Baebies

Durham,  NC 
United States
http://www.baebies.com
  • Booth: 3581

Booth Profile

Baebies, guided by the vision that everyone deserves a healthy start, delivers innovative products and services for newborn screening and pediatric testing. SEEKER® is the only newborn screening platform authorized by the U.S. FDA for lysosomal storage diseases. Still under development, FINDER is a rapid near-patient newborn testing solution. FINDER is not available at this time for sale or use in any territory.


 Press Releases

  • Innovative Newborn Screening and Pediatric Testing Company Ships 2 Millionth Test

    DURHAM, N.C., October 31, 2017 — Baebies, a growth-stage company that delivers innovative products and services for newborn screening and pediatric testing, today announced that it has secured $10 million in Series B financing in an oversubscribed round anchored by BOE Technology Group Co., Ltd. BOE is a global leader in semiconductor display industry as well as an IoT company providing intelligent interface products and services for information interaction and human health. Baebies also received funding from family offices, with continued support from current investors and the North Carolina Biotechnology Center.

    The company also announced the shipment of its 2 millionth test. The company’s SEEKER® product was cleared by the FDA earlier this year and remains the only newborn screening platform authorized for testing for lysosomal storage disorders.

    “Baebies digital microfluidic technology is the future of newborn screening methods and we’re proud to collaborate in technology development and play a role in bringing this technology to the global market,” said Lijun Mao, General Manager of BOE Sensor Technology Co., Ltd. “As new technologies arise in healthcare, we want to back the most innovative and promising companies. Baebies has demonstrated rapid growth in the company’s product pipeline and team. The company is a tremendous fit with our Healthcare business, which is committed to offering people-oriented healthcare services by developing mobile healthcare, digital hospitals, regenerative medicine and healthcare park solutions,” said Wei Wu, PhD, Healthcare Investment Director of BOE Ventures.

    “This has been an exciting year for Baebies: our team has grown to 60 talented employees, we have secured FDA clearance for our SEEKER screening platform and we recently announced a global distribution partnership with Labsystems Diagnostics to expand the product offerings in the newborn screening space,” said Richard West, Baebies co-Founder and CEO. “We are getting closer to our goal of expanding newborn screening and pediatric testing worldwide to the millions of babies that don’t have access to it.”

    “When Richard West and I founded this company in 2014, we set a goal that by 2018 we would provide 2 million chances for a healthy start. Early intervention is critical and we are thrilled to have reached this milestone early. We never lose sight of the fact that every test shipped holds the potential to save a life,” said Vamsee Pamula, PhD, Baebies co-Founder and President.

    About Baebies
    At Baebies our sole focus is to advance newborn screening and other pediatric testing worldwide. Baebies is guided by the vision that “everyone deserves a healthy start”. Baebies delivers innovative products and services to make life better for all babies. Baebies offers SEEKER®, the only newborn screening platform authorized by the U.S. FDA for lysosomal storage diseases and is developing FINDER, a rapid near-patient newborn testing solution. FINDER is not available at this time for sale or use in any territory. By bringing new technologies and new tests to the healthcare community, Baebies is providing hope to parents and the chance at a better life to newborns. For more information visit www.baebies.com.

    About BOE
    Founded in Beijing, April 1993, BOE Technology Group Co., Ltd. is a world leading semiconductor and IoT company providing intelligent interface products and services for information interaction and human health. BOE’s three core businesses are Display and Sensor Devices, Smart Systems and Healthcare Services. For more information visit: www.boe.com.

    CONTACT:
    Jessica Kettler
    jkettler@baebies.com
    +1 (919) 328-8332

  • DURHAM, N.C., July 31, 2017 – Baebies is pleased to announce that SEEKERTM, a high throughput newborn screening laboratory solution, now has CE Mark and available in Europe and other countries that recognize CE Mark. SEEKER quantitatively measures the activity of lysosomal enzymes from newborn dried blood spot specimens. Reduced activity of these enzymes may be indicative of Mucopolysaccharidosis Type I (MPS I), Pompe, Gaucher or Fabry disease.

    Newborn screening for lysosomal storage diseases (LSDs) has gained interest worldwide with the increasing availability of effective treatment options and accessible screening methods. In addition, several recent studies have highlighted higher incidence rates for certain LSDs than previously reported. “SEEKER’s ease of use enables the platform to be used in virtually any newborn screening program,” says Jerry Walter, Founder and President of the National Fabry Disease Foundation. “More babies screened for LSDs means more babies identified and diagnosed through clinical follow-up.”

    “As a company focused on newborn screening and pediatric testing, SEEKER’s CE Mark allows Baebies to build on the mission that everyone deserves a healthy start by expanding access to newborn screening to all babies around the world,” says Jan Østrup, a pioneer in neonatal screening product development and a member of the Baebies’ Scientific Advisory Board.

    “We are delighted to announce CE Mark for SEEKER,” said Richard West, Co-Founder and Chief Executive Officer of Baebies. “There is a tremendous interest in SEEKER outside the US due to its simple implementation and we are actively engaged with several customers,” added West.

    As countries start or expand newborn screening programs, labs are challenged to find easy and cost-efficient ways to implement new assays. To address these needs, Baebies delivers SEEKER, a reliable, fast and easy to use solution for high throughput newborn screening. The pioneering platform features:

    • Digital microfluidic technology which minimizes sample and reagent volumes.
    • Minimal, easy to use equipment making installation and training quick and simple.
    • All electronic workstation with no required daily maintenance so the platform is always up and running.
    • Proprietary software that guides all skill levels through the minimal hands-on workflow.

    Baebies’ SEEKER received U.S. FDA authorization in February 2017 after a thorough review that included a clinical study of over 150,000 subjects, with no known false negatives reported. For more information on Baebies’ SEEKER platform, visit www.baebies.com.

    About SEEKERTM

    SEEKER is a high throughput laboratory solution that quantitatively measures the activity of lysosomal storage enzymes from newborn dried blood spot specimens. As the first newborn screening platform for lysosomal storage disorders authorized by the U.S. FDA, SEEKER is designed for ease of use, simple implementation and no daily maintenance.

    About Baebies

    At Baebies our sole focus is to advance newborn screening and other pediatric testing worldwide. Baebies is guided by the vision that “everyone deserves a healthy start”. Baebies delivers innovative products and services to make life better for millions of babies. By bringing new technologies and new tests to the healthcare community, Baebies is providing hope to parents and the chance at a better life to newborns. Baebies SEEKER is the only newborn screening platform for authorized by the U.S. FDA for lysosomal storage diseases. For more information visit www.baebies.com.

    CONTACT:
    Jessica Kettler
    jkettler@baebies.com
    +1 919-328-8332

  • DURHAM, N.C., February 3, 2017 – Baebies, Inc., a company focused on advancing newborn screening and pediatric testing, announced today it has received de novo clearance from the U.S. Food and Drug Administration (FDA) for SEEKER. SEEKER quantitatively measures the activity of lysosomal enzymes α-L-iduronidase (IDUA), α-D-glucosidase (GAA), β-glucocerebrosidase (GBA) and α-D-galactosidase A (GLA) from newborn dried blood spot specimens. Reduced activity of these enzymes may be indicative of lysosomal storage diseases (LSDs) Mucopolysaccharidosis Type I (MPS I), Pompe, Gaucher or Fabry, respectively.

    Baebies SEEKER FDA Clearance

    SEEKER IS DESIGNED FOR EASE OF USE, MINIMAL MAINTENANCE AND FLEXIBLE FUTURE EXPANSION.

    “Although these LSDs have FDA approved therapies, this is a significant milestone for the LSD community, as SEEKER is the first FDA cleared product for LSD testing,” said Vamsee Pamula, President and Co-Founder of Baebies. “FDA’s clearance of SEEKER resulted from a thorough and rigorous review. We look forward to providing SEEKER kits to implement safe, effective, easy and reliable screening for LSDs. SEEKER is the only FDA authorized test on the market.”

    Newborn screening, widely recognized as one of the most successful public health programs in the U.S., ensures that all babies are screened for certain serious conditions at birth. The program started more than 50 years ago and has since expanded to include more than 30 metabolic and genetic diseases. The recent addition of Pompe disease and MPS I to the Recommended Uniform Screening Panel (RUSP) have brought more recognition to the benefit of early detection through newborn screening for LSDs.

    “As LSDs are being added to the RUSP, state newborn screening programs are making plans to begin screening. FDA clearance enables state laboratories to confidently implement testing while minimizing the validation effort resulting in a cost effective implementation,” said Bradford Therrell, Jr., PhD, the Director of the National Newborn Screening and Global Resource Center.

    About Baebies, Inc.
    At Baebies our sole focus is to advance newborn screening and other pediatric testing worldwide. Baebies is guided by the vision that “everyone deserves a healthy start”. Baebies is developing innovative, easy to use and connected products to make life better for millions of babies. By bringing new technologies and new tests to the healthcare community, Baebies is providing hope to parents and the chance at a better life to newborns. For more information, please visit www.baebies.com.

    Press Contact
    Jessica Kettler
    jkettler@baebies.com
    +1 (919)-328-8332

  • DURHAM, N.C., July 31, 2017 – Baebies, Inc., a company focused on advancing newborn screening and pediatric testing, announced the first assays on the FINDER launch panel, currently under development. The panel includes tests for total serum bilirubin, albumin, direct bilirubin, and glucose-6-phosphate dehydrogenase (G6PD) on a single cartridge, making it the first comprehensive, rapid and near-patient testing solution for hyperbilirubinemia. A robust pipeline of future panels for other disorders using the same cartridge on FINDER is also in development.

    Hyperbilirubinemia is a condition in which bilirubin levels in the blood are elevated and the newborn becomes jaundiced. When unmonitored or untreated, neonatal jaundice can lead to severe neurotoxicity, including kernicterus and other associated morbidities.

    There is currently a gap in point of care testing devices for G6PD, a deficiency that leads to hyperbilirubinemia and approximately 21% of kernicterus cases. The FINDER launch panel will address a critical need for G6PD testing and brings together the most common analytes used to assess hyperbilirubinemia. Each test on the FINDER launch panel contributes to a more complete understanding of why jaundice develops in a newborn. Rapid access to these measurements may allow clinicians to treat severe neonatal hyperbilirubinemia faster and more effectively, thereby preventing irreversible neurological damage.

    “Our neonates have very limited volume of blood available for the many tests and technologies required for current hyperbilirubinemia standard of care. Identifying newborns at-risk for hyperbilirubinemia using a single drop of blood on FINDER not only reduces the amount of pain a neonate must endure, but also reduces the time to provide physicians with important information that will direct care,” says Dr. Michael Cotten, Director of Neonatology Clinical Research at Duke University School of Medicine.

    FINDER is the only platform specifically designed to address the unique needs of neonatal testing. FINDER substantially decreases both sample size and testing time, enables testing in the nursery or anywhere in the hospital, and delivers comprehensive test panels – even across multiple test types – to solve acute problems in neonatology. Simple operations and test flexibility enable FINDER to provide results in minutes.

    About Baebies, Inc.

    At Baebies our sole focus is to advance newborn screening and other pediatric testing worldwide. Baebies is guided by the vision that “everyone deserves a healthy start”. Baebies delivers innovative products and services to make life better for millions of babies. By bringing new technologies and new tests to the healthcare community, Baebies is providing hope to parents and the chance at a better life to newborns. FINDER is not available at this time for sale or use in any territory. For more information visit www.baebies.com.

    CONTACT:
    Jessica Kettler
    Jkettler@baebies.com
    +1 (919) 328-8332


 Additional Info

Included in the Export Interest Directory?
Yes
Business Needs:
Distributor/Agent/Representative, Investor
Products to be exported:
SEEKER® is the only newborn screening platform authorized by the U.S. FDA for lysosomal storage diseases. SEEKER is a high throughput laboratory solution that quantitatively measures the activity of lysosomal enzymes from newborn dried blood spot specimens. Reduced activity of these enzymes may be indicative of Mucopolysaccharidosis Type I (MPS I), Pompe, Gaucher or Fabry disease.
Countries of Interest:
China