ImpediMed Announces PREVENT Interim Results – “Practice-Changing”

Following >1,100 breast cancer survivors, PREVENT is the largest,
multi-site randomized controlled trial (RCT) ever performed to study
lymphedema prevention

CARLSBAD, Calif. & BRISBANE, Australia–(BUSINESS WIRE)–ImpediMed
Limited (ASX:IPD), a global provider of medical technology to
non-invasively measure, monitor and manage tissue composition and fluid
status using bioimpedance spectroscopy (BIS), today announces the
publication of the peer-reviewed manuscript of the PREVENT interim
analysis.

Sheila H. Ridner, Ph.D., RN, FAAN, principal investigator of PREVENT and
the Martha Rivers Ingram Professor of Nursing at Vanderbilt University
School of Nursing, delivered the interim results at a podium
presentation during the 20^th Annual Scientific Meeting of
American Society of Breast Surgeons in Dallas, Friday, May 3, 2019.

These interim results are important and support the use of subclinical
detection with BIS and early intervention for patients with breast
cancer at risk for lymphedema. While the results did not reach
statistical significance at this time, they were demonstrated to be
clinically meaningful and thus practice-changing.

The paper concluded: “The results of this interim analysis demonstrate
that patients undergoing surveillance with BIS had reduced but
non-statistically significant reductions in the rates of progression
requiring CDP compared with TM. These results are currently supportive
of the need for subclinical detection and early intervention for
patients with BCRL, with a 10% absolute reduction and 67% relative
reduction in the rates of CDP. Further data with a longer follow-up than
in this study is expected in the years to come and will strengthen these
early, positive, practice-changing results.”

The manuscript was published in the Annals of Surgical Oncology,
the most cited surgical oncology journal. It is also one of the most
cited surgical journals in the world, with nearly 14,000 citations in
2016 to articles published within the last five years.

A copy of the manuscript is available here.

Dr. Ridner states, “These early findings mean that the majority of women
could potentially avoid this debilitating condition if BIS screening
were the norm. My hope is that someday every breast cancer patient at
risk will have access to this valuable tool.”

Academy award winning actress and LE&RN spokesperson, Kathy Bates
presented the keynote address at the meeting, speaking on her personal
journey with lymphedema. She advocated for pre-operative measures and
post-surgical prospective monitoring with L-Dex. Bates says, “Patients
can now take advantage of technology like L-Dex by ImpediMed….to measure
lymph flow prior to surgery and after to determine if there are any
changes indicating that a patient is at risk to develop lymphedema
because the earlier one starts the better the outcome.”

Richard Carreon, managing director and CEO, ImpediMed, says, “We now
have the evidence from a randomized controlled trial that supports the
findings from multiple real-world studies that the use of BIS in a
prospective surveillance model does improve patient outcomes. We are
confident that we will reach the study endpoint as the current data
represents less than half the patients and with only 1/3 of the follow
up duration completed.”

About ImpediMed

Founded and headquartered in Brisbane, Australia, with U.S. and European
operations, ImpediMed is the world leader in the design and manufacture
of medical devices employing bioimpedance spectroscopy (BIS)
technologies for use in the non-invasive clinical assessment and
monitoring of tissue composition and fluid status. ImpediMed produces a
family of FDA cleared and CE Marked medical devices, including SOZO® for
multiple indications, including heart failure and lymphedema, sold in
select markets globally. Visit www.impedimed.com.

About BIS

Bioimpedance spectroscopy (BIS) differs fundamentally from other
bioimpedance approaches. ImpediMed’s BIS devices measure impedance at
256 different frequencies over a full spectrum from 3 kHz to 1000 kHz
and do not depend upon population-specific prediction equations to
generate fluid volumes or tissue masses. ImpediMed’s BIS technology does
not assume that extracellular fluid (ECF) and intracellular fluid (ICF)
are uniformly distributed. Therefore, this technique provides a more
direct and individualized measure of ECF, ICF, and total body water
(TBW) compartments of the body compared with other approaches. This has
significant advantages, particularly in-patient populations with altered
fluid homeostasis.

Abbreviations:

BCRL – breast cancer related lymphedema
BIS – bioimpedance
spectroscopy
CDP – complex decongestive physiotherapy
LE&RN –
the Lymphatic Education and Research Network
TM – tape measure

Contacts

Media:
CPR Online
Laura Carabello
lcarabello@cpronline.com
201.641.1911
x12

Australian:
WE Buchan
Kyahn Williamson
kwilliamson@we-buchan.com
+613
8866 1214