quarterly newsletter - quanta€¦ · quarterly newsletter. ce mark for updated sc+. fda in-centre...
TRANSCRIPT
We are pleased to share with you our inaugural quarterly newsletter. We hope that you find this to be informative andvery much welcome your feedback.The last three months (and indeed year) have been a busy and productive time for Quanta. We have made great progresson multiple fronts: building our production capacity, producing launch stock, completing formal test activities andestablishing commercial capabilities. As we prepare for our UK commercial launch at the start of the new year, we have astrong customer pipeline, with initial accounts and patients already identified. Moreover, we stand to benefit frommomentous changes happening in kidney health, which are driving increased demand for home therapies and our offering.Our mission is to ‘improve the lives of dialysis patients through innovation’ by empowering patients to take control oftheir lives. We have dedicated our lives to achieving this vision by creating SC+, which is truly a game-changing personalhaemodialysis system. We would like to thank all our shareholders, stakeholders and partners for your continued supportand collaboration. We look forward to working with you as Quanta embarks upon the next exciting chapter of our journey!
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
Upcoming milestones
Over the summer, we announced that we raised $48 million in the first closing of our Series C funding round. Morerecently, we completed a second close, bringing the round to a total of $64 million. These funds will support our UKcommercial launch and our FDA 510(k) submission for SC+. The round was led by a Swiss private family office incombination with btov Partners and co-led by Wellington Partners and Seroba Life Sciences, along with participation fromother existing investors.In August, we began Human Factors Testing of SC+ in the US in collaboration with Design Science, a leading specialist inmedical device usability. Human Factors Testing is used to assess how intended users interact with a medical device inrepresentative real-world conditions and is a crucial step towards Quanta’s 510(k) submission and ultimately towards USmarket entry. Since then, testing in US healthcare practitioners and UK patients has been successfully completed.Subsequently in August, Quanta announced the appointment of Benchmark Electronics, one of the leading medical devicesmanufacturers, as our production partner for the SC+ machine. The first batch of prototype devices were manufactured atBenchmark earlier this year. Final test devices were manufactured and delivered over the summer, with production/clinicaldevices currently in production for delivery by the start of 2020.Additionally we have started to work with BBraun, one of the world's leading providers and manufacturers of healthcaresolutions, to provide ancillary non-proprietary and pharmacy products to Quanta’s home haemodialysis patients.
Updates
Dear shareholders, stakeholders and partners:
NOVEMBER 2019
Quanta in the newsFollowing announcement of the American Kidney Health Initiative in July, where PresidentTrump signed an executive order to transform the way kidney disease is prevented, diagnosed,and treated within the next decade, Quanta issued an announcement welcoming the initiativeand supporting the cause. This resulted in international media coverage in the Wall StreetJournal looking at how recent federal efforts to improve Kidney health could benefitstart-ups seeking better management of kidney disease. The article highlighted Quanta’srecent fundraise and its plans to expand internationally. CEO, John E. Milad, andCMO, Dr Paul Komenda, shared their initial reactions in a thought piece which received wideengagement on LinkedIn.
The Series C funding round received media coverage from publicationsincluding national papers (The Sunday Times), trade press(BioWorld MedTech, FirstWorld MedTech, LaBiotech, Mass Device) andbusiness press: (Finsmes, Tech-eu, The Business Desk andInsider Media Limited).Our talents in innovation were also recognised in New Electronicsmagazine which published an article reviewing Quanta’s technology inlight of its recent win of ‘Electronic Product of the Year’ at the BritishEngineering Excellence Awards.CEO, John E. Milad was also quoted in the Healio Nephrology News andIssues, talking about the quality of life improvements promised by a moveto in-home dialysis. In the article, John linked the improvements inoutcomes for dialysis patients to more accessible and more frequenttreatment.Quanta was also featured in a research note issued by Morgan Stanley,which provided a deep dive into the home dialysis market and emergingplayers such as Quanta.
Morgan Stanley noted in a recent research report on home dialysis that Quanta’s SC+ may have the competitive edge compared to the NxStage System One.
Christmas in AugustOn 16th August, the first shipment of test SC+ machines were received at Quanta. All three devices arrived in excellent condition and ran with no problems following their transatlantic trip. Opening the box felt like Christmas in August!
Meet QuantaMembers of the Quanta team will be present at the following scientific and investor events in the coming months.
19th NovemberConsilium Healthcare Conference, London
20th – 21st NovemberJefferies Healthcare Conference, London
21st NovemberCanaccord Conference, New York
3rd – 4th DecemberPiper Jeffreys Conference, New York
13th – 16th JanuaryJP Morgan Conference, San Francisco
4th FebruaryLSX World Congress, London
10th – 11th FebruaryBIO CEO and Investor Conference, New York
8th – 11th FebruaryAnnual Dialysis Conference, Kansas
19th – 20th FebruaryEuropean Life Sciences CEO Forum, Zurich
Click on the hyperlinks for further information
We’re going to be featuredon the front cover of NewDesign Magazine – watchthis space!
Contact us
@QuantaDT
https://bit.ly/36lNG4q
Email us atT: +44 (0) 1789 400 043E: [email protected]
Visit us atTything RoadAlcesterWarwickshireB49 6EUhttps://www.quantadt.com
ConferencesWe’ve been busy attending and participating in various conferences, including sponsoring and presenting at the Annual UKDialysis Conference in Manchester and attending the Scottish Renal Registry where we engaged and networked with leadersin the field of nephrology and kidney care.
Nominated as‘Innovator of the Year’
Growing Business AwardsSeptember 2019
Shortlisted as‘Tech Innovation of the Year’
UK Tech AwardsSeptember 2019
Shortlisted as‘Lifestars European Medtech
Company of the Year’LifeStars AwardsNovember 2019
AwardsQuanta won the prestigious ‘New Electronic Product of theYear’ award at the British Engineering Excellence Awards inOctober.
Quanta has also been nominated and shortlisted for thefollowing awards in the period:
AppointmentsBarry Fulkerson, an industry veteran who helped in thelaunch of NxStage, has joined the team as an advisor,providing expertise on regulatory pathway, humanfactors testing and overall guidance ahead of thecommercial launch of SC+.
Most recently, we attended the American Society of NephrologyKidney Week in Washington DC, where we had enthusiasticresponse from potential US customers and partners. We alsopresented a poster (see page 4) reporting on results from anexperimental prototype of SC+ developed to assess thefeasibility of using a small, simple haemodialysis system todeliver enhanced solute clearance comparable tohemodiafiltration (HDF), without any added complexity.
facebook.com/QuantaDT
As an Easter egg to ourreaders, we also include inthis issue a link link to ourprior human factors testresults, which were publishedearlier this year in a leadingpeer reviewed journal(page 5).
