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Quarterly Update Q-2 2021 BYONYKS

BLOODLESS DIALYSIS
 52 year back
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1969

Today, 52 years
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HEMO
DIALYSIS
PERITONEAL
DIALYSIS ?
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BREAK THROUGH
TREATMENT?

SELF MIXING
DIALYSATE

REUSABLE
DISPOSABLE
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PROGRESS REPORT
BASE LINE MACHINE
FACTORY
PRODUCT Pure Vanilla Ice Cream
APP - IOT Basic Automatic
Peritoneal Dialysis Machine
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FACTORY
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MANUFACTURING
PLANT
• Manufacturing Site Leased (Complies with
DRAP guideline)

• Structural & civil design/drawings and

process flow design completed

• Work already started

• Some production machines ordered

MANUFACTURING
PLANT LAYOUT

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MANUFACTURING PLAN 3D MODEL

Medical grade flooring & walls underway No cost to us - expansion of 2nd hall by owner
 MANUFACTURING PROGRESS
Medical grade flooring & walls underway No cost to us - expansion of 2nd hall by owner
 MANUFACTURING PROGRESS
Medical grade flooring & walls underway No cost to us - expansion of 2nd hall by owner
EXTRUDER TESTED IN CHINA
BEFORE SHIPMENT

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 Machines in Transit

TUBE STERILIZED
EXTRUDER CHAMBER

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PRODUCT
Bloodless Dialysis Machine
Disposable Kit
 SENSING SUB-SYSTEMS
Patient MPX
Pressure Sensor

Loadcell pressure
Sensor
Pressure Sensing Sub-systems
Patient Side:
1. MPX Pressure Sensor - Primary
LED pressure
2. Loadcell Sensor - Secondary
Sensor
3. LED Sensor – Tertiary
All these systems measure both the
negative and positive pressure form
the patient.
Source Side:
1. MPX Pressure Sensor
MPX Chamber

Source MPX
Chamber
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Enclosure
for first 100 machines
 Enclosure
for first 100 machines

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Enclosure
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https://youtu.be/25ZuKkbHdqM?t=126
BYONYKS APP
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BYONYKS APP
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Make machine
Test runs
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REGULATORY CERTIFICATES
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REGULATORY AFFAIRS
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SIGNED
MOU

DRAP APPROVAL PROCESS & FDA/CE
PREPARATIONS
DRAP Process
• We are engaged and working with
DRAP on a regular basis
• Manufacturing approval received
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FDA & CE Preparation
• Consultants hired in USA to prepare
exhaustive documents to meet
requirements
• ISO and other certifications required
by FDA have been started
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PATIENT
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PATIENT TREATMENTS
• The female patient had volume overload issues. • APD therapy is performed twice a week
• Good UF results • Better UF and the patient is feeling quite satisfied
• Satisfactory results • He cannot wait to have it at home!

https://pk.mashable.com/video/4821/whatsa pp-video-2020-08-26-at-120521-pmmp4
 BAHRIA
INTERNATIONAL
HOSPITAL

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IP Protection
US
Pakistan
&
International
IP Protection in the US

• 2 Design patents filed

• 8 PPA
• 4 Trademarks

IP Protection in Pakistan

• 2 Patents filed
• 8 Trademarks – 1 got registered
• 4 Copyright

International Filing

• 1 Design Patent – WIPO (UK, EU, Canada)

• 2 PCT applications
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THE TEAM
BIGGEST ASSET IS OUR STRONG TEAM WORKING TOGETHER!
 THE
TEAM
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SALAHUDDIN KHAN
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RENACON PHARMA
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SIGNED MOU
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Q&A
GANTT CHART
(START OF PRODUCTION AUGUST 11, 2021)

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PRODUCT
Bloodless dialysis machine
Disposable Kit
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FUTURE
 Tubes to MPX
Chamber

1. MPX PRESSURE
SENSOR MPX Pressure
Sensors

• Fluid in the cassette acts

against the membrane Trapped Air
which then acts against
Trapped air in MPX
Chamber.
• MPX Pressure sensor reads
4 kPa against 15kPa in
Cassette which is then
regressed. MPX Chamber
• O-ring protrusion from
surface is 0.5 mm.
 Cassette
2. LOADCELL
PRESSURE SENSOR Loadcell
Plunger
• A plunger is used for transmitting
the load from the membrane onto
the loadcell as shown in fig.
• The membrane is prestressed with
the plunger, this is to ensure that Loadcell
the membrane covers both
negative and positive pressure
range. Loadcell
• Based on the membrane behavior Cover
the load on the loadcell is either
increased or decreased, which is Plunger
calibrated against the pressure Nut
sensor.
Loadcell
Cartridge
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TEAM BUILDING IN USA

Sheela Gayatri [Software]

Farzeen Christie [FDA]
Kevin Christie [Electrical]
Tyler Fontaine [Electrical]

Inline
Kelly Catale [Human Factors]
Kara Johnson [FDA]
 3. LED PRESSURE SENSOR
• LED Is transmitting light onto
the membrane. Where a LED
reflective a surface is pasted.
• The reflected light is received
on a photodiode as shown in
fig.
• Received light intensity is
increased or decreased with
membrane deflection, which is
measured on the sensor.
• The received electrical signal is
calibrated to be used as
pressure sensor.

LED Pressure
LED Mount Photodiode
Sensor