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Overview of Tenon Medical, Inc.
Tenon Medical, Inc. is a specialized medical device company that has developed a novel, minimally invasive approach to addressing sacroiliac (SI) joint disorders. At its core, the Company focuses on the Catamaran System, a unique titanium implant engineered to stabilize and fuse the SI joint with reduced surgical trauma through an innovative inferior-posterior approach. This method is designed to protect critical neural and vascular structures while ensuring penetration into the strongest cortical bone, thereby aligning with the established AO principles of arthrodesis: proper joint preparation, rigid fixation, and effective bone graft augmentation.
Technology and Clinical Application
The Catamaran System is at the forefront of medical innovation, relying on a robust titanium implant that traverses both the axial and sagittal planes of the ilium and sacrum. Its transfixing design not only offers immediate stabilization but is also engineered for long-term fusion, making it an effective option for patients with SI joint dysfunction. The Company’s approach emphasises a less invasive procedure which supports improved clinical outcomes, evidenced by enhanced patient satisfaction and significant reductions in pain and disability scores based on interim clinical studies.
Commercial Model and Market Position
Operating within the competitive medical device industry, Tenon Medical has strategically targeted three distinct commercial opportunities: primary SI joint procedures, revision procedures for failed SI joint implants, and SI joint fusion adjuncts to spine fusion constructs. The majority of the Company’s revenue is generated through the sales of the Catamaran System to a select group of specialized clinicians. This focused business model not only ensures a concentrated approach to market penetration but also reinforces its niche positioning in the treatment of lower back pain caused by SI joint disorders.
Innovation, Education, and Clinical Data
Tenon Medical’s commitment to innovation is further underscored by its extensive intellectual property portfolio, which includes several granted patents and numerous pending applications that protect its proprietary technology. The Company places a strong emphasis on educational initiatives and targeted training sessions for physicians, ensuring that its clinical partners are well-versed in the advantages of this minimally invasive approach. Robust clinical data and positive interim results from post-market studies reinforce the safety and efficacy of the Catamaran System, adding to the overall trustworthiness and authoritativeness of the business.
Industry Expertise and Future Outlook
With decades of cumulative experience in medical device innovation, Tenon Medical leverages its deep clinical insights and technical expertise in the SI joint market. Its precise approach to implant design and surgical technique illustrates a profound understanding of spine and orthopedic surgery, positioning the Company as a trusted provider of specialized implant solutions. The educational programs, along with comprehensive clinical studies and positive patient outcomes, serve as a testament to the Company’s commitment to advancing patient care through less invasive, highly effective surgical solutions.
Competitive Landscape
Within a market populated by various medical device innovators, Tenon Medical differentiates itself through its focus on a specific, underserved clinical niche. The innovative design of the Catamaran System, combined with a rigorous emphasis on clinician education and a robust patent portfolio, reinforces its competitive position. The Company’s strategy of targeting a limited number of high-volume, specialized clinicians allows for precise market penetration and fosters strong relationships within the medical community, which bolsters its credibility and trust among healthcare providers.
Summary
Overall, Tenon Medical, Inc. exemplifies a focused, research-driven approach to solving complex SI joint disorders through innovative, minimally invasive technology. The integration of robust clinical evidence, a targeted business model, and deep domain expertise positions the Company as a significant, authoritative player in its field, offering a trusted solution for clinicians and enhancing patient outcomes.
Tenon Medical (NASDAQ:TNON), a company focused on sacroiliac joint disorders treatment, has announced a $2.5 million registered direct offering priced at-the-market under Nasdaq rules. The company will issue 1,271,500 shares of common stock at $2.00 per share to a single healthcare focused institutional investor.
In a concurrent private placement, Tenon will also issue warrants to purchase up to 1,271,500 shares of common stock with an exercise price of $2.00 per share. These warrants will be immediately exercisable and expire after five years.
The offering is expected to close around March 27, 2025. A.G.P./Alliance Global Partners is serving as the sole placement agent. The proceeds will be used for working capital and general corporate purposes.
Tenon Medical (NASDAQ:TNON), a company focused on sacroiliac joint disorders treatment, has announced a registered direct offering and concurrent private placement priced at-the-market under Nasdaq rules. The company will issue 733,500 shares of common stock at $2.00 per share to a single healthcare focused institutional investor.
In the concurrent private placement, Tenon will issue warrants to purchase up to 733,500 additional shares at an exercise price of $2.00 per share, exercisable immediately with a five-year expiration. The offering, expected to close around March 26, 2025, aims to raise approximately $1.5 million in gross proceeds for working capital and general corporate purposes. A.G.P./Alliance Global Partners is serving as the sole placement agent.
Tenon Medical (NASDAQ:TNON) has received FDA clearance for an expanded indication of its Catamaran SI Joint Fusion System. The new clearance allows the device to be used in augmenting thoracolumbar fusion, enabling treatment of the SI joint either as a standalone procedure or to augment spinal fusion.
This regulatory milestone opens up a new market opportunity for the company in complex spine surgery. The Catamaran system's unique design provides physicians with enhanced flexibility in patient treatment. The company's ongoing MAINSAIL clinical trial demonstrates the system's ability to achieve authentic fusion of the SI Joint in a safe, reliable, and efficient manner.
Tenon Medical (NASDAQ:TNON) reported its Q4 and full-year 2024 financial results, showing mixed performance. Full-year revenue reached $3.3 million, marking a 12% increase from 2023, with improved gross profit of $1.7 million and gross margin of 52%.
Q4 2024 revenue remained flat at $0.8 million compared to Q4 2023, while gross profit decreased to $353,000 from $559,000, with margins declining to 46% from 69%. The company's Catamaran SI Joint Fusion System achieved significant milestones, including positive interim results from the MAINSAIL Study and completion of over 1,000 surgical procedures.
Notable developments include the expansion of their patent portfolio to twelve U.S. and international patents, successful initial clinical procedures with the new Catamaran SE platform, and securing an additional $3M in capital in March 2025. The company plans a national commercial launch of Catamaran SE in mid-2025.
Tenon Medical (NASDAQ:TNON), a company focused on sacroiliac joint disorders treatment, has secured $3.0 million in gross proceeds through a warrant inducement transaction with an existing healthcare-focused institutional investor. The agreement involves the immediate exercise of Series A and B Warrants for 2,445,700 total shares at a reduced price of $1.25 per share.
In exchange, the investor will receive new unregistered warrants in a private placement: Series C-1 Warrants for 2,445,700 shares and Series C-2 Warrants for 1,222,850 shares, both with a $1.25 exercise price. The C-1 Warrants will expire in 5 years and C-2 Warrants in 3 years from stockholder approval date. The transaction is expected to close around March 12, 2025.
The company plans to use the net proceeds for working capital and general corporate purposes. A.G.P./Alliance Global Partners served as the exclusive financial advisor for this transaction.
Tenon Medical (NASDAQ:TNON) has received approval for two additional patents from the European Patent Office for their Catamaran SI Joint Fixation Device. The patents, which will be granted within the European Community, are focused on the company's novel sacroiliac joint prostheses technology. According to Richard Ginn, Co-Founder and Chief Technology Officer, this approval strengthens Tenon's global patent portfolio and demonstrates their dedication to innovation in treating Sacroiliac Joint (SIJ) disorders.
Tenon Medical (NASDAQ:TNON), a company focused on Sacroiliac Joint (SIJ) disorders treatment, has scheduled its Q4 and full year 2024 financial results release for March 20, 2025, after market close. The company will host a conference call at 4:30 p.m. Eastern Time on the same day, featuring a Q&A session with its covering analyst.
The earnings call replay will be accessible through April 3, 2025, via Tenon's Investor Relations website or by telephone using the access code 13751490.
Tenon Medical (NASDAQ:TNON), a company focused on treating Sacroiliac Joint (SIJ) disorders, has announced that CFO Kevin Williamson will conduct one-on-one investor meetings during the 43rd Annual J.P. Morgan Healthcare Conference week in San Francisco, starting January 13th, 2025.
The conference is recognized as the healthcare industry's premier global investment forum, featuring over 500 healthcare companies and bringing together executives, investors, and innovators from across the healthcare sector. The event showcases innovations in biotechnology, pharmaceuticals, and healthcare technologies.
Interested parties can schedule meetings with Tenon's management by contacting their investor relations team at tenon@mzgroup.us.
Tenon Medical has successfully completed initial clinical cases with its new Catamaran SE SI Joint Fixation Device across multiple centers in Idaho, Pennsylvania, Minnesota, Arizona, and Utah. The new implant features a 30% reduction in width compared to the original Catamaran device, making it suitable for smaller SI joint anatomy or revision surgeries. The device is a single, MRI-compatible titanium implant designed to stabilize and fuse the SI joint. Over 750 Catamaran fixation devices have been implanted to date for treating SI Joint dysfunction, sacroiliitis, and revision cases.
Tenon Medical (NASDAQ: TNON), a company focused on Sacroiliac Joint (SIJ) disorders treatment, has scheduled its Q3 2024 financial results release for November 13, 2024, after market close. The company will host a conference call at 4:30 p.m. Eastern Time on the same day, featuring a Q&A session with covering analysts. The call will be accessible via phone (1-800-717-1738 US, 1-646-307-1865 International) and webcast. A replay will be available through November 27, 2024, via the company's IR website or telephone.