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Rapid Tests for Assessment of
TIA/Ischemic Stroke, Concussions
& Risk of Posttraumatic Epilepsy
Start testStart test
Problem
Currently, there is an urgent need for simple, rapid and on-field/on-site
assays assessing TIA, risk of ischemic stroke, severity of concussions &
risk of posttraumatic epilepsy
Potential users of assays:
Emergency providers
Trauma centers
Military and civilian hospitals
Neurologists, surgeons, and anesthesiologists
Sport clubs and schools
Medical offices at schools
Out-patient services
Insurance companies
Expert committes that determine return to work, duty, or play following a brain injury
Time is Brain
Solution
Rapid tests for assessment of TIA, risk of ischemic stroke,
severity of concussions & risk of posttraumatic epilepsy
Results within 5 minutes, with color detection via mobile
applications (IOS, Android, W8)
On-field or on-site detection (stadium,
emergency room, ambulance, combat)
User-friendly and affordable cost per
strip test
Laboratory devices unnecessary
Color detection software adjusts to existing
mobile platforms (IOS, Android, W8)
Safety of personal data storage in the
Cloud, with restricted access
Company background Developed proprietary cost-effective ELISA test kits for assessment of the risk
of ischemic stroke, post-traumatic epilepsy, and the severity of brain damage
after mild TBI
ELISA test kits for the risk of stroke and post-traumatic epilepsy have been
approved by the state Dept. for Control of Medications and Medical Devices of
Ministry of Health of the Russian Federation in 1998-2003
In 2005, stroke biomarkers were licensed to Bayer Diagnostics (Siemens
Medical Solution) for use in and automatic analyzer
Certificate Europa (CE Mark) clearance in the 27 EU countries since 2008. In
the US, the test kits are available for research use until FDA- approved
In 2000-2014, more than 29 peer-reviewed manuscripts published in
professional medical journals
Results of clinical trials of ELISA test-kits in Russia, Europe, and USA have
been presented at international conferences (2002-2014) and in textbooks
published in Russia (2003, 2013) and the UK (2012)
Market
Marketing strategy
Network of clinical and reference
laboratories
Private medical centers
Federal clinics and hospitals
Pharmacy/Drug store networks
Big Pharma (companion diagnostic)
Regions
Mild TBI Strokes
Number of new cases per year
Russia 1 million 499,000
China 13 million 8 million
USA 1.3 million 795,000
Europe 1.2 million 1.3 million
IVD, POC market
(market share, %)
Annual revenues, billion USD
2012 2017 2020
World wide (100%) 52,8 69,1 88
BRICS (13%-19%) 7,0 9,0 12,0
Russia (1%-2%) 0,5 1,25 2,0
0,5 1,25
Russia
7
9BRICS
0
5
10
15
[2012] [2017] [2020]
BLN
. U
SD
IVD market growth dynamics
Statistics of Strokes and mTBI by country: Target market:
CompetitorsAlternative Solutions
Product and
CompanyDisease Technology
Turnaround
Time
Test price
USD
Revenues
2013-14
USD
PLAC test
diaDexus, USA
Risk of stroke in
atherosclerosisELISA 5-7 days $185-$276
$23-24
milliion
Thrombx
Quest Diagnostics,
USA
Thrombotic
processesPCR 7-14 days $900 $1,9 billion
GFAP, UCH
Banyan Biomarkers,
USA
TBI ELISA 5-7 days —* —*
Cerebral Arrays I and II
Randox Labs, UK
Cerebrovascular
disease, Alzheimer
disease, and
multiple sclerosis
ELISA biochip 24 hours$7,253-
$8,222 ≥$120 million.
*In development; not commercially available
Advantages of the DRD Ltd.productRetail price <10 USD for each test
Differentiation of ischemic stroke from hemorrhagic stroke (NR2 peptide)
Severity of a concussion (AMPAR peptide)
Risk of ischemic stroke (NR2 antibody)
Risk of posttraumatic epilepsy (AMPAR antibody)
StagesAdvantages (Time)
Other Solutions DRD Ltd. Solutions
PhlebotomyVenous blood withdrawal and
centrifugation, 1 hourDigit blood sample
Blood sample preparation
and supplies
Sample dilution, dosing
(30-45 min, multi-channel pipette)Not needed
Reaction time2X incubation for 30 minutes
or 1 incubation for 1 hour
Seconds
(maximum 1 minute)
Additional reagentsBuffers, controls, conjugate,
substrate (preparation)Applied to test zone
Results processing
Reaction detection on the reader,
calibration curve, filing a report
(up to 2 hours)
Automatic image processing
using mobile application
(3-4 minutes)
Technology
Assays based on identifying glutamate neuroreceptor
peptide fragments and their antibodies in peripheral blood
Technical documentation for DRD Ltd. products
Blood sampling
from the digit
~20 µl sample,
19-second reaction timeResults in
<5 minutes
Photographing
the test strip
2,5 см
5 см
Scientific Basis
AMPA receptors located on
neuronal dendrites and axons
Concussions
NR2
peptides
GluR1
antibodies
AMPAR
peptidesStrokes
GluGlu
Glucose GlucoseMet
ATP
Htcy
B6
CysNMDA receptors are
located on the outer
wall of the brain’s
microvessels
The scheme of ionotropic glutamate
neuroreceptor localization
Epilepsy
Concussions Concussions
AMPAR
peptides
Road map
2018 Full scale
manufacturing
launch (GMP, ISO)
Enter Chinese
market
Initiate product
marketing in
India, South
Africa, Brazil
2017 Initiation of sales
in Russia
Partners search
in Custom Union
and BRICS
countries
Create marketing
materials, search
for distributors
Test prototype
(lateral flow)
Mobile
application
prototype
Patenting POC
rapid tests
Software
patenting
Clinical trials
in Russia
Pilot
manufacturing
of rapid tests
according to
GMP and ISO
Trademark(s)
registrations
in Russia and
abroad
2015 2016
TeamPotapov Alexander A.
MD, DSc, professor, Acad. RAS
Director Burdenko Neurosurgery Institute
Russian neurosurgeon and specialist in neurotraumatology
Published more than 250 manuscripts, monographs, manuals and textbooks
Dambinova Svetlana A.
PhD, DSc, professor
Outstanding Scientist of Buryatia and the Russian
Federation, a leader in brain biomarkers area
Authored over 300 scientific manuscripts, 36 international
patents with 16 patents transferred to industry
Skoromets Alexander A.
MD, DSc, professor, Acad. RAS
Chair of the Dept. Neurology and Neurosurgery with Clinic at
St. Petersburg Pavlov’ State Medical University
Authored over 850 scientific papers on neurology, including
textbooks for medical students, manuals and handbooks for
neurologists
Pokatsky Vyacheslav S.
CFO, DRD Ltd.
Member of the Parliament , Republic of Buryatia
Over 20 years’ investing experience in business
Owner of the holding "MV-Cinema-group" Republic of
Buryatia with a market capitalization of 1 billion rub
Zhimbiev Anzhey Ts.
CEO, DRD Ltd.
Economist and financier with 10-year experience in the
business
Development of mobile applications and services
«Young Master of Business» 2011 competition "Young
Entrepreneur of Russia"
Izykenova Galina A.
PhD, CTO, DRD Ltd.
Biotechnology
GRACE Labs
Author and co-author of over 60 research papers and five
international patents
Alexandrova Evgenya V.
MD, PhD, Medical director of DRD Ltd.
Clinical Trials, Burdenko Neurosurgery Institute
TBI clinic and cerebrovascular disease
Author of more than 15 scientific papers, coordinator of
Russian and international grants
Khunteev German A.
MD, PhD, Head of the Clinical Laboratory
Dept. Neurology and Neurosurgery with Clinic at
St. Petersburg Pavlov’ State Medical University
Clinic of cerebrovascular pathology
Authored more than 27 scientific papers
Danilenko Uliana I.
PhD, GRACE Labs
Preclinical trials
Reagents quality control: HPLC, mass spectrometry,
electron microscopy focal
Author and co-author of over 15 scientific papers
Burov Sergey V.
PhD, Institute of Macromolecular Compounds, RAS,
St. Petersburg
Head of Lab peptide synthesis and polymer microspheres
Author of over 170 scientific publications and 12 patents
Co-investigators
Scientific Project Leaders
DRD Biotech | DRD ltd.
Dambinova Svetlana
+1 (404) 661 4658
dambinova@aol.com
Zhimbiev Anzhey
+7 (914) 840 09 02
office@drdbiotech.ru
www.drdbiotech.ru
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