Cardiac Dimensions said it has all the makings of a dominant competitor in the functional mitral regurgitation (FMR) market.  And the Kirkland WA-based company isn’t letting the fact that it’s the smallest of three firms competing in the FMR space hinder its path in obtaining a top spot.

On Thursday, Cardiac Dimensions announced it had reached a significant milestone, by closing on a $39 million Series B round in an effort to build clinical evidence for its Carillon Mitral Contour System. The funding will be used to help continue the 450-patient CARILLON Trial Pivotal Study and complete the follow-up and publication of the landmark randomized, double-blinded REDUCE FMR global study. The U.S. trial will help the company obtain a PMA for the Carillon Mitral Contour System. The firm  has CE mark for the device. 

Cardiac Dimensions said the trials were unique because none of its competitors have a double-blinded study assessing FMR treatment.

“We have created and designed a technology that helps with an annuloplasty approach to give assistant to patients with functional mitral regurgitation,” Gregory Casciaro, president and CEO of Cardiac Dimensions. “We do it differently than some of the competition out there in that ours is called an indirect annuloplasty- meaning that we effectively try to treat those patients on their annulus but never directly.”

The company said the Carillon Mitral Contour System is introduced through a large vein from the right side of the patient.

“A very simplistic way of looking at the device is that we fix the door frame being too big for the doors,” Rick Wypych, CFO of Cardiac Dimensions, told MD+DI. “The door frame is just too big for the doors in which case the doors don’t shut appropriately. In relation to the heart, what that does is cause regurgitation, which means the blood is going the wrong way.”

The Carillon Mitral Contour System cinches the valve or doorframe smaller, so it can close appropriately. 

Against the Giants

Cardiac Dimensions might prove to be the little private company that could in the FMR market. It faces off against two publicly-traded medtech powerhouses – Abbott Laboratories and Edwards Lifesciences.

Casciaro cited Abbott’s MitraClip as the top player in the space. The technology is a surgical approach using a catheter to clip the doors or leaflets of the heart together. The MitraClip received FDA approval for the treatment of primary functional regurgitation in 2013.

The Abbott Park, IL-based company is also seeking to gain FDA approval for an FMR indication. The company completed its clinical trial for this indication and it is speculated the firm could present data at the upcoming Transcatheter Cardiovascular Therapeutics meeting.

“From there Abbott will probably go in front of the FDA and go in front of a panel,” Casciaro said.

Irvine, CA-based Edwards competes in the FMR market with the Cardioband device. Edwards gained access to Cardioband through its $340 million plus milestone payments acquisition of Valtech Cardio Ltd. Cardioband has had CE mark since 2015.

“They are a direct annuloplasty fix,” Casciaro said. “This means they go right onto the door jam and with a semicircular band they go through a transseptal puncture through the heart and screw down into their system onto the annulus directly.”

Casciaro said the recent funding round is significant because it will help the company not only become a more viable competitor, but turn the page in the company’s continuing story.

“With this funding we’re going to get the opportunity to now demonstrate to the U.S. physician base, as we’ve done over in Europe … when you’re looking for something that’s safe – we’ve got it,” Casciaro said. “When you’re looking at something that’s easy to learn and perform – we’ve got it. When you look at something that has the ability to demonstrate its performance – we’ve got it.”