Our Technology

The SaNP (Sarah Nanoparticles)

New Phase has developed a promising therapeutic technology based on hyperthermia

In general, cancer cells exposed to temperatures between 41°C to 45°C are more sensitive to heat than normal cells, mainly due to the complexity of the vascular architecture in solid tumors. Tumor cells with a disorganized
vascular structure, unlike normal cells, have difficulty dissipating heat, because of their inability to increase blood flow in response to heat.

Sarah Nanotechnology comprises of a new type of super-paramagnetic iron oxide nanoparticles developed and patented by New Phase.

These nanoparticles termed Sarah Nanoparticles (SaNPs) contain multiple cores of iron oxide embedded within a Phase Change Material (PCM), coated with polyethylene glycol (PEG). This coating ensures that the nanoparticles remain chemically and pharmacologically inert in the human body.

The SaNPs were designed to be administrated systemically to patients diagnosed with stage IV metastatic solid tumors and become localized via the enhanced permeability and retention (EPR) effect on cancer cells.
Following delivery and accumulation of SaNPs, the iron oxide core is activated by Alternating Magnetic Field (AMF) exposure generated by an electromagnetic induction system (EIS). The PCM controls the temperature of the SaNPs that heat the cancer cells. All these features make the SaNPs unique and are the prerequisite for the feasibility of Sarah
Nanotechnology to treat metastatic solid tumors through the delivery of thermal energy produced by AMF
application to malignant cells, thereby causing magnetic hyperthermia-induced cancer cell death at a
controllable temperature.

Our Technology

The alternating magnetic
field generator EIS

Sarah Nanotechnology is applied to the
patient in a specially designed Electromagnetic Induction System (EIS) that generates an AMF. The patient lies on a bed and undergoes partial body AMF
application in the EIS at a frequency of 290±10% kHz. The rapid alternation of the polarity of AMF causes the iron oxide core of the SaNP to change polarity
enabling generation of therapeutic
treatment temperatures.

The AMF application profile is carefully planned and controlled, to prevent any adverse effects of heating to healthy tissues. Patient thermal regulation is maintained during treatment via a specially designed cooling blanket and continuous monitoring with fiber optical temperature sensors attached to the patient.

Regulatory Status

The Sarah Nanotechnology system has been classified by the regulatory authorities as a medical device class III.
New Phase has collaborated with the FDA, Health Canada, and the Israeli Ministry of Health (MOH) to define the appropriate regulatory strategy.
We have recently received approval from the Israeli MOH to start a First-in-Human study in 15 patients to evaluate the safety of SaNPs.

ISO

New Phase holds an ISO 13485:2016 Quality System certificate from BSI.

The nanoparticles are developed and manufactured at New Phase facility in a clean room environment.
The EIS is developed at a sub-contractor under New Phase’s design and development specifications.

BSI Quality System Certificate