embecta Announces FDA 510(k) Submission for Insulin Patch Pump
09 Gennaio 2024 - 12:00PM
Embecta Corp. ("embecta") (Nasdaq: EMBC), a global diabetes care
company with a 100-year legacy in insulin delivery, today announced
that it has submitted a 510(k) premarket filing to the U.S. Food
and Drug Administration (FDA) for a proprietary disposable insulin
delivery system.
"This patch pump is intended for people who require
insulin to manage diabetes and is informed by the unique needs of
people with type 2 diabetes and their healthcare providers," said
Colleen Riley, Chief Technology Officer, embecta. "We worked with
them to address the needs of those who may require more daily
insulin and are looking for a simplified and convenient option for
automated insulin delivery that offers the ease of use and
discretion of a patch pump, along with a larger 300U insulin
reservoir."
"While 9 out of 10 people with diabetes are living
with type 2 diabetes, the majority of the automated insulin
delivery solutions currently on the market were designed for people
living with type 1 diabetes," said Henry Anhalt, D.O., Chief
Medical Officer, embecta. "The broader diabetes care community —
including clinicians, caregivers, and people living with type 2
diabetes — desires more individualized therapeutic options and
tools designed to lighten the burden of managing diabetes and to
improve outcomes for each of the growing number of people living
with diabetes."
"Since we became an independent company in April
2022, our team has been working diligently on our priorities, which
include investing for growth — notably in the development of a
patch pump," said Devdatt (Dev) Kurdikar, Chief Executive Officer
of embecta. "The 510(k) submission of our patch pump to the FDA is
an important step in the advancement of our strategic priorities,
and we look forward to working with the FDA to seek clearance for a
product that we believe has the potential to positively impact type
2 diabetes management for many people."
embecta continues to advance its patch pump
development program, with plans for a closed-loop version including
an insulin-dosing algorithm in a future FDA submission.
About embecta embecta is a
global diabetes care company that is leveraging its 100-year legacy
in insulin delivery to empower people with diabetes to live their
best life through innovative solutions, partnerships, and the
passion of more than 2,000 employees around the globe. For more
information, visit embecta.com or follow our social
channels
on LinkedIn, Facebook, Instagram and Twitter.
Safe Harbor Statement Regarding
Forward-Looking Statements
This press release contains express or implied
"forward-looking statements" as that term is defined in the Private
Securities Litigation Reform Act of 1995 and other securities laws.
These forward-looking statements concern embecta’s current
expectations regarding its future results from operations, business
plans, product performance and impact, and new and anticipated
product approvals and launches. These forward-looking statements
are subject to various known and unknown risks, uncertainties and
other factors, and you should not rely upon them except as
statements of our present intentions and of embecta’s present
expectations, which may or may not occur. When embecta uses words
such as "believes," "expects," "anticipates," "estimates," "plans,"
"intends", "pursue", "will," "seek," or similar expressions, it is
making forward-looking statements. For example, embecta is using
forward-looking statements when it discusses continuing to advance
its patch pump development program, plans for a closed-loop
version, future FDA submissions, and working with the FDA to seek
clearance for any of the foregoing. Although embecta believes that
its forward-looking statements are based on reasonable assumptions,
its expected results may not be achieved, and actual results may
differ materially from its expectations. In addition, important
factors that could cause actual results to differ from expectations
include, among others: (i) embecta’s ability to obtain clearance
from the FDA of any product; (ii) its ability to market and sell
such products successfully; (iii) its ability to anticipate the
needs of people with diabetes; (iv) its ability to successfully
complete clinical trials, obtain regulatory clearance and obtain
approvals for its products; (v) its ability to manufacture such
products in a cost-effective manner, obtain appropriate
intellectual property protection for such products, gain and
maintain market acceptance of such products, secure distribution
channels, and obtain access, coverage and reimbursement for such
products; (vi) future economic, competitive, reimbursement and
regulatory conditions; (vii) litigation; (viii) financial market
conditions; (ix) future business decisions made by embecta and its
competitors; and (x) the other risks described in embecta’s
periodic reports filed with the Securities and Exchange Commission,
including under the caption "Risk Factors" in its most recent
Annual Report on Form 10-K, as further updated by its Quarterly
Reports on Form 10-Q it has filed or will file hereafter. Except as
required by law, embecta undertakes no obligation to update any
forward-looking statements appearing in this press release.
Contacts: |
|
MediaChristian GlazarSr. Director, Corporate
Communications908-821-6922Contact Media Relations |
InvestorsPravesh KhandelwalVP, Head of Investor
Relations551-264-6547Contact IR |
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