Oncomfort creates cushion for growth with 10M series A fundraising – BioWorld Online

Oncomfort SA finalized a 10 million (US$11.8 million) series A fundraising round to further develop its Digital Sedation product and pursue international expansion. Debiopharm and Crdit Mutuel Innovation led the round with participation from Wallonia Innovation and Growth and previous investors. Digital Sedation uses virtual reality to deliver clinical hypnotherapy combined with integrative therapeutic techniques to relieve patients' pain and anxiety before, during and after medical procedures without medication.

With this series A funding, we will accelerate our product development with a broader engineering team and invest in the international expansion of Oncomfort, said Mario Huyghe, CEO of Oncomfort. More specifically, the Brussels-based company plans to use the funding to develop new clinical applications, support additional clinical sessions and add more capabilities to allow the Digital Sedation technology to be used by anyone that has basic training on the device, Huyghe told BioWorld.

Digital Sedation gained a CE mark in June 2018 and the devices manager application, included in the companys Sedakit, received European clearance the following year. Currently, it is available in Belgium, The Netherlands, Luxembourg and France and recently secured its first users in Switzerland and Germany. The company plans to expand to 15 additional European countries in the next year and is preparing its de novo 510(k) application to the U.S. FDA in the first quarter of 2021, Huyghe said.

Digital Sedation has had extensive validation in clinical trial settings, and more than 60,000 patients have used it. The technology has been used for in vitro fertilization pre-oocytes puncture, preparation for breast surgery, allergen specific immunotherapy for children, and painful procedures such as drain removals and bone biopsies without use of anesthesia or other medication and in urological surgery with and without intravenous sedation and minor orthopedic surgery with spinal anesthesia. Multiple studies demonstrate a reduction in pain and anxiety, improved patient satisfaction and less need for other types of sedation.

Those results strongly appealed to the investors. "Our investment in Oncomfort's digital sedation solution is based on the strong potential of digital therapeutics as well as the specific intellectual property and scientific evidence that Oncomfort has built over recent years," said Karine Lignel, CEO of Crdit Mutuel Innovation.

"We are delighted to find a scientifically validated digital tool to support the overall journey of patients, which frequently includes various levels of pain, anxiety, and fear. The fact that advanced Virtual Reality in combination with hypnotherapy and integrative therapeutic techniques can be used to effectively sedate patients is truly impressive and offers an interesting option for patients to find physical and emotional relief," explained Thierry Mauvernay, president of Debiopharm Innovation Fund.

Crdit Mutuel Innovations Director of Participations, Delphine Cardi, will join the Oncomfort board of directors as will Tanja Dowe, CEO of Debiopharm.

We are extremely pleased that they wanted to join the board because of their experience in therapeutics. They really bring the level of financial and business knowledge up significantly, noted Huyghe. Both women also have advanced degrees in microbiology/cell biology and biochemistry.

Digital therapy

"We are at a tipping point in our digital therapy," Huyghe said. "The medical community has discovered the advantages and potential of Digital Sedation to relieve pain and anxiety without medication. Virtual reality acts as an enabler for this digital therapy. Yet, Oncomfort's true potential comes from the scientific evidence of its digital sedation and the multidisciplinary co-creation with the expertise of anesthesiologists, neurologists, psychologists and hypnotherapists.

The company offers seven clinical sessions with an additional one now coming online next month. Each is available in 12 languages and can be tailored to the patients age, duration of intervention and type of procedure to provide a range of levels of sedation.

Applications

Digital Sedation was originally developed to help oncology patients, leading to its name oncology + comfort it has the potential to ease anxiety and pain in many other settings. Research to date has focused on use within health care facilities for surgical procedures, radiotherapy, interventional cardiology, and diagnostics. Recent results indicate that Digital Sedation also reduces the duration of labor, calms mothers and increases satisfaction with the childbirth process, Huyghe said.

Studies have shown Digital Sedation reduces apneas during surgery by 85% and involuntary movement by 65%, shortens surgery time by 11%, and provides better sedation than midazolam. Nearly half of patients report extreme satisfaction and anesthesiologists found it substantially more satisfactory than other options.

The course we have taken from the beginning is a very evidence-based approach that is well analyzed and studied so that we know that the efficacy is concrete and clear. We take the same approach to all applications, Huyghe explained. We want to break through as a new standard of care and we have to have the evidence required for medical devices that we deliver the desired outcome.

The potential for wider use of Digital Sedation was clear to one of the new board members. "With this investment in Oncomfort, we want to push the boundaries to inspire health care stakeholders to acknowledge that there is much more we can do for patients through digital technology," said Dowe.

Link:
Oncomfort creates cushion for growth with 10M series A fundraising - BioWorld Online