Associated tags: Flo, FREEDOM, Quality of life, Patient, Health, Medical Devices, Medical Supplies, KRMD, Pharmaceutical, Pharmaceutical industry, KORU, Health Technology, Medical device
Locations: CANADA, COLORADO, NJ, UNITED STATES, NORTH AMERICA, NEW JERSEY, EUROPE, LINDA, EU
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EPS Novel Therapies net revenues declined by 21.3% primarily driven by a milestone completion for a collaboration agreement in the prior year period.
Key Points:
- Novel Therapies net revenues declined by 21.3% primarily driven by a milestone completion for a collaboration agreement in the prior year period.
- Cash and cash equivalents were $10.8 million as of March 31, 2024, reflecting cash usage of $0.7 million in the first quarter of 2024.
- Non-GAAP financial measures should not be considered a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.
- Non-GAAP financial measures are meant to supplement, and to be viewed in conjunction with, GAAP financial results.
KORU Medical Systems, Inc. (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions, today announced a successful appeal related to an ongoing audit by its notified body in the EU, The British Standards Institute (BSI).
Key Points:
- KORU Medical Systems, Inc. (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions, today announced a successful appeal related to an ongoing audit by its notified body in the EU, The British Standards Institute (BSI).
- The Company’s appeal of an assessment report from BSI regarding a recommendation against continued certification in connection with prior audit nonconformance, was upheld.
- As a result, the Company will proceed through the routine BSI assessment process without suspension or interruption of the Company’s sale of products in the EU.
- “Our products remain certified, marketed and sold in the EU, and we are excited by the continued expansion of our international business.”
Retrieved on:
Wednesday, April 17, 2024
KORU Medical Systems (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions, today announced that the Company will report first quarter 2024 financial results on Wednesday, May 1, 2024.
Key Points:
- KORU Medical Systems (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions, today announced that the Company will report first quarter 2024 financial results on Wednesday, May 1, 2024.
- KORU Medical’s management will host a conference call and webcast at 4:30 p.m.
- ET that day to discuss the financial results and provide a corporate update.
- The conference call can be accessed by dialing (877)-407-0784 for participants in the U.S. or Canada and (201)-689-8560 for international callers.
Medical Devices,
Health,
Pharmaceutical,
Clinical Trials,
Medical Supplies,
Immunodeficiency,
Conference,
KRMD,
PIDD,
Therapy,
Patient,
Impact,
Literature,
Primary immunodeficiency,
Medical device The study, authored by KORU Medical, analyzed data from a large national specialty pharmacy, capturing drug receipts over 4.5 years for 3,787 US PIDD patients using KORU Medical FREEDOM60® and FreedomEdge® infusion systems for self-administered SCIg therapy.
Key Points:
- The study, authored by KORU Medical, analyzed data from a large national specialty pharmacy, capturing drug receipts over 4.5 years for 3,787 US PIDD patients using KORU Medical FREEDOM60® and FreedomEdge® infusion systems for self-administered SCIg therapy.
- We believe it provides valuable insights into the effectiveness of KORU Medical’s Freedom Infusion System in promoting treatment compliance in large volume subcutaneous delivery.
- “These findings highlight the positive impact of KORU Medical’s Freedom Infusion System on subcutaneous immunoglobulin therapy for patients with primary immunodeficiency disease," said Brent Rutland, Vice President, Medical Affairs at KORU Medical.
- These results, with the KORU Freedom Infusion System, also demonstrate the company’s potential to support a broader range of developmental subcutaneous drug therapies.”
Retrieved on:
Wednesday, March 13, 2024
Medical Devices,
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Pharmaceutical,
Health Technology,
Medical Supplies,
Research,
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NRE,
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HSBC Bank USA,
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GAAP,
HSBC Bank,
ID,
Information management,
BSI,
Bank Gross profit increased $1.3 million or 8.7% for the year ended December 31, 2023, compared to the same period in 2022.
Key Points:
- Gross profit increased $1.3 million or 8.7% for the year ended December 31, 2023, compared to the same period in 2022.
- Allowing for a one-time inventory adjustment for a product discontinuation, adjusted gross margin for the year ended 2023 was 59.6%.
- This new debt facility provides KORU Medical with additional capital flexibility to support a reserve for growth and strategic opportunities.
- Non-GAAP financial measures are meant to supplement, and to be viewed in conjunction with, GAAP financial results.
Research,
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Pharmaceutical industry KORU Medical Systems, Inc. (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions, today announced a collaboration with a global pharmaceutical manufacturer to initiate a feasibility study with KORU’s Freedom Infusion System for an already commercialized rare disease therapy.
Key Points:
- KORU Medical Systems, Inc. (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions, today announced a collaboration with a global pharmaceutical manufacturer to initiate a feasibility study with KORU’s Freedom Infusion System for an already commercialized rare disease therapy.
- Upon successful completion of the feasibility study, KORU Medical intends to develop a customized Freedom System that will deliver this large volume therapy via subcutaneous administration.
- “Expansion of our use case from home subcutaneous administration into these new settings demonstrates the versatility and flexibility of the KORU Medical Freedom Infusion System in delivering life-changing therapies wherever patients are being treated.
- Upon success of the feasibility study, we expect to submit the device for FDA clearance within the next 12 months.”
Medical Devices,
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Safety,
Therapy,
Immunodeficiency,
Patient,
Clinical trial,
DSM-IV codes,
Pharmaceutical industry KORU Medical Systems, Inc. (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions, is pleased to announce a clinical supply agreement for a novel subcutaneous immunoglobulin (SCIg) drug entering Phase 3 trials.
Key Points:
- KORU Medical Systems, Inc. (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions, is pleased to announce a clinical supply agreement for a novel subcutaneous immunoglobulin (SCIg) drug entering Phase 3 trials.
- The custom product developed for this clinical trial under a prior agreement was built off the foundation of the KORU Medical Freedom System and tailored to meet the unique subcutaneous infusion administration specifications of this novel drug.
- "We are excited to announce the execution of this Phase 3 clinical supply agreement, marking a critical step forward in our commitment to advancing healthcare through innovation.
- Assuming successful completion and results of the Phase 3 trial, we expect to file a 510k and commercialize with this novel SCIg drug."
Retrieved on:
Wednesday, February 21, 2024
KORU Medical Systems (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and easy-to-use subcutaneous infusion solutions that improve quality of life for patients, today announced that the Company will report fourth quarter and full year 2023 financial results on Wednesday, March 13, 2024.
Key Points:
- KORU Medical Systems (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and easy-to-use subcutaneous infusion solutions that improve quality of life for patients, today announced that the Company will report fourth quarter and full year 2023 financial results on Wednesday, March 13, 2024.
- KORU Medical’s management will host a conference call and webcast at 4:30 p.m.
- ET that day to discuss the financial results and provide a corporate update.
- A live and archived webcast of the event can be accessed via the IR Calendar on the News/Events page of the Investors section of KORU Medical’s website at www.korumedical.com .
Retrieved on:
Wednesday, November 29, 2023
Managed Care,
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KORU,
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Baozou Big News Events,
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Piper KORU Medical Systems (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and easy-to-use subcutaneous drug delivery systems that improve quality of life for patients, today announced that the Company will participate in Piper Sandler’s 35th Annual Healthcare Conference on November 29, 2023.
Key Points:
- KORU Medical Systems (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and easy-to-use subcutaneous drug delivery systems that improve quality of life for patients, today announced that the Company will participate in Piper Sandler’s 35th Annual Healthcare Conference on November 29, 2023.
- KORU Medical's management is scheduled to present at Piper Sandler’s 35th Annual Healthcare Conference on November 29, 2023, at 1:30 pm ET.
- Interested parties can access the live and archived webcast on the News/Events page of the Investors section of KORU Medical’s website at www.korumedical.com .
Retrieved on:
Tuesday, November 28, 2023
KORU Medical Systems, Inc. (NASDAQ: KRMD) ("KORU Medical" or the "Company"), a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and easy-to-use specialty subcutaneous infusion solutions that improve quality of life for patients, today announced it will host an investor day at the Mahwah, NJ headquarters on Tuesday, December 5, 2023, from 10:00 a.m. to 12:00 p.m. Eastern Time.
Key Points:
- KORU Medical Systems, Inc. (NASDAQ: KRMD) ("KORU Medical" or the "Company"), a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and easy-to-use specialty subcutaneous infusion solutions that improve quality of life for patients, today announced it will host an investor day at the Mahwah, NJ headquarters on Tuesday, December 5, 2023, from 10:00 a.m. to 12:00 p.m. Eastern Time.
- The event will include presentations by members of management and an expert immunologist.
- The presentations will cover KORU Medical’s key markets, growth strategy, product portfolio, and operational and financial performance.
- For those who cannot attend in-person, a live and archived webcast of the presentations will be available on the News/Events page of the Investors section of KORU Medical System's website at www.korumedical.com .
