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Masimo Announces First CE-marked Third-party Masimo Open Connect® Module for the Root® Patient Monitoring and Connectivity Hub

Published

5 years ago

April 29, 2019

Reading Time: 5 minutes

NEUCHATEL, Switzerland–(BUSINESS WIRE)–Masimo (NASDAQ:
MASI) and Mdoloris
Medical Systems announced today the CE marking of the Mdoloris
Analgesia Nociception Index (ANI^®) module for the Masimo Root^®
Patient Monitoring and Connectivity Hub, the first commercially
available result of a Masimo Open Connect^® (MOC) third-party
partnership, between Mdoloris and Masimo.

Masimo’s unique approach to medical technology integration through
Masimo Open Connect partnerships addresses some of the major barriers to
new technology adoption in patient monitoring. The Root platform’s open
architecture and advanced connectivity enable third-party companies to
bypass barriers and the time it takes for traditional multi-parameter
monitor integration by controlling their own Root integration projects.
Third parties can then independently develop, obtain regulatory
approvals, and commercialize their own external MOC-9^® module
or MOC-C^® app for Root using Masimo’s MOC software
development kit and support from Masimo’s engineering and distribution
teams.

Joe Kiani, Founder and CEO of Masimo, said, “We are proud to announce
ANI, the first commercially available third-party MOC-9 module for Root,
the first of many to come. With the ongoing expansion of its
capabilities, Root becomes a more powerful bedside platform than ever.
We believe that Root with Masimo Open Connect can do for patient
monitoring what the PC did for computing: speed up the patient
monitoring innovation cycle, reduce the cost of patient monitoring, and
prolong the useful life of the equipment hospitals invest in.”

“We are delighted to be able to announce that ANI is now cleared for
sale in the EU,” said Fabien Pagniez, Founder and CEO of Mdoloris
Medical Systems. “We consider Masimo to be the most innovative company
in the patient monitoring space and we believe Root offers a unique and
compelling solution for implementing our ANI technology.”

ANI on Masimo Root has not received 510(k) clearance and is not
available for sale in the United States.

@MasimoInnovates |
#Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive
monitoring technologies. Our mission is to improve patient outcomes and
reduce the cost of care. In 1995, the company debuted Masimo SET^®
Measure-through Motion and Low Perfusion pulse oximetry, which has been
shown in over 100 independent and objective studies to outperform other
pulse oximetry technologies.¹ Masimo SET^® has also
been shown to help clinicians reduce severe retinopathy of prematurity
in neonates,² improve CCHD screening in newborns,³
and, when used for continuous monitoring with Masimo Patient SafetyNet
in post-surgical wards, reduce rapid response activations and costs.^4-6
Masimo SET^® is estimated to be used on more than 100 million
patients in leading hospitals and other healthcare settings around the
world,⁷ and is the primary pulse oximetry at 9 of the top 10
hospitals listed in the 2018-19 U.S. News and World Report Best
Hospitals Honor Roll.⁸ In 2005, Masimo introduced rainbow^®
Pulse CO-Oximetry technology, allowing noninvasive and continuous
monitoring of blood constituents that previously could only be measured
invasively, including total hemoglobin (SpHb^®), oxygen
content (SpOC), carboxyhemoglobin (SpCO^®), methemoglobin
(SpMet^®), Pleth Variability Index (PVi^®), and more
recently, Oxygen Reserve Index (ORi), in addition to SpO₂,
pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root^®,
an intuitive patient monitoring and connectivity platform with the
Masimo Open Connect^® (MOC-9^®) interface, enabling
other companies to augment Root with new features and measurement
capabilities. Masimo is also taking an active leadership role in mHealth
with products such as the Radius-7^® wearable patient monitor,
iSpO₂^® pulse oximeter for smartphones, and the
MightySat fingertip pulse oximeter. Additional information about Masimo
and its products may be found at www.masimo.com.
Published clinical studies on Masimo products can be found at http://www.masimo.com/evidence/featured-studies/feature/.

ORi has not received FDA 510(k) clearance and is not available for sale
in the United States. The use of the trademark Patient SafetyNet is
under license from University HealthSystem Consortium.

About Mdoloris Medical Systems

Mdoloris (www.mdoloris.com),
a medical devices manufacturer, was created in June 2010 out of 23 years
of academic research performed in Lille University hospital, France. It
has an international representation in more than 64 countries and a
scientific, technical and medical acknowledgement. Mdoloris has so far
developed three products, all able to continuously assess the pain level
of patients (the ANI technology for patients older than two years old,
the NIPE technology for neonates, and the PTA technology for pets). Its
innovative technologies provide clinical added value for clinicians who
are not able to communicate with their patients in order to personalize
pain medications and avoid known side effects due to over- and
under-dosage of such drugs. More than 1,200 devices are now used by
anesthesiologists and intensivists worldwide and more than 140,000
patients have benefited from Mdoloris’ technologies. Mdoloris’s
standalone monitor promoting its innovative adult technology has
received 510(k) clearance through the HFVI brand in the US under the
number K142969. Mdoloris recently closed a nine-million euro fundraising
round in order to keep developing new-to-the-world technologies that
always keep one target in mind: helping clinicians improve the quality
of care.

References

Published clinical studies on pulse oximetry and the benefits of
Masimo SET^® can be found on our website at http://www.masimo.com.
Comparative studies include independent and objective studies which
are comprised of abstracts presented at scientific meetings and
peer-reviewed journal articles.
Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm
Infants through Changes in Clinical Practice and SpO₂
Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
de-Wahl Granelli A et al. Impact of pulse oximetry screening on the
detection of duct dependent congenital heart disease: a Swedish
prospective screening study in 39,821 newborns. BMJ. 2009;Jan
8;338.
Taenzer AH et al. Impact of pulse oximetry surveillance on rescue
events and intensive care unit transfers: a before-and-after
concurrence study. Anesthesiology. 2010:112(2):282-287.
Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia
Patient Safety Foundation Newsletter. Spring-Summer 2012.
McGrath SP et al. Surveillance Monitoring Management for General Care
Units: Strategy, Design, and Implementation. The Joint Commission
Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
Estimate: Masimo data on file.
http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements

This press release includes forward-looking statements as defined in
Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934, in connection with the Private
Securities Litigation Reform Act of 1995. These forward-looking
statements include, among others, statements regarding the potential
effectiveness of Masimo Root^®. These forward-looking
statements are based on current expectations about future events
affecting us and are subject to risks and uncertainties, all of which
are difficult to predict and many of which are beyond our control and
could cause our actual results to differ materially and adversely from
those expressed in our forward-looking statements as a result of various
risk factors, including, but not limited to: risks related to our
assumptions regarding the repeatability of clinical results; risks
related to our belief that Masimo’s unique noninvasive measurement
technologies, including Masimo Root, contribute to positive clinical
outcomes and patient safety; risks related to our belief that Masimo
noninvasive medical breakthroughs provide cost-effective solutions and
unique advantages; as well as other factors discussed in the “Risk
Factors” section of our most recent reports filed with the Securities
and Exchange Commission (“SEC”), which may be obtained for free at the
SEC’s website at www.sec.gov.
Although we believe that the expectations reflected in our
forward-looking statements are reasonable, we do not know whether our
expectations will prove correct. All forward-looking statements included
in this press release are expressly qualified in their entirety by the
foregoing cautionary statements. You are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of
today’s date. We do not undertake any obligation to update, amend or
clarify these statements or the “Risk Factors” contained in our most
recent reports filed with the SEC, whether as a result of new
information, future events or otherwise, except as may be required under
the applicable securities laws.

Contacts

Masimo
Evan Lamb
949-396-3376
[email protected]

Mdoloris
Pierrick Niewiadowski
[email protected]

transfer

IMC to transfer its Oranim Pharmacy shares back to the seller

Published

2 days ago

April 16, 2024

CISION (PR Newswire)

imc-to-transfer-its-oranim-pharmacy-shares-back-to-the-seller

TORONTO and GLIL YAM, Israel, April 16, 2024 /PRNewswire/ — IM Cannabis Corp. (CSE: IMCC) (NASDAQ: IMCC) (the “Company” or “IMC“), a leading medical cannabis company with operations in Israel and Germany, is announcing that, further to the news release dated January 12, 2024, the Company has decided not to make remaining installment payments installments (i.e. NIS 5,873K including interest or 2,154K CAD) by IMC Holdings Ltd., and as such will transfer the 51% shares held by IMC Holdings Ltd back to the seller.

“With the April 1^st cannabis legalization in Germany, we are focusing our resources on the German market, where we expect to see the biggest growth potential,” said Oren Shuster, CEO of IMC. “With both of our core markets, Germany and Israel, currently undergoing rapid evolution, we need to assure that we allocate our resources to the growth opportunities where we expect the best return on investment.”

About IM Cannabis Corp.

IMC (Nasdaq: IMCC) (CSE: IMCC) is an international cannabis company that provides premium cannabis products to medical patients in Israel and Germany, two of the largest medical cannabis markets. The Company has recently exited operations in Canada to pivot its focus and resources to achieve sustainable and profitable growth in its highest value markets, Israel and Germany. The Company leverages a transnational ecosystem powered by a unique data-driven approach and a globally sourced product supply chain. With an unwavering commitment to responsible growth and compliance with the strictest regulatory environments, the Company strives to amplify its commercial and brand power to become a global high-quality cannabis player.

The IMC ecosystem operates in Israel through its commercial relationship with Focus Medical Herbs Ltd., which imports and distributes cannabis to medical patients, leveraging years of proprietary data and patient insights. The Company also operates medical cannabis retail pharmacies, online platforms, distribution centers, and logistical hubs in Israel that enable the safe delivery and quality control of IMC’s products throughout the entire value chain. In Germany, the IMC ecosystem operates through Adjupharm GmbH, where it distributes cannabis to pharmacies for medical cannabis patients. Until recently, the Company also actively operated in Canada through Trichome Financial Corp and its wholly owned subsidiaries, where it cultivated, processed, packaged, and sold premium and ultra-premium cannabis at its own facilities under the WAGNERS and Highland Grow brands for the adult-use market in Canada. The Company has exited operations in Canada and considers these operations discontinued.

Disclaimer for Forward-Looking Statements

This press release contains forward-looking information or forward-looking statements under applicable Canadian and U.S. securities laws (collectively, “forward-looking statements”). All information that addresses activities or developments that we expect to occur in the future are forward-looking statements. Forward-looking statements are often, but not always, identified by the use of words such as “seek”, “anticipate”, “believe”, “plan”, “estimate”, “expect”, “likely” and “intend” and statements that an event or result “may”, “will”, “should”, “could” or “might” occur or be achieved and other similar expressions. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. In the press release, such forward-looking statements include, but are not limited to, the occurrence of growth opportunities and the likelihood of growth potential.

Forward-looking statements are based on assumptions that may prove to be incorrect, including but not limited to: the development and introduction of new products; continuing demand for medical and adult-use recreational cannabis in the markets in which the Company operates; the Company’s ability to reach patients through both e-commerce and brick and mortar retail operations; the Company’s ability to maintain and renew or obtain required licenses; the effectiveness of its products for medical cannabis patients and recreational consumers; and the Company’s ability to market its brands and services successfully to its anticipated customers and medical cannabis patients.

The above lists of forward-looking statements and assumptions are not exhaustive. Since forward-looking statements address future events and conditions, by their very nature they involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated or implied by such forward looking statements due to a number of factors and risks. These include: any failure of the Company to maintain “de facto” control over Focus Medical in accordance with IFRS 10; the failure of the Company to comply with applicable regulatory requirements in a highly regulated industry; unexpected changes in governmental policies and regulations in the jurisdictions in which the Company operates; the effect of the reform on the Company; the Company’s ability to continue to meet the listing requirements of the Canadian Securities Exchange and the NASDAQ Capital Market; any unexpected failure to maintain in good standing or renew its licenses; the ability of the Company and Focus Medical (collectively, the “Group”) to deliver on their sales commitments or growth objectives; the reliance of the Group on third-party supply agreements to provide sufficient quantities of medical cannabis to fulfil the Group’s obligations; the Group’s possible exposure to liability, the perceived level of risk related thereto, and the anticipated results of any litigation or other similar disputes or legal proceedings involving the Group; the impact of increasing competition; any lack of merger and acquisition opportunities; adverse market conditions; the inherent uncertainty of production quantities, qualities and cost estimates and the potential for unexpected costs and expenses; risks of product liability and other safety-related liability from the usage of the Group’s cannabis products; supply chain constraints; reliance on key personnel; the risk of defaulting on existing debt and war, conflict and civil unrest in Eastern Europe and the Middle East

Any forward-looking statement included in this press release is made as of the date of this press release and is based on the beliefs, estimates, expectations and opinions of management on the date such forward-looking information is made.

The Company does not undertake any obligation to update forward-looking statements except as required by applicable securities laws. Investors should not place undue reliance on forward-looking statements. Forward-looking statements contained in this press release are expressly qualified by this cautionary statement.

Company Contacts:

Anna Taranko, Director Investor & Public Relations
IM Cannabis Corp.
+49 157 80554338
[email protected]

Oren Shuster, Chief Executive Officer
IM Cannabis Corp.
[email protected]

Logo – https://mma.prnewswire.com/media/1742228/IM_Cannabis_Logo.jpg

View original content:https://www.prnewswire.co.uk/news-releases/imc-to-transfer-its-oranim-pharmacy-shares-back-to-the-seller-302117984.html

Cannabis

Right on Brands Announces Major Product Line Expansion via HONEY® Brands

Published

2 days ago

April 16, 2024

GlobeNewswire

CCELL®

CCELL Launches Environmentally Conscious Eco Star AIO Vaporizer

Published

3 days ago

April 15, 2024

CISION (PR Newswire)

ccell-launches-environmentally-conscious-eco-star-aio-vaporizer

SHENZHEN, China, April 15, 2024 /PRNewswire/ — CCELL®, the world’s leading technology brand focused on creating trendsetting vape hardware products and advanced vaporization technology, today announced the launch of the Eco Star, the company’s all-in-one vaporizer focused on sustainability, wide-ranging oil compatibility, and ease of use.

The Eco Star’s casing material is made of biodegradable and plant-based PLA, a material that can be decomposed by bacteria or other living organisms. By adopting this type of eco-friendly casing, CCELL seeks to provide an option that can reduce the cannabis industry’s overall environmental impact and build a more sustainable society.

Built within the casing is a removable and recyclable lithium-ion battery. This thoughtful pull-apart design allows consumers to easily remove the battery before disposing of the casing, empowering them to contribute towards a greener Earth.

The Eco Star also features complete compatibility with all types of cannabis oils, clog-free dual air vents, and an isolated airway that ensures the cleanest possible vapor.

With increasing environmental challenges worldwide and tightening regulations on vape products, the Eco Star was introduced with the intention of raising environmental awareness across the industry.

The company has also implemented other measures to align its practices with its long-standing sustainability-focused values. These include offering biodegradable and plant-based PLA mouthpieces among its customization options. Additionally, the company uses energy-efficient aqueous processing in producing its patented ceramic heating cores to reduce greenhouse gas emissions.

Before the product’s official launch, CCELL provided their customers and consumers with an early look at the Eco Star at TPE24 and Hall of Flowers Ventura in the US, and Spannabis Barcelona in Spain.

Disclaimer for battery disposal: CCELL does not recycle lithium-ion batteries. Battery recycling requirements may vary by country, city, etc. Please contact your local recycling center for more details before disposal.

About CCELL®

CCELL® is a technology brand and global innovator in the portable vaporizer space that revolutionized the industry by introducing the ceramic heating component. CCELL® was born in the headquarters of Shenzhen Smoore Technology Limited, which has more than 10 years of expertise in the vaporization industry. With advanced R&D resources, patented technologies, strong production capabilities, and reliable quality control systems, CCELL® is recognized around the world for its exceptional vaporization technology and top-quality devices.

Learn more about CCELL® at www.ccell.com as well as on LinkedIn, Instagram, Facebook, Twitter, and YouTube.