STOCK TITAN

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

Rhea-AI Impact
(High)
Rhea-AI Sentiment
(Positive)
Tags

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.

Loading...
Loading translation...

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

News Market Reaction

%
1 alert
% News Effect

On the day this news was published, TNON declined NaN%, reflecting a moderate negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

EvoluSIon study patients: 250 patients Opioid use reduction: 57.1% decrease Radiographic fusion rate: 68.7% +3 more
6 metrics
EvoluSIon study patients 250 patients Clinical evidence base for SImmetry+ SI Joint Fusion System
Opioid use reduction 57.1% decrease Reduction in pre-operative opioid use at 12 months in EvoluSIon study
Radiographic fusion rate 68.7% Patients with SI joint fusion at 12 months confirmed by CT
Implant count cleared One to three implants Regulatory clearance range for SImmetry+ SI Joint Fusion System
Current share price $1.14 Price before news; 80.51% below 52-week high
52-week range $0.85–$5.85 Low and high over the last 52 weeks

Market Reality Check

Price: $0.9222 Vol: Volume 62,008 is about 0....
low vol
$0.9222 Last Close
Volume Volume 62,008 is about 0.5x the 20-day average of 122,947, indicating subdued trading ahead of broader reaction. low
Technical Shares at $1.14 trade below the 200-day MA of $1.20 and sit 80.51% under the 52-week high, despite being 34.12% above the 52-week low.

Peers on Argus

While TNON was down 2.61%, peers showed mixed action: RSLS gained 29.8%, while P...

While TNON was down 2.61%, peers showed mixed action: RSLS gained 29.8%, while PAVM, SINT, and XAIR were modestly negative and DHAI was flat. This points to stock-specific trading rather than a coordinated medical devices move.

Historical Context

5 past events · Latest: Dec 04 (Positive)
Pattern 5 events
Date Event Sentiment Move Catalyst
Dec 04 Product launch update Positive +0.0% Initial clinical use of SImmetry+ SI Joint Fusion System in multiple centers.
Nov 14 PIPE financing close Negative +0.0% Closed $2.85M at-the-market PIPE with shares and warrants issued.
Nov 13 Q3 2025 earnings Positive -8.5% Reported 32% YoY revenue growth and higher margins but wider net loss.
Nov 11 PIPE pricing Negative +0.0% Priced $2.85M PIPE with common shares and three-year warrants.
Nov 03 Earnings timing Neutral -0.8% Announced timing and call details for Q3 2025 financial results.
Pattern Detected

Recent TNON news often saw muted or negative price reactions: a positive Q3 report coincided with an 8.53% drop, while financing and product updates generally produced flat trading.

Recent Company History

Over the last few months, Tenon reported growing Q3 2025 revenue of $1.2M with a 66% gross margin and continued net losses of $3.3M. The company expanded its SI joint portfolio through the SiVantage acquisition and launched Catamaran SE and SImmetry+ initiatives. It also completed an at-the-market PIPE raising about $2.85M via 2,217,904 shares plus warrants, alongside insider purchases disclosed in multiple Form 4s. Today’s SImmetry+ initial-case announcement builds on this multi-product sacro-pelvic fusion strategy and prior clinical evidence (EvoluSIon study).

Market Pulse Summary

This announcement highlights initial real-world use of Tenon’s SImmetry+ SI Joint Fusion System, bac...
Analysis

This announcement highlights initial real-world use of Tenon’s SImmetry+ SI Joint Fusion System, backed by 12‑month EvoluSIon data in 250 patients with 68.7% radiographic fusion and a 57.1% decrease in opioid use. It extends a multi-approach sacro‑pelvic strategy alongside Catamaran, following recent portfolio-expanding acquisitions and PIPE financing. Investors may watch future updates on broader commercial rollout, procedure volumes, and how these technologies affect revenue growth and margins alongside ongoing capital needs.

Key Terms

3D-printed titanium implants, bone graft, arthrodesis, radiographic fusion, +1 more
5 terms
3D-printed titanium implants technical
"SImmetry+ combines 3D-printed titanium implants, a robust joint decorticator..."
Metal medical devices made by building a titanium part layer by layer with a 3D printer to match a patient’s anatomy, commonly used for bone, joint, or dental implants. Investors care because the technology can reduce manufacturing waste, enable personalized fits that may improve surgical outcomes, and create new pricing and regulatory considerations that affect sales growth, profit margins, and reimbursement prospects in the healthcare market.
bone graft medical
"including joint decortication, bone graft placement, and rigid fixation..."
A bone graft is a surgical procedure that places natural or synthetic material into a damaged or missing bone area to provide a scaffold that helps the body rebuild bone and restore strength. For investors, bone grafts are important because they drive sales of implants, biologic materials and surgical tools, and are sensitive to clinical outcomes, regulatory approvals and reimbursement—factors that affect companies’ revenue and growth prospects.
arthrodesis medical
"both designed to be minimally invasive, enable authentic arthrodesis and supported..."
Arthrodesis is a surgical procedure that permanently joins two bones in a joint, effectively eliminating movement in that area. It is often used to reduce pain and stabilize a joint affected by injury or disease. For investors, understanding this term helps clarify how medical treatments can impact healthcare companies and the broader industry, especially as demand for joint stabilization procedures grows with aging populations.
radiographic fusion medical
"at 12 months, 68.7% of patients showed radiographic fusion of the SI joint..."
Radiographic fusion is a medical process where two or more bones are permanently joined together, often confirmed through imaging scans like X-rays. It is similar to welding two pieces of metal so they become one solid piece, which can improve stability and function. For investors, understanding radiographic fusion is important because it can influence the demand for related medical devices and procedures, impacting industry growth and company performance.
computed tomography (CT) medical
"radiographic fusion of the SI joint confirmed by computed tomography (CT)..."
Computed tomography (CT) is a medical imaging technique that uses X-ray technology to create detailed cross-sectional pictures of the inside of the body, similar to taking multiple slices of a loaf of bread to see its internal structure. For investors, understanding CT is important because it represents advanced technology that can improve diagnostics and healthcare efficiency, potentially influencing the performance of companies involved in medical imaging and health services.

AI-generated analysis. Not financial advice.

~ 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. MAINSAILTM, 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.
Tenon Medical, Inc.

NASDAQ:TNON

TNON Rankings

TNON Latest News

TNON Latest SEC Filings

TNON Stock Data

10.33M
9.32M
14.47%
1.4%
7.17%
Medical Devices
Surgical & Medical Instruments & Apparatus
Link
United States
LOS GATOS