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NeoTherma Oncology Announces FDA IDE Submission to Permit Investigational Treatment of Pancreatic Cancer Patients with Its FDA-Designated Breakthrough Device, the VectRx™ Thermal Oncology System
[January 09, 2020]

NeoTherma Oncology Announces FDA IDE Submission to Permit Investigational Treatment of Pancreatic Cancer Patients with Its FDA-Designated Breakthrough Device, the VectRx™ Thermal Oncology System


WICHITA, Kan., Jan. 09, 2020 (GLOBE NEWSWIRE) -- 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 ath 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 37°C to ~ 42°C 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
512-461-0197
emiller@neothermaoncology.com

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