Lexington Biosciences Inc. (OTCQB: LXGTF)(CSE: LNB)
Breaking News
December 7, 2017
LEXINGTON HIRES MEDICAL DEVICE REIMBURSEMENT EXPERTS
Company engages Navigant Consulting to formulate strategy for coverage policy
Vancouver, British Columbia --December 7, 2017 – Lexington Biosciences, Inc.
(CSE: LNB) (OTCQB:
LXGTF) (the
“Company” or “Lexington”), a development-stage medical device company, is
pleased to announce entry into a strategic business relationship with a San
Francisco arm of Navigant Consulting Inc., formerly Quorum Consulting.
The intent of the relationship is to work with the relevant authorities towards
developing a coverage policy in support of the planned commercial rollout of
Lexington’s HeartSentry endothelial function measurement product.
Navigant Consulting is a specialized professional services firm based in
Chicago, Illinois. The company has nearly 50 offices across the United States,
Canada, Europe, Middle East and Asia. Navigant recently acquired
Quorum Consulting, a San
Francisco based specialist service provider with extensive experience in the
field of medical device reimbursement and health economics. Services include a
proven ability to define strategic business opportunities and of influencing
global coverage and payment policies. For more information, visit:
www.navigant.com .
Lexington’s President Eric Willis comments, “As recently announced, we are
moving ahead quickly towards the commencement of our HeartSentry pilot clinical
research study designed to build the foundational dataset ultimately aimed at
supporting FDA clearance. As we plan for market entry, we know that a key
element to commercial success will come
from fielding a product that meets the threshold for medical insurance coverage.
Regulatory approval rarely guarantees payment coverage for new devices, so we
are undertaking what we believe is the prudent strategy of beginning that
process today. We are delighted to have the opportunity to work with the
Navigant team and feel certain the advice and direction we receive will prove
invaluable towards providing HeartSentry the best strategy for market
introduction.”
To find out more about Lexington Biosciences, interested readers are invited to
visit our website and
view our video
featuring principal HeartSentry inventor Dr. Jonathan Maltz, Ph.D., which
provides an excellent overview of our business proposition and opportunity
ahead. Please also follow us on
Facebook,
Twitter and
LinkedIn.
About Lexington Biosciences, Inc. (CSE: LNB / OTCQB: LXGTF)
Lexington Biosciences is a medical device company developing the HeartSentry, a
new non-invasive diagnostic device to measure and monitor cardiovascular health
by assessing the function of a person’s vascular endothelium - the vital
innermost lining of a person’s cardiovascular system. Currently, the standard of
care is measurement using expensive external ultrasound by a highly trained
technician. The HeartSentry core technology was developed at the University of
California Berkeley over a fifteen-year R&D period involving many research
studies and product iterations resulting in a portfolio of multiple pending and
issued patents licensed to the company. Our aim is to make HeartSentry accurate,
quick, and cost effective so it can become the standard of care for
cardiologists, general practitioners, and ultimately patients for first line
evaluation of a person’s cardiovascular health. Lexington is engaged with the US
FDA and other regulatory agencies on the required product approvals for the
HeartSentry. For more information about the company please visit: https://lexingtonbiosciences.com/.
Eric Willis
CEO & Director
CAUTIONARY DISCLAIMER STATEMENT: The Canadian Securities Exchange has not
reviewed and does not accept responsibility for the adequacy or accuracy of the
content of this news release.
This news release contains forward-looking statements relating to the completion
of the listing of the Company’s shares on the Canadian Securities Exchange and
other statements that are not historical facts. Forward-looking statements are
often identified by terms such as "will", "may", "should", "anticipate",
"expects" and similar expressions. All statements other than statements of
historical fact, included in this release are forward-looking statements that
involve risks and uncertainties. There can be no assurance that such statements
will prove to be accurate and actual results and future events could differ
materially from those anticipated in such statements. Important factors that
could cause actual results to differ materially from the Company's expectations
include the failure to satisfy the conditions of the Canadian Securities
Exchange and other risks detailed from time to time in the filings made by the
Company with securities regulations.
The reader is cautioned that assumptions used in the preparation of any
forward-looking information may prove to be incorrect. Events or circumstances
may cause actual results to differ materially from those predicted, as a result
of numerous known and unknown risks, uncertainties, and other factors, many of
which are beyond the control of the Company. The reader is cautioned not to
place undue reliance on any forward-looking information. Such information,
although considered reasonable by management at the time of preparation, may
prove to be incorrect and actual results may differ materially from those
anticipated. Forward-looking statements contained in this news release are
expressly qualified by this cautionary statement. The forward-looking statements
contained in this news release are made as of the date of this news release and
the Company will update or revise publicly any of the included forward-looking
statements as expressly required by applicable law.
CONTACT:
Lexington Biosciences, Inc.
+1 (800) 320-2640
info@lexingtonbiosciences.com
www.lexingtonbiosciences.com
Renmark Financial Communications Inc.
Laura Welsh: lwelsh@renmarkfinancial.com
Tel: (416) 644-2020 or (514) 939-3989
www.renmarkfinancial.com
SOURCE Lexington Biosciences, Inc.
Lexington Biosciences Engages
Clinical Research Organization
HeartSentry advances to pilot
clinical studies with world class research team
Vancouver, British Columbia --Nov 30, 2017 – Lexington Biosciences, Inc.
(CSE: LNB) (OTCQB:
LXGTF) (the
“Company” or “Lexington”), a development-stage medical device company, is
pleased to announce the engagement of San Francisco Bay Area-based Diablo
Clinical Research to conduct its upcoming HeartSentry pilot clinical studies.
Lexington recently announced delivery of its initial order of HeartSentry
devices slated for clinical trials. With today's announcement, plans are now
advancing to initiate commencement of a pilot clinical research study designed
to begin gathering the foundational dataset aimed at supporting FDA clearance.
Diablo Clinical Research has specialized in clinical research for over 22 years.
Founded in 1995, Diablo's team has conducted over 600 studies with thousands of
patients and in the process, has assembled a database comprising over
15,000 patients who have either completed a study, are currently enrolled in a
study, or have expressed interest in future clinical study participation. The
firm has 4 MDs on staff with specialties in endocrinology, internal medicine,
and cardiology. Find out more at: www.diabloclinical.com.
Dr. Geoff Tison, Cardiologist and Assistant Professor in the Division of
Cardiology at the University of California San Francisco and Medical Advisor to
the company comments, "After a fifteen-year research process, I am excited to
see Lexington beginning their clinical research efforts in order to gather
clinical study data for the HeartSentry device. With the recent publication of
the more stringent American Heart Association hypertension management
guidelines, there is increased awareness of the need to more closely monitor
patients for cardiovascular risk factors, which HeartSentry is well positioned
to do."
Lexington's President Eric Willis comments, "After nine months of concerted
effort by our design and production team, the arrival of our first human-use
HeartSentry devices allows us to accelerate our plans to move ahead with our
pilot study. Diablo Clinical Research is a proven and respected establishment
with the capability to launch our research program efficiently and
cost-effectively. They have been extremely helpful in the determination process
which has led to today's announcement. We are excited to begin this next step of
our development phase, and look forward to sharing quantifiable results in the
near future.
To find out more about Lexington Biosciences, interested readers are invited to
visit our website and view our video featuring principal HeartSentry inventor
Dr. Jonathan Maltz, Ph.D., which provides an excellent overview of our business
proposition and opportunity ahead.
About Lexington Biosciences, Inc. (CSE: LNB) (OTCQB: LXGTF)
Lexington Biosciences is a medical device company developing the HeartSentry, a
new non-invasive diagnostic device to measure and monitor cardiovascular health
by assessing the function of a person's vascular endothelium -- the vital
innermost lining of a person's cardiovascular system. Currently, the standard of
care is measurement using expensive external ultrasound by a highly trained
technician. The HeartSentry core technology was developed at the University of
California Berkeley over a fifteen-year R&D period involving many research
studies and product iterations resulting in portfolio of multiple pending and
issued patents licensed to the company. By taking delivery of the clinical trial
ready HeartSentry units the company will commence studies as soon as possible.
Our aim is to make HeartSentry accurate, quick, and cost effective so it can
become the standard of care for cardiologists, general practitioners, and
ultimately patients for first line evaluation of a person's cardiovascular
health. Lexington is engaged with the US FDA and other regulatory agencies on
the required product approvals for the HeartSentry. For more information about
the company please visit: https://lexingtonbiosciences.com/.
Eric Willis
CEO & Director
CAUTIONARY DISCLAIMER STATEMENT: The Canadian Securities Exchange has not
reviewed and does not accept responsibility for the adequacy or accuracy of the
content of this news release.
This news release contains forward-looking statements relating to the completion
of the listing of the Company's shares on the Canadian Securities Exchange and
other statements that are not historical facts. Forward-looking statements are
often identified by terms such as "will", "may", "should", "anticipate",
"expects" and similar expressions. All statements other than statements of
historical fact, included in this release are forward-looking statements that
involve risks and uncertainties. There can be no assurance that such statements
will prove to be accurate and actual results and future events could differ
materially from those anticipated in such statements. Important factors that
could cause actual results to differ materially from the Company's expectations
include the failure to satisfy the conditions of the Canadian Securities
Exchange and other risks detailed from time to time in the filings made by the
Company with securities regulations.
The reader is cautioned that assumptions used in the preparation of any
forward-looking information may prove to be incorrect. Events or circumstances
may cause actual results to differ materially from those predicted, as a result
of numerous known and unknown risks, uncertainties, and other factors, many of
which are beyond the control of the Company. The reader is cautioned not to
place undue reliance on any forward-looking information. Such information,
although considered reasonable by management at the time of preparation, may
prove to be incorrect and actual results may differ materially from those
anticipated. Forward-looking statements contained in this news release are
expressly qualified by this cautionary statement. The forward-looking statements
contained in this news release are made as of the date of this news release and
the Company will update or revise publicly any of the included forward-looking
statements as expressly required by applicable law.
CONTACT: Lexington Biosciences, Inc.
+1 (800) 320-2640
info@lexingtonbiosciences.com
www.lexingtonbiosciences.com
Renmark Financial Communications Inc.
Laura Welsh: lwelsh@renmarkfinancial.com
Tel: (416) 644-2020 or (514) 939-3989
www.renmarkfinancial.com
Source: Lexington Biosciences, Inc.
Lexington Biosciences Receives
HeartSentry Trial Units
Vancouver, British Columbia --Oct 31, 2017 – Lexington Biosciences, Inc.
(CSE: LNB) (OTCQB:
LXGTF) (the
“Company” or “Lexington”), a development-stage medical device company, is
pleased to announce receipt of the first HeartSentry human-use units from its
manufacturer.
Company President Eric Willis comments, "We are delighted to take delivery of
these first HeartSentry human-use units from our manufacturer. The design and
production team have worked for nine months to perfect the HeartSentry
technology and device design, and we have achieved a significant milestone by
moving the HeartSentry out of the lab and
into a hand-held mobile unit ready for clinical trials. We look forward to being
able to commence study enrollment in our upcoming HeartSentry clinical study in
order to gather the foundational dataset aimed at supporting FDA clearance. To
find out more about Lexington Biosciences, I invite interested readers to visit
our website and view our video featuring the principal HeartSentry inventor, Dr.
Jonathan Maltz, Ph.D., which provides an excellent overview of our business
proposition and opportunity ahead."
About Lexington Biosciences, Inc. (CSE: LNB) (OTCQB: LXGTF)
Lexington Biosciences is a medical device company developing the HeartSentry, a
new non-invasive diagnostic device to measure and monitor cardiovascular health
by assessing the function of a person's vascular endothelium - the vital
innermost lining of a person's cardiovascular system. Currently, the standard of
care is measurement using expensive external ultrasound by a highly trained
technician. The HeartSentry core technology was developed at the University of
California Berkeley over a fifteen-year R&D period involving many research
studies and product iterations resulting in portfolio of multiple pending and
issued patents licensed to the company. By taking delivery of the clinical trial
ready HeartSentry units the company will commence studies as soon as possible.
Our aim is to make HeartSentry accurate, quick, and cost effective so it can
become the standard of care for cardiologists, general practitioners, and
ultimately patients for first line evaluation of a person's cardiovascular
health. Lexington is engaged with the US FDA and other regulatory agencies on
the required product approvals for the HeartSentry. For more information about
the company please visit: https://lexingtonbiosciences.com/.
Eric Willis
CEO & Director
CAUTIONARY DISCLAIMER STATEMENT: The Canadian Securities Exchange has not
reviewed and does not accept responsibility for the adequacy or accuracy of the
content of this news release.
This news release contains forward-looking statements relating to the completion
of the listing of the Company's shares on the Canadian Securities Exchange and
other statements that are not historical facts. Forward-looking statements are
often identified by terms such as "will", "may", "should", "anticipate",
"expects" and similar expressions. All statements other than statements of
historical fact, included in this release are forward-looking statements that
involve risks and uncertainties. There can be no assurance that such statements
will prove to be accurate and actual results and future events could differ
materially from those anticipated in such statements. Important factors that
could cause actual results to differ materially from the Company's expectations
include the failure to satisfy the conditions of the Canadian Securities
Exchange and other risks detailed from time to time in the filings made by the
Company with securities regulations.
The reader is cautioned that assumptions used in the preparation of any
forward-looking information may prove to be incorrect. Events or circumstances
may cause actual results to differ materially from those predicted, as a result
of numerous known and unknown risks, uncertainties, and other factors, many of
which are beyond the control of the Company. The reader is cautioned not to
place undue reliance on any forward-looking information. Such information,
although considered reasonable by management at the time of preparation, may
prove to be incorrect and actual results may differ materially from those
anticipated. Forward-looking statements contained in this news release are
expressly qualified by this cautionary statement. The forward-looking statements
contained in this news release are made as of the date of this news release and
the Company will update or revise publicly any of the included forward-looking
statements as expressly required by applicable law.
CONTACT:
Lexington Biosciences, Inc.
+1 (800) 320-2640
info@lexingtonbiosciences.com
www.lexingtonbiosciences.com
Renmark Financial Communications Inc.
Laura Welsh
lwelsh@renmarkfinancial.com
Tel: (416) 644-2020 or (514) 939-3989
www.renmarkfinancial.com
Source: Lexington Biosciences, Inc.
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About Lexington Biosciences Inc. :
LLexington BioSciences Inc (CSE: LNB), aims to become a leader in the
development of clinical grade cardiovascular self-measurement solutions for home
and clinical use.
Lexington is currently taking steps to commercialize a universal, simple,
effective and revolutionary technology for personalized measurement and
monitoring of vascular health to prevent cardiovascular disease at its earliest
stages.
The device, brand named HEARTSENTRY, has been extensively tested to measure the
function of the endothelium, the cells that line all arteries and are critical
to the prevention of atherosclerosis, heart attacks and stroke, the two leading
causes of death world-wide with over 17.5 million deaths each year. *
The significant value of measuring endothelial function is supported by
thousands of peer-reviewed studies. For ease of use and familiarity, this life
saving technology has been combined into traditional blood pressure cuff
equipment.
The unit is designed to utilize Bluetooth and Cloud technology to provide
up-to-date and accurate readings of an individual’s complete cardiovascular
health via electronic monitoring for risk-assessment and treatment effectiveness
targeting the prevention of heart attack and stroke.
Our top scientific research support and prudent business leadership aims to
realize the successful introduction of this potentially disruptive technology to
directly target the unmet medical need for early detection in this rapidly
growing global marketplace.
*World Health Organization (WHO) estimate
Heart (cardiovascular) disease and stroke are the No.1 killers world-wide. - -
World Health Organization (WHO)
Nearly 1 in 3 deaths in the United States each year are caused by heart disease
and stroke.
Of the approximately 1.5 million people suffering heart attacks annually in the
U.S., more than 250,000 will die within one hour of their incident.
Nearly 1/3 of the ~ 600,000 annual cardiovascular disease deaths in the U.S.
could be prevented through changes in lifestyle habits. - Center for Disease
Control (CDC), Atlanta
Unfortunately, for up to 50% of these individuals, the FIRST SYMPTOM of coronary
artery disease is sudden cardiac death, or a heart attack.
Lexington BioSciences has developed HeartSentry as a first-in-class device for
the personalized measurement and monitoring of vascular health to identify
cardiovascular disease at its earliest stages.
HeartSentry has been extensively tested to measure the function of the
endothelium, the cells that line all arteries and are critical to the prevention
of atherosclerosis, heart attacks and stroke, the two leading causes of death
worldwide with over 17.5 million deaths each year. *
The significant value of measuring endothelial function is supported by
thousands of peer-reviewed studies. For ease of use and familiarity, this life
saving technology has been combined into traditional blood pressure cuff
equipment.
The unit is designed to communicate via Bluetooth technology to provide
up-to-date and accurate readings of an individual’s complete cardiovascular
health through electronic monitoring for cardiovascular risk-assessment and to
aid treatment effectiveness for the prevention of heart attack and stroke.
HeartSentry targets the rapidly growing self-measurement medical device sector
and is deigned for both personal and clinical use. Simplicity and functionality
are key elements of the design.
Lexington BioSciences are developers of clinical grade cardiovascular self
measurement solutions and HeartSentry is it’s flagship, and first device
currently advancing to commercial deployment.
*World Health Organization (WHO) estimate
HeartSentry: Personal Cardiovascular Health Monitor
A simple and effective device that accurately measures the function of the
endothelium.
HeartSentry is designed to efficiently measure increases in arterial volume
which occur when the endothelial cells of the artery are stimulated, and the
muscles in the wall of the artery relax.
A proprietary blood pressure cuff utilizes specialized algorithms to interpret
changes in the volume of blood in the arm. In a relaxed, dilated artery, the
volume change over the cardiac cycle is much greater than baseline levels,
typically by more than 80% in healthy subjects.
The HeartSentry inflatable cuff is outwardly identical to a standard blood
pressure cuff, but is differentiated by its advanced firmware and software which
operates a patent-protected measurement protocol.
The fully automated device is compact and inexpensive enough for commercial use
in the home care market and primary care physician offices. Its integrated
Bluetooth technology can communicate with nearby smart applications which can
act as a portal to cloud-based technologies enabling advanced ongoing monitoring
opportunities between patient and clinical care providers.
Research Results
Initial studies with 50 patients demonstrated a strong correlation to ultrasound
results. The diagnostic value of the measurement is supported by thousands of
peer-reviewed studies.
Testing
500% improved sensitivity over the current standard (ultrasound in a clinic with
a trained technician) for endothelial function measurement
A consistently higher accuracy
Much lower variability
Summary
- For at-risk individuals or post cardiac event patients.
- Improves early stage detection of heart disease.
- Monitors ongoing treatment effectiveness.
- Compact risk assessment solution – for home or clinical use.
- Critical cardiovascular health data aids prevention of atherosclerosis, heart
attacks & stroke.
- Bluetooth integrates with wearable technology.
- Simple & easy to use for consumers.
- No similar personal use system commercially available.
- Inexpensive and suitable for mass retail consumer sales.
- Technology extensively tested and proven.
Mission Statement
Lexington Biosciences seeks to create and promote a suite of meaningful data
centered cardiovascular monitoring technologies to provide patients relevant
metrics so that they can lead longer and healthier lives.
Values
Excellence. Create a challenging and dynamic environment with excellence as an
achievable goal in all we do.
Progress. Our work is focused on improving the lives of others. We believe the
tools to achieve a healthy society must improve and we intend to be a positive
part of this ongoing evolution.
Innovate. Consistently deliver exceptional products, identify clearly unmet
needs and solve them, and always seek the potential for ever better results.
Trust. Engender trust by always performing in an ethical and professional
manner.
Respect. Treat our stakeholders, investors, vendors, suppliers and future
customers as we would like to be treated ourselves.
SOURCE:https://lexingtonbiosciences.com/
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