DENVER – Here's an interesting marketing challenge.

How do you market a product that addresses an unmet need, a serious injury – but rather infrequent, and frequently debatable, and failing to show up on the radar of patients or the healthcare system in general? Or even denied by the specialists responsible for the injury?

That is the tough task that has been facing Encision (Gunbarrrel, Colorado), the developer of a system that is used to prevent electrosurgical instrument burns that can occur during laparoscopic procedures in the abdomen. But it is making headway.

The company is highlighting the risk of these injuries and the need to move this risk into public consciousness – especially among women female. It is a risk that can essentially be reduced to zero, according to Dave Newton, one of the founders of Encision, and Jack Serino, president/CEO of the company.

Serino delivered the company's secret-disclosing and rather eye-opening value proposition on the concluding day of BioWest 2006 last week. And he and Newton provided an even closer inside look at the company a day before for a small group of reporters at the company's headquarters facility in a suburb of Boulder.

He reels off a variety of statistics concerning injuries in hospitals, from the Institute of Medicine (Washington) report indicating nearly 100,000 each year in the U.S., to wrong-site surgeries at the rate of one out of every 112,000 each year.

Positioning the case in terms of another hidden-injury problem moving into larger consciousness, he cites figures for surgical awareness, 1-to-2 for every 1,000 surgeries, a problem that has been addressed most aggressively by Aspect Medical (Newton, Massachusetts) with its BIS monitoring system (and with the parallel marketing obstacle faced by Encision). The frequency of electrosurgical laparoscopic surgery burns Serino places at about double that of surgical awareness – about 2-to-5 for every 1,000 procedures.

The types of injuries are chilling: primarily burned and burst bowels or damage to other organs that produce severe abdominal pain and often fever and a trip to the ER. The most severe case may move to peritonitis, sepsis and, in the worst-case-of-all scenarios, death.

Thus, when the victims of these injuries must be moved to the intensive care unit, 25% fail to leave alive, Serino asserts.

The cause of these injuries? Uncontrolled electricity leaping from the tip of the instruments used in these minimally invasive procedures, Serino says.

Electricity “always wants to try to escape,” he says, from the tip of these instruments which are charged up to 700 degrees C. (1,292 degrees F) and then used to cut or seal the organs targeted in these procedures. Standard coaxial shielding is used to block this escape but is not always perfect. And the high concentration of saline in the human body also may facilitate these escapes.

The injuries frequently will happen outside the limited view of the physician in these keyhole procedures.

But why do these occur outside the view of the public or, even, healthcare regulators?

While there are probably several reasons, Serino emphasizes one. Primarily, these injuries often cannot be diagnosed at the time of the procedure. Then, they may show themselves three to seven days later and so not related to the procedure – or alternately, identified simply, he says, “after the dust settles,” as an “act of god” or a learning-curve anomaly.

And he says that because of the generally hidden nature of these injuries, those reported represent only a “tip-of-the-iceberg” presence.

While an article earlier this year in the New York Times focused on these problems, citing a recent large liability suit, Serino doesn't say much about the issue in terms of identifying the legal opportunity and need.

“We're not chasing ambulances,” he says. (And thus he does not accuse physicians or hospital personnel of deliberately covering up such cases – though, quite obviously, the potential legal problems implied offer a huge incentive for providers to avoid, rather than to identify, the true cause.)

Encision's solution to these injuries is fairly simple – shutting down the electrical current when it threatens escape from the device tip or falls outside the programmed parameters of ordinary bandwidth. This is achieved with a VCR-sized instrument dubbed AEM, for Active Electrode Monitoring.

The AEM box is attached to the device that charges the instruments, and the technology works very much like a grounded circuit breaker. Encision says it is the only company to offer this safety system and that it totally eliminates these stray burns.

Additionally, the company assembles the electrosurgical instruments, and Serino and Newton describe the provision of the instrument package as “cost-neutral” or provided at a discount, for pricing that is comparable and requiring no change in procedural technique.

The company finds itself in Colorado because of the fertile ground provided by another electrosurgical specialist, ValleyLab (Boulder), where Newton previously worked.

Serino notes that these large manufacturers of electrosurgical devices used in laparoscopy generally play down or ignore the problem, but that they eventually may see the “first-do-no-harm” light – as Encision partners.

And while he declines to offer specifics, Serino refers to “some initial discussions” that might result in partnering fruition.

Newton and Serino provide no neat answer to our original question concerning the best marketing strategy for an unseen or ignored medical need, except for continued hard sales work and (what our reportorial group will provide) additional media coverage.

The company's persistence appears to be having results, Encision most recently reporting positive financials for 1Q07 ended June 30, a 20% increase in revenue over the year-ago period, net income of more than $100,000 and a million-dollar milestone – June '06 as its first-ever $1 million revenue month.

Finally, Serino points to another large reason why the issue needs highlighting: its impact not just on the individual but on potential offspring.

Somewhat more than 80% of the laparoscopic procedures where such electrosurgical may occur are for women. And of these, he says, about 80% are in their prime reproductive years, from age 20 to the mid-40s.

But to whomever these injuries happen, Serino puts the trauma in succinct terms: They are “a sad thing – and totally preventable.”