Endotronix’s cloud-based disease management platform for heart failure
Congestive heart failure affects 5.7 million Americans and costs the system $30.5 billion including the cost of health care services, medications and in lost productivity due to missed days at work.
A myriad efforts are underway to tackle both the treatment and the cost burden of the disease. The chief executive officer of one startup, Woodridge, Illinois-based Endotronix that recently raised $32 million in a Series C round, believes that a hardware and software strategy might be a winning combination in managing CHF patients.
The software strategy allows the company to make some headway commercially quickly, said Harry Rowland, in a recent phone interview. That’s because it is a disease management platform that can help cardiology practices and heart failure clinics manage their sick patients remotely — without having to intervene only for them to be rushed to the ER. There is a big penalty to hospitals these days for repeat admissions of heart failure patients within 30 days of a hospital discharge.
Endotronix’s hardware strategy follows in the footsteps of a startup, CardioMEMS, that was acquired by St. Jude Medical as soon as FDA cleared its wireless, implantable pulmonary artery pressure sensor in 2014. Endotronix is preparing for IRB (institutional review boards) approvals that can help the company to begin clinical trials of its sensor device.
But a portion of the $32 million raised this month will be used to ramp up and commercialize the digital health, remote monitoring piece. Rowland believes it can bring much-needed support to besieged cardiology care teams.
“The challenges in caring for these patients is that you are inundated,” he declared. “There are so many patients who have heart failure who are coming in for the office visits and are hospitalized. How do you manage that and how do you manage a huge workload in the clinic and the hospital and how do you on top of that start reaching out to the patients proactively before they come in?”
A Deep-dive Into Specialty Pharma
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Rowland is hoping that Endotronix’s care management solution can help to decrease the load. The remote monitoring piece of the digital strategy can pull data from devices in the home — blood pressure, pulse oximeter, weighing machines and heart rate monitors and when approved its sensor device — and make that data available to cardiology teams that include cardiologists, nurses and care coordinators. But the software can also allow patients and care team to communicate.
Perhaps still more valuable is the platform can potentially fit into the clinical workflow, the stumbling block when it comes to digital health’s adoption.
“On the clinician’s back end, it’s about organizing that information in a meaningful way, having protocolized care that integrates that information so there’s routine follow-up when it needs to happen and then urgent follow-up also when that needs to happen.
Of course being able to integrate with the electronic medical record would be ideal, but given various different systems out there, Rowland has opted to have a standalone platform that has the ability to share data with a provider’s EMR as opposed to true EMR integration.
“The big industry question is that how do we become part of the system,” he said, acknowledging the challenge of new technology adoption in clinical practices.
The next six months will be focused on rolling out the care management platform in clinical sites. But the hope is that down the road when the sensor implant has gone through clinical trials and approved, Endotronix will have a truly robust system for tackling advanced heart failure rates that marry care management with an intense medical device therapy.
The software solution does have some reimbursement from private payers and Medicare, Rowland said. But the sensor implant — if the fate of St. Jude Medical’s CardioMEMS wireless heart failure system is any indication — might encounter some trouble.
Although clinical data has shown that the CardioMEMS implant can dramatically reduce hospitalizations of congestive heart failure patients, regional Medicare Administrative Contractors (MACs) have declined to cover it. There has been some speculation over whether the device’s price — the list price is $18,000 — is too high. St. Jude Medical is seeking a national coverage decision for the device from Centers for Medicare and Medicaid Services.
Rowland is confident that Medicare will ultimately see the value of the device. The CardioMEMS device senses changes in cardiac pressure, a metric widely considered the most accurate sign for worsening heart failure, but until recently was only available in a clinical setting.
“Some of the MAC decisions were based more on the first set of CHAMPION data (the pivotal trial on which the 2014 FDA approval was based) and as we get to see the long-term data, it’s more and more robust,” Rowland said.
