NEW YORK, Sept. 17, 2026 (GLOBE NEWSWIRE) — Emanate Biomedical, Inc., a medical technology company creating a new category of clinician-directed at-home oral care, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for Perio PODS™, a periodontal wound dressing consisting of single-use, patient-matched dental trays preloaded with engineered hydrogel.

The device is intended to protect injured periodontal tissue following planned non-surgical periodontal procedures by forming a temporary physical barrier to avoid further irritation. Approximately 31 million non-surgical periodontal procedures, including scaling and root planing and periodontal maintenance, are performed annually in the United States to treat periodontitis, yet there has been no FDA-cleared at-home periodontal wound dressing indicated to protect injured tissue following these procedures during the critical healing phase.

“Non-surgical periodontal procedures treat periodontitis, a chronic disease, but create an acute wound – the healing of which is essential to a successful outcome,” said Jarret Fass, Co-Founder and CEO of Emanate. “Yet while wound care is fundamental across medicine, dentistry has historically lacked a purpose-built solution to protect treated tissues at home during the critical healing phase. FDA clearance of Perio PODS represents an important milestone toward addressing this longstanding treatment gap and establishing a new paradigm in periodontal care.”

In a separate 45-patient investigational randomized controlled trial conducted at the ADA Forsyth Institute, a globally recognized oral health research institution, use of Perio PODS under a study-specific treatment regimen was associated with significantly greater reductions in periodontal pocket depth and multiple markers of gingival inflammation compared with periodontal debridement alone. Results from the study were selected for oral presentation at the 2026 IADR General Session.

“The results were encouraging across both clinical measures and inflammatory biomarkers,” said Hatice Hasturk, DDS, PhD, Principal Investigator and Director of the Center for Clinical and Translational Research at ADA Forsyth Institute. “These findings highlight the promise of Perio PODS and its potential to meaningfully advance how we support periodontal healing following treatment.” A larger multicenter randomized controlled trial evaluating Perio PODS is underway through the McGuire Institute, a leading national private-practice periodontal clinical research network.

Emanate has also assembled a Clinical Leadership Council comprising internationally recognized researchers and clinical leaders across periodontology and dentistry, including Dr. Panos Papapanou, Dr. Georgios Kotsakis, Dr. Robert Mongrain, Dr. Curry Leavitt and Dr. Jason Stoner. “For decades, periodontists have had limited ability to protect treated periodontal tissues during the critical healing period after a patient leaves the office,” said Dr. Jason Stoner, a nationally recognized periodontist and clinical leader. “Perio PODS gives us a practical way to address that gap and fits naturally into existing periodontal treatment workflows.”

Emanate is advancing manufacturing scale-up and commercial infrastructure in preparation for a phased U.S. launch of Perio PODS in 2027. Leading periodontal and general dental practices across the U.S. have joined the company’s growing Launch Partner Program. The company has raised $11 million to date from Pierpoint Capital.

About Perio PODS

Perio PODS is a patient-matched periodontal wound dressing consisting of single-use dental trays preloaded with engineered hydrogel. The hydrogel is a water-based polymer matrix containing chlorhexidine digluconate as a preservative and specifically formulated for use within the Perio PODS system. Perio PODS is prescribed by a dental professional for at-home use twice daily for 30 minutes for up to 15 days following a planned non-surgical periodontal procedure. Each patient’s Perio PODS are custom manufactured by Emanate using a digital impression captured by the dental practice and supplied to the practice for administration immediately following the procedure and subsequent at-home use. Perio PODS is the commercial name for Emanate Tray, which received FDA 510(k) clearance in 2026.

About Emanate

Emanate is a medical technology company creating a new category of clinician-directed at-home oral care. The company’s patent-protected PODS™ technology is a configurable platform combining patient-matched, single-use dental trays with preloaded engineered hydrogel for applications across oral diseases and wounds. Perio PODS, the first product built on the platform, is an FDA-cleared periodontal wound dressing designed to protect injured periodontal tissue following non-surgical periodontal procedures. Emanate plans to address the most consequential unmet needs in oral health. Founded in 2019 by Dr. Peter Zegarelli, a dentist with more than 40 years of clinical experience, together with a team of experienced MedTech entrepreneurs and operators, Emanate is headquartered in New York City, with R&D and manufacturing operations in Redwood City, California.

For more information, visit emanatebiomedical.com.

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Contact: Bob Geller

Email: bob@bobgellercomms.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/1c691b06-a3f4-44f6-a3b3-3e7289890bf0


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Emanate Biomedical Inc.