Tenon Medical Announces Successful Completion of Initial Cases with New SImmetry(R)+ SI Joint Fusion System

Rhea-AI Summary

Tenon Medical (NASDAQ:TNON) announced completion of initial clinical procedures using its new SImmetry+ SI Joint Fusion System on December 4, 2025, with cases at Centers of Excellence in Florida, Arizona, Ohio, and Texas.

The minimally invasive lateral system uses 3D-printed titanium implants, joint decortication, and a bone graft delivery system, cleared for use with one to three implants. Tenon cites published 12-month EvoluSIon data (250 patients): 68.7% radiographic fusion at 12 months and a 57.1% decrease in pre-operative opioid use.

Tenon is conducting a controlled early-access rollout with select SI fusion physicians to gather procedural feedback ahead of broader commercial launch.

Positive

• 68.7% radiographic fusion at 12 months (EvoluSIon, 250 patients)
• 57.1% decrease in pre-operative opioid use at 12 months
• Initial clinical implants completed across four states during early-access rollout

Negative

• Commercial availability limited to a controlled early-access rollout pending broader launch
• Published fusion rate of 68.7% indicates not all patients achieved radiographic fusion at 12 months

Insights

Healthcare Device Strategist

Tenon's controlled early rollout of SImmetry+ shows clinical uptake and potential near-term revenue, backed by published 12-month data.

The announcement reports initial procedures across multiple US centers using the SImmetry+ SI Joint Fusion System and frames the device as a lateral, minimally invasive option that pairs 3D-printed titanium implants with decortication and graft delivery to pursue biologic fusion. The company describes an early-access rollout to experienced physicians to gather procedural feedback and prepare for broader commercial launch, and cites 12-month outcomes from the EvoluSIon study showing safety, pain and quality-of-life improvements, a 57.1% reduction in pre-operative opioid use, and radiographic fusion in 68.7% of patients by CT review.

The main dependencies and risks are clear from the disclosure: broader commercial impact depends on scaled physician adoption, further procedural feedback, and successful transition from alpha/early-access cases to full launch; the press release does not disclose pricing, reimbursement status, or specific revenue figures. Watch for additional alpha case outcomes, formal commercial launch communications, and any stated reimbursement or sales metrics over the next 6–18 months to assess tangible revenue impact and market share changes.

~ Procedures Completed in Various Spine Centers of Excellence Throughout the Country Including Florida, Arizona, Ohio, and Texas ~

~SImmetry+ combines 3D-printed titanium implants, a robust joint decorticator, and a streamlined bone graft delivery system to offer treatment solutions aligned with established fusion principles ~

~ Immediate revenue impact opportunity while significantly advancing Tenon's competitive position in redefining SI joint fusion with a multi-approach portfolio in rapidly expanding sacro-pelvic market ~

LOS GATOS, CA / ACCESS Newswire / December 4, 2025 / Tenon Medical, Inc. (NASDAQ:TNON) ("Tenon" or the "Company"), a company redefining care for patients suffering from sacro-pelvic disorders, today announced the completion of the first clinical procedures utilizing the Company's new SImmetry+ SI Joint Fusion System. Ali Araghi, DO, Orthopedic Spine Surgeon in Phoenix, Arizona, Brian Fiani, DO Board Certified Neurosurgeon in Tampa, FL., Kraig Kristof, MD, Orthopedic Spine Surgeon in Toledo, OH., and Sunil Panchal, MD Interventional Pain physician in Tampa, FL. were among the first physicians to successfully implant the SImmetry+ system in patients diagnosed with sacroiliac joint dysfunction.

The SImmetry+ SI Joint Fusion System is a next-generation, minimally invasive lateral access solution that incorporates well-established orthopedic fusion principles-including joint decortication, bone graft placement, and rigid fixation-with the goal of achieving a true biological fusion across the SI joint. The system features 3D-printed titanium implants engineered to effectively stabilize the SI Joint by incorporating a self-drilling, self-tapping, and self-harvesting design to streamline implantation and enhance bone preparation and fusion. The system is cleared for use with one to three implants, allowing physicians flexibility based on patient anatomy and pathology.

Initial physician use of SImmetry+ is currently underway through a controlled, early-access rollout with a select group of experienced SI fusion physicians as listed above. These early adopters will provide important procedural and clinical feedback on the implant design, technique, and instrumentation to support a broader commercial launch readiness. Additional alpha cases are currently being scheduled at multiple Centers of Excellence across the United States.

Clinical evidence supporting the SImmetry+ system includes 12-month outcomes from the EvoluSIon study, published in the International Journal of Spine Surgery. Among 250 treated patients, the procedure demonstrated a strong safety profile and resulted in meaningful reductions in pain and improvement in quality-of-life measures. Patients also experienced a 57.1% decrease in pre-operative opioid use and at 12 months, 68.7% of patients showed radiographic fusion of the SI joint confirmed by computed tomography (CT) and independently reviewed by a trained radiologist.

"The first successful clinical use of SImmetry+ represents another meaningful milestone in Tenon's mission to advance sacro-pelvic fusion options for physicians and their SI joint patients," said Steve Foster, President and Chief Executive Officer of Tenon Medical. "Ongoing feedback from our physician advisors guides us in refining every aspect of the system and workflow. These technologies only reach their full potential with world-class clinical insight, and we are deeply grateful for the expertise our advisors bring. SImmetry+ combines proven orthopedic fusion principles with modern implant and instrument design to support a true fusion approach. Early clinical feedback reinforces our belief that this next-generation technology can further accelerate adoption and strengthen our growing sacro-pelvic portfolio."

The SImmetry+ and Catamaran^® SI Joint Fusion System are the foundation of Tenon's growing portfolio of advanced technologies. Together, these platforms uniquely position the Company with multiple surgical approaches-lateral and inferior-posterior-both designed to be minimally invasive, enable authentic arthrodesis and supported by robust clinical evidence, including the published prospective Mainsail^™ and EVoluSIon SI joint fusion studies. These differentiated technologies will enable physicians to customize treatment plans for their patients with an innovative portfolio that spans SI joint, spinal fusion, revision surgery and deformity adjuncts - each solution engineered to deliver fusion outcomes more reliably. This multi-platform, multi-approach strategy strengthens Tenon's competitive advantage in the expanding SI joint fusion market and underscores the Company's commitment to delivering proven, durable outcomes for physicians and patients

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 three commercial opportunities with its System in the SI Joint market which include: 1) Primary SI Joint procedures, 2) Revision procedures of failed SI Joint implants and 3) Augmenting spinal fusion. For more information, please visit www.tenonmed.com.

The Tenon Medical logo shown above, and Catamaran^®, PiSIF^®, CAT PiSIF^®, ETAD^®, Posterior Inferior Sacroiliac Fusion^®, CAT SIJ Fusion System^®, Catamaran SIJ Fusion System^®, Catamaran Inferior Posterior Fusion System^®, Catamaran Transfixation Fusion System^®, Catamaran Transfixation Fusion Device^®, SImmetry^® are registered trademarks of Tenon Medical, Inc. MAINSAIL^TM, and SImmetry+ are also trademarks of Tenon Medical, Inc.

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 ACCESS Newswire

FAQ

What did Tenon Medical (TNON) announce on December 4, 2025 about SImmetry+?

Tenon announced initial clinical procedures using the SImmetry+ SI Joint Fusion System and an early-access rollout at select US centers.

What clinical evidence supports Tenon’s SImmetry+ system for TNON investors?

EvoluSIon study (250 patients) showed 68.7% radiographic fusion at 12 months and a 57.1% reduction in pre-operative opioid use.

How many implants does the SImmetry+ system allow per procedure for TNON patients?

The system is cleared for use with one to three implants, enabling physician flexibility by anatomy and pathology.

Where were the first SImmetry+ procedures performed under TNON’s early-access program?

Initial cases were completed at Centers of Excellence in Florida, Arizona, Ohio, and Texas.

Will SImmetry+ immediately drive revenue for Tenon (TNON)?

The company cites an immediate revenue impact opportunity, but commercial distribution is currently limited to an early-access rollout.

What are the next steps before SImmetry+ is widely available to TNON shareholders?

Tenon will collect procedural and clinical feedback from early adopters to refine the system ahead of a broader commercial launch.