PR96875

TEL AVIV, Israel, July 6, 2022 /PRNewswire=KYODO JBN/ --

- Company's patented polymeric fiber is a breakthrough in the world of

miniaturizing visualization

- Zsquare ENT-Flex(TM) Rhinolaryngoscope advances the ENT category with a

best-in-class 2.3mm outer diameter for high-resolution image quality at the

lowest cost for the single-use market

Zsquare, a leading developer of high-performance, single-use endoscopes,

announces that it received Food and Drug Administration 510K clearance to

market its first product, the Zsquare ENT-Flex(TM) Rhinolaryngoscope. Zsquare

plans a pilot launch in leading United States hospitals and physician practice

offices by Q4 2022.

The Zsquare ENT-Flex(TM) Rhinolaryngoscope is indicated for use in diagnostic

ENT procedures by way of the nose and throat and is the only scalable platform

capable of transmitting high-resolution images in flexible, single-use

endoscopes. Zsquare ENT-Flex(TM) is the first single-use endoscope using a

hybrid design in which its all-optical disposable shell fully covers a reusable

imaging core. The enhanced design provides health professionals with high

resolution imaging at the lowest cost-per-use in single-use endoscopy, through

the smallest diameter endoscope shaft. This unique engineering has several

benefits, including improved patient comfort, enhanced diagnostic quality and

significant savings for providers and payers. The size and image quality of

this first-to-market Zsquare product offer greater accessibility in endoscopic

procedures.

"As the world continues to confront cross contamination risks, Zsquare has

collaborated closely with clinicians and regulatory authorities to pioneer

innovative technologies with groundbreaking patient-care capabilities to

advance the endoscopy industry's shift to single-use devices." Said Asaf

Shahmoon, CEO and Co-Founder of Zsquare. "This is a significant milestone and

delivers on our pledge to transform the endoscopy market, setting a new

standard for single-use endoscopes," he added.

The company's patented polymeric imaging fiber is a breakthrough in the world

of miniaturizing visual fiber-optics. Its flexible, ultra-thin properties

enable smaller than ever endoscopes that can access formerly unreachable

anatomical sites without compromising image quality. The hybrid endoscope

design enables rapid cross-industry scalability by allowing the same imaging

core to be used with different indication-specific disposable shells that are

purpose-made for ENT, urology, bronchoscopy, GI, gynecology and more.

"We are very excited for this major achievement.", Said Eyal Agmoni, Chairman

of Chartered Group, Zsquare's leading investor. "As we continue to support

Zsquare's rapid growth, this milestone enables it to ramp up activity and

establish mass manufacturing capabilities to achieve the production of millions

of units per year, on its way to take over the single-use endoscopy market."

The Company believes that this initial regulatory achievement is a

steppingstone for Zsquare as the approval of its reusable components supports

accelerated clearance of single-use shells for other clinical fields such as

cystoscopy, bronchoscopy, gastroenterology and more.

"The Zsquare ENT-Flex(TM) Rhinolaryngoscope is the first single-use endoscope

to show superior capabilities than reusable scopes with the same diameter –

from superior image quality to a smaller outer diameter," said Professor Hisao

Tajiri, M.D., senior advisor, Japan Gastroenterological Endoscopy Society

(JGES) and member of the Zsquare Scientific Advisory Board. "This

groundbreaking FDA approval to market opens the door to an industry shift

toward affordable, high-performance hybrid single-use endoscopes in other

indications of use."

About Zsquare:

Zsquare, a privately held medical device company, has developed the only

scalable platform capable of transmitting high-resolution images in flexible,

single-use endoscopes. The two-part endoscope design allows the same imaging

core to be used while switching indication-specific shells that are

purpose-made for ENT, bronchoscopy, duodenoscopy, urology, gynecology, and

more. The cost-effective, high-performance endoscopes enable access to unserved

indications, improve performance in current practices, and solve the industry's

cross-contamination challenge. Advancing endoscopic diagnostic technologies,

Zsquare is democratizing patient care and optimizing patient outcomes and

hospital efficiency one single-use endoscope at a time.

For more information: https://www.zsquaremedical.com/  

Follow Zsquare on LinkedIn [

https://www.linkedin.com/company/zsquare/?originalSubdomain=il ] |Twitter [

https://twitter.com/Zsquare_medical ]

Company Contact:

Chen Goldstein

+972-524258183

chen.goldstein@zsquaremedical.com

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Logo - https://mma.prnewswire.com/media/1136770/Zsquare_Logo.jpg

Source: Zsquare