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smallTalk

smallTalk

医疗设备制造业

Cleveland，Ohio 293 位关注者

smallTalk? is a technology startup developing the first intervention to improve brain development in preterm infants.

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smallTalk? is a seed stage technology startup developing the first intervention to improve brain development in preterm infants. Each year, nearly 400,000 U.S. infants are born preterm, with millions more worldwide. These children face heightened risks of neurodevelopmental outcomes. Many of the neurodevelopmental issues stem from the neonatal intensive care unit (NICU) environment itself. A key element that is compromised in the NICU is “infant-directed speech”. Such speech is vital for brain development, with preterm infants showing better neurobehavioral and language outcomes with increasing levels of exposure. Yet fewer than 20% of parents can interact daily with their NICU infant due to socioeconomic and other barriers, making reliance on parental visits insufficient. With the support of a $2.5M NIH grant, smallTalk has developed the first medical device designed to improve brain development in preterm infants. Our NICU Connect System includes our voice recording app, the NICU Connect? speaker (designed specifically for use in the NICU) and the Paci? sensor, which fits into a NICU pacifier to communicate suck strength data to the speaker. During a therapy session, the sensor equipped pacifier is used by the baby to enable active interaction with the recorded voice. The speaker sets and adjusts an individualized threshold of suck strength, communicating wirelessly with the sensor. When the threshold is met, the baby is rewarded with ten seconds of maternal voice. In published feasibility studies, this active learning therapy has resulted in significant improvement in speech sound processing, a brain measure associated with speech, language and neurodevelopmental outcomes. Sessions are conducted once daily for two weeks by a nurse or therapist, making it simple to implement in NICU’s from Level II to Level IV. NICU Connect ACTIVE is not available for sale. We are currently enrolling a pivotal clinical trial designed to support an application to FDA.

网站
https://www.smalltalk.tech
所属行业
医疗设备制造业
规模
2-10 人
总部
Cleveland，Ohio
类型
私人持股
创立
2018
领域
Pediatric Devices、Neonatology、Medical Devices、Consumer Products、Infant Care、Preterm Infants、Neurodevelopment、Neonatal Intensive Care、Neonatal Therapy和NICU

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  • 查看smallTalk的组织主页
    smallTalk

    293 位关注者

    smallTalk is honored to join the Techstars portfolio through our participation in Techstars Columbus Powered by The Ohio State University! An amazing time for the smallTalk team as we enter the market with the NICU Egg and near the finish of our NIH supported pivotal clinical study to support FDA submission of our Active Egg for preterm infants in NICU care. Thanks Tim Grace, Autumn Hankinson and Gabrielle Rudd! Jessica Melton, Nathalie Maitre, Annalisa Perfetto, Ph.D.

    查看Tim Grace的档案
    Tim Grace

    Managing Director @ Techstars Columbus powered by Ohio State

    TODAY'S THE DAY!! ? Welcome Techstars Columbus Powered by The Ohio State University Spring 2025 companies! So excited to work with these incredible founders over the next 13 weeks. Now it's time for you to meet them: Avionova (Noor Haj-Tamim) - Wearable technology that prevents spatial disorientation for pilots, astronauts, and people with balance disorders. Fovionics (Gabriel Habech, Mike Romano) - The world’s first hands free and affordable technology for the visually impaired. Generation Environment (Kristen Kammerer) - Moving money from people to planet through micro-philanthropy. Nyad (Virginia Szepietowski, Christopher Braithwaite) - Microbiology co-pilot for wastewater operators. OfSpectrum (Yechen Wang, Yishu Huang, Linxi Li) - AI platform for protecting voices from deepfake manipulation. Okkanti (Karen Laing) - Whole health pregnancy care platform expanding opportunities for caregivers and expectant families to thrive. Pull To Refresh Inc. (Arin Crumley, Christopher Paliqaw) - Accelerating carbon sequestration by sinking seaweed at scale. RYN (Camryn Ellis) - AI fashion engine that reduces the stress of getting dressed. smallTalk (Dean Koch, Nathalie Maitre) - First medical device that improves brain development in preterm infants. Sonnet (Anurag Kejriwal) - AI-native productivity software for professionals in regulated industries. Read more here! https://lnkd.in/gJSZr_dD

  • 查看smallTalk的组织主页
    smallTalk

    293 位关注者

    An update from CEO Dean Koch on what we accomplished in 2024!

    查看Dean Koch的档案
    Dean Koch

    CEO @ smallTalk. 2x Founder. Techstars '25.

    ?? Reflecting on a Transformative 2024 with smallTalk ?? I’m incredibly proud to share what we’ve accomplished this year as we work to revolutionize care for preterm infants and their families in the neonatal intensive care unit (NICU). For parents, separation from their newborn in the NICU creates immense stress and uncertainty, often leading to higher rates of depression, anxiety, and post-traumatic stress. For infants, a NICU stay can take a toll on their developing brains, with longer hospitalizations tied to adverse neurodevelopmental outcomes. At smallTalk, we’re dedicated to utilizing our patented voice technology to help address these challenges. 2024 was a year of incredible progress! Our work is partially funded by you, the taxpayer, through a $2.5M Phase II SBIR grant. ?? Q1 Highlights Finalized labeling and clinical study plan for the Active Egg—our pacifier-activated speaker to improve brain development in hospitalized preterm infants (pending FDA clearance). Launched our pivotal, multi-site RCT funded by the NIH. Approximately 200 preterm infants, 32 weeks and older. 20 sessions. - Control Group: Daily exposure to maternal voice via the NICU Egg speaker. - Intervention Group: Daily exposure to pacifier-activated maternal voice via the Active Egg speaker and sensor. - Outcome: Time-locked EEG measurement of speech-sound processing (Event Related Potentials), a biomarker of brain development associated with neurodevelopmental outcomes. ?? Q2 Highlights Exhibited the NICU Egg at the National Association of Neonatal Therapists conference. Overwhelming enthusiasm, at the meeting's busiest booth! Accelerated patient enrollment in our study, putting us on time and on budget.? ?? Q3 Highlights Initiated early product evaluations with select NICUs, ramping up efforts to gather valuable feedback. Exhibited at the National Association of Neonatal Nurses conference. Nurses love our nurse-driven product design! ?? Q4 Highlights Joined the Trailblazer Health Accelerator in #CLE, securing up to $125K in non-dilutive funding and invaluable connections through JumpStart Inc.. Launched our $1M Seed Round, successfully closing over $350K to date. Selected an Ohio-based partner for manufacturing and began the transfer process. Celebrated eight newly issued patents, bringing our total to 14 issued patents worldwide. 2024's milestones bring us closer to our vision of improving neurodevelopmental outcomes for preterm infants while strengthening the bond between parents and their babies. The NICU Egg will be available for sale to hospital NICU’s starting in April! Thank you to our partners, supporters, and the inspiring NICU community for believing in our mission. #NICU #NeonatalCare #Innovation #Neurodevelopment Rev1 Ventures Nationwide Children's Hospital Design Central Big Kitty Labs Odic Incorporated JALEX Medical, LLC Midwest Pediatric Device Consortium Consortium for Technology & Innovation in Pediatrics Project Medtech

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    查看Dean Koch的档案
    Dean Koch

    CEO @ smallTalk. 2x Founder. Techstars '25.

    Today, Sept 30th, is NICU Awareness Day, and I'd like to recognize the hard work of all the physicians, nurses, therapists and staff that make the NICU such an amazing place. The majority of my career has revolved around the neonatal intensive care unit. First, an effort to equip obstetricians and maternal-fetal specialists with tools to better predict and prevent preterm birth (these infants are the majority in the typical NICU). And now, an effort to support NICU's and families and the brain development of hospitalized infants. Recently, in a pitch, I was asked to share my “founders story”. What motivated me to start smallTalk with Nathalie Maitre (and Nationwide Children's Hospital and Rev1 Ventures)? I was part of the Adeza Biomedical team that brought the first preterm birth diagnostic test to market, and with that same team developed the first drug FDA cleared to prevent preterm birth. The business was incredibly successful. But, the rate of preterm birth has stayed steady at about 12%. Zero impact, nothing, on the very problem we tried to solve. What I saw in Nathalie's work was an incredible opportunity. To actually improve the developing brain. With a simple therapy, using their own mother's voice in the NICU, to literally change the trajectory of their lives. At smallTalk, our work is to support the baby in the NICU, and their family at home. While their hospital stay is necessary, it is an awful place for the developing brain, and the separation of the newborn from their family has an incredibly powerful impact on everyone. For the baby, a lack of exposure to infant directed speech, typically provided by the mother, contributes to speech, language and neurodevelopmental outcomes that lag their peer babies. We are bringing our first solution, the smallTalk NICU Egg, to market now. It is designed for simple implementation in the NICU. Designed to provide recorded maternal/caregiver voice at a safe volume and duration for the baby. And designed for the parents, to engage and enhance their involvement in the care of their child, even when they can’t be present. The Egg speaker also serves as the foundation of a therapeutic device, currently in an NIH funded pivotal clinical trial, that will be the first device to improve brain development in preterm infants. We look forward to sharing our work with the physicians, nurses, therapists and other hospital staff, supporting NICU babies and their families in the coming years.

  • 查看smallTalk的组织主页
    smallTalk

    293 位关注者

    smallTalk is very excited to bring this solution to NICU parents, and NICU's this summer. #nicu #nicubaby #neonatal #preemie #nicuwarrior #babytech

    查看Design Central的组织主页
    Design Central

    5,606 位关注者

    Soon, the smallTalk? Connect speaker will improve short-term and long-term outcomes for infants across the country! In our latest article, learn how Design Central supported smallTalk's mission to revolutionize neurodevelopmental outcomes for NICU babies. This innovative device, available for request this summer, will solve a long-known problem without introducing risk. https://lnkd.in/gUhciw4h Nationwide Children's Hospital, Rev1 Ventures, JobsOhio, Consortium for Technology & Innovation in Pediatrics, Midwest Pediatric Device Consortium, The Batchery, gener8tor #wearedesigncentral #medicaldevice #innovation #medtech #NICU

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