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BabyStrong – taVNS paired infant feeding therapy
FDA Breakthrough Device Designation

BabyStrong™

Breakthrough in Infant Feeding Therapy

BabyStrong is an innovative, non-invasive therapy that combines transcutaneous auricular vagus nerve stimulation (taVNS) with bottle feeding to improve feeding outcomes for preterm and term infants who struggle with oral feeding.

Feeding difficulty is a major reason for prolonged hospitalization for preterm and term infants in the U.S. Current therapies rely on trial and error, coupled with simple feeding practice as skills develop over time. BabyStrong safely promotes the necessary neuroplasticity in a novel way.

Pioneered at MUSC by Dr. Jenkins, Dr. George, and Dr. Badran, and jointly developed with support from the Zucker Institute for Innovation Commercialization (ZI).

How It Works

The therapy pairs transcutaneous auricular vagus nerve stimulation with feeding to restore brain function. It consists of an external pulse generator (EPG) connected to a pair of stimulating contacts that are attached to the ear via an adhesive. Clinicians can simultaneously administer stimulation therapy while feeding the baby.

Clinical Evidence

In clinical trials, taVNS paired with bottle feeding improved feeding outcomes and was well accepted by parents and care providers. Pharmacologic mitigation of oxidative stress may improve response to taVNS paired with motor training in patients with CNS neuroinflammation and oxidative stress.

  • Innovative, non-invasive therapy for neonatal feeding difficulty — no surgical intervention required
  • Enhances neural motor learning to improve feeding outcomes by promoting activity-dependent neuroplasticity
  • Simple clinical setup: an OT, SLP, or nurse can complete the initial device setup and place the electrodes on the ear
  • Simultaneous administration: clinicians administer stimulation therapy while feeding the baby — no added procedure time
  • Patented electrode design enhances precision and uniqueness in the market, with a pending approval pathway
  • Well accepted by parents and care providers in clinical trials
  • Reduces invasive methods: reduces the need for placement of G tubes / NG tubes for home feeding after discharge
  • Faster recovery: lowers the occurrence of feeding delays that can set neonates back and extend hospitalization
  • Earlier oral feeds: decreases the time to reach full oral feeds, leading to earlier discharge from the NICU
  • Lower costs: reduces hospital costs associated with prolonged NICU stays and invasive feeding interventions
  • NICU capacity: increases the capacity of the NICU by enabling faster patient throughput and bed availability
  • 1Neonatal Intensive Care Units (NICUs) for infants with feeding challenges
  • 2Pediatric rehabilitation centers aiding infants with neurological conditions
  • 3Home healthcare settings for continued therapy post-hospital discharge
  • 4Global markets with advanced neonatal care systems
  • 5Long-term care facilities for infants with complex needs
Designation
FDA Breakthrough Device
Grant
Phase II NIH
Patents
2 U.S. Patents Issued, 6 ex-U.S. Issued, and additional patents pending
Seeking
Licensing & Co-Development
Medical innovation collaboration

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Bringing a medical breakthrough to market takes more than great science — it requires the right strategy, validation, and partnerships. FRD Accel works alongside innovators to turn complex ideas into real-world healthcare solutions that improve lives.

Whether you're in early research or preparing for commercialization, our team is ready to help you move forward with clarity and confidence.

Our Mission

Empowering medical technology innovators to transform discoveries into patient-ready solutions.

Our Vision

Advancing healthcare through impactful innovation and strategic collaboration.

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