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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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