The Memo: CygnusMed Building the First Endovascular Access System Allowing for Continuous Blood Pressure Monitoring

Under the direction of Founder and CEO Firas Al-Ali, MD, CygnusMed is developing an endovascular access system designed to create continuous sealing of the guiding catheter, eliminating blood reflux and stagnation into it, a first in endovascular intervention. This significantly reduces embolic risk and blood loss while enabling continuous arterial pressure monitoring during endovascular procedures. Headquartered in Akron, Ohio, the company is advancing its EndoSphinx platform to address long-standing limitations in endovascular technologies, beginning in neuroendovascular care and with a long-term vision to expand across the full spectrum of endovascular procedures worldwide.

Origin Story

CygnusMed was born directly from clinical experience. Al-Ali, a neuro-interventionalist with more than 25 years of practice, repeatedly encountered “limitations in existing endovascular technologies that are often accepted as unavoidable but carry real consequences for patients.”

One particular case profoundly shaped his thinking. “I performed an elective brain aneurysm coiling on a young woman. The procedure itself was technically flawless,” he explained. “Shortly after waking up from anesthesia, however, the patient complained of a mild headache. An MRI revealed a small focal embolic lesion in the region where I had been working.”

The patient exhibited no neurological deficits and was discharged without symptoms, but the finding raised a deeper concern. “This was not a difficult or complicated case, yet an embolic event still occurred. That realization prompted a critical question: if embolization can occur in a perfectly executed procedure, then the problem must be structural, not technical.”

That insight led him to reexamine the fundamentals of endovascular intervention. “I began to analyze the mechanics of endovascular intervention and identified a key issue: current systems allow blood to reflux back into the guiding catheter lumen. This blood stagnates within the catheter, where it can clot. When contrast is subsequently injected, these microthrombi are flushed back into the circulation.”

From this realization, CygnusMed and its foundational technology, EndoSphinx, were created. “I developed a novel valve system designed to continuously seal the system, including time of microcatheter insertion, removal, or manipulation, maintaining constant, stable pressure inside the guiding catheter so blood does not reflux and clot within it, decreasing the risk of embolism. It also significantly reduces current blood loss, an important limitation in all endovascular systems. With a constant pressure inside the system, integrating a pressure sensor in the device allows for constant blood pressure monitoring, eliminating the current need for a second arterial obtained solely for this purpose,” he said. 

The Current Landscape

Endovascular procedures are among the most widely performed interventions in modern medicine. Each year, approximately 10 million endovascular procedures are performed in the United States alone, with more than 25 million procedures worldwide. In every one of these interventions, the operator must insert a guiding catheter into the patient’s blood vessel, with the external end connected to a hemostatic valve.

Despite the scale and growth of endovascular care, key clinical, operational, and economic challenges remain largely unaddressed.

“Current systems allow uncontrolled saline flushing while still permitting blood to reflux into the guiding catheter,” Dr. Al-Ali explained. “This blood stagnates and can clot. When contrast is injected, these microthrombi are flushed back into the circulation, effectively causing a shower of emboli to the target organ, whether the brain, heart, kidneys, or peripheral vasculature.”

Blood loss represents another underrecognized issue. “Because catheter sealing is intermittent rather than continuous, blood loss during endovascular procedures is common and often underestimated,” he said. “Up to 4% of patients undergoing endovascular interventions lose as much as 25% of their circulating blood volume, leading to higher mortality, increased complications, and elevated readmission rates.”

The economic impact is significant. “Each readmission can cost hospitals up to $17,000, costs that are unreimbursed when occurring within 30 days of the index procedure.”

Finally, many procedures require a second arterial line for pressure monitoring. “In nearly half of endovascular procedures, physicians must place an additional arterial line solely for hemodynamic monitoring,” he said. “This adds 10 to 15 minutes to procedure time and increases costs by up to $1,100 per case, while exposing patients to additional procedural risk, and time delay for the angio suite schedule translates into lost revenue to the hospital.”

Together, these issues represent a persistent clinical and operational burden across millions of procedures each year.

Inside the Innovation

According to Al-Ali, the EndoSphinx system is not a variation of existing devices; instead, it represents a fundamental shift in endovascular intervention after more than 70 years of established practice.

“EndoSphinx provides continuous sealing of the guiding catheter through an integrated Cygnus valve, allowing microcatheter insertion, removal, and manipulation without loss of seal,” Al-Ali said. 

Traditional systems rely on intermittent sealing that must be opened during device manipulation. “These openings result in transient pressure drops within the guiding catheter, allowing blood to enter the system and escape outside the patient,” he explained. “This process promotes blood stagnation and clot formation within the catheter, increases the risk of embolism, causes blood loss, and necessitates the use of a second arterial line solely for continuous blood pressure monitoring.”

EndoSphinx is designed to eliminate these events entirely. “By providing continuous sealing of the guiding catheter at all times, EndoSphinx prevents blood entry and intraluminal clot formation, eliminates blood loss, and enables continuous arterial pressure monitoring without the need for a second arterial access.”

The system maintains a fully sealed system even during microcatheter insertion, removal, and manipulation. “For the first time in endovascular intervention, the guiding catheter can be continuously flushed with no blood entering the system,” he said. “This significantly reduces the risk of embolic complications and establishes a new standard of safety in endovascular procedures.”

In addition to improving safety, the technology will streamline workflows and reduce costs. “EndoSphinx renders the additional arterial line and manifold obsolete, reducing procedural time and cost, while improving clinical outcomes,” Dr. Al-Ali noted.

Progress and Milestones

CygnusMed has already achieved several key milestones. The company completed a pre-seed round supported by 12 neurointerventionalist investors, a milestone that reflects strong physician engagement and good product-market fit.

“This makes us a unique startup with significant participation from clinicians who are also the end users of the technology,” Al-Ali said.

The company reached a design freeze in February 2026 and is now raising a Seed round of $1.5 to $2.0 million. This funding will support completion of the final device and FDA testing, submission for FDA clearance through the 510(k) pathway, and execution of the EndoSphinx clinical study across six early-adopter sites. “The study will evaluate the accuracy of blood pressure measurements obtained with EndoSphinx compared to the current gold standard, a second arterial line, and will also compare blood loss between the current standard of care and EndoSphinx,” he said. “We are confident the data will demonstrate a significant reduction in blood loss.”

CygnusMed has outlined an ambitious development timeline:

• July 2026: Final product ready for FDA testing
• August–September 2026: Industry-sponsored study launched at six U.S. early-adopter sites
• September–October 2026: Study completion (4–6 weeks)
• Q4 2026: Anticipated FDA 510(k) clearance; Series A financing
• Q1 2027: Commercial product launch

CygnusMed plans to begin in neuroendovascular procedures in the United States before expanding internationally and across peripheral vascular and coronary interventions.

As CygnusMed advances toward clinical validation and commercialization, the company is focused on redefining the safety and efficiency of endovascular care.

Join Us at LSI USA ‘26

Al-Ali has been selected to present at LSI USA ‘26, March 16th–20th, in front of hundreds of global medical technology companies. Join us in welcoming him to the event in Dana Point, CA, where he will share the latest updates on CygnusMed’s technology and development.