Did you hear that Bill Gates visited MIT and helped researchers invent a new birth control device that lasts 16 years?
If you’ve been online at all in July, you may have stumbled across that rather intriguing story. “Bill Gates Wants to Turn Your Birth Control on With a Remote,” read the headline on Gizmodo, a gadget site.
But the real story of the implantable birth control device is even more amazing. The MIT-spawned startup that has been developing it, MicroChips, has been around since 1999. It has raised north of $75 million in venture capital and grant funding -- and has still not gotten a product past the federal approval process for medical devices or booked a dollar of revenue. It has been through four chief executives, and just last week hired its fifth, Cheryl Blanchard, a former chief scientific officer at Zimmer, a publicly-held maker of orthopedic implants. It once employed about 40 people, before shedding all but two.
And now, in part thanks to Bill Gates and his wife, Melinda, the Lexington company is growing again, and hoping to get a new kind of birth control device onto the market as soon as 2018. The company is back up to 10 employees, and it may soon outgrow its Lexington office.
MicroChips’ roots trace back to 1993.
University of Michigan undergraduate John Santini was in Cambridge for a summer fellowship when he saw a presentation given by MIT professor Michael Cima. One slide in particular intrigued Santini: What if you could use a microchip, the same kind that sits inside your iPad, as an implantable pharmacy? The chip would hold tiny doses of a drug, and electronic signals would release it over months or years. Santini started developing the idea, and later devoted his graduate work at MIT to building prototypes. Eventually, with some early funding from Waltham-based Polaris Partners, the research became a company.
When I visited MicroChips a decade ago, it was getting ready to begin animal testing of its device. Think of it as a very small muffin tin, with doses of a drug in each cup, and each cup covered with a metal foil. A zap of electricity from an on-board battery would cause the foil to dissolve and release the drug inside. And the dosing could either happen on a pre-set schedule — like once a day — or as needed, directed by a doctor or patient using a remote control. The cups also could hold diagnostic sensors instead of drugs, to measure things like the amount of sugar in a diabetic’s blood. It was dazzling stuff, and the company never seemed to have trouble raising money from investors like Polaris or medical device giants like Medtronic, or attracting press coverage.
Seven years later, the company was getting ready to start its first clinical trial with human patients.
From a peak of about 40 employees, it was down to just four. The seven-patient trial used the MicroChips device to deliver a drug called Forteo, which is used to improve bone density in patients suffering from osteoporosis. (Ordinarily, patients take the drug as a daily injection.) But even though the trial results, published in 2012, showed that the device could deliver the drug consistently, that version of the device only held 20 doses (or 20 days’ worth), and it was big: about half an inch thick, and roughly the shape of a large egg. The typical patient on Forteo needed to take it for two years. The data was good, but larger companies didn’t exactly bust down the door to help MicroChips bring the product to market.
By that point, most of the company’s employees had been laid off, its office in Bedford shut down, and the lab equipment put into storage. Just two employees remained, shacked up in free office space at Polaris.
But they were working feverishly on upgrading the device that had been used in the trial, shrinking it down to about the size of two Scrabble tiles stacked atop each other. And while they were reducing its size, they were increasing the amount of drugs it could hold. “We managed to improve the drug volume-to-device volume by a factor of 100,” says Bob Farra, the company’s president and one of the two employees during that “skeleton crew” era. It can be implanted in an outpatient procedure, he says, and because of its smaller size, doctors may be able to use surgical glue instead of stitches to close up the incision. (In the original trial, the devices were inserted atop the hip, just below the belt line.)
One of MicroChips’ founders and board members, MIT professor Bob Langer, says that Bill Gates and staffers from the Gates Foundation dropped by his lab about two years ago.
Langer recalls, “They have this list of things they’re interested in, and they asked, could we help them on birth control,” with a special focus on the developing world, where pharmacies and clinics can be scarce and hard to get to. That meeting led to $6.2 million in grants for the startup, and a new lease on life. The new version of the device can deliver 200 monthly doses of progestin, a synthetic form of the hormone progesterone. That’s sixteen years worth — and longer, Farra points out, if a woman turns the device off when she is pregnant, trying to get pregnant, or not sexually active.
The eventual cost of the device will be a big factor on its adoption in the US and abroad; so will women’s willingness to get an implant. Currently, only about half of one percent of women in the U.S. have had an implant, according to data from the nonprofit Guttmacher Institute.
But today’s implantable products, like Merck’s Implanon, last only about three years, and must be removed — as opposed to just switched off — when a woman wants to conceive.
Very few companies, even in the methodical and heavily regulated life sciences business, get fifteen years, more than $75 million in funding, and this many chances to try to get a first product to market. Langer still sees the MicroChips device as “a technology that could change the world some day,” adding, “we don’t give up easily.”
I asked Farra whether there was ever a day when the company was down to two employees when he was dubious about MicroChips’s future — maybe while driving to work on a sleety Monday in February. He corrected me. At one point, his only engineer quit, and the company was actually down to just him.
“I was very excited, every day, to be working toward a commercial product,” Farra told me. Really? Every day? “I think most people who know me would say I’m an optimist.”