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Entolimod™ as a radiation countermeasure for Acute Radiation Syndrome

High doses of radiation exposure can result in life-threatening acute radiation syndrome, or ARS, as manifested by severe morbidity. Entolimod™ is effective in protecting against, and mitigating the development of, the hematopoietic and gastrointestinal subsyndromes of ARS in rodents and nonhuman primates. Entolimod™ treatment reduces radiation-induced apoptosis and accelerates the regeneration of progenitors in radiation-damaged tissues. The drug has been evaluated clinically for its pharmacokinetics, toxicity, and biomarkers.

The FDA has granted investigational new drug, fast-track, and orphan drug statuses to Entolimod™. Its safety, efficacy, and animal-to-human dose conversion data allowed its progression with a pre-emergency use authorization application submission.

This study was published in the peer-review journal Drug Discovery Today, Volume 26, Number 1, January 2021. Vijay K. Singh and Thomas M. Seed.

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Tivic VNS Optimization Study

Tivic has already confirmed the effectiveness of its non-invasive cervical vagus nerve stimulation (ncVNS) platform. Data show Tivic’s platform induces responses in the autonomic, cardiac, and central nervous systems. A current trial, which is being conducted by The Feinstein Institute of Bioelectronic Medicine is now underway to identify device parameters that optimally influence autonomic nervous system (ANS) function, including the frequency and the duration of potential treatments. Tivic Health plans to use these results to prioritize clinical indications it will carry forward into further testing and commercial development.
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Tivic Health Study Demonstrated Clinically Effective Biological Changes in Response to Cervical Vagus Nerve Stimulation

Tivic Health’s pilot research study validated its novel and proprietary approach to ncVNS using objective measures of the autonomic nervous system, cardiac function, and brain activity. The strength of the data suggest Tivic’s differentiated approach to ncVNS may yield superior clinical outcomes when compared to the current status quo in vagus nerve stimulation.

Shubham Debnath1, 2, Fylaktis Fylaktou1, 2, Todd J. Levy1, 2, Blake T. Gurfein3, Theodoros P. Zanos1, 2
1 Institute of Bioelectronic Medicine, Feinstein Institutes for Medical Research, 350 Community
Dr, Manhasset, NY, 11030
2Institute of Health System Science, Feinstein Institutes for Medical Research, 350 Community Dr., Manhasset, NY 11030
3Tivic Health Systems, Inc., Fremont, CA 94025

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The clinical trial showing the effectiveness of Tivic’s ClearUP® product technology was published in the peer-reviewed publication International Forum of Allergy & Rhinology and is titled

Microcurrent technology for rapid relief of sinus pain: a randomized, placebo‐controlled, double‐blinded clinical trial.

The study was published in the peer-reviewed publication International Forum of Allergy & Rhinology (Vol. 9, No. 4, pp. 352-356). Maul, X. A., Borchard, N. A., Hwang, P. H., & Nayak, J. V. (2019, April).
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Learn more about Tivic’s Prospective trial examining safety and efficacy of microcurrent stimulation for the treatment of sinus pain and congestion, which found that self-administered periorbital microcurrent treatment given at home was efficacious in significantly reducing moderate sinus pain for up to 6 hours and significantly reducing moderate pain and congestion over four weeks of daily use. Microcurrent therapy was found to be safe with only minor side effects that resolved without intervention.

The study was published in the peer-reviewed journal Bioelectronic Medicine, 5(1), 1-9. Goldsobel, A. B., Prabhakar, N., & Gurfein, B. T. (2019).

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