NZ Innovator of the Year Finalist: Professor Simon Malpas, CEO and Co-founder

Kitea Health is celebrating the recognition of its CEO and co-founder, Professor Simon Malpas, as a finalist for the Innovator of the Year award, presented by the Kiwibank, New Zealander of the Year Awards. This acknowledgment signifies the impact of Professor Malpas's extensive work and the innovative approach Kitea Health embodies.

The announcment recognition celebrates his decades of groundbreaking research, from the Auckland Bioengineering Institute at the Univerisity of Auckland, other international life science companies, and now Kitea Health. It underscores the impact of his visionary innovation. With only three finalists selected from the nation, this honor highlights the extraordinary significance of his work and Kitea Health's mission.

Kitea Selected: FDA Total Product Life Cycle Advisory Program (TAP)

Kitea Health are thrilled to announce that Kitea has reached another significant milestone in our mission to enhance the lives of individuals with hydrocephalus. Off the back of the FDA Breakthrough Device Designation, we are proud to join the FDA’s exclusive Total Product Life Cycle Advisory (TAP) program.

As one of only 65 devices worldwide selected for this program, we will benefit from expedited interactions with the FDA, akin to a breakthrough designation on steroids! This program also facilitates crucial engagements with payers and patient groups, underscoring the FDA’s commitment to ensuring innovative products are not only approved but also reimbursed promptly.

Following our initial meeting, we are highly encouraged by the agency’s interest in our product and are eager to advance our efforts to align with Centers for Medicare and Medicaid Services (CMS) and insurance companies in the US.

FDA Breakthrough Device Designation

Kite Health achieved a major milestone over the weekend by securing Breakthrough Device Designation from the FDA for its innovative pressure monitoring technology. This designation signifies that the FDA recognizes the potential of Kitea's technology to significantly improve the management of chronic health conditions.

For Kitea, this breakthrough designation is a game-changer. It accelerates the development and regulatory review process, potentially bringing their life-saving technology to market faster. This recognition is a testament to Kitea's groundbreaking work and positions them as a leader in the global medical device industry.