Below, we are re-publishing with permission the press-release issued by Laguna Tech USA on October 24, 2023

• New heart valves, ALPHA and ZETA, designed to provide flexibility and optionality regardless of high, low or zero calcification status
• Patients with aortic regurgitation achieve complete resolution of regurgitation immediately following procedure.
• First-in-class, Aortic Valve Systems offer self-expanding or balloon-expanding versatility based on physician preference and patient case dynamics
• Versatile designs expected to significantly broaden patient eligibility for implant

IRVINE, Calif., Oct. 24, 2023 (GLOBE NEWSWIRE) — Laguna Tech USA, a privately-held medical technology company dedicated to innovations in structural heart solutions to broaden useability and applicability for patients, today announced that the first-in-human clinical case was completed with the Zeta Balloon Expandable Aortic Valve System and additional patients have been successfully treated in the feasibility clinical study of its investigational ALPHA Self-Expanding Aortic Valve system to treat aortic regurgitation.   To date, two patients have been successfully treated in the Alpha Aortic Valve study, with both achieving complete resolution of aortic regurgitation immediately following the procedure, which has been maintained at the 30-day follow-up examination.

The ALPHA system is a uniquely designed one-piece self-expanding transcatheter valve engineered with a low profile valve and delivery system, with six support arms for simpler, better positioning within the aortic annulus and cusps.   The ZETA system is a novel balloon-expandable transcatheter valve with six expanding arms and a low profile covered delivery system. The six expanding arms allow for simple positioning of the valve into the aortic annulus and cusps.

The feasibility study is being conducted at the Instituto Nacional de Torax in Santiago, Chile, and Tbilisi Heart and Vascular Clinic in Georgia.

The lead primary investigator, Dr. Scott Lim, a cardiologist from the University of Virginia noted, “The Laguna Tech USA Alpha Self Expanding Aortic Valve and Zeta balloon Expandable Aortic Valves performed as designed, allowing us to successfully and percutaneously treat these first patients at high surgical risk with severe aortic regurgitation, and in one case, with concomitant significant calcific aortic stenosis. I look forward to these novel transcatheter aortic valves being further investigated in larger studies, as this initial experience is quite encouraging toward helping us address a significant unmet patient need in those with complex aortic valve disease.”

Dr. Cristian Dauvergene, Chief of Interventional Cardiology, Instituto Nacional de Torax, added, “We were able to successfully implant the Zeta Aortic Valve very simply and efficiently aided by the low profile and straightforward transcatheter implantation allowing for advantageous placement in the heart. We are excited to be a part of the success of the first procedure of this important next-gen TAVI system, and we look forward to participating in Laguna Tech USA’s clinical study.”

“With this successful groundbreaking first in human clinical experience with the ZETA valve and the additional successful ALPHA valve implants, we have a growing body of evidence supporting the promise of our next-gen, differentiated aortic valves, which represent much-needed advancement in the field,” said Gilbert Madrid, chief executive officer of Laguna Tech USA. “Specifically, our valve designs are intended to address an unfortunate, longstanding gap in the applicability of heart solutions because of rigid and unyielding technology designs that eliminate many patients as prospective candidates. With two varying valve designs, each leveraging advanced technology and engineering of existing products on the market, we look forward to the potential of our technology to significantly expand the number of patients with aortic valve regurgitation who may be treated with our minimally invasive treatment options.”

About the ALPHA Aortic Valve System
The ALPHA Aortic Valve is designed to restore heart function by placing support arms in the aortic cusps and placement of the valve within the annulus. The valve self-expands into the annulus to form a new functioning valve and seals at the annulus to prevent paravalvular leak. The system was invented at Laguna Tech USA with the first prototype entering preclinical development in 2022. The system is engineered with a unique design and to increase the versatility, flexibility, and positioning of the device in the annulus for improved placement within the patient.

About the ZETA Aortic Valve System
The ZETA Aortic Valve is designed to restore heart function by placing support arms in the aortic cusps and placement of the valve within the annulus. The valve is balloon expandable into the annulus to form a new functioning valve and seals at the annulus to prevent paravalvular leak. The system was invented at Laguna Tech USA with the first prototype entering preclinical development in 2022. The system is engineered with a unique design and materials to increase the versatility, simplicity, and positioning of the device in the annulus for improved placement within the patient.

About Laguna Tech USA
Laguna Tech USA is a privately held medical technology company focused on providing innovative, less invasive structural heart solutions to a significantly expanded group of patients who previously were excluded as candidates for valve replacements. Laguna Tech USA believes its highly differentiated next-generation engineering offers versatility and flexibility, and therefore feasibility, of its valves in addressing diverse heart conditions across a broad population of patients. The company’s lead investigational devices for aortic regurgitation are the ALPHA Aortic Valve, a self-expanding valve, and the ZETA Aortic Valve, a balloon-expandable valve for aortic regurgitation. In addition, the iNValve Mitral and Tricuspid valve is a transseptal valve in the R&D pipeline.