Medtech Breakthrough: Galvanize Therapeutics Gains FDA Clearance for INUMI Flex Endoscopic Needle

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At LSI USA ’24 medtech conference Galvanize Therapeutics has reached a significant milestone in the medtech industry with the FDA clearance of its INUMI Flex Endoscopic Needle. This groundbreaking device is part of the Aliya pulsed electric field (PEF) portfolio, which is designed to offer precise and minimally invasive solutions for soft tissue ablation. The FDA’s approval is a pivotal moment, opening up new treatment options across multiple medical fields, including cardiovascular, general surgery, lung, and aesthetic procedures.

The INUMI Flex Endoscopic Needle marks a major leap forward in the treatment of soft tissue conditions. By harnessing pulsed electric field technology, the device provides a minimally invasive approach to tissue ablation, aimed at reducing recovery times and enhancing procedural outcomes. This clearance is a critical step toward expanding the clinical use of PEF technology and represents an important advancement in the broader medtech innovation landscape.

Designed to deliver controlled and precise electric pulses to targeted tissue, the INUMI Flex offers effective ablation with minimal collateral damage to surrounding healthy tissues. This precision is especially beneficial in delicate surgeries, such as those involving cardiovascular and lung procedures, where careful handling of tissues is essential.

Analyst Insights: A New Standard in a Rapidly Expanding Market


Galvanize Therapeutics’ Aliya PEF portfolio stands out due to its innovative technology and broad versatility. The addition of the INUMI Flex Endoscopic Needle strengthens the portfolio, providing an even more powerful tool to address a wide range of medical conditions with improved efficiency and precision.

According to LSI’s Global Market Analysis and Projections (MAP), the PEF market is one of the fastest-growing segments in the medtech sector. Projected to grow at a remarkable compound annual growth rate (CAGR) of 80.7% from 2023 to 2028, the market is benefiting from the nascent stage of PEF technology, along with the expected surge in regulatory approvals for devices using this cutting-edge technology.

More on Galvanize Therapeutics


Galvanize Therapeutics has quickly emerged as a leader in the medtech field, having been selected to present at prominent industry events such as LSI USA ’24. This flagship event brought together top medtech companies, venture capital and private equity investors, and global strategics to discuss the future of healthcare technology.

You can view Galvanize Therapeutics’ presentation from LSI USA ‘24 at the following link, along with access to a rich library of proprietary content from both U.S. and European events:

For more information about Galvanize Therapeutics, a comprehensive company profile is available in LSI’s Companies & Deals Database. This resource provides coverage on over 6,000 medtech companies, featuring their deals, presentations, executive summaries, and more. Learn how LSI’s Companies & Deals Database and full suite of market intelligence solutions can provide you with invaluable insights into the medtech industry on our website.