© by BiPAD, Inc.

Risks of Investing in BiPAD:

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  1. Intellectual Property: A) Some of the patents required to protect the BiPAD device have already been issued and others are still pending. There is always a risk that we will not be granted patents on those still pending. B) Competitors could find a way to circumvent our intellectual property. Mitigation: Part of funds raised will be used to accelerate processing of pending patents.

  2. Hospitals as Customers: Hospitals might refuse to purchase our product over low cost bipolar cords that require use of a foot pedal. Mitigation: Surgeons often champion product introductions into the operating room. Surgeons acceptance of 90% or better suggests that this will happen for BiPAD. Also, we discovered that operating room nurses are often even stronger proponents of BiPAD than surgeons, possibly because they do not like having to reposition foot pedals under the operating table during surgery for surgeons. However, we believe that these nurses and staff will promote use of BiPAD in a hospital. 

  3. Failure to adopt: Some surgeons might refuse to consider use of a hand-switch after many years of using a foot pedal. Surgeons might object if they feel that the BiPAD cord is more stiff than the standard bipolar forceps cord.         Mitigation: We designed the BiPAD switch with this issue in mind. First, the foot pedal can be used in tandem with the BiPAD hand switch. In fact, the surgeon can press either the foot pedal or the hand switch or both to activate the bipolar generator. Second, the switch component of the BiPAD hand switch slides off of the forceps connector reverting the BiPAD cable to a standard cable. The cable has been re-designed so that the stiffness of the BiPAD cord will closely resemble that of a simple, non-hand-switched cord.

  4. Failure to obtain 510K Certification: While the risk of failure is low, there is a possibility that additional testing or repeat testing will be required which could increase the cost of certification. Mitigation: Our team has considerable experience in achieving 510 certification for medical devices. We have selected a highly experienced legal team to provide support in this process. They have evaluated our product and defined the predicate device as the foot pedal and determined that the 510 certification process for BiPAD should be low risk.

  5. Challenges manufacturing product at an acceptable price point for market acceptance. Mitigation: We have obtained a BiPAD trademark and a design patent in China given that ultimately, at least some of the production might be done in that country. All product required for 510K certification and for BiPAD beta testing will be produced in the United States.