In a significant milestone in the medtech industry, Galvanize Therapeutics has received FDA clearance for its INUMI Flex Endoscopic Needle. This innovative device is a part of the Aliya pulsed electric field (PEF) portfolio, designed for soft tissue ablation. The FDA's approval paves the way for enhanced treatment options in various medical fields, including cardiovascular, general surgery, lung, and aesthetics.

The INUMI Flex Endoscopic Needle represents a leap forward in the treatment of soft tissue conditions. Utilizing pulsed electric field technology, the device offers a minimally invasive approach to tissue ablation, aiming to reduce patient recovery time and improve procedural outcomes. This approval marks an essential step in expanding the use of PEF in clinical settings; a significant step in medtech innovation more broadly.

The device is designed to deliver precise and controlled electric pulses to targeted tissues, leading to effective ablation with minimal damage to surrounding areas. This precision is particularly beneficial in procedures requiring delicate handling of tissues, such as those in cardiovascular and lung surgeries.

Analyst Insights: Setting New Standards in a Nascent, Rapidly-Expanding Expanding Market 

Galvanize Therapeutics' Aliya PEF portfolio is distinguished by its advanced technology and versatility. The inclusion of the INUMI Flex Endoscopic Needle enhances the portfolio's capability to address a broader range of medical conditions by offering a tool that combines efficiency with precision.

According to LSI's Global Market Analysis and Projections (MAP), the pulsed electric field market is amongst the fastest-growing segments in the medtech industry. The market is projected to expand at an astounding compound annual growth rate (CAGR) of 80.7% from 2023 to 2028. This rapid growth is primarily due to the nascent nature of the PEF market and the anticipated increase in regulatory approvals for devices utilizing this technology.

The adoption of pulsed electric field technology across various medical fields, including cardiovascular, general surgery, lung, and aesthetics, highlights its broad applicability and transformative potential. As more PEF devices receive regulatory clearance, the market is expected to experience exponential growth, driven by the demand for minimally invasive and highly effective treatment options.

More on Galvanize Therapeutics

Galvanize Therapeutics has been one of the emerging medtech companies selected to present at previous LSI events, including LSI USA ‘24 – the flagship LSI medtech event, which convened hundreds of leading medtech companies, venture capital and private equity investors, global strategics, and more.

The company’s presentation at LSI USA ‘24 can be found at the link below, alongside our deep library of proprietary content from premier events in the USA and Europe:

• Jonathan Waldstreicher Presents Galvanize Therapeutics at LSI USA '24

For more information on Galvanize Therapeutics, a full company profile is available in LSI’s proprietary Companies & Deals Database. The database provides coverage of over 6,000 medtech companies with their associated deals, presentations, executive summaries, and more. Learn more about LSI’s Companies & Deals database, coverage of the PEF market, and full suite of market intelligence solutions for the medtech industry on our website.