Company to aggressively promote INSPIRA™ ART100 in the
U.S. and additional markets following FDA clearance, as well as
accelerate plans for ground-breaking INSPIRA™ ART
(Gen2)
RA'ANANA, Israel, June 20,
2024 /PRNewswire/
-- Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq:
IINN), (Nasdaq: IINNW) (the "Company" or "Inspira"), a
breakthrough medical technology company, announced today that the
Company's President and co-founder, Mr. Joe
Hayon, presented a business plan with targets for the
Company's next-generation technologies on a Company conference call
today.
On the call, Inspira unveiled plans to build an opportunity for
a share of the $19 billion mechanical
ventilation market. Inspira's mission is to eliminate the need for
traditional mechanical ventilators, with its flagship the
INSPIRA™ ART (Gen 2) device, being designed to perform direct
blood oxygenation, with the patient potentially being awake and
without the need for intubation.
Alongside the ongoing development of the INSPIRA ART (Gen 2)
game-changing adaptive blood oxygenation technology, the Company is
working on the multi-site deployment of the 510(k) U.S. Food and
Drug Administration (FDA) Cleared INSPIRA ART100, a cardiopulmonary
support device. Under the existing distribution agreements with
Glo-Med Networks, Inc, the Company has already received the first
purchase order from the U.S. distributor, with its first shipment
scheduled for Q4 2024.
Key Highlights from the Presentation:
- The Company outlined the ground-breaking INSPIRA™ ART
(Gen2) technology, with the aim of targeting a share of the
projected $19 billion global
mechanical ventilation market size estimated by 2030.
- Business goals for 2024-2025: Inspira is on track to
submit its HYLA™ blood sensor, a key component of the INSPIRA™ ART
(Gen 2) system, for FDA Clearance with Company plans to integrate
the technology into the next generation of the INSPIRA™ ART100
device. In addition, Inspira is on track with phase 2 research and
development for the VORTX™ blood delivery system and phase 3
verification and validation testing of the HYLA blood
sensor.
- Inspira plans to deploy the INSPIRA™ ART100 in
multiple sites and countries, and leverage it as a
penetration model for the subsequent generation of its technology,
the INSPIRA™ ART (Gen 2). We strongly believe that the
INSPIRA™ ART100 research and
development and regulatory success story is indicative of future
potential breakthrough with INSPIRA™ ART
(Gen 2)
About Inspira Technologies OXY B.H.N. LTD.
Inspira™ Technologies is an innovative medical technology
company in the life support arena. The INSPIRA™ ART (Gen 2),
also known as the INSPIRA™ ART500, shall include the Company's
Adaptive Blood Oxygenation technology and is being designed to
continuously measure the patient's blood parameters in real-time,
delivering needed oxygen volume straight into the blood. By
elevating patient oxygen saturation levels in minutes, this
technology potentially allows patients to remain awake during
treatment and therefore may enable patients to be treated in and
beyond intensive care units, reducing the need for mechanical
ventilation systems that require intubation and medically induced
coma.
The Company received FDA 510(k) clearance for its INSPIRA
ART100, a Cardiopulmonary Bypass System.
The Company's other products, including the INSPIRA ART (Gen 2)
and HYLA™ blood sensor, have not been cleared or approved for
marketing and sales by the US Food and Drug Administration (FDA) or
any other regulatory authority.
For more information, please visit our corporate
website: https://inspira-technologies.com
Forward-Looking Statements
This press release contains express or implied forward-looking
statements pursuant to U.S. Federal securities laws. These
forward-looking statements and their implications are based on the
current expectations of the management of the Company only and are
subject to a number of factors and uncertainties that could cause
actual results to differ materially from those described in the
forward-looking statements. For example, the Company is using
forward-looking statements when it discusses its plans to build an
opportunity for a share of the $19
billion mechanical ventilation market , the potential
benefits of its systems and products, the expected delivery of a
purchase order, its regulatory status with regards to the HYLA
Blood Sensor, its plan to integrate the HYLA Blood Sensor into the
next generation of the INSPIRA ART100 system, its research and
development and verification and validation testing progress with
its products, its plans with regards to the deployment of the
INSPIRA ART100, and the belief that the INSPIRA ART100 is a
penetration, research and development and regulatory model for the
INSPIRA ART (Gen 2). These forward-looking statements and their
implications are based solely on the current expectations of the
Company's management and are subject to a number of factors and
uncertainties that could cause actual results to differ materially
from those described in the forward-looking statements. Except as
otherwise required by law, the Company undertakes no obligation to
publicly release any revisions to these forward-looking statements
to reflect events or circumstances after the date hereof or to
reflect the occurrence of unanticipated events. More detailed
information about the risks and uncertainties affecting the Company
is contained under the heading "Risk Factors" in the Company's
annual report on Form 20-F for the fiscal year ended December 31, 2023 filed with the U.S. Securities
and Exchange Commission (the "SEC"), which is available on the
SEC's website, http://www.sec.gov
For more details:
Public Relations Manager
Adi Shmueli
Inspira Technologies
info@inspirao2.com
+972-9-9664485
Copyright © 2018-2024 Inspira Technologies OXY B.H.N. LTD., All
rights reserved.
Logo:
https://mma.prnewswire.com/media/1668495/Inspira_Technologies_Logo.jpg
View original
content:https://www.prnewswire.com/news-releases/inspira-announces-business-plan-targets-302178006.html
SOURCE Inspira Technologies