Bipolar Advantages

These bipolar devices offer clinical, economic and practical advantages over other devices. If UPP can be performed with existing monopolar instruments, what would prompt surgeons to choose these particular bipolar instruments instead? The answer to that question is as follows:

Advantages of Bipolar Instruments Generally

1. Less wide-spread thermal damage to tissue.
2. Less bleeding. (Combined with 1 above, promoting greater patient comfort and healing.)
3. Virtual elimination of capacitive coupling - lower risk of patient burns or unintended damage to surrounding tissue.

Advantages of These Specific Bipolar Instruments

1. Design allows activation of electrodes to take place outside patient's mouth; surgeon's fingers needn't enter confined space of patient's mouth to perform delicate cut (i.e., more precise positioning and control is achievable before and during cutting).
2. Configuration and design of activation controls (ring configuration and handle configuration) facilitates surgeon's control of the speed of the cut.
3. Design of barrel of instruments guides the travel of the blades/electrodes in the desired dimension to facilitate making incisions only where desired (i.e., inherent mechanical benefit of sliding jaw design focuses movement and pressure to assist in precision cutting)
4. Coagulation in blended cut takes place upon contact with edge of electrode as cut is performed.
5. Design allows for offering of barrels with electrodes/blades with differing range of dimensions to allow practitioners to choose size based upon differing anatomical requirements of patient.
6. Cost advantages over laser, Somnoplasty and most other methods. See Comparison Chart
7. Design of instruments to be compatible with most manufacturers' generators with bipolar mode (preferably macro bipolar) facilitates sales to many practitioners for potential of immediate and wide market penetration.
8. Once a practitioner purchases a handle actuator, orders for replacement barrels are ensured.

Anticipated FDA Approval Process

At this time the FDA approval process has not begun. It is anticipated that a 510(k) clearance, as opposed to a Premarket Approval ("PMA"), would only be necessary for the devices that are "substantially similar" to "predicate devices." Further, since the devices rely on known electrosurgical principles and operate utilizing approved electrosurgical generators, a strong argument exists that the devices present a "non-significant risk" to patients when compared to existing monopolar devices. See the Discussion of FDA Process.

Advantages to your Company

The low-cost suite of bipolar electrosurgical devices for performing UPP are designed to be compatible with the generator units of most manufacturers. Moreover, licensing of the above will provide your company with a proprietary line of hand pieces to enhance its product line, whether it manufactures and distributes or merely distributes generators and/or handpieces. Licensing of the methodology provides opportunities for other creative marketing programs. We hope that you will find that these devices will allow your company to uniquely position itself to offer an inexpensive answer to medical practitioners in treating the large numbers of habitual snorers in an expanding market.

We are interested in entering into an exclusive licensing agreement with your company (or an assignment of rights to the patent applications) in return for a royalty (with a minimum amount per year) to permit final product development, to allow the submission of the appropriate FDA applications, to conduct clinical trials and to manufacture, distribute and sell the devices described in this disclosure as well as licensing of the methodology.