Endotronix said the Cordella product platform consists of a comprehensive remote patient management software solution coupled with an implantable pulmonary artery sensor (pictured here) to streamline heart failure care management and provide early detection of worsening heart failure.Pixabay
Sometimes medtech companies need more than a nod from FDA for a product to be successful. And sometimes - if it isn’t in place already – companies need to look at a viable reimbursement path before they can even think of filing for approval.
That’s the strategy Endotronix is employing concerning the clinical development of the Cordella Pulmonary Artery Sensor (Cordella Sensor). The Lisle, Il-based company is jointly pursuing FDA approval of the technology and reimbursement from the Centers for Medicare & Medicaid Services.
To run a robust clinical trial to support both approval and a National Coverage Decision (NCD) for Cordella, Endotronix has expanded its series D round – now raising $35 million and bringing the financing to a total of $70 million, said Harry Rowland, Endotronix CEO. The company originally raised $45 million for the series D round last year.
“For our space of pulmonary artery pressure-guided heart failure management there has been a player before us – CardioMems, a company that worked to develop the market and the initial clinical evidence base,” Rowland, told MD+DI.
Atlanta-based CardioMems was acquired by St. Jude Medical for $455 million in 2014. Abbott Laboratories inherited the CardioMems technology when it closed out its $25 billion-acquisition of St. Jude Medical.
“One of the real items for the broad use of the [CardioMems] technology has been the lack of a long-term larger-randomized controlled trial without any issues of bias with it, that provides the clinical evidence to drive an NCD. So, that market has been in place and it has been growing, but it has struggled with lack of a National Coverage Decision.”
He added, “For us being the second mover into this space, it’s not sufficient for us to just get PMA approval and still be in a position where there are areas of the country that can’t use the technology.”
The firm’s product platform consists of a comprehensive remote patient management software solution coupled with an implantable pulmonary artery sensor to streamline heart failure care management and provide early detection of worsening heart failure.
Endotronix said its robust clinical trial evaluating the technology and called the PROACTIVE-HF IDE, will have 60 sites across the U.S. and enroll more than 950 patients. The company is looking at getting its first enrollment this quarter and submission to FDA in the mid-2021-time frame.
A Closer Look at the Financing
Rowland said the financing round will be significant in helping the company to move forward.
The expansion for LSP-led round includes new investment from an additional unnamed medical device strategic investor as well as participation from existing investors, including Aperture Venture Partners, BioVentures Investors, Lumira Ventures, OSF Ventures, Seroba Life Sciences, Skydeck LLC, SV Health Investors, Wanxiang Healthcare Investments, and an unnamed corporate strategic investor.
“When we embraced this larger expanded scope of trial that went both for NCD and PMA, the reaction for the financial markets was surprisingly positive,” Rowland said. “It required more financial resources - without a doubt - and we were pleasantly surprised by the reaction of the financial markets who responded to us taking on that challenge as an opportunity to definitively provide clinical evidence needed to support patient access to the commercialization of this technology.”