Revolutionizing Stroke Treatment: Non-Invasive Histotripsy Technology

The Current State of Stroke Treatment

Stroke remains a leading cause of death and disability worldwide, with limited access to effective treatments in many regions. Dr. Amir Hassan, founder of Quantosis, is working to change that with an innovative non-invasive approach to treating stroke.

Currently, mechanical thrombectomy is considered the gold standard for treating large vessel occlusion strokes. This involves threading a catheter through blood vessels to physically remove the clot blocking blood flow to the brain. While effective, mechanical thrombectomy has several limitations:

• It requires a highly specialized comprehensive stroke center with interventional capabilities
• Access is limited, with less than 3% of the world's population having ready access to thrombectomy
• The procedure is invasive and can potentially damage blood vessel walls
• There are significant time delays in transporting patients to capable centers

Dr. Hassan saw an opportunity to radically rethink stroke treatment to overcome these challenges.

The Genesis of Quantosis

As a practicing interventional neurologist and leader in the field, Dr. Hassan was intimately familiar with the limitations of current stroke treatments. The idea for Quantosis was sparked by witnessing a colleague's efforts to expand stroke care access in Ethiopia:

"My partner who is originally from Ethiopia...decided that after three years of working with the Ethiopian government and the medical school where he went to, they wouldn't invest in a biplane suite. So he gets a bunch of us together and says, 'Hey guys, we're going to buy half a biplane. I found a private hospital that's going to buy half and I'm going to donate 5 years of my time there and I'm going to just build a program, start training fellows there, and we're going to have the first comprehensive stroke center in a country of 120 million people.'"

This selfless act highlighted the immense need for more accessible stroke treatment options globally. Dr. Hassan realized that finding enough specialists willing to make such sacrifices was not a scalable solution. There had to be a better way to democratize stroke care.

During the early days of the COVID-19 pandemic, Dr. Hassan found himself with extra time to contemplate this challenge. He began exploring various technologies that could potentially treat stroke non-invasively, including lasers and ultrasound.

After hitting roadblocks with existing approaches, a conversation with his AI-expert friend and eventual co-founder led to the key insight - why not use ultrasound from outside the skull rather than through a catheter? This sparked the idea for Quantosis' novel histotripsy-based technology.

Histotripsy: A Non-Invasive Approach

Histotripsy uses focused ultrasound waves to generate cavitation bubbles that can mechanically break down tissue. While histotripsy has shown promise for treating tumors and other conditions, applying it to stroke through the skull presented unique challenges.

The Quantosis team had to develop a proprietary probe design and algorithm to allow the histotripsy waves to penetrate bone and precisely target clots in brain blood vessels. As Dr. Hassan explains:

"Our secret sauce is a unique architectural design with multiple probes within each probe and then of course the frequency pulse pulses per burst that allows us to penetrate bone. So that's never been done before. Nobody's ever been able to do it."

In addition to penetrating bone, the Quantosis system breaks up clots in a controlled manner:

"We actually break up a clot in a unique way so that you're breaking off pieces...imagine like, you know, shearing a clot a thousand times a second, just taking a piece off that's 250 microns until you get to nothing. That's the whole idea of what we're doing."

This approach allows for more precise treatment compared to other ultrasound methods that might scatter clot fragments unpredictably.

The Quantosis System

The Quantosis device is designed for simplicity and portability:

• A computer-on-wheels system with a power generator base
• Two probes that combine transcranial Doppler (TCD) and histotripsy capabilities
• Probes are positioned on the temporal window of the skull
• AI-guided scanning to locate the clot
• Two-button operation for nurses or technicians

The treatment process is straightforward:

1. Patient is confirmed to have a large vessel occlusion via CT imaging
2. Quantosis system is brought to the patient's bedside
3. Probes are positioned on the skull
4. System scans to locate the clot
5. Histotripsy treatment is activated
6. Process repeats for up to two treatment cycles

The entire procedure takes less than 45 seconds per treatment cycle. Based on current testing, Dr. Hassan estimates they may achieve a 70% recanalization rate for middle cerebral artery occlusions.

Expanding Access to Stroke Treatment

The portability and ease-of-use of the Quantosis system could dramatically expand access to effective stroke treatment:

"In my mind yes in 5 years we're commercializing to primary stroke centers urgent cares comprehensive stroke centers and you're significantly decreasing that onset to treatment time because in the United States it's average about 5.8 hours that you'll go to a primary center first then go to a a hub like a comprehensive center versus if you come into a comprehensive center the average treatment time from onset's around three and a half hours."

Looking further ahead, Dr. Hassan envisions even broader availability:

"In my mind 10 years from now, it's not only at urgent cares and primary stroke centers, it's at it's on every ambulance, right? This is like a defibrillator. It's on every ambulance. Patients got a stroke, they call 911, they go there, they put it on, it scans the middle cerebral artery, diagnoses large vessel occlusion, and then hits the clot with histotripsy."

This level of access could save countless lives and prevent long-term disability for stroke patients who currently lack timely access to treatment.

Regulatory Pathway and Clinical Testing

Quantosis is pursuing FDA approval through the De Novo pathway, with plans for first-in-human trials in 2026. The team is working closely with regulatory partners like the Jacobs Institute to optimize their approach.

Key milestones in their development process include:

• Benchtop testing showing clot dissolution without vessel damage
• Porcine carotid artery studies demonstrating safety and efficacy
• Ongoing safety studies in pediatric porcine models
• Planned GLP (Good Laboratory Practice) study in late 2023
• First-in-human trial targeted for 2026
• Potential pivotal trial starting in 2027

By conducting initial trials in the US, Quantosis aims to streamline the regulatory process compared to starting with trials outside the US.

Funding and Future Plans

Quantosis has successfully raised an initial friends and family round of $3.1 million. They are now in the process of raising a Series A to fund continued development and early clinical trials.

Key focus areas for the Series A funding include:

• Strategic hires including full-time engineers, CTO, and COO
• Finalizing the commercial-ready device design
• Conducting the GLP study
• Preparing for first-in-human trials

Looking ahead, Dr. Hassan anticipates a potential Series B round to fund the pivotal clinical trial starting in 2027.

Conclusion

Quantosis represents a bold reimagining of stroke treatment with the potential to save lives and prevent disability on a global scale. By combining AI, histotripsy, and innovative engineering, Dr. Hassan and his team are working to make effective stroke care as ubiquitous as defibrillators.

While significant work remains to prove the safety and efficacy of this approach, the Quantosis system offers an exciting glimpse into a future where geography and specialized facilities no longer limit access to life-saving stroke treatment. As development continues and clinical trials begin, Quantosis will be a company to watch in the neurovascular space.

Article created from: https://www.youtube.com/watch?v=C_XPXScKDEM