PALM BEACH GARDENS, Fla. - Johnson & Johnson's DePuy Synthes has obtained FDA 510(k) clearance for its VELYS™ Robotic-Assisted Solution to be used in unicompartmental knee arthroplasty (UKA), commonly known as partial knee replacement. The clearance, announced today, extends the application of the VELYS robotic platform, which is already in use for total knee arthroplasty (TKA) procedures.
The VELYS robotic system is designed to aid surgeons in the precise placement of knee implants without the need for a CT scan, and is compatible with the SIGMA™ HP (NYSE:HPQ) Partial Knee Implant. This implant has shown improved 12-year survivorship when compared to others in its class, according to a national joint registry.
Dr. John Redmond, an orthopedic surgeon from Jacksonville, FL, emphasized the potential benefits of the VELYS system for UKA, highlighting the possibility of more personalized procedures and reproducible outcomes. Robotics in knee surgery aims to address challenges such as limited visibility and access, which can impact the learning curve and consistency of results.
The VELYS system includes features like the PROADJUST™ PLANNING SCREEN for personalized planning and the ACCUBALANCE™ GRAPH for balancing throughout the full range of motion. It will also be showcased at the Annual Meeting of the American Association of Hip and Knee Surgeons in November, with commercial availability details to be announced later.
Johnson & Johnson MedTech and DePuy Synthes are focused on advancing patient care by providing comprehensive orthopedic solutions and driving innovation in medical technologies and digital surgery. This latest FDA clearance is a step toward enhancing the efficiency and effectiveness of partial knee replacements.
This news is based on a press release statement from DePuy Synthes, a company within Johnson & Johnson's MedTech segment. The company cautions that the forward-looking statements in the press release are not guarantees of future performance and involve known and unknown risks and uncertainties.
In other recent news, AbbVie (NYSE:ABBV)'s arthritis drug Humira continues to dominate the market despite competition from nine biosimilars. According to health policy professor Stacie Dusetzina, regulatory reforms are needed to increase competition and facilitate patient access to biosimilars. However, the biosimilar industry reports an estimated $6 billion in lost potential savings since their introduction.
On the pharmaceutical front, Johnson & Johnson (J&J) has finalized its acquisition of Shockwave Medical (NASDAQ:SWAV). Citi has adjusted its price target for J&J to $180, maintaining a 'Buy' rating. The acquisition is expected to result in a $0.10 EPS dilution in 2024 and a $0.17 dilution in 2025, becoming accretive to earnings in 2026.
In legal matters, J&J has been ordered to pay $260 million in an Oregon talc case. This comes as the company is working on a proposed $6.48 billion settlement to resolve the majority of talc-related lawsuits. Furthermore, US lawmakers have requested a briefing from the FBI regarding GenScript Biotechnology Co and its ties to China. GenScript collaborated with J&J to develop the cancer cell therapy Carvykti.
Lastly, industry observers predict a similar scenario with the introduction of biosimilars for J&J’s Crohn’s disease treatment, Stelara. CVS's Chief Medical Officer, Sree Chaguturu, stated that the company continues to provide coverage for Humira while assessing which manufacturers produce high-quality biosimilars. These recent developments highlight the dynamic nature of the pharmaceutical industry.
InvestingPro Insights
As Johnson & Johnson's DePuy Synthes gains momentum with its latest FDA clearance for the VELYS™ Robotic-Assisted Solution, investors might be keen to understand the financial health and market positioning of the parent company, Johnson & Johnson (JNJ). Here are some key insights based on the latest data:
Johnson & Johnson's market capitalization stands strong at $352.39 billion, reflecting the substantial size and stability of the company within the healthcare industry. The company's P/E ratio, an indicator of what the market is willing to pay for a company's earnings, is currently at 9.47, which may suggest that the company's shares are valued reasonably in relation to its earnings. Additionally, the company's P/E ratio for the last twelve months as of Q1 2024 is 18.32, which provides another perspective on its valuation.
Investors might also take interest in Johnson & Johnson's dividend track record, which is a testament to its commitment to shareholder returns. Johnson & Johnson has not only maintained but also raised its dividend for 54 consecutive years, showcasing a strong and consistent return to shareholders. With a dividend yield of 3.39% as of mid-2024, income-focused investors may find Johnson & Johnson an attractive option for their portfolios.
Moreover, the company's stock is currently trading near its 52-week low, which could potentially offer a buying opportunity for value investors. This is complemented by the company's low price volatility, making it a less risky bet in times of market uncertainty.
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