Endotronix makes the wireless, implantable pulmonary artery pressure sensor to monitor chronic heart failure patients. FDA wants a pivotal trial to tests its effectiveness
Last week Endotronix, a digital health medtech startup based in Lisle, Illinois, announced that it has raised $45 million in a Series D funding round.
That money will come in handy as the Food & Drug Administration is sending the company down the premarket approval route even though there is a predicate device already available in the U.S. It’s an interesting though not wholly unexpected plot twist given the novelty of the heart failure implant that Endotronix is developing.
But what is perhaps more interesting is how the same FDA has reacted to Endotronix’s software product — the Cordella Heart Failure system that the company has recently launched to help cardiology clinics and other providers to manage patients with chronic heart failure.
Whereas FDA officials have sought to put the brakes on the speed by which the sensor implant is approved, the care management piece was cleared with nary a raised eyebrow. In fact, officials helped in classifying the software platform and even in the system architecture, said the company’s CEO and co-founder, Harry Rowland.
“FDA in our view does have a very clear mandate for digital health solutions and software,” Rowland said in a phone interview Thursday in advance of the fundraising announcement. “They feel very empowered to be aggressive there and our Cordella Heart Failure System has benefited from that.”
But it’s a tale of two cities at the FDA when it came to figuring out the regulatory road to hoe for the implantable wireless sensor. The Cordella sensor is a wireless implantable sensor that measures the pressure of the pulmonary artery. It can be viewed as a next-generation device to one made by then Atlanta startup CardioMEMS that won a landmark approval from the FDA in 2014 after being rejected the first time.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Landmark, because CardioMEMS was digitizing and miniaturizing and bringing to the home a device platform that has been widely known in a hospital setting to accurately portray the status of a heart failure patient. In fact, the moment the approval was announced, St. Jude Medical (now part of Abbott) that had been an investor in CardioMEMS bought it outright. The CardioMEMS device comprises a small paper-clip sized sensor implant, a pillow and a handheld reader, connected by cables to the pillow. The Champion pivotal trial along with other studies have shown that the system can significantly lower heart-failure related admissions.
“We all thought there was a logical approach: Outcomes based on pulmonary artery pressure have been shown in the randomized study and in the real world. Therefore if you can safely and accurately measure pulmonary artery pressures, one can assume that you can generate same types of outcomes,” Rowland said of the thinking the company had in trying to avoid a full-fledged randomized control trial.
Turns out this was wishful thinking and FDA rejected Endotronix’s proposals for conducting a single arm trial or provide more diagnostic endpoints to settle on a regulatory pathway. The Champion trial was not enough.
“FDA approvals for new classes of therapy really [requires] a couple of devices and a couple of thousand of patients through before they open up to studies to say an objective performance criteria or non-inferiority against a certain metric,” Rowland said. “FDA sees [the Cordella sensor] as a therapeutic device. Even though we provide diagnostic data, it is viewed through the lens of a therapeutic and therapeutic devices require hard clinical outcomes.”
Hence the company is now ramping up for the Proactive pivotal trial with an investigational device exemption application to be submitted by the end of the year. Rowland said neither he nor his investors were necessarily daunted by the prospect of having to do a large pivotal trial.
“As a venture-backed company we are certainly looking at more expeditious routes to approval but the FDA and CMS requested a higher level of evidence and we are going to rise to that challenge,” he declared. “It’s always about getting to the next milestone expeditiously, but we don’t always make the path we have to take.”
The new $45 million Series D round, which brought both new and existing investors to Endotronix will help to support that trial, among other things. The round was led by LSP, investing from its LSP Health Economics Fund 2, and included Aperture Venture Partners, BioVentures Investors, Lumira Ventures, OSF Ventures, Seroba Life Sciences, SV Health Investors, Wanxiang
Healthcare Investments, and an unnamed corporate strategic investor.
The money will also be used to launch a trial in Europe to obtain CE Mark and to to expand the use of the clinical workflow tool that FDA helped to launch quickly in June. Since its launch 75 patients in the U.S. who are chronic heart failure patients have signed up on the Cordella System, Rowland said.
The Cordella Heat Failure System is a software platform that collects vital signs data from heart failure patients and helps clinicians to mange them remotely.
The workflow tool is intended to better document and manage heart failure patients who in most cases are cared for only episodically when they are seen in the office or are in admitted to the hospital. Now, with the software management system, nurses can better monitor patients whose drug doses may change or treatment otherwise adjusted. And the cherry on the top, per Rowland, is that by better caring for these patients, the cardiology practice can also get better reimbursement.
“Right now when clinicians have to change the dose of a drug, they have no feedback — what happened to the patient after the medication dose change, so no feedback for three months or six months until the patient comes back in and as a result, they are less likely to change doses of medication without that,” he said. “So we built a software platform to support that part of the care delivery paradigm and we help them document when they are doing medical reconciliation, they are talking with the patient about treatment adjustment — all these small things that happen in the course of care we help document that, and that leads to codes that they are able to submit for reimbursement.”
While the company founded in 2007, now 80 employees strong, looks to hits its stride with the heart-failure management product, the FDA premarket approval for the Cordella sensor will not arrive for a few years. But that approval should help in getting reimbursement from the Centers for the Medicare and Medicaid Services, where officials, like those at the FDA, have also indicated the desire for a large, randomized trial.
Meanwhile, St. Jude Medical (now part of Abbott) has still not obtained a National Coverage Decision from CMS to cover the CardioMEMS device nationally. The device is still covered regionally where processes vary by MACS (Medicare and Abbott launched the Guide-HF trial in March to add to the body of evidence that the device is effective and should win comprehensive coverage from CMS.
Although the randomized controlled pathway was not his “first choice” for a trial to commercialize the Cordella sensor, Rowland said he is excited to “move the field forward.”
Photo: Endotronix
