Longeveron Partners with Kinesiometrics to Create and Implement Cutting-Edge Smart Phone App to Measure Physical Responses to Cell Therapy
September 13 2021 - 9:19AM
Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or
"Company"), a clinical stage biotechnology company developing its
proprietary product, Lomecel-B, and other cellular therapies for
chronic aging-related and life-threatening conditions, has entered
into an agreement with Kinesiometrics Inc., (“Kinesiometrics”) to
provide a cutting-edge, digital data-driven solution for objective
real-time measurement of functional capacity and quality of life in
Longeveron’s clinical studies. The data is accessible to Longeveron
and recipients of Lomecel-B via an Application downloadable on the
subjects’ mobile phones.
Longeveron recently announced the results of a
Phase 2b Aging Frailty study, which showed that frail subjects
(average age for study was 75.2 years) with impaired mobility could
walk nearly 50 meters further 180 days after a single intravenous
infusion of Lomecel-B (200 million Lomecel-B group; p=0.0065). This
increase was durable, persisting through 270 days (200 million
Lomecel-B group change from baseline 47.9 meters; p=0.0115, and
p<0.0077 compared to placebo). By comparison, the
placebo-treated subjects change from baseline at 180 days and 270
days was 8.0 meters (p=0.5371) and -15.5 meters (p=0.2728),
respectively.
Kinesiometrics will provide Longeveron with a
patented Software as a Solution (SaaS), mobile-phone based platform
that can collect not only years of historical data regarding a
subject’s activity levels via steps, distance walked, flights
climbed and energy expenditure, but also real-time response
information for comparison of activity level changes pre- and
post-Lomecel-B infusion. This vital data may be used to understand
and gauge outcomes of treatment regimens, and information is
presented in an easy to understand and compelling graphical format.
With the Kinesiometrics technology, activity levels can be provided
continuously, rather than relying solely on single time points
throughout the follow-up period. This could provide rapid
understanding of the effect of Lomecel-B and has the potential to
reduce the number of protocol-specific visits a research subject
needs to make to the clinic.
“Both walking speed and walking distance are
highly accurate clinical indicators of overall health in older
people, as well as powerful predictors of survival,” said Dr. Kevin
Ramdas, Director of Clinical Affairs at Longeveron. “With this new
tool, we will get a richer and more comprehensive understanding of
a subject’s functional performance before and after infusion with
Lomecel-B.”
“We are extremely excited about the
collaboration with Kinesiometrics as it fits perfectly with our
strategic vision to develop biological solutions for aging,” said
Geoff Green, CEO of Longeveron. “The Kinesiometrics platform has
the potential to help us advance our clinical development program
and gain greater insights into how Lomecel-B impacts patient’s
quality of life and functional capacity. The new data generated may
help with FDA regulatory filings and is highly consistent with the
introduction of digital wearable technology into advancement of
novel therapeutic strategies.”
Dr. Michael Wang, a co-founder of Kinesiometrics
and Chief of Neurosurgery at the University of Miami Hospital
commented, “We have been looking for a partner that understands the
need to use novel and modern digital methods to accelerate how
patient outcomes are measured. Longeveron understands the core
value of using data visualization that allows clinicians to
identify critical inflection points and setbacks during a patient’s
recovery phase, and we look forward to working with Longeveron to
achieve the goal of helping patients increase in their functional
capacity and quality of life.”
About Longeveron Inc.
Longeveron is a clinical stage biotechnology
company developing cellular therapies for specific aging-related
and life-threatening conditions. The Company’s lead investigational
product is the LOMECEL-B™ cell-based therapy product (“Lomecel-B”),
which is derived from culture-expanded medicinal signaling cells
(MSCs) that are sourced from bone marrow of young, healthy adult
donors. Longeveron believes that by using the same cells that
promote tissue repair, organ maintenance, and immune system
function, it can develop safe and effective therapies for some of
the most difficult disorders associated with the aging process and
other medical disorders. Longeveron is currently sponsoring Phase 1
and 2 clinical trials in the following indications: Aging Frailty,
Alzheimer’s disease, the Metabolic Syndrome, Acute Respiratory
Distress Syndrome (ARDS), and hypoplastic left heart syndrome
(HLHS). The Company’s mission is to advance Lomecel-B and other
cell-based product candidates into pivotal Phase 3 trials, with the
goal of achieving regulatory approvals, subsequent
commercialization and broad use by the healthcare community.
Additional information about the Company is available at
www.longeveron.com.
About Kinesiometrics Inc.
Kinesiometrics has created a smartphone-based
application to enhance our understanding of the post-surgical and
post-treatment for patients. Based on thousands of data points,
artificial intelligence will guide the intervention decision-making
and recovery process. By partnering with academic medical centers,
medical device, pharmaceutical, and insurance companies, we are
conducting multiple trials to delineate the relationship between
objective physical activity data, and patient outcome as well as
its effect on the overall health economics. The raw
accelerometer data gleaned from the patients’ smartphones is fully
encrypted and Health Insurance Portability and Accountability Act
(HIPAA) compliant and uses machine learning algorithms for
output.
Cautionary Note Regarding
Forward-Looking Statements
Certain statements in this press release that
are not historical facts are forward-looking statements that
reflect management's current expectations, assumptions, and
estimates of future performance and economic conditions, and
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"on condition," "target," "see," "potential," "estimates,"
"preliminary," or "anticipates" or the negative thereof or
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other future events, circumstances, or effects. Moreover,
forward-looking statements in this release include, but are not
limited to, statements about the ability of our clinical trials to
demonstrate safety and efficacy of our product candidates, and
other positive results; the timing and focus of our ongoing and
future preclinical studies and clinical trials; the size of the
market opportunity for our product candidates, the beneficial
characteristics, safety, efficacy and therapeutic effects of our
product candidates; our ability to obtain and maintain regulatory
approval of our product candidates, our plans and ability to obtain
or protect intellectual property rights, including extensions of
existing patent terms where available and our ability to avoid
infringing the intellectual property rights of others. Further
information relating to factors that may impact the Company's
results and forward-looking statements are disclosed in the
Company's filings with the Securities and Exchange Commission. The
forward-looking statements contained in this press release are made
as of the date of this press release, and the Company disclaims any
intention or obligation, other than imposed by law, to update or
revise any forward-looking statements, whether as a result of new
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Contact:Brendan PayneStern
Investor RelationsTel: (212) 362-1200Email:
Brendan.payne@sternir.com
Kinesiometrics
Contactinfo@kinesiometrics.org
Source: Longeveron IncSource: LGVN
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