EIC Accelerator Check: Respinova and Its COPD Air-Pulse Device

Respinova spent more than a decade building one product: Pulsehaler, a handheld device that sends rapid pulses of air pressure into the lungs of people with chronic obstructive pulmonary disease (COPD), to pry open the small airways that collapse as the disease progresses. The Israeli company was selected in the European Innovation Council's 7 October 2020 cut-off, listed with blended finance in the European Commission's list of EIC Accelerator pilot winners. The resulting project, OPEN-LUNGS, received an EU grant of €880,475.75 to run a multicentre international clinical trial, obtain CE mark approval and launch the device, according to CORDIS. It was Respinova's third Horizon 2020 grant for the same device.

The record since then is thin. The US Food and Drug Administration cleared Pulsehaler in March 2021. No results of the multicentre trial, no CE certificate and no European launch have been announced. OPEN-LUNGS closed in February 2023 without a published report. The company's website stopped working in August 2024, and the Israeli company register now flags Respinova as a "violating company", with its last annual report on file for 2023.

A Company That Has Gone Quiet

On paper Respinova still exists. The Israeli Corporations Authority's open register data lists it as an active private company, incorporated on 15 September 2008, with an address on HaHagana Street in Ramat HaSharon; OpenCorporates also shows it as active, with a Herzliya post box. The same register record marks it as a "violating company" and gives 2023 as the last year for which an annual report was filed. Under section 362A of the Israeli Companies Law, the registrar declares a company violating when it fails to pay its annual fee or file its annual report, and may then refuse to register its actions and impose fines, as Bizportal explains.

Public activity has stopped. The company's Wix website was still online in June 2024, with a copyright line from 2022, but by 27 August 2024 the address returned a Wix "ConnectYourDomain" error, and in October 2026 the domain shows a parking page. The Israeli start-up database Startupim lists Respinova as not active and says it ceased operating in March 2025. No second source confirms that date, and no insolvency or liquidation appears in the register record. With no news, filings or product activity for more than 18 months, the company is classed here as dormant.

The Technology: Pressure Pulses for Collapsed Airways

COPD narrows and damages the airways; inhaled drugs relax the smooth muscle around the larger ones. Respinova's argument, set out in its STOP-COPD report, is that much of the disease sits in the small airways at the edge of the lung, which have no smooth muscle for drugs to act on. Pulsehaler delivers "a stream of low pressure, high frequency, pressure pulses into the airway while the patient breathes on it". According to the company's archived technology page, the pulses travel faster inside the airways than in the surrounding tissue, creating momentary forces that open collapsed airways, while positive pressure on exhalation keeps them open and the vibration thins mucus.

The company described itself as the only treatment able to reopen the small airways. That is its own claim. Vibration and airway clearance devices already exist, as the STOP-COPD report itself acknowledges, and the FDA cleared Pulsehaler through the 510(k) route, which rests on substantial equivalence to devices already on the market. The FDA database files it under the product code "Spirometer, Therapeutic (Incentive)", with the decision on 31 March 2021 after a submission on 17 November 2020. HCPLive reported on 6 April 2021 that the clearance covers helping to open airways and clear secretions in patients with respiratory diseases such as COPD, asthma and cystic fibrosis.

The clinical evidence

Two small studies are published. In a randomised, double-blind crossover trial at Hadassah in Jerusalem, published in 2012 in the journal COPD, 22 patients who completed the study walked 61.8 metres further in six minutes after two weeks with the device, against 15.4 metres with a sham device; lung function and two quality-of-life scores also improved. The trial was registered as NCT00821418 and ran from August 2009 to February 2010. A second study of 15 patients, published online in July 2021 with Respinova's chief medical officer Noam Gavriely as first author, found that adding Pulsehaler to a nebuliser sent 3.08 times more of an inhaled drug to the edge of the lung.

The larger trial meant to confirm these results is the gap. Respinova registered a sham-controlled study of 104 patients, NCT04236076, with a planned start in May 2020 and completion in June 2021. Its registry entry was last updated in April 2020, its status is "unknown" and it shows no results. A PubMed search for Pulsehaler returns only the two studies above.

What OPEN-LUNGS Promised, and What CORDIS Shows

OPEN-LUNGS followed two earlier Horizon 2020 grants for the same device. A €50,000 SME Instrument Phase 1 feasibility study ran from December 2017 to April 2018. STOP-COPD, selected in the October 2018 cut-off of the SME Instrument Phase 2 and listed in the cumulative EC list linked above, received €2,414,365.63 towards a €3,449,093.75 budget from February 2019 to July 2022, to finish the design, prepare mass manufacturing, obtain regulatory approval and run a clinical study. In November 2019 chief executive Cliff Ansel told Science|Business that the EU money had made the company shift its launch focus from the US to Europe; the publication added that "a larger-scale third clinical trial" was "about to begin".

The October 2020 award then funded the commercial step. OPEN-LUNGS ran from 1 March 2021 to 28 February 2023 with a total cost of €1,257,822.50, of which the EU paid 70%. Its objective promised three things: a multicentre international trial "to further build data on Pulsehaler efficacy and support marketing launch", CE mark approval, and a launch that would scale up "sales, marketing, and production". The EC list shows the award as blended finance. Respinova does not appear among the roughly 320 organisations on the EIC Fund's list of invested companies, checked across all pages on 18 October 2026, so there is no public evidence that the equity part was ever invested. Respinova was the only beneficiary of the project.

CORDIS has no periodic report for OPEN-LUNGS, and its results page lists no deliverables or publications. The closing report of STOP-COPD, last updated in January 2023, is the latest account from the company. It says Respinova completed the design, passed verification testing, implemented an ISO 13485 quality system and passed audits under the EU Medical Device Regulation, obtained FDA clearance, "passed the review of our Notified Body of our technical file for CE Mark" and "initiated the clinical trial". A passed technical file review is not a CE certificate. No CE marking has been announced, and the EU's EUDAMED device database returns no device named Pulsehaler.

1. STOP-COPD: final design and verificationDeliveredPer the STOP-COPD report, with ISO 13485 certification.
2. STOP-COPD: regulatory approvalPartlyFDA 510(k) clearance in March 2021; no CE mark.
3. OPEN-LUNGS: multicentre international trialNot achievedNCT04236076 status unknown since April 2020; no results published.
4. OPEN-LUNGS: CE mark approvalNot achievedTechnical file reviewed; no certificate announced, no EUDAMED entry.
5. OPEN-LUNGS: market launch and scale-upNot achievedNo sales, distributor or production scale-up announced.
6. OPEN-LUNGS: project reportingNoneNo periodic report on CORDIS.

What Respinova Achieved Since the Award

The FDA clearance is the one milestone confirmed by an independent record. It came four weeks after OPEN-LUNGS started and was a goal of the earlier STOP-COPD project. Ansel called it a major milestone, since the device had not been cleared or approved by any regulator before, according to HCPLive. Beyond that, no customer, distributor, sales figure, funding round or new partnership has been announced since the award. The team page archived in April 2023 listed ten managers and staff and an advisory board of six, including pulmonologists from UCLA and the University of Colorado. Its clinical page at the time still cited only the 2012 and 2021 studies.

How much private money the company raised could not be verified. Startupim gives a total of $7.76 million with a $2.7 million grant in February 2019 as the latest round, and names no investors. Respinova does not file public accounts, so revenue, losses and headcount after 2020 are not known.

Why Europe Should Care

COPD is a large and growing cost for European health systems. The CORDIS summaries, quoting company figures, put the number of affected Europeans at 50 million and the annual cost at €141 billion. Chronic respiratory diseases are one of the five strands of the EU's Healthier Together initiative on non-communicable diseases, launched in December 2021. A drug-free device that improves breathing would fit that agenda. But the EU grants were explicitly meant to bring Pulsehaler to European patients first, and the record shows a US clearance and no European launch.

The Verdict

Respinova has not been asked for comment for this article. It is based entirely on public records, company statements and EU project data, linked throughout.