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OrthoPediatrics Announces Expanded Enabling Technology Market Opportunity

MWN-AI** Summary

OrthoPediatrics Corp. (Nasdaq: KIDS), a company specializing in pediatric orthopedic care, has announced a significant development following its partner iotaMotion receiving FDA 510(k) clearance for the iotaSOFT® Insertion System to be used in patients aged four and older. This advancement expands the availability of robotic-assisted cochlear implantation to school-aged children, enhancing the surgical experience for pediatric patients needing cochlear implants.

David Bailey, President & CEO of OrthoPediatrics, expressed optimism about this milestone, highlighting the opportunity to leverage their existing expertise to improve clinical care and operational efficiency in the ENT realm. This strategic partnership forms part of their Enabling Technologies division's mission to address unmet pediatric needs with cutting-edge, digital health technologies, aligning with the company’s long-term vision to expand its offerings while maintaining a sustainable business model characterized by diverse revenue streams.

Cincinnati Children’s Hospital has become the first dedicated pediatric center to adopt the iotaSOFT system, joining a network of over 35 prestigious cochlear implant centers nationwide, including nearly half of U.S. neurotology fellowship training programs. Dr. Daniel Choo of Cincinnati Children’s emphasized the importance of robotic-assisted cochlear implantation, which represents a significant evolution in their cochlear implant services.

Founded in 2006, OrthoPediatrics has established itself as a leading provider in pediatric orthopedics, offering a comprehensive range of over 85 products focused on trauma, deformity, scoliosis, and sports medicine. The company’s global sales efforts target pediatric orthopedics across the United States and in over 75 international markets, reinforcing its commitment to improving the lives of children worldwide.

MWN-AI** Analysis

OrthoPediatrics Corp. (NASDAQ: KIDS) has recently unveiled a significant growth opportunity following the FDA's clearance of the iotaSOFT® Insertion System for pediatric use, allowing robotic-assisted cochlear implantation for children aged four and older. This development positions OrthoPediatrics strategically within the expansive market of pediatric healthcare technology, particularly in the field of otolaryngology.

By partnering with iotaMotion, OrthoPediatrics is leveraging its expertise in pediatric orthopedics to address critical unmet needs in pediatric ENT care. The iotaSOFT system's ability to reduce surgical variability and enhance the precision of cochlear implant surgeries could lead to better patient outcomes, potentially expanding its adoption across leading pediatric medical centers. The early adoption by Cincinnati Children’s Hospital marks a promising start, potentially paving the way for broader market acceptance across the United States and internationally.

Investors should take note of the strategic implications of this expansion. By diversifying its offerings beyond orthopedic solutions, OrthoPediatrics is embracing a capital-light business model that emphasizes innovation while maintaining a focus on synergistic growth. The company aims to deepen its impact in the pediatric care continuum, which could lead to diversified revenue streams and sustained profitability.

Given the company’s focus on improving clinical care through technology, the expected growth in the pediatric cochlear implant market represents a compelling opportunity for long-term investment. Analysts may want to monitor the adoption rate of the iotaSOFT system among other hospitals, as well as its impact on OrthoPediatrics’ financials.

In summary, OrthoPediatrics’ strategic move into robotic-assisted ENT solutions is expected to enhance its market position. Investors should consider the long-term potential and evaluate entry points, mindful of sector developments and performance against industry benchmarks.

**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.

Source: GlobeNewswire

WARSAW, Ind., Feb. 03, 2026 (GLOBE NEWSWIRE) -- OrthoPediatrics Corp. (“OrthoPediatrics” or the “Company”) (Nasdaq: KIDS), a company focused exclusively on advancing the field of pediatric orthopedics, today announced its partner, iotaMotion, has received FDA 510(k) clearance for expanded pediatric use of its iotaSOFT® Insertion System. The system is now cleared for use in patients four years of age and older, extending access to robotic-assisted cochlear implantation for school-aged children.

OrthoPediatrics has an existing partnership with iotaMotion to bring its robotic-assisted insertion system, designed to enhance the cochlear implant surgery, to pediatric providers, caregivers, and patients. The iotaSOFT system is the first and only FDA authorized open platform robotic-assisted technology that aims to decrease surgical variability by controlling the speed and consistency of a cochlear implant electrode array insertion. The device is now indicated for children four years and older.

“This milestone allows us to leverage our existing capabilities and bring the same discipline, focus, and pediatric-first expertise beyond orthopedics. We are excited to extend our ability to help more children through improved clinical care and efficiency in the ENT space with an advanced technology like iotaSOFT,” commented David Bailey, President & CEO of OrthoPediatrics. “This partnership is a perfect strategic fit for our Enabling Technologies division where we are applying our core mission of addressing unmet pediatric needs with cutting edge digital health and advanced technology solutions. This approach supports our long-term vision to thoughtfully expand into adjacent areas of the pediatric care continuum, deepening our impact for patients, providers, and caregivers while maintaining a capital-light, cash-friendly business model supported by diverse revenue streams.”

As part of this milestone, Cincinnati Children’s Hospital, a nationally ranked pediatric medical center, has become the first dedicated pediatric center to adopt the iotaSOFT Insertion System. Cincinnati Children’s joins over 35 leading cochlear implant centers across the United States, including nearly half of U.S. neurotology fellowship training programs, that have adopted this innovative technology.

"At Cincinnati Children's, our focus is delivering the highest standard of care while thoughtfully integrating innovations that benefit our patients," said Dr. Daniel Choo, chief clinical growth officer and professor of otolaryngology–head and neck surgery. "Robotic-assisted cochlear implantation represents a meaningful advancement in our cochlear implant program."

About OrthoPediatrics Corp.
Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on advancing the field of pediatric orthopedics. As such, it has developed the most comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets over 85 products that serve three of the largest categories within the pediatric orthopedic market. This product offering spans trauma and deformity, scoliosis, and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and over 75 countries outside the United States. For more information, please visit www.orthopediatrics.com. For more information about the OrthoPediatrics Specialty Bracing portfolio, please visit www.opsb.com.

About iotaMotion
iotaMotion, Inc. is a medical technology company based in St. Paul, Minnesota, dedicated to advancing cochlear implant surgery beyond human capability through robotic-assisted solutions. Its flagship technology, the iotaSOFT® Insertion System, is designed to preserve delicate intracochlear structures through slow and consistent electrode array insertion. The system is commercially available in the United States and under clinical investigation in other global markets.

For more information, visit http://www.iotamotion.com/ and follow us on LinkedInXFacebookYouTube.

Investor Contact
Philip Trip Taylor
Gilmartin Group
[email protected]
415-937-5406


FAQ**

How does the expansion of the iotaSOFT® Insertion System for OrthoPediatrics Corp. KIDS impact the company's long-term growth strategy and its position in the pediatric healthcare market?

The expansion of the iotaSOFT® Insertion System enhances OrthoPediatrics Corp.'s product offerings, strengthens its market position in pediatric healthcare, and supports its long-term growth strategy by addressing unmet needs in pediatric orthopedic surgery.

What measures is OrthoPediatrics Corp. KIDS taking to ensure the successful adoption of the iotaSOFT technology at leading pediatric centers like Cincinnati Children's Hospital?

OrthoPediatrics Corp. is facilitating the successful adoption of iotaSOFT technology at leading pediatric centers like Cincinnati Children's Hospital through comprehensive training programs, educational initiatives, and collaborations with key opinion leaders in pediatric orthopedics.

Can you elaborate on how the FDA clearance for the iotaSOFT system enhances OrthoPediatrics Corp. KIDS' competitive edge in the robotic-assisted surgical technology space?

The FDA clearance for the iotaSOFT system positions OrthoPediatrics Corp. (KIDS) as a leader in robotic-assisted surgical technology by validating its innovative approach, enhancing market credibility, and potentially increasing adoption among healthcare providers, ultimately driving revenue growth.

How does OrthoPediatrics Corp. KIDS plan to leverage its partnership with iotaMotion to address unmet needs in pediatric cochlear implantation and expand its product offerings?

OrthoPediatrics Corp. (KIDS) plans to leverage its partnership with iotaMotion to enhance pediatric cochlear implantation solutions and broaden its product offerings by integrating advanced technology and innovative solutions to meet the specific needs of pediatric patients.

**MWN-AI FAQ is based on asking OpenAI questions about OrthoPediatrics Corp. (NASDAQ: KIDS).

OrthoPediatrics Corp.

NASDAQ: KIDS

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February 26, 2026 04:31:07 am
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