By Avigayil Kadesh
Anyone with an asthmatic child – and there are millions of us in the world – knows how difficult it is to administer inhaled medications properly. Even if you can persuade the kid to hold still, you can’t make sure she’s breathing deeply enough to get the treatment delivered effectively to the lungs.
So it’s not surprising that an Israeli father conceived the idea for an innovative dry powder inhaler (DPI) to help increase the device’s effectiveness, particularly for children, the elderly and those with disabilities. Inspiro Medical, the company he founded to develop and market the Inspiromatic, is a portfolio company of Trendlines’ Misgav Venture Accelerator in northern Israel.
Considering that an estimated 300 million people worldwide suffer from asthma, and an additional 210 million people have chronic obstructive pulmonary disease (COPD), Inspiro’s unique device is likely to be a hot item on pharmacy shelves.
“My son had asthma at age five, and I was working in medical device startups and had a lot of experience in that field,” explains founder Nimrod Kaufmann, a mechanical engineer with 10 years of R&D experience in medical devices.
“We were using a state-of-the-art nebulizer with him, and I started thinking of better ways to treat him. DPIs are more effective, easier to use, and don’t require parents to prepare the dose of medication. But children cannot use them properly, nor can people who are too ill.
“So I thought, ‘Why can’t we develop a device sophisticated enough to deliver dry powder formulations?’ and my next step was to meet Dr. Guy Steuer, a senior pulmonologist at Schneider Children’s Medical Center in Petah Tikvah.”
Steuer liked the idea so much that he helped Kaufmann design it and remains involved in the clinical side of the development process. By mid-2010, they were ready to apply to business incubators. Inspiro was launched at Misgav later that year and Kaufmann quit his job to become the full-time CEO.
Real-time feedback and data logger
Kaufmann explains that dry powder must be inhaled forcefully to empty the premeasured capsule and to break down the drug particles enough to reach deep into the lungs. “You must inhale a certain volume, not too fast and not too slow. It’s not simple.”
While many patients don’t use a DPI correctly, many others stop using it when they feel better – ignoring the need for maintenance. Physicians have no way of monitoring either of these situations, so their treatment decisions necessarily involve guesswork. Kaufmann’s invention addresses that problem too.
“Our smart dry-powder inhaler consists of three main features to overcome those issues,” he says.
Inspiromatic’s active internal mechanism breaks down the particles via a flow sensor that detects the right time to deliver the medication and disperses the particles in the right size without need for forceful inhalation. If the patient inhales effectively, a green light comes on. If not, a red light comes on. A beep sounds when the unit detects that the whole dose has been delivered.
The flow sensor and the internal microcontroller also store data in the device. “It knows if the patient really inhaled correctly or didn’t, so the physician can access this data and see if the drug was delivered successfully and if not, why not. This makes it much easier to find the problems and provide solutions.”
Good test results
Kaufmann’s son is eight now, and it could be a few more years until his dad’s DPI device hits the market.
“We just got Health Ministry approval for our first clinical trial in Israel within two or three months, and we are in negotiations with several pharma companies,” says Kaufmann. “This is a drug-device combination product, meaning it must have a [drug] formulation designed to be used with the specific device. We can use generic formulations adapted to our device or we can work with pharma partners to develop new formulations.”
A working prototype, developed with the help of subcontractors specializing in various relevant fields, was tested in the lab using existing drug formulations.
“We had really good results over existing devices on the market,” says Kaufmann. “Now we are also looking to raise $1 million to develop our device to the point where we can get the [European] CE Mark, but we still will need approval for the drug-device combination.”
The long-term goal is to get approval in both the European and American markets.