embecta Announces FDA Clearance of its Disposable Patch Pump for Insulin Delivery Informed by the Unique Needs of People with Type 2 Diabetes
September 03 2024 - 5:30AM
Embecta Corp. ("embecta") (Nasdaq: EMBC), a global diabetes care
company with a 100-year legacy in insulin delivery, today announced
it has received 510(k) clearance from the U.S. Food and Drug
Administration (FDA) for its proprietary disposable insulin
delivery system. Indicated for adults who require insulin to manage
diabetes, including both type 1 (T1D) and type 2 (T2D), the system
includes a tubeless patch pump design with a 300-unit insulin
reservoir that was informed by feedback from people with T2D and
their healthcare providers.
“FDA clearance of our disposable insulin delivery system has
been a top strategic priority for our team since launching embecta
as an independent company, and achieving this milestone through
strong execution exemplifies our commitment to making life better
for the growing number of people living with diabetes,” said Dev
Kurdikar, CEO. “As we continue to advance toward our vision of a
life unlimited by diabetes, our team has focused on developing a
patch pump that could address some of the most significant
obstacles to adopting pump therapy for people who use insulin daily
to manage their diabetes. This platform is also serving as the
basis for an automated insulin delivery system in development.”
The system includes a wearable, fully disposable patch pump that
provides adjustable basal and bolus insulin for up to three days,
depending on the needs of the user. The patch pump features a
300-unit insulin reservoir that accommodates people who have higher
daily insulin needs, which is typically true of people with T2D.
For such people, the on-market patch pumps may not hold enough
insulin to meet their needs for three days.2 For example, a recent
embecta-sponsored study3 showed that a 300-unit insulin reservoir
would meet the needs of 64% of adults with T2D for three-day wear,
while a 200-unit reservoir would only meet the needs of 38% of that
same population.
In addition to the patch pump, the system comprises a
locked-down controller featuring Bluetooth® wireless technology
with a color touchscreen designed to create a simplified interface
and user experience.
“Our research and development, medical affairs and regulatory
teams identified an unmet need within the diabetes community and
shepherded this project from concept to clearance with dedication
and diligence,” said Dr. Colleen Riley, Chief Technology Officer.
“I want to thank the embecta team for their commitment to serving
people with diabetes and thank the FDA for their timely review and
clearance of a system that has the potential to reduce the burden
of managing diabetes for more people and significantly move
innovation in this area forward.”
embecta’s patch pump development program also includes plans for
a closed-loop version including an insulin-dosing algorithm in a
future FDA submission.
References: 1Viral Shah, MD, et al, Insulin
dosing in U.S. adults with type 2 diabetes (T2D) on multiple daily
injections (MDI): A retrospective cohort study2Ekanayake P, Edelman
S. Identifying patients with type 2 diabetes who might benefit from
insulin pump therapy: Literature review, clinical opportunities,
potential benefits and challenges. Diabetes Obes Metab. 2023;
1‐18.3 Eugene E. Wright, Jr., MD, et al, Evaluating Need for Larger
Insulin Reservoir in Patch Pumps: Leveraging Retrospective Dose
Data for US Adults with T2D on MDI,
https://www.embectamedical.com/pdf/ADA-Poster-1902.pdf 4 Freckmann
G, Buck S, Waldenmaier D, et al. Insulin Pump Therapy for Patients
With Type 2 Diabetes Mellitus: Evidence, Current Barriers, and New
Technologies. Journal of Diabetes Science and Technology.
2021;15(4):901-915.
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 X.Safe
Harbor Statement Regarding Forward-Looking StatementsThis
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," “potentially”, “may,” or similar
expressions, it is making forward-looking statements. For example,
embecta is using forward-looking statements when it discusses
continuing to invest in 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 and other trials with
favorable results, obtain regulatory clearance and obtain approvals
for its products; (v) its ability to manufacture such products in a
cost-effective manner, comply with FDA’s quality system
regulations, 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; (x)
technological innovations or changes in clinical practice adversely
affecting embecta’s business; and (xi) 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: |
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MediaChristian GlazarSr. Director, Corporate
Communications908-821-6922Contact Media Relations |
Investors Pravesh KhandelwalVP, Head of Investor Relations
551-264-6547 Contact IR |
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