Voluntis Receives CE Mark for Oleena, Key Milestone to the Future Commercialization of Its Digital Therapeutics for Oncology
16 Novembre 2020 - 8:00AM
Business Wire
- First Digital Therapeutic for oncology based on the
Theraxium platform to receive regulatory approval in the European
Union
- Marketing authorization to commercialize Oleena now received
both in the US and in the EU
- 12th regulatory clearance (worldwide) obtained by Voluntis
for a proprietary digital therapeutic
Regulatory News:
Voluntis (Paris:VTX) (Euronext Paris, Ticker: VTX - ISIN:
FR0004183960), a leader in digital therapeutics, today announced
that it has received the CE mark for Oleena. This is a key first
step ahead of the commercialization of its oncology solutions in
the European Union.
Oleena, a digital therapy to support treatments of cancer
patients
Oleena is Voluntis’ proprietary digital therapeutic that enables
patients to self-manage symptoms across a wide range of cancer
therapies, and also allows care teams to remotely monitor patients.
Oleena is based on Voluntis’ Theraxium platform, and its patented
algorithm engine, which also serves as the foundation for digital
therapeutics the company co-develops with life science
partners.
Using embedded evidence-based clinical algorithms, Oleena
delivers automated recommendations to patients in real-time. These
recommendations are based on a personalized patient care plan. They
focus on:
- self-management of symptoms (e.g. advice on dietary
adjustments, use of symptomatic treatments over a certain period of
time),
- personalized dosing of medication,
- guidance for the self-monitoring of relevant health
indicators,
- and identifying the need for escalation of care.
Paving the way to commercialization of oncology digital
therapeutics in the EU
The CE mark of Oleena paves the way to the future
commercialization of Voluntis’ oncology digital therapeutics in the
EU, where there are an estimated 3.9 million new cancer cases
annually1. Recent real-world research has shown that up to 89% of
patients experience side effects related to cancer treatments2. If
not managed appropriately, these symptoms may result in
hospitalizations and ER visits, which could have been partially
avoided by delivering highly personalized, proactive real-time
support for patients at home.
This regulatory approval happens at a time when healthcare
professionals and health systems are increasingly turning to remote
patient monitoring solutions. This is currently illustrated during
the Covid-19 pandemic with patient access to hospital services and
oncology centers being significantly reduced. These solutions can
support both patients and their care teams in the management of
at-home treatments. Oleena enables healthcare providers to easily
access patient data remotely so they can monitor patients’
treatment and if necessary, intervene.
“The CE mark of Oleena, a key milestone on our strategic
roadmap, is an important step towards the commercial launch of our
oncology digital therapeutics in Europe” said Pierre Leurent, Chief
Executive Officer. “Following our groundbreaking marketing
authorization received in the US last year, we look forward to
supporting our partners in the future commercial rollout of our
solutions on both sides of the Atlantic.”
“This twelfth regulatory clearance obtained over the past seven
years speaks to the maturity of Voluntis’ proprietary platform and
processes in the field of digital therapeutics.” added Raffi
Krikorian, SVP Global Quality and Regulatory Affairs. “Leveraging
our ISO 13485 and MDSAP certified Quality Management System, we are
glad to provide our partners with state-of-the-art capabilities to
quickly design and bring to market digital therapeutics that make a
difference for patients around the world.”
About Voluntis
Voluntis creates digital therapeutics that empower people with
chronic conditions to self-manage their treatment every day, thus
improving real-world outcomes. Voluntis’ solutions, combining
mobile and web apps, use clinical algorithms to deliver
personalized recommendations to patients and their care teams. For
example, these recommendations are used to adjust treatment dosage,
manage side effects or monitor symptoms. Leveraging its Theraxium
technology platform, Voluntis has designed and operates multiple
digital therapeutics, especially in oncology and diabetes. Voluntis
has long-standing partnerships with leading life science companies.
Based in Cambridge, MA, and Paris, France, Voluntis is a founding
member of the Digital Therapeutics Alliance. For more information,
please visit: www.voluntis.com
Mnemo : VTX - ISIN : FR0004183960
Disclaimer
This press release contains certain forward-looking statements
concerning Voluntis group and its business, including its prospects
and product candidate development. Such forward-looking statements
are based on assumptions that Voluntis considers to be reasonable.
However, there can be no assurance that the estimates contained in
such forward-looking statements will be verified, which estimates
are subject to numerous risks including the risks set forth in the
2019 annual financial report and the 2020 half-year financial
report published by Voluntis respectively on April 30, 2020 and
September 29, 2020 (a copy of which is available on
www.voluntis.com) and to the development of economic conditions,
financial markets and the markets in which Voluntis operates. The
forward-looking statements contained in this press release are also
subject to risks not yet known to Voluntis or not currently
considered material by Voluntis. The occurrence of all or part of
such risks could cause actual results, financial conditions,
performance or achievements of Voluntis to be materially different
from such forward-looking statements. Voluntis expressly declines
any obligation to update such forward-looking statements
________________________
1 https://canceratlas.cancer.org/the-burden/europe/
2 PLOS. 12(10). DOI: 10.1371/journal.pone.0184360.
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ACTUS Media relations Vivien Ferran vferran@actus.fr +33
(0)1 53 67 36 34
ACTUS Investor relations Jérôme Fabreguettes-Leib
voluntis@actus.fr +33 (0)1 53 67 36 78
Voluntis Chief Financial Officer Guillaume Floch
investisseurs@voluntis.com +33 (0)1 41 38 39 20