Immucise™ Intradermal Injection System

References

^{1. Intradermal Delivery of Vaccines, A review of the literature and the potential for development for use in low- and middle-income countries, August 27, 2009}

^{2. Internal Company data}

^{3. Shimizu, Sakiko et al. “Performance and usability evaluation of novel intradermal injection device Immucise™ and reanalysis of intradermal administration trials of influenza vaccine for the elderly.” Vaccine vol. 40,6 (2022): 873-879}

^{4. Traditional 510(k) – Immucise Intradermal Injection System Section 11: Device Description}

Public Studies

^{1. Sakiko Shimizu, Ryo Tanaka, Eriko Itoh, Minami Maekawa-Matsuura, Yoichiro Iwase, Performance and usability evaluation of novel intradermal injection device Immucise™ and reanalysis of intradermal administration trials of influenza vaccine for the elderly, Vaccine, Volume 40, Issue 6, 7 February 2022, Pages 873-879 https://www.sciencedirect.com/science/article/pii/S0264410X21016698?via%3Dihub_}

^{2. Ryo Arakane, Hitomi Nakatani, Emi Fujisaki, Akiko Takahama, Katsuyasu Ishida, Michiharu Yoshiike, Tetsuo Nakayama, Fumih iko Takeshita, Immunogenicity and safety of the new intradermal influenza vaccine in adults and elderly: A randomized phase 1/2 clinical trial, Vaccine, Volume 33, Issue 46, 17 November 2015, Pages 6340-6350, https://www.sciencedirect.com/science/article/pii/S0264410X15012566?via%3Dihub}

Disclosures

^{This intradermal injection system is manufactured for clinical trials and/or studies of specific pharmaceutical and/or medicinal products only. Its specifications and/or images may be changed without notice, even if the device has been approved and/or registered in specific countries and/or regions. Notwithstanding any existing approval or registration, this device may not be available in all geographic regions. For further detail please refer to instruction for use or check with contact person in Terumo Corporation.}

^{The contents herein may contain information which is protected by intellectual property rights owned by Terumo Corporation. Any use of the information contained herein (including, but not limited to, total or partial reproduction, communication or distribution in any form) by entities other than the designated entities is prohibited.}

^{Terumo Corporation}

^{Terumo Medical Care Solutions – Pharmaceutical}

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