Senseonics Announces Business Updates
January 04 2022 - 4:45PM
Business Wire
Senseonics Holdings, Inc. (NYSE American: SENS), a medical
technology company focused on the development and manufacturing of
long-term, implantable continuous glucose monitoring (CGM) systems
for people with diabetes, today announced operational and financial
business updates.
Operational and Financial Updates
- Substantive review with the FDA for the PMA supplement for the
next generation Eversense 180-day CGM system is nearing completion,
all queries raised have been answered and a decision regarding
approval is expected in the coming weeks
- Designing plans with Ascensia Diabetes Care for a smooth
transition to the 180-day system in the U.S., pending FDA approval,
including:
- Marketing campaigns to highlight the availability of system
upgrade programs for patients and to increase overall patient
awareness
- Payor engagement regarding reimbursement and coverage
transitions These plans are being designed with a goal of
minimizing the impact to patients, providers and sales, taking into
account the expected use of existing inventory in Q1 2022 and
initiating transition to the new product in Q2 2022
- Reiterating 2021 financial outlook expectation for full year
2021 global net revenue to be in the middle of the revenue guidance
range of $12.0 million to $15.0 million
“We understand that the FDA is at full capacity managing the
backlog of COVID-19 related filings creating longer than expected
review timelines. We are confident a decision regarding approval of
the 180-day system will be made in the coming weeks as the FDA
continues to clear out the backlog,” said Tim Goodnow, PhD,
President and Chief Executive Officer of Senseonics. “In 2021 we
integrated operations and coordination activities with our
commercial collaborator Ascensia Diabetes Care. A thoughtful
go-to-market strategy is being designed to target a smooth
transition to the 180-day system while providing uninterrupted
service for patients, providers and payors. We are excited to
advance long-term solutions for people with diabetes as we continue
to aim to make the new 180-day system available in the U.S..”
About Senseonics
Senseonics Holdings, Inc. is a medical technology company
focused on the development and manufacturing of glucose monitoring
products designed to transform lives in the global diabetes
community with differentiated, long-term implantable glucose
management technology. Senseonics' CGM systems, Eversense® and
Eversense® XL, include a small sensor inserted completely under the
skin that communicates with a smart transmitter worn over the
sensor. The glucose data are automatically sent every 5 minutes to
a mobile app on the user's smartphone.
Forward Looking Statements
Any statements in this press release about future expectations,
plans and prospects for Senseonics, including statements about
Senseonics’ expected net revenue for the full year of 2021 and the
full year of 2022, the timing and outcome of the potential decision
on the 180-day Eversense system from the FDA, the timing,
effectiveness and readiness for launch of the 180-day Eversense
system, the ability to collaborate with Ascensia Diabetes Care, the
ability to smoothly transition patients, physicians and payors, the
impact of existing inventory and transition timing on financial
results, the ability to manage such impact, and other statements
containing the words “believe,” “expect,” “intend,” “may,”
“projects,” “will,” “planned,” and similar expressions, constitute
forward-looking statements within the meaning of The Private
Securities Litigation Reform Act of 1995. Actual results may differ
materially from those indicated by such forward-looking statements
as a result of various important factors, including: uncertainties
in the regulatory approval process, uncertainties inherent in the
commercial launch and commercial expansion of the product,
uncertainties in insurer, regulatory and administrative processes
and decisions, uncertainties in the duration and severity of the
COVID-19 pandemic, and such other factors as are set forth in the
risk factors detailed in Senseonics’ Annual Report on Form 10-K for
the year ended December 31, 2020, Senseonics’ Quarterly Report on
Form 10-Q for the quarter ended September 30, 2021 and Senseonics’
other filings with the SEC under the heading “Risk Factors.” In
addition, the forward-looking statements included in this press
release represent Senseonics’ views as of the date hereof.
Senseonics anticipates that subsequent events and developments will
cause Senseonics’ views to change. However, while Senseonics may
elect to update these forward-looking statements at some point in
the future, Senseonics specifically disclaims any obligation to do
so except as required by law. These forward-looking statements
should not be relied upon as representing Senseonics’ views as of
any date subsequent to the date hereof.
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version on businesswire.com: https://www.businesswire.com/news/home/20220104006026/en/
Senseonics Investor Contact: Philip Taylor Investor
Relations 415-937-5406 investors@senseonics.com
Senseonics Media Contact: Mirasol Panlilio 301-556-1631
Mirasol.panlilio@senseonics.com
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