KRMD

KORU Medical Systems Signs Supply Agreement for a Phase III Clinical Trial for a Novel Endocrinological Biologic

Retrieved on: 
Mardi, mai 14, 2024
Medical Supplies, Medical Devices, Health, Health Technology, Clinical Trials, Pharmaceutical, Enzyme replacement therapy, Orphan drug, Patient, DSM-IV codes, FDA, Phase, Breakthrough therapy, Fast Track, KRMD, 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 the signing of a Phase III clinical supply agreement for a novel enzyme replacement therapy to treat a rare endocrinological disease.

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 the signing of a Phase III clinical supply agreement for a novel enzyme replacement therapy to treat a rare endocrinological disease.
  • Since then, the KORU Medical Freedom System successfully passed validation testing to meet the subcutaneous infusion administration specifications for this novel drug.
  • The Phase III trial will evaluate bi-weekly infusions using the Freedom System.
  • If successful in the Phase III trial, this drug would be the first disease-modifying treatment option for the 10,000 patients worldwide afflicted by this rare genetic disease.

KORU Medical Systems Announces Successful Appeal in EU Notified Body Review

Retrieved on: 
Jeudi, avril 11, 2024
Medical Devices, Health, Pharmaceutical, Health Technology, Medical Supplies, BSI, Sale, Certification, Patient, KRMD

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.”

KORU Medical Systems to Report First Quarter 2024 Financial Results on May 1, 2024

Retrieved on: 
Mercredi, avril 17, 2024
Medical Supplies, Health, Health Technology, Other Health, Managed Care, Pharmaceutical, Webcast, Calendar, KRMD

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.

KORU Medical Systems to Present Data Demonstrating 97% Adherence on Its Freedom Infusion System for Large Volume Subcutaneous Administration at NHIA 2024 Conference

Retrieved on: 
Lundi, mars 18, 2024
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.”

KORU Medical Systems Announces a Feasibility Study to Enter Ambulatory Infusion Settings with a Commercialized Biologic

Retrieved on: 
Lundi, mars 11, 2024
Research, Medical Devices, Medical Supplies, Hospitals, Clinical Trials, Health Technology, Biotechnology, Pharmaceutical, Health, Science, KRMD, AIS, Patient, Health care, European, FDA, AIC, 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.”

KORU Medical Systems Signs a Clinical Supply Agreement for Phase 3 Trial with Leading Pharma Partner Using Custom Device for a Novel Subcutaneous Immunoglobulin

Retrieved on: 
Mercredi, mars 6, 2024
Medical Devices, Hospitals, Clinical Trials, Health Technology, Biotechnology, Managed Care, Health, Pharmaceutical, General Health, KRMD, 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."

KORU Medical Systems to Report Fourth Quarter and Full Year 2023 Financial Results on March 13, 2024

Retrieved on: 
Mercredi, février 21, 2024
Medical Devices, Health, Pharmaceutical, Health Technology, Medical Supplies, Quality of life, KRMD, Calendar, Webcast, Patient

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 .

KORU Medical Systems to Participate in Piper Sandler’s 35th Annual Healthcare Conference

Retrieved on: 
Mercredi, novembre 29, 2023
Managed Care, Pharmaceutical, Health, Medical Devices, Interest, KORU, Quality of life, Patient, Baozou Big News Events, KRMD, Conference, Pharmaceutical industry, 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 .

KORU Medical Systems, Inc. to Host Investor Day on December 5, 2023

Retrieved on: 
Mardi, novembre 28, 2023
Medical Devices, Health, Pharmaceutical, Health Technology, Medical Supplies, KORU, Quality of life, Patient, KRMD, Baozou Big News Events

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 .

KORU Medical Systems, Inc. Announces Development Agreement for Next-generation Subcutaneous Immunoglobulin Infusion System

Retrieved on: 
Mercredi, novembre 8, 2023
Biotechnology, Medical Devices, Health, Pharmaceutical, Medical Supplies, Linda, Pharmacy, Quality of life, KORU, KRMD, FDA, Patient, Therapy, Life, Medical device

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 a development agreement with a biopharmaceutical manufacturer for KORU Medical to develop and seek regulatory approval for a next-generation infusion system for its subcutaneous immunoglobulin (SCIg) therapy.

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 a development agreement with a biopharmaceutical manufacturer for KORU Medical to develop and seek regulatory approval for a next-generation infusion system for its subcutaneous immunoglobulin (SCIg) therapy.
  • “This collaboration is another milestone in our strategy to provide the best infusion experience to SCIg patients,” said Linda Tharby, KORU Medical’s President and CEO.
  • KORU Medical has been the first to receive FDA 510(k) clearance for every new SCIg drug approved since 2020.
  • We’re excited to collaborate with a biopharmaceutical company on this new innovative infusion system.”