QUARTERLY NEWSLETTER - Quanta Dialysis Technologies …€¦ · QUARTERLY NEWSLETTER. CE Mark for...

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Welcome to Quanta’s second Quarterly Newsletter. We were delighted with the overwhelmingly positive response to our first newsletter and hope you’ll find this edition equally informative. The last three months have once again been very busy for Quanta. As we continue to prepare for commercialisation, in December we successfully applied CE Mark to our next generation of SC+, enabling us to sell into Europe. We also delivered our 510(k) submission to the FDA for in-centre use, which will open the door for US market access. We have contracted our first customer, which is a prestigious NHS clinic in England, and are preparing to initiate training and treatments for our first home patient. Watch this space! QUARTERLY NEWSLETTER CE Mark for updated SC+ FDA in-centre 510(k) submission UK Commercial launch Completion of Human Factors Testing in US patients FDA Clearance Milestone progress Our new website went live earlier this month, showcasing our award-winning next generation SC+ device. Alongside a stylistic redesign, our new website introduces some of our new messaging centred around the people SC+ is designed to help. Our new tagline, engineered for freedom’ relates to the freedom that people will experience through being able to dialyse when and where they want to for as long as they need when compared to the three-times-a-week in-centre regimen experienced by the vast majority of patients. Engineered for freedom Welcome February 2020 Beautifully engineered, the new website is split into four distinct sections; the homepage , explore SC+ (where you can read more on the features of SC+), for patients (where functional benefits relating to the patients are highlighted) and for clinicians (where functional benefits to healthcare professionals are discussed).

Transcript of QUARTERLY NEWSLETTER - Quanta Dialysis Technologies …€¦ · QUARTERLY NEWSLETTER. CE Mark for...

Page 1: QUARTERLY NEWSLETTER - Quanta Dialysis Technologies …€¦ · QUARTERLY NEWSLETTER. CE Mark for updated SC+. FDA in-centre. 510(k) submission UK Commercial launch. Completion of

Welcome to Quanta’s second Quarterly Newsletter. We were delighted with the overwhelmingly positive response to ourfirst newsletter and hope you’ll find this edition equally informative.The last three months have once again been very busy for Quanta. As we continue to prepare for commercialisation, inDecember we successfully applied CE Mark to our next generation of SC+, enabling us to sell into Europe. We also deliveredour 510(k) submission to the FDA for in-centre use, which will open the door for US market access.We have contracted our first customer, which is a prestigious NHS clinic in England, and are preparing to initiate trainingand treatments for our first home patient. Watch this space!

QUARTERLY NEWSLETTER

CE Mark for updated SC+

FDA in-centre 510(k) submission

UK Commercial launch

Completion of Human Factors Testing in US patients

FDA Clearance

Milestone progress

Our new website went live earlier this month,showcasing our award-winning next generation SC+device. Alongside a stylistic redesign, our new websiteintroduces some of our new messaging centred aroundthe people SC+ is designed to help. Our new tagline,‘engineered for freedom’ relates to the freedom thatpeople will experience through being able to dialysewhen and where they want to for as long as they needwhen compared to the three-times-a-week in-centreregimen experienced by the vast majority of patients.

Engineered for freedom

Welcome

February 2020

Beautifully engineered, the new website is split into fourdistinct sections; the homepage, explore SC+ (where youcan read more on the features of SC+), for patients (wherefunctional benefits relating to the patients are highlighted)and for clinicians (where functional benefits to healthcareprofessionals are discussed).

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Quanta in the newsQuanta’s partnership with B.Braun Avitum UK was covered by Tech Trade, MedTech Insight, whichwelcomed the news with an article highlighting the Company’s efforts to support kidney patients andits plans to expand the business in the US.

Quanta’s CEO, John E. Milad, took part in a Podcast series with Tim Lawrie, entitled ‘MedTech Growth’where he spoke passionately about growing up on the East Coast of the United States to becomingCEO of an innovative MedTech business. As part of the interview, John also talks about how he seesthe healthcare landscape, fundraising, growth journeys and his learnings along the way.

Christmas partyOn 12th December, the Quanta Team descended on the town of Stratford-upon-Avon for the Christmas Party, held at the Royal Shakespeare Theatre. A good time was had by all, following what had been an extremely busy yet rewarding year.

Meet QuantaMembers of the Quanta team will be present at the following scientific and investor events in the coming months.

13th MarchWorld Kidney Day Dinner, Knutsford, England

26th - 29th MarchWorld Congress of Nephrology, Abu Dhabi

21st - 23rd April MedTech Innovation Summit, Dublin, Ireland

7th MayWellington Partners Life Science Day, Munich

6th - 8th JuneERA-EDTA, Milan, Italy

24th - 26th JuneUK Kidney Week, Birmingham, England

Click on the hyperlinks for further information

ConferencesThe start of 2020 got off to a busy start with the annual JP Morgan Healthcare Conference, where management met with an exhaustive number of investors, advisers and industry players. Reception to the Quanta story was overwhelmingly positive, especially in light of the company’s progress in the last year.CEO, John E. Milad, also spoke on the panel of Consilium Strategic Communications’Healthcare Conference on the topic of ‘the future of the healthcare industry’ and was also part of the London Stock Exchange Kidney Health Day Innovation Panel titled ‘driving innovation in devices and diagnostics’. More recently, John also spoke on the LSX World Congress Keynote on ‘unpacking value-based healthcare and multi-stakeholder led value creation’ with like-minded leaders in the MedTech sector: Stephen Dorrell (Chairman, LaingBuisson), Frank Maddux (CMO, Fresenius Medical Care), Maarten Akkerman (VP, Medtronic) and Richard di Benedetto (President, Aetna).

ADC was held in Kansas, Missouri, this year, showcasing a strong home haemodialysis programme. Chief Medical Officer, Dr. Paul Komenda presented Quanta’s latest poster, ‘Annual Therapy Cost of Dialysis in the United Kingdom with the Quanta SC+ Personal Haemodialysis System’ (see page 4) as well as also presenting SC+ in the ‘Home Dialysis Machines’ session hosted by Dr Robert Lockridge.

There continues to be a tremendous amount of growing interest in home dialysis following President Trump’s executive order on Advancing American Kidney Health. As an example of this, during the Annual Dialysis Conference (ADC), Fresenius Medical Care were clearly visible in their support of getting more patients on home dialysis. CMS have published a target of getting 50% of patients home by 2025, further reinforcing the Executive Order signed by the President, which sets out to achieve 80% of patients with kidney failure to be treated at home by 2025 (the latter figure notably including transplant patients).

Quanta High-Efficiency DialysisWe’re excited to share that our manuscript on Quanta High-Efficiency Dialysis (Q-HED) has been accepted for publication in Plos One. We don’t yet have a publication date but will share with you once available.

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Contact us

@QuantaDT

https://bit.ly/36lNG4q

Contact us T: +44 (0) 1789 400 043E: [email protected]: quantadt.com

Visit usTything Road, AlcesterWarwickshireB49 6EU

Progress in the United StatesWe’re excited to announce that we have filed our 510(k) submission with the FDA,which is the first step to getting SC+ into the US Market. The submission covers SC+for in-centre use and paves the way to Quanta’s US market entry.

AwardsQuanta was shortlisted as ‘Innovator of the Year’ at the2019 Growing Business Awards and as ‘European MedTechCompany of the Year’ at the European Lifestars Awards.

Appointments

John Lipman, an experienced MedTech veteran, is joining Quanta to start the process of building out a US team and refining the company’s US Strategy.

He is accompanied by Deb Singer, a leading US Sales Manager, previously responsible for placing the NxStage System One into the US market.

Barry Fulkerson, who previously joined Quanta as an advisor, assumes the position of Chief of Operations.

facebook.com/QuantaDT

CE Mark awardedIn addition to our 510(k) submission, we’re also excited to announce that we havesuccessfully secured CE Mark for our next generation SC+ device, enabling us to sellinto Europe. The photo shown to the left shows CEO, John E. Milad, signing the officialregistration document with (from left to right): Steve Lane (Commercial Director), AmitBose (Chief Engineer), Mark Prockter (Programme Director), Rolf Wildeman (Chief ofOperations) and Chris Rule (Director of Quality and Regulatory Affairs).

Collaboration with B. Braun Avitum UK LtdIn January, we announced Quanta’s collaboration with B. Braun Avitum UK Ltd toprovide products and support services to Quanta’s UK patients using SC+ at home.Under the agreement, B. Braun are responsible for delivering patients’ monthlyprescriptions of pharmaceuticals, dialysis consumables and ancillaries using theirmanaged delivery solution, offering flexibility and convenience by enabling patientsto schedule deliveries direct to their home address, at a time convenient to them.

First human use SC+ machines arriveCodenamed ‘Adam’ and ‘Eve’, the first clinical-use next generationSC+ devices left Benchmark, Quanta’s approved manufacturer, at thebeginning of the year. This marks a huge milestone for Quanta asthese machines will be the first devices for clinical use. After a lot ofhard work, people joining the team, and multiple visits between theUK and the US, this is what its really all about.

Pictured front row (left to right): Terry Fliflet, Jerry Moore, GailFitzgerald, Gregg Kubisiak. Pictured back row (left to right): TomBuswell, Joseph Schurch, Bob French, Nichole Corcoran, Laurie Teig,David Bockin, Shawn Smith.