From Cystic Fibrosis to COVID-19: A Medical Solution Like No Other

(Image via Dymedso Inc.)

Airway clearance therapy has been a cornerstone of treatments aimed at minimizing the devastating effects of airway obstruction, infection, and inflammation caused by a buildup of mucus in lung conditions … but finding a non-invasive solution that really works has been a bit of a challenge within the healthcare industry.

That is, until now ….

An innovative Montreal-based medical device company is revolutionizing the airway clearance industry by using proprietary acoustic technology to treat respiratory conditions, including those related to viral infections such as COVID -19.

That Company is Dymedso Inc. Its product, the Frequencer®, is a unique technology platform that uses acoustic sound waves to treat patients who are challenged clearing their airways.

This medical device provides airway clearance therapy and promotes bronchial drainage by inducing acoustic vibrations through the chest walls and deep into the lungs, displacing mucus and enabling patients to breather better.

Intended to be a component of chest physiotherapy by providing a convenient airway clearance method without harsh external thorax manipulation, the Frequencer® is indicated for patients who have respiratory ailments typically seen in patients suffering from cystic fibrosis as well as chronic obstructive pulmonary disease (COPD), bronchiectasis, ciliary dyskinesia syndromes, asthma, muscular dystrophy, neuromuscular degenerative disorders, postoperative atelectasis, and thoracic wall defects.

The Frequencer® has been cleared by Health Canada and the U.S. Food and Drug Administration (FDA). Dymedso also holds the CE mark in Europe. It is approved for sale in the United States, the European Union, Canada and the Middle East.

Following an agreement with Bold Capital Enterprises Ltd. (TSX-V: Bold) and a reverse takeover (RTO), Dymedso is getting ready to bring its cutting-edge platform public.

Stockhouse Editorial caught up with the Company’s Chairman Executive Officer, Richard Boudreault to find out more ….

1. Thank you for joining us. The Frequencer® appears to serve a major market need, is there anything you can add for investors about how it works and the size / type of market it serves?

Respiratory disease is major global health problem responsible for the death of 1 in 6 people. Over the last several years, there has been a surge of cases related to cystic fibrosis, asthma, and chronic obstructive pulmonary disease (COPD). And over the last 2 decades we have seen an increasing incidence of infectious diseases like COVID-19 creating treatable acute respiratory distress. The cost to care for these patients is also on the rise. For instance the annual cost to care for a Cystic Fibrosis patient is USD 15,571 and could cost the patient USD 306K over his or her lifetime. For a disease like COPD, which is linked to environmental air quality and impacts more than 3 million Canadians, the total cost of care is upwards of USD 16 billion. And now with the COVID crisis, the impact on Canadian healthcare costs is estimated to be an additional USD 26.9 billion this year.

Patients with Respiratory disorders such as these have increased amounts of mucus in their lungs, making it difficult for them to clear their airways and breathe. We designed the Dymedso Frequencer® to treat these conditions, while improving both the patient’s quality of life and the total cost of their care.

2. There has been potential noted for the Frequencer® to play a role in combating the COVID-19 crisis, can you elaborate a bit on this?

Infectious diseases like COVID-19 often result in acute respiratory distress syndrome (ARDS) in patients. With COVID-19, 33% of the hospitalized patients developed ARDS. And one retrospective study of 191 COVID-19 patients in China showed that 98% of the non-survivors had respiratory failure and 93% had ARDS. Researchers found large amounts of sticky mucus and hyaline membranes in the deep-seated airways of the deceased patients. Sadly, over 1.5 million deaths have been reported globally and approximately 50% of these deaths occurred in patients who were mechanically ventilated.

Dymedso has seen a surge of its sales of the Frequencer® as a result of the pandemic, particularly within Canada, France, Germany and as far reaching as Kuwait, to assist in mucus recruitment and removal from patient lungs to improve the quality of their care. What makes our product unique is that it is a painless, non-invasive device, compatible with mechanical ventilation to effectively clear airway secretions and ultimately improve the outcomes of these very critical patients.

We are pleased to share that we recently distributed 24 Frequencer® devices to 12 healthcare institutions in the Quebec provinces, to treat lung infections and help combat the next wave of COVID-19. This was made possible through Programme Innovation, sponsored by Québec’s Ministère de la Santé et des Services sociaux and Ministère de l’Économie et de l’Innovation.

3. This is a medical solution unlike any other on the market, how was it developed?

Louis Plante, co-founder of Dymedso and a Cystic Fibrosis (CF) patient, woke up one morning wondering why he had an excessive cough while attending a concert. He hypothesized that his coughing may have been related to sitting close to a large loudspeaker while listening to a lecturer speak. He began the process of developing and testing a device that could generate low-frequency vibrations to be used in airway clearance therapy.

He developed his first prototype in his home garage and used it on himself. After much trial and error, he found his optimum frequency for treatment to be approximately 40Hz. Mr. Plante received clapping, a manual form of chest physiotherapy (CPT), most of his life. Clapping or percussion is the manual external striking of the chest wall with a cupped hand or mechanical device, in a rhythmic fashion to loosen secretions from the bronchial walls. With clapping, Mr. Plante expectorated around 5 to 25 grams of mucus, but when using his device, the Frequencer® at 40Hz, he expectorated between 65 to 95 grams of mucus, making the device more effective in clearing his airways.

4. What sets the Frequencer® apart from other common, similar, treatments?

Well this question is best answered by our patient feedback. In over 78 patient surveys, our patients stated that they greatly preferred the Frequencer® to their standard chest physiotherapy. They shared that it has helped them expectorate more mucus and breathe better, particularly during an illness or an infection. They also liked how easy it is to use, how it fit into their daily schedule, and that it didn’t cause them any pain or discomfort.

But in addition to this, the Dymedso Frequencer® is designed to be used on patients of all ages, including those who require the most critical care. I have already shared how the device can be used on mechanically ventilated patients, but it can also be used non-invasively to treat lung disorders of neonates and infants, where other devices and methods may be considered too invasive and unsafe, putting them at risk for long-term lung disorders. To date, several prominent hospitals in the United States, Nova Scotia and other provinces in Canada are using the Frequencer® in their Neonatal Intensive Care Units (NICUs) and Pediatric Intensive Care Units (PICUs) to provide safe and effective chest physiotherapy to these special patients.

5. What kind of research has been published supporting the Frequencer®?

The effectiveness of the Frequencer® was first clinically demonstrated with the support of the Canadian Cystic Fibrosis Foundation. A clinical study was conducted by the Centre Hospitalier Universitaire de Sherbrooke and the Centre Hospitalier de l’Université de Montréal to demonstrate the safety and effectiveness of the Frequencer® to help clear secretions from the airways of individuals with Cystic Fibrosis. Additional studies over the years have supported the device’s safety and effectiveness.

But I would also like to highlight some of our recent studies that are in progress today that are of particular importance.

The first is an observational study on COVID-19 patients, sponsored by the Quebec Government, whereby 24 Frequencer® devices have been deployed at 11 University Hospitals and 1 Long-Term Care facility in Quebec. The Frequencer® will be employed in this non-comparative multicenter clinical-economic study as an addition to standard care with the goal of demonstrating clinical relevance and economic efficiency.

In addition, a multicenter crossover randomized controlled trial is underway at Centre Hospitalier Universitaire Sainte-Justine, Department of Pediatrics, Montreal and the Montreal General Hospital to compare the effectiveness of the Frequencer® vs. Chest Physiotherapy (CPT) for mobilizing secretions in mechanically ventilated children and adults with respiratory distress linked to COVID-19 infection.

And lastly, approved by the Health Research Ethics Board of University of Montreal, Canada, a study will be conducted by the Centre Hospitalier Universitaire Sainte-Justine, Department of Pediatrics, Montreal, to examine the tolerance, feasibility and physiological effects of airway clearance using the Frequencer® on pediatric patients.

We look forward to providing an update on these studies in the coming months.

6. What can investors expect in terms of news flow from the Company in the coming months?

We are committed to ongoing research and expect to share additional case studies and clinical trial results that demonstrate better patient care and health outcomes. These studies will cover a wide range of patient respiratory conditions including COPD and COVID-19 and will include different critical care patients including neonates and pediatric patients.

7. Thank you again for taking the time to speak with us about what your Company has to offer.

To find out more about the Company, visit dymedso.com.



FULL DISCLOSURE: This is a paid article produced by Stockhouse Publishing.