NeoTherma Oncology’s mission is to provide clinicians with new cutting-edge hyperthermia tools that improve outcomes and quality of life for cancer patients, because we believe cancer doesn’t have to win.
NeoTherma Oncology is developing a groundbreaking type of radio frequency (RF) thermal treatment for deep solid tumors that is expected to increase the efficacy of current cancer treatments such as chemotherapy and radiation. The ability to enhance and support existing treatments has the potential to give oncologists the missing tool they need to improve outcomes and quality of life for their patients.
NeoTherma's non-invasive technology seamlessly integrates into the clinic, including established MRI treatment suites. Our clinical development strategy has set us apart as industry innovators with the vision to reimagine patient care.
The inspiration for NeoTherma Oncology evolved from an idea developed by a broadcast engineer from Erie, Pennsylvania, John Kanzius, who early in his career learned about the power of radio waves and was determined to find a better way to treat cancer... Read More
After retirement, John was diagnosed with B-cell Leukemia and treated at MD Anderson Cancer Center (Houston, Texas). While sitting day after day in the oncology unit, watching young children endure the same debilitating treatments he was going through, he became determined to find a better way to treat cancer: one that would focus the treatments on killing the cancer while minimizing the brutality of cancer treatment side effects.
John's imagination and determination led him to develop the Kanzius Device; he used his passion and charisma to raise funding and encourage researchers to join him. Early laboratory experiments provided data that demonstrated potential human benefits.
Subsequently, new investors provided support with the objective of moving the product concept out of an academic setting and into the professional realm of medical device research and development. An early prototype demonstrated performance that was encouraging to NeoTherma and the FDA, and they designated the NeoTherma VectRx™ a “Breakthrough” device.
NeoTherma Oncology is a clinical stage medical device company developing a proprietary Thermal Treatment (VectRx™) system for deep solid tumors. Our technology is based on applying a safe, non-invasive, non-ionizing electromagnetic field to produce local-regional hyperthermic temperatures in tumor tissue, intended to increase the effectiveness of anticancer radiotherapy, chemotherapy and immunotherapy. The energy emitted by VectRx™ increases blood perfusion in the tumor micro-environment, enhancing drug delivery, reversing treatment-resistant hypoxia, and promoting a therapeutic immune response.
We are integrating our novel application of electromagnetic field physics with cutting-edge MRI thermographic imaging and computational simulation in a medical device that promises to be a disruptive adjuvant treatment for deep solid tumors, initially targeting pancreatic cancer. Evidence shows that modestly raising the temperature in the tumor microenvironment (from the normal core temperature of 37°C to 41-43°C) significantly increases the effectiveness of radio-, chemo- and immunotherapies with minimal side effects.
Peer-reviewed clinical evidence from a number of centers around the world demonstrates that RF thermal therapy works by increasing blood perfusion in the tumor micro-environment (allowing drugs to better penetrate), reversing radiation treatment-resistant hypoxia (increasing intratumoral reactive oxygen) and promoting a therapeutic immune response similar and likely additive to immune checkpoint inhibition (increasing immunogenic tumor cell surface protein expression). Our lead target, unresectable pancreatic adenocarcinoma, is statistically the deadliest of all solid tumors, and the technology may be equally applicable to a wide range of solid tumors.
Importantly, mild hyperthermia (41-43°C) has been demonstrated to initiate an effective immune response on its own. Thus, it may be an even better complement to immunotherapy as radiotherapy and chemotherapy may suppress the main actors of the immune system.
Hyperthermia has been used globally to treat cancer for decades, most often in conjunction with radiation and/or chemotherapy. A few links to hyperthermia organizations are below:
European Society for Hyperthermic Oncology
American Cancer Society – Hyperthermia commentary
A diagnosis of pancreatic cancer can be devastating. Below are a few resources for information.
NeoTherma Oncology Grows Engineering Leadership Team – WICHITA, Kansas
Posted March, 2022
NeoTherma Oncology (NTO) announces they have expanded their leadership team with key senior staff who will advance the development and commercialization of the VectRx™ System. NTO’s new additions include:
Neotherma Oncology Chooses Master Control as their Quality Management System - WICHITA, Kansas
Posted October, 2021
NeoTherma Oncology (NTO) announces they have chosen the Master Control QMS, supporting their strong commitment to quality in all products and services. Master Control is used by over 1000 highly regulated companies and is considered one of the world's leading QMS solutions.
NeoTherma Oncology Opens Clinical Study - WICHITA, Kansas
Posted July 2021
NeoTherma Oncology, having achieved both FDA approval for its Investigational Device Exemption for an Early Feasibility Study of the VectRx™ System and institutional review board approval at an east coast National Cancer Institute-designated Cancer Center, has initiated recruitment for a first-in-human trial in patients with pancreatic cancer.
NeoTherma Oncology Announces Bob Larson as New Chief Executive Officer - WICHITA, Kansas
Posted January 2021
Neotherma Oncology (NTO) announces the appointment of Bob Larson as Chief Executive Officer effective immediately. Bob is an experienced health care executive with 30+ years spread across the medical device, bio-pharmaceutical, and tech industries. He has held senior leadership positions at companies ranging from startups to Fortune 500 multi-nationals such as Johnson & Johnson and Zoetis.
Posted on January 9, 2020
by Globe NewsWire
WICHITA, Kansas- (January 9, 2020)- NeoTherma Oncology, (NTO) a privately held medical device company developing novel non-invasive treatments for solid tumors, today announces they have submitted an Investigational Device Exemption (IDE) application to the Food and Drug Administration (FDA) to initiate First-in-Human (FiH) studies of the VectRx™ System in patients with pancreatic cancer being treated with standard of care chemotherapy under the Early Feasibility Study (EFS) Guidance. Previously granted 'Breakthrough Technology' designation by the FDA, company CEO Dr. Michael Wandell stated, device development and preclinical work have advanced to the point that we are prepared to move forward upon FDA approval to begin the clinical studies of the VectRx™ System investigational device.
The FiH clinical investigation will be conducted in a limited number of volunteers with pancreatic adenocarcinoma to evaluate the VectRx™ System design by gathering initial clinical safety and performance data useful in making any modifications to the final design. Dr. Wandell added, we have made significant progress in systems development so the investigational treatment of humans with pancreatic cancer is the next milestone on the path toward commercialization. Our non-human testing and extensive simulation work give us confidence that this iterative step will successfully position VectRx™ for a subsequent pivotal clinical evaluation.
The VectRx™ System integrates a novel application of electromagnetic field physics with cutting-edge MRI thermographic imaging and computational simulation in a medical device that promises to be a disruptive adjuvant treatment of pancreatic cancer and other solid tumors. Extensive evidence from clinical trials using hyperthermia in a number of cancers has demonstrated that raising the temperature in the tumor from the normal core temperature of 37C to ~ 42C significantly increases the effectiveness of radio-, chemo- and immunotherapies with negligible additional side effects.
About Pancreatic Cancer
The American Cancer Society1 estimates that 57,600 new cases of pancreatic cancer will be diagnosed in 2020. Pancreatic cancer is the fourth leading cause of cancer death in both men and women, with an estimated 47,050 deaths in 2020. Less than 20% of patients are candidates for surgery. Radiation therapy and chemotherapy are treatment options but rarely produce a cure. For all stages combined, the 5-year relative survival rate is approximately 9%.
About NeoTherma Oncology
NeoTherma Oncology is a private, developmental stage medical device company developing the proprietary VectRx™ System for solid tumors. Our technology is based on applying a safe, non-invasive, nonionizing electromagnetic field to produce local 'fever-range' temperatures in tumor tissue, intended to increase the effectiveness of anticancer radiotherapy, chemotherapy and immunotherapy. More information is available at www.neothermaoncology.com
The VectRx™ System is not yet available commercially or for human clinical studies at this time.
1 American Cancer Society - Cancer Facts and Figures 2020.
Contact: Erik Miller
Phone: 512-461-0197; emiller@neothermaoncology.com
NeoTherma Oncology Receives NCI Grant to Advance VectRx™ MRI Thermometry
Posted on August 21, 2018
by Nasdaq Globe NewsWire
WICHITA, Kan., Aug. 21, 2018 (GLOBE NEWSWIRE) -- NeoTherma Oncology (NTO), developer of an advanced bioelectric medical device for noninvasive treatment of serious cancers, today announced the Company was recently awarded Small Business Innovation Research grant from the National Cancer Institute (NCI) of the National Institutes of Health (NIH). This Phase I award provides resources to enable 'Quantifiable Thermal Therapy Using Magnetic Resonance Thermometry Imaging'. Under terms of the grant, NTO will work closely with researchers from the Department of Radiology and Imaging Science, Utah Center for Advanced Imaging and Research at the University of Utah School of Medicine.
This grant demonstrates NCI's recognition of the importance of our development of noninvasive Magnetic Resonance Thermometry Imaging (MRTI) techniques in partnership with Dr. Dennis Parker's team at the Utah Center for Advanced Imaging Research (UCAIR), stated Michael Wandell, NTO's Chief Executive Officer. NCI's support of this collaboration results from a combination of our encouraging pre-clinical studies and a growing interest in MRI-guided thermal treatment as a safe and effective, non-invasive adjuvant therapy for serious tumors found deep in the body.
In April 2017, NTO announced that the FDA had designated its VectRx™ thermal oncology treatment platform a 'Breakthrough Therapy' for Pancreatic Cancer, expediting patient access to this novel adjuvant therapy [1]. Further, in May 2017 NTO presented its pre-clinical results at the annual meeting of the Society for Thermal Medicine demonstrating the safety and effectiveness of radiofrequency generated heat delivery to deep organs in a large animal model.
It is clear that non-invasive treatment and thermal monitoring using available clinical MRIs would be beneficial as well as preferable to cancer patients, commented UCAIR's Dr. Dennis Parker. Our engineering experience combined with the advanced medical device development expertise of the NTO team bodes well for the successful development of a useful tool to help in the treatment of deep solid tumors such as those seen in pancreatic cancer.
Key objectives in this phase 1 program are to develop MRTI techniques to guide thermal treatment applications in the abdomen and support the integration of the temperature information into cancer treatment planning.
About NeoTherma Oncology
NeoTherma Oncology is developing VectRx™, a noninvasive thermal oncology therapeutic device system for treatment of a wide range of cancers in addition to Pancreatic Ductal Adenocarcinoma, the eighth most common cancer but the fourth leading cause of cancer death in the United States. VectRx is designed to 'plug and play' with the global installed base of MRI scanners to deliver non-invasive, image-guided adjuvant thermal oncology therapy, which is expected to increase life expectancy and improve quality of life of patients who receive it in addition to standard-of-care radio-, chemo- and immuno- therapies.
Contact: Erik Miller - Cell: +1-512-461-0197; emiller@neothermaoncology.com
NeoTherma Oncology Raises $6 Million to Advance VectRx™ to Human Testing
Posted on August 14, 2018
by Nasdaq Globe NewsWire
WICHITA, Kan., Aug. 14, 2018 (GLOBE NEWSWIRE) -- NeoTherma Oncology (NTO), developer of an advanced bioelectric medical device for noninvasive treatment of serious cancers, today announced the closing of a $6 million capital raise. The financing provides the resources to conduct human testing of NTO's VectRx™ thermal oncology treatment platform, designated by FDA as a 'Breakthrough Therapy' for Pancreatic Cancer, expediting patient access to this novel adjuvant therapy[1]. The Series A convertible note raise was co-led by a current investor, Gary Barnett, along with new investment groups, Flor-Med Partners, LLC and R & K Edwards Investments, LLC, and others.
In making the announcement, CEO Mike Wandell said, This investment provides us the ability to realize a dream - completing and qualifying the VectRx™ medical device to begin clinical studies in patients with pancreatic cancer, demonstrating the benefits of NTO's adjuvant thermal oncology therapy. We are grateful both that our current investors have confirmed their confidence in the value of the technology and our ability to commercialize it, as well as that our savvy new investors also recognize its transformative benefit to the cancer treatment market. We are excited to move forward with these partners as we seek to demonstrate the safety and efficacy for patient care together with a strong ROI for our investors.
R & K Edwards Investments, LLC is very excited about the unique, innovative cancer treatment technology developed by NeoTherma Oncology and the management team led by Dr. Michael Wandell, said Ron Edwards, Managing Member. NTO has quickly established undeniable credibility as they have developed their cutting-edge technology, evidenced by FDA's Breakthrough therapy designation, and the endorsements of expert clinicians we interviewed during the diligence process. We look forward to supporting and sharing in the success of NTO as it progresses to commercialization.
About NeoTherma Oncology
NeoTherma Oncology is developing VectRx™, a noninvasive thermal oncology therapeutic device system for treatment of a wide range of cancers in addition to Pancreatic Ductal Adenocarcinoma, the eighth most common cancer but the fourth leading cause of cancer death in the United States. VectRx is designed to 'plug and play' with the global installed base of MRI scanners to deliver non-invasive, image-guided adjuvant thermal oncology therapy, which is expected to increase life expectancy and improve quality of life of patients who receive it in addition to standard-of-care radio-, chemo- and immuno- therapies.
Contact: Erik Miller - Cell: +1-512-461-0197; emiller@neothermaoncology.com
Posted on May 10, 2017
by Nasdaq Globe NewsWire
WICHITA, Kan., May 10, 2017 (GLOBE NEWSWIRE) -- NeoTherma Oncology, (NTO) a privately held medical device company developing novel non-invasive treatments for solid tumors, reported the results of a pre-clinical porcine study that demonstrated the safe and effective heating of the pancreas with a prototype version of its Vectron TTx device.
Key Findings and Conclusions:
A reproduction of the abstract is available at:
http://www.globenewswire.com/NewsRoom/AttachmentNg/d5693c6e-fa4e-4145-b3ec-0fd8ae3a87d7
These results reported the safety, based on analysis of gross pathology and blood serum biomarkers, and the efficacy of deep tissue heating, determined with surgically placed temperature probes, in a cohort of Yucatan mini-pigs treated with the device. The NTO design and the experimental in vivo results are promising and demonstrate evidence that the Vectron TTx delivers energy to produce deep therapeutic temperature elevations which could be extremely effective for treating pancreatic cancer and other disease within the pelvis and abdomen, commented Dr. Chris Diederich, Professor and Director of Clinical Hyperthermia, UCSF Radiation Oncology. He continued, this promising approach should provide a practical and accurate means to produce heat deep within the body as an effective adjuvant to radiation therapy, immunotherapy, and/or nanoparticle and chemotherapy.
Dr. Michael Wandell, CEO of NTO said Our team was pleased with the successful outcome of this study and we were pleased to present the results to the experts at STM. We could not be happier with these data as they allow to move to device development for human use. Also, these data were key elements of the information submitted to FDA that lead to their designation of our Vectron TTx device as Breakthrough Status within the Expedited Access for Premarket Approval Program. Further positive impressions came from clinicians with experience in the delivery of hyperthermia such as Dr. Mark Hurwitz, Director of Thermal Oncology, Professor of Radiation Oncology, Thomas Jefferson University Hospital who commented, I believe NeoTherma Oncology's evidence-based medicine approach to clinically validating the Vectron device will not only drive adoption by the medical community, but further corroborate the effectiveness of hyperthermia as a new pillar of cancer therapy.
The American Cancer Society1 estimates that 53,670 new cases of pancreatic cancer will be diagnosed in 2017. Pancreatic cancer is the fourth leading cause of cancer death in both men and women, with an estimated 43,090 deaths in 2017. Less than 20% of patients are candidates for surgery. Radiation therapy and chemotherapy are treatment options but rarely produce a cure. For all stages combined, the 5-year relative survival rate is 8%.
NeoTherma Oncology is a private, developmental stage medical device company developing the proprietary Vectron Thermal Treatment (TTx) system for solid tumors. Our technology is based on the non-invasive application of safe, nonionizing electromagnetic field to produce local 'fever-range' temperatures in tumor tissue. This energy has been shown to significantly increase the effectiveness of anticancer radiotherapy, chemotherapy and immunotherapy. More information is available at www.neothermaoncology.com
CAUTION: The Vectron device is investigational medical device and is not yet eligible for human clinical studies nor available for sale.Posted on April 4, 2017
by Nasdaq Globe NewsWire
WICHITA, Kan., April 04, 2017 (GLOBE NEWSWIRE) -- NeoTherma Oncology, (NTO) a privately held medical device company developing novel non-invasive treatments for solid tumors, today announces that the United States Food and Drug Administration (FDA) has granted the company's petition to admit its Vectron TTx treatment for Pancreatic Cancer as Breakthrough Device under FDA's Expedited Access Pathway (EAP).
Signed by President Obama in December 2016, the 21st Century Cures Act added a new section (515C) to the Food Drug and Cosmetics Act (FDCA) to codify a process for priority review of Breakthrough Devices offering more effective treatment of life-threatening or irreversibly debilitating human disease or conditions under FDA's Expedited Access for Pre Market Approval (EAP) guidance. The EAP program dramatically accelerates access to novel treatments to address unmet medical needs for patients and their physicians to innovative or breakthrough treatments.
The Vectron TTx integrates a novel application of electromagnetic field physics with cutting-edge MRI thermographic imaging and computational simulation in a medical device that promises to be a disruptive adjuvant treatment for pancreatic and other cancers. Evidence indicates that modestly raising the temperature in the tumor microenvironment from the normal core temperature of 37C to ~ 42C significantly increases the effectiveness of radio-, chemo- and immunotherapies with negligible additional side effects — plus its own direct cancer cell killing effects. The first planned clinical target is pancreatic cancer, the most deadly of the common cancers with an 8% 5-year survival rate. The NTO system demonstrated impressive capability to heat deep tissues in a large in vivo porcine model, said Paul Stauffer, Director of Thermal Oncology Physics at Thomas Jefferson University Hospital after witnessing preclinical animal testing. This new treatment approach appears poised to make a significant impact on treatment of difficult to reach deep tissue diseases like pancreatic cancer and other intrathoracic tumors.
The EAP pathway is an incredible opportunity to speed FDA approval of breakthrough treatments, and we are honored to have Vectron TTx be so designated by the FDA, said Dr. Michael Wandell CEO of NeoTherma Oncology. As a result, we are now working closely with the FDA to reduce the time to get our noninvasive treatment to patients, while meeting FDA's high standards of valid scientific evidence demonstrating the safety and effectiveness, potentially improving these patients' quality of life and life expectancy.
In clinical practice and, certainly, with pancreatic cancer we are searching for distinct new treatments to improve patient outcomes. Radiation therapy and chemotherapy are only marginally successful in treatment of pancreatic cancer, often at the expense of side effects which can impact quality of life, said Mark Hurwitz, the Vice Chair for Quality, Safety and Performance Excellence and Director of Thermal Oncology in the Department of Radiation Oncology at Thomas Jefferson University Hospital. The ability to improve drug access to the tumor for the chemotherapy and enhance the anti-neoplastic effects of radiation therapy, if proven by the NTO device, may potentiate both therapies to benefit the patient.
The American Cancer Society1 estimates that 53,670 new cases of pancreatic cancer will be diagnosed in 2017. Pancreatic cancer is the fourth leading cause of cancer death in both men and women, with an estimated 43,090 deaths in 2017. Less than 20% of patients are candidates for surgery. Radiation therapy and chemotherapy are treatment options but rarely produce a cure. For all stages combined, the 5-year relative survival rate is 8%.
NeoTherma Oncology is a private, developmental stage medical device company developing the proprietary Vectron Thermal Treatment (TTx) system for solid tumors. Our technology is based on applying a safe, non-invasive, nonionizing electromagnetic field to produce local 'fever-range' temperatures in tumor tissue, intended to increase the effectiveness of anticancer radiotherapy, chemotherapy and immunotherapy. More information is available at www.neothermaoncology.com
CAUTION: The Vectron device is investigational and is not yet available for human clinical studies nor available for sale.Neotherma Oncology is led by experienced healthcare executives who are working toward the dream of more effective treatments for cancer.
Health care executive with 30+ years spread across the medical device, bio-pharmaceutical, and tech industries. Has held senior leadership positions from startups to Fortune 500 multi-nationals such as Johnson & Johnson and Zoetis.
20+ years in corporate finance, structure and strategy. Led operations for BGS companies and as President of Premier Management involved in asset and debt restructuring and tax hearings.
20+ years experience in device development and cancer research at Univ. of Texas, Rice University and MD Anderson Cancer Center. Inventor of a large portfolio of medical device patents and author of 30+ peer-reviewed publications.
Healthcare executive with demonstrable successes in market assessment and growth. Led commercial activities for Aspen Biopharma, Radix Biosolutions, Luminex, Safety Syringes and Biosite.
25 years experience in instrumentation R&D, product management, global marketing and business development. Successful development and launch of diagnostic systems for Applied Biosystems-MDS Sciex.
Medical device product design for 48 years, including cardiac pacemaker, MRI scanners, and phased arrays. As an independent consultant for 22 years, worked closely with startup companies and research institutions to solve problems and guide development.
40+ years in Medical and Biotech product design as both a mechanical and electrical engineer. Engineering manager at Hewlett Packard and Omnicell, and led engineering teams for several startups.
NeoTherma Oncology also has relationships with thought-leading medical and scientific advisors and collaborates with industry-leading experts to ensure expedient product development and success.
PO Box 487
Wichita, KS, 67201
Erik Miller
VP Marketing and Business Development
emiller@neothermaoncology.com