InPress Technologies, a California-based device startup, has an ambitious plan to solve a potentially fatal problem for pregnant women around the world. Company Co-Founder Jessie Becker said she hopes the InPress device will become the standard of care in the United States to ensure women’s ability to bear children in the future. Plus, she said it could provide a realistic, affordable standard of care for women in emerging markets and developing countries, where PPH is one of the leading causes of maternal death. (In fact, 99 percent of all maternal deaths occur in developing countries, according to the World Health Organization.)
These goals may sound lofty, but Becker and fellow co-founder Nathan Bair have had success with the startup so far. The project received support from Cal Poly‘s San Luis Obispo Hothouse accelerator, and is now one of the startups at the Fogarty Institute for Innovation. They’ve finished animal trials, raised a million-dollar seed round and are nearing a design freeze, with plans to begin the human trials this winter.
Becker said she wants to help women in the US avoid hysterectomy due to postpartum hemorrhaging in the U.S. The same problem is often fatal for women in developing countries. About 80 percent of PPH is due to uterine atony, when the uterus fails to contract and its blood vessels remain fully dilated after birth, which causes unobstructed bleeding. The InPress stops uterine bleeding by working with the body to contract the uterus.
The single-use device would be inserted into the uterus, where a proprietary mechanism works to contract the uterus gently. It would take away the need for (and expense of) drugs and surgery. It also drains lost blood into a vacuum canister so the physician knows exactly how much blood has been lost.
What typically happens now in U.S. hospitals? If uterine contraction isn’t occurring after a mother delivers her baby, the OBGYN will typically prescribe one of four medications to help the muscle contract, Becker said. If that doesn’t work, the physician will move on to bilateral uterine massage (not as comfortable as it sounds).
Next, OBGYNs rely on a balloon tamponade, probably the most-used device for managing PPH. This device has a pretty high success rate–around 80 percent. The tamponade is also indicated for use for up to 24 hours. Or, Becker said, the doctor may even decide to manually contract the uterus using sutures, sometimes in combination with the tamponade. Becker said the tamponade is a “last-ditch effort” physicians make before going into “major invasive surgery.”
When the tamponades and sutures don’t work, doctors sometimes perform hysterectomies.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Becker said the InPress could definitely replace the tamponade, but also potentially the pharmaceuticals, because it works with the body to help the uterus contract.
Planned future milestones that will push the company in that direction include raising a Series A round by the time the startup leaves Fogarty, completing U.S. clinical trials in 2014 and applying for both the CE mark and a 510k clearance in 2014. Becker said they hope to receive the nod from the FDA and commercially launch the InPress in 2015.
