Why We Invested In Sooma Medical

Opportunity

An estimated 3.8% of humanity experiences depression, including 5% of adults (4% among men and 6% among women), and 5.7% of adults older than 60 years. Approximately 280 million people in the world have depression.

Depression is also about 50% more common among women than among men. Worldwide, more than 10% of pregnant women and women who have just given birth experience depression. More than 700 000 people die due to suicide every year. Suicide is the fourth leading cause of death in 15–29-year-olds.

Depression is a prevalent psychiatric disorder that often leads to poor quality of life and impaired functioning. Treatment during the acute phase of a major depressive episode aims to help the patient reach a remission state and eventually return to their baseline level of functioning. There are multiple treatment options available these days, including:

• Pharmacotherapy, especially selective serotonin reuptake inhibitors (SSRI) antidepressants, remains the most frequent option for treating depression during the acute phase.
• Depression-focused psychotherapy is the second most common option for helping patients overcome the acute phase, maintain remission, and prevent relapses.
• Electroconvulsive therapy is the most effective somatic therapy for depression in some specific situations (for example in pharmacoresistant cases or severe major depression or bipolar disorder cases who have not found relief with other treatments).
• Digital therapeutics are a growing trend and have shown some promise. However, these still have multiple hurdles down the line, including regulatory, reimbursement and other wide adoption hurdles.

Despite these available options, research indicates a predominant increasing trend in the prevalence of depression globally. The percentage of U.S. adults diagnosed with depression at some point in their lifetime has reached 29.0%, which is nearly 10 percentage points higher than in 2015.

There are several reasons why the prevalence of depression is still growing globally:

• Limited access to care: Many individuals with depression do not have access to appropriate treatment due to financial, geographical, or social barriers. In low- and middle-income countries, more than 75% of people with mental disorders receive no treatment
• Stigma and shame: Depression is often perceived as a sign of weakness or personal failure, which can lead to individuals not seeking help or not disclosing their condition to healthcare providers
• Misunderstanding and misdiagnosis: Depression can be mistaken for other conditions, leading to delayed or inappropriate treatment. Additionally, some individuals may not recognize their symptoms as indicative of depression
• Co-occurring disorders: Depression often co-occurs with other mental health conditions, such as anxiety disorders, which can complicate treatment and increase the risk of relapse
• Complexity of depression: Depression is a complex condition that can be influenced by various factors, including genetics, environment, and lifestyle, making it challenging to develop a one-size-fits-all treatment approach

Finnish innovation backed by deep clinical validation

Sooma has developed a non-invasive, at-home neuromodulation therapy using Transcranial Direct Current Stimulation (tDCS) that promises a side-effect-free treatment for depression and chronic pain. Sooma’s therapy has demonstrated remarkable results, achieving a 60% response rate with excellent treatment adherence. With over 20,000 patients treated and regulatory approvals in 35 countries, Sooma’s technology is showcasing a blend of innovation, efficacy, and patient accessibility that we believe is set to redefine the mental health treatment landscape.

Backed by multiple clinical studies, Sooma’s tDCS technology has been the subject of 13 eligible randomised controlled trials (RCTs) and 14 open-label studies. The company puts a lot of effort into generating Phase IV post-market data, with the latest showing close to 97% of all patients exhibiting an improvement in their depression score after completing the treatment. Sooma’s solution is a fully regulated medical device in Europe, and the company will be entering the U.S. and other new markets to expand their positive impact on the mental health space around the world.

The clinical guideline status for tDCS as a treatment for depression is already positive, with the treatment being found definitely effective (Level A). This is based on systematic reviews and meta-analyses of clinical trials where tDCS has been used in patients with major depressive disorder. The evidence suggests that tDCS can have a significant therapeutic effect on depression scores, and it is often well-tolerated with minor side effects.

The Team Driving Success

The company is led by the founder and CEO Tuomas Neuvonen, an engineer by background, who through all the ups and downs over the years has brought together a stellar team at Sooma that is poised to bring their technology to new heights. The company has additionally established a Scientific Advisory Board and are constantly generating more clinical insight, with a view towards adapting their breakthrough technology for other neurological and psychiatric conditions in the future.

The Funding Round

This recent funding round of €5M, led by Voima Ventures in collaboration with Verge HealthTech Fund and Stephen Industries, a Helsinki-based family office investing in health technology solutions, will fuel Sooma’s commercial expansion, including their anticipated launch in the U.S.. It also paves the way for further research and development, ensuring that Sooma remains at the forefront of neuromodulation technology.

What’s Next?

We are truly pleased to join Sooma and its team on the journey of bringing new groundbreaking mental care globally and we cannot wait to see what the future will look like and the impact the company will make.

At Verge HealthTech Fund, we are continually on the lookout for groundbreaking companies that are pushing the boundaries of health technology. Should you be one or look to jump in the journey that is creating a healthtech company, feel free to reach out to us!

Erki Mölder

Managing Partner