Regulatory

Report
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
[email protected]

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