Needle dislodgement – The Issue • In the US alone, more than; 2 / 2 / 200 – 2 patients die due to VND every week – 2 patients are seriously injured every day due to VND – 200 needles are dislodged every day • RPA estimates that 1 in 720 hemodialysis treatments performed in the US has a VND4 • Haemodialysis nurses tells that they believe dislodgement related incidents are often not reported 2 • It is estimated that 136 patients die annually, in the US alone, due to venous needle dislodgement1 • VA clinics reports that 1 of 62500 treatments result in a serious bleeding and in worst case death • After a VND, the patient has a higher risk of mortality, due to infections5 1) Sandroni S. Catastrophic Hemorrhage from Venous needle dislodgement during hemodialysis. Journal of the American Society of Nephrology, volume 19, November 2008 2) Ny teknik, issue 33, 15th August 2007 3) Patients Safety Advisory; Veteran Health Administration Warning System; Published by VA Central Office; October 21, 2008 4) Renal physicians association, US, patient survey 2007 5) Gambro, France 3 Market Potential Patient population approximatly 2 mil ESRD patients 89% are treated with HemoDialysis (HD) 1.8 million 362 000 HD 271 500 HD 270 000 HD 900 000 HD Aisa Paciffic Latin America & Other North America incl. Canada EU, Africa & Middle East 270 million HD treatments annually Where are our markets? • Market size – – – – Sweden – 3 500 patients UK – 20 000 patients Germany – 65 000 patients USA – 300 000 patients • Market structure – – – – – Safety a concern? KOL Organization of customers Regulatory Legal • Accessibility – Ways to market (Regulatory bodies, distributors/agents Interests grps) – Speed of adoption Implementing Redsense is in alignment with the EU directiv It’s a regulatory must! Council directive 93/42/EEC concerning medical devices ” The solutions adopted by the manufacturer for the design and construction of the device must confirm to safety principles, taking account of the generally acknowledged state of the art. In selection of the most appropriate solutions, the manufacturer must apply the following principles in the following order: - eliminate or reduce risks as far as possible (inherent design and construction) - where appropriate take adequate protection measures including alarms if necessary, in relation to the risks that cannot be eliminat ed, - Inform the user on the user of the residual risks due to any shortcomings of the measures adopted.”32 © Redsense Medical 2011 • w ww.redsensemedical.com Avoid unnecessary risk by saving cost in healthcare -Patients trust and safety Avoid unnecessary risk by saving cost in healthcare -Healthcare savings • Patient trust and safety • Healthcare savings Redsense – reduces cost for the Health care system VND is one of the most serious complications in hemodialysis which can have tragic results if the dislodgement is not recognized immediately. Prompt recognition and response may prevent VND from developing into a disaster for everyone involved. Utilizing all resources available, from procedures to monitoring the access site by a blood loss detector such as Redsense, will provide a much needed security. 23 Reduce the risk and reduce costs, the use of Redsense can save millions. Globally VND incidents per year Cost for a VND incident:23 Patients with VND, mean: Ahlmén 7 (5/2880) RPA*2 (1/156/4/0,05) 423 750 0,1736% 0,1282% 487 500 360 000 Cost savings, the use of Redsense can save millions: Estimating the cost of Redsense 2.7 € per treatment (3 patients per device ). By using Redsense on 20% of the HD patients: - Healthcare savings close to 200 000 000 € can be made annually. –VND minor: Limiting intervention to blood transfusion and extra EPO dose which all can be car ried out at the dialysis clinic and an extra day for observation: Patients with serious VND, mean 3 357 Veterans A airs17 (1/62500) Sandroni4 (1/126718) Blood transfusion Extra EPO Extra day in hospital 970 € 745 € 2 980 € 4 493 2 216 Total: 4 695 € 0,0016% 0,0008% Patient deaths due t o VND, mean 4 Sandroni (1/3*126718) Gambro21 (1/500000) * Needle Dislodgement 0,0002% 0,0002% Based on Ahlmén study ab out 40% of the VND’s need blood transfusion and t wo extra days in the hospital 7 650 739 562 –Serious event with hospitalization: Regular hospitalization for blood loss anemia (4 days) 170 000 € 1 day of anemia ther apy includes EPO, blood transfusion, iron and possibly plasma expanders or albumin 42 500 € / day Emergency Room (ER) 22 350 € or more Intensive Care Unit (ICU), hospitalization (1 day) 14 900 € - 29 800 € Thus cost range from 170 000 € to 223 500 € and up Example: A patient in the ERfor 4 h r eceived oxygen at 2 L/min, blood drawn for routine panel, an abdominal CT scan; the bill was 24 700 € Let’s roll • • • • • • USA – direct sales Germany – direct sales (but later) UK – distributors (started w direct sales) Europe – distributors Asia – wait (different regulatory) Australia – distributor (large on self HD) Customers Number of Clinics Using Samples of key customers: • USA gov. of Veterain Affairs – First clinic started 2008 – All clinics mandatory from Nov. 9 ’10 – Appr. 20% adaptation 200 180 160 140 120 100 80 60 40 20 0 • Scotland – started using RS 2009 – Appr. 15 -18% adaptation • Cleveland clinics – – – – acute hospital, started 2010 Art. Publ. Nov 2011 Used by all AVF/Grafs • FMC-NA 2008 2009 2010 2011 – Nocturnal use Reflections • Do you need to be best in class? • Governmental bodies – Läkemedelsverket – FDA – Veteran Affairs • Funds – Business Angels – VC – Vinova, Almi Tack! Summery • Market acceptance – CE March 2007 – FDA clearance clinic Oct 2007 – FDA clearance home May 2010 • Redsense is being sold in 13 countries: – Sweden, USA, Canada, Denmark, Finland, Germany, Holland, Belgium, France, Italy, Spain, Austria, Australia • Examples of clinics: – Cleveland clinics, VA-hospitals, Glasgow (all of Scotland), NÄL, Skejby etc Patrik.Byhmer@redsensemedical.com