Icentia Receives U.S. Food and Drug Administration (FDA) Clearance for CardioSTAT®

Quebec City, April 6st, 2023: Icentia Inc., today announced that it has received FDA 510(k) clearance for CardioSTAT, an ambulatory, continuous ECG monitoring solution that relies on a wire free, single-use recorder.

“This approval marks a key milestone for our company. The FDA clearance opens the door to the world’s largest medical device market. With the cost effectiveness and demonstrated ability of our cardiac monitoring solution to provide effective patient care and outcomes, we have no doubts that CardioSTAT will make a meaningful difference in the diagnosis of patients with cardiac disorders in the United States.”, said Pierre Paquet, co-founder and Chief Executive Officer at Icentia.

CardioSTAT has now become the leading wearable cardiac monitoring solution in Canada. Expansion has followed in 2018 with the United Kingdom, where it is experiencing an exceptional adoption rate. To this day, CardioSTAT has been prescribed to more than 170,000 patients. With this clearance, Icentia will be able to pursue its mission of becoming a world leader in ambulatory cardiac monitoring by extending its market to the United States.

The CardioSTAT solution differentiates itself by being the most flexible solution available: physicians have a choice of multiple monitoring durations ranging from 24 hours to 14 days. The pay by duration model enables healthcare professionals to demonstrate cost savings while addressing a wide range of clinical needs. In addition to offering an efficient ECG data analysis service, Icentia also provides the ability for healthcare institutions and diagnostic facilities to benefit from the streamlined workflow of the CardioSTAT single-use recorder while performing the data analysis themselves using Icentia’s cost effective proprietary software.

About CardioSTAT

The CardioSTAT recorder is a flexible, lightweight, and showerproof device designed to be comfortably worn on the upper chest. It can record up to 14 days of data with a compliance rate of 99,9%(1). This enables medical practitioners to detect heart anomalies that are generally difficult to identify, such as atrial fibrillation, which affects from 1% to 3% of the world population (up to 9% of people aged over 65 and 17% of people over 80%) and contributes to more than 140,000 deaths per year with stroke being the leading cause of serious long-term disability in the US(2).

About Icentia

Icentia is a Canadian medical technology company that develops medical devices and operates cardiac diagnostic testing facilities in Canada and the United Kingdom. It is committed to improving cardiac monitoring and accessibility for both patients and physicians, by offering leading edge solutions to major problems in the field of medical testing.

For more information, please visit:

www.icentia.com

www.cardiostat.com

 References

(1).      Internal data collected on more than 90,000 patients, Icentia Inc. 2018-2021

(2). Stroke awareness foundation, facts and statistics Stroke Facts & Statistics - Stroke Awareness Foundation (strokeinfo.org)

Icentia Is Proud To Announce That It Has Been Listed as One of Canada’s Top Growing Companies for the Fourth Consecutive Year in the Globe and Mail’s 2022 Ranking

Icentia, a medical device and ECG analysis solutions company, announced that it has been listed in the Globe and Mail's ranking of Canada's Top Growing companies for the fourth consecutive year. It is rare for companies to be listed in this ranking for several years in a row, which is a testament to the Icentia’s consistent growth. 

"It fills us with great pride to be part of this prestigious ranking once again. It is a reward not only for the work done over the years by the whole Icentia Team, but it also demonstrates our willingness and ability to serve more and more patients around the world.  Our growth is driven by offering market leading solutions and customer service, developed by listening to our customers’ and market needs," explains Pierre Paquet, CEO of Icentia.

Since the launch of the CardioSTAT recorder in 2015, Icentia continues its development across Canada but also internationally. After a successful launch in the United Kingdom in 2018, the company has recently expanded in 2022 into the Republic of Ireland and is targeting other territories in the coming years. 

Canada’s Top Growing Companies is an editorial ranking that was launched in 2019. It aims to celebrate bold entrepreneurial achievement and bring the accomplishments of innovative Canadian businesses to the forefront.

The full list of 2022 winners along with editorial coverage is published in the October issue of Report on Business magazine. The list is out now and online here. 

“Canada's Top Growing Companies recognizes the tremendous ambition and innovation of entrepreneurs in Canada," says Dawn Calleja, Editor of Report on Business magazine. “The next generation of Canadian businesses can draw inspiration from this ranking.” 

“In an uncertain world, the success stories of the companies marked in this year’s Report on Business magazine’s list of Top Growing Companies are a beacon of optimism,” says Phillip Crawley, Publisher and CEO of The Globe and Mail. “The Globe and Mail congratulates them on their achievements.”

Icentia Records the Largest Public Single-lead ECG Dataset of 11,000 Patients and 2 Billion Annotated Beats Using CardioSTAT

The company aims to help improve arrhythmia detection through donation of tremendous dataset gifted to the general public through PhysioNet.

Icentia released its largest public dataset to date - a record-breaking 11,000 patients’ ECG records and 2 billion beats recorded over one week . The CardioSTAT recorder was developed by Icentia, a company dedicated to improving arrhythmia detection using ECG data.

Their new dataset includes annotations of each beat type by certified technologists, such as normal beats, premature atrial contraction, and premature ventricular contraction, and rhythms such as normal sinus rhythm, atrial fibrillation, and atrial flutter.

The prevalence of arrhythmia are becoming alarmingly common, with 2.7 to 6.1 million patients in the U.S having Afib alone, with estimates of this number rising to a staggering  12.1 million by 2030.   Despite new automated methods of detecting arrhythmia using machine learning, ECG technologists and cardiologists still encounter ECG anomalies that do not fit the known arrhythmia morphology, hence the need for human expertise and intervention to compliment computer-based learning. 

 To assist medical professionals, continue to investigate these rhythm anomalies and have a dataset of raw ECG signals to compare and match them to, Icentia recorded 2 billion labeled beats from 11k patients. The data is completely anonymized, extracted from patients who wore a CardioSTAT recorder for one week on average, ensuring each patient recorded a significant and statistically sizeable number of beats and rhythms for maximum data authenticity and trustworthiness.

 To perform this ground-breaking data gathering project, Icentia utilized its’ CardioSTAT recorder, a compact, single-use and portable ECG recorder engineered to continuously monitor long term electrocardiograms.

 Once the raw data was extracted from the patients CardioSTAT recorder, Icentia's certified technologists performed annotation using their proprietary analysis tools. They thoroughly analyzed the complete record and labeled the beat and rhythm types. This final data was then reviewed and approved by a senior technologist before becoming a publicly available dataset on PhysioNet.

 Through the public availability of this data, Icentia hopes to help cardiologists and ECG specialists fight this public health challenge of arrhythmia, through early diagnosis and treatments. 

To know more about CardioSTAT, visit www.cardiostat.com or to download the 11k dataset, visit the Physionet repository at www.physionet.org

Ambulatory cardiac monitoring: Icentia’s CardioSTAT reaches 100 000 tests

Icentia, a Canadian company that specializes in medical devices, has delivered its 100 000th CardioSTAT test.

For Icentia, such a milestone reflects the relevance of its ambition: Since it launched the test in 2015, it has worked to simplify heart rhythm anomaly detection for patients in Canada and the United Kingdom. As a symbolic aspect of this success, the 100 000th test was recorded with a patient at the renowned Quebec Heart and Lung Institute (IUCPQ), which has partnered with Icentia in the development of this innovation since 2013.

Designed and made in Canada, CardioSTAT is an electrocardiography (ECG) device that enables simple, long-term and high-quality recordings. Worn on the upper chest, it can produce up to 14 days of data. This can enable medical practitioners to detect heart anomalies that are generally difficult to identify, such as atrial fibrillation, which affects from 1% to 3% of the world population (up to 9% of people aged over 65 and 17% of people over 80). Discrete and comfortable, CardioSTAT is a viable alternative for patients and doctors to the conventional test (the Holter test), usually limited to 48 hours. Since the Covid-19 pandemic, patients can also implement the CardioSTAT test directly at home, avoiding hospital visits and reducing contamination risks, as well as the medical staff’s workload.

CardioSTAT is now used by hundreds of health institutions in Canada and the United Kingdom. Icentia and its 120 employees are proud of this international recognition, at a time when the company considers expanding to other countries.

Firmly positioned in a rapidly growing wearable devices industry, Icentia was part of the Globe and Mail’s top growing companies list in Canada for a third consecutive year in 2021. 

“Reaching 100 000 CardioSTAT tests is a great economic success, but especially human, as this milestone means we have helped as many patients. We are working hard to assist many more in the years to come,” says Pierre Paquet, cofounder and CEO of Icentia.

About the Quebec Heart and Lung Institute

The Quebec Heart and Lung Institute (IUCPQ) is a leader in its field. The university hospital offers care, specialized services and ultra-specialized services programs to treat cardiopulmonary diseases and illnesses linked to obesity. More specifically in the field of cardiology, the IUCPQ has the highest clinical volume in tertiary cardiology on a single site in Canada, in addition to pioneering in several other key elements, such as cardiac electrophysiology.

Icentia Named One of Globe and Mail’s Top Growing Companies in Canada for a Third Consecutive Year

Icentia, a fast-growing medtech company, secured a spot on Globe and Mail’s annual list of Canada’s Top Growing Companies, becoming one of the few companies to be listed in this ranking for a third year in a row.

Icentia placed in the first quartile of the 448 companies on the 2021 list, this time with a 524% revenue increase over the past three years.

“I am extremely proud that the success of Icentia has been recognized again this year.” says Pierre Paquet, CEO of Icentia. “Not only have we been able to get through the pandemic, but we continued to grow through it by quickly adapting our offering to the new challenges healthcare institutions are facing. This is a testament to the value we bring to the healthcare industry by listening to our clients and constantly adapting to their evolving needs.”

Launched in 2019, the Canada’s Top Growing Companies editorial ranking aims to celebrate entrepreneurial achievement in Canada by identifying and amplifying the success of growth-minded, independent businesses in Canada. It is a voluntary program; companies complete an in-depth application process to qualify. In total, 448 companies earned a spot on this year’s ranking.

 The full list of 2021 winners and accompanying editorial coverage is published in the October issue of Report on Business magazine—out now—and online.

 “As we look toward the future, Canada’s Top Growing Companies offer both inspiration and practical insights for other firms facing similar challenges,” says James Cowan, Editor of Report on Business Magazine. “The entrepreneurs behind these companies are smart, tenacious, and unwavering in their commitment to their goals.”

 “Any business leader seeking inspiration should look no further than the 448 businesses on this year’s Report on Business ranking of Canada’s Top Growing Companies,” says Phillip Crawley, Publisher and CEO of The Globe and Mail. “Their growth helps to make Canada a better place, and we are proud to bring their stories to our readers.”

Home-based Heart Monitoring Now Available to All Canadians Through Icentia

CANADIAN COMPANY DRIVES AT-HOME CARDIAC MONITORING NATIONWIDE DURING PANDEMIC

Icentia Inc. will be providing a new home-based service nationwide that will enable patients with heart rhythm disorders to have access to an ambulatory cardiac test from the safety of their homes while the pandemic surges on.

Icentia enables at-home tests through its CardioSTAT® device, a Canadian designed and manufactured, proven alternative to traditional Holter monitor tests. Since its introduction in 2015, the CardioSTAT test has become the tool of choice for hundreds of physicians across Canada and the United Kingdom for the detection of heart rhythm disorders.

This inventive and life-saving solution is now being implemented nationally for at-home tests in much needed times.

As the pandemic rages on, wait times in the Canadian healthcare system are becoming a serious issue. Backlogs for all procedures, including ECG monitoring, continue to grow. Social distancing and contamination risk requirements have increased the burden on hospitals and clinics, bolstering the demand for home-based tests. “The pandemic is forcing our healthcare system to evolve and adapt. This smart and accurate cardiac monitoring technology is what Canadians need right now to stay safe and keep healthy,” explains Dr. Marko Mrkobrada, Internist, London Health Sciences Centre, London, ON.

This new home-based solution, where no visit to health care facility for hook up or device return is required, promises to lighten the load on medical staff while also increasing safety for all. “We are glad to relieve some of the pressure on our healthcare system and to contribute to more safety through our home-based, patient-initiated tests. CardioSTAT test, which has proven to be easy to use, reliable and safe over the past years, makes even more sense in today’s context,” says Icentia CEO Pierre Paquet.

Icentia Is Part Of Canada’s Top Growing Companies Ranking For The Second Year in a Row

Icentia Inc. is pleased to announce it placed No. 28 on the 2020 Report on Business ranking of Canada’s Top Growing Companies. Canada’s Top Growing Companies ranks Canadian companies on three-year revenue growth. Icentia earned its spot with three-year growth of 1,998 %.

“We are proud to be one of the "Canada’s Top Growing Companies" for the second year in a row. This is a great recognition to us of our determination to excel in the quality of our products and in the support we provide to all of our customers around the world. ” explains Mr. Pierre Paquet, co-founder and CEO of Icentia. "This sustained growth is also the confirmation that Icentia has understood the needs of the market for ambulatory tests and home care, sectors for which the demand for efficient solutions is constantly increasing. ”

Launched in 2019, the Canada’s Top Growing Companies editorial ranking aims to celebrate entrepreneurial achievement in Canada by identifying and amplifying the success of growth-minded, independent businesses in Canada. It is a voluntary program; companies had to complete an in-depth application process in order to qualify. In total, 400 companies earned a spot on this year’s ranking. 

The full list of 2020 winners, and accompanying editorial coverage, is published in the October issue of Report on Business magazine—out now—and online at tgam.ca/TopGrowing.

“The stories of Canada’s Top Growing Companies are worth telling at any time, but are especially relevant in the wake of COVID-19 pandemic,” says James Cowan, Editor of Report on Business magazine. “As businesses work to rebuild the economy, their resilience and innovation make for essential reading.”

“Any business leader seeking inspiration should look no further than the 400 businesses on this year’s Report on Business ranking of Canada’s Top Growing Companies,” says Phillip Crawley, Publisher and CEO of The Globe and Mail. “Their growth helps to make Canada a better place, and we are proud to bring their stories to our readers.”

About The Globe and Mail

The Globe and Mail is Canada’s foremost news media company, leading the national discussion and causing policy change through brave and independent journalism since 1844. With award-winning coverage of business, politics and national affairs, The Globe and Mail newspaper reaches 5.9 million readers every week in print or digital formats, and Report on Business magazine reaches 2.1 million readers in print and digital every issue. The Globe and Mail’s investment in innovative data science means that as the world continues to change, so does The Globe. The Globe and Mail is owned by Woodbridge, the investment arm of the Thomson family.

Icentia Concludes New Financing Round Led by Crédit Mutuel Equity

The Québec company specializing in the development of innovative solutions for medical testing is pursuing its international growth strategy

Icentia is proud to announce the completion of its latest round of financing to accelerate its international growth. The financing was led by the North American venture capital arm of Crédit Mutuel Equity (formerly CIC Capital), the private equity subsidiary of one of France’s largest banking groups, Crédit Mutuel Alliance Fédérale. Investissement Québec and private investors also participated in the financing.

 “As we aim to become the global benchmark in electrophysiological data monitoring within a few years, this new round of financing will allow us to pursue our ambitious growth plan in Europe as well as internationally. We are privileged to be able to count on the expertise and global reach of Crédit Mutuel Equity along with their financial support,” said Pierre Paquet, President and CEO of Icentia.

 “We are proud to partner with the Icentia team, which is the Canadian reference in cardiac data capture and processing to the greater benefit of patients. Icentia already has a strong track record of growth. As a value-added partner, we aim to contribute to accelerating its international marketing phase, especially in Europe,” said Ludovic André, Managing Director, Venture Capital, Crédit Mutuel Equity.

 As the manufacturer of innovative medical devices, including CardioSTAT, Icentia’s mission is to help doctors identify early and accurate warning signs of potential heart problems.

 Icentia, headquartered in Québec City, employs over 85 people and recently opened an office in the United Kingdom. The company is ranked No. 48 in TheGlobe and Mail’s Report on Business list of Canada’s Top Growing Companies, with growth of 1,137% over three years.

About Crédit Mutuel Equity

Crédit Mutuel Equity is the private equity arm of Crédit Mutuel Alliance Fédérale, which encompasses its venture capital, growth capital and buyout activities.

 Crédit Mutuel Equity supports business leaders at all stages of their companies’ development, from seed phase to buyout, by providing them with the means and the time required to implement their transformational projects. Crédit Mutuel Equity brings together a network of over 350 business leaders and entrepreneurs that share similar convictions and that can benefit from each other’s experiences, no matter the nature of their projects. Investing its own funds (€3.0 billion), Crédit Mutuel Equity’s investments are tailored to the time horizons and growth strategies of the companies in which it invests, whether in France, Canada, the United States, Germany or Switzerland.

Quebec Grants Nearly $ 1.2 Million To Icentia To Support The Marketing Of The CardioSTAT Test

The Quebec government is providing Icentia with financial assistance of $ 1,151,500 in the form of a loan under the Biomed Propulsion program, administered by Investissement Québec. The company will be able to accelerate the commercialization of the CardioSTAT test in Canada and the United Kingdom, in addition to attacking new markets.

Vanier-Les Rivières deputy Mario Asselin made the announcement today on behalf of the Economy and Innovation Minister and Responsible Minister for the Lanaudière region, Pierre Fitzgibbon.

The CardioSTAT test is based on a portable wireless ECG recorder that provides continuous monitoring for up to 14 days. The small device allows an accurate diagnosis of cardiac abnormalities without interfering with the patient in his daily activities.

Quotes:

"The life sciences represent one of the most dynamic industries in the Capitale-Nationale, where companies from the Quebec VITAE niche of excellence are grouped together. Icentia is one of them, and the Government of Quebec is pleased to help this flagship of our local economy to continue its international growth. I am even more proud that the investment announced today will create around thirty quality and well-paid jobs. "

Mario Asselin, Deputy for Vanier-Les Rivières

"Collaboration between businesses, universities and research centers is one of the keys to stimulating innovation in Quebec. Icentia’s success stems, among other things, from its collaboration with the Quebec Heart and Lung Institute, which made it possible to design this very light heart rate monitor. The team also works with the Quebec Institute of Artificial Intelligence, MILA, for the continuous improvement of its data analysis software. Stimulating innovation and increasing exports are two of our priorities as a government, and the Icentia project is fully in line with our objectives. "

Pierre Fitzgibbon, Economy and Innovation Minister and Responsible Minister for the Lanaudière region

"The CardioSTAT test is an exemplary innovation that allows us to collect crucial information over a longer period of time in order to effectively detect heart problems and prevent their consequences. Our government is committed to supporting the implementation of such innovative projects, which help improve the daily quality of life for many people. "

Danielle McCann, Health and Social Services Minister

“A long-standing partner of the company, Investissement Québec is proud to renew its confidence in Icentia, a player with high potential in the medical technology sector, so that it benefits from the flexibility necessary to develop new markets and consolidate its position, in Quebec and abroad, all in order to accelerate its growth. "

Guy LeBlanc, President and CEO of Investissement Québec

Highlights:

• Founded in 2012, Icentia specializes in the development of medical devices and analytical services. The company offers a range of innovative medical tests for healthcare facilities.

• Last September, Icentia ranked 48th among the 400 fastest growing Canadian companies according to the Globe and Mail. The ranking is based on growth in business revenues over the past three years.

• The main objective of the Biomed Propulsion program is to financially support Quebec companies with high growth potential in the life sciences sector, in order to encourage them to commercialize the results of their research, while favoring the contribution of private investors.

Icentia places No. 48 on The Globe and Mail’s brand-new ranking of Canada’s Top Growing Companies

Icentia Inc. is pleased to announce it placed No. 48 on the inaugural Report on Business ranking of Canada’s Top Growing Companies. Canada’s Top Growing Companies ranks Canadian companies on three-year revenue growth. Icentia earned its spot with three-year growth of 1,137%.

“Achieving such a high growth has a lot to do with our strong focus on individuals. Primarily, the patients and caregivers, who are our prime source of inspiration and feedback in designing the right products. Also, the people who joined our ranks and bring to work every day their passion, their team spirit and their commitment towards our mission,” says Icentia’s co-founder and Chief Executive Officer, Mr. Pierre Paquet. “Our success is due to the right value proposition combined with a strong team that supports our patients and clients”. 

Launched in 2019, the Canada’s Top Growing Companies ranking program aims to celebrate entrepreneurial achievement in Canada by identifying and amplifying the success of growth-minded, independent businesses in Canada.  “We created the Canada’s Top Growing Companies program because we believe there is much Report on Business readers can learn from the successes of the country’s best entrepreneurs,” says Derek DeCloet, Editor of Report on Business and Executive Editor at The Globe and Mail. “We’re excited to be telling their stories.”

“The 400 companies on the inaugural Report on Business ranking of Canada’s Top Growing Companies ranking demonstrate ambition, innovation and tremendous business acumen,” says Phillip Crawley, Publisher and CEO of The Globe and Mail. “Their contributions to the economy help to make Canada a better place, and warrant commendation.”

About The Globe and Mail

The Globe and Mail is Canada’s foremost news media company, leading the national discussion and causing policy change through brave and independent journalism since 1844. With our award-winning coverage of business, politics and national affairs, The Globe and Mail newspaper reaches 6.6 million readers every week in our print or digital formats, and Report on Business magazine reaches 1.8 million readers in print and digital every issue. Our investment in innovative data science means that as the world continues to change, so does The Globe. The Globe and Mail is owned by Woodbridge, the investment arm of the Thomson family.