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For Imediate release

IsoGuardian Completes Milestone Pilot Study

Clinical Evaluation at Albany Medical Center ] Demonstrates Procurement-Ready Performance for Hospitals 

Media Contact

Sara Rudin
Founder & CEO, IsoGuardian, Inc.
Albany, NY
info@isoguardian.com
www.isoguardian.com

ALBANY, N.Y. — February 28, 2026

IsoGuardian, Inc., a medical device company based in Albany, New York, announced the completion of a clinical pilot study at Albany Medical Center evaluating its FDA-registered reusable Level 2 isolation gown. Conducted across inpatient and procedural outpatient units, the study found strong positive results and marks a formal institutional validation milestone for the company, signaling institutional readiness.


  

Pilot was facilitated in conjunction with Albany Medical College’s Office of Translational Research, Innovation, and Technology Transfer (OTR) with 3rd party principal investigators. Evaluations took place over the course of 2 weeks in 4 departments in Albany Medical Center. A total of 116 daily surveys and 41 end-of-week surveys were collected from participating clinicians.


Left: Stephanie Dosiek and Sara Rudin
Photo courtesy of Albany Medical Center.

Results

Photo courtesy of Albany Medical Center.

Daily survey responses indicated:

  • Protective  —   95% positive
  • Easy to use —  91% positive
  • Comfortable — 85% positive


Clinicians described the gown as “comfortable/stylish/high quality,” noted that it “feels more protective,” and highlighted its “fully encompassing” coverage compared to standard gowns.


Albany Med Health System’s release of results can be found at: https://www.albanymed.org/news/pilot-study-tests-isolation-gowns-in-collaboration-with-colleges-business-incubator/The article further noted that “conversations are ongoing about the potential use of the gowns on a larger scale at Albany Medical Center.”

Innovation Support

  

IsoGuardian’s progress reflects active collaboration across Albany’s innovation ecosystem. The company is supported through a joint incubation initiative with the Albany Med  (OTR) and STEAM Garden. OTR is assisting with medical market entry strategy, including coordination and execution of the Albany Med pilot study, while STEAM Garden has provided operational space and funding support, including IsoGuardian’s FDA registration activities. Funding for the pilot was provided through an award from FuzeHub’s Commercialization Competition, a highly competitive, statewide competition recognizing emerging technologies with strong commercial potential. 


“This milestone represents the completion of formal clinical validation in a real hospital environment,” said Sara Rudin, Founder of IsoGuardian. “The strength of results provided meaningful confirmation and proved our product claims of safety, usability, and comfort.”


Independent laboratory testing demonstrated significant improvements in tear strength, hydrostatic pressure resistance, and breathability compared to standard gowns. The IsoGuardian gown is engineered for 300 industrial wash cycles, supporting durability and cost efficiency in clinical settings.


IsoGuardian has secured regulatory compliance, strong and scalable supply partners capable of providing 7M gowns a month, and with pilot validation complete IsoGuardian’s next step is securing bridge funding for operational readiness as the company prepares for broader institutional engagement.

Downloads

IsoGuardian Pilot press release 03 03 2026 (docx)Download
PPC_6654 (JPG)Download
PPC_6674 (JPG)Download

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