The Silicon Review
“Fast, accurate, and life-sustaining high fidelity arterial pressure monitoring immediately upon insertion, when it matters most.”
The current state of healthcare today in the world is one that focuses on cost containment, while at the same time, providing the advancements of modern technology to an aging population. Finding effective treatment methods and instruments at affordable levels, while at the same time providing patients with high-quality care is certainly a tightrope act many healthcare providers walk.
Not providing care and services is certainly not an option; therefore, the medical industry must find innovative solutions, incorporating the latest technology, thereby providing the most effective level of healthcare, both in and out of the hospital environment.
Given the preceding, we’re pleased to present Endophys Holdings, LLC
The firm is setting a trend in the field of medical devices and services and is filling a void that is present in the medical field through its innovation. Endophys’ Pressure Sensing Access System provides vascular access and high fidelity blood pressure data immediately upon insertion, from a simple single device. When compared to a traditional arm cuff, this offers physicians faster access to more accurate hemodynamic information – measuring inter-arterial blood pressure at a rate of 1,000 times per second — for critical patient diagnosis without the need to alter their technique. It’s an intelligent approach to improving patient care, while decreasing OR time, costs and space.
In conversation with Phillip D. Purdy co-founder, Endophys holdings, LLC
What is the reason behind the genesis of Endophys?
As a physician who was performing catheter-based procedures on patients, I was not satisfied with the fidelity or frequency of the blood pressure measurements that were used to monitor patients during cases. In meetings over the years, I saw multiple case presentations of complications that resulted from blood pressure fluctuations that were not appreciated at the time of their occurrence. That is when I decided to build a new device.
Does your company have a flagship product or a core technology?
We developed a technique to embed a fiberoptic pressure sensor in the wall of a type of catheter called a sheath that is inserted in an artery (usually in the leg or the wrist) at the beginning of a cath lab procedure. The sheath is used to insert other catheters in cardiology, neuro, or other vascular structures for diagnostic or therapeutic procedures. Our Pressure Sensing Access Sheath gives immediate, high-resolution blood pressure monitoring at the time of sheath insertion and shortens the time to intervention in stroke and other critical situations where time delays are highly associated with worsened outcomes.
Could you describe the working of your product and how it would help patients?
A fiberoptic sensor embedded in the sheath measures pressures 1000 times a second, with resolution in tenths of a millimeter of mercury in our digital output. That pressure is displayed on our Blood Pressure Monitor and also on the patient care monitor. The pressure monitoring begins immediately upon insertion of the sheath into the artery and does not interfere with the functioning of the sheath to introduce other catheters, because the sensor is separated from the inner lumen in the sheath that is used to insert the other catheters.
What challenges did you face during the early days of the company?
I was on the faculty at a medical school, and the intellectual property was owned by the University, and I, therefore, had to work within the constraints of the University. I had access to funds from patent royalties from another group of patents I developed, so I was fortunate in that regard.
It was very challenging to find a combination of industry resources and capabilities to put together to create this product. At some point, there is a conflict between the mission of a university and the mission of a commercial enterprise, so I needed to identify a funding source and expertise that would carry the technology over into the private sector.
When was the first time that your equipment was used on a patient?
The first clinical case was conducted in April 2016. That revealed a need to refine the interface between the sheath and its introducer. After a small tweak to the device, the improved version was first successfully used in March 2017.
How did you go about gaining FDA clearance for your device?
I identified private companies with expertise in catheter development and manufacture, expertise in fiberoptic sensors and supporting electronics, and quality/regulatory. This was a learn-as-you-go experience, and the process stretched over approximately 3 years.
How would you describe your current standing in the market?
We are a startup, but have a growing patent portfolio and expanding product line, and there are numerous opportunities for devices where current solutions are inadequate. Our product line is unique, and our patent portfolio creates barriers to competiton.
Invasive blood pressure monitoring in medicine hasn’t changed significantly in more than 50 years. The entire PC industry and digital revolution have occurred, and we still monitor blood pressure in the operating room, the emergency room, the cath lab, the ICU, and elsewhere using analog technology. Endophys is positioned to change that. A study from Vanderbilt, published in the Journal of Neurointerventional Surgery, also found our cost to be little different from the current cost of the analog blood pressure monitoring + sheath combination, without the time delays or quality compromises involved in the analog technology.
Where do you see yourself in a couple of years from now?
We are not limited to the vascular sheath market. Our platform can have applications in many treatment environments, in addition to stroke interventions. However, the vascular sheath market worldwide is >15 million devices/year, so we have a considerable growth opportunity. We are currently developing products for cardiology and other indications. We are primed for growth for the next several years.
The driving force behind the legacy of Endophys
Dr. Phillip D. Purdy, M.D., is the Co-founder of Endophys Holdings, LLC. He was also a former Vice-Chairperson of Clinical Operations, Department of Radiology a UT Southwestern Medical Center, has worked with catheter-based procedures over the course of his 30-year career – and knew there had to be a better option for blood pressure monitoring during highly invasive procedures. He holds 24 international patents, including several for the Endophys Pressure Sensing Access System.
Bringing analog blood pressure monitoring to the digital age, Dr. Purdy developed the Endophys system that features a small fiber-optic pressure sensor embedded in the wall of the catheter, making it possible to simultaneously and robustly monitor blood pressure while also using the sheath for performing procedures.
“We are growing into a very large market, with a product that is uniquely positioned and patent-protected.”