CE Mark for updated SC+

FDA in-centre 510(k) submission

UK Commercial launch

FDA Clearance

Completion of Human Factors Testing /Secure IDE to start US home study

Milestone progress

Welcome to the latest edition of Quanta’s Quarterly Newsletter. Over the last three months, we havecontinued to support our NHS customers through the COVID-19 pandemic by providing SC+ to ICUs. Thishas enabled the NHS to continue providing the life sustaining therapy required by acute kidney failurepatients, despite systemic shortages of supplies. We have now trained over 100 NHS critical care nurses touse SC+, all of whom have completed training in under six-hours. This is a remarkably short time to learnabout, and become proficient in using, a new dialysis system—which is a strong testament to the ease ofuse inherent in the design of SC+. In tandem, we are also busy training our first commercial home patient,whom we hope to send home with SC+ over the next month or so.

Meanwhile, our 510(k) submission to the FDA continues to progress well, with clearance expected laterthis year, and our US commercial launch preparations are underway.

Quanta’s team has adapted well to the remote working and social distancing necessitated by COVID-19,maintaining high productivity and effectiveness even as headcount has grown by 25 people to support UKcommercialisation activities and US market launch preparations. This is an exciting time as we more fullybecome a commercial operation and see the positive impact we have on patients’ lives.

QUARTERLY NEWSLETTER

Welcome

August 2020

Hooman Hakami Appointed to Quanta BoardQuanta announced the appointment of Hooman Hakami to the Company’s Board as an independentNon-Executive Director. Hooman has more than 30 years of leadership experience, including seniorpositions at two of the world’s most recognised medical devices companies. At Medtronic, he wasExecutive Vice President and President of the Diabetes Group. Prior to that he spent more than 20 years atGeneral Electric, where he was a Company Officer. Upon his appointment, Quanta Chairman,Johan de Ruiter, said ‘I am very pleased to welcome Hooman to the Quanta Board. His commercialexperience in introducing disruptive technologies will be a large asset to the Company’.

Flow Balance Optimisation and Fluid Removal Accuracy PaperOur latest clinical paper on Flow Balance Optimisation and Fluid Removal Accuracy was published on the 4th August and is now availableon Taylor and Francis Online. The paper discusses how fluid management is integral to haemodialysis, both to correct abnormalities in apatient’s plasma composition and to maintain fluid balance, and consequently a critical design element of haemodialysis machines.

The paper describes the design, evaluation and performance of the flow balance and ultrafiltration functions of the SC+ system to deliverclinically specified fluid removal with both passive and active control measures, in laboratory conditions designed to simulate a widerange of therapies. The results reported show that SC+ provides best in class performance with average flow balance error only 1 mL/hr,which is two orders of magnitude better than the requirements set out by the relevant technical standards.

Upcoming Virtual Events3rd SeptemberBTOV Investor Portfolio

9th & 10th SeptemberWells Fargo

15th – 18th SeptemberLSX Health Tech Leaders Partners

21st September Quanta Webinar

5th – 15th OctoberUK Kidney Week

22nd – 25th OctoberAmerican Society of Nephrology (ASN)

17th – 20th November11th Annual Jefferies Global Healthcare Conference

John E. Milad,CEO, Quanta Dialysis Technologies

Click on the hyperlinks for further information

NewsflowQuanta CEO, John E. Milad, this month, presented Quanta at the Private Healthcare Company Virtual Summer Symposium, hosted by LifeSci Advisors and also at the Genomics 2.0 and MedTech Innovations Virtual Summit held by UBS. In addition, we continue to share updates on the Survivor’s: Life Unfiltered Virtual Exhibition as well as welcoming Hooman Hakami to Quanta’s Board of Directors. Quanta was also shortlisted for the ‘Emerging Stars’ award at the 2020 European Mediscience Awards, which are scheduled to take place on 10th November 2020.

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Virtual ERA-EDTA and Poster PublicationsDespite ERA-EDTA being entirely virtual this year, Quanta submitted three abstracts and posters for publication that can be seen overthe next few pages. The first of these posters shows that in a health-economic analysis, SC+ is associated with lowercost-per-treatment than conventional haemodialysis, when used for self-care, in-centre and home haemodialysis on both a 3x andalternate day regimen. The second poster shows that SC+ is able to maintain highly accurate fluid management, well within the limitsrequired by technical standards. Lastly, the third poster shows that both healthcare professionals and patients were able tosuccessfully operate SC+ independently with a high level of use safety despite minimal training and learning decay.

Quanta Sponsors Survivor’s: Life Unfiltered ExhibitionQuanta is proud to be the headline sponsor of the Survivors: Life Unfiltered exhibition.This exhibition was curated by Quanta’s Patient Advocate, Maddy Warren who, herselfis a Home HD patient and photographer Richard Booth. 34 participants with agesranging from 2 to 78 years old, who are dialysis patients or have experienced being ondialysis, share their unique stories covering diverse topics such as mortality, mentalhealth, body image, gratitude, survivor’s guilt, silver linings, reconciling with a “new”normal and finding hope, whilst living with a life limiting condition.

The exhibition aims to portray the strength, vulnerability and resilience of those whoare affected by Chronic Kidney Disease (CKD), shining a light on some of the challengesthey face as well as sharing powerful human stories that offer a unique perspective onthe world.

Fez Awan, Dialysis Patient. Photography Credit: © Richard Booth

There are many hidden sides to this seemingly invisible condition, withsignificant mental health implications as well as the huge amounts of time thatpeople have to dedicate into keeping themselves alive. The exhibitionimportantly shows people from all walks of life and highlights the fact thatkidney disease does not discriminate.

“We are very grateful to Quanta, Kidney Care UK and Kidney Research UK forembracing the potential of this project as sponsors. As with everything duringCOVID-19 times we have had to be inventive, reimagining Survivors as an onlineexhibition, until we can revisit our national tour planned in 2021”. (MaddyWarren). Please visit our 3D exhibition at http://www.survivorsunfiltered.co.ukand follow the exhibition on social media @survivorslifeunfiltered for more newsand updates.

Maddy Warren, Quanta Patient Advocate. Photography Credit: © Richard Booth

Why the US needs Dialysis in Long-Term Care HomesIn his latest blog, Chief Medical Officer, Dr Paul Komenda discusses why we should be keeping our mostvulnerable patients safe during the COVID-19 pandemic. In the US alone, 65,000 dialysis patients reside inlong-term care facilities and are having to travel to clinics three-times a week, for their four-hourhaemodialysis treatment. Mixing with others, in close proximity, crowded waiting rooms whilst having theirtreatment is raising persistent concerns. 43% of all COVID-19 related deaths have been linked tolong-term care facilities in the US. In his blog, Paul emphasises the need to make routine dialysis available inlong-term care homes for these vulnerable patients.

Did you see that Quanta has been shortlisted for the ‘Emerging Stars’ award at the 2020 European Mediscience Awards?

Click here to access the full poster.

Click here to access the full poster.

Watch out for the paper associated with this poster, which has been accepted for publication by a prominent peer reviewed publication over the next few months!

Click here to access the full poster.