlands)
Kantonsspital Aarau (Switzerland)
Maria Sklodowska-Curie (Poland)
Haukeland University Hospital (Norway)
Cleveland Clinic (Ohio, Florida)
University of Maryland (Maryland)
Long Beach Memorial (California)
Sitemann Cancer Center (Missouri)
New York University Hospital Center (New York)
Temple University Hospital (Pennsylvania)
Texas Oncology, Sammon Cancer Center (Texas)
Zhengzhou University Hospital (China)
Sahmyook Seoul Hospital (South Korea)
Liaocheng Hospital (China)
Beijing Hospital of Health Ministry (China)
Foshan 1st Peoples Hospital (China)
The Affiliated Traditional Chinese Hospital (China)
Zhanjiang Hospital (China)
Wonkwang University Hospital (Korea)
Zhejiang Xioshan Hospital (China)
Clinical Test Results
Hyperthermia kills cells in solid tumors without damaging normal tissues because higher temperatures selectively destroy hypoxic cells with low pH, a condition of tumor cells and not normal cells. The low pH and hypoxic condition of tumor cells also make them radiation resistant, which makes hyperthermia and complementary radiation treatments. In addition, the elevated temperatures that would not be fatal to normal cells can destroy cancerous tissue, which lacks the regular vascular supply that dissipates heat and supplies oxygen. These effects of Hyperthermia on blood flow and tumor oxygenation make the cancer cells more susceptible to other anticancer therapies, including radiation and chemotherapy. Hyperthermia has also been shown to inhibit cellular repair mechanisms, induce heat-shock proteins, denature proteins, induce apoptosis, inhibit angiogenesis, and reduce the tumor resistance sometimes observed with other cancer therapies.
Clinical studies show Hyperthermia can more than double the efficacy of radiation therapy in select tumors without an increase in toxicity and can enhance the effectiveness of several chemotherapeutic agents, providing a safe and productive treatment for many types of solid tumors. Published data from 18 randomized trials on Hyperthermia demonstrated significantly better results from Hyperthermia combined with radiotherapy (n=13), chemotherapy (n=3), and radiotherapy plus chemotherapy (n=2) compared to the same treatment without Hyperthermia.
The most advanced testing of the above concepts was done through a phase III randomized study conducted at Erasmus Medical Center – Daniel den Hoed Cancer Center (DHCC), Rotterdam. The objective of the study was to compare Hyperthermia (H.T.) delivered using the Hyperthermia System B and radiation (R.T.) to R.T. only treatment of 65 advanced cervical cancer patients, referred to as the Company Intent-to-Treat ("the Company ITT") population. Thirty-three patients were randomized into R.T. combined with H.T., and 32 were randomized into R.T. alone. All patients had prognostic indicators associated with a poorer outcome for cervical cancer. The study met its primary endpoint of a 20% increase in complete response rates for cervical cancer patients receiving H.T. and R.T. compared to R.T. alone. (Complete response (C.R.) was defined as the disappearance of all viable tumors in the irradiated volume.) These data were a subset of the Deep Dutch Hyperthermia Trial data published in The Lancet. (Van der Zee J, Gonzalez-Gonzalez D, Van Rhoon GC, et al. Comparison of radiotherapy alone with radiotherapy plus Hyperthermia in locally advanced pelvic tumors: a prospective, randomized, multicentre trial. Lancet 2000;355:1119-1125.)
A meta-analysis that included all published, randomized studies that compared Hyperthermia and radiation therapy to radiation therapy alone was published. The analysis involved 23 studies of 1,861 patients. This meta-analysis showed a significant improvement in outcome from adding Hyperthermia to radiotherapy for several tumor sites, i.e., chest wall, cervix, rectum, bladder, melanoma, and head and neck, to a high degree of statistical significance. For melanoma, after two years, local control (local regression or disappearance of the tumor) was 28% for the control group of patients who received radiation therapy alone versus 46% local control for the patients who received both Hyperthermia and radiation therapy. For recurrent breast cancer, the complete response rate (complete disappearance of the tumor) increased from 38% for those receiving radiation therapy alone to 60% for those patients who received both Hyperthermia and radiation therapy. For glioblastoma (brain cancer), the two-year survival rate for patients who received radiation therapy alone was 15%, compared to a 31% survival rate two years after treatment for those who received both Hyperthermia and radiation therapy. For advanced cervical cancer, the complete response rate (disappearance of the tumor) rose from 57% for patients who received radiation treatments alone to 83% for patients receiving both Hyperthermia and radiation therapy. The cervical cancer data was based on the condition of patients three years after treatment. High-risk soft-tissue sarcoma patients were 30% more likely to be alive and cancer-free almost three years after starting treatment if Hyperthermia was added to their chemotherapy treatment. Median disease-free survival was 32 months in the hyperthermia and chemotherapy group vs. 17 months in the chemotherapy-only group. Almost three years after starting treatment, the sarcoma patients treated with Hyperthermia and chemotherapy were 42% less likely to experience a recurrence of their cancer at the same site or to die than those who were getting chemotherapy alone.
Hyperthermia can have other therapeutic uses. Clinical studies have shown that Hyperthermia can shrink tumors before surgery, potentially making resection easier or even possible. Research has shown that Hyperthermia can activate some gene therapies by speeding gene production (heat-mediated gene therapy). Hyperthermia may play a role in developing new anti-tumor vaccines based on producing heat shock proteins. Research has shown that Hyperthermia may be an angiogenesis inhibitor, which helps prevent cancer from inducing the growth of new blood vessels to expand its blood supply. Hyperthermia may also become a follow-up therapy for other angiogenesis inhibitors, used in the final destruction of cancer cells depleted of blood by angiogenesis inhibitor therapy. Hyperthermia has been shown to improve a patient's quality of life. Even when there is no hope for survival, Hyperthermia may provide benefits by alleviating some of the side effects of cancer.
Pancreatic cancer treatment is struggling to find a successful treatment for the disease. The average survival rate globally is around 11%. A recent dual-arm phase III clinical study of 117 patients published in the European Journal of Cancer compared the standard of care gemcitabine with Hyperthermia plus cisplatin and gemcitabine. The group who received the hyperthermia treatment showed a remarkable increase in the median 5-year survival rate of 28.4% compared to the chemotherapy-only group at 18.7%.