Hi friend,

Aisel, Lissun, Ours Privacy and Lean Therapeutics all raised funding rounds this week.

Limbic became the first mental health company selected for the FDA's TEMPO pilot, with their newly announced product “Unpacked”. Just today, SonderMind joined them, with their smartphone-based SonderMind Adjunctive Care Application (SACA) also accepted into TEMPO.

There is a new scoping review in Nature digital medicine on the mental health harms of LLM-based chatbots, new research on the impact of semaglutide use for people living with psychiatric conditions, and The Path published a small study examining engagement with its AI chatbot, Mental.

Let’s get into it!

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What happened in mental health last week?

Industry News:

⏺️ Ours Privacy raised $15 million to expand its healthcare marketing platform. The Series A was led by Lightbank and Health Velocity Capital. Ours Privacy integrates data from sources including websites and electronic health records, removing protected health information before sending marketing signals to third-party platforms. The company serves more than 200 healthcare organisations, amid growing regulatory scrutiny of patient-data tracking technologies. The founders created Ours after experiencing the problem first-hand when running the couples therapy business, OurRitual. (link)

⏺️ Leal Therapeutics raised $30M in a Series A extension, adding Eli Lilly as a new investor. The clinical-stage biopharmaceutical company is developing neuro-metabolic therapeutics for CNS disorders. Proceeds will advance LTX-001, a brain-penetrant GLS1 inhibitor, through an initial data readout from its newly initiated Phase 1b/2a trial in schizophrenia, and progress LTX-002 through additional dosing cohorts in an ongoing ALS trial. The round brings Leal's total funding to $114M. (link)

⏺️ Aisel Health raised €1.7 million to expand its AI software for psychiatric care. Aisel develops an “operating system” that helps psychiatric clinicians organise information from patient records, interviews and other documents, aiming to reduce administrative work and surface relevant clinical context. The pre-seed round was led by Caesar Ventures, with the funding supporting growth of Aisel’s clinical and engineering teams and their expansion in the UK. (link)

⏺️ Lissun raised ₹48 crore ($5.5M) in a Series A round to expand child development centres across India. The Gurugram-based platform, which supports children with special needs and developmental delays through its Sunshine by LISSUN brand, currently runs 25 centres delivering more than 10,000 therapy sessions per month. The round was led by Colossa Ventures, with participation from Physis Capital and existing investors. Funds will expand the centre network and build AI-led clinical tools. (link)

⏺️ Radial acquired the management company behind Mindful Health Solutions, creating the largest interventional psychiatry network in the US. The deal brings Radial's total clinics under management to 27 across seven states, with more than 100 clinicians treating major depressive disorder, PTSD, OCD, and suicidality using TMS, esketamine, IV ketamine and other neuromodulation treatments. Terms were not disclosed. (link)

⏺️ Cityblock Health agreed to acquire Homeward Health alongside a $116M Series E. Cityblock provides medical, behavioural, and social care primarily to people covered by Medicaid or both Medicare and Medicaid, while Homeward serves nearly 50,000 rural Medicare Advantage members. Alongside the deal, Cityblock raised a $116 million Series E led by General Catalyst. The combined platform will serve almost 200,000 people and has $2.2 billion in annualised revenue. (link)

⏺️ Johnson & Johnson is set to lead an $85 million Series C for Delix Therapeutics, a biotech developing drugs designed to promote brain plasticity without causing a psychedelic trip. According to documents reviewed by Psychedelic Alpha, the financing would value Delix at $190 million before the investment. Delix is developing neuroplastogens that aim to capture potential therapeutic properties associated with psychedelics while allowing more conventional at-home dosing. (link)

⏺️ Advanced Recovery Systems acquired Promises Behavioral Health, forming a 24-facility addiction and mental health network across 14 states. The combined company offers medical detox, inpatient, residential and outpatient treatment. Financial terms were not disclosed. (link)

⏺️ Limbic became the first mental health company selected for the FDA's TEMPO pilot. Starting August 27th, Limbic’s newly announced “Unpacked” service will deliver clinician-supervised cognitive behavioural therapy to Medicare beneficiaries with depression or anxiety, using scheduled phone conversations with an AI voice agent between clinician check-ins. Licensed clinicians remain responsible for each patient, reviewing sessions and progress, receiving safety alerts, and adjusting or taking over treatment when appropriate. The TEMPO pilot lets device makers offer new technology to Medicare patients ahead of full FDA authorisation in exchange for real-world outcomes data. Limbic joins two other companies, Cadence and Dexcom, in the broader pilot. (link)

⏺️ SonderMind was also selected for the FDA’s TEMPO pilot, with its smartphone-based SonderMind Adjunctive Care Application (SACA). The behavioural health app is intended for adults aged 22+ being treated for moderate depression and/or anxiety and is designed to reduce symptoms alongside, rather than replace, psychotherapy and/or medication. (link)

⏺️ Former Resilience Lab founders, Marc Goldberg and Christine Carville, announced the launch of Cendera Health, a new company for families navigating serious mental illness. The duo previously founded Resilience Lab in 2019, which was acquired by Cerebral last year. Cendera describes itself as building "the first accountable, full-stack care model for families navigating complex mental illness." (link)

⏺️ Grow Therapy launched "Compass Parenting," a framework to help parents guide their children through digital-era mental health challenges. The framework draws on new survey data showing 91% of parents rate their child's mental health as good or excellent, compared with just 54% of teens who agree, and that 59% of teens keep distress to themselves rather than telling a parent. The framework, developed with clinical psychologist Dr Jacinta Jimenez, encourages parents to focus less on policing screen time and more on helping children build emotional regulation and self-awareness through curiosity, collaboration and open conversation. (link)

⏺️ HHS awarded $96.7M in grants to strengthen behavioural health services nationwide. The largest share, $63.4M, funds the Projects for Assistance in Transition from Homelessness programme across all 50 states. The remaining funds support suicide prevention, substance use treatment, peer support and disaster-related emotional support. (link)

⏺️ The FDA opened a public comment period on how it should regulate generative AI-enabled medical devices. A discussion paper released by the FDA explores a new regulatory approach for generative AI medical devices, including assessing their “competency” in a way partly inspired by how doctors are evaluated. Comments are due October 19th. You can read our recent guides to regulation of Mental Health AI here. (link)

⏺️ SAMHSA published a major policy report on AI in mental health services, with 12 recommendations for regulators. The report, authored by researchers at Beth Israel Deaconess Medical Center and Harvard Medical School, calls for matching oversight to clinical risk, mandatory crisis-indicator reporting, and independent benchmarking rather than vendor-controlled safety claims. (link)

⏺️ Ballmer Group gave $125M to expand the University of Oregon’s undergraduate training model for child behavioural health. The programme trains bachelor’s-level providers to address youth mental health needs under clinical supervision, with the funding establishing a national hub and supporting expansion to other universities. Separately, Oregon passed a law licensing bachelor's-level behavioural health providers trained under this model. This funding comes in addition to the Ballmer Group’s $110 million commitment earlier this year to expand the behavioural health workforce in Los Angeles. (link)

⏺️ Medicaid spending on psychotherapy rose 156% over seven years. Analysis of federal data from BHB found patient numbers rose 40% and claims 43%, while the average payment per claim increased 65%, making higher payments a major driver of spending growth. Individual psychotherapy accounted for 81% of spending, while nonprofits and government organisations were the largest recipients of payments. (link)

⏺️ HHS expanded federal reimbursement for peer-support services. The HHS added two peer-support programmes to the federal list eligible for Medicaid child-welfare prevention reimbursement. Family-Based Recovery and the Wellness Recovery Action Plan (WRAP) can now be claimed by any state, aiming to help parents overcome addiction while keeping children out of foster care. Iowa is the first state to participate. (link)

⏺️ A new independent body has launched to set safety and governance standards for digital health and AI tools in Australasia. The Digital Health Standards Council of Australasia (DHSCA) will support healthcare organisations with AI governance and plans to assess lower-risk tools using GUARDS, a six-domain clinical and technical safety framework. It also intends to seek approval in 2027 to accredit services against national safety and quality standards. (link)

⏺️ A large Headway study found that nearly one in five people starting outpatient mental health care reported recent suicidal thoughts. Researchers analysed routine screening data from 189,225 commercially insured patients aged 6–64 across all 50 US states. Overall, 18.6% reported some level of suicidal ideation at their first appointment, rising to 32.8% among 13–17-year-olds. Rates were also higher in more socially vulnerable areas, while West Virginia and Alaska combined high rates with shortages of mental health clinicians. (link)

⏺️ OpenAI launched ChatGPT for Teens, automatically applying stronger safeguards to under-18 accounts. The system uses age prediction to detect likely teen users and blocks romantic or companionship framing, adds Study Mode, and expands parental alerts to cover eating disorder conversations, among other high-risk topics. (link)

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Research News:

⏺️ A scoping review identified evidence of inappropriate mental health responses from AI chatbots and associations between chatbot overreliance and poorer cognitive and academic performance. Researchers searched five literature databases and identified 3,137 articles, narrowing to 119 studies focused on the mental health harms of LLM-based chatbots. Vignette-based studies found chatbots responded inappropriately to mental health queries compared with clinical standards, and cognitive overreliance on chatbots was associated with decreased cognitive and academic performance. (link)

⏺️ A study of 13,007 US adults with psychiatric conditions found that semaglutide use was associated with fewer cognitive problems over the following year. Researchers compared 1,261 people prescribed semaglutide with matched groups receiving sitagliptin, empagliflozin, glipizide or no diabetes treatment. Semaglutide was associated with better overall cognitive scores than empagliflozin, glipizide and no treatment, particularly for memory and other cognitive functions, but not significantly better than sitagliptin. The findings were most consistent in people with major depression. Because this was an observational study using health records, it cannot prove semaglutide caused the better cognitive outcomes, and the researchers say randomised trials are needed to confirm the findings. (link)

⏺️ The Path published findings from a study using their AI chatbot “Mental”, finding that users with longer, more occasional sessions reported lower depression and anxiety symptoms than those who used it for shorter sessions more consistently. Researchers analysed 112 US adults who had completed at least five AI-chat sessions, grouping them by interaction depth and whether use was clustered or evenly spread over time. Users with longer, clustered sessions reported the lowest depression and anxiety, while those with brief, regularly spaced sessions reported the highest. The study was cross-sectional, so it cannot show whether these engagement patterns affected symptoms or whether existing symptoms shaped how people used the chatbot. (link)

⏺️ A study found that making an action plan was the most effective part of a brief digital intervention for depression. Researchers randomly assigned 889 US adults with elevated depressive symptoms to different combinations of psychoeducation, peer testimonials and an action plan. The action plan produced small reductions in depression at both two and eight weeks, while psychoeducation and testimonials did not show significant independent effects. Participants who viewed the intervention as more credible and expected it to help also experienced greater symptom reductions. (link)

⏺️ A JAMA viewpoint argued that autonomous AI will eventually outperform doctors using AI as an assistive tool. The authors, including medical ethicist Ezekiel Emanuel and venture capitalist Vinod Khosla, drew on studies of simulated patient encounters to argue that fully autonomous AI diagnosis and treatment planning could exceed the accuracy of human clinicians working alongside AI tools in cognitive medical functions. The authors argue that AI already matches or exceeds doctors in gathering patient information, diagnosis, selecting tests, recommending guideline-based treatment and managing some chronic diseases. (link)

⏺️ A global genetic study found binge-eating behaviour and anorexia nervosa share some genetic risk factors but are also genetically distinct. Researchers conducted genome-wide association studies comparing people with binge-eating behaviour, anorexia nervosa or neither condition, finding each phenotype had both shared and unique genetic associations. The findings suggest treatments tailored to each disorder's distinct biology may be more effective than a one-size-fits-all approach. (link)

That’s all for this week.

Keep fighting the good fight!

Steve Duke

Founder of Hemingway

P.S. If you find these updates valuable, consider becoming a Hemingway Pro Member. As a Pro Member, you will get access to even deeper industry insights and will be invited to join our community of over 500 mental health leaders.