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New device for detection and analysis of swallowing disorders

Posted in Industry News on 16th Nov 2021

  • SWALLIS DSATM offers a new approach to swallowing assessment for patients at risk of Dysphagia (Swallowing Disorders), a condition that affects up to 75% of stroke patients as well as patients affected by Parkinson’s Disease, SLA, with incidence increasing with age. 50% of post long-intubation patients with COVID19 also present with dysphagia.
  • CE mark is an important milestone for upcoming launches in markets worldwide
  • SWALLIS DSATM soon to be launched in Europe

Toulouse, France, November 23, 2021 – Swallis Medical, the French medical startup company with ambition to revolutionise the management of dysphagia, has recently highlighted the successful completion of the CE conformity assessment procedure for SWALLIS DSATM (Device for Swallowing Analysis). The innovative Medical Device represents the first of a series of devices that the company intends to launch to bring meaningful innovation to the market of Dysphagia, by providing tools that healthcare professionals can easily adopt to assess the state of swallowing physiology of their patients.

Swallis Medical can now carry the CE mark for a medical device class I, the first step in the bigger vision of the company to address a public health issue and a  high unmet medical need. Swallis Medical plans first to launch Swallis DSATM in France, Belgium, Germany and then the rest of Europe through a direct sales organisation in France and a network of distribution partners in Europe. Other markets will follow.

SWALLIS DSATM is a necklace device which detects and measures swallowing signals. A dedicated proprietary application, Swallis Analyzer, allows the display in real time of signals captured around the neck and analysis of recorded signals. Events can be labelled during observation or during the analysis. The annotated signals synchronised with the video can then be stored (locally and on the Health Data Cloud) for later comparison. A patented video capture solution synchronised to signals, complete the solution for transmission and sharing on a tele-care platform.

An easy technology for objective evaluation

The project started from our interactions with Swallowing Experts and what we heard was a painful and stressful absence of a tool to perform an objective swallowing exam when access to the imaging equipment continues to be difficult and, even when available, is invasive, irradiant and logistically demanding“, explains Linda Nicolini, founding CEO of Swallis Medical. “This leaves healthcare professionals without proper tools to help patients. We believe that Swallis DSA has the potential to improve health outcomes and quality of life of millions of patients worldwide, for their families and contribute to the positive evolution of standards of care. We’ll prove it by immediately deploying an ambitious Evidence Based strategy, to support both our clinical and medico-economic claims”.

“Being granted the CE mark certification for SWALLIS DSATM is an exciting and important milestone, adds Nicolini. “I am proud of our achievements and would like to thank the whole team involved in this huge effort, as well as our advisors and clinical partners, our investors and public partners, our subcontractors and the entire ecosystem that strives to encourage and support the entrepreneurial effort.”

“In my day-to-day work, I experience the patients’ and families despair associated with dysphagia and the nurses and doctors’ frustration with their inability to provide patients with a swallowing exam to support feeding and reeducation decision making” said Xavier Cormary, Speech Language Therapist in Toulouse and the surrounding region. “The immediate advantage of Swallis DSA is its ease of use and portability; for the first time we have access to an objective measure of the swallowing activity outside of the hospital and without cumbersome and invasive exams. It is a first step that allows us to monitor and follow evolution of the patient, recommend modified textures when needed, but also let the patient continue enjoying normal food whenever possible”.

“Swallis DSA is an important step forward in the management of dysphagia and will rapidly find its place in the standard   of care. We also look forward to the technology evolution where validated algorithms will empower an increasingly precise diagnosis of the pathology and a rehabilitation program will support a treatment strategy” added Prof. Virginie Woisard, founder of the Voice and Deglutition Unit, Otorhinolaryngology Department, Rangueil Larrey University Hospital of Toulouse, France.

Dysphagia, a health condition with multiple consequences

Swallowing is a complex mechanism that can be described as a series of actions in which organs, nerves and muscles each play a role. The proper functioning of swallowing ensures that the material (saliva, food bolus) is directed into the digestive system and that the airways remain open and free and entry of residues into the airways and lungs is prevented. This physiological mechanism can be compromised. Neurological disorders represent the most common cause of impaired swallowing, also known as Oropharyngeal Dysphagia. Dysphagia affects up to 75% of stroke patients as well as patients affected by Parkinson’s Disease, SLA, with incidence increasing with age. 50% of post-hospital patients with COVID19 also present with dysphagia.

The main complications of Dysphagia are respiratory infections and undernutrition that can get severe and bring to pneumonia and death.

Early detection and treatment of Dysphagia reduces complications, hospitalisations’ length and number and mortality rates, as well as the use of drugs such as antibiotics and industrial textured foods.

Early Dysphagia detection is difficult because it is based on solutions which all have strong limitations because of their limited sensitivity and specificity or because of their invasive and irradiant character, limited availability and demanding logistics and trained staff.