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FDA Clearance for MY01 Continuous Compartment Pressure Monitor

Oxford Academic

Comparison of Three Devices to Measure Pressure for Acute Compartment Syndrome

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July 28th 2021

“Cold Steel” Podcast

“Cold Steele” Podcast

Our CMO, Dr. Ed Harvey, has made a second appearance on the Canadian Journal of Surgery podcast  “Cold Steel” hosted by Dr. Chad Ball. In this episode, they discussed innovation by dissecting the meaning of this frequently used keyword, as well as touching on the different aspects needed for one to achieve it.

Both podcasts linked below:

https://podcasts.apple.com/us/podcast/e85-ed-harvey-on-innovation/id1463568273?i=1000529512490

https://soundcloud.com/cjs-podcast/e49-ed-harvey-on-the-canadian-journal-of-surgery-and-ebm-in-surgery 

July 21st 2021

EFORT 2020 abstract

EFORT 2020 abstract

As the year 2020 was filled with missed or virtual events, we will be posting some of the great research MY01 has been a part of. To kickstart this recap, we presented multiple abstracts at the EFORT virtual congress in 2020 with one of our best one being the “Does the Deep Posterior Compartment Exist? An Updated Lower Leg ACS”. 

July 14th 2021

COA Recap

COA Recap

The Canadian orthopaedic association held a great virtual event for their annual meeting last month. Our CEO Charles Allan and our CMO Dr. Ed Harvey hosted a talk on start-ups and funding where all the doctors present will be or are currently using our device.

During their presentations, our CEO, Charles Allan and our CMO Dr. Ed Harvey covered a slew of topics surrounding start-ups and their funding. The highlights of the event where:  

-The challenges of innovation whilst being a surgeon : Idea needs to have marketable potential

-the importance of your team : surrounding yourself with the right people can make or break your venture

-challenges and funding opportunities in the early stages of a start-up

July 7th 2021

JBJS “Orthojoe”

JBJS “Orthojoe”

The JBJS “Orthojoe” podcast episode 12 about innovation that featured Dr. Ed Harvey, our CMO, now has the video interview available. Dr. Marc Swiontkowski and Dr. Mohit Bhandari asked some compelling questions about innovation from a surgeon’s point-of-view and the road taken to achieve success.

Click here to check it out.

 

June 9th 2021

COA

COA

The annual COA meeting will be held next week, from June 15th to June 19th. We will be presenting at the online conference as our CEO Charles Allan and our CMO Dr. Ed Harvey will be discussing start-ups and how to fund your side gig. As a teaser for the event, check out the MY01 related research presented at last year’s COA by clicking the image.

 

June 7th 2021

Medgadget

Medgadget

Our CEO, Charles Allan, recently sat down with Conn Hastings from Medgadget to discuss the prevalence of compartment syndrome. Charles also commented on why the MY01 Continuous Compartment Pressure Monitor is the only device on the market that practically enables precise digital pressure readouts continuously over time.

Read the full article at https://www.medgadget.com/2021/06/diagnosing-acute-compartment-syndrome-interview-with-charles-allan-ceo-of-my01.html

 

June 2nd 2021

Fraser Gurd Surgical Research Day

Fraser Gurd Surgical Research Day

For this year’s Annual McGill Fraser Gurd Surgical Research Day held on the 27th of may, our CMO, Dr. Ed Harvey, gave a talk on “Wearables, Sensors, and Digital Health”. This event is the main event of Mcgill’s department of surgery that showcases resident and staff driven research. 

 

May 26th 2021

JBJS Podcast

JBJS Podcast

Our CMO @Dr. Ed Harvey was a guest on the @JBJS podcast OrthoJoe hosted by @Dr. Marc Swiontkowski and Dr. Mohit Bhandari to discuss innovation; what it really entails and the importance of building the right team if you want to succeed. The episode aired on the 24th of May and is available here

 

May 19th 2021

AAOS guidelines

AAOS guidelines

The American Association of Orthopedic Surgeons (AAOS) recommends Continuous Pressure Monitoring as the best method for ruling out Compartment Syndrome. The MY01 Continuous Compartmental Pressure Monitor was purpose built to do just that! Only the MY01 device provides quick, reliable and continuous pressure measurements to aid in diagnosis of Compartment syndrome. Giving medical professionals a tool they can use to follow the AAOS CPG guidelines.

https://journals.lww.com/jaaos/Fulltext/2020/02010/Management_of_Acute_Compartment_Syndrome.5.aspx

May 12th 2021

Fast Company

Fast Company 

We are honoured to have been selected in Fast Company’s World Changing Ideas of 2021. Our mission is to empower healthcare professionals with the ability to pre-empt severe medical conditions. Improving patient outcomes drives our team towards excellence and constant innovation.

May 6th 2021

FDA Clearance

FDA Clearance 

On December 10th, the MY01 Continuous Compartmental Pressure Monitor received another major certification! The Bluetooth enabled MY01 device was officially cleared by the FDA. We are thrilled to announce that upon receiving our 510K clearance, our device is commercially available with full Bluetooth capability across the United States.

Our team is on a mission to empower healthcare professionals with the ability to pre-empt severe medical conditions (including Acute Compartment Syndrome) thereby improving patient outcomes.

Apr 28th 2021

Trauma news

Trauma news

MY01’s Continuous Compartmental Pressure Monitor is designed to aid healthcare professionals in diagnosing Acute Compartment Syndrome. The rapidly evolving condition, if misdiagnosed, can lead to unnecessary fasciotomies, necrosis  or even to potential amputations.

Get the device in your hands by booking a trial on our website.

Check out the article to learn more : https://www.trauma-news.com/2021/02/how-to-use-the-my01-monitor-as-a-diagnostic-aid-for-acute-compartment-syndrome/

Apr 21st 2021

Three Devices Comparison

Three Devices Comparison

The Journal of Military Medicine published a paper comparing performance of the three different devices to measure pressure for diagnosis of Acute Compartment Syndrome.

The study shows that compared to the Synthes and the STIC devices, the MY01 Continuous Compartmental Pressure Monitor showed 600% more accurate results in tracking pressure changes and thus is the truest indicator of reference pressure in the ACS model.

Apr 14th 2021

Future of Health Podcast

Future of Healthcare Podcast

The featured guest this week on the Future of Healthcare, a podcast highlighting new trends in the healthcare industry was our Chief Medical Officer, Dr. Ed Harvey. He and Marta Bordignon discussed his experience as a co-founder of MY01, with a deeper dive into the entrepreneurial side of MY01.

Topics such as the company’s origin story to the importance of having the right team are explored throughout the podcast.

Tune in to the podcast to learn more : https://lnkd.in/dJAyeAh

Apr 7th 2021

Company Value: Mindfulness

Company Value: Mindfulness

We are mindful of our people: We make sure all our customers, patients, physicians and Hospitals are top of mind when making decisions both small and large.

At MY01, we take pride in being customer driven and aiming to provide a superior experience every step of the way. We implement our company values in everything we do so we can achieve our mission to empower healthcare professionals with the ability to pre-empt severe medical conditions thereby improving patient outcomes.

Mar 31th 2021

Company Value: Purpose

Company Value: Purpose

We act with purpose: We take pride in our work and stand by our decisions as a team. Every contribution, opinion and idea matters.

At MY01, we strive to foster a culture where our team members can attain their full potential and grow within our ranks. We implement our company values in everything we do so we can achieve our mission to empower healthcare professionals with the ability to pre-empt severe medical conditions thereby improving patient outcomes

Mar 24th 2021

MY01 Run

MY01 Run

MY01’s commitment to health and wellness starts at home! Every week on Wednesdays, some of our team members (socially distance) gather to participate in the MY01 run & walk as part of our team health challenge. This initiative helps promote an active lifestyle within our ranks while allowing for some team bonding time.

Mar 17th 2021

cICP Measurement

cICP Measurement

Acute Compartment Syndrome (ACS) is a rapidly evolving condition that requires clinical assessment and ideally Continuous Intracompartmental Pressure Continuous (ICP) monitoring as it can aid and facilitate decision making where clinical assessments alone fail to indicate the early signs of ACS.

The American Academy of Orthopaedic Surgeons (AAOS) recognizes the importance of Continuous ICP in diagnosing ACS. The MY01 device leverages MicroElectroMechanical System (MEMS) technology to continuously measure a patient’s Intracompartmental Pressure. Compared to current methods, MEMS sensing technology allows for reliable continuous ICP measurement, aiding timely detection of ACS.

Mar 8th 2021

International Women’s Day

International Women’s Day

Today, on International Women’s Day, we want to take a moment to celebrate all the Women in our network and in our wider community. Let this day serve as a call to action for accelerating gender parity and as a reminder that we must continue to promote full and equal access to participation in science for women and girls around the world. At MY01, we vouch to be an equal opportunity and affirmative action employer and we are committed to advancing gender equality in the workplace.

Mar 3rd 2021

Tiger Woods

Tiger Woods

An unfortunate car crash has led to Tiger Woods, one of the best golf players in the world, to be hospitalized because of a severely broken leg. He developed compartment syndrome and had to undergo a fasciotomy to release the pressure in his muscle. “If that pressure doesn’t get released quickly – and by quickly, I mean within an hour or so – it can cause permanent damage, it can even lead to amputation.” per Dr. Torres. The MY01 device is purpose built to aid healthcare professionals in the diagnosis of acute compartment syndrome (ACS) to ensure that the syndrome is caught in a timely manner.

Feb 24th 2021

Team Technical Expertise

Teams Technical Expertise

At MY01, we  are dedicated to providing healthcare professionals with the ability to pre-empt severe medical conditions. Our team has been continuously growing over the last few years, and we now count 50 employees across our different subsidiaries, from 20 countries (and totalling 80 graduate and postgraduate degrees).The technical expertise and the diverse nature of our team has allowed for an influx of knowledge and creativity that has led to us becoming leaders in the development of MEMS sensor technology.

Feb 17th 2021

Pushing the Envelope

Pushing the Envelope

On Friday the 12th, MY01 participated in the 11th annual Orthopaedic Trauma & Fracture Care class. Dr. Harvey’s presentation on the value of our device in aiding in the diagnosis of Acute Compartment Syndrome was followed up by Dr. Leighton’s presentation (one of our lead champion surgeons) on his latest research which utilises the MY01 continuous compartmental pressure monitor.

Feb 10th 2021

OBIO Summit

OBIO Summit

MY01 is thrilled to kick off our 2021 event calendar at the OBIO investment summit. Our CEO, Charles Allan, will be sharing our progress towards becoming part of the standard of care for compartment syndrome at 1 pm Est, wednesday the 10th. The virtual event, which starts today, will allow us to share the stage with leaders from fellow Canadian Medtech companies and connect with the community.

Feb 4th 2021

CE Mark

CE Mark

We are pleased to share that our Continuous Compartmental Pressure Monitor received its CE mark and is commercially available across the European Union. Our team is extremely excited to collaborate with European healthcare practitioners and would welcome the opportunity to book discovery discussions.

This huge milestone will allow us to further our mission of empowering healthcare workers all over the world with the ability to pre-empt severe medical conditions.

Jan 13th 2021

AAOS guidelines

AAOS guidelines

The American Academy of Orthopaedic Surgeons (AAOS) recognizes that continuous intracompartmental pressure is an important measure to monitor when concerned with Acute Compartment Syndrome (ACS). MY01 believes that optimal management of ACS lies in a combinational approach, augmenting standard clinical practice with continuous compartmental pressure monitoring.

MY01 was purpose built, using physician feedback, to enable continuous pressure monitoring.

Jan 6th 2021

CEOCFO

CEOCFO 

Our CEO, Charles Allan, sat down with CEOCFO magazine’s Senior Editor, Lynn Fosse, to discuss an array of topics regarding our company and device. A comprehensive dive into our mission to empower healthcare professionals and the cost benefits related to the use of MY01 are just a few of the subjects tackled during this interview.

We look forward to the upcoming year as we plan to further expand our presence in hospitals and aid in the diagnosis of ACS.

Dec 23rd 2020

Year in review

Year in review

Despite its challenges, 2020 was a productive year for the MY01 Team! We worked extremely hard to achieve several major milestones. Despite challenges presented by coronavirus, we managed to receive three significant certifications: our Health Canada Medical Device License, CE mark and FDA 510(k) clearance.

We also kicked-off two post-market studies with several sites currently running, including MUHC in Montreal,QC and Queen Elizabeth Hospital in Halifax, NS. Physicians are pleased with both our device and customer experience!

MY01 also contributed to science with our first major academic article published in the Journal of Military Medicine. The team also presented numerous posters and abstracts at the most high-profile conferences in our field. MY01 is laser focused on execution and we’re excited to share even more of our work with the #MedTech community in the coming year.

Dec 4th 2020

AO Online Conference

AO Online Conference

Our Chief Medical Officer, Dr. Ed Harvey presented at the AO online conference “Research: pearls for success for surgeons”. Dr. Harvey provided insights on his experience with Knowledge Translation of new discoveries and how they can be used to shape clinical practice. Members of the cast also include Dr. Ted Miclau  and Dr. Mike McKee who are also part of the Scientific Advisory Board of MY01.

Dec 2nd 2020

Cold Steel Podcast

Cold Steel Podcast

MY01’s Chief Medical Officer, Dr. Ed Harvey was the special guest recently on The Canadian Journal of Surgery’s  ‘Cold Steel’ Podcast with host  Dr. Chad Ball. Dr. Harvey spoke about his work life balance, research interests, and his approach as the Editor-in-Chief of the Canadian Journal of Surgery.

Be sure to also listen in on episode 51 where Dr. Harvey will speak to his experience as the Co-Founder & Chief Medical Officer (CMO) of MY01.

http://canjsurg.ca/podcasts

Nov 18th 2020

Health Canada License

Health Canada License

The MY01 Continuous Compartmental Pressure Monitor received its Health Canada Medical Device License in February this year. This was a big milestone for our team as the device is now commercially available in our home country!

Notre moniteur continu de pression compartimentale, MY01, a reçu sa licence d’instrument médical de la part de santé canada en Février dernier. Ceci fut un événement marquant pour notre équipe car nous pouvons enfin commercialiser notre produit au Canada, notre pays d’origine!

Oct 23rd 2020

COTS Study

COTS study

The onboarding for the COTS (Canadian Orthopaedic Trauma Society) cross Canada post-market study in Halifax was done at Dalhousie university on October 21st. The Queen Elizabeth II Health Sciences Centre received MY01 devices and has begun its study.

Feb 25th 2020

MY01 first in human test

When you really stand behind your product you don’t need to look too far for a volunteer to test it on. None other than our CEO Charles Allan was the volunteer for our first in-human test.

Feb 17th 2020

MD&M West 2020 Conference

George and Faisal were at the Medical Design & Manufacturing (MD&M) West 2020 conference meeting existing and potential suppliers. They were taking the opportunity to develop new supply chain additions for the manufacturing of MY01.

Feb 6th 2020

MY01 is present at Mcgill Techfair

MY01 was born from a research project at McGill and we keep recruiting talent from our Alma Mater.  For the second year in a row we had the opportunity to present our company at the McGill engineering department open house. We met several candidates for new interns.

Jan 21st 2020

EWI SOMOS 2020

MY01 was present at the Extremity War Injuries Society of Military Orthopedic Surgeons (EWI SOMOS) conference in Washington DC. We were selected to present two posters titled “Comparison of devices for acute compartment syndrome under real world conditions” and “Validation of a human model of compartment syndrome”

Nov 20th 2019

MY01 is presented at the CHUM

Our CFO, Simon Sanscartier, giving a presentation on MY01 at the  InnovAction conference at the CHUM, a three day event focused around healthcare and value-based innovation in the Quebec biotechnology sphere.

Oct 22nd 2019

DKOU 2019

Our CMO was one of the two invited keynote speakers from the COTS (Canadian orthopaedic trauma society) group that delivered talks. Also, our booth at the German congress of orthopaedics and traumatology in Berlin was a great success as we got to further the build of a pipeline with reputable German champion surgeons. These new contacts will be the starting point for our clinical trials in Europe.

Sep 25th 2019

OTA 2019

We had our first OTA corporate sponsor experience. We were able to meet a large new group of interested clinicians at our first OTA meeting. We were pleasantly surprised when the MY01 device was prominently mentioned in the compartment syndrome symposium.   

Aug 21st 2019

MHSRS 2019

Charles and Ed presented a poster at the largest American Military conference of the year in Orlando, FL.  The MHSRS is an annual four-day educational symposium that draws approximately 2,900 attendees. We had the opportunity to discuss the advances of the MY01 device and the science behind it.

Aug 15th 2019

Visit to California

With the help of @MEDTEQ_CA our team (Anthony Sirgi and Faisal Al-Kabariti) went down to California. They visited current and potential new suppliers, evaluated their capabilities to meet product specs, and shared with them our Regulatory plan and expectations.

Jun 27th 2019

My01 meets the Minister of Economy and Innovation, Mr. Pierre Fitzgibbon

Thanks to our partnership with C2Mi we had the opportunity to introduce Mr. Fitzgibbon to the MY01 device, we talked about our growth as a company in the biotechnology ecosystem in Montreal and in Quebec. Mr. Fitzgibbon was eager to know more about the technology and to see how the company grows.

Jun 10th 2019

MY01 is awarded a prize for exemplary integration of its immigrant workforce

Most of our employees are first generation immigrants. They are all newly graduated in science or engineering from McGill University.  Some time ago, some of them expressed their interest in joining the Ordre des Ingénieurs du Québec. French being a requirement to join the OIQ, french classes have been implemented in the office.

Link to the video can be found here

May 23rd 2019

McGill Clinical Innovation Competition Finals

This year MY01 made it to the finals of the McGill Clinical Innovation Competition (CLIC). The CLIC competition was started in 2017 at McGill in order to recognize McGill Faculty members, including learners and graduates, who conceive and develop novel innovations that aim to improve healthcare and outcomes. Cooper delivered a Ted talk-style presentation in front a panel of judges comprised of leaders in clinical care, academia, industry, engineering and business.

May 17th 2019

GETRAUM 2019

MY01 is presented at the GETRAUM (Groupe d’Etude en TRAUMatologie; the Trauma Research Group) conference in Strasbourg, France. Many prominent orthopaedic surgeons were present and were eager to try the MY01 device. We got the chance to discuss with a number of members of the European Federation of National Associations of Orthopedics and Traumatology (EFORT), the largest consortium of orthopedic and traumatology in Europe.

April 10th 2019

MY01 is presented at Medtech Strategist in Dublin

Simon flew to Dublin and got the chance to present at the Medtech Strategist event in Dublin. The event is recognized to be one of the leading medical technology investment forums in Europe. The presentation piqued the interest of doctors, investors and distributors who are referring to our device as “the next big thing” in the ortho/trauma fields.

March 28th 2019

MY01 took the MTEC annual symposium by storm

Simon and Cooper flew down to Charleston, S.C. for the fourth Medical Technology Enterprise Consortium (MTEC)  symposium. The most prominent figures in American military medicine were present. MY01 delivered presentations both during a formal military pitch event and poster session. This opportunity positions MY01 to leverage further U.S. military funding opportunities.

March 28th 2019

MY01 gets a feature in La Voix de l’Est

Nxtsens and MY01 get a feature in the Quebec journal “La Voix de l’Est”. The journal focuses mostly on the regional development of Quebec and took a great interest in our technology, as well as in our involvement with C2Mi, a Bromont-based manufacturing facility. The full article can be found here.

Feb 24th 2019

Nxtsens presents MY01 in front of the Premier of Quebec

MY01 was presented to Quebec’s Prime Minister, Francois Legault, who announced a $26M grant to our partner C2Mi. In collaboration with C2MI, our joint team developed the most critical part of MY01 – its biocompatible micro-sensor and we are slated to receive $500k of that grant to subsidize the development of MY01 and its early production at C2Mi.

Link to the article can be found here.

Jan 22nd 2019

MY01 presented at the EWI SOMOS Conference in Washington DC.

The government shutdown might have affected politicians and the FDA, but it didn’t slow the excitement of surgeons for MY01. Ed and Charles went down to Washington to present our device and the data the team gathered at the Society of Military Orthopaedic Surgeons Extremity War Injuries Conference (SOMOS EWI). Presenting our research at the poster session, we drew the attention of many surgeons and further confirmed their excitement for the availability of MY01 as a tool for ACS diagnosis. We also participated in the think tank on current concepts in acute compartment syndrome. We were able to communicate with physician decision makers for future market development and the ongoing funding of ACS research

 

Jan 9th 2019

Intuitive process allowed surgeons to use MY01 within minutes – Sacre Coeur Hospital in Montreal

Anticipating the Montreal study kick-off; Abdel, Cooper, and Dr. Harvey traveled across the island to meet the trauma team at Sacré-Coeur. We introduced the study goals, walked the surgeons, residents and researchers though the application and onboarding process, and had the opportunity to demonstrate the device functionality on a simulated fracture wound. The feedback and interest we received was overwhelmingly positive. Dr. Harvey commented on the noticeable physician excitement.

Nov 30th 2018

ODT Journal Feature

MY01 was recently featured in Orthopaedic Design and Technology Magazine. Dr. Harvey delivered some remarks on our competitive edge, and why early diagnosis of ACS is critical in driving better patient outcomes, and lowering the total cost of care. The full article can be found here

Sept 26th 2018

MY01 Wins at the Medtech Conference in Philadelphia

Simon and Charles traveled to Philadelphia to introduce MY01 to potential strategic companies and investors. Winning the best video award was a great PR opportunity at the event! M. Paul L’Archevesque, director of innovation at the Ministry of Health and Social Services, was happy we won an award.

Oct 19th 2018

MY01 at the Orthopaedic Trauma Association (OTA) Annual Meeting

Even without a booth, we made a splash at the 2018 OTA Annual Meeting. Ed presented MY01 in front of the Canadian Orthopaedic Trauma Society (COTS). The final details of the Canadian study were reviewed by Dr. Ross Leighton (president of COTS) and there was unanimous interest in participating in clinical trials. The hands-on session with the device was well received. We also had the opportunity to meet with Dr. Schmidt, a world expert in compartment syndrome research, who will be including our device in the next two Major Extremity Trauma Research Consortium (METRC) study proposals. We met with surgeons from around the world who showed interest in purchasing our device.

Oct 12th 2018

MY01 Presented at the International Society of Orthopaedic Surgery and Traumatology Conference(SICOT)

Dr. Harvey participated in several panels speaking on Acute Compartment Syndrome at SICOT. The consensus was clear that a better diagnostic tool for ACS was necessary to improve patient outcomes. From there, Dr. Harvey presented the most recent data from MY01 after which Dr. Schatzker (globally regarded in Trauma Care) mentioned the importance of this work! Meanwhile, our CFO, Simon was busy making European connections at SICOT’s closing dinner in Montreal.

Dec 5th 2017

Node Health Conference

NODE health digital medicine conference in NYC aims to further the digital medicine validation process by bringing structure, scalability and reliability to it.

Spring & Summer 2016

Dobson Cup & X-1

Before we were known as MY01, we were Nxtsens. Our parent company was awarded second place in the health science track at the McGill flagship startup competition – the Dobson cup. The follow up to this achievement was our invitation to participate in the X-1 program during the summer of 2016. X-1 is the first Montreal-based accelerator and that experience allowed us to map out the corporate strategy for MY01.

March 30th 2015

Incorporate Company

What started off as a Master’s project at McGill University became an official startup as our founders: Charles, Ed and George, officially registered Nxtsens Microsystems as a corporate entity. The intellectual property that would allow us to launch MY01 was part of this parent company.