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Vibration-integrated Lancing System to Reduce Stress, Pain Response, Heel Damage and Developmental Harm from Recurring Heel Sticks in Neonates

Award Number: R44NS155776
ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/18/2016
PERIOD OF PERFORMANCE END DATE: 08/31/2029

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Vibration-integrated Lancing System to Reduce Stress, Pain Response, Heel Damage and Developmental Harm from Recurring Heel Sticks in Neonates - This Phase IIB SBIR further develops and clinically tests the BabyGentleStick Heel Stick Helper (BGS), a device that reduces the pain and stress associated with heel sticks through vibration-induced analgesia. BGS delivers vibration through a commercial heel stick lancet to the target area, effectively numbing/masking pain signals prior to and during lancing. Blood collection in neonates is routinely necessary, with heel sticks being the most common technique for small volume samples. Heel sticks are considered one of the most frequent, painful procedures performed in the neonatal intensive care unit (NICU), resulting in a repeated pain response that negatively impacts development. Clinical and laboratory studies suggest that preterm neonates are especially vulnerable and can exhibit sensitization to repeat stimuli. Recently, evidence for developmental plasticity in the neonatal brain suggests that repetitive painful experiences during this period or prolonged exposure to analgesic drugs may also alter neuronal and synaptic organization permanently. A solution is needed that provides drug-free reduction of the pain and stress responses to heel sticks and post-lance heel squeezing in neonates. BGS achieves these aims and meets the NIH/NICHD goal of “Methods to reduce pain in all of perinatal care in newborn infants, in mothers in labor, during postpartum after spontaneous delivery and cesarean section.” The innovation is the combination of vibration-induced analgesia with a high-speed automatic lance in a single easy-to-use Handpiece, without compromising blood sample quality or volume. Phase II demonstrated compelling reductions in pain response in clinical evaluations in patients 33 weeks+ of gestational age. Critical next steps: 1) BGS Model 1 510(k) Clearance, along with reduced costs, 2) BGS market expansion by developing BGS Model 2, integrating the BD Quikheel™ safety lancet, and adding 25% of the lancet market to the 42% already accessed by BGS Model 1, 3) Clinically evaluating BGS Model 2 in younger and more fragile patient populations (<28 wks), who undergo the greatest number of repeated heel sticks, and in more ethnically diverse populations than the Phase II studies, and 4) Increasing adoption and markets with business development tasks. Specific Aims: Aim 1 – Implement critical cost reductions and submit 510(k) for BGS Model 1. Aim 2 – Develop BGS Model 2 to accommodate BD QuikheelTM safety lancet’s unique shape and blade release. Aim 3 – Transition BGS Model 2 toward Clinical Studies, Regulatory Submission, and Manufacturing. Aim 4 – Demonstrate reduction in pain and stress response in younger patients (<28 wk) through clinical studies (LCH, CNH) and prepare BGS Model 2 Regulatory Submission. Aim 5 – Business Development Activities (via TABA funds).


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $1,040,504 )
2026	2026	ACTUATED MEDICAL, INC.	320 ROLLING RIDGE DR	BELLEFONTE	PA	16823	CENTRE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	4	9/17/2026	COMPETING CONTINUATION	$1,040,504
														Subtotal = $1,040,504

Grand Total All Awards = $1,040,504

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Vibration-integrated Lancing System to Reduce Stress, Pain Response, Heel Damage and Developmental Harm from Recurring Heel Sticks in Neonates

Award Number: R44NS155776

ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 05/18/2016

PERIOD OF PERFORMANCE END DATE: 08/31/2029

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