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4 hours ago
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Tenon Medical Announces Initial Case Series Utilizing Catamaran(R) SI Joint Fusion System to Enhance Stabilization of the SI Joint for Patients Undergoing Lumbar Fusion
~ Andrew J. Trontis, MD from Progressive Spine and Orthopaedics, (Englewood, NJ) Completes Initial Case Series ~ LOS GATOS, CA / / June 12, 2025 / Tenon Medical, Inc. (NASDAQ:TNON) ("Tenon" or the "Company"), a company transforming care for patients suffering from certain Sacroiliac Joint (SIJ) disorders, today announced the completion of an initial case series utilizing the Catamaran® SI Joint Fusion System (the "Catamaran") to immobilize & stabilize the SI Joint providing added support at the base of a lumbar or thoracolumbar fusion. The case series was completed by Andrew J. Trontis, MD from Progressive Spine & Orthopaedics in Englewood, New Jersey. As announced previously by the Company, the Catamaran recently received an expanded indication for use from the U.S. Food and Drug Administration (FDA). The Catamaran is now approved to augment immobilization and stabilization of the SI joint for patients undergoing sacropelvic fixation as part of a lumbar fusion. "As an orthopedic spine surgeon managing complex spinal pathology, I am always looking for innovations that deliver long-term value to my patients," said Andrew J. Trontis, MD. "Integrating Catamaran into spinal fusion constructs has meaningfully enhanced my surgical approach - offering robust stabilization at the base of the fusion without adding significant morbidity, blood loss, or operative time. By securing this foundation early, we can reduce the risk of future sacroiliac joint pain or pelvic instrumentation failure, ultimately supporting more durable outcomes." "Achieving FDA clearance for Catamaran's use in augmenting spinal fusion has been a pivotal objective for Tenon throughout the system's development," added Steven M. Foster, President and CEO of Tenon Medical. "With our growing clinical experience and emerging data from the MAINSAIL trial, it's evident that we're providing a safe, dependable, and efficient method for authentic SI joint fusion. We believe Catamaran will be a crucial tool in addressing the sacropelvic biomechanical challenges presented during a complex spine surgery." This expanded indication is poised to open a substantial new market opportunity for the Company by addressing the need for robust SI joint stabilization and fixation as part of complex spinal fusion procedures. The Company remains committed to advancing care for patients with SI joint disorders and is excited about the potential of the expanded Catamaran indication to benefit a broader patient population. About Tenon Medical, Medical, Inc., a medical device company, is focused on developing and commercializing innovative surgical solutions that provide patients with SIJ disorders with a lasting solution for their pain. The Company has developed a minimally invasive surgical implant system, Catamaran®, that provides SIJ fusion for the treatment of chronic SIJ pain. The Catamaran System is designed to provide a novel and less invasive surgical solution for patients suffering from certain SIJ disorders. Forward-Looking StatementsThis press release contains forward-looking statements. Forward-looking statements are generally identifiable by the use of words like "may," "will," "should," "could," "expect," "anticipate," "estimate," "believe," "intend," "continue," "predict," "project," "plan," "seek," "would," "could," and other similar expressions. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the statements. Factors that may cause actual results to differ from those expressed or implied include, but are not limited to, the Company's ability to commercialize the Catamaran system, the effectiveness of the Catamaran system, and the Company's ability to obtain additional capital to fund its operations. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. About Tenon Medical, 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. For more information, please visit The Tenon Medical logo Tenon Medical, and Catamaran are registered trademarks of Tenon Medical, Inc. MAINSAIL is a trademark of Tenon Medical Safe HarborThis 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 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 Devine203-741-8811MZ North Americatenon@ SOURCE: Tenon Medical, Inc. View the original press release on ACCESS Newswire
Yahoo
14-05-2025
- Business
- Yahoo
Q1 2025 Tenon Medical Inc Earnings Call
Steven Foster; President, Chief Executive Officer, Director; Tenon Medical Inc Kevin Williamson; Chief Financial Officer; Tenon Medical Inc Scott Henry; Analyst; Alliance Global Partners Nicholas Sherwood; Analyst; Maxim Group Operator Greetings, and welcome to the Tenon Medical first-quarter 2025 financial results and corporate update conference call. As a reminder, this call is being recorded. Your hosts today are Steve Foster, President and Chief Executive Officer; and Kevin Williamson, Chief Financial Officer. Mr. Foster and Mr. Williamson will present results of operations for the first quarter ended March 31, 2025, and provide a corporate update. A press release detailing these results was released today and is available on the Investor Relations section of our company's website, Before we begin the formal presentation, I would like to remind everyone that statements made on the call and webcast may include predictions, estimates and other information that might be considered forward-looking. While these forward-looking statements represent our current judgment on what the future holds, they are subject to risks and uncertainties that could cause actual results to differ materially. You are cautioned not to place undue reliance on these forward-looking statements, which reflect our opinions only as of the date of this presentation. Please keep in mind that we are not obligating ourselves to revise or publicly release the results of any revision to these forward-looking statements in light of new information or future events. Throughout today's discussion, we will attempt to present some important factors relating to our business that may affect our predictions. For a more complete discussion of these factors and other risks, you should review our quarterly and annual reports on file with the Securities and Exchange Commission at At this time, I'll turn the call over to Tenon Medical's Chief Executive Officer, Steve Foster. Please go ahead, sir. Steven Foster Thank you, Sachi, and good afternoon, everyone. I'm pleased to welcome you to today's first quarter 2025 financial results and corporate update conference call for Tenon Medical. The first quarter was highlighted by continued progress in building evidence to support the Catamaran approach and technique while adding versatility via the upcoming full launch of the new SE platform in the midyear. During the quarter, revenue improved steadily by 1% over the prior year quarter, partially impacted by reimbursement pre-authorization headwinds that we believe to be transient in nature. We expect future coding clarity, combined with our recently published clinical data will positively impact these issues going forward. As we move forward to sustainable revenue growth, our stable cost structure is expected to maintain a gross margin performance at recent levels and improve with increases in revenue. With the completion of the Alpha clinical review of our new Catamaran SE platform, a second-generation and smaller version of our implant and access profile, we are now preparing for its full commercial launch in the midyear. The SE extends the line of implant offerings for physicians preferring a smaller Catamaran implant and access profile while performing SI joint fusion procedures. During the Alpha clinical review, we found that the features of SE are well received across physician specialties and applications. In particular, the low profile of SE provides significant flexibility for the physician when doing SI revision surgery. In March, the FDA cleared the Catamaran SI Joint Fusion System for an extended indication for use in augmenting thoracal lumbar fusion. With this approval, the Catamaran is now indicated to treat the SI joint as either a stand-alone treatment or to augment a spinal fusion. We believe this can be an important tool in the complex spine surgeon arsenal to support the base of a multilevel fusion. Recognition from the FDA of Catamaran's use to augment spinal fusion has been a long-term goal and further expands the platform's versatility. This new indication also opens the door to a previously untapped market and the potential for increased adoption. Underscoring our technical advances, we received 2 European patents during the first quarter directed to the novel Catamaran SI joint fixation device. This continued development of our intellectual property portfolio improves our competitive position in the industry and protects the overall portfolio. The Catamaran SI Joint Fusion System Intellectual Property portfolio now includes 12 issued US and foreign patents, along with 31 pending US and foreign patent applications. Tenon is committed to funding and executing clinical research that reinforces the safety and effectiveness of our technologies. Our post-market study, we call MAINSAIL is Tenon's prospective multicenter single-arm study that evaluates clinical outcomes of patients with sacroiliac joint disruption or degenerative sacroiliitis treated with the Catamaran SI Joint Fusion System. Patients will be evaluated for a period of up to 24 months, reviewing various patient-reported outcomes, radiographic assessments and adverse events. In short, the data collected aims to show the Catamaran system delivers on its promises. Tenon announced the first peer-reviewed publication of our interim analysis from the MAINSAIL study in the third quarter of 2024. This interim analysis presents early experiences in the first 33 consecutive patients treated with the Catamaran SI joint fusion system across 6 US clinical sites with primary and secondary clinical endpoints analysis at 6 months and radiographic CT fusion assessment performed by independent reviewers at 12 months. Notable outcomes from this interim analysis include statistically significant reduction in SI joint pain and disability scoring at 6 months, a robust safety profile and high patient satisfaction throughout all follow-up time points. Results provided definitive evidence of fusion response at 12 months and efficient surgical technique and procedure workflow. This peer-reviewed analysis reinforced that the Catamaran system's minimally invasive inferior posterior approach is safe and effective in the objective of relieving pain and reducing disability in adult patients diagnosed with SI joint disruption or degenerative sacroiliitis that failed nonsurgical treatment. Early results and evaluations solidify our thesis that the Catamaran's unique design and less invasive inferior posterior approach is functioning as intended to optimize patient outcomes. Of note, the interim data from our study and the over 1,000 surgeries performed to date with the Catamaran system demonstrate its exceptional safety profile, benefiting patients and the patients they treat. The second interim analysis will be published midyear 2025. At the time of publication, approximately 1/2 of the up to 50 targeted enrollments will have crossed the 12-month milestone in follow-up. This 12-month milestone includes a CT scan to assess fusion of the SI joint [indiscernible] geographic data with ODI and VAS scores at predetermined time points will provide increasingly robust evidence to support Catamaran technology. The importance of this clinical research for the company cannot be overstated. It will be compelling for treating physicians and payers alike within a market segment that is lacking peer-reviewed data. While innovative technologies are exciting for treating physicians, clinical research is required to reinforce the value proposition. Additionally, these data sets are foundation to achieve positive coverage throughout the payer network. Our ongoing workshop activities led by a network of valued physician faculty combined with the robust commercial infrastructure rebuild have prepared us for rapid expansion. We hosted 34 physicians in Catamaran workshops during the first quarter of 2025. During the quarter, we took the opportunity to strengthen our balance sheet to execute on these upcoming milestones and fund growth initiatives. In March, we received a total of $7.1 million in gross proceeds from equity financing, which contributed to a cash balance of $10.3 million at quarter's end. Combined with a balanced financial discipline, we are confident that we have the cash runway to advance Tenon into our next phase of growth. Looking ahead, we are now focusing our investments on driving our top line via commercial expansion and focus on our workshop and training programs. In addition, we will be finishing investments in launching our Catamaran SE platform as well as completing the vital MAINSAIL prospective trial. And with that, I'll turn it over to Kevin to discuss our financials. Kevin Williamson Thank you, Steve. I will now provide a summarized review of our financial results. A full breakdown is available in our press release that crossed the wire this afternoon. Our revenue was $726,000 in the first quarter of 2025, an increase of 1% compared to $719,000 in the first quarter of 2024. The increase in revenue was primarily due to an increase in implants per surgical procedure, partially offset by a slight decrease in ASP driven by account mix. We remain focused on investing in our growth initiatives and continue to see positive results building. We believe the upcoming Catamaran SE commercial launch paired with the publishing of our second interim analysis of our MAINSAIL study will be growth catalysts along with the continued expansion of our sales force throughout the remainder of 2025. Gross profit in the first quarter of 2025 was $323,000 or 44% of revenue compared to $470,000 or 65% of revenue in the comparable year ago quarter. Gross margin percentage varied from period to period, driven by the absorption of production overhead costs into our standard costs with operating leverage created by lower fixed costs. Operating expenses totaled $4 million for the first quarter of 2025 as compared to expenses of $4 million in the first quarter of 2024. Operating expenses were flat due to increases in sales and marketing, offset primarily by decreases in professional fees, stock-based compensation and insurance costs. With continued planned investments in growth, including expanding the sales force, participation in industry trade show events, prioritizing market access efforts and driving reimbursement and coverage initiatives, increases in sales and marketing expenses are expected in future quarters. Net loss was $3.6 million for the first quarter of 2025 as compared to a loss of $3.6 million in the same period of 2024. While we expect to continue to improve our net loss, the company does expect to incur additional losses in the future. Now turning to the balance sheet. As of March 31, 2025, cash and cash equivalents totaled $10.3 million as compared to $6.5 million as of December 31, 2024. Our healthy balance sheet is fortified with ample cash runway to accelerate investment in our growth initiatives, which was further boosted by 3 financing transactions in Q1 2025, totaling $7.1 million in gross proceeds. Lastly, as of March 31, 2025, the company has no outstanding debt. I will now turn the call back to Steve for closing thoughts. Steven Foster Thank you, Kevin. We are proud of the progress that's been made and the work that has gone into uniquely positioning Tenon Medical to grow with this expanding market. Going forward, we will be investing heavily in growth through commercial operations, clinical research and product refinement. I thank you all for attending. And now I'd like to hand the call over to our operator to begin our question-and-answer session with our covering analysts. Sachi? Operator (Operator Instructions) Scott Henry, Alliance Global Partners. Scott Henry I guess for starters, when we think about top line revenues, how would you describe your expectations for the trajectory through the year? Would you expect sequential growth every quarter? And just any thoughts as regards to 2Q, at least in broad terms, how we should think about the revenue growth there? Steven Foster Yes. Thank you, Scott. So a couple of different factors. One, we mentioned earlier is the reimbursement environment. I was privileged enough to attend the recent AMA meeting up in New York City. I do believe that there are clarifications coming in coding that will assist in moving things along in the pre-authorization phase. When physicians submit a patient for pre-authorization, they're simply seeking sort of the thumbs up, if you will, to proceed with the procedure. That has been delayed a good bit because of coding confusion and things of that nature. So we do anticipate that will start to resolve. Now that's not the flick of a switch, right? The coding book comes out in 2026. People will be processing this information. So it's not an overnight thing. It's a bit difficult to predict. But we do anticipate that will improve and get better and better as time goes along here, and that will contribute to us delivering incremental growth quarter-over-quarter. The second part of that is the building of our team, right, the onboarding of commercial resources to go out and sell the technology aggressively, engage distributors in different geographies and what have you. And that's really the part that we're focused on. So look, we anticipate being able to deliver incremental growth as these things develop, the second quarter and beyond in particular. And I think that's the way I would answer your question. Those are the 2 critical factors. Scott Henry Okay. And then when we think about the SE launch coming in the middle of the year, how -- will that be an inflection point? Or is that something that will help build the platform over the long run, but we won't notice a spike at that point? Just trying to get a sense of how we should be thinking about that product in the short term and in the long run. Steven Foster Yes. We believe it leans more towards an inflection point, right? We launched our initial product 1.5 years to 2 years ago. You get feedback immediately from the variety of different scenarios that our physicians face. And I can't stress enough that the revision component when there's other SI technologies there, having a smaller and lower profile implant can be really beneficial because you kind of have to work around stuff that's already there in really simple terms. So we do think it's going to be an inflection point. We think it will bring more physicians into the adoption phase of the technology. We've gotten a lot of feedback that people were seeking a lower profile. So we're excited about delivering this technology, and we think it will help us tremendously in delivering at the top line. Scott Henry Okay. And final question, just on the G&A. It was a little lower in the first quarter than the fourth quarter as well as, I believe, any of the quarters in 2024. Is that reflective of what we should see for the rest of the year? Or was there some noise in that number? Kevin Williamson I'm happy to jump in here. Scott, thanks for joining. I think reflective of the quarter and what you'll see moving forward with some additional investments and mainly on the sales side where you'll see those investments in the growth initiatives that we discussed in our remarks. Operator Nicholas Sherwood, Maxim Group. Nicholas Sherwood My first question is, how does the new indication for multiple spinal fusion surgeries expand your total addressable market? Steven Foster Thank you, Nicholas. Yes, this is a really important clearance for us. So to be clear, right, the physicians oftentimes because of the way the patient presents, choose to fuse multiple levels of the lumbar or even thoracic spine, right? It could be because of deformity, it could be because of degenerative issues, et cetera, right? When they do that, they have specific concerns at what we refer to as the bottom of that construct, right, which is the sacropelvic part of the anatomy, right? And one of the challenges there is the SI joint is moving, right? It's moving around. It may be a part of the patient's pain, it may not. But we all know from long experience that if we put any kind of hardware across the joint that's moving, over time, the body breaks it down and either shapes it loose or even at times fractures that hardware. The purpose of augmenting a long construct like that with Catamaran is to immobilize the SI joint in the short term, protect that hardware that's being placed there, so it doesn't create lucencies, shape loose, fracture, et cetera. And then set the joint up to heal and fuse in the long term, so the SI joint doesn't become an issue for the patient, right? So just -- I want to take just a moment to sort of describe what we're trying to accomplish there. It's all about immobilizing the SI joint, healing it so it doesn't move in the future. There are thousands of those kinds of procedures done in the US market alone every single year. It's obviously a very big market and the biggest players in spine participate in that market with their pedicle screws, their rods, their interbody spacers, their biologics, their computer-assisted navigation technology, all those things. right? And so us participating in that space, in the sacropelvic part of that construct is really meaningful, right? And so we believe it's a significant increase in addressable market, the way the technology can be implemented in one of these instances. And it really now is about us going out and explaining that value proposition to complex spine surgeons, presenting the data that we have, both biomechanical and clinical data and compelling them to look at this as a solution for their patients. So significant opportunity for us moving forward. Nicholas Sherwood Understood. And can you kind of talk about the reaction you've gotten about that approval from your trained physician base? And also, is there any additional insurance reimbursement work that -- or approvals that need to be received before the device can be used in these surgeries? Steven Foster Yes. The reaction from physicians -- again, it's early, we just got the clearance, et cetera. But the reaction is a positive because there is a lot of concern about the sacropelvic component of those long constructs. As a matter of fact, we were just out down in Florida at a significant spine meeting down there. And there was a full 3-hour afternoon session focused exclusively on, hey, what do we do in the sacropelvic part of a construct? What do we do at the bottom of this construct? So it's a hot topic. It's a significant issue that's seeking solutions out there right now. So the way I would respond to your question is there's a lot of interest. There are a lot of inquiries. There are a lot of opportunities to train. So we're in those early stages of moving physicians towards adopting the technology and making it part of their practice. As to reimbursement, yes, it's a slightly different reimbursement setup in those types of scenarios because there's obviously a big spinal procedure with a long incision and things like that going on as part of that procedure. In these instances, more often than not, we find physicians wanting to utilize our technology, what they refer to as bilaterally, right? So there's an SI joint on the left, there's an SI joint on the right. In that instance, there would be 2 Catamaran implants used in the procedure to immobilize both the left and the right side. And we believe that existing codes for the fusion of the SI joint will be applicable in this scenario. We'll see as things move along, but we anticipate the coding is there and clear for the application of our technology in these instances. Nicholas Sherwood Got it. My last question is, can you kind of talk about the success you've had in targeting physicians for your workshops? I know that you started to develop a more targeted approach to recruiting physicians. Have you improved your capabilities in targeting the right people to get more retention rates and more procedures done by the physicians that you trained? Steven Foster It's a great question [indiscernible] so -- and there's 2 big components to that, right? One is having the data to target appropriately, and we made some investments there. The second thing is to be able to bring training to them. There's a big difference between asking a physician to burn their weekend, fly somewhere, stay in a hotel, get trained, et cetera, versus being able to bring the technology to them in their own clinic and utilize our synthetic model and do the training right there in a very convenient and efficient way for them. We now have both of those things in place. So we do believe that we're targeting better and that we're delivering a meaningful training in the most cost-effective and efficient manner possible for the physician. Operator There are no further questions at this time. I would like to turn the floor back over to Steven Foster, CEO, for closing comments. Steven Foster Thank you, Sachi. We appreciate your help. And I'd like to thank each of you for joining our earnings conference call today and look forward to continuing to update you on our ongoing progress and growth. If we were unable to answer any of your questions, please reach out to our IR firm, MZ Group, who will be more than happy to assist. And with that, I wish everyone a good day. Operator This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
13-05-2025
- Business
- Yahoo
Tenon Medical Reports First Quarter 2025 Financial Results
~ FDA Clearance of Catamaran® SI Joint Fusion System for New Indication to Augment Spinal Fusion ~ ~ Catamaran® SI Joint Fusion Technology Protected with Robust Patent Portfolio of Twelve U.S. and International Patents ~ ~ Received Gross Proceeds of ~$7.0 Million from Equity Financing Transactions ~ ~ National Commercial Launch of Catamaran SE in Mid-2025 ~ LOS GATOS, CA / / May 13, 2025 / Tenon Medical, Inc. (NASDAQ:TNON) ("Tenon Medical" or the "Company"), a company transforming care for patients suffering from certain Sacroiliac Joint (SIJ) disorders, today reported financial results for the first quarter ended March 31, 2025. Financial Results and Business Updates First Quarter 2025 Results: Revenue of $0.7 million, in line with the first quarter of 2024. Gross profit of $323,000, as compared to $470,000 in the first quarter of 2024. Gross margin of 44%, as compared to 65% in the first quarter of 2024. Cash and cash equivalents of $10.3 million as of March 31, 2025. Tenon received a total of $7.1 million in aggregate gross proceeds from equity financing transactions in March 2025, strengthened balance sheet to fund growth initiatives. U.S. Food and Drug Administration (FDA) provided clearance of an expanded indication for the Catamaran® SI Joint Fusion System for use in augmenting thoracolumbar fusion. With this approval, the Catamaran is now indicated to treat the SI joint as either a stand-alone treatment or to augment a spinal fusion. Granted issuance of two additional European patents highlighting a commitment to enhancing SI joint stabilization systems and methods, addressing the need for revision of other ineffective SI joint devices and as a patent protection mechanism. Hosted 34 physicians in targeted workshop activities and Catamaran focused training sessions within the First Quarter. Full commercial launch of Catamaran SE expected in mid-2025. Steve Foster, President and Chief Executive Officer of Tenon Medical, commented, "The first quarter of 2025 was underscored by a steady revenue improvement, partially impacted by reimbursement preauthorization headwinds that we believe to be transient in nature. Throughout the quarter we continued to invest in sales and marketing initiatives, with our sales operation highlighting compelling published clinical data and the upcoming full launch of the new SE platform mid-year. This new platform continues to receive positive responses from initial clinical experiences with its focus on reduction in access and implant size, providing options for physicians seeking a smaller profile for primary and revision SI applications. During the quarter we received clearance from the FDA for an expanded indication to utilize Catamaran in augmenting thoracolumbar fusion. With this approval, Catamaran is now indicated to treat the SI joint as either a stand-alone treatment or to augment a spinal fusion. We believe this can be an important tool in the complex spine surgeon arsenal to support the foundation of a multi-level fusion and to protect the various alar/iliac hardware used in such cases. By providing physicians with an option to augment the pelvic component of their construct we expect to unlock access to a significant market share and increased adoption. We continued to build on our global intellectual property portfolio with two additional European patents within the European Community. With the issuance of three US patents during the fourth quarter, the Catamaran® SI Joint Fusion System now comprises twelve issued U.S. and foreign (International) patents, and thirty-one pending U.S. and foreign patent applications. The additional patents recognize the novel Catamaran® SI joint prostheses as a solution to specifically address the need for revision of other ineffective SI joint devices and reinforces our commitment to innovation. Operationally, we took several steps to opportunistically strengthen our balance sheet allowing us to execute on upcoming milestones and fund growth initiatives. Three transactions totaling $7.1 million in aggregate gross proceeds from equity transactions contributed to a cash and cash equivalents balance of $10.3 million at quarter end. Combined with a balanced financial discipline, we are confident that we have the cash runway to advance Tenon into our next phase of growth. Looking ahead, upcoming catalysts include the full enrollment of our MAINSAIL post-market clinical trial for the Catamaran SI Joint Fusion System® and the next release of the study's interim analysis, which will be published mid-year 2025. Our restructured sales operation will continue to deliver results through our revamped training and education program, participation in trade shows, and marketing efforts throughout 2025. Taken together, as our clinical experience grows and the data from our clinical trial emerges, we believe we are ideally positioned to ramp up our broader market introduction and commercialization," concluded Foster. First Quarter 2025 Financial Results Revenue was $0.7 million in the first quarter of 2025, in line with revenue of $0.7 million in the comparable year ago period. The number of surgical procedures in the first quarter was flat as compared to the same period in 2024. The increase in revenue was driven by an increase in implants per procedure, partially offset by a slight decrease in ASP due to account mix. Gross profit in the first quarter of 2025 was $0.3 million, or 44% of revenues, compared to $0.5 million, or 65% of revenues in the comparable year ago quarter. Gross margin percentage continues to sustain a healthy level and varied from period to period driven by the absorption of production overhead costs into our standard cost and operating leverage created by lower relative fixed costs. Operating expenses totaled $4.0 million for the first quarter of 2025, as compared to expenses of $4.0 million in the first quarter of 2024. Operating expenses were flat due to increases in sales and marketing commission and payroll expenses, offset by decreases in professional fees, stock-based compensation and insurance costs. Continued investment in commercial activities will include sales force expansion, market access programs and reimbursement and coverage initiatives. As a result, increases in sales and marketing expenses are expected in future quarters. Net loss was $3.6 million for the first quarter of 2025, as compared to a loss of $3.6 million in the same period of 2024. The Company expects to incur additional losses in the future. As of March 31, 2025, cash and cash equivalents totaled $10.3 million, as compared to $6.5 million as of December 31, 2024. Tenon received a total of $7.1 million in aggregate gross proceeds from equity financing transactions in March 2025. As of March 31, 2025, the Company had no outstanding debt. First Quarter 2025 Earnings Conference Call Management will host a conference call at 4:30 p.m. ET (1:30 p.m. PT) today, Tuesday, May 13, 2025, to discuss Tenon's first quarter 2025 financial results, provide a corporate update, and conclude with Q&A with the Company's covering analyst. To participate, please use the following information: Date: Tuesday, May 13, 2025 Time: 4:30 p.m. Eastern time Dial-in: 1-877-407-0792 International Dial-in: 1-201-689-8263 Webcast: TNON Conference Call Please dial in at least 10 minutes before the start of the call to ensure timely participation. An audio playback of the call will be available through May 28, 2025 by dialing 1-844-512-2921 (USA) or 1-412-317-6671 (International). The access code will be 13752970. In addition, a webcast replay will be available on Tenon's Investor Relations website at 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 includes: 1) Primary SI Joint procedures, 2) Revision procedures of failed SI Joint implants and 3) SI Joint fusion adjunct to a spine fusion construct. For more information, please visit 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®, and Catamaran Transfixation Fusion Device® are registered trademarks of Tenon Medical, Inc. MAINSAILTM is also a trademark 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," and similar expressions and the negative versions thereof. These forward-looking statements, include, but are not limited to, statements regarding the completion of the Offering, the satisfaction of customary closing conditions related to the Offering and the anticipated use of proceeds therefrom. 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 Tenon's actual results to be materially different than those expressed in any forward-looking statements, please review Tenon's Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and updated from time to time in our Form 10-Q filings and in our other public filings on file with the SEC at 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. Investor Contact Shannon DevineMZ North America203-741-8811tenon@ Tenon Medical, Balance Sheets (Unaudited)(In thousands, except share data) March 31, December 31, 2025 2024 ASSETS Current assets: Cash and cash equivalents $ 10,311 $ 6,535 Accounts receivable, net 886 863 Inventory, net 607 606 Prepaid expenses and other current assets 186 206 Total current assets 11,990 8,210 Property and equipment, net 698 752 Deposits 51 51 Operating lease right-of-use asset 334 399 Deferred offering costs 321 431 TOTAL ASSETS $ 13,394 $ 9,843 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 496 $ 369 Accrued expenses 911 910 Current portion of accrued commissions 493 303 Current portion of operating lease liability 295 287 Total current liabilities 2,195 1,869 Accrued commissions, net of current portion 1,758 1,862 Operating lease liability, net of current portion 65 141 Total liabilities 4,018 3,872 Stockholders' equity: Series A convertible preferred stock, $0.001 par value; 4,500,000 shares authorized at March 31, 2025 and December 31, 2024; 256,968 shares issued and outstanding at March 31, 2025 and December 31, 2024 3,300 3,300 Series B convertible preferred stock, $0.001 par value; 491,222 shares authorized at March 31, 2025 and December 31, 2024; 86,454 shares issued and outstanding at March 31, 2025 and December 31, 2024 452 452 Common stock, $0.001 par value; 130,000,000 shares authorized at March 31, 2025 and December 31, 2024; 7,589,965 and 3,138,804 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively 8 3 Additional paid-in capital 77,978 70,962 Accumulated deficit (72,362 ) (68,746 ) Total stockholders' equity 9,376 5,971 TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 13,394 $ 9,843 Tenon Medical, Statements of Operations and Comprehensive Loss (Unaudited)(In thousands, except per share data) Three Months Ended March 31, 2025 2024 Revenue $ 726 $ 719 Cost of revenue 403 249 Gross Profit 323 470 Operating Expenses Research and development 691 669 Sales and marketing 1,647 1,381 General and administrative 1,662 1,926 Total Operating Expenses 4,000 3,976 Loss from Operations (3,677 ) (3,506 ) Other Income (Expense), net Gain on investments 61 27 Interest expense - (34 ) Other expense - (63 ) Total Other Income (Expense), net 61 (70 ) Net Loss $ (3,616 ) $ (3,576 ) Net Loss Per Share of Common Stock Basic and diluted $ (1.01 ) $ (10.02 ) Weighted Average Shares of Common Stock Outstanding Basic and diluted 3,597 357 Consolidated Statements of Comprehensive Loss: Net loss $ (3,616 ) $ (3,576 ) Foreign currency translation adjustment - 46 Total Comprehensive Loss $ (3,616 ) $ (3,530 ) SOURCE: Tenon Medical, Inc. 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Time of India
23-04-2025
- Business
- Time of India
NR Narayana Murthy's Catamaran funds auto parts maker Sedemac
Infosys founder NR Narayana Murthy 's family office Catamaran has made an investment in Pune-based automotive electronic and electrical component maker Sedemac Mechatronics . The financials of the transaction could not be ascertained. 'It was a secondary transaction. One of the early investors has exited and Catamaran has joined the cap table,' said a person privy to the development. The secondary deal comes ahead of talks of a potential initial public offering ( IPO ) of Rs 800-1,000 crore. While the exiting investor was not disclosed, its early investors include Nandan Nilekani-backed NRJN Family Trust, which invested in 2017, and growth investor Iron Pillar, which infused capital in 2018. The Catamaran deal also comes along the lines of the potential growth seen in the domestic supply chain in precision manufacturing in India. Its other investors include Xponentia Capital Partners, A91 Partners and 360 ONE Asset along with family offices of Infosys co-founder Kris Gopalakrishnan and Mindtree co-founder NS Parthasarathy, Raintree Family Office of Leena Dandekar and logistics & courier company AFL Pvt Ltd's chairman and managing director Cyrus Guzder. Both Catamaran and Sedemac founder Shashikanth Suryanarayanan declined to comment. Catamaran has over $1 billion in assets with public and private investments across technology, manufacturing, deep tech and ecommerce. The family office has backed around 28 private firms including Acko, Udaan, PaperBoat and Elon Musk's SpaceX. Its most recent publicly known investment was in July 2024 in Bengaluru-headquartered Eton Solutions, a cloud-based software services firm for family offices. Last year, Catamaran's president Deepak Padaki told ETabout the investor's strategy to focus on public market companies and plans to expand its portfolio with intelligent manufacturing startups focused on robotics, predictive analytics, maintenance, etc. In May last year, Sedemac, the brand name under which the company operates, saw a $100 million (then around Rs 830 crore) investment round led by Xponentia Capital Partners, A91 Partners and 360 ONE Asset at a valuation of $230 million. However, a majority of the funding was a secondary transaction with around $9 million of the investment infused into building a new manufacturing plant. That round saw the full exit of the company's first institutional investor Nexus Venture Partners along with TR Capital and Montane Ventures. Since its inception in 2007, the company has raised nearly $26 million (around Rs 220 crore as on Tuesday's exchange rate). Sedemac, an acronym for Separating Decision Making from Actuation, the principle behind mechatronics, was founded by IIT-Bombay professor Suryanarayanan and his lab students—Manish Sharma, Amit Dixit and Pushkaraj Panse. The company makes critical components used to help generate power in automotive vehicles. Its products are used in small engines, electric vehicles and e-bikes. Sedemac employs over 400 people and caters to large original equipment manufacturers (OEMs) in India, including Hero Motocorp , Mahindra Group and TVS. The firm has a development centre and two manufacturing plants in India.
