The tremoFlo™ C-100 Airwave Oscillometry System (AOS) Final nominee at the 2015 Manning awards

Thorasys is proud to announce that Dr. Geoff Maksym of Dalhousie University and Dr. Thomas Schuessler President of Thorasys are the final 2015 Manning Innovation Award nominees for their innovative tremoFlo™ C-100 Airwave Oscillometry System (AOS) ™.

The 34th Manning Awards will be held on October 2nd 2015 in Saskatoon, SK.

https://twitter.com/ManningAwardsCA/status/581187021798043648

Welcome to ERS 2014!

Today was the first day of the exhibit at 2014 ERS Congress in Munich, Germany, and we were happy to welcome many visitors at our booth. For more opportunities to meet our team, get a live demonstration of the tremoFlo and discuss lung function assessment without patient effort, stop by Hall A1 Booth D.15 near the ERS Lounge during the following times:

  • Monday September 8th, 9:00am-5:00pm
  • Tuesday September 9th, 9:00am-5:00pm
  • Wednesday September 10th, 9:00am-12:00pm

We look forward to seeing you in Munich!

ERS2014Thorasys

Newly TGA-certified tremoFlo™ C-100 on display at TSANZSRS

The tremoFlo Airwave Oscillometry System continues to break ground in markets around the world. Only a few weeks after approval in Europe and Canada, we have earned approval by the Australian Therapeutic Goods Administration (TGA), so that the tremoFlo is now available for diagnostic and clinical use in Australia.

“I very much want to thank our team for their great work and enthusiasm as they continue to execute our regulatory strategy on or even ahead of schedule” says Dr. Thomas Schuessler, President and CEO of THORASYS. “Australia is known to excel in pulmonary research and medicine, and we are happy to serve this knowledgeable customer base.”

TSANZSRS Hero

The tremoFlo Airwave Oscillometry System will be on display at the joint Thoracic Society of Australia and New Zealand and Australia and New Zealands Society for Respiratory Science (TSANZRS) conference on April 4-9 in Adelaide. Come visit us at the BIRD Healthcare booth within the exhibition hall. We hope to see you there!

[ email hidden; JavaScript is required | View TGA Certificate | Follow us on TwitterConnect on LinkedIn ]

tremoFlo™ C-100 is now Health Canada approved!

The entire THORASYS team is happy to announce we have obtained our Health Canada certificate for the tremoFlo C-100. This is a proud moment for any Canadian medical device company, and we are excited to begin sales in Canada. Hospitals, clinics and research facilities across Canada can now offer effortless lung function measures to patients of all ages, including children as young as two years old.

tremoFlo Snow

Heidi Giesbrecht, Product Manager, said “to be certified in your home market is a great achievement. We look forward to working with all of our current and new customers in Canada. Next we will turn our attention to certification with the FDA in the coming months.”

[ email hidden; JavaScript is required | View Health Canada Certificate | Follow us on TwitterConnect on LinkedIn ]

tremoFlo™ C-100 Airwave Oscillation System™ receives CE Mark

We are pleased to announce that on January 8, 2014, our tremoFlo C-100 Airwave Oscillometry System received its CE Mark as a class II medical device. This makes the tremoFlo C-100 the first and only approved handheld Oscillometry system for effortless lung function testing in Europe.

tremoFlo CE Mark small

“The CE Mark is an important milestone on our regulatory and go-to-market roadmap,” says Thomas F. Schuessler, President and CEO of THORASYS Thoracic Medical Systems Inc. “I would like to thank all members of our excellent team for their dedication and hard work that has allowed us to reach this important milestone on schedule.”

Europe is the first jurisdiction where the tremoFlo C-100 is authorized as a medical device to diagnose and monitor lung disease. Applications for regulatory approval are currently in progress in a variety of other jurisdictions, including Canada and the United States, and updates will be provided regularly on this blog.

[email hidden; JavaScript is required | View CE Certificate | Follow on Twitter | Connect on LinkedIn]

Thorasys is awarded ISO 13485 certification

THORASYS Thoracic Medical Systems Inc. is proud to announce that on December 2nd, 2013 we obtained our ISO 13485:2003 certificate by the British Standards Institute (BSI).


This is an important milestone for THORASYS as ISO 13485 is a major certification required for medical devices.
A requirement for certification is a thorough verification and assessment of the organisation’s Quality Management System and design and manufacturing installations by a neutral accredited auditor.


“Receiving the ISO 13485 certification is an acknowledgement of our ongoing commitment to the highest quality throughout Thorasys operations. The certification is a requirement to register the tremoFlo™ C-100 in many regions and we are excited moving forward. We anticipate commercialization of the tremoFlo in Europe and Canada within the coming weeks,” said Sébastien Jutras, VP Operations.


The certificate can be viewed here.
If you have any questions about the certification standard, please contact THORASYS at email hidden; JavaScript is required.
Follow us on Twitter @Thorasys
Connect with THORASYS on LinkedIn

Variation in Airway Resistance: A Measure of Airway Heterogeneity?

The objective of the Forced Oscillation measurements that can be performed with the tremoFlo is first and foremost to produce a direct, instantaneous measure of airway resistance. However, there exists a body of recent literature that suggests that looking at the variations in airway resistance (VAR) over time, rather than at resistance itself, may be indicative of certain disease patterns and could possible reflect how well a patient is managed.

VAR & Hetergoneity

For several years now, the VAR technique has been a subject of interest for THROASYS’ Chief Scientific Advisor, Dr. Geoff Maksym, who heads the Biomedical Engineering Department at Dalhousie University in Halifax. In their most recent publication on this topic recently published in the Journal of Applied Physiology(1), Leary et al. further investigated this technique by mathematically modeling the stochastic and spatial heterogeneity in a human airway tree in order to develop a better understanding of the mechanisms that cause temporal variations in respiratory system resistance.

The authors used a multi-branch airway tree model to explore how variation in airway diameter is related to changes in airflow in the lung that are known to occur in asthma. They found that variation in airway resistance was explained not only by fluctuations in airway diameters that might occur with fluctuations in airway smooth muscle activity, but was also sensitive to changes in average airway constriction and the presence of ventilation defects, both of which are also increased in asthma. These findings provide new mechanisms and improve our understanding of why variation in airway resistance is increased in asthma.

Congratulations to Ph.D. students Del Leary and Swati Bhatawadekar for this excellent contribution.

Next Steps

At the recent Annual Biomedical Engineering Society meeting that took place in Hartford, Connecticut from October 13-15, 2011, the authors presented further research on this topic(2-5) carried out in collaboration with colleagues from Harvard University in Boston, Massachusetts and Western University in London, Ontario. Some of these studies feature measurement of airway reactance in asthmatics while others included the use of hyper-polarized gases to image the distribution of ventilation in patients with COPD.

We wish the authors best of luck and look forward to this work appearing in full-length manuscripts.

 

1. Del Leary, Swati A. Bhatawadekar, Grace Parraga, and Geoffrey N. Maksym, “Modeling Stochastic and Spatial Heterogeneity in a Human Airway Tree to Determine Variation in Respiratory System Resistance J Appl Physiol; http://jap.physiology.org/content/early/2011/10/11/japplphysiol.00633.2011.abstract.

2. D. Leary, A. Braune, T. Winkler, and G. Maksym. Modeling and Quantifying Heterogeneity of Airway Narrowing and the Contribution to Lung Mechanics. Platform presentation.

3. D. Leary, G. Parraga, and G. Maksym. Image-guided Stochastic Modeling of the Lung – Influence of Patchy Ventilation on Impedance Variability in Asthma. Platform presentation.

4. S. A. Bhatawadekar, P. Hernandez, C. McParland, S. Fulton, and G. N. Maksym, Bronchodilatory Induced Changes in Airway Reactance and Its Variation in Asthma.

5. A. Braune, D. Leary, G. N. Maksym, and T. Winkler, Effect of Symmetric vs. Asymmetric Tree Geometry and Airway Size on the Emergence of Ventilation Defects.

Welcome to THORASYS

Hello, and welcome to the Thorasys blog!

Thorasys Thoracic Medical Systems is an innovative medical device start-up located in Halifax, Nova Scotia, Canada. Our activities focus on the development of the tremoFlo, a novel medical device for the diagnosis and monitoring of respiratory diseases such as Asthma and COPD. The tremoFlo is scheduled to reach the market in 2012.

The tremoFlo is a small, portable device that uses the Forced Oscillation Technique (FOT) to provide accurate measurements of airway resistance and reactance. The tremoFlo does not require patient effort or cooperation and can hence be used comfortably by a wide range of paediatric, adult and elderly subjects, including mobility impaired patients and those who are unable to perform a voluntary manoeuvre. The tremoFlo can potentially replace so-called “spirometers” that require patient effort and cooperation to assess lung function.

The tremoFlo is currently being field tested at several sites throughout North America, and field testing in Europe is expected to start soon. This blog will provide regular updates about the tremoFlo development as we prepare for commercial release in several jurisdictions in the first half of 2012.