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several of her friends relayed their troubles either getting pregnant or unsuccessfully attempting IVF—a process in which an egg is fertilized by sperm outside the body, in a petri dish, and then injected back into the womb. Indeed, according to the Centers for Disease Control and Prevention’s latest report on assisted reproductive technology in 2010, some 41.5 percent of IVF cycles from fresh embryos resulted in live births.
“I started to realize that IVF was the only thing we have,” Dipp says.
So Dipp scoured academic centers in the U.S., U.K, and Europe to find something that would improve IVF. She and her team acquired technologies being worked on Tilly and Harvard University scientist David Sinclair.
The idea was this: there are stem cells in the ovary known as egg precursor cells that ultimately mature into eggs. If there were a way to isolate these cells and jumpstart that process, a woman in her late 30s or early 40s with older eggs could use those cells to ultimately produce younger, healthier eggs and increase her chances of not only getting pregnant, but having a healthy baby. That process, if proven, would debunk the idea that a woman has a finite number of eggs.
OvaScience’s business model to capitalize on this approach is a two-step process, the first of which is Augment.
Augment is a process designed to upgrade the success rate of IVF by injecting mitochondria, the cell’s power plant, from egg precursor cells into older eggs outside the body, rejuvenating them and theoretically increasing the chance of pregnancy. OvaScience has a portfolio of patents and patent applications surrounding methods for isolating egg precursor cells and using them to treat infertility.
The selling point for OvaScience would be for women to avoid potentially going through IVF several times, shelling out, on average, about $16,000 a pop if a women uses her own eggs—$26,000 if she uses eggs from donors—and dealing with the hassles of the procedure. Those involve, of note, 10 days of hormone injections, which have a number of side effects.
“Women typically have to go through two to three cycles before they get pregnant or they quit,” Dipp says.
The Augment process is the same as traditional IVF, except for two key additions: First, a doctor performs an ovarian tissue biopsy, through which the egg precursor cells and their mitochondria are retrieved. Second, when the father’s sperm is injected into an egg, the mitochondria are injected along with it. This, OvaScience says, gives the eggs the energy boost needed for a successful pregnancy.
OvaScience doesn’t need to take the Augment procedure through the three phases of clinical trials that a biotech would have to for a new chemical entity. But it is conducting an 80-patient clinical study of Augment anyway to prove that it works. OvaScience began the study in December, and aims to enroll 80 women between 38 and 42 years old that have failed anywhere from two to five IVF procedures.
“The whole goal here is to identify patients who basically have age-related infertility—so, those where we think we can make a big difference,” Dipp says.
Half of those women will undergo standard IVF procedures, while the other half will use Augment. OvaScience’s goal is to show a big increase in the number of healthy, live births. Dipp expects those results by the end of 2014, at which point OvaScience hopes to have the data in hand to begin selling the system. (Dipp says the company also plans to do an international study before selling Augment outside the U.S., and is slowly adding to its team to help push that effort forward.)
The question then becomes whether OvaScience can successfully ramp up sales, and the company faces a key challenge in doing so: are the benefits of Augment big enough to convince people to pay for it? The problem with that, of course, is it’s a big out-of-pocket check. But Dipp argues that that’s an expense most women choosing IVF are already logging. While roughly 15 states in the U.S. offer some form of reimbursement for IVF, Dipp says coverage can depend on the person’s employer, and women often don’t want to go through the steps mandated by the insurance company—such as first trying, and failing, several cycles of a generic drug named clomiphene citrate (Clomid) that is supposed to stimulate ovulation.
“So even when they have the insurance, they’re often paying out of pocket,” Dipp says.
OvaScience is discussing right now whether to price it at a premium to current IVF treatments, or comparably.
“We’re thinking about it as, if we can save you an IVF cycle, would you be willing to pay the cost of that cycle up front?” Dipp says. “That’s generally the ballpark we’re thinking about, but to be clear we haven’t decided on a price yet.”
Then, once OvaScience rolls out Augment, its real test will begin. Namely, whether it can prove that OvaTure—the name for its process of turning egg precursor cells into eggs, and successfully fertilizing them—works.
Here’s the process OvaScience has in mind: A woman would get an ovarian tissue biopsy to retrieve an egg precursor cell. That egg would be matured and fertilized in vitro before being injected back into the womb. The upshot is big: not only does it eliminate hormone injections, which, side-effects notwithstanding, aren’t available to all women (those with cancer, for example); but also, the egg created is young and healthy, increasing the chances of pregnancy and lowering the likelihood of birth defects.
Of course, OvaScience has a very long way to go to get there. Researchers behind OvaScience have only proven so far that the egg precursor cells from mice can be matured and fertilized. Dipp says the company is in the process of proving that concept works in a human egg right now, with pre-clinical studies underway overseas, and hopes to have proven, by the first half of next year, that fertilization in that scenario can take place. While OvaScience may be gearing up to sell Augment around that time, even Dipp acknowledges what’s more important.