Galvanize Therapeutics Announces Merger to Create the Premier Pulsed Electric Field Therapy Company and Completion of $100 Million Series B Financing

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• Merger unites three companies created by life sciences venture capital firm ATP—Gala Therapeutics, Galaxy Medical, and Galvanize Therapeutics—to create a single company based on the Aliya^TM Pulsed Electric Field (PEF) energy platform
• Galvanize is developing and commercializing systems for chronic bronchitis symptoms, cardiac arrhythmias, solid tumors, and drug delivery
• $100 million funding round led by Fidelity Management & Research Company with participation by ATP, Intuitive Surgical, and Gilmartin Capital
• Galvanize announces recent U.S. Food and Drug Administration 510(k) regulatory clearance for its Aliya^TM system for soft tissue ablation; its RheOx^® system has CE Mark for treatment of chronic bronchitis symptoms, and its CENTAURI^TM system has CE Mark for treatment of paroxysmal atrial fibrillation

SAN CARLOS, Calif., Sept. 15, 2022 /PRNewswire/ -- Galvanize Therapeutics, Inc., a commercial-stage biomedical platform company operating at the convergence of engineering, biology and healthcare delivery, today announced it has completed a $100 million Series B financing to advance and commercialize its unique Aliya^TM Pulsed Electric Field (PEF) energy platform for the treatment of chronic bronchitis symptoms, cardiac arrhythmias, solid tumors, and for drug delivery. Galvanize was created and incubated by the life sciences venture capital firm ATP (Apple Tree Partners), originally as three companies—Gala Therapeutics, Galaxy Medical, and Galvanize Therapeutics—that recently merged into one company under the Galvanize Therapeutics name. The funding round was led by Fidelity Management & Research Company with participation by Intuitive Surgical, ATP, and Gilmartin Capital.

"We are energized by this vote of confidence from our investors in our technology platform and team as we seek to bring transformative electrosurgical therapies to patients worldwide," said Jonathan Waldstreicher, M.D., founder and CEO of Galvanize Therapeutics and a partner at ATP. "We designed the customizable Aliya energy platform to serve patients in a variety of challenging disease categories, and the integration of our market-specific strategies and innovative products within Galvanize is an exciting milestone in the execution of our vision. We are investing meaningfully to prove safety and demonstrate enhanced outcomes in our initial clinical targets, and we continue to explore additional platform applications."

Centered on disease biology and how energy can alter cellular physiology, Galvanize developed the Aliya energy platform to produce high voltage, high frequency electrical current to interfere with cellular function in tissue. Unlike other ablation modalities, Aliya energy is non-thermal. The electrical waveforms are designed to be delivered through single monopolar electrodes to enable more consistent and predictable treatment zones with minimal muscle contraction that previously plagued high voltage technologies.

One Core Platform, Several Targets

Galvanize is developing and commercializing its energy platform for several indications, adapting its core technology for each application:

• Chronic Bronchitis: The RheOx^® system is a minimally invasive bronchoscopic therapy that reduces the abnormal mucus-producing cells in the airways of chronic bronchitis patients. RheOx has CE Mark and recently launched in select hospitals in Italy, Switzerland, Denmark and Germany, with new customers adopting RheOx each week. Following Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA), the RheSolve pivotal clinical trial is enrolling in the United States and Europe to support a U.S. Premarket Approval (PMA) submission for RheOx.
  
  
• Cardiac Arrhythmias: The CENTAURI™ system disrupts aberrant electrical signals in the heart which cause cardiac arrhythmias, including atrial fibrillation. CENTAURI delivers a novel proprietary waveform and is compatible with several marketed catheters and mapping systems. CENTAURI has CE Mark and currently is launching in Europe.
  
  
• Soft Tissue Ablation: The Aliya™ system recently received 510(k) clearance from the U.S. FDA for soft tissue ablation. Through a single percutaneous electrode inserted in the target tissue, the physician delivers a pre-programmed dose of energy. Aliya is now launching at select U.S. hospitals.
  
  
• Immuno-Oncology: The Aliya™ energy platform is being studied to treat solid tumors by combining PEF-mediated cell death and neoantigen creation, designed to stimulate the patient's own immune system to activate against the tumor. Galvanize's preclinical data and early clinical data from the INCITE-ES trial conducted outside the U.S. have demonstrated signals of immune activation.
  
  
• Drug Delivery: A system for local delivery of therapeutic agents is under development.

RheOx and CENTAURI were developed in ATP portfolio companies Gala Therapeutics (founded 2015) and Galaxy Medical (founded 2020), respectively, both of which now are part of Galvanize Therapeutics.

"ATP makes investments to translate incredible science into treatments that can transform lives, and I believe the Galvanize PEF energy platform exemplifies the remarkable breakthroughs we can accomplish with our singular investment and incubation model," said Seth Harrison, M.D., ATP's founder and managing partner. "ATP invested over a period of years to build an adaptable therapeutic device platform capable of addressing some of the most intractable medical problems that have not been solved yet by drugs, and it is gratifying to see the vision being realized. The Galvanize team has developed ingenious solutions for patients and their doctors that they are now delivering to healthcare systems every day."

Doug Godshall, president & CEO of Shockwave Medical, and chair of Saluda Medical, who previously was chair of Gala Therapeutics, has been appointed chair of the board of Galvanize Therapeutics. Mr. Godshall commented: "At Gala over the last few years, we observed the life-changing outcomes that RheOx can achieve in debilitated chronic bronchitis patients, and I am excited to work with the broader Galvanize team as they expand their efforts." He added:

"Galvanize is unique because of the way Jon and his talented team have created a single, highly sophisticated technology across three unique clinical applications. With a deep portfolio of clinical studies already under way, I am highly impressed by what the team has accomplished to-date and am quite enthusiastic about the significant impact Galvanize is going to have for a wide spectrum of patients."

About Galvanize Therapeutics

Galvanize Therapeutics aims to become the global leader in delivering medical technology innovations that drive biologic processes to treat a range of diseases, starting with treating chronic bronchitis symptoms, cardiac arrhythmias, and solid tumors. Formed by ATP (Apple Tree Partners) in 2022, Galvanize has its headquarters in San Carlos, Calif., and is researching and commercializing its revolutionary Aliya^TM Pulsed Electric Field (PEF) energy platform in the United States and Europe. For more information, please visit www.galvanizetx.com.

SOURCE Galvanize Therapeutics