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Confirmation
of Catheter
Vascular Location
ILAN KEIDAN MD
ARNALDO MAYER PHD
ZACHI BERGER PHD MBA
SHEBA MEDICAL CENTER
2016
CoVa
An Ounce of Prevention Is Worth a Pound
of Cure … as Well as a Pound of Cash
Highlights Prototype ready and tested in P3 on 200 patients, PCT IP examined
Unmet clinical need
Huge market potential
Simple non-invasive technology
Utilizing clinically approved chemical solution
Patent in PCT stage, already examined
Tested in phase 3 on 200 patients - statistically significant results
Prototype and clinical developed by $250K by Kamin CSO
Simple regulatory pathway
International recognition in 5 leading medical journals
Business Model – sell preventive products
Avoid high hospitalization costs and suing costs
2 years + $500K = START SALES
The clinical need:
Extravasation and Infiltration Infiltration is the inadvertent leakage of a non-vesicant
solution from its intended vascular pathway (vein) into the surrounding tissue
Large volume of infiltrate can cause compression of nerves and acute limb compartment syndrome demanding fasciotomy and has long term disability
Extravasation is the inadvertent leakage of a vesicant solution from its intended vascular pathway (vein) into the surrounding tissue
Extravasation rate is about 11% of catheter insertion, the incidence of infiltration is much higher
The degree of injury ranges from mild skin reaction to severe necrosis and even surgical amputation
Professional Guidelines* A blood return from the IV device should be obtained before administering a
vesicant. A blood return is a fairly reliable indicator that the IV device is correctly placed and vesicants will enter the patient’s venous system as intended.
If a blood return is not obtained from a peripheral IV
device, insert a new peripheral IV in another location.
If a blood return is not obtained from a central venous access
1. reposition or place the patient in a supine.
2. flush the line and attempt to aspirate blood.
3. attempt to aspirate with a larger syringe.
If a blood return continues to be unobtainable, institutional policies should be followed, which may include declotting the central catheter using a thrombolytic agent or obtaining a dye study to confirm catheter placement and patency
*Chemotherapy and Biotherapy Guidelines and Recommendations for Practice, 3rd ed. Pittsburgh: Oncology Nursing Society; 2009:105–111.
What is the best Solution
The best "treatment" of extravasation is
prevention and recognition
So what do we have to offer ?
An Ounce of Prevention Is Worth a Pound of
Cure … as Well as a Pound of Cash - Julie
Niezgoda, MD - JOURNAL OF VASCULAR
ACCESS 2014
Our Solution: The CoVa Test
NaHCO3 Na+HCO3 + H+ H2CO2
H20 + CO2
1. A small volume of Sodium Bicarbonate
(NaHCO3) solution is administrated IV
2. Detecting the increased CO2 exhalation is a
functional proof of the correct positioning and
performance of the infusion line
Rapidly exhaled by lungs
The concept
The end-tidal carbon dioxide response to a defined amount of intravenous injection of sodium bicarbonate (ETCOS) is predictable and reproducible by Capnograph
An intravenous administration of sodium bicarbonate (NaHCO3) forms excess CO2, resulting in an immediate increase in end-tidal carbon dioxide tension (PETCO2)
We have studied this phenomena starting from the chemistry, physics, physiology and ending with the mathematics and finally the clinical aspects and uses
Capnography* Clinical Use
Etiologies of hypocapnea/hypercapnea
Endotracheal intubation
Cardiopulmonary resuscitation
Respiratory problems
Miscellaneous – volumetric capnography, sedation
Novel uses by CoVa
*CO2 measurement
The Product – Clinical Prototype
https://docs.google.com/file/d/0BwHZrAIltxMORk40TFNmTzBtLWM/edit
Illustration of end-tidal CO2 response to injection of 20 ml 4.2%
sodium bicarbonate in a patient. (Injection started at time 0 while
Capnography is illustrated for 70 seconds after injection)
Phase 3 Clinical CO2 detection
The pattern of end-tidal carbon dioxide change over 120 seconds after the
injection of 20 ml sodium bicarbonate 4.2% in comparison to injection of 20 ml
normal saline (Mean and 95% predictive interval)
Phase 3 clinical results
Automatic Implementation:
a machine learning approach
0 5 10 15 20 25 30 35 40 45 500
5
10
15
20
25
30
35
Time (sec)
PC
O2
(mm
Hg
)
Classifier training
Trained Classifier
Input Co2 signal
0 5 10 15 20 25 30 35 40 45 500
5
10
15
20
25
30
35
Time (sec)
PC
O2
(mm
Hg
)
Trained classifier
Bicarbonate detected / not
detected
Input Co2 signal
Preprocessing
Learning phase Classification phase
Preprocessing
Signal Label
Working Prototype
in Clinical Trial
IP
PCT/IB2012/052288 :
"PROVIDING EVIDENCE WHETHER AN INTRAVASCULAR CONDUIT
IS CORRECTLY POSITIONED“
The application was evaluated by the European authority and all device
claims were allowed
A provisional application was submitted in July 2014 covering the
algorithm as well as other indications
Regulation
EU: CE class I
US: 510k class II device, de novo device (as there is no current solution) - simple regulatory pathway.
Can lead to STANDART OF CARE
Product development pipline
Stand alone 2
Add on 1 Disk On Key
Integrated feature 3
Current prototype 1
Scientific and Medical
Recognition
Sodium Bicarbonate Verifies Intravenous Position of Catheters in Ventilated
Patients Ilan Keidan, MD,*† Erez Ben-Menachem, MBCHB, MBA, FANZCA,*
Aviv Barzilai, MD, Israel Nur, PhD,* and Haim Berkenstadt, MD*. ANESTHESIA
& ANALGESIA August 2011 • Volume 113 • Number 2
Intravenous Sodium Bicarbonate Verifies Intravenous Position of Catheters
in Ventilated Children. Ilan Keidan, MD,*† Erez Ben-Menachem, MBCHB,
FANZCA,* Sno Ellen White, MD,† and Haim Berkenstadt, MD* ANESTHESIA &
ANALGESIA October 2012 • Volume 115 • Number 4
A simple diagnostic test to confirm correct placement of intravenous
catheters before chemotherapy. ilan keidan, MD, Erez Ben-Menachem,
Raanan Berger, Estella Derazne, Haim Berkenstadt. JOURNAL OF
VASCULAR ACCESS in review 2014
A functional test for the detection of infusion lines extravasation. Arnaldo
Mayer, Adi Zholkover, Ilan Keidan.
Editorial Publication:
Anesthesia an Analgesia
The article in this issue of Anesthesia & Analgesia
by Keidan et al.7 is a small randomized clinical trial
using a diluted solution of sodium bicarbonate to
confirm IV catheter placement in 18 mechanically
ventilated children by observing the increase in end-
tidal carbon dioxide. The complications of
extravasation of both peripheral IV catheters and
central lines meet the definition of a HAC as defined
by the Department of Health and Human Services.
Keiden et al. have described a technique that could
reasonably prevent the complications of a
nonfunctioning peripheral IV line. As suggested by
the authors, further studies are needed to assess
this technique for central venous catheter placement
when the consequences of a misplaced line are
much more catastrophic, leading to increased length
of stay/costs and decreased patient–family
satisfaction assessments.
October 2012 • Volume 115 • Number 4
Article title: A simple diagnostic test to confirm correct placement of
intravenous catheters before chemotherapy Accepted for publication in: JOURNAL OF VASCULAR ACCESS
Dear Dr. keidan,
We have evaluated your manuscript above and I would like to
compliment you: your work is outstanding and it has been
accepted for publication in JOURNAL OF VASCULAR ACCESS.
It was accepted on Nov 02, 2014.
Your contribution has now been assigned to the Technical Editors and you will receive the proof directly from the Publisher, together with any query.Please make sure your proofs are checked carefully and returned to the
Publisher within 48 hours from receipt, as this will ensure rapid online release of your article. It will be scheduled for print publication in one of the next available issues.
Thank you for submitting your work to our Journal.
With kind regards,
Maurizio Gallieni, M.D.Coordinating EditorJOURNAL OF VASCULAR ACCESShttp://jva.edmgr.com/
Frequency of the problems
associated with malposition of IVs
Over 100,000 doses of chemotherapy and in excess of 1,000,000 intravenous (IV) infusions given every day around the world
Infiltration is the most commonly identified complication of peripheral IV therapy. The reported incidence is 23-78% for neonates and approximately 20% for adults and carries the potential for long-term sequelae
Extravasation rate is about 11% of catheter insertion with higher rates within the elderly and neonate populations
In the American Society of Anesthesiologists Closed Claims Project database, 2.1% of all claims (all ages) are related to peripheral catheters
Analysis of the problems
associated with malposition
of IVs
Complication Claims
resulting in
payment (%)
2007 $
median case
payment
2007 $
highest case
payment
Skin necrosis 58 47,000 154,000
Swelling
/inflammation
38 11,000 43,000
Nerve
damage
55 50,000 1,200,000
other 57 69,000 11,550,000
Anesth Analg 2009;109:124–9
Costs of the problems
associated with malposition
of IVs
Raleys - Your Local Solicitors
Compensation for extravasation injury
Rotherham Hospital have recently agreed to pay compensation to a Barnsley man for their
failure to provide proper treatment following what is known as an extravasation injury.
An extravasation injury is the term used to describe the damage caused by leakage of
solutions from the vein to the surrounding tissue spaces during intravenous
administration. Once an extravasation has occurred, damage can continue for months and
involve nerves, tendons and joints. If treatment is delayed, surgical debridement, skin
grafting, and even amputation may be the unfortunate consequences.
As a result of the Hospital’s failures, this unfortunate man suffered a build up of scar tissue,
increased stiffness and significant pain in his hand lasting for several years. His wrist and
elbow were also affected.
Marketing advantages
Huge clinical and economic problem
Novel preventive product
The only objective method to detect correct position of IV catheter
Phase I, II and III clinical studies are available and published with
excellent statistically results
Easy to implement in current clinically used equipment
Potential to save large sums of money in claims and damages (for
hospitals and insurers) and avoid high hospitalization costs
Potential sales of disk-on-key hardware and software as insurance
policy to hospitals
Potential to become THE STANDART OF CARE in the area
Pressure to use the products by PATIENT SOCIAL NETWORKS
The Team
Ilan Keidan, MD – Founder and clinical consultant
Zachi Berger, Ph.D. MBA – CEO/Founder
Arnaldo Mayer, Ph.D. – Algorithm development
System Engineer – CTO - TBD
Engineering subcontractor – TBD
Clinical development – Sheba Medical Center
The Sheba Medical Center
The Kamin Project - Introduction
Goal – FROM A THEORETICAL IDEA TO A COMMERCIAL PRODUCT
Two year project partially funded by the ministry of commerce
Chosen projects are the ones deemed by an advisory committee to
have the highest probability to evolve into commercial end-product
The funding is estimated at 400,000 IS per year – total 800,000 IS
Kamin Project - Milestones
Phase II,III clinical study in oncological patients ( adults and
children) to further evaluate the system in detecting correct position
of both peripheral and centrally placed intravenous catheter
(approved by IRB)
Creating an algorithm (software) for a prototype “IV Detector”
Clinical study to validate the algorithm
Development of prototype of the “IV Detector”
Patent protection
Phase III Phase II Phase I
Rat study
Adults
Children
Ex-vivo
tissue study
Adults oncology
study
Pediatric
oncology study
Pig study intra-
arterial injection
Algorithm
development
Algorithm
validation
Inline testing
incorporated into the
Capnostream 20 R
capnograph
Stand - alone
device
2013 2
014
Volunteers
Contro
lled
ventila
tion
Sponta
neous v
entila
tion
Other uses for the
technique
2 years Development Plan
Quarters Activity Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8
1
Extension of the signal dataset: acquisition of 50 new saline and
50 bicarbonate signals
2
Design of the standalone and add-on devices
3
Optimization of the algorithms
4
Construction of add-on device prototypes
5
Implementation of the algorithm into embedded environment for
add-on devices
6
Construction of prototype for an incorporated (commercial
monitors) device
7
Testing of the add-on devices
8
Regulatory completion
9
Marketing assessment and business development
Background for marketing options
Avoidance of IV catheter complications like extravasation is basis for many clinical articles
WW Governmental agencies and private ones invest large budgets in avoiding these complications that cost a lot to the health system
The major device companies that develop monitoring systems also develop Capnogrph modules
Those modules are part of integrated monitoring systems (including heart rate, blood pressure, etc) or a stand alone device for CO2 measurement – Capnograph
We can utilize these themes to leverage our marketing options by signing deals with the key players in the area
Utilize Patient Social Networks to put pressure on Medical Centers To utilize the product
Market potential The global market for intravenous therapy and vein access
was $19.3 billion in 2013. The market reached $20.3 billion
in 2014 and is expected to reach about $27.2 billion in
2019, registering a compound annual growth (CAGR) of
6.0% over the next five years.
