Medical Equipment Developer Business Plan

Medquip, Inc.

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Products

Medquip, Inc. will initially market three distinct products.

1. The Visi-Band, a disposable device that is used in endoscopic variceal ligation procedures.
2. The Visi-Gator, a partially disposable device that is used to remove blood clots during various endoscopic surgical procedures.
3. The Visi-Lyser, a suction/irrigation device for laparoscopic procedures.

The technology used in these products is the subject of seven patents in the application process.

These three product areas may be more generally defined as follows:

1. Endoscopy Devices--used for esophageal variceal ligation, hemorrhoidal ligation.
   The Visi-Band: Consisting of ligating bands with greater stretchability and grip (Super-Elastic bands incorporated into a multi-band dispensing device).
   
2. Endoscopy Devices--used for lysis (tissue dissolving).
   The Visi-Gator: Consisting of a rotary cutting tool to clear fundal pools of blood in the stomach.
   
3. Endoscopy Devices--used for suction/irrigation and tissue removal.
   The Visi-Lyser: Consisting of a suction/irrigation tool to remove tissue effectively.

3.1 Product Description

A detailed and technical description of the Medquip, Inc. initial product line follows:

Multiple Ligating Band Dispenser:
The Visi-Band

Application is endoscopic variceal ligation which is a rapidly growing surgical procedure quickly replacing sclerotherapy for the removal of polyps in both upper and lower gastro-intestinal exploration.

Scope: This innovation applies to the internal technology of ligating bands independent of the dispenser or delivery system. Visi-Band is a pre-loaded delivery device for applying multiple ligating bands remotely from the distal tip of an endoscope. (The leading current product in this category is the Speedband made by Boston Scientific).

Clinical Advantages: A perceived clinical advantage of these bands is ligation of a greater range of tissue sizes with a single band. These ligating bands stretch easily over the largest tissue to be ligated and yet will grip securely even the tiniest tissue to be removed. These bands can have an inner diameter near zero so that even tiny varices are gripped firmly.

Current State of the Art Technology: Market-leading bands today are molded of homogeneous rubber materials. Material properties of elasticity have limited the stretch of conventional ligating bands to a range of about seven-fold. A typical market-leading band for esophageal variceal ligation has an inner diameter of 1.8mm. This band can stretch to a maximum inner diameter of 12.4 mm to ligate a varix. This maximum size roughly corresponds to the endoscope diameter. A varix of 1.8 mm would not be ligated because the band would be loose around the tissue.

Medquip Technology: The Super-Elastic Band innovation effectively engineers the band material stresses in a way that increases the apparent stretchability of the band many times. We have created bands with proximate zero inner diameters, which can be stretched at least as large as conventional bands with large inner diameters. Bands created with this technology can also hold their elasticity for longer periods of time. The basis of our technology is an internal compressive pre-stress at the band inner diameter. This can be achieved in at least five practical ways covered in our patent documentation. The true zero inner diameter band is a result of the compressive forces creating small scale creasing or wrinkling which fill the band interior. Bands made to date exhibit an effective elasticity of 20 times and more versus the seven times stretch in the market-leading band.

Medquip ligation devices should have an unprecedented and superior range of application to meet ligation requirements. Super-Elastic Bands can mean fewer special sized devices to manufacture, purchase, specify, and stock. This fits well in a managed-care environment through lower costs with inherent clinical advantages. Medquip and the health care system could benefit from higher volumes of a smaller number of different products.

Further Clinical Advantages:

• Visi-Band is designed for multiple band ligations with a single scope insertion.
• Visi-Band delivers maximum visibility with zero "tunnel vision" during insertion and exploration, a limitation of all competitors.
• Visi-Band delivers maximum mobility by being nearly flush with the distal end of the endoscope during insertion and exploration.
• Visi-Band should be significantly faster to install to the endoscope by having many fewer assembly parts and steps than the competition.
• Visi-Band is smaller in diameter than Speedband for patient acceptance and comfort.
• Visi-Band patient entry is smoother and protected at all times from miss-fires by a smooth, transparently clear outer shield.
• Visi-Band can ligate smaller varices with the super-elastic bands as described above.
• Visi-Band can be supplied in a single configuration with multiple bands, seven or eight, at a cost similar to the competition's three or six band unit.

Note: Today's multiple ligating band dispensers release bands off a tube at the distal endoscope end with typically two filaments for each band. This tube is at least as long as the endoscope diameter and creates severe "tunnel vision" because the bands typically cover the outside surface of the clear plastic tube. This added length also reduces the mobility of the distal tip. Each filament must be precisely assembled and triggered for each band. Bands exposed on the outside of the tube are prone to miss-fire as evidenced by a clear shield with instruction to remove just prior to insertion into the patient. A conically tapered dispenser is typical and necessary to help bands roll off the distal end. This taper increases the diameter of the ligating unit. Installation is a complex, multiple step process often involving a separate ligating unit, handle unit, a trip wire, scope fastener, and irrigation catheter. Actuating a competitive unit can cause the distal tip to move from the tension of the trip wire.

Medquip Technology: The Medquip Visi-Band multiple band ligator is planned to have two components, the ligating unit and handle. The Ligating Unit comprises a clear tubular base with bands stretched around the distal end, a clear sleeve outside of and concentric with the base, and a trip tube which passes through the biopsy channel of the scope. The ligating unit mounts in a retracted position around and substantially flush with the distal tip of the endoscope. The ligating unit is placed on the distal tip of the scope by pushing the trip tube through the biopsy channel. The handle is then snapped on the free end of the trip tube. The unit is extended distally prior to ligation, and the sleeve is moved axially to load then deliver a single band at a time. No individual filaments are required for each band so manufacturing cost is low. The unit is "digitally" actuated by repeated axial motion of the sleeve rather than small incremental displacements. The tip of the scope should not move because a compressive force in the tube cancels the tension in the trip wire internal to the trip tube.

Summary of advantages over currently available products:

1. Better visibility due to side-mounting of band dispensing device.
2. Smaller band, more stretch, enabling banding of smaller varices.
3. Internal loading of bands, enabling protection (bands are not dislodged).
4. Capable of carrying more bands (8 vs. 6).
5. Significant reduction in manufacturing and assembly costs.

Lysis (tissue dissolving) Rotary Cutting/Suction Tool:
The Visi-Gator

Applications include the removal of blood clot and stray tissue during suction irrigation in laparoscopic surgery, examination of bleeding ulcers in the stomach, hematoma, clot in the fallopian tube, or cerebral aneurysm. Current solutions employ crude tubes that incorporate a few holes for anti-clogging combined with drug treatments which are largely ineffective.

Scope: An uncleared fundal pool of retained blood in the stomach precludes complete visualization of the stomach in 5.6% of cases of acute upper gastrointestinal bleeding. According to an October 1997 article in Gastrointestinal Endoscopy: "In conclusion, the results of this study provide evidence that the inability to clear a fundal pool of blood at the time of emergent upper endoscopy for acute UGI bleeding is associated with substantial morbidity and mortality and ... Aggressive mechanical and/or pharmacological measures to clear the fundus of blood are warranted in patients undergoing urgent endoscopy for acute UGI bleeding."

Clinical Advantages: The Visi-Gator tool may be inserted from the outside into the biopsy channel of the endoscope as needed. The scope does not need to be withdrawn to install and use the Visi-Gator.

Current State of the Art Technology: Lavage with suction is frequently ineffective due to clot integrity and clogging of suction channels. High-pressure water jets penetrate beyond the clot, potentially penetrating and damaging soft tissues.

Medquip Technology: Visi-Gator is a thin, ultra-flexible, spring-like device that is introduced through the biopsy channel to the distal end of the endoscope. High-speed rotations of one or more of many concentric spiral elements both drive rotating lysing filaments and positively pump solids and liquids out. Centripetal force expands and stiffens the filaments from a stored position during insertion to a generally planar and circular path. Vacuum may also be applied. A hollow central channel may also be provided for irrigation, access, or other therapy.

Further Clinical Advantages:

• Visi-Gator clot dissolving aggressiveness varies from mild to intense and is proportional to the adjustable input speed control.
• Visi-Gator actively draws fluid and solids up through the biopsy channel with a positive pumping action.
• Visi-Gator continues to dissolve solids even as they pass through the biopsy channel.
• Visi-Gator will tend to be non-clogging and self-cleaning.
• Visi-Gator does not rub high-speed surfaces against the biopsy channel and cause high rates of wear.
• Visi-Gator provides a central channel for clear water irrigation, additional suction or other therapy.
• Visi-Gator motor driver is envisioned to be reusable. The fluid path and lysis head is likely to be disposable.
• Visi-Gator dissolving action and lysing head is transparent. One can see through the scope real time in the zone of clot lysis continuously as the lysing progresses.
• Visi-Gator appears to be capable of rapid clot lysis yet is gentle to tissue.
• Visi-Gator tip is soft and pliant to flex over any non-clot tissues.
• Visi-Gator lysis zone is generally a defined planar disc perpendicular to the axis of the distal end of the scope.
• Visi-Gator allows lysis not to penetrate beyond the disc boundaries.

Suction Irrigation Device for General Laparoscopic Surgery: (incorporated into Visi-Gator):
The Visi-Lyser

Scope: Visi-Lyser suction irrigation device includes a self contained, stand-alone suction/irrigation device to aid the surgeon during laparoscopic surgical procedures.
Clinical Advantages: Lysis of the clot or tissue at the entry point, which will tend to be clog resistant. A likely disposable fluid path and reusable power head.

Current State of the Art Technology: Conventional suction irrigation devices are prone to clog when presented with a clot during surgery.

Medquip Technology: Similar to the Visi-Gator tool with the lysing filaments contained within a perforated suction tube.

Note: The Visi-Lyser is designed to work with the Visi-Gator in laparoscopic procedures but may also be used by itself in distinct procedures.

One embodiment inserts into the working channel of an endoscope as an accessory. A flexible spiral spring-like element rotates at several thousand RPM inside of a close spiral spring tube of opposite hand wind. A tiny motor on the outside proximal end of the endoscope spins the spiral element. Liquid or solid material inside the spiral element windings is drawn from distal to proximal positions by the interaction of the rotating and stationary spiral geometry. Suction is preferably applied at the proximal end of the spiral element before the motor. At the distal end of the spiral element, a generally spherical ball tip covers the spiral end to protect soft tissues from the spiral screwing into tissue and causing trauma. Projecting from the tip is a single or multiple of filaments, which spin at the high speed of the spiral element. The filaments lyse the unwanted clot or soft tissue fragments, depending on speed of rotation, diameter, material, and construction details. The filaments may optionally be extended or retracted from the outside to lyse differing diameters or body cavity sections. Rotation speed of the motor is a direct way to control aggressiveness of lysis dynamically from the outside. A flexible tube may be placed at the center of the rotating spiral element to carry water or saline to flush the cavity being lysed. A single or multiple of apertures near the distal end of the water tube may spray a jet sideways to clear potential clogs. The water center tube is preferentially not rotating.

In a second embodiment, designed for suction irrigation of a surgical site, the rotating filaments and spiral are placed in a tube with small apertures. The filaments rotating inside server to lyse clot and tissue which would normally clog the apertures. A rotating jet of water inside could also serve to clear any clogs. The spiral element could also be present inside.

Advantages over currently available products: No Products Currently Available.

Note: A variety of medical journal articles and research studies are available that cover both potential product areas.

Patent searches and filings are under way with Sidley and Austin. Opinion is that as many as seven distinct patents may be available and obtainable on the three devices cumulatively. Mr. Smith has assigned these patents (as obtained) and any future issued patents in the medical device arena to Medquip, Inc.

3.2 Competitive Comparison

The leading product currently available in the endoscopic variceal ligation market is the Speedband made by Boston Scientific. Other product entries are from C.R. Bard and Wilson-Cook. The Speedband from the Microvasive division of Boston Scientific is far and away the market leader with an estimated 60% market share. The Six Shooter from Wilson-Cook has a 20% market share. Rapid-Fire made by C.R. Bard has a 10% market share. All of the devices are disposable (single patient use).

Eric Smith, a founder of Medquip and the developer of Medquip's patented technologies had significant participation in the design of the Speedband. He is aware of both its strengths and shortcomings. The Visi-Band is a much improved product in a rapidly growing market application. Many of the product advantages were highlighted in the previous section of this plan. To summarize the key advantages:

• Band itself enables smaller varices to be banded.
• Smaller hole plus more stretch in band.
• Device has better field of view.
• Device has better mobility.
• Bands are fired internally vs. externally.
• Significant cost reductions in mfg.

The Visi-Gator and the Visi-Lyser represent an entirely new application with no current competition. Their use can potentially range from stomach procedures to heart procedures and a variety of other surgical procedures. Together they solve the well documented and acknowledged problem of lack of visibility in endoscopic procedures where blood clots are involved. The Visi-Lyser also allows an improved and more efficient means of removing fundal pools of clotted blood and tissue.

3.3 Sales Literature

Sales literature for Medquip, Inc. remains to be developed.

3.4 Sourcing

Primary raw materials needed for Medquip products are as follows:

1. Molded plastic parts.
2. The tooling and molds (capital expenditure).
3. Band material (polymer).
4. Small electric motor.

All of these components are easily sourced and multiple suppliers have been identified. In addition, injection molders have been identified to manufacture the molded components for Medquip products. There are multiple potential sources.

A potential source for additional research and design help and compliance is Valnet in Puerto Rico.

Medquip will perform final assembly and distribution from its own facility in Puerto Rico or utilizing contract manufacturing depending on the extent of financial support from the government of Puerto Rico.

3.5 Technology

Sidley and Austin is patent attorney for Medquip, Inc. Seven patents have been authored and filed. All patents take into account both offensive and defensive postures in their claims. Opinion of legal counsel is strong and firm that all of Medquip's patent applications are enforceable and defensible.

The principal areas (general descriptions) of the patents applied for are as follows:

1. The ligating band itself.
2. The movable dispenser.
3. The dispenser itself.
4. Two additional alternative dispensers.
5. The tissue dissolving device.
6. The transporting catheter.
7. The dispenser control device.

Care has been taken to take into account all potential claims of the inventions as well as to protect them from possible competition from other technologies (including inferior ones). All patent application documents are available for examination by potential investors. The first document is entitled "A ligating structure having greater stretchability, greater shelf life, and greater ligating characteristics and method of manufacture." It lists more than 40 independent claims.

Also available is the assignment of all patents in the medical device field (above listed and future developed) by Eric Smith to Medquip, Inc. The first four patents listed above relate to the Visi-Band. The last two relate to the Visi-Gator.

Trademark application has been filed on the name Medquip. Trademark applications are in process on the names Visi-Band, Visi-Gator, and Visi-Lyser. No conflicts or other use of these names has been found in an initial search.

3.6 Future Products

Plans for future development by Medquip include additional ideas and technologies to be created by Eric Smith as VP of R&D for Medquip. In addition Medquip may seek to acquire technologies developed by others once it attains sufficient capitalization to do so. It is the objective of Medquip to both innovate and market its products. Once an industry reputation has been achieved and marketing channels opened expansion into other medical device areas becomes potentially rewarding.

A recent article in Red Herring indicates the bio-tech field in general is a current hotbed of activity and most of the companies involved are early-stage development companies.