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Tag: NASDAQ:TNON

  • Pre-Market Rally: Tenon Medical (TNON) Soars On Regulatory Milestone

    Pre-Market Rally: Tenon Medical (TNON) Soars On Regulatory Milestone

    A remarkable 342.69% increase in Tenon Medical, Inc. (NASDAQ: TNON) shares have caused the stock price to soar to $4.33 in pre-market trading. The company’s recent disclosure of a crucial regulatory breakthrough is what’s causing this notable surge. Investor confidence over the company’s advancement in the medical device business is reflected in the spike in stock value.

    The FDA Approves Catamaran for Wider Use

    The FDA in the United States gave Tenon Medical a significant endorsement when it approved an extended indication for their Catamaran Sacroiliac Joint (SIJ) Fusion System.

    The FDA has authorized the device to be used as a supplement to thoracolumbar fusion surgeries as well as a stand-alone therapy for SI joint dysfunction. This approval ushers in a new age of expansion and potential for TNON by opening up a hitherto unexplored market.

    The Catamaran System’s Importance for Spinal Fusion

    The Catamaran system is unique because of its creative design, which increases treatment versatility for complicated spinal disorders. Tenon Medical has reached a major milestone with the FDA’s approval to utilize the device in spinal fusion surgeries.

    It is clear that the system has shown itself to be a safe, dependable, and efficient alternative for SI joint fusion, significantly expanding the surgical choices accessible to spine experts as TNON continues to collect data from the ongoing MAINSAIL clinical trial.

    Enhancing Europe’s Patent Position

    The European Patent Office has given Tenon Medical two additional patents for the Catamaran SI Joint Fixation Device, which is good news in addition to the FDA’s clearance.

    This milestone highlights the company’s continued dedication to innovation in the medical technology industry and strengthens its expanding portfolio of intellectual property. Tenon Medical improves its competitiveness in the international market with these new patents.

  • Tenon (TNON) Shares Rally In Pre-Market Following Clinical Success

    Tenon (TNON) Shares Rally In Pre-Market Following Clinical Success

    Tenon Medical, Inc. (NASDAQ: TNON) recently announced successful outcomes in the initial phase of its clinical study for the Catamaran SE SI Joint Fixation Device, spurring a notable increase in its stock value. As of the latest pre-market data, TNON shares are trading at $3.92, marking a 20.24% rise, driven by growing optimism about the potential of this innovative implant.

    Enhancements in Device Design and Application

    The Catamaran SE, a new iteration of Tenon’s established SI Joint Fixation Device, boasts a 30% reduction in implant width, enabling its application in patients with smaller sacroiliac (SI) joint anatomy and in cases where revision of failed SI joint implants is required.

    This size reduction offers significant advantages for surgeons, particularly in anatomies with limited space or in previously treated joints that demand more precision. The initial feedback from physicians using the Catamaran SE is expected to aid Tenon in refining the product for a broader market release in the coming months.

    Expanding Clinical Reach Across Centers of Excellence

    Clinical procedures with the Catamaran SE have been successfully performed at multiple medical centers of excellence, including locations in Idaho, Pennsylvania, Minnesota, Arizona, and Utah. This successful deployment underscores the device’s potential in achieving stable fixation of the SI joint through a minimally invasive approach.

    The Catamaran and Catamaran SE devices consist of MRI-compatible titanium implants with a two-pontoon system connected by an osteotome bridge, which allows for secure, longitudinal fixation of the joint.

    Commitment to AO Principles and Broader Patient Options

    Tenon Medical designed the Catamaran SE in line with the AO principles of arthrodesis, which emphasize joint preparation, rigid fixation, and adequate bone grafting. Both devices are implanted using a minimally invasive approach targeting the sacrum and ilium’s dense cortical bone, aiming to achieve long-term fusion of the SI joint. To date, over 750 Catamaran devices have been successfully implanted, addressing primary SI joint dysfunction and revision cases.

    Strategic Market Expansion for SI Joint Fixation

    Following the promising outcomes from the Catamaran SI Joint Fusion System MAINSAIL Study, Tenon Medical (TNON) is now positioned to offer physicians a versatile portfolio of SI joint fixation solutions. This expanded offering aims to address the diverse anatomical needs of patients and refine treatment strategies, ultimately broadening TNON’s market reach and enhancing options for patients and healthcare providers alike.

  • After Market Rise For Tenon Medical (TNON) Stock After New Patents Issued

    After Market Rise For Tenon Medical (TNON) Stock After New Patents Issued

    Tenon Medical, Inc. (NASDAQ: TNON) had a notable increase in stock performance following the announcement of many new patents. The stock jumped 38.48% in after-hours trading, finishing at $4.75, despite a 2% drop during the normal trading session. Following the company’s recent intellectual property accomplishments, investor confidence has returned, as seen by this valuation spike.

    New Patents Bolster Catamaran SI Joint Fusion System

    Tenon Medical (TNON) was granted three new U.S. patents, Nos. 12,115,075, 12,115,076, and 12,115,077. Improvements to the business’s Catamaran Sacroiliac Joint (SIJ) Stabilization Prostheses are the subject of the first two patents.

    These prostheses feature innovative drug delivery mechanisms designed to improve the sealing within the SI joint bone structure and foster bone growth around and within the implant. These advancements are expected to significantly enhance the effectiveness of the Catamaran system in stabilizing the SI joint.

    Patent No. 12,115,077 is directed towards addressing failed SI joint stabilizations that have resulted from other commercial implants. It introduces unique designs and methods that allow surgeons to correct these failures without having to remove the original, ineffective implants.

    Strengthening Tenon Medical’s Intellectual Property Portfolio

    These patents complete Tenon Medical’s portfolio, which now includes twelve granted U.S. and foreign patents and twenty-three pending applications. The company’s strategic focus on innovation and technical improvement, especially in the creation of minimally invasive solutions for SI joint stability, is supported by this expanding portfolio.

    Effect on Growth Strategy and Competitive Position

    In addition to confirming Tenon Medical’s innovative prosthesis, the recent acknowledgement from the U.S. Patent and Trademark Office (USPTO) fortifies the business’s competitive advantage in the market.

    Tenon’s growth plan heavily relies on obtaining these patents, which allow the business to safeguard its intellectual technology and go on with commercialization initiatives. The business’s dedication to protecting intellectual property keeps establishing its position as a pioneer in creating cutting-edge, minimally invasive SI joint stabilization techniques.

  • Tenon Medical (TNON) Stock Rebounds After-Hours On Regulatory Patent Approvals

    Tenon Medical (TNON) Stock Rebounds After-Hours On Regulatory Patent Approvals

    Following the regulatory approval of multiple patent processes, shares of Tenon Medical, Inc. (NASDAQ: TNON) surged in after-hours trading. TNON stock experience an after-hour rebound of 37.78% to $6.93. That followed the stock closing at $5.03, marking a 4.19% decline during the regular trading session. The surge came after the company announced significant advancements in its intellectual property portfolio.

    Issuance of Key Patent Notices to Tenon Medical

    Tenon Medical (TNON) revealed that it has been issued with three Notices of Allowance by the United States Patent and Trademark Office (USPTO). These notices were associated with its U.S. Patent Application Numbers 17/469,132 and 17/468,811, both of entitled “Sacroiliac Joint (SIJ) Stabilization Prostheses.”

    The other notice is associated with a third patent, 18/612,032, named “Systems, Apparatus, and Methods for Stabilizing Sacroiliac Joints.” In the upcoming ninety days, it is anticipated that these patents will be officially granted.

    TNON is Strengthening the SI Joint Prostheses Portfolio

    The new patents cover innovations in sacroiliac (SI) joint prostheses. U.S. Patent Applications 17/469,132 and 17/468,811 focus on prostheses that incorporate drug delivery compositions designed to promote bone growth around the implant. Meanwhile, the third patent (18/612,032) is centered on SI joint prostheses with unique configurations to rectify failed SI joint stabilization from previous implants without needing to remove the original implant.

    Strategic Intellectual Property Expansion

    With the addition of these patents, Tenon Medical is further solidifying its growing intellectual property portfolio. These new patents join the company’s existing collection of nine issued U.S. and international patents and 26 pending patent applications. This portfolio plays a key role in supporting the company’s Catamaran SI Joint Fusion System, a cornerstone of its commercial strategy.

    As Tenon Medical continues its aggressive expansion in intellectual property, the company is positioning itself as a leader in the industry by protecting its innovations and securing a competitive edge in the field of minimally invasive SI joint stabilization.

  • Pre-Market Surge For Tenon Medical (TNON) As New Joint Fusion System Announced

    Pre-Market Surge For Tenon Medical (TNON) As New Joint Fusion System Announced

    Tenon Medical, Inc. (NASDAQ: TNON) has witnessed a significant uptick in its stock value following the announcement of its new Catamaran SE Sacroiliac Joint Fusion System. As of the latest pre-market update, shares of TNON have surged by an impressive 235.68%, reaching a trading price of $14.77.

    Tenon Introducing the Catamaran SE System

    Tenon Medical (TNON) has revealed plans for the initial alpha launch of its Catamaran SE Sacroiliac Joint Fusion System, scheduled to commence at the beginning of the fourth quarter. This new system extends Tenon Medical’s line of implant solutions, offering a smaller, refined version of the original Catamaran fixation device. The Catamaran SE is designed to address the needs of physicians who require a more compact implant for SI joint fusion procedures.

    Enhanced Design and Features

    The Catamaran SE offers a notable 30% reduction in implant width compared to its predecessor, making it an ideal choice for patients with smaller SI joint anatomies or for cases where previous implants have failed and space is constrained. Additionally, the SE implant includes a manual hand drill option, catering to physicians who prefer manual drilling during the implantation process or lack access to power tools at their treatment locations.

    TNON Eyeing Market Launch and Future Prospects

    The alpha launch of the Catamaran SE will provide essential initial feedback from a select group of physicians, paving the way for a broader market introduction in the upcoming months. This development follows Tenon Medical’s recent announcement of positive interim outcomes from the MAINSAIL Study of the Catamaran SI Joint Fusion System.

    Technical Specifications and Clinical Impact

    Both the Catamaran and Catamaran SE SI Joint Fixation devices are robust, MRI-compatible titanium implants featuring two pontoons linked by an osteotome bridge. This design aims to achieve immediate fixation and stabilization of the SI joint along its longitudinal axis, supporting long-term fusion success.

    Since its introduction, the Catamaran implant has been used in over 700 procedures to address primary SI joint dysfunction, sacroiliitis, and revisions of previously treated SI joints. The upcoming launch of the Catamaran SE is expected to offer physicians enhanced options for treating SI Joint disease, and Tenon Medical (NASD: TNON) anticipates a successful transition from the limited alpha launch to a full market introduction.