The company, founded just last year, brings significant expertise in a number of channels to the table, despite its short history.
CEO Dr. Alan Lotvin co-founded Sequel, bringing decades of experience as an interventional cardiologist, then in specialty pharmaceuticals, and finally as EVP of CVS’ Caremark pharmacy benefits management business.
DEKA R&D developed the underlying drug delivery technology for twiist, which Sequel will market. Dean Kamen, co-founder of Sequel and founder of DEKA, commercialized the first wearable insulin pump for diabetes. In March, he said the system “represents the next generation of insulin delivery.”
Speaking to Drug Delivery Business News at the American Diabetes Association Scientific Sessions in Orlando, Florida, Lotvin explained how the Manchester, New Hampshire-based company is looking to carve out its place in the automated insulin delivery space.
“It’s important to emphasize that all AID systems are better than [an insulin] pen,” Lotvin said. “But, that doesn’t mean they can’t be improved upon. We’re still in a scenario where we have a lot of work to do.”
What is the Sequel Med Tech twiist automated insulin delivery system and how does it work?
twiist, powered by the Tidepool Loop automated insulin delivery algorithm, directly measures the volume and flow of insulin delivered with every microdose. It offers the capability and flexibility to address each patient’s individual dosing needs. twiist received clearance for people ages six and up with type 1 diabetes.
The device itself features a durable component that lasts for two years — and a disposable component that is changed out every three days. The disposable component contains a 300-unit reservoir, while the durable component contains four rechargeable batteries.
Uniquely, the device features a pumping mechanism that significantly differs from other automated insulin delivery systems. Lotvin explained that Medtronic, Tandem and Beta Bionics are all what’s considered a screw pump. He described Insulet’s Omnipod pumping mechanism as a “back and forth pump.”
Sequel, meanwhile, utilizes sound waves that measure each pulse of insulin. This enables precision and helps understand exactly how much insulin the patient receives in a dose.
Lotvin related the mechanism to a kid blowing over a Coke bottle, or perhaps later on in life, a beer bottle. If they drank a little more from the bottle, and blew again, the sound would come in at a lower tone.
He said that, despite complex physics, if the container is rigid, the only thing that matters is the height of the air column. If he can measure the air column before pouring out or drinking the liquid, and after, he can subtract the necessary amount.
According to Lotvin, a high-frequency tone can provide “that millionth of a liter level of accuracy.”
“We have a different pumping mechanism,” he said. “Most importantly, we have a different measurement approach and the measurement actually happens in the chamber. This is just a reservoir. We measure the volume using sound waves. It’s really cool.”
Lotvin and VP of Marketing, Christopher Gilbert, provided an in-depth look at Sequel at ADA:
What sets twiist apart?
Other features that Sequel lists as potential differentiators from the rest of the field include multiple discreet bolus options. Users can utilize the on-device bolus button, an Apple iPhone app for bolusing, as well as the Apple Watch.
twist also offers retroactive meal adjustments, allowing carb entries not only before but also after a meal. Its wide target glucose range stretches from 87 mg/dL to 180 mg/dL.
Perhaps most notably, twiist alerts users to blockages up to nine times faster than other available automated insulin delivery systems. Sequel’s pump detects “silent insulin non-delivery” caused by blockages and prevents infusion of air. It features an acoustic sensor that measures the volume of insulin delivered with each pulse in real time.
A recent study compared twiist to three U.S. commercial insulin pumps. According to the abstract, it found that twiist outperformed commercial pumps on long-term basal flow rate error. It produced occlusion detection between five and 30 times faster, depending on the basal rate. The pump also was associated with significantly lower (two to five times) pressures at time of occlusion.
Lotvin broke the differentiators into three parts. The first was the volume delivery measurements. Second, he pointed to the Tidepool algorithm. Third is accessibility. The company wants to make twiist the lowest net cost pump in the pharmacy channel.
“We’ve really thought about how to make this device as accessible as possible… making it available through the pharmacy channel,” he said. “Based on my background in pharmacy, we’re saying, ‘How do we solve as many problems for a patient as we can?’ [We want to make it so] the person doesn’t become the systems integrator, we are the systems integrator for them.
What’s next for Sequel?
FDA clearance was the first big step for Sequel Med Tech, Lotvin said, but more remains on the plate moving forward.
First, the company is engaging with CGM makers to pair sensors with the system to complete the automated insulin delivery loop. Sequel wants to get as many options available for potential users of twiist as possible, and that extends to the CGMs it may pair with.
“We’re big believers in choice,” Lotvin said. “If you look at the problem in this market right now, only a third of people who should be using AID systems are. People should have a choice of CGM, a choice of pumps and a choice of algorithms in the future. I think no one is quite there yet, but that’s kind of our vision.”
Once the company squares away CGM integration, it anticipates a commercial launch later this year. He doesn’t expect the company’s innovation to end there.
“Like everyone else, we have a development pathway,” Lotvin said. “We have a great device now. We want to be sure we continue to create more features that matter to people. I don’t want to make whiz-bang things that don’t make a difference.
“We want to expand this market more than anything. Helping people get access to these devices is really important.”
