Ian Solomon, VP business development at medical devices start-up SteadyMed, holds out a tiny battery wrapped in silver with a small translucent pouch resting on top. “That’s it,” he says matter of factly. “That’s really all the product is – an expanding battery that pushes on a pouch to deliver medicine. It’s that simple.”
He holds it up for study, then brings out the completed prototype, the PatchPump, a miniature patch-like drug delivery pump that is shaped like an inverted contact lens. It’s not much larger than the battery he showed a moment ago. There’s a small button one side for patients to push when they require a dose of medicine, and adhesive material to stick to the skin on the other. At a later stage a tiny computer chip and a small flexible micro needle to inject the medicine painlessly into the patient’s subcutaneous fat will be added.
“This pump is simpler and cheaper than anything comparable on the market. There’s nothing that comes close to it in price,” Solomon tells ISRAEL21c.
This matters. The drug delivery pump market is today worth $83 billion worldwide, and promises to become increasingly significant over the next few years. Apart from diabetics, who already use infusion pumps, people with chronic pain also need a pump, as do patients with cancer and congestive heart failure, anyone in fact who requires frequent injections to treat their illness.
On top of this, the drug industry is changing, and the new drugs emerging from the laboratory are more sophisticated and have larger molecules that cannot be turned into oral medicines. The result is that most new drugs are deliverable only through injection.
Infusion pumps do exist today, but they are expensive, large and cumbersome, and therefore rarely used.
“Infusion pumps give tremendous control of injectable drugs and are far superior to daily injections because they are virtually pain free, but there are so many drawbacks to the current models that people don’t really bother with them,” says Solomon. “Our goal was to take the good infusion capabilities of a large pump but put them in a tiny inexpensive one.”
So far so good. The PatchPump does exactly what it is supposed to do. Patients can stick on the ready-to-use pump and give themselves a dose of whatever medicine it is they need at regular intervals during the day. The patch fits discreetly under clothes, and there is no chance of giving yourself an overdose by unintentionally pressing too many times on the button, for example, because the pump contains a lock out feature preventing doses from being made too closely together. After three days, the pump can be thrown away.
The uniqueness of the PatchPump lies in the Ecell electro-chemical battery, which has taken the company two years to develop. Normally there is a chemical reaction inside a battery that causes the material inside to expand as current is used. SteadyMed took what was essentially a bug in the battery and turned it into an advantage.
“Most people work with batteries to give them more power, we optimized it to give maximum displacement,” explains Solomon. “We have a battery that increases in volume by 250% – it’s a massively expanding battery. Every time the patient pushes the button, the battery expands, pumping the medicine out without any additional power source.”
As a result, the company doesn’t need to add an expensive motor with a power supply to control the infusion pump, as other mini infusion pumps do. “Our battery is inexpensive and weak in power, it doesn’t even generate heat when it is used. This has to be the cheapest possible way to drive an infusion pump,” says Solomon.
The company has already been in contact with battery manufacturers and estimates that it will cost in the region of 35 cents each to make the batteries, while the total cost of producing the patch will be about $2. Compare that to an existing disposable pump for diabetics, which costs over $10 to produce, and sells at $32. “This is too much money for a disposable item,” says Solomon.
The size of the battery can also be changed according to the amount of medicine required. Some drug manufacturers are interested in introducing daily patches to users because of the added simplicity for larger markets, while others might want to make larger ones.
“As long as we keep the same proportions between the battery and the pouch, the battery is completely scalable,” says Solomon. “It’s a platform for drug companies to tell us what they want.”
Developing a battery like this is not an easy task, and early on its short life, the company brought on two of the world’s leading names in battery development, Niles Fleischer and Jonathan Goldstein as consultants.
The first market the company plans to target is the chronic pain market. According to the American Pain Foundation (APF), more than 50 million people in the US experience chronic pain that interferes with daily living. Chronic pain is diagnosed as pain that lasts for six months or longer and older people are especially susceptible. The APF says pain is the number one complaint of older Americans and one in five regularly use painkillers.
Most of these painkillers are oral analgesics, but some people in acute pain are given pumps to take home. Chronic pain has two phases, ongoing and breakthrough pain events. On average, says Solomon, patients might have a breakthrough pain event about three times a day. During these they take extra medication, mostly a different type of painkiller from their usual one.
Oral delivery of painkillers during a breakthrough pain event means a delay in treatment, while the mix of two different painkillers, each with separate side effects, is not recommended. “Infusion pumps have the advantage because the painkiller, whether it’s morphine or some other drug, is delivered immediately, and you can give yourself an extra dose of the same drug if you have a breakthrough pain event,” says Solomon.
SteadyMed was founded at the RAD BioMed Incubator in June 2005 by Solomon, Amir Genosar, and Gideon Kahana. While the three founders worked on an unpaid basis, most of the rest of the work was outsourced to sub-contractors. During the first year, battery development was carried out at the National Battery Center at Bar Ilan University in Ramat Gan, before it was brought in-house, and then outsourced again to a US battery development company.
“We wanted to ensure that our battery was very simple and that it could actually be made. At the end of development we want to be able to go a battery manufacturer in China and say, ‘these are the specifications, make it,'” says Solomon.
In the first two years, the company was funded by the incubator, but at the end of this period, Zohar Zisapel, the owner of RAD, stepped in and invested more money. To date the company has raised $700,000.
The company left the incubator a few months ago, though it is still located at the RAD BioMed offices in Atidim, outside of Tel Aviv, and the prototype has now been completed. SteadyMed’s next goal is to prove the pump works effectively in trials for the FDA – which should be completed within a year – and then go on to clinical trials to prove the pump is compatible with specific drugs and does not cause any adverse effects to the medications.
“This isn’t just bureaucracy,” says Solomon. “One company developed a pump for insulin, but the pump caused a vibration when it was used, and this vibration caused the insulin to crystallize.”
If all goes well, the final PatchPump could be on the market by 2011. In the meantime, the company is sparking a great deal of interest in the pharmaceutical industry.
“We have interest from all the pump manufacturers, and major insulin and drug producers,” says Solomon. “The drug companies know that they have a new generation of injectable drugs coming out on the market, and no real awareness of how they are going to deliver them. In addition, it costs much more to develop a drug than a device, and if you package an inexpensive drug in a more sophisticated way, then the package raises the value.”
SteadyMed’s next task is to raise money. It aims to raise $7 million in two rounds to get the PumpPatch through the regulatory process. The company is now in negotiations with various potential partners, and is looking with great interest at strategic partners, mostly at this stage in Israel. Solomon is confident.
“In our business, the price is everything,” he says. “It’s the lowest price device that will have all the customers. I can’t see how anyone else could make an infusion pump for any less money, and our absolute advantage in price, will bring us close to an absolute advantage in the market.”