PEORIA — Endotronix, Inc., the medtech startup that started up in Peoria, got a big boost in September when an investor syndicate including OSF Ventures offered them nearly $45 million.
“This $45 million in financing is helping us bring the product back to the U.S to conduct a large, several hundred patient clinical study to get FDA approval,” said Harry Roland, CEO of Endotronix, which is now based in Chicago.
The product is the Cordella PA Pressure Sensor, a tiny device which is inserted into the heart of heart failure patients. It has been in Europe for the first round of patient testing. About 10 patients are currently using the device there, said Roland.
“We implanted the device in the first patient in 2017,” he said. “It goes into the patient permanently. It helps their cardiologist manage their heart failure. It helps them feel better, and ultimately may lead to a longer life.”
The sensor, which is inserted into the heart with a catheter, measures pulmonary artery pressure. Rising pressure in the heart is an indicator that a patient’s condition is deteriorating, said Roland.
“The pressure in the heart rises weeks to a month in advance of hospitalization,” he said. “It’s the canary in the coal mine. The sensor gives doctors time to react, to make a therapy change to get the pressure down before the patient has to be hospitalized.”
The sensor is an improvement on St. Jude Medical’s CardioMEMS™ HF System which received FDA approval in 2014.
“We are building on that base of knowledge,” said Roland. The CardioMEMS system is also an implanted sensor, but the information is relayed through an older, less patient-friendly program than the one developed by Endotronix, said Roland.
“We have implemented it in a unique and innovative way,” he said.
The sensor wirelessly transmits information to the Cordella Heart Failure System which sends it to the patient’s medical team. Patients with less severe disease can use the Cordella system without the sensor. The Cordella system received FDA approval in early 2017 and became available to patients in July.
“The Cordella Heart Failure System is a health management program heart failure patients can do at home,” said Roland. “The application wakes up when it’s time to take measurements and walks the patient through the process. It takes about three minutes.”
Every morning patients transmit their weight, heart rate and blood pressure to their doctor. The information helps the care team spot trends to better manage the patient’s chronic condition, said Roland. Once the sensor is available, heart pressures can also be measured daily and sent to the healthcare team.
“When they have the sensor, patients will take an additional measurement which takes about 20 seconds,” said Roland. “The clinician will now have a very unique and powerful piece of information.”
Endotronix came to be through a collaboration between Roland and Dr. Anthony Nunez, a cardiothoracic surgeon who, when the two met, was working for Heartcare Midwest in Peoria. Roland had recently finished his doctorate at Georgia Tech and followed his wife to Peoria where she was working for Caterpillar, Inc.
“Dr. Nunez and I met through people I met at Peoria High Tech, a precursor to Peoria NEXT,” said Roland. “We had a breakfast meeting at Le Peep Restaurant in February 2007. In June we decided to start Endotronix.”
Nunez was fascinated with the idea of wireless pressures sensing in the body, said Roland, and since both men had watched family members suffer from heart failure, they were inspired to create a device to improve the quality of life for those patients.
“The two of us teamed up. In those early years at Peoria NEXT we did some really foundational work with Dr. Prasad Shastry, who teaches electrical engineering and wireless radio frequency technology at Bradley University. We worked with some of his students and recent graduates, and through that work advanced the ideas.”
While in Peoria the company secured several rounds of financing, including an earlier contribution from OSF Ventures in 2016, and continued to grow. In 2013 the decision was made to move to Chicago.
“I was spending a tremendous amount of time getting to the airport in Chicago, and we had a young child. My wife has family in Chicago and we needed to be close to them. At that point it made sense to continue to grow the company in Chicago,” said Roland.
The Cordella sensor is a promising piece of technology which could help reduce both hospitalizations and mortality in heart failure patients, a fact which made it an attractive investment for OSF Ventures, said Stan Lynall, Vice President of Venture Investments for OSF HealthCare.
“We look for technology that will improve our ability to treat patients,” he said.
Nearly 6 million Americans live with heart failure, the leading cause of hospitalizations for people over 65. Annual treatment costs exceed $31 billion.
“Heart failure patients are the number one cost to Medicare,” said Roland. “It’s a huge impact on the healthcare system and there are many related societal costs.”
Roland said the clinical trials will likely begin early next year. They will happen at medical centers across the United States. Though it’s too soon to say, an OSF HealthCare facility may participate in the trial.
“There’s an interest on both sides to evaluate doing a clinical trial at OSF,” said Roland.
The trial will run for a couple years, and the sensor could be available to the public as early as 2021.
Leslie Renken can be reached at 686-3250 or email@example.com. Follow her on Twitter.com/LeslieRenken, and subscribe to her on Facebook.com/leslie.renken.