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Roche Stock to Benefit From Accu-Chek Smartguide Launch in Europe

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Roche (RHHBY - Free Report) is set to enter the competitive continuous glucose monitor (CGM) market in Europe following the CE mark approval of its Accu-Chek Smartguide in July.

The Swiss pharmaceutical company plans to launch the device in the Netherlands, Switzerland and Germany, targeting adults with Type 1 or Type 2 diabetes. Sérgio Moreiras, Roche’s international business leader for continuous monitoring, shared details about the launch at the European Association for the Study of Diabetes annual meeting in Madrid.

The Accu-Chek Smartguide offers a 14-day wearability period and uses predictive algorithms that Roche believes should differentiate it from the likes of competitors like Abbott and Dexcom. However, one potential drawback is that the Smartguide requires initial calibration with a finger stick, a step that is eliminated in newer CGMs from established players — Abbott (ABT - Free Report) and Dexcom (DXCM - Free Report) .

RHHBY CGM’s Innovative Features and Predictive Algorithms

Roche’s CGM introduces several predictive features aimed at enhancing patient safety. The device can assess the risk of low blood glucose within 30 minutes, forecast glucose levels for the next two hours and predict the likelihood of night-time hypoglycemia. These features are designed to provide timely alerts, allowing users to take preventative actions before glucose levels drop dangerously low.

Pau Herrero, Roche’s lead for algorithm and decision support technology, emphasized that these predictions rely on machine learning models that analyze several days of patient data. This approach contrasts with the traditional trend arrows used by other CGMs, which forecast glucose levels over a shorter period of 20 minutes.

In trials conducted across three datasets, the Accu-Chek Smartguide demonstrated 95% sensitivity and 99% specificity in predicting low glucose levels within 30 minutes, along with 77% accuracy for detecting night-time hypoglycemia. RHHBY believes that these advanced predictive capabilities will make the Smartguide a unique offering in the CGM market.

Addressing the issue of hypoglycemia, Moreiras noted that it remains a significant concern for people with diabetes, especially those with Type 1. He added that more than 40% of individuals with Type 1 diabetes experience nighttime hypoglycemic events, while those with Type 2 diabetes face an average of 23 hypoglycemic incidents per year. This risk prompted Roche to focus on providing solutions to manage and prevent hypoglycemia.

RHHBY’s Price Performance

Year to date, RHHBY’s shares have risen 6.9% compared with the industry’s growth of 25%. The S&P 500 has gained 16.3% in the same time frame.

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RHHBY to Compete With Established Players

As Roche enters the CGM market, it should face strong competition from established players like Abbott and Dexcom. Abbott’s FreeStyle Libre and Dexcom’s G6 and G7 are already widely used in Europe and the United States. ABT and DXCM’s CGM devices are known for their ease of use, factory-calibrated sensors and long wear times. In comparison, Roche’s Smartguide may appeal to users seeking more advanced predictive features.

Another potential drawback of Roche’s Smartguide is its requirement for initial calibration via a finger stick. In contrast, newer models from both Abbott and Dexcom offer factory-calibrated sensors, making them more user-friendly and reducing the burden on patients.

Looking ahead, Roche is in discussions with the FDA about a potential launch of the Smartguide in the United States, though no timeline has been provided. The company is also considering a pediatric version of the device. However, it has not shared any details yet.

As Roche prepares for the European launch, its success will depend on how well the Smartguide can compete with established CGMs while offering a unique approach to diabetes management.

Favorable Industry Prospects for RHHBY

Per a report by Grand View Research, the CGM device market size was valued at $4.6 billion in 2023 and is expected to witness a CAGR of 7.2% from 2024 to 2030.

Given the market potential, RHHBY’s entry in this segment is likely to provide a boost to its long-term prospects.

RHHBY’s Zacks Rank & Another Stock to Consider

Roche currently carries a Zacks Rank #2 (Buy).

Intuitive Surgical (ISRG - Free Report) is another top-ranked stock from the broader medical space, sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Intuitive Surgical has an estimated long-term growth rate of 17.4%. Its earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 8.97%.        

ISRG’s shares have risen 46.4% compared with the industry’s 9.2% growth year to date.

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