Stroke Treatment with Ultrasound

SonoLysis Therapy: Stroke Treatment with Ultrasound

Cerevast Therapeutics is developing a non-invasive treatment for acute ischemic stroke known as sonothrombolysis, or SonoLysis for short. This treatment harnesses the acoustic energy from externally applied ultrasound to treat stroke-causing clots in the blood vessels of the brain.

The initial treatment of ischemic stroke typically occurs in the hospital emergency room. This is critical timeframe in which diagnostic assessments are being performed and treatment options are being evaluated.

There is a saying amongst stroke neurologists that “Time is Brain.” This is particularly evident in the immediate period following the onset of an ischemic stroke. Consider the following statistics:

  1. Approximately 32,000 neurons will die every second (1.9 million per minute)
  2. In that same minute, the brain will lose 14 billion synapses, the vital intersection between neurons
  3. Also lost in that minute are 7.5 miles of myelinated fibers, the insulating material found on the axon of neurons that is essential for proper functioning of the nervous system

It is therefore imperative that treatment be initiated as quickly as possible in order to restore blood flow to the oxygen-deprived regions of the brain that are down-stream of the blood clot or thrombus. In order for treatments to be initiated quickly, however; they must also be easy to use given the often times hectic emergency room environment when treating life-or-death situations such as ischemic stroke.

To address these challenges, Cerevast has developed an operator-independent ultrasonic headframe called the ClotBust-ERTM. This device can be rapidly and easily deployed by virtually any emergency room staff to safely administer the ultrasound energy for SonoLysis therapy.

Royal Philips Electronics has announced a collaborative agreement with ImaRx Therapeutics, Inc., a Tucson, AZ company, to advance the development of a novel treatment for acute ischemic strokes. As the press release is stating, “Philips’ Medical Systems division will provide ultrasound devices and technical assistance to ImaRx during laboratory and preclinical studies. The objective of the collaboration is to determine the optimal ultrasound parameters to use with ImaRx’s proprietary MRX-801 microbubble technology.”

The company is tight lipped about its potentially therapeutic MRX-801 microbubbles, but according to the Securities Registration Statement (S-1) with the SEC (of all the places), the company’s ultrasound-responsive microbubbles are lipid micelles:

Our MRX-801 microbubbles are a proprietary formulation of a lipid shell encapsulating an inert biocompatible gas. We believe the sub-micron size of our MRX-801 microbubbles allows them to penetrate a blood clot, so that when ultrasound is applied their expansion and contraction, or cavitation, can break the clot into very small particles. We believe that these product candidates have the potential to treat a broad variety of vascular disorders associated with blood clots.

More about the company’s technology:

SonoLysis therapy involves administration of our MRX-801 microbubbles with ultrasound, but without the administration of a thrombolytic drug. To administer our SonoLysis therapy, MRX-801 microbubbles are injected intravenously into the bloodstream, disperse naturally throughout the body including to the site of the blood clot. Ultrasound is then administered to the site of the blood clot, and the energy from the ultrasound causes the MRX-801 microbubbles to expand and contract vigorously, or cavitate. We believe this cavitation both mechanically breaks up the blood clot and helps to enhance the body’s natural clot dissolving processes. The gas released by the MRX-801 microbubbles is then cleared from the body simply by exhaling, and the lipid shell is processed like other fats in the body. Because SonoLysis therapy does not involve use of a thrombolytic drug and its associated risk of bleeding, we believe SonoLysis therapy may offer advantages over existing treatments for ischemic stroke, including extending the treatment window beyond three hours from onset of symptoms and broadening treatment availability to patients for whom thrombolytic drugs are contraindicated due to risk of bleeding. We have not yet conducted any clinical trials using our proprietary MRX-801 microbubbles with ultrasound to treat blood clot indications without a thrombolytic drug. We estimate that if approved, over 200,000 ischemic stroke patients in the U.S. could be eligible for SonoLysis therapy annually.

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