KORU Medical Receives FDA Clearance for RYSTIGGO Infusion System
- FDA Approval: KORU Medical has received FDA clearance for the FreedomEDGE® infusion system to deliver RYSTIGGO® therapy to patients with generalized myasthenia gravis, reinforcing the company's leadership in the large-volume subcutaneous infusion market.
- Increased Treatment Flexibility: The approval allows healthcare professionals to provide flexible treatment options in clinical settings, which is expected to significantly enhance patient access to care and improve quality of life.
- Significant Market Potential: RYSTIGGO®, a novel biologic administered weekly at 3mL-6mL over six weeks, with subsequent cycles based on clinical evaluation, demonstrates vast potential in treating chronic autoimmune disorders.
- Strategic Expansion Plans: KORU Medical aims to extend the Freedom platform to more drug therapies and patient populations, further enhancing its market competitiveness and driving future growth and innovation.
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KORU Medical Receives FDA Clearance for RYSTIGGO Infusion System
- FDA Approval: KORU Medical has received FDA clearance for the FreedomEDGE® infusion system to deliver RYSTIGGO® therapy to patients with generalized myasthenia gravis, reinforcing the company's leadership in the large-volume subcutaneous infusion market.
- Increased Treatment Flexibility: The approval allows healthcare professionals to provide flexible treatment options in clinical settings, which is expected to significantly enhance patient access to care and improve quality of life.
- Significant Market Potential: RYSTIGGO®, a novel biologic administered weekly at 3mL-6mL over six weeks, with subsequent cycles based on clinical evaluation, demonstrates vast potential in treating chronic autoimmune disorders.
- Strategic Expansion Plans: KORU Medical aims to extend the Freedom platform to more drug therapies and patient populations, further enhancing its market competitiveness and driving future growth and innovation.
KORU Medical Submits 510(k) for FreedomEDGE® System to Administer PHESGO®
- Market Expansion Milestone: KORU Medical's submission of a 510(k) application aims to utilize the FreedomEDGE® infusion system for subcutaneous administration of PHESGO®, marking a significant step in the company's strategy to penetrate the oncology infusion market, which is expected to enhance market share and meet rising demand.
- Technological Innovation: The system is designed to support large-volume subcutaneous drug delivery, streamlining clinical workflows and is anticipated to significantly improve nursing satisfaction while reducing patient treatment time, thereby enhancing overall treatment efficiency.
- Alignment with Industry Trends: As cancer therapies shift from intravenous to subcutaneous delivery, KORU Medical's technological advancements not only align with this trend but also position the company to potentially lead in the future drug delivery device market.
- Future Growth Potential: KORU Medical anticipates market entry upon FDA approval, which will lay the groundwork for long-term growth in the oncology sector and further solidify its leadership in patient-centric solutions.
Revvity Enhances AI-Powered Scientific Research with Signals Xynthetica
Introduction of Signals Xynthetica: Revvity, Inc. has launched Signals Xynthetica, an AI-augmented design platform aimed at enhancing molecular and materials discovery, integrating advanced design capabilities with experimental data in a Models-as-a-Service (MaaS) framework.
Addressing R&D Bottlenecks: The platform seeks to bridge the gap between computational models and experimental workflows, promoting a continuous learning loop that enhances predictive insights and aligns AI predictions with laboratory practices.
Strategic Evolution: Revvity is transitioning from providing standalone scientific tools to becoming a platform-centric technology partner, focusing on AI-driven insights and seamless integration of scientific data across various applications, including drug discovery and clinical laboratories.
Market Position and Future Prospects: While Revvity's stock performance has been modest compared to industry peers, the introduction of Signals Xynthetica and other AI initiatives positions the company for potential growth as demand for integrated predictive tools in scientific research increases.
KORU Medical Appoints Eric Schiller as CTO to Drive Innovation Strategy
- Leadership Change: KORU Medical announced the appointment of Eric Schiller as Chief Technology Officer effective December 29, 2025, bringing over 25 years of industry experience that is expected to enhance the company's product development and innovation pipeline, thereby improving market responsiveness.
- Strategic Technology Integration: Eric's experience at Sanofi in global device development will aid KORU in aligning product portfolio planning with evolving market needs, which will strengthen the company's competitive position.
- Innovation Acceleration: His addition is set to accelerate KORU's R&D capabilities and advance next-generation platforms aimed at enhancing patient quality of life and meeting the needs of pharmaceutical partners.
- Industry Impact: As an inventor on multiple U.S. patents, Eric's technical leadership and strategic mindset will provide crucial support for KORU in the rapidly evolving medical technology sector, facilitating the company's expansion into new therapeutic applications.
KORU Medical Plans to Pursue FDA Approval for FreedomEDGE Infusion System in Late 2025 to Early 2026
510(k) Application Submission: KORU Medical Systems plans to submit a 510(k) application to the FDA for its FreedomEDGE Syringe Infusion System in late 2025 or early 2026, seeking clearance for use with a commercial oncology drug.
Infusion System Overview: The FreedomEDGE Infusion System is designed for large-volume subcutaneous drug delivery, proven with over 15 years of use, 45,000 patients, and 2 million annual infusions across more than 30 countries.
Multicenter Study Presentation: KORU Medical will present data from a multicenter study comparing the FreedomEDGE System to manual push techniques at the ESID/EHA/SIOPE Focused Symposium in November 2025, highlighting high satisfaction rates among nurses and patients.
Stock Performance: KRMD's stock has traded between $4.32 and $4.57 over the past year, closing at $4.49, reflecting a 3.94% increase in the latest trading session.
KORU Medical Systems to Attend Upcoming Investor Conferences
Upcoming Investor Conferences: KORU Medical Systems will participate in three investor conferences, including the Craig-Hallum Alpha Select Conference on November 18, 2025, the Canaccord Genuity MedTech Forum on November 20, 2025, and the Piper Sandler Healthcare Conference on December 2, 2025.
Product Overview: KORU Medical specializes in developing and commercializing patient-centric subcutaneous infusion solutions, including the Freedom Syringe Infusion System, which has been FDA cleared since 1994 and is designed for both home self-administration and use in ambulatory infusion centers.
Clinical Trials Support: The company also provides products for biopharmaceutical companies during clinical trials and can customize its infusion systems for various drug categories.
Investor Relations Contact: For more information, interested parties can visit KORU Medical's website or contact investor relations via email.
KORU Medical Receives FDA Clearance for RYSTIGGO Infusion System
- FDA Approval: KORU Medical has received FDA clearance for the FreedomEDGE® infusion system to deliver RYSTIGGO® therapy to patients with generalized myasthenia gravis, reinforcing the company's leadership in the large-volume subcutaneous infusion market.
- Increased Treatment Flexibility: The approval allows healthcare professionals to provide flexible treatment options in clinical settings, which is expected to significantly enhance patient access to care and improve quality of life.
- Significant Market Potential: RYSTIGGO®, a novel biologic administered weekly at 3mL-6mL over six weeks, with subsequent cycles based on clinical evaluation, demonstrates vast potential in treating chronic autoimmune disorders.
- Strategic Expansion Plans: KORU Medical aims to extend the Freedom platform to more drug therapies and patient populations, further enhancing its market competitiveness and driving future growth and innovation.
KORU Medical Submits 510(k) for FreedomEDGE® System to Administer PHESGO®
- Market Expansion Milestone: KORU Medical's submission of a 510(k) application aims to utilize the FreedomEDGE® infusion system for subcutaneous administration of PHESGO®, marking a significant step in the company's strategy to penetrate the oncology infusion market, which is expected to enhance market share and meet rising demand.
- Technological Innovation: The system is designed to support large-volume subcutaneous drug delivery, streamlining clinical workflows and is anticipated to significantly improve nursing satisfaction while reducing patient treatment time, thereby enhancing overall treatment efficiency.
- Alignment with Industry Trends: As cancer therapies shift from intravenous to subcutaneous delivery, KORU Medical's technological advancements not only align with this trend but also position the company to potentially lead in the future drug delivery device market.
- Future Growth Potential: KORU Medical anticipates market entry upon FDA approval, which will lay the groundwork for long-term growth in the oncology sector and further solidify its leadership in patient-centric solutions.
Revvity Enhances AI-Powered Scientific Research with Signals Xynthetica
Introduction of Signals Xynthetica: Revvity, Inc. has launched Signals Xynthetica, an AI-augmented design platform aimed at enhancing molecular and materials discovery, integrating advanced design capabilities with experimental data in a Models-as-a-Service (MaaS) framework.
Addressing R&D Bottlenecks: The platform seeks to bridge the gap between computational models and experimental workflows, promoting a continuous learning loop that enhances predictive insights and aligns AI predictions with laboratory practices.
Strategic Evolution: Revvity is transitioning from providing standalone scientific tools to becoming a platform-centric technology partner, focusing on AI-driven insights and seamless integration of scientific data across various applications, including drug discovery and clinical laboratories.
Market Position and Future Prospects: While Revvity's stock performance has been modest compared to industry peers, the introduction of Signals Xynthetica and other AI initiatives positions the company for potential growth as demand for integrated predictive tools in scientific research increases.
KORU Medical Appoints Eric Schiller as CTO to Drive Innovation Strategy
- Leadership Change: KORU Medical announced the appointment of Eric Schiller as Chief Technology Officer effective December 29, 2025, bringing over 25 years of industry experience that is expected to enhance the company's product development and innovation pipeline, thereby improving market responsiveness.
- Strategic Technology Integration: Eric's experience at Sanofi in global device development will aid KORU in aligning product portfolio planning with evolving market needs, which will strengthen the company's competitive position.
- Innovation Acceleration: His addition is set to accelerate KORU's R&D capabilities and advance next-generation platforms aimed at enhancing patient quality of life and meeting the needs of pharmaceutical partners.
- Industry Impact: As an inventor on multiple U.S. patents, Eric's technical leadership and strategic mindset will provide crucial support for KORU in the rapidly evolving medical technology sector, facilitating the company's expansion into new therapeutic applications.
KORU Medical Plans to Pursue FDA Approval for FreedomEDGE Infusion System in Late 2025 to Early 2026
510(k) Application Submission: KORU Medical Systems plans to submit a 510(k) application to the FDA for its FreedomEDGE Syringe Infusion System in late 2025 or early 2026, seeking clearance for use with a commercial oncology drug.
Infusion System Overview: The FreedomEDGE Infusion System is designed for large-volume subcutaneous drug delivery, proven with over 15 years of use, 45,000 patients, and 2 million annual infusions across more than 30 countries.
Multicenter Study Presentation: KORU Medical will present data from a multicenter study comparing the FreedomEDGE System to manual push techniques at the ESID/EHA/SIOPE Focused Symposium in November 2025, highlighting high satisfaction rates among nurses and patients.
Stock Performance: KRMD's stock has traded between $4.32 and $4.57 over the past year, closing at $4.49, reflecting a 3.94% increase in the latest trading session.
KORU Medical Systems to Attend Upcoming Investor Conferences
Upcoming Investor Conferences: KORU Medical Systems will participate in three investor conferences, including the Craig-Hallum Alpha Select Conference on November 18, 2025, the Canaccord Genuity MedTech Forum on November 20, 2025, and the Piper Sandler Healthcare Conference on December 2, 2025.
Product Overview: KORU Medical specializes in developing and commercializing patient-centric subcutaneous infusion solutions, including the Freedom Syringe Infusion System, which has been FDA cleared since 1994 and is designed for both home self-administration and use in ambulatory infusion centers.
Clinical Trials Support: The company also provides products for biopharmaceutical companies during clinical trials and can customize its infusion systems for various drug categories.
Investor Relations Contact: For more information, interested parties can visit KORU Medical's website or contact investor relations via email.
