Startups Update: Where Are They Now?

From cutting-edge gene therapies to transformative medical devices, startups are redefining what’s possible in-patient care and technology. Born from pioneering research and nurtured through strategic collaborations, startups are tackling critical challenges—from neonatal care to oncology and rare genetic disorders—while advancing toward commercialization. Supported by the Office of Technology Commercialization, which facilitates the transfer of breakthrough innovations to industry partners, these companies exemplify how bold ideas become real-world solutions.

Clarametyx is pioneering a novel anti-biofilm therapeutic platform aimed at disrupting the protective biofilm structures that shield bacteria from treatment. This technology targets biofilm formation at its source, offering a promising approach for chronic and recurrent infections. With its lead candidate, CMTX-101, advancing into Phase 2 clinical trials, Clarametyx is positioned to deliver a breakthrough solution for patients affected by persistent respiratory diseases and other biofilm related conditions.

“Clarametyx is championing a novel anti-biofilm technology discovered by experts at Nationwide Children’s Hospital. Since the company was launched in 2020 to move the invention into development, our close collaboration with the OTC has been crucial to our progress. Our lead program, CMTX-101, has now advanced into a Phase 2 clinical trial and we continue to progress with additional potential applications for the technology. We are grateful for the continued support of the entire OTC team that continues to champion this innovative approach, which could benefit many populations affected by chronic respiratory diseases.”- David V. Richards, Chief Executive Officer, Clarametyx

• Principal Investigator: Lauren Bakaletz, PhD, principal investigator in the Center for Microbe and Immunity Research; Steve Goodman, PhD, principal investigator in the Center for Microbe and Immunity Research
• Technology Type: Therapeutic; Vaccine approach is in the pipeline
• Development Stage: Currently in Phase 2 clinical trials.
• Disease Indication: Cystic Fibrosis (CF)-associated pulmonary biofilm infections.

Genosera has secured a license from Nationwide Children’s for a platform technology designed to treat muscle disease. This approach is distinctive in that it delivers a gene therapy vector containing two components: one to replace the defective gene responsible for the disease and another to promote muscle growth. This dual-gene strategy represents a novel therapeutic modality for muscle disorders. In addition, Genosera plans to license a second platform technology based on a conventional gene-replacement approach. This program delivers the functional lipase A gene and has the potential to address multiple indications. Genosera is also pursuing a third licensing opportunity for a technology targeting limb-girdle muscular dystrophy (LGMD) type 2I and congenital muscular dystrophy type 1D (MDC1D), further expanding its portfolio of genetic therapies for severe inherited disorders.

• Principal Investigator: Paul Martin, PhD, Jerry R. Mendell Center for Gene Therapy
• Technology Type: Gene Therapy/Therapeutic
• Development Stage: Ranges from proof of concept in cells to proof of concept in animal models; Principal investigator is generating preclinical IND enabling studies for all programs lipase A license executed.
• Disease Indication: Muscular Dystrophies, lipase A Deficiency, Non-alcoholic Fatty Liver Disease and Non-alcoholic Steatohepatitis.

SmallTalk® is advancing neonatal care with its Active Egg, a pacifier-integrated medical device that delivers suck-contingent maternal voice to preterm infants, supporting speech-sound processing and neurodevelopment. Complementing this regulated device is the NICU Egg, a non-regulated speaker and recording app designed to generate early revenue and enable hospital-based trials. Together, these innovations aim to improve developmental outcomes for vulnerable infants while paving the way for broader clinical adoption.

“SmallTalk is proud to collaborate with Nationwide Children’s Hospital and the Office of Technology Commercialization to translate research on brain development in preterm infants into real-world impact for NICU families. With licensed technology and continued support from OTC, we have successfully completed product development of our first product, launching the NICU Egg System into hospital settings. Our next product, the Active Egg, creates a new category of NICU technology designed to actively improve brain development and outcomes in hospitalized preterm infants.” – Dean Koch, Chief Executive Officer, Founder, SmallTalk.

• Principal Investigator: Nathalie Maitre, MD, PhD, Emory University School of Medicine
• Technology Type: Medical Device
• Development Stage: Active Egg: Pivotal clinical study enrolling; seeking FDA clearance in 2026. NICU Egg: Commercially available as a non-regulated product; used for early revenue and evidence generation.
• Disease Indication: Preterm infants (≥32 weeks PMA) in NICU at risk for impaired speech-sound processing and poor long-term neurodevelopment.

Storilly, the flagship platform created by the Nexa Institute, supports early speech-language development through a clinician- and parent-built digital platform created in collaboration with Nationwide Children’s Hospital. Its therapist-guided storybook tools help families reinforce practice between sessions, offering real-time tracking and tailored activities that turn everyday reading into effective at-home therapy. Designed to complement in-clinic care, Storilly’s tools aim to improve child outcomes while supporting speech-language pathologists with streamlined family engagement and progress monitoring.

“Nexa Institute’s collaboration with the OTC has been foundational in translating cutting-edge clinical expertise into a commercially scalable digital health coaching platform for families. Together, we have launched Storilly into the market to support children’s speech and language development, grown our user base and built the infrastructure to expand into literacy, hearing loss and neurodivergent support. Looking ahead, we are focused on deepening our clinical partnerships and scaling access so that every family can get timely, evidence-based developmental support at home.” – Bill Locker, Chief Executive Officer, Storilly.

• Principal Investigator: Prashant S. Malhotra, MD, FAAP, Department of Otolaryngology and the Hearing Program.
• Technology Type: Medical Device
• Development Stage: Beta testing the software and finishing up pilot studies.
• Disease Indication: Initial testing was children with hearing loss, but technology is designed for all children in speech language therapy.

Vironexis is developing a next-generation AAV-based immuno-oncology platform that enables durable, systemic T-cell-mediated tumor killing. Using low-dose AAV to “vectorize” T-cell engagers, the liver becomes a continuous source of bispecific antibodies targeting hematologic solid tumors. This innovative approach aims to provide long-lasting targeted cancer therapy with fewer doses.

“We have been fortunate to be a multiple time licensee working with the OTC. In just a few short years, we have taken an initial research concept to two FDA approved clinical trials treating several patients with the first gene therapy directed at cancer. Our team has grown into three separate labs with a national, soon to be global, footprint. We truly believe that with the OTC working together with us, we are going to make one of the biggest patient impacts in oncology that we have seen in decades.” – Samit Varma, Chief Executive Officer and Board Member, Vironexis.

• Principal Investigator: Timothy P. Cripe, MD, Division Chief of Hematology/Oncology & BMT, Center for Childhood Cancer Research.
• Technology Type: Gene Therapy/Therapeutic
• Development Stage: Company is in early clinical stage. VNX-101 received FDA IND approval; Fast Track + Rare Pediatric Disease designations; Phase 1/2 first-in-human trial starting. Other programs are in pre-IND, IND-enabling or preclinical development.

Zotarix LLC, a Columbus-based startup from Nationwide Children’s, develops innovations to improve surgical safety. Its lead product, ApollOSTM, is a single-use silicone lip guard designed to prevent thermal and mechanical injuries during transoral procedures like tonsillectomy and adenoidectomy. Partnering with Grace Medical for manufacturing and distribution, Zotarix is advancing regulatory efforts and sponsoring an IRB-approved clinical trial to validate this first-of-its-kind device.

“Zotarix LLC is committed to the development of surgical safety device solutions to redefine the standard of care by reducing preventable harm for patients.” – Kris Jatana, MD, FAAP, FACS, Professor in the Department of Otolaryngology-Head and Neck Surgery at Wexner Medical Center at The Ohio State University and Nationwide Children’s Hospital; Chief Executive Officer, Zotarix.

• Principal Investigator: Kris Jatana, MD, FAAP, FACS and Charles Elmaraghy, FAAP, FACS, Chief, Department of Otolaryngology – Head and Neck Surgery.
• Technology Type: Medical Device
• Development Stage: Clinical trials in progress.
• Disease Indication: Intended for use with any oral surgery involving an electrocautery device.