PKvitality and the EIC Accelerator: Glucose Watch Never Shipped

PKvitality, a Paris start-up, spent a decade on one idea: a smartwatch that measures glucose through micro-needles under its case, so that people with diabetes would not need finger pricks or a visible sensor patch. In the EIC Accelerator pilot's March 2020 cut-off it was selected for blended finance, according to the European Commission's list of selected companies, which names PKVITALITY as the only beneficiary of the project. CORDIS lists an EU grant of €2,289,963.38 towards a €3,271,376.25 project, K Watch Glucose, running from 1 November 2020 to 31 October 2023.

The watch never reached the market. On 1 February 2023 the Paris commercial court opened receivership proceedings, recording that the company had stopped paying its debts on 24 January 2023, and on 27 April 2023 it converted them into a judicial liquidation, according to notices in the official gazette BODACC and a summary of the case by Copeps. PKvitality has been insolvent since, six months before its EIC project was due to end.

Where PKvitality Stands Now

PKvitality is in judicial liquidation. The national company directory still lists the legal entity as administratively active, because a company in liquidation stays on the register until the proceedings are closed, according to the recherche-entreprises register service. The last BODACC notice, published on 11 April 2024, says the liquidator filed the statement of creditors' claims with the court on 9 April 2024. No notice closing the liquidation, and no notice of a sale of the business, has been published since.

When the court opened proceedings, the administrator invited offers to take over the business by 22 February 2023, according to Copeps, which put the staff at 27 and listed a portfolio of about 50 patents that had been valued in June 2022. Whether anyone bid, and who now holds the patents, could not be verified. The company's website, pkvitality.com, returns an empty page; the last news on it, preserved by the Internet Archive, is dated June 2022.

The Technology: Glucose From Under the Watch

Continuous glucose monitors already exist as patches stuck to the arm or belly with a filament under the skin. PKvitality's project report on CORDIS names the complaints it set out to fix: pain when the sensor is inserted, problems with the adhesive, a visible patch that marks the wearer as ill, and cost. Its answer, called SkinTaste, was a weekly disposable capsule of micro-needles coated with a biochemical sensor, clipped under a smartwatch that reads, stores and displays the glucose signal. The needles were under 0.7 millimetres long, according to the CORDIS objective, short enough, the company argued, not to reach pain nerves.

The selling points were comfort and discretion rather than new chemistry. The open question was accuracy. On 26 July 2022 PKvitality said its third human trial, at the AMCR Institute in California, reached a mean absolute relative difference (MARD) of 16%, against the 17 to 18% it had aimed for, and that its first two studies had shown 19%, according to its press release. Notebookcheck, citing the company, reported 29% for the first trial and 19% for the second, and a launch "around 2024" at an expected $199 for the watch and about $99.90 a month for the sensors. Gizmodo Japan reported the June 2022 trial and the improvement but no figures. The trial numbers come from the company; the study registered on ClinicalTrials.gov (35 participants planned, started 15 November 2021) has posted no results, and its status has not been updated since May 2022.

Six months after that statement the company stopped paying its debts.

What the EIC Project Promised, and What the Record Shows

The K Watch Glucose grant agreement was signed on 5 October 2020. Its objective on CORDIS was to commercialise the watch: clinical validation, certification as a medical device, industrialisation, and distribution networks in the EU and North America. The proposal projected 830,000 active users five years after the programme, a cumulative profit of €201.1 million and 139 new jobs. It was PKvitality's second EU grant: a Phase 1 feasibility study under the SME Instrument, also called KWatch Glucose, received €50,000 in 2017.

The only periodic report on CORDIS covers the first year, to 31 October 2021. It reports more than 3,500 sensors used in laboratory tests, a passed stage 1 ISO 13485 quality audit with BSI as notified body, a contract with a "tier 1" manufacturer for the watch, a secured site for a sensor factory, 36 patents filed and more than 60,000 newsletter subscribers. CORDIS publishes no report for the remaining two years and no final results. The project is marked closed on CORDIS, which does not mention the liquidation.

1. First clinical trialsPartlyThree early US trials; results presented at ATTD 2022, none posted on ClinicalTrials.gov.
2. Clinical validationNot achievedNo pivotal study announced before the liquidation.
3. Medical device certificationNot achievedStage 1 ISO 13485 audit only; no CE mark or FDA clearance announced.
4. Industrial productionNot achieved"Final" watch design announced in May 2022, per the company site; no production announced.
5. EU and North American salesNot achievedNo product sold; liquidation in April 2023.
6. 139 new jobsMissed27 staff when proceedings opened.

Judged fairly, the grant paid for real development work: a sensor tested thousands of times, a watch design, three trials with improving accuracy figures and a growing patent portfolio. What it did not produce was the thing the project was for, an approved, manufactured monitor in patients' hands. The project counts here as partly delivered.

The Money

PKvitality raised money from many sources. In January 2020 Beurer, a German maker of blood glucose meters, invested and took exclusive distribution rights for Germany, Austria and Italy. Beurer's own announcement puts the investment at €2 million, while EU-Startups reported €2.25 million. In November 2021 the consultancy Inspiralia, which describes PKvitality as its client, wrote that the company had accepted an equity offer from the EIC and that "the additional €2.5M just secured from the EIC fund" would accelerate clinical trials, according to an archived copy of its post.

Whether that equity was paid in could not be verified. PKvitality does not appear among the 326 organisations on the EIC Fund's list of invested companies (checked on all 17 pages), and no other source confirms an EIC Fund investment. In April 2022 the company opened a crowdfunding round on WiSEED and said it had "already raised more than €18 million in funding, two thirds of which in shares", from business angels, Beurer and public bodies it named as "Region, Bpifrance and Europe", according to its announcement. That total is the company's own and is not itemised.

The accounts give little away. The last fully public figures, in the INPI ratios dataset, are for the year to June 2016, when PK Paris booked revenue of €406,632 and a net loss of €368,161. For the period to December 2018 the dataset shows no revenue, a net profit of €27,406 and a financial autonomy ratio of minus 24.8%, which means equity was negative. The accounts for 2019, 2020 and 2021 were filed with a confidentiality declaration, according to BODACC, and no accounts for 2022 were published.

Why Europe Should Care

Diabetes is one of the five strands of the Commission's Healthier Together initiative on non-communicable diseases, launched in December 2021 for 2022 to 2027. PKvitality's own CORDIS report puts the number of people with diabetes in Europe at 60 million, with €90 billion in direct costs, and counts 4 million users of continuous glucose monitors at the end of 2020. A European-made monitor that patients would actually wear was the policy case for the grant.

The case also shows the limit of an EU grant for medical hardware. Clinical trials, a notified-body audit and a sensor factory all had to be paid for before the first sale, and the €2.29 million covered only part of that. PKvitality ran out of money between its third early trial and the pivotal study that certification would have required.

The Verdict

PKvitality's liquidator and the EIC have not been asked for comment for this article. It is based entirely on public records, company statements and EU project data, linked throughout.