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Our Technology
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.
Publications
Scientific
Publications
- Tumor Necrosis in a Breast Cancer Case as a Result of a
Novel Systemic Magnetic Nanoparticle Hyperthermia “Firstin-
Human” Safety and Feasibility Trial, February , 2024 https://newphase.co.il/wp-content/uploads/2024/03/JCCR-24-127609-q2-Approved-2.pdf
- A Validated Methodological Approach to Prove the Safety of Clinical Electromagnetic Induction Systems in Magnetic Hyperthermia, January 2024, https://www.mdpi.com/2072-6694/16/3/621
Abstract for Oral Presentation
Safety Assessment of Sarah Nanotechnology in Swine Models
Abstract for Oral Presentation
Sarah Nanotechnology: A Novel Approach for Metastatic Cancer Treatment
- Self-regulating novel iron oxide nanoparticle-based magnetic hyperthermia in swine: biocompatibility,
biodistribution, and safety assessments,
September 2022
https://pubmed.ncbi.nlm.nih.gov/35635572/
- Novel Nanoparticle-Based Cancer Treatment, Effectively Inhibits Lung Metastases and Improves Survival in a Murine Breast Cancer Model, November 2021 https://pubmed.ncbi.nlm.nih.gov/34804962/
- Fe3O4 Nanoparticles and Paraffin Wax as Phase Change Materials Embedded in Polymer Matrixes for Temperature-Controlled Magnetic Hyperthermia, October 2021 https://pubs.acs.org/doi/10.1021/acsanm.1c02676
- Novel Approach for Magnetic Nanoparticle-based Hyperthermia for Metastatic Cancer Treatment, December 2020 https://biomedres.us/fulltexts/BJSTR.MS.ID.005254.php
News & Press
09/07/24
We are proud to announce that New Phase Ltd. has received the Innovative Investigation Award at the Atlas Juniors 2024 Project Competition!
09/06/24
New Phase’s innovative cancer treatment has received FDA approval for U.S. clinical trials.
Our Founder and CEO Ofer Shalev discussed with CTech by Calcalist how our technology turns advanced cancer into a chronic ailment, extending lifespans and reducing symptoms without traditional side effects
19/04/24
Interview about New Phase Ltd. with Ofer Shalev, Founder and CEO, conducted by Hadar Aviel on an innovation magazine of Assuta Medical Centers.
03/01/24
“New Heat Therapy Aims to Turn Cancer from Fatal to Chronic”.
NoCamels – Israeli Tech & Innovation News, features an insightful interview with Ofer Shalev, Founder and CEO of New Phase Ltd.
13/08/23
Take a listen to this enlightening and valuable interview with Ofer Shalev conducted by Reem Sherman for the great Geekonomy podcast
30/05/2023
We would like to express our sincere gratitude to the Israel Brazil Chamber of Commerce and Industry and the Israel-Australia Chamber of Commerce (IACC) for orchestrating BTG Pactual, the largest investment bank in Latin America, a very successful visit to New Phase Ltd. yesterday.
Special thanks to our professional and dedicated team who led the delegates on an enlightening tour of biology, chemistry, engineering, and our clean room.
We hope this amazing visit will deepen our already strong relationship with Brazilian investors
16/02/2023
We congratulate Prof. Dan Peer, our Scientific Advisory Board member and a global expert in the field of RNA therapeutics and vaccines, to be elected to the US National Academy of Engineering (NAE), part of three US National Academies: science, engineering and medicine
28/01/2023
Check out the i24NEWS video article about New Phase’s breakthrough technology that has shown signs of being able to destroy tumors in patients with stage 4 cancer.
This means, hopefully, turning cancer from terminal to chronic.
Beilinson Hospital is currently conducting clinical trials.
Through our revolutionary approach to cancer treatment we look forward to bringing hope and a brighter future to all those affected by this terrible disease
18/09/2022
It was a great pleasure for us to take part in Calcalist’s fifth Mind The Tech conference held last week, in New York.
For New Phase, this is a wonderful opportunity to present to israel’s high-tech and financial community our important activity in our mission to change cancer from a terminal illness to a chronic ailment.
19/01/2023
We are honored and thrilled to be selected by BIRD Foundation as one of the new nine binational approved projects.
This grant funding approval is another recognition for our super important innovation and technology to change cancer from a fatal disease into chronic ailment to save lives
06/03/2022
New Phase has begun human trials with a technology to extend lives of terminally ill cancer patients. The company’s technology is intended to extend the lives of terminally ill patients by heating cancerous cells
03/02/2022
our CEO Ofer Shalev talking about our mission on GLZ with Dror Globerman
(Starting from 36:35)
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