IceCure Medical (from Facebook)
IceCure Medical, BrainStorm Cell Therapeutics, and NeuroSense Therapeutics are three Israeli medtech firms that all made new moves this week. BrainStorm Cell Therapeutics Inc., a developer of adult stem cell therapeutics for neurodegenerative diseases, announced that the U.S. Food and Drug Administration (FDA) will hold an Advisory Committee Meeting (‘ADCOM’) to discuss the company’s Biologics License Application (BLA) for NurOwn for the treatment of amyotrophic lateral sclerosis (ALS).
IceCure Medical, the Israeli developer of minimally-invasive cryoablation technology, the ProSense System, announced the National Medical Products Administration (“NMPA”) of China approved the Company’s IceSense3 disposable cryoprobes for commercial use, to be used in combination with the Company’s IceSense3 console, which was previously approved by the NMPA.
And NeuroSense Therapeutics, and Israeli startup developing treatments for severe neurodegenerative diseases, signed a collaboration agreement with Massachusetts General Hospital’s NeuroEpigenetics Lab to explore the neurotherapeutic effects of its lead combination drug, PrimeC.
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The objective of the collaborative studies is to expand the understanding of PrimeC’s mechanism of action in attenuating ALS-related pathology, specifically TDP-43 accumulation, autophagy defects, mitochondrial dysfunction, and oxidative stress. To address this, ALS- or control-SNs derived from post-mortem brains will be used to treat SH-SY5Y cells to induce reactive oxygen species and mitochondrial dysfunction, as previously shown by the Sadri-Vakili lab, in the presence or absence of PrimeC. Importantly, the studies will compare the potential therapeutic effect of PrimeC combination therapy relative to each one of its FDA-approved compounds, ciprofloxacin and celecoxib, separately, to further demonstrate the beneficial synergistic effect of PrimeC as a combination therapy.
Dr. Shiran Zimri, Head of Scientific Programs at NeuroSense Therapeutics
Founded by CEO Micha Breakstone and CTO Edmund Benami as well as scientific co-founder Gil Shklarski who previously served as CTO of Flatiron Health, NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and Parkinson’s disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense’s strategy is to develop combined therapies targeting multiple pathways associated with these diseases.
NeuroSense’s Vice President of R&D, Dr. Shiran Zimri stated, “Having worked closely with Massachusetts General Hospital on our biomarker studies, we are pleased to formally establish this important collaboration with Dr. Sadri-Vakili’s team, where we hope to elucidate PrimeC’s efficacy via key measurements that correlate with our Phase 2b ALS study endpoints.”
BrainStorm Cell Therapeutics Inc. is a developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement.
BrainStorm says the NurOwn technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders.
Stacy Lindborg, Ph.D., BrainStorm’s Co-Chief Executive Officer commented, “ALS is a horrific, neurodegenerative disease that moves at a terrifying speed, robbing people of their ability to move, speak, eat, and breathe. Securing an ADCOM represents an important step towards our goal of making NurOwn broadly available to individuals living with ALS who are in urgent need of new, effective therapies. The meeting will provide an open forum for BrainStorm and the FDA, together with medical experts, statisticians, and the ALS community, to thoughtfully review all available evidence supporting NurOwn. We remain confident in NurOwn and we are committed to doing everything in our power to make the product available quickly to people living with ALS. We look forward to a robust scientific discussion.”
As for IceCure Medical, they said that with this latest approval, the company and its partners in China can address a significant market with its novel and proven technology to treat malignant and benign tissue of the breast, lung, bone, liver, and kidneys, as well as palliative interventions.
“With approximately 430,000 new breast cancer cases in 2022 alone, and a healthcare system readily adopting new technologies that produce improved outcomes, we see China as a prime market for our cryoablation system,” stated Eyal Shamir, IceCure’s Chief Executive Officer. “Having received regulatory approval for commercial sales of both our console and cryoprobes, we expect to effectively monetize our distribution agreement in the Chinese market.”
IceCure Medical Ltd. (Nasdaq: ICCM) (TASE: ICCM) develops and markets ProSense®, an advanced liquid-nitrogen-based cryoablation therapy for the treatment of tumors (benign and cancerous) by freezing, with the primary focus areas being breast, kidney, bone and lung cancer. Its minimally invasive technology is a safe and effective alternative to hospital surgical tumor removal that is easily performed in a relatively short procedure. The system is marketed and sold worldwide for the indications cleared to date by the U.S. Food and Drug Administration and approved in Europe with the CE Mark.
Founded in 2006, IceCure Medical is a medical device company innovating cryotherapy solutions to treat benign and malignant tumors with our liquid nitrogen based ProSense Cryoablation System for women’s health and interventional oncology.
