iTolerance, Inc. Appoints Sandra Cohen Kalter to Strategic Advisory Group

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Legal & regulatory executive with extensive expertise in FDA law and regulatory leadership for one of the world's leading medical device companies

MIAMI, FL / ACCESS Newswire / September 22, 2025 / iTolerance, Inc. ("iTolerance" or the "Company"), an early-stage privately-held biotechnology company focused on the development of innovative regenerative medicines, today announced the appointment of Sandra Cohen Kalter to its Strategic Advisory Group.

"This appointment represents another step toward bolstering our ability to navigate complex regulatory pathways, potentially accelerate clinical translation and unlock the full potential of our pipeline. Our Strategic Advisory Group was formed to provide strategic guidance from individuals with a diverse background of expertise to support our initiatives, and Sandra is a wonderful addition that provides valuable insight and expertise. Over the course of her career, Sandra has navigated a number of regulatory pathways, inspections and integrations which have provided her with a depth and breadth of expertise that we believe will be instrumental as we move our development plans forward," commented Anthony Japour, Chief Executive Officer of iTolerance.

Mrs. Kalter added, "I am pleased to serve in this capacity for iTolerance and leverage my knowledge and experience from my career to help advance this important technology forward. iTolerance's platform technology, which has the potential to eliminate the need for life-long immunosuppression, continues to demonstrate promise, and I look forward to bolstering the Company's efforts to provide patients with a treatment option where there remains significant unmet need."

Sandra Cohen Kalter is a seasoned senior legal executive most recently serving as Vice President & Chief Regulatory Counsel at Medtronic plc ("Medtronic"), overseeing global strategies in regulatory compliance, quality, clinical affairs and medical safety for a world-renowned medical-device leader. She has led transformative enterprise-wide initiatives, including a patient safety and quality program that delivered major reductions in FDA findings and field corrective actions.

Additional career highlights include:

• Built and managed an in-house FDA legal team that navigated 17 regulatory inspections in a single year, ensuring product continuity

• Guided due diligence and integration efforts for more than 27 acquisitions, led regulatory responses to FDA violations and high-profile media scrutiny, and helped steer approval strategies for groundbreaking devices like the Evolut TAVR system and Micra leadless pacemaker

• Previously served as FDA/Health Care Counsel at King & Spalding LLP, where she advised on complex regulatory filings and FDA panel proceedings

• Received several awards including: Service to FDLI Award, Food and Drug Law Institute, 2023; Rapaport Lifetime Achievement Award, Juvenile Diabetes Research Foundation, 2019; Medtronic Wallin Leadership Award, June 2010; Marketing Campaign Team Award, Spinal & Biologics "Just the Facts," 2010; Medtronic Star of Excellence Award, 2009

• Member of AdvaMed (Advanced Medical Technology Association) Legal Committee and Business Case for Quality Working Group

• Co-Chair of AdvaMed Advertising and Promotion Working Group , Off-Label Working Group, and Business Case for Quality Working Group

• Board of Directors of Food and Drug Law Institute (FDLI)

• Board of Directors of Juvenile Diabetes Research Foundation (JDRF) and Corporate Recruitment Chair of JDFR One Walk

• Member of Food and Drug Law Institute Medical Devices Advisory Committee

Mrs. Kalter attended George Washington University, The National Law Center and received a Juris Doctor Degree and a Bachelor of Science in Journalism from Northwestern University.

About iTolerance, Inc.

iTolerance is a regenerative medicine company developing technologies to enable tissue, organoid or cell therapy without requiring life-long immunosuppression. Leveraging its proprietary biotechnology-derived Streptavidin-FasL fusion protein/biotin-PEG microgel (SA-FasL microgel) platform technology, iTOL-100, iTolerance is advancing a pipeline of programs using both allogenic cadaveric and stem cell-derived pancreatic islets to potentially cure Type 1 diabetes. Utilizing iTOL-100 to induce local immune tolerance, the Company is developing its lead indication as a potential cure for Type 1 Diabetes without the need for life-long immunosuppression. Additionally, the Company is developing iTOL-201 for treating liver failure by utilizing hepatocytes and iTOL-401 as a nanoparticle formulation for large organ transplants without the need for life-long immunosuppression. For more information, please visit itolerance.com.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of the "safe-harbor" provisions of the Private Securities Litigation Reform Act of 1995. When used herein, words such as "anticipate", "being", "will", "plan", "may", "continue", and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking.

All forward-looking statements are based upon the Company's current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, anticipated levels of revenues, future national or regional economic and competitive conditions, and difficulties in developing the Company's platform technology. Consequently, forward-looking statements should be regarded solely as the Company's current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. The Company cannot guarantee future results, events, levels of activity, performance or achievements. The Company does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.

Investor Contact

Jenene Thomas

Chief Executive Officer

JTC Team, LLC

T: 908.824.0775

[email protected]

Media Contact

Susan Roberts

T:202.779.0929

[email protected]

SOURCE: iTolerance, Inc.