OrthoPediatrics Announces Expanded Enabling Technology Market Opportunity

Rhea-AI Summary

OrthoPediatrics (Nasdaq: KIDS) announced that partner iotaMotion received FDA 510(k) clearance to expand use of the iotaSOFT® cochlear implant insertion system to patients four years and older on Feb. 3, 2026. The clearance extends access to robotic-assisted cochlear implantation for school-aged children.

Cincinnati Children’s Hospital is the first dedicated pediatric center to adopt iotaSOFT, joining over 35 U.S. cochlear implant centers and many neurotology fellowship programs that have adopted the technology. OrthoPediatrics positions this as strategic growth for its Enabling Technologies division to expand beyond orthopedics while remaining capital-light.

Positive

• FDA 510(k) clearance expanding iotaSOFT use to patients age 4+
• Adoption by Cincinnati Children’s Hospital as first dedicated pediatric center
• 35+ U.S. cochlear implant centers already using iotaSOFT
• Positions OrthoPediatrics’ Enabling Technologies division to expand beyond orthopedics

Negative

• None.

Key Figures

Pediatric indication age: 4 years and older Pediatric indication age (stated): four years of age and older Adopting centers: over 35 cochlear implant centers +1 more

4 metrics

Pediatric indication age 4 years and older FDA 510(k) clearance for iotaSOFT insertion system

Pediatric indication age (stated) four years of age and older Device indication language in clearance

Adopting centers over 35 cochlear implant centers U.S. centers that have adopted iotaSOFT system

Training programs penetration nearly half of U.S. neurotology fellowship programs Fellowship programs using iotaSOFT technology

Market Reality Check

Price: $16.97 Vol: Volume 106,715 is 0.65x t...

low vol

$16.97 Last Close

Volume Volume 106,715 is 0.65x the 20-day average of 164,441, indicating lighter trading ahead of this news. low

Technical Shares at 17.29 are trading below the 200-day MA of 19.56, reflecting a prior downtrend.

Peers on Argus

While KIDS was down 0.97%, key peers showed mixed moves: TMCI -3.42%, ZIMV flat,...

While KIDS was down 0.97%, key peers showed mixed moves: TMCI -3.42%, ZIMV flat, and others like BVS, CTKB, and LAB up between 1.44% and 3.79%, pointing to a stock-specific setup rather than a uniform sector trend.

Historical Context

5 past events · Latest: Jan 12 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 12	Prelim FY25 results	Positive	+9.8%	Record preliminary 2025 revenue, strong growth and 2026 guidance update.
Nov 13	Product portfolio expansion	Positive	-0.4%	Launch of two new PediHip bracing products for pediatric hip care.
Nov 04	Investor conferences	Neutral	-1.3%	Participation in multiple healthcare investor conferences and webcasts.
Oct 28	Q3 2025 earnings	Positive	-0.3%	Q3 revenue and EBITDA growth with improved free cash flow usage.
Oct 28	FDA device approval	Positive	-0.3%	FDA approval for 3P Pediatric Plating Platform Small-Mini System.

Pattern Detected

Recent history shows several positive operating or FDA updates where the stock reaction was flat to negative, with only the strong preliminary 2025 revenue and guidance update drawing a clearly positive move.

Recent Company History

Over the last few months, OrthoPediatrics reported record preliminary 2025 net revenue of $236.1M with 15% growth and issued 2026 revenue guidance of $262M–$266M, which coincided with a 9.83% gain. The company also expanded its specialty bracing portfolio, reported Q3 2025 results with $61.2M revenue and improved adjusted EBITDA of $6.2M, and secured its 6th FDA approval of 2025. Many of these positive operational updates saw muted or slightly negative price reactions, framing today’s enabling-technology news within a pattern of cautious trading.

Market Pulse Summary

This announcement highlights expansion of OrthoPediatrics’ enabling technologies through FDA 510(k) ...

Analysis

This announcement highlights expansion of OrthoPediatrics’ enabling technologies through FDA 510(k) clearance for iotaSOFT in children four years and older, and early adoption by more than 35 centers and a major pediatric hospital. It extends the company’s reach beyond core orthopedics into ENT-focused care. Investors may watch future disclosures for utilization trends, revenue contribution from this partnership, and how it complements prior growth and FDA approvals.

Key Terms

510(k) clearance, cochlear implant

2 terms

510(k) clearance regulatory

"iotaMotion, has received FDA 510(k) clearance for expanded pediatric use"

A 510(k) clearance is a U.S. regulatory approval that lets a medical device be sold because it is shown to be substantially similar to an already-legal device; think of it as a passport saying the new product is close enough to a known item to enter the market without a full, lengthy review. For investors, 510(k) clearance signals faster, lower-cost market access and reduced regulatory risk compared with new, untested device pathways, which can materially affect timelines, costs and revenue prospects.

cochlear implant medical

"robotic-assisted cochlear implantation for school-aged children"

A cochlear implant is a surgically implanted medical device that converts sound into electrical signals and stimulates the inner ear to provide a sense of hearing for people with severe hearing loss, working like a tiny radio and wiring that bypasses damaged parts of the ear. Investors track cochlear implants because they involve durable hardware, ongoing service and upgrades, regulatory approvals, reimbursement rules and surgical volumes—factors that drive revenue, margins and long-term market growth.

AI-generated analysis. Not financial advice.

OrthoPediatrics partner iotaMotion receives FDA clearance for use of its iotaSOFT® cochlear implant insertion system in patients four years and older

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 LinkedIn, X, Facebook, YouTube.

Investor Contact
Philip Trip Taylor
Gilmartin Group
philip@gilmartinir.com
415-937-5406

FAQ

What did OrthoPediatrics (KIDS) announce about iotaSOFT on February 3, 2026?

OrthoPediatrics announced that partner iotaMotion received FDA 510(k) clearance to use iotaSOFT in patients age four and older. According to the company, this extends robotic-assisted cochlear implant access to school-aged children and supports its Enabling Technologies growth.

How does the FDA clearance for iotaSOFT affect pediatric cochlear implantation for children age 4 and up?

The clearance allows the iotaSOFT system to be used in children four years and older, increasing clinical access. According to the company, this enables robotic-assisted insertions aimed at reducing surgical variability and improving consistency in pediatric ENT care.

Which pediatric center first adopted iotaSOFT following the expanded clearance announced by KIDS?

Cincinnati Children’s Hospital became the first dedicated pediatric center to adopt the iotaSOFT system after the expanded clearance. According to the company, the center joins over 35 U.S. cochlear implant centers already using the technology.

What is unique about the iotaSOFT insertion system highlighted by OrthoPediatrics (KIDS)?

iotaSOFT is described as the first and only FDA-authorized open platform robotic-assisted insertion system for cochlear implants. According to the company, it aims to control insertion speed and consistency to decrease surgical variability.

What strategic role does the iotaSOFT partnership play for OrthoPediatrics’ Enabling Technologies division?

The partnership supports OrthoPediatrics’ strategy to expand beyond orthopedics with a capital-light model and diverse revenue streams. According to the company, it applies pediatric-first expertise to adjacent digital health and advanced technology solutions.