Funds to be Used for Commercial Expansion in Europe and Australia

KIRKLAND, Washington, Sept. 29, 2020 /PRNewswire/ -- Cardiac Dimensions^®, a leader in the development of innovative, minimally invasive treatments for functional mitral regurgitation (FMR) in patients with heart failure, today announced the company has closed a $17.5 million Series C financing. All existing shareholders participated in the round including Aperture Venture Partners, Arboretum Ventures, Hostplus, Life Sciences Partners, Lumira Ventures, and M. H. Carnegie & Co.

The financing will be used to accelerate commercial sales of Cardiac Dimensions' Carillon Mitral Contour System^® in Europe and allow for expansion into other geographies such as Australia. Earlier this month, Australia's Therapeutic Goods Administration approved the Carillon System for commercial use in FMR patients with mild to severe mitral regurgitation.

"The Carillon System is a transformative product which has shown great success in helping an extremely large patient population with very few options," said Rick Wypych, Chief Executive Officer and President of Cardiac Dimensions. "The new round of financing will allow for continued growth of sales in Europe and provide capital for our expansion efforts into other geographies–such as Australia. We thank our investors for their continued support as our business shows excellent results despite the challenging environment."

An estimated 26 million people, worldwide, suffer from heart failureⁱ and of those, approximately 70 percent have functional mitral regurgitation. FMR is due to the mitral valve not closing tightly, resulting in blood flowing or leaking backwards through the mitral valve. This further decreases the amount of oxygenated blood that is pumped out to the body, increases the symptoms associated with heart failure, and decreases the quality of life of those who have been diagnosed.

"We're excited to support the expansion of sales of the Carillon System," said Trevor Moody of M. H. Carnegie & Co. "Cardiac Dimensions' innovative efforts and dedication to expanding access to the Carillon System will soon allow people worldwide to benefit from this therapeutic innovation."

About the Carillon Mitral Contour System

The Carillon System offers a simple right heart approach to transcatheter mitral valve repair designed to reshape the anatomy and function of the mitral apparatus from the coronary sinus. Distal and proximal anchors, connected by a shaping ribbon, utilize the heart's venous anatomy to cinch the mitral apparatus without compromising the valve or future treatment options.^ii,iii The Carillon System is designed to treat the primary cause of functional mitral regurgitation in patients with MR grades 2+, 3+ and 4+ and is the first and only device to demonstrate a reduction in regurgitant volume and favorable left ventricular remodeling in a randomized sham-controlled clinical trial of percutaneous valve therapy.^iv,v,vi The Carillon System is CE-marked (0344) and has been implanted in over 1,200 patients in the U.S., Europe, Australia, Turkey and the Middle East. The Carillon System is currently being studied in The CARILLON Trial pivotal trial and limited to investigational use in the United States.

About Cardiac Dimensions

Cardiac Dimensions is a leader in the development of innovative, minimally invasive treatments to address heart failure and related cardiovascular conditions. Privately held, the company's lead investors include Aperture Venture Partners, Arboretum Ventures, HostPlus, Life Sciences Partners, Lumira Ventures and M.H. Carnegie & Co. Cardiac Dimensions is headquartered in Kirkland, Washington and has operations in the United States, Australia and Germany. For more information, visit cardiacdimensions.com^[1].

ⁱ Lipiecki J, Kaye DM, Witte KK, et al. Long-Term Survival Following Transcatheter Mitral Valve Repair: Pooled Analysis of Prospective Trials with the Carillon Device. Cardiovascular Revascularization Medicine. Advance online publication. doi:10.1016/j.carrev.2020.02.012.ⁱⁱ Hoppe UC, Brandt MC, Degen H, et al. Percutaneous mitral annuloplasty device leaves free access to cardiac veins for resynchronization therapy. Catheter Cardiovasc Interv. 2009;74(3):506-11.ⁱⁱⁱ Latib, A. "Coronary Sinus Annuloplasty." New York, Montefiore Medical Center.^iv Lipiecki J, Siminiak T, Sievert H, et al. Coronary sinus-based percutaneous annuloplasty as treatment for functional mitral regurgitation: the TITAN II trial. BMJ Open Heart. 2016; 3^v Siminiak T, et. al. Treatment of functional mitral regurgitation by percutaneous annuloplasty: Results of the TITAN Trial. Eur J Heart Fail. 2012;14:931-38.^vi Sievert, H. 2018. REDUCE-FMR: A Sham-controlled Randomized Trial of Transcatheter Indirect Mitral Annuloplasty in Heart Failure Patients with Functional Mitral Regurgitation. Presented at TCT 2018, San Diego, CA.

References

1. ^{^} cardiacdimensions.com (c212.net)