Ivenix Infusion System Receives FDA 510(k) Clearance; Poised to Revolutionize the Infusion Pump Industry

Aimed at reducing medication errors and related healthcare costs,
Ivenix prepares to bring its infusion system to the $4.7 billion North
American infusion market

BOSTON–(BUSINESS WIRE)–#FDA–The U.S. Food and Drug Administration (FDA) has issued 510(k) clearance
for the Ivenix Infusion System, ushering in a new era of infusion
systems designed to make infusions safer, while lowering the total cost
of ownership. Ivenix
looks to disrupt the $4.7 billion North American infusion market, which
has been fraught with dangerous and costly errors associated with legacy
technologies. The Ivenix Infusion System is the first and only
large-volume pump and infusion system designed from the ground up to
meet the new
FDA infusion pump guidelines, adopted in 2014 to address the
recurring safety problems associated with infusion pumps.

Outdated technology and poor user interfaces of current infusion systems
have led to persistent errors, pump recalls, cybersecurity threats and
high costs. Infusion-related errors account for more than 50% of the 1.5
million adverse drug events reported annually to the FDA, and
infusion-related adverse drug events account for more than $2 billion in
annual healthcare costs.

“For years, I’ve studied smart infusion pump safety and efficiency,”
said Karen Giuliano, Ph.D., RN, FAAN, Associate Professor and Executive
Director of Healthcare Innovation at Northeastern University Bouvé
College of Health Sciences. “My research has focused on revealing the
serious usability challenges, which exist in the most commonly used IV
smart pumps. Data suggest that the Ivenix Infusion System can enable
clinicians to more quickly administer IV medications with significantly
fewer errors as compared to today’s leading pumps. Nurses, and the
healthcare industry as a whole, have been waiting for an innovative
solution like this.”

Ivenix sets a new standard in infusion delivery by rethinking safety,
simplicity and interoperability, while providing capabilities not
available in any other pump. The Ivenix infusion platform incorporates a
patented, adaptive flow control technology, which provides best-in-class
flow accuracy and continuity designed to eliminate the risk of free
flow. The simple and intuitive user interface makes interoperability
easy and aims to reduce alarms. Along with reducing infusion-related
errors, Ivenix has the potential to drive down the total cost of
ownership by up to 40%.

“We started out knowing that in order to effectively solve today’s
medication safety concerns, we needed to build more than a pump,” said
George Gray, CTO of Ivenix. “Instead, we built an infusion system that
is centered around patients and provides the rich information clinicians
need to make safe decisions. In our efforts to make the pump safer, we
challenged the status quo and eliminated many of the error-prone tasks
that result in preventable adverse drug events. In addition, we examined
all the costs associated with owning and operating a pump and found ways
to significantly reduce those costs for the hospital. We’re pleased that
the FDA cleared our next-generation infusion system. We believe it will
dramatically transform the industry.”

The cleared Ivenix Infusion System includes:

• A large-volume infusion pump with a smartphone-like user interface,
  advanced pumping technology that measures flow to maximize accuracy,
  and a system that is able to anticipate and prevent critical use
  errors;
• A portfolio of administration sets to accommodate the diverse infusion
  needs of healthcare organizations; and
• An infusion management suite of end-to-end administration tools,
  applications and analytics to remotely monitor infusions and
  proactively manage improvements.

In addition to meeting the new FDA guidelines, Ivenix has directly
addressed the industry’s call to action to improve the safety of pumps
set by the ECRI Institute for Safe Medication Practices, and the
Association for the Advancement of Medical Instrumentation.

With FDA clearance in place, Ivenix is preparing to bring the Ivenix
Infusion System to the U.S. infusion market.

“The demand for a safer, more efficient and more cost-effective infusion
system has been overwhelming,” said Susan Niemeier, MHA, RN, CNO at
Ivenix. “We’ve had healthcare organizations offer to delay formal
product evaluations to ensure Ivenix could be part of the process. The
industry is ready for change and we can’t wait to deliver on it.”

About Ivenix
Ivenix,
Inc. is a medical technology company with a vision to eliminate
infusion-related patient harm. The company was founded to develop
innovative solutions that transform infusion delivery. Ivenix designed
an infusion system from the ground up to streamline medication delivery
and bring legacy technology into the digital age. The Ivenix Infusion
System includes a large-volume infusion pump supported by a robust
infusion management system designed to set new standards in usability,
medication precision and interoperability. For more information, visit www.ivenix.com
or follow @IvenixInc on Twitter.

Contacts

Caroline Curran
910-409-4126
ivenix@metiscomm.com