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Senseonics Stock Down Despite New FDA Approval for Eversense 365

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Senseonics Holdings, Inc. (SENS - Free Report) , along with Ascensia Diabetes Care, announced the receipt of the FDA’s clearance for the next-generation Eversense 365 continuous glucose monitoring (CGM) system for people with Type 1 and Type 2 diabetes aged 18 years and above. Eversense 365 has been cleared as an integrated CGM (iCGM) system, indicating that it can integrate with compatible medical devices, including insulin pumps, as part of an automated insulin delivery system.

Ascensia, a subsidiary of PHC Holdings Corporation, expects to initiate the U.S. launch of Eversense 365 U.S. in the fourth quarter of 2024, with work ongoing to transition coverage availability to facilitate immediate access to as many users as possible.

The latest FDA clearance of Senseonics’ Eversense 365 is expected to significantly solidify its foothold in the CGM business across the nation.

Likely Trend of SENS Stock Following the News

Following the announcement on Sept. 17, 2024, shares of the company moved nearly 20% south to $0.35 at yesterday’s close. 

Historically, the company has gained a high level of synergies from its partnerships and regulatory clearances. Although the latest regulatory clearance is likely to be beneficial for SENS’ top-line growth going forward, the stock plunged as it continued its week-long downtrend.

Meanwhile, Senseonics currently has a market capitalization of $186.3 million. It has a current ratio of 3.1, higher than the industry’s 2.3. In the last reported quarter, SENS delivered a breakeven earnings surprise.

Significance of Approval of Senseonics’ iCGM System

Per Senseonics, Eversense 365 is the world’s first One-Year CGM system, representing a significant breakthrough in diabetes technology and management. With a single sensor, the Eversense 365 system is expected to provide one year of use compared with 10-14 days with short-term CGMs for minimal life disruption.

Senseonics’ management believes that the Eversense 365 is optimally suited to aid diabetics increase time in range of desired glucose levels and lower A1c levels.

Industry Prospects in Favor of SENS’

Per a report by Grand View Research, the global CGM device market size was valued at $4.60 billion in 2023 and is expected to reach $7.51 billion by 2030 at a CAGR of approximately 7.2%. Factors like the rising cases of diabetes and the increasing adoption of CGM devices are likely to drive the market.

Given the market potential, the latest regulatory approval is expected to provide a significant boost to Senseonics’ business.

Senseonics’ Notable Developments

Last month, Senseonics reported its second-quarter 2024 results, wherein it registered a solid uptick in its revenues. During the quarter, the company began first-in-human testing for the Gemini System, a fully implantable self-powering system designed to include a flash glucose monitor with no on-body component for people with type 2 diabetes.

In May, Senseonics, in partnership with our global commercial partner, Ascensia Diabetes Care, and St. Louis-based Mercy, announced a collaboration that marks the first time Senseonics’ Eversense CGM technology will be used across a health system and the first implementation of Senseonics’ new Eversense Remote Patient Monitoring (RPM) solution to drive significant advancement in diabetes management for patients.

The same month, Senseonics announced a strategic partnership with Rimidi for the development of its Eversense RPM Program for use by healthcare providers. The partnership will integrate Eversense glucose data into Rimidi's comprehensive clinical management platform used by health systems, capitated health plans and physician practices.

SENS’ Share Price Performance

Shares of the company have lost 33.2% in the past year against the industry’s 6.7% rise and the S&P 500's 31.5% growth.

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Senseonics’ Zacks Rank & Stocks to Consider 

Currently, SENS carries a Zacks Rank #4 (Sell).

Some better-ranked stocks in the broader medical space are DaVita Inc. (DVA - Free Report) , Baxter International Inc. (BAX - Free Report) and Boston Scientific Corporation (BSX - Free Report) .

DaVita, flaunting a Zacks Rank #1 (Strong Buy) at present, has an estimated long-term growth rate of 17.5%. DVA’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 24.2%. You can see the complete list of today’s Zacks #1 Rank stocks here.

DaVita’s shares have gained 62.8% compared with the industry’s 31.1% rise in the past year.

Baxter, carrying a Zacks Rank of 2 (Buy) at present, has an estimated long-term growth rate of 10%. BAX’s earnings surpassed estimates in each of the trailing four quarters, with the average being 3.7%.

Baxter has gained 4.3% compared with the industry’s 22.1% rise in the past year.

Boston Scientific, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 12.6%. BSX’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 7.2%.

Boston Scientific’s shares have rallied 55% compared with the industry’s 22.1% rise in the past year.

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