Manufacturing Facility in Nanome

· Factory area of 1,500 m2

· Class 10,000 clean workshop of 500 m2

· R&D labs

· A full set of balloon and guide wire manufacturing

· Sound physical, chemical and microbiological laboratories

· Independent material unpacking, incoming inspection, packaging, quality inspection, warehouse and other areas

Core Technology and Manufacturing Process

Balloon forming
End catheter welding
UV light gluing and curing
Catheter bending curvature shaping
Branch catheter tip shaping
Stent drug spraying
Hydrophilic coating of pipes and wires
Drug stent crimping
Catheter developing ring swaging
Handpiece laser marking
Luminous wire making
Guide wire welding and grinding
Wire centerless grinding
PTFE hydrophobic coating of pipes and wires
Sealing and packaging
Product Testing Process
Straightness test of guide wireProduct sterility testingPhysical and chemical properties testing (GC/LC) Clean environment standard testingSterility microbiological testing
Balloon burst pressure testingTension test of pipes and wiresCatheter luminous flux testCoating peel force testingCatheter pushability testingBalloon vacuum leak testCatheter passability testSurface friction test Fracture resistance testingCatheter torquability test

Cardiovascular Family

NaviloonTM PTCA Balloon Catheter          NayutusTM PTCA Guide Wire          NatoiseTM High Pressure/ NC Balloon Catheter          NaviatorTM CTO Balloon Catheter          NaosmoothTMPeripheral Balloon Dilatation Catheter          Navitrek TM Disposable Coronary Balloon Catheter
NaviloonTM PTCA Balloon Catheter

• Semi-compliant balloon, monorail fast exchange design

• Good passability, pushability and trackability

• Balloon has a memory fold that can be dilated and retracted multiple times

• Catheter tip is designed with an integrated taper to facilitate access to complex diseased vessels

Diameter/length                      8mm                      12mm                      15mm                      20mm                      25mm                      30mm
1.5mm                      CS1508                      CS1512                      CS1515                      CS1520                      CS1525                      N/A
2.0mm                      CS2008                      CS2012                      CS2015                      CS2020                      CS2025                      CS2030
2.5mm                      CS2508                      CS2512                      CS2515                      CS2520                      CS2525                      CS2530
3.0mm                      N/A                      CS3012                      CS3015                      CS3020                      CS3025                      CS3030
3.5mm                      N/A                      CS3512                      CS3515                      CS3520                      CS3525                      CS3530
2.0mm                      N/A                      CS4012                      CS4015                      CS4020                      CS4025                      CS4030
NayutusTM PTCA Guide Wire

• 0.014" diameter with good torque control and maneuverability

• Excellent applicable materials with good durability

• Hydrophilic coating of the tip and proximal PTFE coating to effectively reduce frictional resistance into the vessel

Product model                      FL10                      IN30                      ST60
Product type                      Floppy                      Intermediate                      Standard
Tip stiffness                      1.0g                      3.0g                      6.0g
Guide wire length                        1850mm                        1850mm                        1850mm
NatoiseTM High Pressure/ NC Balloon Catheter

• Re-dilatation after stent implantation

• Low compliance - balloon diameter changes little with increasing pressure, allowing more accurate inflation

• RBP: 20 ATM, resistant to high pressure challenges such as stent post-dilatation, calcified lesions

Diameter/length                      10mm                      12mm                      15mm                      8mm                      12mm                      15mm
2.5mm                      HP2510                      HP2512                      HP2515                      HP2520                      HP2525                      HP2530
2.75mm                    HP27510                    HP27512                    HP27515                    HP27520                    HP27525                    HP27530
3.0mm                      HP3010                      HP3012                      HP3015                      HP3020                      HP3025                      HP3030
3.5mm                      HP3510                      HP3512                      HP3515                      HP3520                      HP3525                      HP3530
4.0mm                      HP4010                      HP4012                      HP4015                      HP4020                      HP4025                      HP4030
NaviatorTM CTO Balloon Catheter

• One of the smallest diameter balloons in the world with a catheter diameter of 1.0 mm and a through diameter of only 0.0215"/0.546 mm

• Balloon has a memory fold that can be dilated and retracted multiple times

• Excellent hydrophilic coating facilitates access to CTO lesion vessels

Balloon length                      Diameter 1.0mm
8mm                      CT1008
12mm                      CT1012
15mm                      CT1015
                     NaosmoothTMPeripheral Balloon Dilatation Catheter

• Catheter tip taper designed to avoid damage to vessel upon entry

• RBP up to 25 ATM to ensure safety in dilating calcified vessels

• Dual access design: Guide wire access and oblique compression access

Diameter/length                      10mm                      20mm                      40mm                      60mm                      80mm                      100mm
4.0mm                      HYD4010                      HYD4020                      HYD4040                      HYD4060                      HYD4080                      HYD40100
5.0mm                      HYD5010                      HYD5020                      HYD5040                      HYD5060                      HYD5080                      HYD50100
6.0mm                      HYD6010                      HYD6020                      HYD6040                      HYD6060                      HYD6080                      HYD60100
7.0mm                      HYD7010                      HYD7020                      HYD7040                      HYD7060                      HYD7080                      HYD70100
                     Navitrek TM Disposable Coronary Balloon Catheter

• The distal catheter has multiple stretches with catheter OD up to 0.75 mmm

• The inner catheter has a progressively stretched super-thin crimp diameter

• Complete specifications, adapted to different lesion sites

Diameter/length                      5mm                      8mm                      10mm                      12mm                      15mm
1.00mm                      PB10005                      PB10008                      PB10010                      PB10012                      PB10015
1.25mm                      PB12505                      PB12508                      PB12510                      PB12512                      PB12515
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Product Market Access (Nanos Medical)
Cardiovascular Class III:
Product nameApplied inApproved in
PTCA Balloon Catheter May 2016November 2017
PTCA Guide Wire October 2016March 2018
High Pressure/ NC Balloon Catheter June 2018October 2019
CTO Balloon Catheter May 2020March 2021
Peripheral Balloon Dilatation CatheterMay 2020April 2021
Disposable Coronary Balloon Catheter December 2020February 2022
Company Licensed Patents (Cardiovascular)
SNPatent namePatent number
1 A medical guide wire and its manufacturing method03822364.3
2 Double-guide-wire balloon dilatation catheter201920644646.1
3 A balloon dilatation catheter201920551511.0

R&D Project

Submitted for NMPA registration in 2022 Q1,
Registration certificate expected to be granted in 2023 Q2
Double guide wire cutting balloon catheter
Submitted for NMPA registration in 2022 Q1   NMPA registration certificate expected to be granted in 2023 Q2
Neurointerventional intracranial guide wire
Cardiovascular field:
Submitted for NMPA registration in 2021 Q2,Expected to be certified in 2022 Q4
Neurointerventional intracranial balloon catheter

Development and Planning

01
Enrich product lines and provide all-round integrated customer solutions
02
Accelerate the introduction and development of new technology products and start the registration process in overseas markets
03
Consolidate and expand the integrated cooperation mode with universities and hospitals
04
Expand OEM business in time to become a professional balloon catheter manufacturer in China