Storx

Birth asphyxia (deprivation of oxygen) is the second leading cause of neonatal death in developing countries. Strikingly, the same underlying concern coupled with a half-century old inaccurate technology (electronic fetal monitoring) for detection of birth asphyxia, has caused a high rate of interventions in the US, without improving outcomes, compared to other developed countries. The rate of such interventions, such as C-section surgeries, is even higher among Black and Pacific Islander women.

To address the problem, we aim to build a device that objectively assesses fetal health, via direct measurement of fetal blood oxygen saturation, non-invasively through the maternal abdomen. The device can take the form of an inexpensive wearable that high-risk women can wear during pregnancy to receive early warnings (for administration of simple interventions suited for developing regions, such as perineotomy), or a medical device to supplement and improve existing fetal monitors in the labor and delivery rooms. 

Child mortality is a major health problem in the developing world: Over 8 million young children die every year. While the rate of death among children older than one month (59% of the total) has been decreasing in recent decades, the rate of death among newborns (41%) remains stubbornly steady. Asphyxia is the second cause of death among newborns, and accounts for 22% of newborn death. 

The same underlying concern, birth asphyxia, manifests itself differently in the US, where a demonstrably inaccurate technology for detection of fetal hypoxia has fueled 5X increase in the rate of US C-sections since its introduction (currently ~32% out of 4M birth/year), without any improvement in health outcomes associated with birth hypoxia, such as cerebral palsy. C-section is a major abdominal surgery, which increases risk for some health complications, ranging from blood clots, wound infections and post-partum depression for mothers, and bronchopulmonary dysplasia, interstitial lung disease and asthma in babies. In the US, the C-section rate is even higher among African-American women (~35%). For reference, WHO recommends a C-section rate of about 15%, and many western European countries have rates in the low 20%s with better outcomes than the US. 

We aim to build a fetal pulse oximeter that can accurate measure fetal blood oxygen saturation non-invasively through the maternal abdomen. Similar to conventional pulse oximeters, our device works by shining light a few carefully selected wavelengths into the maternal abdomen, followed by careful detection of very weak back scattered light. The detected signal is processed to remove the contamination due to the maternal tissue layers, and to isolate the signal due to the fetal tissue. 

In the developing world, the device can be used in form of an inexpensive self-contained wearable in the care centers to alert care givers to administer associated therapeutics to prevent birth asphyxia (out of our scope, but we collaborate with Dr. Maltepe at UCSF who is developing such therapeutics).

In the developed setting, the device will interface with and will supplement existing electronic fetal monitors to improve their sensitivity for detection of fetal hypoxia. 

in both settings, the device can be marketed as a wearable monitor for high-risk pregnancies that may benefit from longitudinal monitoring of the baby to defer delivery as long as it is safe (which will greatly reduce the likelihood of preterm neonatal mortality). 

Broadly speaking, our target population of expectant mothers (and their families) want safe childbirth.

In the developed world or those in the developing world with access to a reasonable health facility, which has been our immediate focus, the target population includes expectant mothers who prefer to have a safe vaginal delivery. Since fetal health assessment and the recommendation to continue with natural birth or opt for a C-section comes from providers, we have been working with a team of obstetricians, fetal surgeons and neonatologists to better understand the associated decision making process, and focus the solution development efforts on the unmet clinical need. We have recently received IRB approval to test our technology on human subjects antepartum, so direct work with target patients is forthcoming. 

The other target population that can potentially benefit from our solution, though in the longer term, are expectant mothers with access to midwives or a low resource health facility, e.g., in parts of the developing world or remote regions of the developed countries. Such patients and their caregivers could benefit from our solution to objectively decide if continuing with the natural birth is safe, or the use of some relevant intervention (e.g., perineotomy) is justified.

We aim to contribute to the "Decrease the risk of disease" (morbidity and mortality) dimension of the challenge.

Specifically, our solution contributes to reduction of neonatal death due to asphyxia, and reduction of unnecessary interventions, such as C-sections, without compromising safe childbirth.

C-section is a major abdominal surgery, which can result in complications to the mother such as a blood clot, post-operative wound infection, massive hemorrhage, damage to adjacent organs such as the bladder or intestines, and increased risk for postpartum depression. Children born via C-section have increased risks for some complications, including asthma, bronchopulmonary dysplasia, and interstitial lung disease 

Presently, fetal blood oxygen saturation, a key physiological metric for assessing fetal health during labor and delivery, is not readily available to providers. Our technology is innovative, as we can non-invasively and assess fetal health via direct measurement of its blood oxygen saturation. 

Other approaches to improving the existing electronic fetal monitors (which are demonstrated to be inaccurate) include fetal scalp blood draws (to obtain fetal blood oxygenation via blood gas analysis of the sample), transvaginal fetal pulse oximeter probes (which requires direct contact with the fetus), and STAN (fetal EKG analysis, which requires attachment of electrodes to the presenting part of fetal head). 

Our approach is innovative as it 1)directly measure fetal oxygen content (unlike STAN), 2) does not require direct contact with the fetus, which greatly improves applicability, convenience, and barrier to adoption, and 3) offers a continuous view of the fetal health (unlike blood draws from the fetal head).

At a physical level, we leverage the fact that hemoglobin in oxy- and deoxy- state has different absorption signatures in the near infrared region of the spectrum. We shine light into the maternal abdomen, at several carefully selected wavelengths, and detect small amount of diffused light at several carefully selected locations on the outside of the maternal abdomen. The detected signal from several detectors is collectively processed to remove maternal contribution to the signal, and to obtain a coherent estimate of the fetal arterial blood oxygen saturation. In a nutshell, our technology includes precision optical measurement coupled with advanced signal processing algorithms, built into an inexpensive wearable probe. 

The technology has been developed after several years of basic research in an academic environment, supported by peer-reviewed grants from the National Science Foundation and reported in scholarly publications. In addition, Storx Technologies, a startup that is spunoff to bring the technology into the marketplace, has recently received a highly-competitive STTR grant from the National Science Foundation to further advance the technology. 

Our technology operates on the same principle as commodity pulse oximetry, which has been in clinical use for several decades. We leverage the advances in semiconductor technology, which have enabled integrated light sources and inexpensive, highly sensitive light detectors, as well as our proprietary signal processing algorithms to advance the underlying principle of pulse oximetry into non-invasive fetal pulse oximetry. 

The following paper, accepted for publication in IEEE Transactions on Biomedical Engineering, offers an overview of our technology, and its demonstration in a hypoxic fetal lamb model:

https://ieeexplore.ieee.org/document/9112327

The severity of neonatal death due to asphyxia in the developing world is confirmed via many studies (~720,000 cases per year; also recognized by WHO and GATES foundations). Also, there is strong evidence and recognition by ACOG and NICHD that current electronic fetal monitors have high rate of false positives for detection of fetal hypoxia, which has resulted in increased rate of interventions without improvements in outcomes, particularly in a litigious environment such as the US. For example, since the introduction of current monitors in the US in the 1970s, the rate of C-section has risen 5X, while the rate of conditions associated with fetal hypoxia have remained unchanged. 

As such, our theory of change (in settings with access to reasonably-equipped health center) is motivated by the following links:

1) development of a non-invasive inexpensive device for convenient and direct measurement of fetal blood oxygen saturation during birth -> 2) detecting cases of hypoxia and potential for asphyxia -> 3) reduction of unnecessary interventions (as high false positive rate for detection of fetal hypoxia will be addressed) while ensuring safe childbirth in the developed world.

in settings with access to midwives and/or minimally-staffed care centers, the theory of change will look like:

1) same as above -> 2) same as above -> 3) alert caregivers to help using low-tech interventions, such as, perineotomy (or to administer other therapeutics currently under development -sponsored by organizations such as Gates Foundation- to lower fetal oxygen requirement).

The metrics to quantify will include the number of deliveries in which our technology is used, and the associated outcomes, device readings and interventions, if any. A successful change will show safe childbirth with less interventions and/or better outcomes with minimal/well-timed interventions (compared to statistics at the present time) .

We are a newly formed startup that aims to bring a new medical device to market, thus:

Current number of peopled served: 0

Projected number of people impacted within a year: 30-50 patients (pilot study)

Projected number of people impacted within five years: several million patients (assuming a successful medical device is certified and the solution becomes part of the standard of care in the labor and delivery rooms).

Within the next year, we plan to demonstrate device's accuracy and its potential benefits intrapartum, via a pilot study on 30-50 laboring women. This is an intermediate milestone to demonstrate safety and benefits to secure regulatory approval as a medical device.

In the five year, we plan to 1) complete large studies to demonstrate evidence-based reduction of unnecessary interventions in childbirth, while guaranteeing safe delivery, which is a precursor for our device to become part of standard of care for childbirth. . 2) produce and offer the device at scale to support the envisioned enhanced standard of care for intrapartum fetal monitoring.

Data collection and device validation in pregnant and/or laboring women are understandably more regulated, and thus, slower/more expensive to complete. It follows that regulatory review/approval process for a medical device to be used for intrapartum fetal monitoring can be long and expensive. 

Financial resources will be a barrier as we will need to carryout the envisioned patient studies in the early years; and to manufacture, distribute and market the device at scale in the outer years of the 5-year window.

Storx has partnered with a team of clinical and engineering researchers at several leading academic institutions to validate the technology in human subjects, and to revise the technology as necessary. The partnership lowers the cost for Storx to complete such tasks, and in return, it will need to license the intellectual property from the partnering institutions, which in effect de-risks the roadmap for Storx. We have also been in conversation with private investors to raise funding for upcoming development phases, and are optimistic that such resources would become available as early milestones are successfully demonstrated.  

Storx, as a recent spinoff from UC Davis, currently has 1 fulltime employee. Our partner institutions, UC Davis, is a large university, and we collaborate with a team of about 15 researchers affiliated with UC Davis.

Our team has carried out basic research to develop the technology. We have built several device prototype, and have carried out a number of benchtop and in-vivo experiments to perfect the technology. Storx is recently formed to license the IP, and to advance the technology towards impacting patient lives. We believe our intimate familiarity with the problem and the technology, as well as our cohesive integrated team - including individuals with complementary engineering, clinical and business development expertise- put us in a unique position to positively impact the challenge problem.

We closely work with researchers at several leading academic institutions to further the technology, and demonstrate its accuracy and benefits in human subjects. Specifically, we closely work a large team at UC Davis who offer expertise in maternal-fetal medicine, fetal surgery and the relevant engineering aspects of the device technology. We also work eminent clinical researchers at UCLA (w/ ObGyn and Maternal-Fetal medicine expertise), and UCSF (with neonatology and ObGyn expertise). 

Some of these researchers are already engaged in research projects that closely complement our goals. For example, , Dr. Emin Maltepe (UCSF) runs a project supported by the Gates Foundation, which aims to develop therapeutics for mitigating the effect of birth asphyxia (and reducing the associated child mortality) in low-resource settings. 

We aim to reduce the rate of unnecessary C-sections and improve maternal and fetal health outcomes by creating a device that can provide obstetricians with a non-invasive and objective measure of fetal health during active labor. This will be done by creating a device that can provide a non-invasive measure of fetal oxygen saturation through an optical patch placed on the mother's abdomen. Our key customers are hospitals with Labor and Delivery clinics, and our beneficiaries being pregnant mothers and obstetricians monitoring the fetal health. We plan to sell this device to hospitals for use by Maternal-Fetal Medicine specialists in the presence of non-reassuring fetal heart rate tracings (which are present in 80% of all births). We also plan on working with hospitals and insurance providers to integrate the cost of operating the device into a sustainable reimbursement structure, where the hospital and insurance companies save money by performing less Cesarean deliveries and mothers and children receive better health outcomes through natural delivery.

We would like to partner with entities that share/value our goal of improving maternal-fetal health outcomes, and can offer complementary expertise and/or support, to collectively advance towards the shared goal. 

As examples, we hope to connect with individuals and/or organizations who would benefit from access to our technology, or can help us accelerate its development and validation, e.g., via regulatory and/or financial assistance, as a few examples.

Our mission of supporting safer childbirth with improved maternal and fetal health outcomes will improve the quality of life for women and girls, and thus, it squarely fits the scope of Innovation for Women Prize.

Our solution will enable health workers to have a more clear and an objective picture of fetal health during labor and delivery, which will enable them to offer available interventions in a precise and timely manner. 

If awarded, we will use the resources and publicity to further our mission, specifically by accelerating validation of our device intrapartum.

Our core technology leverages machine learning and AI to infer fetal health status from a collection of noisy measurements, and to offer a far more accurate picture of fetal wellbeing during labor and delivery. This information will enable caregivers to support safe delivery while reducing the rate of interventions (as some of them are known to be unnecessary). 

Given the ubiquity of childbirth, and its universal significance across temporal periods and geographical regions, we offer a prime example of using AI/ML to benefit humanity.

If awarded, we will use the resources and publicity to further our mission, specifically by accelerating validation of our device intrapartum.

Our solution will positively contribute to reduction of child mortality, specifically neonatal mortality due to birth asphyxia, which is a goal of the Bill & Melinda Gates Foundation. We already collaborate with Dr. Emin Maltepe (UCSF) who is funded by the Bill & Melinda Gates Foundation to develop therapeutic solutions for this problem, and our diagnostic approach complements such therapeutics well.

If awarded, we will use the resources and publicity to further our mission, specifically by accelerating validation of our device intrapartum.

Our solution will enable caregivers to support safer delivery while reducing the rate of interventions (as some of them are known to be unnecessary). Given the ubiquity of childbirth, and its universal significance across temporal periods and geographical regions, we offer a prime example of a solution that can impact millions of lives.

If awarded, we will use the resources and publicity to further our mission, specifically by accelerating validation of our device intrapartum.