Full Press Release Details
Announces NextFlo Breakthrough
disposable gravity-driven intravenous (IV) infusion set achieves flow accuracy comparable to expensive electronic infusion pumps,
independent of IV bag height.
much of the last century nearly all infusions were driven by gravity. The nurse would hang the IV bag at a reasonable height and
adjust the flow rate using a simple roller clamp and drip chart. Any inadvertent change in the height of the bag during the infusion
would lead to an incorrect flow rate and possible complications," Dr. Engelman explained. "More recently, however,
complex and expensive electronic infusion pumps have become ubiquitous, despite the fact that most infusions are simple boluses
or delivered at a fixed-rate and thus do not require the complexity of these pumps - one of the more egregious examples
of technological overkill in health care today. I believe that once NextFlo is FDA-cleared and commercialized, it will dramatically
simplify infusions, reduce healthcare costs, and have a broad and immediate impact on patient care."
recently completed a series of bench-top tests of NextFlo. These tests demonstrated that NextFlo is able to passively adjust its
resistance and accurately deliver constant flow, comparable to electronic infusion pumps, across a wide range of clinically-relevant
pressures (i.e. IV bag heights). This constant flow was maintained even when the pressure was repeatedly changed during the course
of the infusion. The most definitive test from a clinical point of view (Figure) was performed in a physiologic bench top model
which mimics saline infusions into a vein in a patient's forearm against a typical venous back pressure. Two Identical NextFlo
infusion sets were each connected to an IV bag containing a specified volume of saline fluid and attached to one of the models.
For one infusion (A) the bag was hung at approximately 50 cm (less than 2 feet) above the arm, which would be unusually low in
a clinical setting. For the other infusion (B) the bag was hung at approximately 150 cm (5 feet) above the arm, close to the ceiling,
which would be unusually high. The two infusions were initiated at the same time. Both sets completed their infusions at the same
time indicating identical average flow rates, despite the fact that one infusion (B) was driven by approximately three times the
pressure of the other infusion (A).
bench top testing has also demonstrated several key clinically significant safety features. For example, NextFlo prevents dangerous
air bubbles inadvertently introduced into the system from passing into the patient under clinically relevant conditions. Flow
also stops when meaningful resistance is encountered which is important in preventing dangerous infiltration of certain medications
when an intravenous catheter dislodges from a vein. Finally, the set is physically incapable of inadvertently delivering flows
higher than its specified rate - a serious medication error associated with electronic infusion pumps.
breakthrough represents an important inflection point in the future clinical and commercial value of NextFlo and I am looking
forward to sharing the full details of these exciting results with potential strategic partners in the coming weeks," said
Lishan Aklog, M.D., PAVmed's Chairman and CEO. "I agree with Dr. Engelman that the commercial introduction of NextFlo
should drive a broad-based return to more economic gravity-driven infusions and eliminate the need for electronic infusion pumps
in the majority of patients."
clinical potential is clearly illustrated in the Institute of Medicine's heavily-cited 1999 report on deaths from medical
errors," Dr. Aklog added. "This landmark report along with more recent studies have highlighted medication errors
as the most common type of medical error and electronic infusion pumps as a major contributor to these medication errors. In fact,
the latest generation of smart infusion pumps have been specifically associated with unintended patient risk (Hsu et al,
Patient Safety. 2019 Mar)."
large immediately addressable domestic market opportunity is based on its commercial potential to transform up to 1 million infusions
per day from electronic infusion pumps with significant capital, maintenance and disposable costs, to less costly entirely disposable
gravity-driven infusion sets, while maintaining accuracy and enhancing patient safety," he concluded.
is a fixed-flow intravenous infusion set with a proprietary, passive, pressure-dependent variable flow-resistor, designed to maintain
constant flow with simple gravity-driven infusions independent of the height of the IV bag. The proprietary variable resistor,
which consists of inexpensive, easy-to-manufacture, disposable mechanical parts, adjusts its resistance to flow based on the input
pressure. As a result, constant flow is maintained throughout the duration of the infusion as long as the height of the bag is
kept within a wide range, effectively from the ceiling to just above the infusion site. The infusion set will be provided across
a range of typically prescribed flow rates for medications, fluids and other substance. Safety features include a fixed flow rate
which cannot physically be exceeded despite human error, as well as protection against dangerous air embolism and IV infiltration.
Future generations of the technology promise to provide adjustable flow rates up to a fixed maximum and very low flow rates that
can be incorporated in disposable infusion pumps designed for outpatient use.
development has moved into the industrial/human factors design phase to optimize ergonomics and general usability in clinical
practice. Full design verification and validation testing will follow to support an FDA 510(k) submission later this year and
we believe will be limited to bench-top testing. A first-in-human (FIH) clinical study is planned outside the U.S. once testing
is complete, however demonstration of this groundbreaking technology to interested strategic partners will commence immediately
and proceed in parallel with the regulatory process and initiation of FIH studies.
Inc. is a highly differentiated, multiproduct medical device company employing a unique business model designed to advance innovative
products to commercialization much more rapidly and with significantly less capital than the typical medical device company. This
proprietary model enables PAVmed to pursue an expanding pipeline strategy with a view to enhancing and accelerating value creation.
PAVmed's diversified pipeline of products address unmet clinical needs encompassing a broad spectrum of clinical areas with
attractive regulatory pathways and market opportunities. Its five lead products provide groundbreaking approaches to carpal tunnel
syndrome (CarpX ), precancerous conditions of the esophagus (EsoCheck ), vascular access (PortIO ), pediatric
ear infections (DisappEAR ) and medical infusions (NextFlo ). The company is also developing innovative products in
other areas, such as catheters and tissue ablation, while seeking to further expand its pipeline through engagements with clinician
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