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Molecular Instruments and Standard BioTools Announce Collaboration to Bring Amplified Multi-Omic Readouts to Imaging Mass Cytometry
Businesswire· 2025-11-19 16:30
Core Insights - Molecular Instruments and Standard BioTools have announced a strategic collaboration to enhance Imaging Mass Cytometry (IMC) workflows using HCR imaging technologies, specifically the HCR HiFi Encoder for protein imaging with any primary antibody [1][4][5] Group 1: Collaboration Details - The partnership aims to create a unified platform for high-fidelity multi-omic analysis of RNA and protein targets in complex tissues, enabling amplified detection through HCR Gold and direct protein encoding via the HCR HiFi Encoder [2][4] - This collaboration integrates HCR Gold for RNA and protein imaging with the Hyperion Imaging System, marking the first time amplified detection for both RNA and protein is introduced in IMC technology [3][4] Group 2: Technological Advancements - The integration of HCR amplification with the Hyperion platform is expected to increase sensitivity, enhance flexibility, and accelerate the path from discovery to clinical translation [5] - The collaboration allows researchers to utilize their own primary antibodies in a simplified workflow while achieving robust visualization of low-abundance markers, significantly improving the sensitivity and flexibility of IMC spatial biology workflows [3][4] Group 3: Future Developments - Joint development activities are currently underway, with early-access opportunities available for interested collaborators [6]
Dexcom partners with Disabled American Veterans as part of new strategic initiative
Globenewswire· 2025-11-19 16:05
Core Insights - DAV has formed a strategic partnership with Dexcom to support diabetes care for veterans, marking Dexcom's first collaboration with a nonprofit serving this demographic [1][2] - The partnership aims to address the high prevalence of diabetes among veterans, estimated at around 25%, particularly focusing on Type 2 diabetes [2][3] - DAV's CEO emphasized the increased risk of diabetes among veterans, who are nearly twice as likely to develop the disease compared to the general population [3] Company Overview - DAV is a nonprofit organization dedicated to supporting veterans and their families by helping them access benefits, providing employment resources, and advocating for their needs [5] - Founded in 1920 and chartered by the U.S. Congress in 1932, DAV has nearly 1 million members and offers no-cost services to help veterans [5] Partnership Details - The diabetes resource page, set to launch in early 2026, will provide information on diabetes prevalence and treatment options for veterans [2] - The collaboration aims to empower veterans with knowledge and tools to manage diabetes effectively [3]
IceCure(ICCM) - 2025 Q3 - Earnings Call Transcript
2025-11-19 16:02
Financial Data and Key Metrics Changes - For the nine months ended September 30, 2025, revenue was $2.1 million, a decrease from $2.4 million in the same period of 2024, primarily due to a lack of revenue from Terumo, the distributor in Japan [16] - Gross profit for the same period was $626,000, down from $1,034,000 in the prior year, resulting in a gross margin of 30% compared to 43% in 2024 [17] - Net loss for the nine months ended September 30, 2025, was $10.8 million or $0.18 per share, relatively unchanged from a net loss of $10 million or $0.22 per share in the same period last year [17] - As of September 30, 2025, cash equivalents and short-term deposits were $10 million, up from $7.6 million at the end of 2024, with a cash balance of $11.8 million as of October 31, 2025 [18] Business Line Data and Key Metrics Changes - The decrease in sales during the nine months ended September 30, 2025, was attributed to declines in Japan, other Asian territories, and North America, partially offset by an increase in Latin America [16] - The company expects fluctuations in quarterly revenue as commercial activities ramp up following the FDA's marketing clearance for ProSense [16] Market Data and Key Metrics Changes - The FDA granted marketing authorization for the ProSense cryoablation system to treat low-risk breast cancer, targeting a population of approximately 200,000 patients annually in the U.S. [6][8] - The ProSense system is expected to benefit from a CPT-3 code covering approximately $3,800 in facility costs, which is anticipated to increase to just over $4,000 in early January 2026 [10] Company Strategy and Development Direction - The company is focused on expanding ProSense installations and utilization in the U.S. and globally, with plans for a post-market study involving 30 clinical sites [9][10] - IceCure aims to drive growth by expanding clinical evidence, improving reimbursement, and entering new markets, particularly in Brazil and Japan [12][15] Management's Comments on Operating Environment and Future Outlook - Management believes the FDA marketing authorization has significantly changed the company's growth trajectory and is optimistic about the future [27] - The company is entering an exciting growth phase, with expectations for increased adoption of ProSense in both clinical and commercial settings [15] Other Important Information - The company has received regulatory approval for its next-generation cryoablation system in Israel and secured a notice of patent allowance for its cryo probe in the U.S. and Japan [12][14] - IceCure is experiencing high global interest from clinicians following the FDA decision, with plans for participation in upcoming medical conferences [12] Q&A Session Summary Question: Status of FDA approval for the post-market study - Management confirmed that the protocol has been submitted to the FDA and they are in communication to finalize it, with expectations for approval by early next year [20][21] Question: Clarification on the addressable patient population - Management elaborated that the addressable market includes approximately 46,000 low-risk patients over 70, 88,000 patients not eligible for surgery, and 63,000 patients with benign tumors, totaling over 200,000 potential patients annually in the U.S. [22][24][25]
IceCure(ICCM) - 2025 Q3 - Earnings Call Transcript
2025-11-19 16:02
Financial Data and Key Metrics Changes - For the nine months ended September 30, 2025, revenue was $2.1 million compared to $2.4 million for the same period in 2024, reflecting a decrease due to the absence of revenue from Terumo in 2025 [16] - Gross profit for the nine months ended September 30, 2025, was $626,000, resulting in a gross margin of 30%, down from 43% in the prior year [17] - Total operating expenses decreased to $11.5 million for the nine months ended September 30, 2025, compared to $12.2 million a year ago [17] - Net loss for the nine months ended September 30, 2025, was $10.8 million or $0.18 per share, relatively the same as the net loss of $10 million or $0.22 for the same period last year [17] - As of September 30, 2025, cash equivalents and short-term deposits were $10 million, up from $7.6 million as of December 31, 2024 [18] Business Line Data and Key Metrics Changes - The decrease in sales during the nine months ended September 30, 2025, was attributed to declines in Japan, other territories in Asia, and North America, partially offset by an increase in sales in Latin America [16] Market Data and Key Metrics Changes - The FDA granted marketing authorization for the ProSense cryoablation system to treat low-risk breast cancer, which is expected to address a population of approximately 200,000 patients annually in the U.S. [8][25] - The indication covers about 46,000 women aged 70 and older diagnosed each year, plus an estimated 88,000 patients who are not candidates for surgery [8][24] Company Strategy and Development Direction - The company is focused on expanding ProSense installations and utilization in the U.S. following FDA authorization, with plans to increase the number of commercial sites [9][10] - IceCure aims to implement its sales and marketing strategy targeting a patient population of about 200,000 women annually, while also expanding clinical evidence and improving reimbursement [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence that the FDA marketing authorization has dramatically changed the company's growth trajectory and is optimistic about the future [27] - The company is in a strong financial position to continue executing across regulatory, clinical, and commercial initiatives, with a cash balance of $11.8 million as of October 31, 2025 [18] Other Important Information - The company has secured a distribution agreement in Brazil with expected sales of $6.6 million over the next five years [12] - ProSense has received regulatory approval in Israel for breast cancer and other indications, and the company has a strong intellectual property portfolio [12] Q&A Session Summary Question: Status of FDA approval for the post-market study - Management confirmed that the protocol has been submitted to the FDA and they are in interactive communication to finalize it, with expectations for approval by early next year [20] Question: Update on clinical sites for the post-market study - Management indicated that about 20 sites have been identified, with plans to finalize the protocol and recruit patients by summer 2026 [21] Question: Clarification on the addressable market for cryoablation - Management elaborated that the addressable market includes 46,000 low-risk patients over 70, 88,000 non-surgical candidates, and 63,000 patients with benign tumors, totaling over 200,000 potential patients annually in the U.S. [22][24][25]
Best Momentum Stock to Buy for Nov. 19th
ZACKS· 2025-11-19 16:01
Core Insights - Three stocks are highlighted with strong buy rankings and momentum characteristics for investors to consider on November 19th Group 1: Tactile Systems Technology (TCMD) - Tactile Systems Technology is a medical technology company focused on developing devices for chronic disease treatment at home [1] - The company has a Zacks Rank of 1 (Strong Buy) and its current year earnings estimate has increased by 29% over the last 60 days [1] - Tactile Systems Technology's shares have gained 80% over the last three months, significantly outperforming the S&P 500's gain of 3.2% [2] - The company possesses a Momentum Score of A [2] Group 2: Swedbank (SWDBY) - Swedbank is a leading Nordic-Baltic banking group serving retail and corporate customers in Sweden, Estonia, Lithuania, and Latvia [2] - The bank has a Zacks Rank of 1 and its next year earnings estimate has increased by 1.5% over the last 60 days [2] - Swedbank's shares have gained 6.5% over the last three months, also outperforming the S&P 500's gain of 3.2% [3] - The company possesses a Momentum Score of A [3] Group 3: Naspers (NPSNY) - Naspers is a multinational media group with operations in pay television, Internet subscriber platforms, print media, book publishing, private education, and technology markets [3] - The company has a Zacks Rank of 1 and its current year earnings estimate has increased by 20.7% over the last 60 days [3] - Naspers' shares have gained 6.7% over the last three months, again outperforming the S&P 500's gain of 3.2% [4] - The company possesses a Momentum Score of B [4]
IceCure(ICCM) - 2025 Q3 - Earnings Call Transcript
2025-11-19 16:00
Financial Data and Key Metrics Changes - For the nine months ended September 30, 2025, revenue was $2.1 million compared to $2.4 million for the same period in 2024, reflecting a decrease due to lower sales in Japan and other territories [16] - Gross profit for the same period was $626,000, resulting in a gross margin of 30%, down from 43% in the prior year [17] - Total operating expenses decreased to $11.5 million from $12.2 million a year ago, indicating efforts to optimize spending [17] - Net loss for the nine months was $10.8 million or $0.18 per share, relatively unchanged from a net loss of $10 million or $0.22 for the same period last year [17] - As of September 30, 2025, cash equivalents and short-term deposits were $10 million, up from $7.6 million at the end of 2024 [18] Business Line Data and Key Metrics Changes - The company experienced a $316,000 decrease in sales during the nine months ended September 30, 2025, primarily due to reduced sales in Japan and North America, partially offset by an increase in Latin America [16] - The FDA granted marketing authorization for the ProSense cryoablation system, which is expected to drive growth and support broader access for patients [6][10] Market Data and Key Metrics Changes - The addressable market for ProSense includes approximately 200,000 patients annually in the U.S., consisting of 46,000 women aged 70 and older diagnosed with low-risk breast cancer, 88,000 patients not eligible for surgery, and 63,000 women with benign breast tumors [7][26] - The company has over 20 commercial sites using ProSense prior to FDA authorization, with expectations for organic growth and additional clinical sites planned [10] Company Strategy and Development Direction - The company aims to implement a sales and marketing strategy targeting a patient population of about 200,000 women annually, focusing on expanding clinical evidence and improving reimbursement [15] - The company is also advancing its global regulatory strategy, with plans for ProSense to be submitted for regulatory approval in Japan in the first half of 2026 [14] Management's Comments on Operating Environment and Future Outlook - Management believes the FDA marketing authorization has dramatically changed the company's growth trajectory and is optimistic about the future [28] - The company is confident in its financial position, supported by recent fundraising efforts, which will enable continued execution across regulatory, clinical, and commercial initiatives [18] Other Important Information - The company has received a notice of patent allowance for its cryo probe in the U.S. and Japan, strengthening its intellectual property portfolio [12] - ProSense has gained visibility at leading medical conferences, enhancing its reputation and adoption among clinicians [13] Q&A Session Summary Question: Status of FDA approval for the post-market study - Management confirmed that the protocol has been submitted to the FDA and that they are in communication to finalize it, with expectations for approval by early next year [20][22] Question: Clarification on the addressable market for cryoablation - Management elaborated that the addressable market includes 46,000 low-risk patients, 88,000 non-surgical candidates, and 63,000 benign tumor cases, totaling over 200,000 potential patients annually [24][26]
SHAREHOLDER ALERT Bernstein Liebhard LLP Announces A Securities Fraud Class Action Lawsuit Has Been Filed Against DexCom, Inc. (NASDAQ: DXCM)
Globenewswire· 2025-11-19 15:31
Core Viewpoint - A shareholder has filed a securities class action lawsuit against DexCom, Inc. for alleged misrepresentations regarding the accuracy and functionality of its G7 continuous glucose monitoring system, affecting investors who purchased securities between January 8, 2024, and September 17, 2025 [1][3]. Group 1 - The lawsuit claims that the defendants made false statements about the reliability and enhancements of the Dexcom G7 device, as well as the company's manufacturing capabilities [3]. - Investors who acquired DexCom securities during the specified period are encouraged to consider their legal rights and options regarding the class action [2][4]. - The deadline to file as a lead plaintiff in the class action is December 26, 2025, with no fees or expenses required from shareholders [4]. Group 2 - Bernstein Liebhard LLP, the law firm handling the case, has a history of recovering over $3.5 billion for clients and has represented large public and private pension funds [5]. - The firm has been recognized multiple times for its success in litigating class actions, indicating a strong track record in this area [5].
NovoCure (NasdaqGS:NVCR) 2025 Conference Transcript
2025-11-19 15:02
Summary of Novocure's Presentation at Jefferies 2025 Global Healthcare Conference Company Overview - **Company**: Novocure - **Focus**: Development and commercialization of Tumor Treating Fields (TTFields), an innovative cancer therapy utilizing electric fields to disrupt cancer cell division and induce immunogenic cell death [3][4] Core Insights and Mechanism of Action - **Mechanism**: TTFields selectively target cancer cells by exploiting their electrical properties, allowing for a multifaceted approach to treatment [3][4] - **Combination Therapy**: TTFields can be combined with other systemic therapies without additive toxicity, enhancing treatment efficacy [4] Product Delivery and Revenue Model - **Device Description**: TTFields are delivered via a medical device consisting of an electric field generator and transducer arrays, which can be used at home [5][6] - **Revenue Model**: The company operates on a recurring revenue model by charging a monthly fee for the therapy device [6] Market Presence and Growth - **Established Market**: Novocure has a strong foundation in glioblastoma (GBM) with an annual run rate exceeding $600 million, recognized as the standard of care in multiple countries [9][10] - **Geographical Expansion**: The company has expanded its market presence to Germany, Japan, France, and Spain, with plans for further growth in major markets [7][10] Upcoming Product Launches - **New Indications**: Novocure plans to launch TTFields for non-small cell lung cancer (NSCLC), locally advanced pancreatic cancer, and brain metastases, aiming for four products on the market by the end of 2026 [8][14][27] - **Clinical Data**: Positive clinical data supports the efficacy of TTFields in various cancers, showing significant survival benefits [11][12][13] Financial Investments and R&D - **R&D Investment**: Over the past five years, Novocure has invested $1 billion in research and development to advance its TTFields platform [10] - **Future Catalysts**: The company anticipates a catalyst-rich year ahead with multiple data readouts and product launches expected in 2026 [19][27] Challenges and Strategic Focus - **Market Competition**: The launch of TTFields in the NSCLC market has faced challenges due to competition with established drug therapies [15][18] - **Reimbursement Strategy**: Novocure is navigating the reimbursement landscape, with expectations of a year for commercial payers and two years for Medicare coverage [31][32] Conclusion - **Vision**: Novocure aims to transform cancer treatment by providing innovative therapies that extend survival and improve quality of life for patients with aggressive cancers [28][30] - **Commitment**: The company is dedicated to advancing its pipeline and enhancing treatment options for patients, leveraging its unique technology and clinical data [28][34]
DoorDash, Baidu upgraded: Wall Street's top analyst calls
Yahoo Finance· 2025-11-19 14:44
Core Viewpoint - The article compiles significant research calls from Wall Street, highlighting upgrades for various companies that investors should be aware of [1] Group 1: Company Upgrades - Jefferies upgraded DoorDash (DASH) to Buy from Hold with a price target of $260, increased from $220, citing faster growth in U.S. restaurant delivery as a reason for a more bullish outlook [2] - Nomura upgraded Baidu (BIDU) to Buy from Neutral with a price target of $140, up from $135, due to the substantial growth potential of its 69% owned chip-design subsidiary, Kunlunxin, and management's consideration of enhancing capital returns [2] - UBS upgraded Insulet (PODD) to Buy from Neutral with a price target of $400, raised from $355, anticipating sustained growth momentum through the end of the decade [2] - Jefferies upgraded Zions Bancorp (ZION) to Buy from Hold with a price target of $60, up from $55, arguing that the stock's pullback related to alleged fraud charges is overdone [2] - Goldman Sachs upgraded Medtronic (MDT) to Neutral from Sell with a price target of $111, increased from $81, noting improved new product momentum and positive overall P&L metrics post Q2 results [2]
Will Ion Platform's 52% Growth Make It ISRG's Next Growth Engine?
ZACKS· 2025-11-19 14:06
Core Insights - Intuitive Surgical's (ISRG) third-quarter results indicate a significant shift in its platform mix, with robotic bronchoscopy emerging as a key growth driver, particularly the Ion platform, which saw a 52% year-over-year increase in procedures [1][10] - The Ion platform's adoption is accelerating, supported by new AI-enabled software and promising clinical trial data, which could reshape ISRG's revenue structure in the long term [2][5] Platform Performance - The Ion platform recorded nearly 38,000 procedures, significantly outpacing the 19% growth of da Vinci procedures, which remain the financial backbone of the company [1] - The Ion platform's utilization grew by 14%, indicating increasing throughput and economic viability for pulmonary programs [4] Clinical Advancements - New data from the Zurich randomized controlled trial showed an 84.6% diagnostic yield for Ion combined with mobile cone-beam CT, compared to 23.1% for conventional bronchoscopy, highlighting Ion's potential in early lung cancer detection [3][10] - The study also indicated a nearly 30-percentage-point increase in Stage 1A lung cancer detection following Ion adoption, suggesting a significant clinical impact that could drive procedure volume growth [3] Competitive Landscape - Johnson & Johnson's MONARCH Platform is advancing with a reported 98.7% success rate in reaching small lung nodules and an 83.2% diagnostic yield, positioning it as a strong competitor in the robotic bronchoscopy market [6] - Medtronic's ILLUMISITE Platform shows promising diagnostic accuracy and lower complication rates, although it is not yet a full robotic system [8][11] Financial Performance - ISRG's shares have increased by 4.8% year-to-date, outperforming the industry average of 0.2% [12] - The company trades at a forward price-to-earnings ratio of 57.91, which is above the industry average but lower than its five-year median of 71.53 [13] - The Zacks Consensus Estimate for ISRG's 2025 earnings suggests a 17.3% increase compared to the previous year [14]