Germany's coramaze technologies announced that it is receiving €4.5 million ($5.05 million) in a Series A round led by Israel's Elron Electronic Industries, making it the latest player in the burgeoning field of transcatheter mitral valve devices.
Unlike Twelve, Tendyne and CardiacAQ, which recently agreed to be bought by industry bigwigs, coramaze's device is for mitral valve repair, not replacement. Medtronic, Abbott and Edwards dropped a combined $1 billion on those respective players in the transcatheter replacement space.
"I like the benchmark and so do our investors," coramaze CEO and co-founder Laura Figulla told FierceMedicalDevices noting that none of the companies have yet to obtain a CE mark, though she said she is not in a rush to obtain an exit.
Formed in 2013, the company's investigational device, dubbed mitramaze, is aimed at patients with functional mitral valve regurgitation who are not eligible for open heart surgery and apparently has the potential to broaden its target market to patients who would currently receive open heart surgery, according to a release.
But the majority of patients suffering from the condition are not eligible for invasive open heart surgery because they are too old or frail, or suffer from other complications, Figulla said.
About 4 million people have mitral valve insufficiency, whether due to degenerative or functional mitral regurgitation. The latter occurs because of the enlargement of the heart due to a heart attack or heart failure, and is the most common form of regurgitation, according to the CEO.
Figulla stressed that the transcatheter mitral valve repair market is a complimentary to the replacement one, saying that since functional regurgitation is not a disease of the mitral valve itself, the valve does not necessarily need replacement.
Coramaze will use the funds to prepare its implant for a first-in-human trial next year, followed by a feasibility study for European CE mark approval.
"Mitramaze, by virtue of its design concept, is uniquely qualified to cope with the challenges arising from the high patient-to-patient variability of the anatomy of the mitral valve and the lack of a rigid annulus wall while preserving the natural leaflets of the valve and restoring their functionality," said Christian Jung, senior investment manager at existing investor High-Tech Gründerfonds, in a statement. "We believe that these properties confer upon mitramaze a major edge over competing technologies and are impressed with the rapid progress made by coramaze since our initial investment in 2014." High-Tech Gründerfonds also participated in the round, along with existing investor SeedCapital Dortmund and others.
The company says the self-expanding coramaze features a customized delivery catheter for implantation via the transfemoral (through the leg) approach, with a design that enables atraumatic anchoring in the left atrium, meaning there is no need to puncture adjacent tissue during implantation.
Figulla said the transfemoral approach is preferred because it is less invasive, and was enabled by a low profile delivery catheter with a diameter of 12 French (4 millimeters). She also touted the procedure's speed saying, the valve was deployed in 15 minutes in animal studies, though it will take longer in humans.
Abbott's ($ABT) Mitraclip is the only transcatheter mitral valve repair on the U.S. market. It too accesses the heart via a transfemoral approach. The device posted double-digit sales growth in Q2 2015, according to the company's earnings call.
In Europe, the Mitraclip is joined by Cardiac Dimension's Carillon transcatheter mitral valve repair device, which is threaded into the heart via the jugular vein. The device is a direct competitor to coramaze's investigative version because it is for functional mitral valve regurgitation, while the Mitaclip indicated for degenerative regurgitation in U.S., which is caused by damage to the mitral valve leaflets.
But the real impetus behind the surge of interest in transcatheter mitral valve devices is the success of transaortic valve replacements, which are approaching the $2 billion sales mark this year, led by Medtronic's ($MDT) CoreValve and Edwards' ($EW) Sapien franchises. And the addressable market for mitral valve regurgitation is larger. And the addressable market for mitral valve regurgitation is larger. Figulla said it is a "multibillion dollar" subsegment.
Due to the mitral valve's anatomy, deploying devices to the valve using a catheter is more technically challenging than in the case of the aortic valve. Still, companies and their financial backers are aiming to extend the minimally invasive transcatheter-based approach to the replacement of the mitral valve, in the hopes of a similar clinical and financial payoff.
- read the release