Just last week, OptiScan Biomedical announced that its OptiScanner 5000 glucose monitoring system won 510(k) clearance for use in surgical intensive care units.
The regulatory win was supported by eight rigorous clinical trials, CEO Peter Rule told Drug Delivery Business News, and represents a victory for a technology that the company hopes to expand into a platform system.
The OptiScanner 5000 device is the first of its kind, providing physicians with trending and tracking information to manage their patients’ blood glucose levels in surgical ICUs.
The Hayward, Calif.-based company’s technology uses alarms to alert clinicians when patients are experiencing hyperglycemia and hypoglycemia. The bedside system is automated, updating every 15 minutes with a new measure of glucose levels from plasma, as opposed to whole blood.
“One of the reasons it’s amazing is that there are a lot of companies who’ve have tried and failed in this space. Very large operations and what they tried to do was take their own glucose sensing technologies and apply it to the application of ICU,” CFO Patrick Nugent said.
OptiScan took a different approach, Rule explained.
“What we did is effectively start with a clean sheet of paper and said, ‘What does the ICU really need for continuous monitoring?'”
They came up with four criteria: it needed to be independent of heparin, a blood-thinning drug, and it needed to connect to any catheter. And unlike the outpatient market, Rule said, a glucose monitor designed for use in the ICU should not need to be calibrated or require a long warm-up time.
The company also had to prove that its system could handle the extreme conditions of the ICU, where patients have organs that fail and physicians give drugs that are not usually found in a patient’s system.
“So, the only way to really demonstrate that you can do that, I mean, you can do a lot of bench testing and all of that, that’s very good, but you really do need to run rigorous clinical trials. And those trials take a long time and a lot of money,” Rule said.
Now that the company’s first product has FDA clearance as a glucose monitor, OptiScan hopes to win U.S. approval for its OptiScanner 6000 system, which monitors a patient’s glucose and lactate levels in the ICU. The device won CE Mark clearance in January this year.
“We’ll add to it beyond that, because if you think about the ICU patient, bed number two does not have a glucose problem that’s distinct from bed number four. But bed number four may have a need for lactate monitoring. And bed number five, you might want to know their hemoglobin level and on it goes,” Rule said.
The company also pointed out that its system could eventually be used to deliver insulin based on the glucose levels it measures for each patient. The system already has the hardware in place, Rule said, with reciprocating pumps that power the withdrawal and push-back of blood.
For now, this 60-person company is celebrating what it considers to be the biggest advancement in ICU care in “easily the last 10 years,” according to Rule.