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Redefining the way we manage blood pressure

by Kyle Miller, M.D., M.B.A.

Bold has developed diagnostic wristbands with optical biosensors to measure blood pressure in real-time for long-term unobtrusive monitoring.

Chicago, IL Medical Device

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About this project

The problem we solve:
High blood pressure or hypertension affects more than 80 million in the United States. Hypertension is the leading risk factor for coronary artery disease, stroke, heart failure and chronic kidney disease. Nearly 70% of all healthcare expenditures ($170 B) in the United States are spent managing complications resulting from uncontrolled blood pressure. Notably, high blood pressure is a modifiable risk factor that can be managed with adequate monitoring. Despite the overarching implications, blood pressure monitoring remains limited by poor diagnostic solutions like the traditional blood pressure cuff that provides inaccurate and infrequent measurements confounded by procedural limitations. Inaccurate measurements lead to uncontrolled blood pressure, a $45B problem for our healthcare system. There remains a clinical need for an accurate long term noninvasive blood pressure monitoring device that can fit into the patient's lifestyle.

About our solution:
Bold has developed diagnostic wristbands with optical biosensors to measure blood pressure in real-time for long-term unobtrusive monitoring. The wristbands seamlessly record blood pressure measurements and generate daily reports that are integrated into the patient portal for remote viewing by the clinician. The Bold Bands utilizes a set of pulse waveform sensors to determine the difference in pulse wave arrival times between the right and left hands to obtain real-time blood pressure trends. Preliminary clinical studies demonstrate a consistent difference in pulse arrival times and a strong correlation to changes in blood pressure. Bold Diagnostics is currently conducting a clinical validation study (n=200) under an approved IRB protocol at Northwestern Memorial Hospital to formulate a predictive algorithm that relates DPAT to a clinically relevant absolute blood pressure.
Progress to date: The company's patent pending technology, Differential Pulse Arrival Time, has been implemented with a set of pulse waveform sensors that use light emitting and detecting diodes to determine the difference in pulse wave arrival times between the right and left hands. We have developed a working prototype and conducted preliminary clinical studies that demonstrate proof of concept. The clinical study (n=10) compared DPAT measurements at rest and in response to various environmental stressors known to affect blood pressure. The preliminary study demonstrated (i) a consistent difference in pulse arrival times between the right and left hands and (ii) a strong correlation between DPAT and blood pressure. Study results suggest DPAT is a viable method for continuously measuring blood pressure.

About Our Team


Dr. Kyle Miller, M.D., M.B.A.
General Surgery , Resident
Location: Chicago, Illinois
Medical school: Texas Tech University Health Sciences Center
Bio: Dr. Miller received his BA in Chemistry (Phi Beta Kappa), Medical Degree and MBA in Health Organization Management from Texas Tech University and Texas Tech University Health Sciences Center. He is currently in training as a general surgery resident at Northwestern Memorial Hospital where he is a Clinical Fellow in the Northwestern University Center for Device Development. He is a passionate entrepreneur and medical illustrator.
Practice: Northwestern McGaw
Hospital Affiliation: Northwestern Memorial Hospital
Title: Chief Operating Officer
Twitter: @kylemillermd
LinkedIn: kylemillermd

About Team Members

Jay Pandit
Chief Medical Officer, M.D.
Biography: Dr. Jay Pandit received his undergraduate training in biological sciences and cultural anthropology at Stanford University. He attended University of California San Francisco for medical school and his internal medicine residency training. During his cardiovascular disease fellowship training at Northwestern University, he continues to pursue his interest in the intersection of health technology and patient care.
Twitter: @jpandit1984
Sean Connell
Chief Executive Officer, PhD
Biography: Dr. Sean Connell received his B.S. from the Wallace H. Coulter Department of Biomedical Engineering at the Georgia Institute of Technology and his PhD at the Weldon School of Biomedical Engineering at Purdue University.Prior to joining the Bold as the CEO, Dr. Connell served as the President and co-founding member of the biotechnology company Medtric that was responsible for developing a novel antimicrobial therapeutic for advanced wound care.
Andrew Wu*
Chief Technology Officer, M.S.
Biography: Mr. Andrew Wu received his BS in Biomedical Engineering at Georgia Institute of Technology and his MS in Biomedical Engineering at Northwestern University. He was a 2013 recipient of the “Fifty for the Future” award by Illinois Technology Foundation.

About Our Company


Bold Diagnostics, LLC
Location: Chicago, Illinois
Website: http://bolddiagnostics.com
Twitter: @bolddiagnostics.com
Product stage: proto
Sales: Working on it
Employees: 3-5

How We Help Patients

Bold has developed wearable diagnostic wristbands with optical biosensors based on our patent pending technology to measure blood pressure in real-time for long-term unobtrusive monitoring. The wristbands will provide a comfortable solution that fits into the patient’s lifestyle without negatively impacting routines to ensure compliance. Bold Diagnostics’ monitoring solution provides intelligent decision-based diagnostics for physician's while giving patients behavioral insight. Our solution will help patients and their physicians optimize blood pressure to ensure proper management and prevent the devastating consequences of uncontrolled hypertension.

How We Help Education

The Bold Diagnostics' monitoring solution will give physicians long-term, accurate blood pressure data in which they have never had access to. For the first time, doctors will have insight into a patient's blood pressure and how it's affected by work, stress, exercise and sleep. The data will be passively obtained which is the most critical component for physician education. Without having to utilize a cuff which elicits a sympathetic response and makes patients aware that their blood pressure is being taken, the Bold wearable diagnostic wristbands will provide rich, powerful data to advance our knowledge of blood pressure and its true effects on the cardiovascular system with influences from our environments.

How We Help Physicians

There remains a clinical need for a noninvasive, unobtrusive monitoring system that can acquire accurate blood pressure measurements with greater frequency. Our team interviewed more than 95 physicians that deal with hypertension and they agreed that we lack the tools to adequately manage hypertension. With our patent pending platform that provides long-term, accurate blood pressure trends with reports that are seamlessly uploaded to the patient's electronic medical record, doctors will finally have a tool that takes the guesswork out of hypertension management. Physicians will have comprehensive reports with alerts triggered to help reduce intervention times while aiding with medication titration. Most importantly, physicians will have an efficient tool they can prescribe to help reduce the labor-intensive process of having patients return to clinic for singular, discrete measurements with an inadequate cuff based system.

Challenge Mission

Mission: The Bold team is a unique example of the biodesign innovation process that occurs when physicians and biomedical engineers team up to take an innovative idea from benchtop to bedside to impact lives.
Use of funds: Our team would utilize the funds to further product development as we progress towards a beta prototype device. In addition, we would use the grant to aid with IP portfolio development and prepare our regulatory submission.
Intellectual Property Status: DPAT is currently protected by a provisional patent filing (Application Number: US/62/240,360) with an effective priority date of October 12th, 2015. We have received an exclusive option agreement from Northwestern University to negotiate an exclusive wor
FDA Status: Bold anticipates regulatory clearance through the FDA 510(k) process as based on predicate devices (Visi Monitoring System by Sotera – K112478). Clearance requires demonstration of safety and efficacy with conformance to the SP10 standard or sufficient comparison testing with a predicate device as dictated in CFR 870.1130. Regulatory efforts will be led by Sean Connell, PhD, RAC (Executive Officer), a certified regulatory affairs professional and supported by EdgeOne Medical (Chicago, IL).
Personal Message: Bold has the right team to take move patent pending technology forward. We are redefining how blood pressure is managed. We hope that you share our Bold vision and will support our team!

Supporters

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    05/09/2016 Rebecca Groeninger - Other

    Liked the project.

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    05/04/2016 Sagar Chawla - Medical Student

    Liked the project.

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    05/02/2016 Panagiotis Baziotopoulos - Other

    Followed the project.

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    05/02/2016 Panagiotis Baziotopoulos - Other

    Liked the project.

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    04/30/2016 Mohitkumar Ardeshana - Private

    Liked the project.

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    04/28/2016 Shraddha Kansagra - Pharmacist

    Liked the project.

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    04/28/2016 Shraddha Kansagra - Pharmacist

    Followed the project.

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    04/28/2016 Shraddha Kansagra - Pharmacist

    Interested in trying the project.

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    04/25/2016 Sumaiya Iqbal - Resident

    Liked the project.

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    04/23/2016 Alex Fair - Investor

    Liked the project.

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    04/22/2016 Mr. ASASD ASFSADF - Physician

    Followed the project.

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    04/22/2016 Mr. ASASD ASFSADF - Physician

    Interested in trying the project.

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41

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Kyle Miller, M.D., M.B.A.
Physician
Chief Operating Officer
Texas Tech University Health Sciences Center

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