MDoloris Medical Systems Announces the Regulatory Clearance and the Upcoming Launch of its Analgesia Nociception Index Platform in Japan with Heiwa Bussan

Rhea-AI Summary

MDoloris Medical Systems has received regulatory clearance and marketing approval for its HFVI MOC-9 monitor in Japan. This innovation is the first of its kind for monitoring patients under analgosedation and anesthesia in Japan, integrating with Masimo's Root patient monitoring hub. The HFVI MOC-9 improves assessment of parasympathetic activity during surgeries, enhancing postoperative outcomes and reducing opioid use. Heiwa Bussan will exclusively market this technology in Japan, indicating strong sales potential in a significant market.

Positive

• Regulatory clearance and marketing approval for HFVI MOC-9 in Japan.
• First monitoring solution for analgosedation and anesthesia in Japan.
• Potential to improve postoperative outcomes and reduce opioid use.
• Exclusive partnership with Heiwa Bussan enhances sales potential.

Negative

• None.

PARIS--(BUSINESS WIRE)-- MDoloris Medical Systems, a leader in the field of objective pain monitoring during anesthesia, announces today the regulatory clearance and marketing approval of its HFVI MOC-9, High Frequency Variability Index monitor, in Japan. MDoloris’ HFVI MOC-9 Technology is the first monitoring solution for patients going through analgosedation and anesthesia in Japan.

The HFVI MOC-9 is a solution developed by MDoloris for Masimo (NASDAQ: MASI) for integration into its Root patient monitoring and connectivity hub, making it a full brain monitoring system. HFVI is a parameter obtained from the Heart Rate Variability, which is the same as ANI, Analgesia Nociception Index, being popular in Europe, that helps clinicians to assess the parasympathetic activity of patients undergoing surgery or intensive care in Japan.

“We are thrilled to become the exclusive business partner of Mdoloris in Japan. The Japanese clinicians are extremely interested in the innovative and unique technology of Mdoloris which addresses the last unmet need of general anesthesia.　We expect this technology will bring obvious clinical benefits and cost-effective outcomes. Heiwa Bussan has just become the only Japanese company being able to answer this need in the real world. Thereafter, we are extremely excited by the sales potential of such an innovative product”, declares Shinichi Hasuda, Representative Director of Heiwa Bussan.

“We are excited by this additional major milestone successfully passed by MDoloris in 2021 in Asia Pacific after the obtention of reimbursement and successful sales launch in South Korea, despite the pandemic impact. Thanks to the fantastic job performed with Heiwa Bussan, the exclusive business partner for both Masimo and MDoloris in Japan, we can look forward to a strong product launch and subsequent growth in one of the largest markets for our solutions.” declares Fabien Pagniez CEO and founder of MDoloris Medical System.

Analgesia Nociception Index

ANI is a parameter obtained from the Heart Rate Variability that helps clinicians to assess the Autonomic Nervous System, guiding the clinicians to titrate their analgesics during the surgery and anesthesia. This improves postoperative pain, PONV scores, shivering scores, and reducing post-operative opioids use (1), as well as, hospital stays (2) and may reduce the Montreal scales values (3), a scale used to asses’ post-operative cognitive disorders.

MDoloris Medical Systems

MDoloris Medical Systems, a venture-backed French company, is the first worldwide company to provide clinicians continuous and non-invasive surgical stress monitoring devices. MDoloris is present in more than 70 countries and has benefited more than 300 000 patients.

Heiwa Bussan

Heiwa Bussan, the Japan-based import and sales company of medical devices, has been dealing with state-of-art medical devices mainly for cardiovascular and other surgeries related area since 1964 and expands its business to anesthesia and intensive care fields in Japan.

1. (1) 2017- Henry D. Upton, MBBS, BMedSc (Hons), Guy L. Ludbrook, MBBS, FANZCA, PhD,Andrew Wing, BMBS (Hons), BSci (Hons), FANZCA, and Jamie W. Sleigh, MD Intraoperative“Analgesia Nociception Index”– Guided Fentanyl Administration During Sevoflurane Anesthesia in Lumbar Discectomy and Laminectomy: A Randomized Clinical Trial Anesthesia & Analgesia july 2017 doi: 10.1213/ANE.0000000000001984.
2. 2020-Ramos-Luengo A, Gardeta Pallarés A, Asensio Merino F. Usefulness of ANI (analgesia nociception index) monitoring for outpatient saphenectomy surgery outcomes: an observational study. J Clin Monit Comput. 2020 Feb 28. doi: 10.1007/s10877-020-00491-1.
3. 2021- Yang, Shuyi; Xiao, Wei; Wu, Hao; Liu, Yang; Feng, Shuai;Management Based on Multimodal Brain Monitoring May Improve Functional Connectivity and Post-operative Neurocognition in Elderly Patients Undergoing Spinal Surgery Frontiers in Aging Neuroscience , Volume 13 – Jul 15, 2021 10.3389/fnagi.2021.705287

View source version on businesswire.com: https://www.businesswire.com/news/home/20211125005619/en/

Jean-François Kitten jf@licencek.com 0972334763

Ilinca Spita i.spita@licencek.com 0972334763

Source: MDoloris Medical Systems

FAQ

What is the significance of the HFVI MOC-9 approval for Masimo?

The HFVI MOC-9 monitor's approval in Japan marks a significant milestone for Masimo as it expands its product offerings in a major healthcare market.

How does the HFVI MOC-9 improve patient outcomes?

The HFVI MOC-9 enhances assessment of parasympathetic activity, which can lead to better management of postoperative pain and reduced opioid consumption.

Who is responsible for marketing the HFVI MOC-9 in Japan?

Heiwa Bussan is the exclusive business partner responsible for marketing the HFVI MOC-9 in Japan.

When was the HFVI MOC-9 approved in Japan?

The HFVI MOC-9 received regulatory clearance and marketing approval on November 25, 2021.

What is the potential market impact of the HFVI MOC-9?

The introduction of HFVI MOC-9 in Japan is expected to create strong sales opportunities, addressing a critical need in anesthesia monitoring.