Pyrexar Day is April 11th, 2016, at this year's ICHO in New Orleans. We have some last-minute updates to our speaker schedule. We will be hosting a "working lunch" starting at 12:15p. Looking forward to seeing you at the event.
Pyrexar Day Event Calendar - April 11, 2016
|8:30a - 9:00a
||Meet and Greet - Refreshments
|9:00a - 9:15a
||Welcome to Pyrexar Day - Mark Falkowski, CEO
|9:15a - 10:00a
||Hyperthermia: A maturing technology moving toward more focused heating - Gerard Van Rhoon, PhD., Erasmus Hospital, Netherlands
|10:00a - 10:45a
||Exploration of BSD-2000 System Applied to Clinical Treatment of Tumors – Dr. Sun Jinghua, Associate Professor, 2nd Affiliated Hospital of Dalian Medical University
|10:45a - 11:30p
||Comprehensive Thermal Oncology Program at the University of Maryland: External, Interstitial, and Proton Thermal Therapy - Dr. Zeljko Vujaskovic, University of Maryland Medical Center
|11:30p - 12:15p
||New Product Announcement & Presentation – Jason Ellsworth, VP Pyrexar Medical
|12:30p – 1:15p
||Capacitive vs. Phased Array Hyperthermia - Paul Turner, CTO Pyrexar Medical
|1:15p – 2:00p
Hyperthermia and Pancreatic Cancer; Adjunct to Radiation, Chemotherapy or Both - Dr. Curt Heese, Cancer Treatment Centers of America, Philadelphia
|2:00p – 2:45p
Using Chemotherapy plus Hyperthermia for Advanced Liver Cancer - Xiao Shaowen, Associate Chief Physician. Beijing University
|2:45p – 3:30p
||Quality Assurance of MR-Guided Deep Regional Hyperthermia in Children with Cancer – Dr. Ruediger Wessalowski Heinrich-Heine University Duesseldorf, Germany
|3:30p – 4:15p
||Hyperthermia Adjunct to Chemotherapy Sarcoma Study - Dr. Rolf Issels, Ludwig-Maximilians-University of Munich
|4:15p - 5:00p
||Hyperthermia with Proton Therapy: The thermoradiobiological basis and the early results from HYPROSAR study – Dr. Niloy Datta, Ksantonsspital Aarau
|5:00p - 5:45p
|| Concepts For Future Deep Phased Array Systems - Paul Turner, CTO Pyrexar Medical
|| Pyrexar Award Presentation
EVENT LOCATION: Intercontinental Hotel New Orleans, 444 St Charles Ave, New Orleans, LA 70130, USA
From The Desk of Mark Falkowski, CEO Pyrexar Medical
As Pyrexar Medical celebrates its the first anniversary, I reflect on the amazing achievements of the past year. Our products are being represented in over 50 countries in the world, with many more in line for distribution. Hyperthermia is on the precipice of a cancer-fighting revolution.
I want to acknowledge those who have pioneered ahead of us, testing, focusing, and perfecting the treatment systems into what we have today. To those in research for discovering the biology of the immune system that reveals why heating cancer tumors is so successful. To the patient advocates that challenge our medical system in the U.S. by demanding hyperthermia. And to the doctors, all over the world, that reach out for new, better, and more effective ways to treat cancer.
And most importantly, I want to thank the Pyrexar Team for sharing this same vision. I recall a Confucius quote “Choose a job you love, and you will never have to work a day in your life.” We all realize that every system that ships out of this facility is changing the life of a patient and a family. I am proud to know we have built a company where we can make a difference.
The world is beginning to embracing the technology of heat, and we will continue to prove... Thermal Therapy Works. Immunology is our next frontier.
The Pyrexar team is celebrating their new ISO 13485 Certification and CE re-certification today. ISO 13485 represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. The ISO standard is also a required compliance to do business in the European Union. The CE mark, a mandatory conformity marking for products sold within the European Economic Area (EEA) since 1985, allows Pyrexar to ship medical devices to any of the 27 Member States of the EU. Much like the FDA clearance in the U.S., the CE mark is well respected and plays a key role in acceptance with regulatory agencies of other nations.
We are proud to announce two new additions to the ICHO/Pyrexar Day event calendar.
Dr. Curt Heese, board-certified radiation oncologist at Cancer Treatment Centers of America, Philadelphia. Dr. Heese will be sharing his experiences using Pyrexar Hyperthermia systems as an adjunct therapy to treat pancreatic cancer.
Dr. Niloy Datta, oncologist and prolific researcher in the field of hyperthermia at Kantonspital Aarau AG, Aarau, Switzerland. Dr. Niloy Data will be sharing early results from a multi-institutional phase I/II clinical study "Hyperthermia and Proton Therapy in Unresectable Soft Tissue Sarcoma (HYPROSAR).
Our goal is to make hyperthermia the "standard of care" in the treatment of cancer. Please join us in spreading the word.
Please welcome our new distribution partner, Clinitech Company Ltd, bringing the hyperthermia technologies into Cuba, the West Indies, Panama, and Venezuela.
Cancer deaths are high (138 per 100,000) in Cuba, according to World Life Expectancy.com, an organization that tracks death causality throughout the world. Cuba's cancer stats rank 31 in the world, slightly lower than the UK, and several points higher than the USA. According to a study in 2001-2003 by the National Cancer Registry, Lung, Prostate, Throat, and Colon had a high incidence in men, while Breast, Cervix, Lung, and Colon cancers were the most prevalent in women.
Clinitech will be providing sales and service for the Pyrexar family of Superficial, Interstitial, and Deep Regional Hyperthermia devices. Leading their team is Ross University School of Medicine, Oncology Professor, Dr. Kamal Malaker, who has successfully used Hyperthermia technology in the treatment of cancer. “We are excited to bring this relatively under-explored, underutilized, well-proven, life-saving technology to the region,” says Wazir Mohammed, Clinitech’s President.
The distribution territory includes Antigua, Aruba, Bahamas, Barbados, Belize, Bermuda, Bonaire, British Virgin Islands, Cayman Islands, Cuba, Curacao, Dominica, Dominican Republic, Grenada, Guyana, Haiti, Jamaica, Montserrat, Panama, Puerto Rico, Saba, St. Ecstasies. St Kitts & Nevis, St Lucia, St Maarten, St Vincent. Suriname, Trinidad, and Tobago. Turks and Caicos. US Virgin Islands (St. Thomas, St. Croix, St John), Venezuela. Visit the "How to Buy" page for contact information.
"Pyrexar must continue our expansion to ensure our cancer-fighting system is offered worldwide, to all cancer patients" - Mark Falkowski, CEO.
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. Fees 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 exciting 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, make 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 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 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 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!