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 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/
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.
The 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/
Cre8MDI is excited to welcome Roy Wallen of Directional Healthcare Advisors to our team. Roy has come alongside to act as Chief Business 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.“
Cre8MDI is pleased to announce that it has been honored to receive a Milestone Achievement Grant (MAP) from the Massachusetts Life Science Center (MLSC) in the amount of $200,000. The MLSC Board approved the first round of Milestone Achievement Program on Tuesday, May 26th.
“The MLSC’s Milestone Achievement Program provides an excellent opportunity for early-stage companies to grow and develop within Massachusetts’ fast-growing innovation economy,” said Governor Charlie Baker.
This new grant program was created to address the need of early-stage life science companies to reach critical value. The MLSC awarded more than $2million in funds to Massachusetts companies in order to support their work toward completion or fulfillment of a defined milestone.
It was a very competitive grant program with many life science companies vying for the funds. The MSLC determined that Cre8MDI met all the criteria and had a clear milestone driven proposal. The Board of Directors, Peer Reviewers, SAB, and Center staff were involved with reviewing the company’s business plan, science and future potential.
“We are pleased to be supporting Cre8MDI with this grant funding to help the company achieve a milestone in their product development” said MLSC Vice President for Communications & Marketing Angus McQuilken. “Cre8MDI is part of a vibrant and growing life sciences community in the Merrimack Valley that is creating jobs, while bringing technologies to market that will improve patient care and human health.”
David Cassidy, President of Cre8MDI stated, “This grant will fund our next stage of development. We are pleased with the validation this grant provides our company as we move forward to predict cardiovascular disease with ease.”
Official MLSC Press Release: http://www.masslifesciences.com/news/announcements/
MAP Grant Press Release by Cre8MDI FINAL
Our current prototype has been rendered with our Lulzbot 3D Printer. The current 3D representation showcases our proposed design for the final device.
3D Printing has been an outstanding tool for our team. We have been able to print samples of all our concepts. We use 3D printing to speed our development time by “instantly” being able to print mechanical parts including brackets, enclosures and new versions of our “egg.”
Cre8MDI’s team has over 25 years of experience and has brought a number of medical devices from concept to market.
Mr. Roy Wallen – Chief Business Officer
Mrs. Marie Getchell – VP Quality and Regulatory
Mr. Mark Lewis – VP Operations & Manufacturing
Mr. Brett Allen – Senior Software Engineer
Mrs. Allison Reveley – Marketing & Public Relations
The multi-disciplined team has expertise in the ares of:
- Biomedical Engineering
- Mechanical Engineering
- Electronics Engineering
- Software Development
- Instrument & Disposable Manufacturing
- Quality Control
- Regulatory, FDA, MDD, ISO, CFDA, PMDA
- Industrial Design & Human Factors
Cre8MDI’s approach to assessing arterial stiffness is based on the gold standard method of measuring aortic (carotid to femoral) pulse wave velocity (PWV). PWV is a well-established index of arterial stiffness and its first clinical use can be traced to Bramwell and the Nobel laureate, A.V. Hill in 1922.
A pulse wave travels from the heart down the arterial wall in advance of blood flow during each heartbeat. The velocity of a pulse wave which propagates in an artery is dependent on the stiffness of that portion of the artery. The more rigid the wall of the artery, the faster the wave moves.
The European Society of Hypertension officially recommended PWV to be part of all routine exams for high blood pressure patients since 2007.
PWV has predictive value on future cardiovascular events such as strokes or heart attaches. This means that people actively monitoring their PWV, will have a longer time horizon to take proactive measures which may stop or reverse these devastating disease. Early diagnosis is the key to better health.
DO YOU KNOW YOUR RISK for HEART DISEASE?
How many of you have been affected by heart attack, stroke, or other cardiovascular complications? Do you know someone who has had a heart attack, stroke, or worse – lost their life because of an undetected heart condition?
At Cre8MDI we have been affected by heart disease, both personally and through family members’ experiences. Heart disease is the leading cause of death in America and the fourth leading cause is another cardiovascular disease, Stroke. Both are preventable through changes in diet and lifestyle and or medications, but most people do not even know when they are at risk. Knowing is half the battle.
Our device, once completed will determine the stiffness of your arteries, thereby telling you your risk before you have any symptoms. It measures the condition of your arteries with sensor technology by using Pulse Wave Velocity (PWV). A stiff artery means that the heart must work overtime to maintain the circulation of nutrients and blood flow to the rest of the body. When blood doesn’t reach the brain, a stroke occurs. When the heart is over-worked; it results in a heart attack.
Currently patients rely on blood pressure to tell them if they may have a cardiovascular disease, however this is not the most accurate way to determine your risk. You must account for hereditary factors, lifestyle choices (what you eat, how much you exercise), environmental components, and stress. Blood pressure can go up or down, but never tells us the condition of your arteries. Once a symptom occurs or risk factor is identified patients then undergo costly tests like MRIs and EKGs. These tests can be avoided or minimized if the condition of patients’ arteries begin being monitored sooner and more simply – like at their primary care physician’s office.
Our hope is to one day have our device in every Primary Care Physican’s office so patients can be best informed of their risk for CVD. Then they can make the necessary dietary and lifestyle changes before it’s too late.
David Cassidy is president and founder of Cre8MDI, LLC, a medical device, start-up company. Cre8MDI’s mission is to develop and commercialize innovative diagnostic devices that will improve the quality of healthcare and reduce cost through early detection of disease. This echoes David’s lifelong commitment to helping others. David has more than 25 years’ experience in the medical device industry including heart assist and IV infusion. He has taken a number of medical devices from concept through production and has authored multiple patents.
David’s most recent success comes as co-founder and inventor for Enginivity LLC, where he created and brought to production a sophisticated, mobile IV fluid warmer called enFlow™. Enginivity LLC was sold 3-1/2 years after the product’s inception to Vital Signs, a GE Healthcare company.
David resides in Massachusetts with his wife and four sons. He enjoys exploring the Southwest with his family, hiking and restoring and building cars.