NeoTherma Oncology Announces FDA Granted Its Vectron Thermal Device for Treatment of Pancreatic Cancer Breakthrough Device Designation within Expedited Access Pathway

WICHITA, Kan., April 04, 2017 -- 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 37°C to ~ 42°C 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.”  

About Pancreatic Cancer
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%.

About Neotherma Oncology
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.

¹ American Cancer Society – Cancer Facts and Figures 2017.

Contact:
Erik Miller
512-461-0197
[email protected]