Colby Holtshouse, former Alydia Health COO and Organon Global MedTech Commercial Lead, who led the commercialization of the JADA® System for postpartum hemorrhage joins Oli ahead of FDA submission
Oli has announced the appointment of medtech leader Colby Holtshouse to its Board of Directors.
Holtshouse brings deep expertise in women’s and maternal health, medtech commercialization and PPH. She previously served as COO at Alydia Health before its acquisition by Organon, where she went on to serve as Global MedTech Commercial Lead and led the commercialization of the JADA® System, a medical device designed to treat and control PPH. JADA was subsequently acquired by Laborie in a transaction valued at up to US$465 million. Holtshouse is now CEO and President of May Health, a clinical stage company developing technology to address PMOS (Polyendocrine Metabolic Ovarian Syndrome) and PMOS-related infertility.
“Colby brings the expertise Oli needs as we move towards regulatory approval and commercialization,” said Tara Croft, CEO at Oli. “Her work bringing a major PPH technology from clinical development to market gives her a unique perspective on the path ahead for Oli. We’re thrilled to have her joining us at this critical stage, as we take Oli from clinical validation towards regulatory approval and, ultimately, into the hands of clinicians and onto the bellies of mothers in birth rooms.” added Croft.
“Much of my career has been focused on bringing new medical technologies to women’s health, particularly in the area of obstetrics, where innovation has been limited despite profound unmet need,” said Colby Holtshouse. “Oli is taking a fundamentally different approach to maternal and fetal monitoring – moving from a simple raw data feed to an intelligent synthesis of multiple inputs, with predictive power designed to identify risk before complications arise. I’m excited to join the Board at such an important point in the company’s journey,” added Holtshouse.
Holtshouse joins Oli following completion of its fourth and final pivotal clinical trial prior to FDA and TGA submission, which successfully enrolled 1,000 mothers across seven hospital sites in the United States and Australia – one of the largest and fastest maternal studies ever conducted.
The trial evaluated Oli’s first clinical application, PPH, defined in the US as excessive bleeding following childbirth, typically over 1000 mL after birth. It is one of the leading causes of maternal mortality worldwide with a mother dying every seven minutes globally as a result despite up to ninety three per cent of these being considered preventable with earlier intervention. PPH can escalate rapidly: about a fifth of a mother’s blood flow goes to the uterus at term, and it can take only three minutes to lose up to 2.1L of blood and threaten a mother’s life.
It is a growing clinical and economic burden in the United States, costing the healthcare system an estimated USD $1.8 billion annually. Among births complicated by PPH, blood transfusion rates more than doubled between 2000 and 2019. And with nearly three-quarters of PPH cases in the US occurring with no identifiable risk factors, the current risk-based assessment approach for PPH is failing.
Oli is designed to predict the onset of PPH before it begins, rather than identifying the condition after significant blood loss has occurred, as is standard practice around the world today. Initial clinical and commercial findings showed that early warning could be provided at least one hour before birth using Oli, and in some cases up to nine hours prior, giving clinicians more time to prepare, intervene and protect the mother and baby before an emergency occurs.
While PPH is Oli’s first clinical application, the technology aims to have the ability to analyze and predict up to 15 conditions and complications across pregnancy and birth, including fetal distress, stillbirth risk and labor progression – with the goal of giving clinicians greater visibility into what is happening to both mother and baby, with no more blind spots.
Oli has raised US$18 million in funding to date and, through its clinical studies, has monitored 1,600 women, analyzed more than 20 million maternal heartbeats and recorded over 100,000 contractions – building the data foundation behind its predictive approach to maternal and fetal care.
“Maternal and fetal monitoring has remained largely unchanged for decades, which is astounding. I’m excited to help guide Oli as it works to make a real difference in the birth experience for mothers and babies, their families and the clinicians beside them,” said Holtshouse.
“At the end of the day, everything we are doing at Oli is about the mother and baby in the birth room, and the clinicians caring for them. If we can signal what’s coming and when it’s time to act, we can help protect the room from the unexpected and give teams more time to act, while also improving the trust, comfort and wearability of monitoring during labour. That’s what we’re working towards.” said Tara Croft, CEO at Oli.
