INNOVATE Corp. (NYSE: VATE) (“INNOVATE” or the “Company”) announced
today that the U.S. Food and Drug Administration (FDA) has approved
the MediBeacon® TGFR for the assessment of kidney function in
patients with normal or impaired renal function.
The TGFR is comprised of the TGFR Sensor, TGFR Monitor, and
Lumitrace® (relmapirazin) injection, a non-radioactive,
non-iodinated fluorescent GFR tracer agent, which together allow
assessment of kidney function by measuring the clearance rate of
the fluorescent agent as it leaves the body. The system records
Lumitrace fluorescence intensity transdermally as a function of
time via a sensor placed on the skin. The TGFR Sensor records 2.5
fluorescent readings per second and the TGFR Monitor will display
the average session tGFR reading at the patient’s bedside or in the
outpatient setting.
The TGFR is validated for use in the assessment of Glomerular
Filtration Rate (GFR) in patients with stable kidney function at
the point of care. The TGFR utilizes an intravenous Lumitrace
injection but does not require blood draws or urine analysis,
unlike current methodologies requiring multiple blood draws or
urine samples. In addition, current clinical practice measured GFR
(mGFR) assessment requires sophisticated clinical laboratory
analysis away from the patient’s point of care.
“The development of a system such as the TGFR that assesses a
patient’s kidney function without the need to use estimating
equations is an important milestone for the nephrology community,”
said Dr. Mitchell Rosner, chair of the Department of Medicine at
University of Virginia and a highly regarded expert who has
authored numerous articles on the challenges of assessing kidney
function. “We are excited to explore applications of the
transdermal GFR methodology in patients where current clinical
practice is understood to be suboptimal.”
Dr. Pierre Galichon, an active kidney researcher at the Sorbonne
Université and an attending physician in kidney transplantation at
Pitié-Salpêtrière Hospital in Paris, said: “It has long been a
challenge to understand kidney function in the context of its
interaction with other vital organs, such as the heart and lungs.
My experience with MediBeacon products in preclinical use, as
relayed in Scientific Reports,2 has been exciting, and I look
forward to evaluating how transdermal GFR can be applied in
clinical practice.”
“The approval of the TGFR by the FDA demonstrates our
proprietary system can provide an effective option for assessing
kidney function,” said Steve Hanley, CEO of MediBeacon. “According
to the National Kidney Foundation, CKD causes more deaths each year
than breast cancer or prostate cancer. It is the under-recognized
public health crisis.3 The potential applications for the TGFR are
numerous, and we look forward to exploring them with clinicians
both in the hospital and outpatient settings.”
The timing of FDA approval aligns well with the Q4 2024
publication by MediBeacon’s Chief Scientific Officer, Dr. Richard
Dorshow, et al. in Kidney International with data that supports the
utility of MediBeacon’s patented agent Lumitrace®.
The TGFR met its primary efficacy endpoint as per agreement with
the FDA by demonstrating a P30 value of 94% while recruiting
patients with a range of GFR values and skin tones. P30 is defined
as the percentage of GFR estimation falling within +/- 30% of
measured GFR (mGFR) values.
P30 Value |
Upper 95% Confidence Bounds |
Lower 95% Confidence Bounds |
94.0% |
96.9% |
89.4% |
In clinical studies no serious or severe adverse events have
been observed. For more information, including the FDA Summary of
Safety and Effectiveness Data, please refer to www.fda.gov.
About INNOVATEINNOVATE Corp. is a
portfolio of best-in-class assets in three key areas of the new
economy – Infrastructure, Life Sciences and Spectrum. Dedicated to
stakeholder capitalism, INNOVATE employs approximately 4,000 people
across its subsidiaries. For more information, please
visit: www.INNOVATECorp.com.
About MediBeacon Inc.MediBeacon is a medical
technology company specializing in the advancement of fluorescent
tracer agents and their transdermal detection. MediBeacon’s use of
proprietary fluorescent tracer agents coupled with transdermal
detection technology focuses on providing vital and actionable
measurement of organ function. MediBeacon owns over 55 granted U.S.
patents and over 215 granted patents worldwide that provide
extensive coverage of the MediBeacon® TGFR, including Lumitrace®
injection, the sensor and algorithms, as well as other strategic
uses of its proprietary pyrazine platform and sensor technology.
The TGFR is approved for human use. Potential technology
applications in gastroenterology, ophthalmology and surgery are in
various stages of clinical development. MediBeacon is based in St.
Louis, Missouri, with additional operations in Mannheim, Germany.
For more information, please visit: www.medibeacon.com.
About Lumitrace® (relmapirazin)
injectionRelmapirazin is a non-radioactive, non-iodinated
pyrazine-based compound, which has been engineered to be inert,
highly fluorescent and have the clearance properties of a GFR
tracer agent in the body. Lumitrace injection has been administered
to over 850 subjects under Investigational Device Exemptions
(IDEs). The unique photophysical characteristics of Lumitrace have
been designed to enable the collection of fluorescence data via a
photodetector sensor placed on the skin. Data collected by the
sensor measures the change in the intensity of Lumitrace
fluorescence over time and is converted into a transdermal GFR
(tGFR) by proprietary algorithms. As noted above, in a phase 2
investigational study mGFR deduced from Lumitrace matched that of
mGFR deduced from iohexol over a range of GFR values. See the peer
reviewed article published in the October 2024 issue of Kidney
International4 by Dorshow et al.
Forward-Looking StatementsCertain statements in
this press release may constitute “forward-looking statements”
within the meaning of the federal securities laws. Forward-looking
statements generally relate to future events, such as the expected
timing of the reverse stock split, the impact of the reverse stock
split on the Company’s share price, and the Company’s ability to
meet the minimum per share bid price requirement for continued
listing on the NYSE. You are cautioned that such statements are not
guarantees of future performance and that INNOVATE’s actual results
may differ materially from those set forth in the forward-looking
statements. All of these forward-looking statements are subject to
risks and uncertainties that may change at any time. Factors that
could cause INNOVATE’s actual expectations to differ materially
from these forward-looking statements include INNOVATE’s ability to
continue to comply with applicable listing standards of the NYSE
and the other factors under the heading “Risk Factors” set forth in
INNOVATE’s Annual Report on Form 10-K, as supplemented by
INNOVATE’s quarterly reports on Form 10-Q. Such filings are
available on our website or at www.sec.gov. You should not place
undue reliance on these forward-looking statements, which are made
only as of the date of this press release. INNOVATE undertakes no
obligation to publicly update or revise forward-looking statements
to reflect subsequent developments, events, or circumstances,
except as may be required under applicable securities laws.
Investor Contact:Solebury Strategic
CommunicationsAnthony Rozmusir@innovatecorp.com (212) 235-2691
IMPORTANT SAFETY INFORMATION FOR TGFR
Indication for Use:The MediBeacon® Transdermal GFR
System (TGFR) is intended to assess the Glomerular Filtration Rate
(GFR) in adult patients with impaired or normal renal function by
noninvasively monitoring fluorescent light emission from an
exogenous tracer agent over time. The MediBeacon TGFR consists of a
monitor and a sensor, which are to be used with the Lumitrace®
tracer only. This device has been validated in patients with stable
renal function.
The MediBeacon TGFR is not approved for use in patients with GFR
<15ml/min/1.73m2, GFR >120ml/min/1.73m2, patients on dialysis
or anuric patients. The use of this device in patients with dynamic
and rapidly changing renal function has not been validated. This
device is not intended to diagnose acute kidney injury (AKI).
Contraindications: There are no known
contraindications.
Warnings and Precautions:
- See ifu.medibeacon.com for full instructions, warnings, and
cautions.
- In clinical studies no serious or severe adverse events have
been observed.
- Lumitrace® injection has light absorbance at 266nm and 435nm,
and broad fluorescent emission at ~560nm when excited at ~440nm.
Any drug activated at these wavelengths should not be used in
conjunction with Lumitrace.
- Lumitrace injection may interfere with clinical laboratory
tests. DO NOT ADMINISTER if the patient is expected to need
clinical laboratory testing while Lumitrace is present in their
system (up to 72 hours for renally-impaired patients). The presence
of Lumitrace decreased B-Type Natriuretic Peptide (BNP) results by
around 20% in limited testing.
- Bolus infusions may impact the GFR assessment temporarily while
the vasculature-tissue equilibrium is re-established.
- During a TGFR session, the patient should be as still as
possible, especially during the “Establishing Baseline” stage. The
current system is designed to compensate for light activity such as
reading or eating after the Baseline stage.
1 Epidemiology of chronic kidney disease: an update 2022, Kidney
International Supplement, 2022 Apr;12(1):7-11.doi:
10.1016/j.kisu.2021.11.003., Csaba P Kovesdy2 Pulmonary
hypertension without heart failure causes cardiorenal syndrome in a
porcine model, Scientific Reports (2023) 13:9130, Orieux et
al, doi.org/10.1038/s41598-023-36124-13 National Kidney
Foundation, Fast Facts (2024 Update), Updated as of
8/6/20244 Clinical validation of the novel fluorescent
glomerular filtration rate tracer agent relmapirazin (MB-102),
Kidney International, Volume 106, Issue 4, P679-687, October 2024,
DOI: 10.1016/j.kint.2024.06.012
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