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LOS GATOS, CA - Tenon Medical, Inc. (NASDAQ:TNON), a micro-cap medical device company with a market capitalization of $3.14 million and impressive gross margins of 52%, has received FDA clearance for an expanded use of its Catamaran SI Joint Fusion System. According to InvestingPro data, while the company maintains a healthy balance sheet with more cash than debt, it faces challenges with rapid cash burn. The system, originally designed for SIJ disorders, can now also be used to augment thoracolumbar fusion in spinal surgeries.
This new indication allows the Catamaran system to be used not only as a stand-alone treatment for the SI joint but also as a supplementary measure in complex spinal procedures. The FDA’s clearance marks a significant milestone for Tenon Medical, potentially opening up a substantial new market segment for the company.
Richard Ginn, Co-Founder and Chief Technology Officer of Tenon Medical, highlighted the FDA’s recognition as an important step for the company, emphasizing the system’s unique design which offers physicians increased flexibility in patient treatment.
Steve Foster, CEO of Tenon Medical, expressed confidence in the Catamaran system’s performance, citing ongoing clinical trials and its potential role in enhancing spinal fusion surgeries. He believes that the system’s ability to achieve authentic fusion of the SI joint safely and efficiently will make it a valuable tool for surgeons.
The Catamaran system, which launched nationally in October 2022, utilizes a novel, less invasive approach with a robust titanium implant designed to stabilize the SI joint. Its surgical approach is intended to avoid critical neural and vascular structures while targeting strong cortical bone. Despite recent market challenges, with the stock down nearly 88% over the past year, the company has maintained revenue growth of 11.92% in the last twelve months. For detailed analysis and additional insights, check out the comprehensive Pro Research Report available on InvestingPro.
Following the FDA clearance, Tenon Medical aims to capitalize on three commercial opportunities within the SI joint market: primary SI joint procedures, revision of failed SI joint implants, and augmentation of spinal fusion. The company maintains strong liquidity with a current ratio of 4.39, positioning it well for these expansion efforts. InvestingPro subscribers can access 12 additional exclusive ProTips and comprehensive financial metrics to better evaluate TNON’s growth potential.
The information in this article is based on a press release statement from Tenon Medical, Inc.
In other recent news, Tenon Medical Inc. reported a 12% increase in full-year revenue for 2024, reaching $3.3 million, despite a 4.7% decline in fourth-quarter revenue compared to the previous year. The company saw an improvement in its gross margin, which rose from 42% to 52%, and a narrowing of its net loss to $13.7 million from $15.6 million in 2023. Tenon Medical’s cash and cash equivalents increased to $6.5 million with no outstanding debt. The firm plans to commercially launch its Catamaran SE platform by mid-2025 as part of its growth strategy. The company is addressing reimbursement challenges and focusing on expanding its market presence, supported by ongoing clinical studies like the MAINSALE study. Tenon Medical also received three new U.S. patents related to its Catamaran system, enhancing its competitive position. The company has expanded its sales force, with six area sales managers and 42 independent distributor contracts in place to support its market expansion efforts.
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