Core Insights - Carlsmed, Inc. reported a revenue of $12.1 million for Q2 2025, marking a 99% year-over-year growth from $6.1 million in Q2 2024 [1][3] - The company expects full-year revenue for 2025 to be between $45.5 million and $47.5 million, representing a growth of 67% to 75% compared to 2024 [4] Financial Performance - Gross profit for Q2 2025 was $8.9 million, up from $4.6 million in Q2 2024, with a gross margin of 73.4% compared to 75.0% in the prior year [3] - Operating expenses increased to $15.4 million in Q2 2025 from $10.9 million in Q2 2024, driven by higher sales and marketing expenses [3] - The net loss for Q2 2025 was $6.8 million, slightly higher than the $6.3 million loss in Q2 2024 [3] Operational Highlights - The company successfully completed its first personalized cervical spine surgery using the AI-enabled aprevo technology platform in July 2025 [2][3] - The aprevo cervical procedures received CMS New Technology Add-On Payment (NTAP) reimbursement effective October 1, 2025 [3] Market Positioning - Carlsmed's growth is attributed to the adoption of its AI-enabled aprevo technology platform, which is recognized for delivering better patient outcomes compared to traditional devices [2] - The company aims to establish itself as the new standard of care in spine fusion surgery as it enters the second half of 2025 [2]

Financial Data and Key Metrics Changes - Revenue for Q2 2025 was $12.1 million, representing a year-over-year growth of 99% compared to $6.1 million in Q2 2024 [5][11] - Gross margin decreased to 73.4% in Q2 2025 from 75% in Q2 2024, primarily due to expedite production fees and material costs [11][12] - Operating expenses increased to $15.4 million in Q2 2025 from $10.9 million in Q2 2024, with R&D expenses slightly rising to $4.2 million [12][13] - GAAP net loss was $6.8 million in Q2 2025 compared to a net loss of $6.3 million in Q2 2024 [13] Business Line Data and Key Metrics Changes - The company reported 199 surgeon users who completed more than one procedure using the Aprivo technology platform, a 72% increase from the previous year [6] - The average revenue per procedure remained constant at approximately $30,000 [16][39] Market Data and Key Metrics Changes - The total addressable market for Aprivo lumbar spine fusions is estimated to exceed $13 billion, with nearly 4,000 spine surgeons in the U.S. [6] - Recent CMS decisions have enhanced hospital reimbursement for Aprivo procedures, translating to an incremental reimbursement of $20,000 to $50,000 depending on procedure complexity [8] Company Strategy and Development Direction - The company aims to establish a new architecture of surgery to improve patient outcomes and reduce healthcare costs [5] - Plans for a commercial launch of the personalized cervical fusion technology using the Aprivo platform are set for 2026 [10][42] - The company is focused on innovation, including a digital production system that reduces turnaround time for implants from over four weeks to ten business days [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about growth due to strong surgeon adoption and compelling clinical data supporting the Aprivo technology [11][16] - The company expects to achieve full-year 2025 revenue guidance of $45.5 million to $47.5 million, representing a growth of 67% to 75% over 2024 [16][51] Other Important Information - The company raised $100.5 million in gross proceeds from its IPO, providing sufficient capital to execute its business strategy [14][15] - Cash used in operating activities for the first half of 2025 was $15.2 million, with a monthly average cash burn of $2.5 million [15] Q&A Session Summary Question: Utilization trends in the quarter - Management noted strong uptake in utilization and new surgeon adoption, exceeding internal plans [20][21] Question: Guidance as a new public company - Management highlighted key growth drivers including recent CMS decisions and ongoing innovation [22][23] Question: Procedure adoption and segmentation - The company has seen growth in short construct fusion procedures, expanding from initial targeting of complex procedures [26][27] Question: Seasonality in revenue guidance - Management acknowledged seasonality in procedure volume but did not provide specific Q3 guidance [29][32] Question: Surgeon training and productivity - The company added 47 new surgeons, reaching a total of 199, and plans to continue investing in education programs [34][35] Question: Pricing and revenue guidance - Average revenue per procedure is expected to remain constant, with growth driven by procedure volume [38][39] Question: Cervical launch preparations - The company is preparing for the cervical launch with recent Medicare announcements and technology advancements [42][43] Question: Artificial intelligence costs - Investments in AI are expected to enhance scalability without disproportionately affecting the P&L [44][45] Question: Revenue outlook and surgeon adds - New surgeon additions are expected to drive revenue growth in subsequent quarters [58][60]

TORONTO and DALLAS, Aug. 28, 2025 /PRNewswire/ - Perimeter Medical Imaging AI, Inc. (TSX-V: PINK) (OTCQX: PYNKF) ("Perimeter" or the "Company"), a commercial-stage medical technology company, today announced the appointment of Ted James, MD, MHCM, FACS, to the newly created position of Chief Medical Officer ("CMO").In this fractional role, Dr. James will bring his clinical and leadership experience to help Perimeter strengthen its medical strategy and accelerate adoption of its technology. His perspective a ...

Core Viewpoint - The strategic cooperation agreement between Teda Biomedical and Suihong Huachuang Technology aims to leverage each other's resources and technological advantages in the AI healthcare sector, focusing on specialized operations and market promotion of AI medical health and data businesses [1][2]. Group 1: Strategic Cooperation - The partnership will enhance resource and technology synergies, utilizing Suihong Huachuang's established government collaborations and sales channels to support Teda Biomedical's AI medical model and related data business market promotion [2]. - Suihong Huachuang's core technological capabilities in AI computing infrastructure and hardware manufacturing will provide stable and efficient computing power for Teda Biomedical's AI medical model training and real-world application [2]. Group 2: Business Development Focus - Teda Biomedical is actively advancing the research and commercialization of AI medical models and related data businesses, emphasizing the importance of high-quality computing resources, stable hardware solutions, and extensive market promotion channels [1]. - The company plans to engage in resource alignment and cooperation discussions to ensure the sustainable and steady advancement of its business [1].

Company Overview - Heartflow, Inc. is a leader in AI technology for coronary artery disease (CAD) [1] - The company is advancing coronary care by transforming CAD into a screenable, diagnosable, and manageable condition [3] - Heartflow One is the only complete, non-invasive, precision coronary care platform providing patient insights throughout the guideline-directed CCTA pathway [3] - The AI-driven platform includes Roadmap™ Analysis, FFRCT Analysis, and Plaque Analysis, supported by the ACC/AHA Chest Pain Guideline and backed by over 600 peer-reviewed publications [3] - Heartflow has assisted clinicians in managing over 400,000 patients worldwide [3] Upcoming Events - Members of Heartflow management will participate in a fireside chat at the Morgan Stanley 23 Annual Global Healthcare Conference on September 10, 2025, at 6:15 a.m. PT / 9:15 a.m. ET [1] - A live and archived version of the fireside chat will be available on the Investor Relations section of the Heartflow website [2]

Core Viewpoint - Sanara MedTech Inc. is set to present at the Cantor Global Healthcare Conference, highlighting its focus on developing transformative medical technologies aimed at improving clinical outcomes and reducing healthcare costs in surgical and wound care markets [1][2]. Company Overview - Sanara MedTech Inc. specializes in medical technology, particularly in surgical, chronic wound, and skin markets, with a commitment to enhancing clinical outcomes and minimizing healthcare expenditures [3]. - The company markets and distributes a range of products, including CellerateRX Surgical Activated Collagen and FORTIFY TRG Tissue Repair Graft, primarily in the North American advanced wound care and surgical tissue repair markets [3]. - Sanara's product portfolio includes advanced biologic products such as ACTIGEN™ Verified Inductive Bone Matrix and BIASURGE Advanced Surgical Solution, along with wound care products like BIAKŌS Antimicrobial Skin and Wound Cleanser [3]. - The company is actively pursuing long-term strategic partnerships to develop products that improve patient outcomes while reducing overall costs [3]. Upcoming Events - Management will participate in a fireside chat presentation at the Cantor Global Healthcare Conference on September 3, 2025, at approximately 2:45 p.m. Eastern Time [1]. - Presentation materials will be available on the company's investor relations website prior to the event, along with a live audio webcast and an archive for replay after the conference [2].

Core Insights - The study published in The Lancet Respiratory Medicine indicates a significant rise in obstructive sleep apnea (OSA) in the U.S. over the next three decades, driven by factors such as an aging population and increasing body mass index (BMI) [1][2][3] Group 1: Prevalence Estimates - By 2050, OSA is projected to affect nearly 77 million U.S. adults, a relative increase of nearly 35% from 2020, impacting 46% of adults aged 30-69 [2] - A 65% relative increase in OSA prevalence among women is expected, reaching 30.4 million cases by 2050, highlighting the need for greater awareness of OSA symptoms in women [6] - A 19% relative increase in OSA prevalence among men is anticipated, reaching 45.9 million cases by 2050, indicating ongoing risks in aging male populations [6] Group 2: Health Implications - OSA is linked to serious health issues, including hypertension, cardiovascular disease, diabetes, and stroke, with over 80% of cases remaining undiagnosed and untreated [3] - The study emphasizes the urgent need for earlier diagnosis, preventative strategies, and healthcare resource allocation to address OSA as a major public health concern [3][5] Group 3: Industry Response - The research calls for expanded screening, increased awareness of symptoms, and improved access to testing and treatment, particularly in home settings [4][5] - The anticipated impact of GLP-1 therapies on future OSA prevalence is limited, with reductions estimated at under 5%, indicating that obesity is just one of many contributing factors to OSA [6] - The study serves as a data-driven forecast to help health systems, payers, and policymakers prepare for the growing prevalence of OSA and improve long-term patient outcomes [5][6]

Financial Data and Key Metrics Changes - The company achieved record quarterly revenue of $17.4 million, representing a robust 17% year-over-year growth, bringing net revenues for the year to $64 million, also a record [6][17] - Operating income reached $3 million in Q4, marking a 30% increase year-over-year, with net income of $2.2 million, a 21% increase compared to the same quarter last year [7][8] - The diluted earnings per share increased to $0.25, a 24% increase versus the prior year [8] - Gross profit increased to $50 million, or 78.1% of net revenues, compared to 76.3% in the previous year [19] Business Line Data and Key Metrics Changes - Home Care segment revenue grew 15% year-over-year to $57.3 million, driven by an increase in direct sales representatives and higher net revenues per approval [6][17] - Hospital Surge revenue increased by 60%, while the distributor channel delivered 76% growth [6] - Non-home care business revenue grew 28.8% to $6.7 million, primarily due to increased distributor and hospital revenue [18] Market Data and Key Metrics Changes - The company reported a significant milestone with the addition of its common stock into the Russell 2000 index, which is expected to improve trading liquidity [9] - The company is targeting the large unrecognized market for bronchiectasis treatment, with an estimated 800,000 patients who could benefit from its SmartVest therapy [11] Company Strategy and Development Direction - The company is focused on expanding its direct sales team, ending the year with 55 representatives, up from 53 the previous year, and plans to increase this number to 61 in fiscal year 2026 [9][18] - The company is implementing a manufacturing optimization plan to add new capacity, expected to be completed in early fiscal year 2026 [14][35] - The company is enhancing its Smart Order e-prescribe solution to streamline order submissions and improve efficiency [15][52] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about future prospects, expecting to deliver double-digit top-line growth and strong operating cash flows in the upcoming fiscal year [21] - The company is well insulated from tariff-related turbulence, with 99% of revenues generated domestically [13] - Management highlighted the importance of the recent FDA approval of a drug for bronchiectasis, which is expected to raise awareness and potentially benefit the company [30][50] Other Important Information - The company completed a $5 million stock repurchase program in Q4, demonstrating confidence in its future [8] - The company maintained zero back orders in Q4 with a first pass yield of 99% [13] Q&A Session Summary Question: Can you provide more color on the strong margins in the quarter? - Management noted that strong growth in home care revenue, a high-margin channel, and a favorable mix within that channel contributed to the gross margin strength [25] Question: What caused the hospital channel to be so strong? - Management indicated that investments in hospital-focused sales reps and the untapped market dynamics contributed to the growth [27] Question: Are you seeing increased awareness around bronchiectasis due to new entrants in the market? - Management believes that the introduction of new drugs has raised awareness of bronchiectasis, which could serve as a tailwind for the company [30] Question: How does the manufacturing optimization plan expand current capacity? - Management stated that the plan is not primarily a margin play but aims to expand growth opportunities within the existing footprint [35] Question: What has been the response to the new CRM system? - Management reported positive feedback from the sales team, indicating that the new system has improved access to data and productivity [42]

Company to Advance Development of its Patented DeviceLAS VEGAS, Aug. 26, 2025 (GLOBE NEWSWIRE) -- Odyssey Health, Inc. (OTCQB: ODYY) (the “Company” or “Odyssey”), a technology and asset acquisition company focused on developing unique, life-saving medical products is pleased to provide the following update on the development of its Save A Life (“SAL”) choking rescue device. Odyssey has created a prototype device and now plans to continue the advancement of the product with the ultimate goal of filing a subm ...

Core Viewpoint - Ventripoint Diagnostics Ltd. is conducting a non-brokered private placement to raise up to CDN$500,000 through unsecured convertible debenture units, which will be convertible into common shares and include purchase warrants [1][2]. Group 1: Offering Details - The offering consists of unsecured convertible debenture units, with each unit having a principal amount of $1,000 convertible into common shares at a price of $0.11 per share [1][2]. - Each unit will also include 9,000 common share purchase warrants, allowing the holder to purchase shares at $0.14 until December 31, 2027 [1][2]. - The debentures will mature on December 31, 2027, and will bear an interest rate of 10%, payable semi-annually either in cash or in common shares at a 20-day VWAP market price [3]. Group 2: Use of Proceeds - The proceeds from the offering will be utilized for operational costs related to sales and marketing, hiring additional key personnel, and general working capital purposes [5]. Group 3: Securities and Compliance - All securities issued will be subject to a hold period of four months plus one day from the closing date of the offering, and the offering is subject to approval by the TSXV [6]. - The securities will not be registered under the U.S. Securities Act of 1933 and cannot be offered or sold in the United States without proper registration or exemption [7]. Group 4: Insider Transactions and Other Issuances - The corporation has issued 564,473 common shares to settle $76,203.59 of debenture interest, with shares subject to a hold period [8]. - An insider transaction involved the issuance of 50,042 shares, which is considered a related party transaction under MI 61-101, relying on exemptions due to the transaction's market capitalization not exceeding 25% [9]. - The corporation has also issued 6,000 common shares related to the exercise of broker's warrants and 200,000 options exercised at $0.11, both subject to a hold period [10][11]. Group 5: Advisory Agreement - An advisory agreement with Fournel Advisory includes a total consideration of 265,000 options exercisable at $0.11 per share and a cash payment of USD $30,000 [12]. Group 6: Company Overview - Ventripoint has established itself as a leader in applying AI to echocardiography, with its VMS+ products providing accurate cardiac measurements comparable to MRI, supported by regulatory approvals in the U.S., Europe, and Canada [14].