What’s in a Name?

Creating a one of kind, brand new medical device is certainly a challenge and comes with many, many, many revisions! Throughout our development stage we have been naming the different components of our device. Though the technology evolves the name has stayed the same for our senors: the eggs!



We are extremely encouraged by the evolution of the technology and functions of “the egg” from our first prototype up to our final ” MAP” Milestone sensor.  We will begin using it to capture patient data soon!


PWV – A Reliable Measurement

“We can Measure Pulse Wave Velocity!” – Cre8MDI

“So what….”

Pulse Wave Velocity is a crucial measurement to determine the health of your arteries. Our device is simple, easy to use, and delivers a reliable measurement. Although the measurement of arterial stiffness has been validated for hundreds of years, using PWV continues to gain momentum in publications.


  • PWV citations in PubMed
    (National Library of Medicine)
  • Total > 3500 in 9 years
  • 2015 –> 940

Grant Recipient – M2D2

The UMass M2D2 $100K Challenge announced award recipients at Mintz Levin, Boston on April 6th.  Cre8MDI was honored to be recognized along with other emerging-technology companies, such as Innoblative Designs, Astraeus Technologies, Fluid-Screen, LaunchPad Medical, and Biorasis.  In all, 72 companies competed for the recognition that goes along with the opportunity to present their technologies to potential investors and others in the medical device community.

Cre8MDI was awarded Honorable Mention and a cash prize for our presentation.  We thank all the sponsors who made these grants possible and for their continued commitment to advancing health technologies.  We also thank the M2D2 program staff for their efforts to execute a successful program with all the logistics behind such an event.  Cre8MDI looks forward to the potential for future collaboration with M2D2, the UMass Lowell engineering departments, and UMass Worcester medical staff and researchers.

m2d2 awards 2016


m2d2 winners

M2D2 Award Winners – Roy Wallen of Cre8MDI on far left.

UMASS M2D2 Press Release: http://blogs.uml.edu/m2d2/2016/04/17/mintz-levin-hosts-m2d2-100k-challenge-awards-event/

M2D2 Innovation 100K Challenge

Cre8MDI  has been chosen as an M2D2 $100K Challenge finalist to make a presentation in a live pitch-off event on March 23rd. Finalists will be vying for a total of $100K in services and prizes from BD, Boston Scientific, M2D2, Mintz Levin, MPR, Omni Components, and R&Q.

Chief Business Officer, Roy Wallen, will be presenting about our Cardio 1:1 device and sharing our plans for market penetration. Winners will be announced on April 6, 2016.


The Massachusetts Medical Device Development Center (M2D2) is a lifeline for the state’s smaller medical device companies, offering inventors and executives easy, affordable, and coordinated access to world-class researchers and resources at the Lowell and Worcester campuses of the University of Massachusetts.


HEART MONTH: February 2016

Every day at Cre8MDI words like “heart, cardio, arteries, blood pressure” and more are discussed, but this is not the norm across America. Many people never consider their heart, until it’s giving them trouble. As the most important muscle in your body, your heart’s condition should be a priority in your life.

The American Red Cross has campaigned to make February “Heart Month” with WEAR RED campaigns, jump rope competitions in elementary schools, and fundraising campaigns to bring to mind the heart and its well-being. Many organizations and clinics have joined the campaign to bring heightened awareness to the general population.

The American Heart Association has defined what it means to have ideal cardiovascular health. Known as “Life’s Simple 7,” these steps can help add years to your life:

  1. Stop smoking

  2. Maintain a healthy weight

  3. Engage in regular physical activity

  4. Eat a healthy diet

  5. Manage blood pressure

  6. Take charge of cholesterol

  7. Keep blood sugar, or glucose, at healthy level

Start-up to Watch

medtechstrategistThe MedTech Strategist featured Cre8MDI as one of their “Start-ups to Watch” in their recent publication.

ABSTRACT: “The science behind the measurement of pulse wave velocity as a surrogate for arterial stiffness and vascular health is reaching a critical mass of acceptance. Cre8MDI aims to enter a prepared market with a simple, easy-to use diagnostic device that will reveal which patients are at risk of suffering future cardiac events.”

For access to the entire article: https://www.innovationinmedtech.com/product/article-purchase-start-ups-watch-cre8mdi-new-measurement-arterial-stiffness-aids-cardiac-risk-stratification-mary-stuart/




Friday, October 30th Cre8MDI, LLC was invited to present at the MassMEDIC MEDTECH Showcase in Waltham, MA.  Roy Wallen spoke on behalf of the Cre8MDI team and shared about the development of the Cardio 1:1™ system and how it could change the face of cardiovascular disease prediction.

Twenty-two other technology companies presented from Massachusetts, California, and Canada. Each shared about their emerging technologies and plans to implement them into mainstream patient care.  Introductions to many consultants and potential investors were made and we look forward to following up with these individuals and companies in the months to come.

Thank you to Tom Sommer, President of MassMEDIC, and Michael Phalen, chairman of MassMedic and Executive Vice President of Boston Scientific Corporation, as well as all the sponsors who made the MassMEDIC MEDTECH Showcase possible.

Roy Wallen - Cre8MDI

What & Why: Pulse Wave Velocity

What is Pulse Wave Velocity and Why Measure It?
Pulse wave velocity (PWV) is a measure of arterial stiffness, based on the rate at which pressure waves move down the vessels of the circulatory system. Pulse wave velocity (PWV), specifically cfPWV (carotid-femoral pulse wave velocity, also known as aortic PWV), is now considered the “gold standard” for measuring arterial stiffness. The leading cause of death in the United States is cardiovascular disease. PWV is a valuable biomarker that can be measured non-invasively and accurately to improve risk prediction of cardiovascular events and mortality.

Many published articles support the facts stated above. Laurent, Cockcroft, Van, et al in the European Heart Journal in 2006 said, “Carotid-femoral PWV is the ‘gold standard’ for arterial stiffness, has the largest amount of epidemiological evidence for its predictive value for CV events, and requires little technical expertise.”

“Aortic stiffness can be assessed in a number of ways, but [PWV] is regarded as the current gold standard and has the most evidence available linking it to cardiovascular risk. The goal of this study was to determine whether aortic pulse wave velocity (aPWV) improves prediction of cardiovascular disease (CVD) events beyond conventional risk factors. The main finding of the current study is that aortic stiffness, assessed by measurement of aPWV, can predict future cardiovascular events and mortality, even after accounting for other established cardiovascular risk factors.”

Ben-Shlomo Y, Spears M, Boustred C et al. Aortic Pulse Wave Velocity Improves Cardiovascular Event Prediction. Journal of the American College of Cardiology. 2014;63(7):636-646.

Why is a better device needed?

Current devices measure PWV using unreliable and difficult-to-use tonometry pressure measurements or expensive imaging (MRI) techniques. Cre8MDI’s approach is much different using a non-invasive, quick, easy, and low-cost way to assess PWV.  Through the use of bio-impedance technology we are able to obtain a more precise distance measurement than the previous mentioned devices.

Pulse Wave Velocity (cfPWV) is the “favored measure of aortic stiffness.” “However, there is no consensus on the measurement of distance traveled by the pulse wave along the aorta to the femoral artery.” After comparing cfPWV values measured invasively and non-invasively, findings supported that “ for noninvasive assessment of PWV, estimation of pulse wave travel distance is critical.”

Weber T, Ammer M, Rammer M et al. Noninvasive determination of carotid–femoral pulse wave velocity depends critically on assessment of travel distance: a comparison with invasive measurement. Journal of Hypertension. 2009;27(8):1624-1630.

Chief Business Officer – Roy Wallen

Cre8MDI is excited to welcome Roy Wallen of Directional Healthcare Advisors to our team. Roy has come alongside to act as Chief BusinPicture1ess Officer and brings his expertise in medical device management and marketing to take Cre8MDI to the next level. Roy began working with us since May and has already tightened our pitch deck, presented in front of investors, and helped us to streamline our demonstration kit. A note from Roy:

The Cre8MDI team has demonstrated great progress toward establishing a new standard of care in predicting cardiovascular disease. With the existing, patent-pending capabilities and our combined start-up experience, I look forward to working with David and the team to execute on the product program that is supported and endorsed by the Massachusetts Life Sciences Center and individual investors.  The Cardio 1:1 System promises to be an easy-to-use and reliable tool to help clinicians manage the leading cause of death in the world.

Patient Story: Heart Attack


We connected with Dave Michaels on twitter, owner of Davradio Productions & The North Texas Sports Network, and he was gracious enough to share his story with us.

In January of 2008, Dave said he had first experienced symptoms of a cardiovascular event, they were not intense from the start, but soon showed themselves to be something serious.

It started on a Sunday, when I was at dinner, and felt a tightness in my left forearm, almost like I had pulled a muscle, it was very annoying, but I figured it was nothing, then later that evening, I felt tightness in my chest, but wrote that off to bad food, slowed my breathing down, and just let it go!

With a stressful and busy week ahead Dave continued working, but by midweek he still didn’t feel right. This was no longer a feeling of pulled muscles or bad food – this was serious. He left work as soon as possible and brought his dog to a friend’s home, then tried to relax.

About 20 minutes into staying there, I felt the pain go from my forearm, up my shoulder then into my neck and jawline – CLASSIC symptoms of having a heart attack! So—instead of calling for an ambulance to come and get me, I  got into my truck and drove to Richardson Medical Center, and walked into the emergency room.
I know that you are not supposed to drive yourself to a hospital when you are in crisis…. BUT!!!!!!!!!! I was confident enough to know that if I could make it without any gas in the truck (which I was on fumes) I would be ok!

Once inside there was a nurse who was distracted with other patients,  but when seeing Dave clearly in pain asked him to write his symptoms. He could barely scribble out the words “Chest pain!” After X-rays and Sonograms, they determined his right heart value was 78% blocked, and he would need a Stent Procedure and Angioplasty.

With a family history of heart disease and this major cardiovascular event, Dave now understands the necessity of preventative care. Since his major heart attack he took action to lose weight and eat right. He has lost and kept off 78 lbs since 2011.

Thinking back, I am guessing I could have maybe fended off all of this had I not gained so much weight. I do watch what I eat now with better care. I try and eat much better balanced meals of fish and poultry, and on occasion meat (beef). For the most part I keep the diet simple!

Thank you for sharing your story Dave! We hope that our medical device will help detect these arterial blockages earlier so patients like you don’t have to experience a dramatic cardiovascular event like the one described above.

Dave Health Transformation

Dave Michaels
Owner – Davradio Productions & The North Texas Sports Network
Director of Communications of the Texas Marshals

#heartpatient #cre8mdi #cre8forhealth