Most people with major depression are treated by trial and error: a doctor prescribes an antidepressant, waits several weeks, and switches if it fails. Elminda, a company founded in Israel in 2006, set out to shorten that wait. Its software reads a patient's EEG, the electrical activity recorded from the scalp, and was meant to predict before treatment starts whether the patient would respond to antidepressants or to transcranial magnetic stimulation (TMS). In the EIC SME Instrument Phase 2 round of 9 January 2019, the Horizon 2020 forerunner of the EIC Accelerator, the EU backed that tool, called PREDICT, with a grant of €1,958,915.
Seven years later the predictor is not on sale anywhere. The company behind it renamed itself Firefly Neuroscience in 2022, listed on Nasdaq in August 2024 through a reverse merger, and today sells subscriptions to an EEG assessment system used in US clinics, according to its 2025 annual report. Predicting which depression treatment will work appears in that report as something the company "may focus on" as its database grows.
Company file
- Legal entity
- Elminda Ltd, Israel, renamed Firefly Neuroscience Ltd on 24 October 2022; subsidiary of Firefly Neuroscience, Inc.
- Founded
- April 2006
- Address at the award
- Shenkar 1, Herzliya, Israel (CORDIS)
- Parent's head office
- Kenmore, New York
- Chief executive
- Greg Lipschitz, since March 2025 (interim from January 2025)
- Listing
- Nasdaq Capital Market, AIFF, since 13 August 2024
- Staff
- 17 full-time employees, March 2026
- EU projects
- PREDICT Phase 1 (808677, 2018); PREDICT Phase 2 (859051, 2019 to 2021)
From Elminda to Firefly Neuroscience
The company's corporate history is set out in its filings with the US Securities and Exchange Commission. Elminda Ltd was formed in April 2006. In July 2022 its shareholders swapped their shares into a new US parent, Elminda Inc., and in September and October 2022 both companies took the name Firefly Neuroscience. On 12 August 2024 that parent merged into WaveDancer, a small Nasdaq-listed software firm, which took the Firefly name; trading under the ticker AIFF began the next day, according to the 10-K for 2025 and the company's merger announcement. Firefly's shareholders received about 92% of the combined company, and a $3.5 million private placement closed alongside the merger.
The Israeli company register was not consulted directly for this article; the name change, incorporation date and group structure come from the SEC filings. The old website, elminda.com, no longer resolves to a working page.
Firefly's main product today is not the depression predictor. In April 2025 it bought Evoke Neuroscience, a US maker of FDA-cleared EEG hardware, for $6.2 million in cash and shares. The combined Evoke System was in use at "more than 85 clinical sites in the United States" at the end of 2025 and still at the end of June 2026, according to the 10-K and the second-quarter 2026 report. Clinics pay a monthly subscription for the hardware, a set number of scans and the reports. The company still files regularly: its annual meeting on 5 August 2026 approved a cut in authorised shares and a larger share plan, according to an 8-K filing.
The Technology: Brain Network Analytics
Elminda's core technology is Brain Network Analytics (BNA). A patient wears an EEG cap while resting and while doing simple cognitive tasks; the software extracts event-related potentials, the brain's electrical responses to those tasks, and compares the patient's patterns with a reference database. BNA was cleared by the US Food and Drug Administration in July 2014 for patients aged 14 to 24, a clearance widened in December 2020 to ages 12 to 85, and received CE approval in Europe in September 2014, according to the filings; Globes also reported the 2014 FDA clearance. These clearances cover measuring and reporting brain activity, not predicting a treatment outcome.
PREDICT was to add that prediction. The Phase 2 objective on CORDIS describes a tool that "predicts responsiveness to antidepressants and TMS treatment" from validated EEG and event-related potential biomarkers. The established alternative is no test at all: the Phase 1 report noted that only about 50% of patients respond to TMS, that a course takes four to six weeks of sessions, and that "there is currently no way to predict who will respond prior to treatment completion". Elminda's FY2024 annual report lists a patent family on the "prediction of TMS treatment outcome", according to the 10-K for 2024.
"We believe that PREDICT has the capability to revolutionise the health market by providing MDD patients with optimised treatment planning and increased and quicker remission rates."
Dr Ziv Peremen, VP Medical Solutions, elminda, to CORDIS, January 2019What PREDICT Promised, and What CORDIS Shows
The EU funded PREDICT twice. A €50,000 Phase 1 feasibility study, project 808677, ran from February to July 2018. Its report says market research persuaded the company to widen the tool from TMS alone to antidepressant drugs as well, and that it planned sales in Germany, Italy and the Netherlands within three years. Elminda then won Phase 2 at the 9 January 2019 cut-off; the European Commission's list of SME Instrument Phase 2 winners names ELMINDA LTD of Herzliya with PREDICT and lists no partner company for the project. A CORDIS news item at the time said Phase 2 would focus on clinical validation and regulatory approval, with EU sales expected to begin in 2021.
The Phase 2 project ran from 1 May 2019 to 30 April 2021. Its final periodic report set three tasks: finish the design and development of the technology, which it had renamed Opti-Me; validate it "in a multi-center clinical study in leading medical centers in Europe"; and prepare CE marking and the first reimbursement requests. On the work done, the report says the software team "identified additional neuromarkers and optimised the algorithms" and that the system was made ready for clinical trials. It reports no trial results, no CE marking and no reimbursement filing.
The trial itself is on ClinicalTrials.gov as NCT04148612. Sponsored by ElMindA, it planned to randomise 390 patients to see whether Opti-Me reports improved prescribing of SSRIs, SNRIs or TMS, at a site in Be'er Ya'akov, Israel, and at the University of Zurich psychiatric hospital. It started on 6 October 2020, six months before the EU project ended, with completion estimated for January 2022. The record was last updated in February 2021, when it was still recruiting; its status is now listed as unknown and no results have been posted.
- Finish design and development of the toolCompany claim onlyThe final report says algorithms were optimised and new neuromarkers found; nothing has been published that shows this.
- Multi-centre clinical validation in EuropeStarted, no resultsTrial NCT04148612 began in October 2020 at one Israeli and one Swiss site; status unknown since February 2021.
- CE marking of the PREDICT systemNot achievedNo CE mark for a treatment-prediction product has been announced. The filings mention a CE mark "in 2021" without naming the product.
- First reimbursement requests and EU sales from 2021Not achievedNo European sale, customer or reimbursement decision has been announced; the company now sells in the United States.
One discrepancy is worth noting. Firefly's annual reports say both that BNA received CE approval on 11 September 2014 and that "we received our European CE mark" in 2021, without saying which product the 2021 mark covers. Whether it relates to the PREDICT work could not be verified.
What the Company Has Done Since the Award
Before the EU grant, Elminda was a well-funded start-up. In November 2015 it raised a $28 million Series C from investors including Shanda Group, the Kraft Group, Wexford Capital, OurCrowd and Healthcrest, according to The Times of Israel and Globes. By the time of its listing, the company said it had invested about $60 million over 15 years and run more than 77,000 BNA scans on more than 17,000 patients.
On depression, the published output since the award is about monitoring rather than prediction. A 25-patient pilot study in the Journal of Affective Disorders Reports in 2024, with Elminda researchers among the authors, used BNA to track brain responses in patients treated with the antidepressant vortioxetine; delayed responses at baseline moved towards those of healthy controls after eight weeks. The 2025 10-K cites it as evidence for "MDD treatment monitoring".
The listing has not fixed the finances. Revenue was $498,000 in 2023, $108,000 in 2024 and $1,142,000 in 2025, the rise coming "primarily" from the Evoke acquisition. The net loss grew from $2.6 million in 2023 to $10.5 million in 2024 and $19.9 million in 2025. Since the merger the company has repeatedly raised money: $8.8 million from warrant exercises in February 2025 and a $2.25 million private placement in early 2026. Its auditor's report for 2025 carries a going-concern warning, and at 30 June 2026 Firefly had $9.2 million in cash against an accumulated deficit of $115.6 million, according to the second-quarter report.
A management turnover after the listing
Jon Olsen, chief executive at the time of the listing, was removed "without cause" on 6 January 2025, and director Greg Lipschitz took over, first as interim and from 26 March 2025 as chief executive. The 2025 report also records a $251,000 impairment of a capitalised upgrade "no longer being expected to be utilized as a result in a change in management and subsequent direction". Headcount was 13 full-time staff in March 2025 and 17 a year later.
Why Europe Should Care
Depression is one of the EU's largest health burdens. The Phase 1 report put its total cost at €170 billion a year in the EU. On 7 June 2023 the European Commission adopted a comprehensive approach to mental health, with 20 flagship initiatives and €1.23 billion in funding opportunities, built around prevention, access to good care and reintegration. An objective test that cuts the months patients spend on drugs that do not work fits that agenda directly.
The European return from this award is harder to find. The money went to an Israeli company. The planned European sales and reimbursement filings never materialised, the trial's Zurich site is in Switzerland, and the company's commercial base is now in the United States.
What the EU funded
A clinically validated, CE-marked EEG tool to predict which depressed patients will respond to antidepressants or TMS, on sale in Europe from 2021.
What the record shows
A trial that started and then went silent, no product launch, a renamed company listed on Nasdaq and an EEG subscription business at about 85 US clinics.
The Verdict
The prediction was never tested in public
Elminda had FDA-cleared technology, a large database and two rounds of EU money for a clear clinical question. The question remains unanswered: no validation result for the depression predictor has been published, and no regulator has cleared it. The company survived and listed, but on a different business, and with a going-concern warning attached.
Firefly Neuroscience has not been asked for comment for this article. It is based entirely on public records, company filings and EU project data, linked throughout.
Sources
- CORDIS, PREDICT Phase 2 fact sheet and periodic report
- CORDIS, PREDICT Phase 1 fact sheet and report
- CORDIS, PREDICT news item, January 2019
- European Commission, SME Instrument Phase 2 selected companies, 2019
- ClinicalTrials.gov, NCT04148612 (Opti-Me)
- Firefly Neuroscience, 10-K for 2025
- Firefly Neuroscience, 10-K for 2024
- Firefly Neuroscience, 10-Q for the second quarter of 2026
- Firefly Neuroscience, 8-K, 7 August 2026
- Firefly Neuroscience, merger closing announcement, August 2024
- The Times of Israel, Series C, November 2015
- Globes, Series C, November 2015
- Journal of Affective Disorders Reports, vortioxetine BNA pilot study, 2024
- European Commission, mental health
- European Commission, press release IP/23/3050, 7 June 2023
