Ivantis receives $17 MM NEA, Delphi Ventures funds to expand Hydrus device clinical activities

Ivantis announced today at the World Glaucoma Congress in Paris that it has received $17 MM in funding from New Enterprise Associates (NEA) and Delphi Ventures. The funds will be used to expand clinical activities for the Hydrus, the world's first intracanalicular ("in the canal") scaffold for treatment of primary open angle glaucoma, a disease that afflicts over 60 million people worldwide. These funds, which constitute the second round of financing, will be used to support multiple randomized controlled trials around the world, including in the United States.

"NEA is pleased to lead Ivantis' latest round of financing. The technology and leadership team are first-rate," said John Nehra, Special Partner at NEA. "The Company has consistently achieved its milestones since its inception in 2007 as an NEA incubator company, and has an internationally recognized Scientific Advisory Board representing all facets of the glaucoma market. All signals are that this technology can potentially revolutionize glaucoma treatment worldwide."

Ivantis' Hydrus device, roughly the size of an eyelash, is placed through a minimally invasive, microsurgical procedure and is designed to reduce eye pressure by reestablishing the patient's natural outflow pathway. Most often, glaucoma patients have both a blockage and a collapse of the natural outflow pathway. The Hydrus device relies on a twofold mechanism of action that creates a large opening through the traditional source of flow blockage (known as the "trabecular meshwork"), and then dilates and scaffolds the conventional pathway through which fluid exits the eye (known as "Schlemm's canal").

Ivantis recently announced that the first patient was enrolled in its first international randomized controlled trial (Hydrus II) in Madrid, Spain. According to Ike Ahmed, M.D., of the University of Toronto and a scientific advisor to Ivantis, "By scaffolding the primary flow path, the Hydrus device provides a novel mechanism of action, offering a significant advance for our glaucoma patients. Importantly, the Company has actively pursued basic science research to fully characterize this new device and it makes physiologic sense. In my own clinical experience, with results approaching one year, I am highly encouraged with my patient outcomes. The procedure is predictable and reliable, and appears to yield a consistent effect."

In addition to their funding and randomized controlled trials, the Company also announced that the Hydrus device received CE mark approval.

"The recent news of our CE Mark, the close of our financing, and the initiation of our international Hydrus II study signify the culmination of many years of inventiveness and hard work by our team on behalf of glaucoma patients worldwide, as well as the surgeons who serve them," said Dave Van Meter, Ivantis' President and CEO. "We are honored and grateful for the continued strong support of our two 'blue chip' investors. With Hydrus II, plus two other randomized controlled trials slated to begin this year, we will continue to validate the superior performance of the Hydrus device through rigorous science and evidence-based medicine. Our goal is to offer our surgeons and patients the utmost confidence that this will be an important product capable of providing clinically significant benefit to glaucoma patients worldwide."