Baebies

615 Davis Drive
Suite 800
Durham,  NC  27709

United States
http://www.baebies.com
  • Booth: 855

Profile

Baebies is guided by the vision that everyone deserves a healthy start. We provide newborn screening, diagnostics, and health management solutions that are patient friendly, easy to use, and cost effective. At AACC we are showcasing a prototype of FINDER™ - a small, innovative and connected testing solution that uses a tiny sample to quickly perform time critical tests. Baebies will also feature SEEKER™, a high throughput, FDA authorized newborn screening platform. Visit booth #855 to learn more!


 Press Releases

  • DURHAM, N.C., February 3, 2017 – Baebies, Inc., a company focused on advancing newborn screening and pediatric testing, announced today it has received de novoclearance 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
    Jeff Florence
    jflorence@baebies.com
    (919)-328-8332

  • DURHAM, N.C., June 30, 2016 – Baebies, Inc., a company focused on advancing newborn screening and pediatric testing, today announced that William A. Hawkins and Nicholas Naclerio, PhD have joined the company’s Board of Directors effective immediately. Mr. Hawkins is the retired Chairman and CEO of Medtronic, a world-renowned innovative medical technology company. Dr. Naclerio is the Founding Partner of Illumina Ventures, an early stage venture capital firm strategically aligned with Illumina, Inc.

    “We are very pleased to welcome both Mr. Hawkins and Dr. Naclerio to our Board and look forward to leveraging their experience as we bring our game-changing product portfolio to market,” said Richard West, Baebies’ Chief Executive Officer and Co-Founder. “Bill and Nick’s proven track records in bringing innovative products to market and their collective global leadership experience make them an excellent addition to our Board.”

    Mr. Hawkins brings over 30 years of experience in innovative technologies, entrepreneurship, and leading global healthcare ventures to the Baebies’ board. Among Mr. Hawkins extensive accomplishments is holding several leadership positions at Medtronic, including serving as Chairman and CEO. Prior to Medtronic, Mr. Hawkins held senior leadership positions at several prominent healthcare companies, such as Johnson & Johnson and Eli Lilly & Co. Most recently, Mr. Hawkins served as President and CEO of Immucor, a provider of transfusion and transplantation diagnostic products worldwide. Mr. Hawkins is active on several public, private and not-for-profit boards and has a consistent track record of shifting healthcare paradigms with innovative solutions.

    With his entrepreneurial experience, Dr. Naclerio will propel Baebies’ product pipeline and push for more innovative ideas to advance pediatric testing. Dr. Naclerio joined Illumina in 2010 and served as Illumina’s Senior Vice President of Corporate and Venture Development through 2016 when he left to found Illumina Ventures in April 2016 as Founding Partner, where he manages investments and participates on company boards. Before joining Illumina, Dr. Naclerio co-founded or served in high profile leadership positions at numerous diagnostic and life science firms, including Quanterix, ParAllele Bioscience, True Materials, and Motorola Life Sciences. Dr. Naclerio has served on a number of corporate and institutional boards.

    “I am thrilled to be joining Baebies’ Board of Directors”, said Bill Hawkins. “The Baebies team has the passion, technology and innovation necessary to rapidly change the landscape of newborn screening and pediatric testing.”

    About Baebies, Inc.
    At Baebies, the 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 a better life to newborns. Baebies is headquartered in Durham, NC. For more information, please visit www.baebies.com.

    CONTACT:
    Jessica Kettler
    Jkettler@baebies.com
    919-328-8332

  • DURHAM, N.C., February 27, 2017 – Baebies, Inc., a company focused on advancing newborn screening and pediatric testing, announced today it has completed a $5 million first close on its Series B financing. The company plans to raise an additional $5 million in the coming months. Baebies received clearance from the U.S. Food and Drug Administration (FDA) for its SEEKER newborn screening system earlier this month.
    “Our FDA clearance creates an opportunity to take the company to the next level. We have a great product and a great team, and this Series B will ensure that we have the financial resources required to complete the journey to commercialization,” said Richard West, Baebies’ CEO.

    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
    Jeff Florence
    jflorence@baebies.com
    (919)-328-8332

  • Baebies Announces CE Mark for SEEKER, an Innovative Newborn Screening Platform for Lysosomal Storage Diseases

    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
    919-328-8332
  • Baebies Announces Assays for FINDER Launch Panel: G6PD, Total Serum Bilirubin, Albumin and Direct Bilirubin

    Experience a hands-on demonstration of FINDERTM at Booth 855 during AACC 2017

    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. A hands-on demonstration of FINDER will be held at Booth 855 during the AACC Annual Scientific Meeting & Clinical Lab Expo in San Diego, California from August 1-3, 2017.

    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
    919-328-8332


 Additional Info

Included in the Export Interest Directory?
No
Business Needs:
Direct Sales, Distributor/Agent/Representative, Investor, Joint Ventures
Countries of Interest:
China