embecta Announces FDA 510(k) Submission for Insulin Patch Pump
Embecta Corp. (EMBC) announces the submission of a 510(k) premarket filing to the FDA for a proprietary disposable insulin delivery system, addressing the needs of people with type 2 diabetes. The company aims to provide a simplified and convenient option for automated insulin delivery, offering a larger 300U insulin reservoir, and plans to develop a closed-loop version with an insulin-dosing algorithm in the future.
The submission of a 510(k) premarket filing by Embecta for a new disposable insulin delivery system represents a strategic move within the medical device sector, particularly in the management of diabetes. The 510(k) process, which is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device, is a critical step for Embecta in expanding its product portfolio. The emphasis on a larger 300U insulin reservoir addresses a specific unmet need in the type 2 diabetes market, potentially offering a competitive advantage.
From a market perspective, the focus on type 2 diabetes, which accounts for the majority of diabetes cases, suggests a significant market opportunity for Embecta. The introduction of a patch pump designed for this demographic could disrupt the current market, which is predominantly tailored to type 1 diabetes management. This could lead to increased market share and revenue for Embecta, assuming the product gains FDA clearance and is well received by the healthcare community.
Embecta's strategic focus on a simplified and convenient insulin delivery option for type 2 diabetes patients is indicative of the evolving landscape of diabetes care. The healthcare industry is moving towards more personalized and patient-centric solutions. A device that caters to the unique needs of type 2 diabetes patients, such as the one Embecta is proposing, aligns with this trend and may lead to improved patient adherence and outcomes.
Moreover, Embecta's mention of future plans for a closed-loop system incorporating an insulin-dosing algorithm suggests a commitment to innovation in diabetes care. Such advancements could position the company as a leader in integrated diabetes management solutions, potentially influencing long-term growth. Stakeholders should monitor the FDA's response to the submission and the subsequent adoption rate among healthcare providers and patients, as these factors will be critical in assessing the impact on Embecta's business trajectory.
The diabetes care market is highly competitive with several established players. Embecta's entry into the automated insulin delivery space with a product tailored to type 2 diabetes could potentially fill a notable gap in the market. Evaluating the potential market size, adoption rates and pricing strategy will be essential in forecasting the impact on Embecta's financial performance. Additionally, the company's ability to navigate the regulatory landscape and secure FDA clearance will be a determining factor in the product's success.
It is also important to consider the implications of healthcare policy changes, insurance coverage and the competitive response from other market participants. The latter could include price adjustments, enhanced marketing efforts, or the rapid development of similar products. These market dynamics will shape the competitive environment and influence Embecta's ability to capitalize on its new offering.
01/09/2024 - 06:00 AM
PARSIPPANY, N.J., Jan. 09, 2024 (GLOBE NEWSWIRE) -- 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.
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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.
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What did Embecta announce recently?
Embecta Corp. announced the submission of a 510(k) premarket filing to the U.S. FDA for a proprietary disposable insulin delivery system.
Who is the Chief Technology Officer of Embecta?
Colleen Riley is the Chief Technology Officer of Embecta.
What is the ticker symbol of Embecta Corp.?
The ticker symbol of Embecta Corp. is EMBC.
What are the unique features of the insulin delivery system submitted by Embecta?
The insulin delivery system offers a larger 300U insulin reservoir and aims to provide a simplified and convenient option for automated insulin delivery.
What are the future plans of Embecta regarding the patch pump development program?
Embecta plans to develop a closed-loop version of the patch pump, including an insulin-dosing algorithm, in a future FDA submission.
