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TransEnterix Announces Broad Reimbursement Approval in Japan for Senhance Digital Laparoscopy System

2019年08月01日 PM08:41
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RESEARCH TRIANGLE PARK, N.C.

TransEnterix, Inc. (NYSE American: TRXC), a medical device company that is pioneering the use of robotics to improve minimally invasive surgery, today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) expert review panel provided reimbursement for procedures performed with the Senhance Surgical System.

The reimbursement, which became effective on July 31, 2019, applies to 98 benign and malignant laparoscopic procedures across general, colorectal, gynecologic, bariatric and urologic surgeries at reimbursement rates equivalent to traditional laparoscopy in Category A1. The Senhance received regulatory approval from the Japanese MHLW on May 22, 2019.

“We are extremely pleased to have obtained reimbursement in Japan, which represents another critical milestone as we work to drive adoption of the Senhance globally,” said Todd M. Pope, TranEnterix President and CEO. “We view Japan as a significant opportunity as it is the world’s second-largest surgical robotics market, and we will continue to work to put our commercial infrastructure in place to support a successful commercial launch.”

Japan is the second-largest medical device market in the world, valued at over $40 billion annually, including over $5 billion in capital equipment spending. There are more than 8,400 hospitals in Japan, of which approximately 80% are private entities. Japanese laparoscopic penetration in surgery is among the highest in the world. The central government has implemented cost containment initiatives in recent years and has approached recent procedure approvals for robotics by establishing reimbursement at the same rate as traditional laparoscopy, which places a high emphasis on procedure cost to influence adoption.

About TransEnterix

TransEnterix is a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options in today’s value-based healthcare environment. The Company is focused on the commercialization of the Senhance Surgical System, which digitizes laparoscopic minimally invasive surgery. The system allows for robotic precision, haptic feedback, surgeon camera control via eye sensing and improved ergonomics while offering responsible economics. The Senhance Surgical System is available for sale in the US, the EU and select other countries. For more information, visit www.transenterix.com.

Forward-Looking Statements

This press release includes statements relating to the current regulatory and commercialization plans for the Senhance Surgical System. These statements and other statements regarding our future plans and goals constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations and include whether obtaining reimbursement for procedures performed in Japan with the Senhance Surgical System will create a considerable market opportunity and whether our commercial infrastructure will be able to support a successful commercial launch in Japan . For a discussion of the risks and uncertainties associated with TransEnterix’s business, please review our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K for the year ended December 31, 2018, filed with the SEC on February 27, 2019 and our other filings we make with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which are based on our expectations as of the date of this press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20190801005529/en/

CONTACT

For TransEnterix, Inc.

Investors:

Mark Klausner, +1 443-213-0501

invest@transenterix.com

or

Media:

Joanna Rice, +1 951-751-1858

joanna@greymattermarketing.com

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