Bipolar electrocautery forceps are the most accurate tool for controlling hemorrhage in millions of surgeries performed worldwide every year. BiPAD® is a unique, ergonomic enhancement for this crucially important surgical instrument. Moreover, BiPAD® is designed to work with most bipolar forceps and most electrocautery generators.
BiPAD® provides surgeons with the first practical hand-activated switch for bipolar electrocautery thereby liberating them from the foot pedal, reducing the time required to initiate electrocautery coagulation, reducing blood loss and eliminating the need for staff to crawl under the operating table to reposition the foot pedal during surgery.
Without BiPAD®, surgeons are often distracted from the operative field by having to step back from the surgical field in order to locate the foot pedal to activate the forceps to stop a hemorrhage. This is even more dangerous when surgery is being performed with a microscope.
Staff is also inconvenienced by the foot pedal. When a surgeon cannot locate the foot pedal, the operating room staff must crawl under the operating table, a non-sterile space. The bipolar is utilized dozens of hundreds of times per case, and relocation of the foot pedal is required 2-4x per case. (ref x)
Not surprisingly, more than 90% of surgeons and operating room staff surveyed say that the BiPAD® hand switch will reduce blood loss, surgeon fatigue, staff exposure to infectious agents and the duration of surgery to such an extent that the device could be transformative.
Because BiPAD® integrated the removable, low-profile hand switch into the consumable cord used to connect the forceps to the generator, our product is poised to enjoy recurrent sales and durable market advantages over the standard cord which requires a foot pedal.
Current status of BiPAD®: prototyping complete, patents issued and pending, design prepped for mold-based manufacturing. Next steps are: 1) manufacturing sufficient product for 510K testing and application, 2) 510K certification and 3) beta testing at selected premier medical centers nationwide. We plan to start raising capital for this purpose shortly. Please contact us at Investors@BiPAD.US for more information or access to passworded documents.
Risks associated with the 510K process have been mitigated, the predicate device has been defined, and we have consultant assessments advising that the BiPAD® is a class II device with low-risk 510K certification.
Risks associated with the sales process have been mitigated by an independent customer acceptance survey which shows 90% surgeon uptake and 94% OR staff uptake. Also, assessment of the acquisition process for this product indicates that products of this nature are most often reviewed by OR product review committees staffed by OR staff who are significantly benefited by this device.
BiPAD®, LLC's goal is to leverage our intellectual property to capture this $400M+ global ($85M USA) consumable cord market.
To learn more, contact us.