Tenon(R) Medical Announces the Introduction of the Catamaran(R) SE SI Joint Fusion System

Rhea-AI Summary

Tenon Medical (NASDAQ:TNON) has announced the alpha launch of its new Catamaran SE SI Joint Fusion System, scheduled for early Q4. This system features a 30% smaller implant compared to the original Catamaran device, offering physicians more options for smaller SI joint anatomy or revising previously treated joints. The SE system also includes a manual drilling option.

Key points:

• Catamaran SE provides choices for varying anatomy and treatment strategies
• Over 700 Catamaran fixation devices have been implanted to date
• The system is based on AO principles of arthrodesis
• Recent positive interim outcomes from the MAINSAIL Study were published

The alpha launch will gather initial user feedback before a broader market introduction.

Positive

• Introduction of Catamaran SE SI Joint Fusion System with 30% smaller implant size
• Manual drilling option added for physicians preferring hand drilling or lacking power sources
• Over 700 Catamaran fixation devices implanted to date
• Positive interim outcomes from MAINSAIL Study recently published

Negative

• None.

Medical Device Analyst

The introduction of Tenon Medical's Catamaran SE SI Joint Fusion System represents a significant advancement in sacroiliac joint treatment options. The 30% reduction in implant size addresses a important need for patients with smaller anatomies or those requiring revision surgeries. This product line extension demonstrates Tenon's commitment to market responsiveness and innovation.

The addition of a manual drilling option expands the device's versatility, potentially increasing its adoption in various healthcare settings. With 700 Catamaran devices already implanted, the SE version could further solidify Tenon's market position. However, the alpha launch phase suggests cautious optimism is warranted until broader market acceptance is confirmed.

Orthopedic Surgeon

The Catamaran SE's design, adhering to AO principles of arthrodesis, is a notable strength. Its focus on joint preparation, rigid fixation and bone graft augmentation aligns with best practices in orthopedic surgery. The minimally invasive inferior-posterior approach is particularly interesting, as it may lead to reduced patient recovery times and potentially better outcomes.

The system's MRI compatibility is a significant advantage, allowing for easier post-operative monitoring. However, long-term studies will be important to fully assess the device's efficacy in achieving successful fusions. The positive interim outcomes from the MAINSAIL study are encouraging, but continued vigilance on patient outcomes will be essential.

Financial Analyst

Tenon Medical's expansion of the Catamaran product line could potentially drive revenue growth and market share gains in the SI joint fusion market. The alpha launch strategy allows for controlled product rollout and refinement based on user feedback, potentially mitigating risks associated with full-scale launches.

However, investors should note that the impact on financials may not be immediate due to the initial release. The company's ability to scale production and navigate regulatory pathways for broader market access will be crucial. While the innovation is promising, Tenon's NASDAQ:TNON stock performance will likely depend on successful commercialization and adoption rates in the coming quarters.

~ New SI Joint Fixation Device Offers a 30% Reduction in Implant Size Providing Physicians Choices for Varying Anatomy and Treatment Strategies with the Catamaran Technology ~

~The SE System Can Also Be Utilized with a Manual Drilling Option During Implant Preparation~

LOS GATOS, CA / ACCESSWIRE / September 12, 2024 / Tenon Medical, Inc. (NASDAQ:TNON) ("Tenon" or the "Company"), a company transforming care for patients suffering from certain Sacroiliac Joint (SIJ) disorders, today announced preparation for the initial alpha launch of the Company's new Catamaran SE SI Joint Fusion System targeted for the beginning of Q4. The Catamaran SE Fixation Device extends the line of implant offerings for physicians preferring a smaller Catamaran implant when performing a SI joint fusion procedure. The new implant offers a 30% reduction in implant width as compared to the original Catamaran fixation device, providing physicians options for smaller SI joint anatomy or revising previously treated SI joints with failed alternative SI joint implants where space is limited. The SE implant also comes with a hand drill option for those physicians who prefer to manually drill during implant preparation or do not have power sources readily available in their treating sites of care.

The alpha launch of the Catamaran SE will provide important initial user feedback from a select group of physician users to support a broader market launch in the coming months. This news of the Catamaran SE comes on the recent announcement by the Company of the Catamaran SI Joint Fusion System MAINSAIL Study's positive interim outcomes publication. Click here to view the publication in its entirety.

The Catamaran and Catamaran SE SI Joint Fixation devices are single robust fully MRI compatible titanium implants comprised of two pontoons, connected by an osteotome bridge, which is designed to transfix the SI joint along its longitudinal axis providing immediate fixation and stabilization of the joint, with the aim of achieving a successful long-term fusion. The Catamaran implant was developed with respect to AO principles of arthrodesis including 1) adequate joint preparation, 2) rigid fixation and stabilization, and 3) adequate bone graft augmentation. Via a minimally invasive inferior-posterior approach the Catamaran & Catamaran SE implant are delivered within the dense cortical bone of the sacrum and ilium, to transfix and stabilize the SI joint for the treatment of SIJ dysfunction. To date there have been over 700 Catamaran fixation devices implanted to treat primary SI Joint dysfunction and sacroiliitis, as well as revise previously treated SI joints with failed alterative SI joint implants.

Bryan Hoelzer, MD, Interventional Pain Physician and Medical Director of Southwest Spine and Pain Center, in Provo, UT., commented, "The clinical evidence validating the safety and efficacy of the inferior-posterior approach to treat SI Joint disease continues to grow with the recent Catamaran MAINSAIL Study publication. Continued advancement in implant technology as seen in the smaller Catamaran SE Fixation Device is exciting and will provide more improved options for myself and, my patients in treating and managing their painful SI joint disorders."and the entire interventional pain community."

Steven M. Foster, President and CEO of Tenon Medical, stated, "As a leader in the SI joint fusion market it is critical that we continually listen to input from our customers and respond with innovative technology that benefits their patients. The development and introduction of the Catamaran SE SI Joint Fusion System will provide our physician users with more choices to treat their patients with SI Joint disease. We look forward to a successful limited alpha launch and then move rapidly to a full market introduction."

About Tenon Medical, Inc.

Tenon Medical, Inc., a medical device company formed in 2012, has developed The Catamaran SI Joint Fusion System that offers a novel, less invasive approach to the SI joint using a single, robust titanium implant. The system features the Catamaran™ Fixation Device which passes through both the axial and sagittal planes of the ilium and sacrum, stabilizing and transfixing the SI Joint along its longitudinal axis. The angle and trajectory of the Catamaran surgical approach is also designed to provide a pathway away from critical neural and vascular structures and into the strongest cortical bone. Since the national launch of the Catamaran SI Joint Fusion System in October 2022 Tenon is focused on two commercial opportunities with its System in the SI Joint market which includes: 1) Primary SI Joint procedures, and 2) Revision procedures of failed SI Joint implants. For more information, please visit https://www.tenonmed.com/.

The Tenon Medical logo Tenon Medical, and Catamaran are registered trademarks of Tenon Medical, Inc. MAINSAIL is a trademark of Tenon Medical

Safe Harbor

This press release contains "forward-looking statements," which are statements related to events, results, activities, or developments that Tenon expects, believes, or anticipates will or may occur in the future. Forward-looking often contains words such as "intends," "estimates," "anticipates," "hopes," "projects," "plans," "expects," "seek," "believes," "see," "should," "will," "would," "target," "aims," and similar expressions and the negative versions thereof. Such statements are based on Tenon's experience and perception of current conditions, trends, expected future developments and other factors it believes are appropriate under the circumstances, and speak only as of the date made. Forward-looking statements are inherently uncertain and actual results may differ materially from assumptions, estimates or expectations reflected or contained in the forward-looking statements as a result of various factors. For details on the uncertainties that may cause our actual results to be materially different than those expressed in our forward-looking statements, please review our Annual Report on 10-K on file with the Securities and Exchange Commission at www.sec.gov, particularly the information contained in the section entitled "Risk Factors". We undertake no obligation to publicly update or revise any forward-looking statements to reflect new information or future events or otherwise unless required by law.

IR Contact:

Shannon Devine / Rory Rumore
203-741-8811
MZ North America
tenon@mzgroup.us

SOURCE: Tenon Medical, Inc.

View the original press release on accesswire.com

FAQ

What is the new product Tenon Medical (TNON) is launching?

Tenon Medical is launching the Catamaran SE SI Joint Fusion System, a new SI Joint Fixation Device that offers a 30% reduction in implant size compared to the original Catamaran device.

When is Tenon Medical (TNON) planning to launch the Catamaran SE system?

Tenon Medical is preparing for the initial alpha launch of the Catamaran SE SI Joint Fusion System targeted for the beginning of Q4.

What are the key features of the Catamaran SE SI Joint Fusion System by Tenon Medical (TNON)?

The Catamaran SE offers a 30% reduction in implant width, provides options for smaller SI joint anatomy, and includes a manual drilling option for implant preparation.

How many Catamaran fixation devices has Tenon Medical (TNON) implanted to date?

To date, over 700 Catamaran fixation devices have been implanted to treat primary SI Joint dysfunction, sacroiliitis, and to revise previously treated SI joints with failed alternative implants.