New World Medical, Inc.

(NWMI) is a high tech medical device company whose goal is to help humanity lead a better life through improved technology and innovation. Presently NWMI’s focus is in the areas of ophthalmology, neuro-surgery, urology and rapid medical diagnostic tests such as, the detection of HIV. The Ahmed Glaucoma Valve has been successfully demonstrated to work in all types of glaucoma cases, particularly neovascular, congenital and uvietic glaucoma. New World Medical, Inc. manufactures and markets its own products. In the U.S. domestic market NWMI distributes its products through a team of sales representatives. In the international market the company has more than 35 exclusive distributors around the world. Along with its own products, NWMI is licensed as a tissue bank, selling human tissue such as sclera and pericardium. The active R & D division of NWMI is intensely involved in developing new products through collaborations with a number of renowned medical universities and individual doctors, in the U.S. and abroad. These partnerships allow NWMI to develop products through a first hand involvement in the medical device industry. Omar Ahmed has recently joined as Vice President, Director and COO of NWMI. New World Medical Inc. was founded by Dr. A. Mateen Ahmed. Dr. Ahmed is also the President, CEO and the Chairman of the Board of Directors for the company. The vision of Dr. Ahmed and NWMI is to help the lives of people around the world. This has earned the company many accolades, including the “Have a Heart, International Goodwill and Understanding Award” given by Soroptimist International.

Mechanics of the Ahmed™ Glaucoma Valve

Venturi-Flo™
The Venturi™ Effect To reduce internal friction within the valve system, the Ahmed™ Glaucoma Valve (AGV™) utilizes a specially designed, tapered trapezoidal chamber to create a Venturi effect to help aqueous flow through the device. As demonstrated by Bernoulli’s equation of hydrodynamic principle, the inlet velocity of aqueous entering the larger port of the Venturi chamber increases significantly as it exits the smaller outlet port of the tapered chamber. In an AGV™ this increased exit velocity greatly helps in evacuating aqueous from the valve, thereby helping to reduce valve friction. Fluid flowing into section 1 = Fluid flowing out of section 2

Section 1 P1 Section 2 P2

V1 V2

Non-Obstructive, Self-Regulating Mechanism The Ahmed™ Glaucoma Valve has no obstruction in its path of fluid flow. For the flow to be non-obstructive, a particle large enough to pass through the lumen of the tube, will easily pass through a much larger opening of the Venturi-Flow™ chamber. The elastic membranes help to regulate fluid flow at all times, consistently by changing their shape. The tension on these membranes is responsible for reducing hypotony.

Product Index

Model

Product

FP7 ................... Ahmed™ Glaucoma Valve Flexible Plate™ S2..................... Ahmed™ Glaucoma Valve FP8 ................... Ahmed™ Glaucoma Valve Flexible Plate™ (Pediatric Size) S3..................... Ahmed™ Glaucoma Valve (Pediatric Size) FX1 ................... Ahmed™ Glaucoma Valve Flexible Bi-Plate™ B1 .................... Ahmed™ Glaucoma Valve Bi-Plate™ FX4 ................... Non-Valved Flexible Plate™ B4 .................... Non-Valved Plate PC..................... Pars Plana Clip™ TE ..................... Tube Extender™

Product Index

Model

Product

PC7................... Ahmed™ Glaucoma Valve Flexible Plate™ FP7 with Pars Plana Clip™ PC8................... Ahmed™ Glaucoma Valve Flexible Plate™ FP8 with Pars Plana Clip™ PS2 ................... Ahmed™ Glaucoma Valve S2 with Pars Plana Clip™ PS3 ................... Ahmed™ Glaucoma Valve S3 with Pars Plana Clip™ TI ...................... Tube Inserter™

Tissue TSH ................... Sclera Hydrated TPH ................... Pericardium Hydrated TPD ................... Pericardium Freeze-Dried

FP7

Model FP7
• Made of medical grade silicone

Ahmed™ Glaucoma Valve Flexible Plate™

• Immediate reduction of intraocular pressure • Unique, non-obstructive valve system to prevent excessive drainage, chamber collapse • Implanted in a true, single-stage procedure • Tapered profile for easy insertion • Silicone plate • Aqueous percolation holes • Thinner Plate Ordering Info:
Model: FP7 - Ahmed™ Glaucoma Valve

Materials:
Valved Plate Body: Drainage Tube: Valve: Medical Grade Silicone Medical Grade Silicone Medical Grade Silicone, Elastomer Membrane

Nominal Specs:
Thickness: Width: Length: Surface Area: Tube Length: Tube Inner Diameter: Tube Outer Diameter: 0.9 13.00 16.00 184.00 25.00 0.305 0.635 mm mm mm mm2 mm mm mm

FP7 Surgical Procedure
Step 1 Step 2 Step 3 Step 4

FP7

The steps illustrated here are intended as a guideline only, and do not represent recommended treatment for any particular patient. The use of any specific surgical technique or maneuver is at the sole discretion of the surgeon.
Step 5 Step 6 Step 7 Step 8

Surgeons should be familiar with the use of glaucoma drainage devices and post-operative care considerations before implanting any drainage device. Reference papers and surgical video tapes are available upon request.

S2

Model S2

Ahmed™ Glaucoma Valve

• Immediate reduction of intraocular pressure • Unique, non-obstructive valve system to prevent excessive drainage, chamber collapse • Implanted in a true, single-stage procedure • Eliminates drainage tube ligature sutures, “rip-chord” sutures, occluding sutures

Ordering Info:
Model: S2 - Ahmed™ Glaucoma Valve

Materials:
Valved Plate Body: Drainage Tube: Valve: Medical Grade Polypropylene Medical Grade Silicone Medical Grade Silicone, Elastomer Membrane

Nominal Specs:
Thickness: Width: Length: Surface Area: Tube Length: Tube Inner Diameter: Tube Outer Diameter: 1.9 13.00 16.00 184.00 25.00 0.305 0.635 mm mm mm mm2 mm mm mm

S2 Surgical Procedure
Step 1 Step 2 Step 3 Step 4

S2

The steps illustrated here are intended as a guideline only, and do not represent recommended treatment for any particular patient. The use of any specific surgical technique or maneuver is at the sole discretion of the surgeon.
Step 5 Step 6 Step 7 Step 8

Surgeons should be familiar with the use of glaucoma drainage devices and post-operative care considerations before implanting any drainage device. Reference papers and surgical video tapes are available upon request.

FP8

Model FP8
• Made of medical grade silicone

Ahmed™ Glaucoma Valve Flexible Plate™

• Used for Pediatrics or small globes • Immediate reduction of intraocular pressure • Unique, non-obstructive valve system to prevent excessive drainage, chamber collapse • Implanted in a true, single-stage procedure • Eliminates drainage tube ligature sutures, “rip-chord” sutures, occluding sutures • Thinner Plate

Ordering Info:
Model: FP8 - Ahmed™ Glaucoma Valve Small

Materials:
Valved Plate Body: Drainage Tube: Valve: Medical Grade Silicone Medical Grade Silicone Medical Grade Silicone, Elastomer Membrane

Nominal Specs:
Width: Length: Surface Area: Tube Length: Tube Inner Diameter: Tube Outer Diameter: 9.60 10.00 96.00 25.00 0.305 0.635 mm mm mm2 mm mm mm

FP8 Surgical Procedure
Step 1 Step 2 Step 3 Step 4

FP8

The steps illustrated here are intended as a guideline only, and do not represent recommended treatment for any particular patient. The use of any specific surgical technique or maneuver is at the sole discretion of the surgeon.
Step 5 Step 6 Step 7 Step 8

Surgeons should be familiar with the use of glaucoma drainage devices and post-operative care considerations before implanting any drainage device. Reference papers and surgical video tapes are available upon request.

S3

Model S3

Ahmed™ Glaucoma Valve

• Used for Pediatrics or small globes • Immediate reduction of intraocular pressure • Unique, non-obstructive valve system to prevent excessive drainage, chamber collapse • Implanted in a true, single-stage procedure • Eliminates drainage tube ligature sutures, “rip-chord” sutures, occluding sutures

Ordering Info:
Model: S3 - Ahmed™ Glaucoma Valve Small

Materials:
Valved Plate Body: Drainage Tube: Valve: Medical Grade Polypropylene Medical Grade Silicone Medical Grade Silicone, Elastomer Membrane

Nominal Specs:
Width: Length: Surface Area: Tube Length: Tube Inner Diameter: Tube Outer Diameter: 9.60 10.00 96.00 25.00 0.305 0.635 mm mm mm2 mm mm mm

S3 Surgical Procedure
Step 1 Step 2 Step 3 Step 4

S3

The steps illustrated here are intended as a guideline only, and do not represent recommended treatment for any particular patient. The use of any specific surgical technique or maneuver is at the sole discretion of the surgeon.
Step 5 Step 6 Step 7 Step 8

Surgeons should be familiar with the use of glaucoma drainage devices and post-operative care considerations before implanting any drainage device. Reference papers and surgical video tapes are available upon request.

FX1

Model FX1
• Made of medical grade silicone

Ahmed™ Glaucoma Valve Flexible Bi-Plate™

• Attachable on either right or left side • Bi-Plate design allows for greater aqueous drainage • Valve and Bi-Plate surface area: 364mm2 • Immediate reduction of intraocular pressure • Unique, non-obstructive valve system to prevent excessive drainage, chamber collapse • Implanted in a true, single-stage procedure • Eliminates drainage tube ligature sutures, “rip-chord” sutures, occluding sutures Ordering Info:
Model: FX1 (Model FP7 with non-valved Plate)

Materials:
Valved Plate Body: Drainage Tube: Valve: Medical Grade Silicone Medical Grade Silicone Medical Grade Silicone, Elastomer Membrane

Nominal Specs:
Width: Length: Tube Length: Surface Area: Tube Inner Diameter: Tube Outer Diameter: Valved Plate 13.00 mm 16.00 mm 25.00 mm 184.00 mm2 0.305 mm 0.635 mm Non-Valved Plate 12.20 mm 14.80 mm 25.00 mm 180.00 mm2 0.305 mm 0.635 mm

B1

Model B1

Ahmed™ Glaucoma Valve Bi-Plate™ • Attachable on either right or left side • Bi-Plate design allows for greater aqueous drainage • Valve and Bi-Plate surface area: 364mm2 • Immediate reduction of intraocular pressure • Unique, non-obstructive valve system to prevent excessive drainage, chamber collapse • Implanted in a true, single-stage procedure • Eliminates drainage tube ligature sutures, “rip-chord” sutures, occluding sutures Ordering Info:
Model: B1 (Model S2 with non-valved Plate)

Materials:
Valved Plate Body: Drainage Tube: Valve: Medical Grade Polypropylene Medical Grade Silicone Medical Grade Silicone, Elastomer Membrane

Nominal Specs:
Width: Length: Tube Length: Surface Area: Tube Inner Diameter: Tube Outer Diameter: Valved Plate 13.00 mm 16.00 mm 25.00 mm 184.00 mm2 0.305 mm 0.635 mm Non-Valved Plate 12.20 mm 14.80 mm 25.00 mm 180.00 mm2 0.305 mm 0.635 mm

FX4

End fixed to the Valved Plate

Model FX4
Flexible Non-Valved Plate •Made of medical grade silicone • Used with existing implants • Can be inserted in existing bleb • Attachable on either right or left side • Increases surface area of existing implant • Can be placed over or under the muscle • Easily sutured on sclera

Non-Valved Plate

Ordering Info:
Model: FX4 - Non-valved Flexible Plate™

Materials:
Non-Valved Plate Body: Drainage Tube: Medical Grade Silicone Medical Grade Silicone

Nominal Specs:
Width: Length: Surface Area: Tube Length: Tube Inner Diameter: Tube Outer Diameter: 12.20 14.80 180.00 25.00 0.305 0.635 mm mm mm2 mm mm mm

FX4 Surgical Procedure
Step 1 Step 2 Step 3 Step 4

FX4

The steps illustrated here are intended as a guideline only, and do not represent recommended treatment for any particular patient. The use of any specific surgical technique or maneuver is at the sole discretion of the surgeon.

Step 5

Step 6

Step 7

Surgeons should be familiar with the use of glaucoma drainage devices and post-operative care considerations before implanting any drainage device. Reference papers and surgical video tapes are available upon request.

B4

End fixed to the Valved Plate

Model B4
Non-Valved Plate • Used with existing implants • Can be inserted in existing bleb • Attachable on either right or left side • Increases surface area of existing implant • Can be placed over or under the muscle • Easily sutured on sclera

Non-Valved Plate

Ordering Info:
Model: B4 - Non-valved Plate

Materials:
Non-Valved Plate Body: Drainage Tube: Medical Grade Polypropylene Medical Grade Silicone

Nominal Specs:
Width: Length: Surface Area: Tube Length: Tube Inner Diameter: Tube Outer Diameter: 12.20 14.80 180.00 25.00 0.305 0.635 mm mm mm2 mm mm mm

B4 Surgical Procedure
Step 1 Step 2 Step 3 Step 4

B4

The steps illustrated here are intended as a guideline only, and do not represent recommended treatment for any particular patient. The use of any specific surgical technique or maneuver is at the sole discretion of the surgeon.

Step 5

Step 6

Step 7

Surgeons should be familiar with the use of glaucoma drainage devices and post-operative care considerations before implanting any drainage device. Reference papers and surgical video tapes are available upon request.

PC

Model PC
Pars Plana Clip™ • Provides for valve tube insertion into the pars plana • Fully adjustable along length of tube • Does not compromise integrity of valve tube • Smooth curvature eliminates kinking • Can be used with any drainage device • Easily sutured on sclera
Int oP te os rio r a Ch mb er
To Valve

Ordering Info:
Model: PC - Pars Plana Clip™

Materials:
Clip: Medical Grade Silicone

Nominal Specs:
Width: Length: Tube Inner Dia.: Positioning Holes Dia.: 4.60 5.80 0.635 0.025 mm mm mm mm

TE

Model TE
Tube Extender™
e Tub fro

he mt

v Val

e

• Provides extra tube length for necessary cases • Provides leak-proof junction between tubes • Helpful in cases where drainage tube is cut too short • Can be used with any drainage device • Easily sutured on sclera

Ordering Info:
Model: TE - Tube Extender™

Materials:
Junction: Drainage Tube: Medical Grade Silicone Medical Grade Silicone

Nominal Specs:
Width: Length: Height: Tube Length: Tube Inner Diameter: Tube Outer Diameter: 2 Positioning Holes: 3.050 4.750 1.140 24.13 0.305 0.635 0.025 mm mm mm mm mm mm in dia.

PC7 & PC8

Models PC7 & PC8
• Made of medical grade silicone • Model FP7 and FP8 valves already integrated with Pars Plana Clip™ • Reduces preptime for posterior chamber insertions • Clip is fully adjustable along tube length • Easily sutured on sclera • Clip allows the tube not to kink

Ahmed™ Glaucoma Flexible Plate™ with Pars Plana Clip™

Model PC7

Model PC8

Ordering Info:
Model: PC7 (Model FP7 with Pars Plana Clip™) Model: PC8 (Model FP8 with Pars Plana Clip™)

Materials:
Valved Plate Body: Drainage Tube: Valve: Clip: Medical Grade Silicone Medical Grade Silicone Medical Grade Silicone, Elastomer Membrane Medical Grade Silicone

PS2 & PS3

Models PS2 & PS3
Ahmed™ Glaucoma Valve with Pars Plana Clip™ • Model PS2 and PS3 valves already integrated with Pars Plana Clip™ • Reduces preptime for posterior chamber insertions • Clip is fully adjustable along tube length • Easily sutured on sclera • Clip allows the tube not to kink Model PS3

Model PS2

Ordering Info:
Model: PS2 (Model S2 with Pars Plana Clip™) Model: PS3 (Model S3 with Pars Plana Clip™)

Materials:
Valved Plate Body: Drainage Tube: Valve: Clip: Medical Grade Polypropylene Medical Grade Silicone Medical Grade Silicone, Elastomer Membrane Medical Grade Silicone

TI

Model TI
Tube Inserter™ • Notched tip secures valve tube • Provides rigidity to valve tube for easy insertion into anterior or posterior chamber • Stainless steel • Serrated grip • Shorter tip helps to provide better view through microscope • Very inexpensive • Re-usable • Can be used with any drainage device

Ordering Info:
Model: TI - Tube Inserter™

TSH / TPH / TPD

Human Allograft Tissue
Sclera & Pericardium • • • • • • • • • • • Biocompatible human tissue Gamma sterilized 2.5 years shelf life Nominal thickness 0.5 mm Pretrimmed for ease of placement Available Freeze Dried or Hydrated for immediate use Cost effective Available as full thickness sclera or pericardium Available in all sizes Can be used as occular tissue for other cosmetic uses Used for leaking blebs

Ordering Info:
TSH (Human Sclera) TPH (Hydrated Pericardium) TPD (Freeze Dried Pericardium)

Comparison of Ahmed™ Glaucoma Valve with Other Drainage Devices
Product
Ahmed™ Glaucoma Valve

Drainage Device
Model S3 Model S2 Bi-Plate BG103-250 BG-101-350 BG103-425 Single Plate Double Plate

Surface Area
96mm2 184mm2 364mm2 250mm2 350mm2 425mm2 135mm2 270mm2

Valved/Non-Valved
Valved Valved Valved Non-Valved Non-Valved Non-Valved Non-Valved Non-Valved

Baerveldt

Molteno

Type
Success Rate (Lowering of IOP) Visual Acuity (Improved or within one Snellen Line) Hypotony (Occurrence) Success Rate with Corneal Grafts

Ahmed™ Glaucoma Valve
95%

Baerveldt
72%

Molteno
60%

82%

62%

70%

8%

26%

14.60%

84.10%

54%

76%

Coleman AL, Mondino BJ, Wilson MR, Casey R. Clinical Experience with the Ahmed™ Glaucoma Valve Implant in Eye with Prior or Concurrent Penetrating Keratoplasties. American Journal of Ophthalmology 1997; 123:54-61 Hodkin MJ, Goldblatt WS, Burgoyne CF, Ball SF. Early Clinical Experience with the Baerveldt Implant in Complicated Glaucomas. American Journal of Ophthalmology 1995; 120:32-40 Huang MC, Netland PA, Coleman AL, Siegner SW, et al. Intermediate-term Clinical Experience with the Ahmed™ Glaucoma Valve Implant. American Journal of Ophthalmology 1999; 127:27-33 Lloyd MA, Baerveldt G, Fellenbaum PS, Sidoti PA, Minckler DS, et al. Intermediate Term Results of a Randomized Clinical Trial of the 350 versus the 500mm Baerveldt Implant. Ophthalmology 1994; 101:1456-1464 McDonnell PJ, Robin JB, Schanzlin DJ, Minckler D, et al. Molteno Implant for Control of Glaucoma in Eyes After Penetrating Keratoplasty. Ophthalmology 1988; 95:364-369 Melmed S. Cahane M, Gutman I, Blumenthal M. Postoperative Complications After Molteno Implant Surgery. American Journal of Ophthalmology 1991; 1:319-322 Mermoud A. Salmon JF, Straker C. Murray AND. Use of the Single Plate Molteno Implant in Refractory Glaucoma. Ophthalmologica 1992; 205:113-120