Latest news with #EuropeanCE
Yahoo
01-07-2025
- Health
- Yahoo
Carthera's ultrasound system earns EMA endorsement as an orphan medical device
Carthera has received an orphan medical device status endorsement for its SonoCloud ultrasound system for treating brain disorders under a new pilot programme by the European Medicines Agency (EMA). The France-based company's SonoCloud system delivers ultrasound to temporarily open the blood-brain barrier. Activated ahead of drug administration, the skull implant is intended to allow therapeutic agents to better reach the brain. Past research has shown that the blood-brain barrier, a natural filtration system of the brain, limits the penetration of more than 98% of drugs. The endorsement means that Carthera will benefit from advice, including support around its clinical development strategy and clarification on the final steps before filing a European CE mark application for its SonoCloud system, from an EMA expert panel. Intended for medical device manufacturers and notified bodies, the endorsement is part of an EU pilot programme to support early access pathways for innovative devices targeting rare diseases. As part of the programme, the EMA has prioritised certain types of orphan medical devices such as those treating life-threatening medical conditions or those that could cause permanent impairment of a bodily function, and novel devices with potential major clinical benefits. 'This is a very important step for the company, since it creates a unique forum for dialogue with the expert panel prior to submitting the technical documentation for conformity assessment,' said Sandra Thiollière, director of regulatory affairs at Carthera. 'In parallel, we are continuing our early-stage contacts with our notified body to prepare for CE marking submission.' Carthera is currently evaluating SonoCloud in improving the treatment of recurrent glioblastoma (rGBM). In 2024, the Sorbonne University spinout shared results from a Phase I/II single-arm trial (NCT03744026) assessing the safety and efficacy of blood-brain barrier disruption with an implantable ultrasound system in rGBM patients receiving carboplatin. In 12 patients who received carboplatin just before using the device, the one-year overall survival rate (OSR) was 58%, with a median OS of 14 months from surgery. The historical rate of survival for patients living with rGBM is around 9-11 months. Carthera is currently recruiting patients for a pivotal trial of SonoCloud. The two-arm trial will enrol 560 patients and evaluate the system combined with carboplatin (CBDCA) versus standard of care, lomustine (CCNU) or temozolomide (TMZ), in patients undergoing planned resection for first recurrence glioblastoma. "Carthera's ultrasound system earns EMA endorsement as an orphan medical device" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Hans India
25-04-2025
- Business
- Hans India
Elite Elevators Launches India's First Fully Customizable Home Elevator
Bengaluru ; To cater to the rising demand for home elevators in multi-story houses and apartments, Elite Elevators, a pioneering global leader in the premium home lift sector, has launched Elite Elevators Bespoke—India's first fully customizable, luxury home elevator. The grand unveiling took place at the company's headquarters in Chennai, attended by senior management and employees. As the home elevator industry continues to evolve, Elite Elevators stays ahead of the trend by combining state-of-the-art technology with unmatched personalization. Bespoke redefines residential mobility, seamlessly integrating with diverse architectural styles to offer a sophisticated and tailored experience. Speaking on this achievement, Mr. Vimal Babu, Founder and CEO of Elite Elevators, said, 'At Elite Elevators, our mission has always been to revolutionize home mobility with world-class innovations. Through its enhanced customizable features, our Bespoke elevators are meticulously designed to integrate seamlessly into their daily lives, enhancing accessibility, safety, and compliance while embodying the perfect blend of aesthetics and technology giving the touch of luxury experience to the customer.' 'With the launch of Elite Elevators Bespoke, we are raising the industry benchmark by offering a truly luxurious, customizable, and seamless home mobility experience.' Mr Vimal added. With an emphasis on personalization, Elite Bespoke enables homeowners to customize every aspect of their elevator. The landing doors are available in custom sizes with centre or side openings, multiple finish/colour options, including full glass, blind, and fire-rated variants. The Landing Operating Panel (LOP) can be tailored with touch or button-based controls, along with customizable finishes and display backgrounds to match the interior aesthetic. The cabin interior presents a range of bespoke options, including customizable corner and ceiling frame colours and shape, flooring materials, unique ceiling designs, and wall finishes. The Car Operating Panel (COP) buttons can also be personalized to complement. Engineered in collaboration with leading European experts, Elite Elevators Bespoke features European CE certified technology, ensuring exceptional safety and performance. The elevator is designed with gearless, noiseless, and pit-less technology, making it suitable for both contemporary and heritage residences. Its energy-efficient system further supports sustainability without compromising on functionality or luxury.
Yahoo
04-03-2025
- Business
- Yahoo
Stereotaxis Inc (STXS) Q4 2024 Earnings Call Highlights: Strong Revenue Growth Amid Strategic ...
Fourth Quarter Revenue: $6.3 million, a 39% increase year-over-year. System Revenue (Q4 2024): $1.4 million, up from $0.1 million in Q4 2023. Recurring Revenue (Q4 2024): $4.9 million, compared to $4.5 million in Q4 2023. Full-Year 2024 Revenue: $26.9 million, slightly up from $26.8 million in 2023. Full-Year System Revenue: $8.6 million, compared to $8.7 million in 2023. System Backlog (Start of 2025): $15.2 million. Full-Year Recurring Revenue: $18.3 million, up from $18 million in 2023. Gross Margin (Q4 2024): Approximately 51%. Gross Margin (Full-Year 2024): Approximately 54%. Operating Expenses (Q4 2024): $10.8 million, including $2.5 million in non-cash stock compensation and $1.1 million non-cash mark-to-market adjustment. Adjusted Operating Expenses (Q4 2024): $7.2 million. Operating Loss (Q4 2024): $7.6 million. Net Loss (Q4 2024): $7.5 million. Adjusted Operating Loss (Q4 2024): $4 million. Adjusted Net Loss (Q4 2024): $3.8 million. Free Cash Flow (Q4 2024): Positive $1.3 million. Free Cash Flow (Full-Year 2024): Negative $8.5 million. Cash and Cash Equivalents (End of 2024): $12.4 million, with no debt. Warning! GuruFocus has detected 9 Warning Signs with STXS. Release Date: March 03, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Stereotaxis Inc (STXS) announced significant milestones with FDA submissions for key catheter innovations, indicating progress in their strategic transformation. The company reported a 39% year-over-year increase in fourth-quarter revenue, totaling $6.3 million, showcasing strong financial performance. Stereotaxis Inc (STXS) received European CE mark approval for the GenesisX robot and MAGiC ablation catheter, with plans for commercial launch in Europe. The strategic acquisition of APT has enhanced Stereotaxis Inc (STXS)'s in-house catheter development and manufacturing capabilities. The company is expanding its product portfolio with the introduction of the EMAGIN vascular catheter, targeting multiple new endovascular indications. Stereotaxis Inc (STXS) faces challenges with FDA regulatory approval timelines, particularly for the MAGiC catheter in the US. The company has a system backlog of $15.2 million, indicating potential delays in revenue recognition. Recurring revenue growth is impacted by catheter shortages from Johnson & Johnson, affecting overall financial performance. Operating expenses increased due to non-cash stock compensation and acquisition-related costs, impacting profitability. The macroeconomic environment and anti-corruption campaigns in China present headwinds for commercial efforts in the region. Q: Can you provide more details on the MAGiC catheter's approval process in the US and what needs to happen for a second-half approval? A: David Fischel, Chairman and CEO, explained that they are enrolling patients in Europe to meet FDA's unmet medical need criteria. The FDA is conducting a detailed review of the PMA submission, and Stereotaxis is responding to questions and refining the submission. There might be an audit of the manufacturing facility in Germany, but it's not certain. The FDA is working collaboratively to ensure a thorough and timely review. Q: How will the MAGiC Sweep high-density mapping catheter fit into the broader ecosystem, and how might it affect your relationship with Abbott? A: David Fischel stated that the MAGiC Sweep will be used in the majority of robotic procedures, allowing physicians to perform high-density mapping robotically. This development is part of a broader strategy and has been communicated to partners like Abbott, with no concerns about its impact on existing relationships. Q: Can you clarify the system revenue guidance for 2025, given the GenesisX launch in Europe and China? A: David Fischel noted that the guidance is conservative, focusing on transitioning existing backlog into revenue. The unpredictability of sales in China and the timing of revenue recognition contribute to the cautious outlook. The guidance does not assume significant sales in China and reflects modest expectations for GenesisX. Q: What is the expected timeline for GenesisX commercial approval in the US? A: David Fischel mentioned that they are responding to FDA questions and expect GenesisX approval before the compatible catheters are approved. They anticipate having at least one compatible catheter approved in the third quarter, allowing for a commercial launch in the US. Q: What is the strategic importance of the EMAGIN vascular guidance catheter, and how do you plan to prioritize its applications? A: David Fischel emphasized that while short-term revenue expectations for EMAGIN are modest, its strategic value is substantial. The catheter will enable the robot to become a multi-specialty platform, expanding its use into neurointervention, interventional cardiology, and oncology. The focus will be on demonstrating clinical utility in these areas to expand the robot's value proposition. Q: Is there any capacity constraint related to the MAGiC catheter, and how are you addressing it? A: David Fischel confirmed that they are ramping up manufacturing in Europe and working through administrative processes with hospitals. The goal is to ensure a steady supply as they scale up sales throughout the year. Q: How frequently do you expect the MAGiC Sweep mapping catheter to be used, and what is the expected impact on catheter sales? A: David Fischel anticipates that the MAGiC Sweep will be used in a significant portion of procedures, potentially increasing the pool of robotic users. The combined sales of MAGiC and MAGiC Sweep are expected to increase disposable revenue per procedure by more than fivefold. Q: What is included in the guidance for the MAGiC launch in Europe and the US? A: David Fischel clarified that the guidance includes $3 million to $4 million related to the MAGiC launch in Europe, with no revenue from a potential US launch included due to uncertainty in approval timelines. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
