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Served as Chief FDA Counsel for Revlon and Johnson & Johnson, as a Board Member at Johnson & Johnson Development Corporation, that company’s strategic venture capital division, and as patent attorney for Schering Plough Pharmacist, FDA regulatory attorney, and patent attorney with 40+ years of professional service and 25+ years of experience in the pharmaceutical industry and investment community
Rosh Pina, Israel, Sept. 13, 2023 (GLOBE NEWSWIRE) — IR-MED Inc., (“IR-MED” or the “Company”) (OTCQB:IRME), a developer of a noninvasive AI-driven spectrographic analysis technology platform to address significant healthcare needs, announced today the appointment of Richard Serbin, Esq. to its Advisory Board as the Company prepares to file for regulatory listing of its PressureSafe™ device with the U.S. Food & Drug Administration (FDA) with the intent of a subsequent market launch in the U.S.
Mr. Serbin was the Chief FDA Counsel for Revlon Corporation and Johnson & Johnson Corporation. He held senior management roles at Johnson & Johnson and served on the Board of Directors of numerous Johnson & Johnson subsidiary companies including Ethicon, Ortho, Johnson & Johnson Consumer Products, Pittman-Moore, McNeil and Johnson & Johnson Development Corporation, that company’s strategic venture capital division.
His broader experience includes serving on the boards of numerous other companies involved in biotechnology, dermatology, veterinary medicine, female healthcare, medical devices, photodynamic therapy, surgical and consumer products. For more than a decade, Mr. Serbin has served as a Senior Advisor to the Swedish American Life Science Summit (SALSS), the leading invitation healthcare summit, held annually in Stockholm, Sweden. Currently, he is Managing Director of Platform Health Ventures, a healthcare strategic and tactical consulting group. He formerly served as Chief Operating Officer of the Gorlin Companies and he served as President of Bradley Pharmaceuticals.
He has a Bachelor of Science and a Bachelor of Pharmacy from Rutgers University and Rutgers University College of Pharmacy, a J.D. degree from Seton Hall Law School, and a Master’s Degree in Trade Regulations and Law from New York University Law School.
Mr. Serbin commented, “IR-MED’s platform technology has tremendous potential in multiple market applications, and its near-term opportunity to transform the way pressure injuries are detected, prevented, and treated, can have a significant impact in improving treatment outcomes, reducing morbidity, and cost savings for healthcare payers. I’m pleased to join the company’s Advisory Board and contribute to its momentum toward bringing innovative, cost-effective, noninvasive solutions to market.”
“We welcome Richard to our Advisory Board. His deep expertise in FDA regulatory matters, patent counsel, business development, and product launch with companies ranging from tech startups to Johnson & Johnson will be a valuable asset, as IR-MED is poised to launch PressureSafe,” commented IR-MED’s Chairman and Interim CEO Oded Bashan.
IR-MED Inc., is developing a noninvasive spectrographic analysis technology platform, allowing healthcare professions to detect, measure and monitor, in real time, different molecules in the blood, in human tissue, and in body fluids without invasive procedures. PressureSafe, the first product under development, is a handheld optical monitoring device that is being developed to support early detection of pressure injuries (PI) to the skin and underlying tissue, regardless of skin tone as it calibrates personally to each patient’s skin.
IR-MED’s technology is being developed to allow accurate readings of biomarkers in a non-invasive method, that may provide caregiver the optimal decision support-system in cases where uncertainties disturb physicians in their decision processes.
IR-MED holds patents protecting its technology and innovations in the noninvasive tissue analysis, and in the modeling and analysis of subcutaneous tissue.
PressureSafe is currently undergoing usability studies at multiple medical centers. It is not yet available for commercial use.
Safe Harbor Statement / Forward-Looking Statements
Statements included in this press release, which are not historical in nature, are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. For example, IR-Med is using forward looking statements when it discusses the timing of the FDA submission and potential market launch, and the potential benefits of its products. Statements relating to the future performance of IR-Med are subject to many factors including, but not limited to, the sufficiency or working capital and our ability to raise the capital needed to fund our development efforts, completion of the development and design of PressureSafe device, results of clinical/useability studies and trials, timing of product development, FDA approval/clearance of products in development, customer acceptance of our products in the market, the introduction of competitive products, the impact of any product liability or other adverse litigation, commercialization and technological difficulties, and the other risks identified in its most recent annual report on Form 10-K filed on March 29, 2023, and the amended annual report on Form 10-K/A filed on May 11, 2023, with the Securities and Exchange Commission. Such statements are based upon the current beliefs and expectations of management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof, and we do not undertake any obligation to update any forward-looking statements, whether as a result of future events, new information, or otherwise.
Sharon Levkoviz, Chief Financial Officer
Tel: +972 (0) 4 6555054