By Greg Licholai, Contributor, Forbes | August 13, 2019
This is an exciting summer for the Digital Therapy (DTX) industry. Recently Voluntis announced marketing authorizationof the first oncology disease management software platform. This comes on the heels of two impressive IPOs for digital health companies Livongo and Health Catalyst. Livingo achieved a valuation of over $3 billion on its first day, and Health Catalyst was over $1 billion. This is welcome news since venture capitalists have invested billions into DTX but have been waiting for liquidity in public markets. Voluntis was one of the first in this category to go public on Euronext Paris in 2018.
The Voluntis announcement is being called the first digital therapeutic broadly applicable to oncology. Chief Executive Officer Pierre Leurent says, “this provides market authorization for all cancer types.” About 15 million people are living with cancer in the US and around 90% experience cancer-related symptoms leading to significant loss of quality of life. This first prescription digital therapeutic to receive marketing authorization from the US Food and Drug Administration (FDA) in oncology provides tailored recommendations that answer specific patient needs and offers individualized experience for care providers.
“This is a very exciting time in digital therapeutics. In addition to being first in class, we are able to target one of the biggest markets and one of the largest costs in disease management,” says Romain Marmot, Chief Operations Officer of Voluntis.
Cancer experts are optimistic about the prospects of digital therapy. Michael Seiden, President of US Oncology Network says, “digital technologies offer significant opportunities to provide higher value cancer care. Innovation and advances from Voluntis … are an important step in bringing practical medical interventions to patients in a timely and highly efficient manner.”
Voluntis’ product is called Oleena and supports patients in the management of their treatment-related symptoms. The mobile application provides personalized and adaptive recommendations based on patients’ individual characteristics, symptom history and treatment plan. The product uses mobile and web technologies that enable self-management of symptoms and remote monitoring by care teams.
“Self-efficacy,” says Marmot, “is what patients are asking for.” He explained that oncology is being approached as a chronic disease for more people. New anticancer agents have encouraging results, but also come with specific side effects. “Patients are asking to be more in control of their disease and want a better quality of life,” he said.
An important factor in the marketing authorization were clinical algorithms founded on evidence-based standards of care for symptom management in oncology issued from US and European consensus guidelines and validated by a panel of clinical experts.
Based on clinical algorithms, the oncology disease management application gives patients real-time insights on what to do and when to do it. Ultimately the platform has the potential to provide benefits by helping to address critical unmet needs such as treatment-related symptoms, including pain, fatigue, depression, and cognitive impairment. Symptoms that can be managed are often undertreated, which risk becoming more severe and leading to unscheduled hospitalizations.
Marmot noted that the company has the responsibility to train physicians how to optimally incorporate digital solutions into their work. “We can’t just create technology and drop it into practices,” he says. “We offer personal training and help integrate into workflow and EMRs [electronic medical records].”
The product can support patients across a wide range of cancer diagnoses and anticancer treatments, including chemotherapy, immunotherapies and targeted therapies, such as PARP, PI3K, CDK4/6 inhibitors.
The positive review and marketing authorization of Voluntis’ Oleena software for oncology-related symptoms management and remote patient monitoring by the FDA was as a class II medical device and exempted from 510(k) requirements, as part of the 21st Century Cures Act.
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