blue_skies
2年前
KORU Medical Systems Announces Novel Therapy Collaboration for Three Indications with Kira Pharmaceuticals
November 08 2022 - 07:01AM
KORU Medical Systems, Inc. (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on the development of innovative and easy-to-use subcutaneous infusion solutions, today announced the progression of its agreement with Kira Pharmaceuticals, including expansion into three important additional indications.
Kira will utilize KORU Medical’s Freedom System for Phase II studies of Kira’s lead program, KP-104, an innovative, first-in-class bifunctional complement inhibitor, in three indications. These diseases, collectively affecting over 150,000 patients in the United States and estimated hundreds of thousands more globally, consist of nephrology conditions IgA Neuropathy (IgAN) and Complement 3 Glomerulopathy (C3G) and hematology condition Thrombotic Microangiopathy secondary to Systemic Lupus Erythematosus (SLE-TMA). The expanded Kira partnership reflects the previously announced collaboration with an unnamed partner for a single hematology indication.
“We selected KORU Medical based on their track record of helping patients receive high-value therapeutics subcutaneously in the comfort of their home,” said Chaomei He, Kira’s Head of Chemistry, Manufacturing, and Controls (CMC). “The Freedom System’s ease of use, global regulatory approvals, experience with tens of thousands of patients, and ability to rapidly enter the clinic gave us confidence that KORU was the right partner for our KP-104 program.”
“We are privileged to work with Kira and help them achieve their mission of helping patients living with complement-mediated disease by providing treatment at home,” said Linda Tharby, KORU Medical’s President and CEO. “The expansion of our work with Kira and progression into Phase II studies is another important milestone in our strategy to grow our novel therapies pipeline in multiple therapeutic areas.”
blue_skies
2年前
KORU Medical Systems Announces Novel Therapy Collaboration for Three Indications with Kira Pharmaceuticals[color=red][/color]
November 08 2022 - 07:01AM
KORU Medical Systems, Inc. (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on the development of innovative and easy-to-use subcutaneous infusion solutions, today announced the progression of its agreement with Kira Pharmaceuticals, including expansion into three important additional indications.
Kira will utilize KORU Medical’s Freedom System for Phase II studies of Kira’s lead program, KP-104, an innovative, first-in-class bifunctional complement inhibitor, in three indications. These diseases, collectively affecting over 150,000 patients in the United States and estimated hundreds of thousands more globally, consist of nephrology conditions IgA Neuropathy (IgAN) and Complement 3 Glomerulopathy (C3G) and hematology condition Thrombotic Microangiopathy secondary to Systemic Lupus Erythematosus (SLE-TMA). The expanded Kira partnership reflects the previously announced collaboration with an unnamed partner for a single hematology indication.
“We selected KORU Medical based on their track record of helping patients receive high-value therapeutics subcutaneously in the comfort of their home,” said Chaomei He, Kira’s Head of Chemistry, Manufacturing, and Controls (CMC). “The Freedom System’s ease of use, global regulatory approvals, experience with tens of thousands of patients, and ability to rapidly enter the clinic gave us confidence that KORU was the right partner for our KP-104 program.”
“We are privileged to work with Kira and help them achieve their mission of helping patients living with complement-mediated disease by providing treatment at home,” said Linda Tharby, KORU Medical’s President and CEO. “The expansion of our work with Kira and progression into Phase II studies is another important milestone in our strategy to grow our novel therapies pipeline in multiple therapeutic areas.”
blue_skies
2年前
KORU Medical Prices Public Offering of Common Stock
June 19, 2020 07:50 AM Eastern Daylight Time
CHESTER, NY--(BUSINESS WIRE)--Repro Med Systems, Inc. d/b/a KORU Medical Systems (Nasdaq: KRMD) (“KORU Medical”) today announced the pricing of its previously announced underwritten public offering of 3,125,000 shares of its common stock at a public offering price of $8.00 per share. The gross proceeds to KORU Medical before deducting the underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $25 million. In connection with the offering, KORU Medical has granted the underwriters a 30-day option to purchase up to an additional 468,750 shares at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about June 23, 2020, subject to customary closing condition
LETS KEEP THINGS IN PERSPECTIVE, TWO YEARS AGO THE SHARE PRICE WASS OVER $8.
https://www.businesswire.com/news/home/20200619005195/en/KORU-Medical-Prices-Public-Offering-of-Common-Stock
Topgun54
3年前
This one is not passing the stink test..............
BRIEF-Repro Med Systems Inc - Karen Fisher, CFO, Will Resign Her Employment Effective As Of June 30, 2022
BY Reuters
— 6:07 PM ET 05/18/2022
May 18 (Reuters) - Repro Med Systems Inc (KRMD):
* REPRO MED SYSTEMS INC (KRMD) - KAREN FISHER, CFO, WILL RESIGN HER EMPLOYMENT EFFECTIVE AS OF JUNE 30, 2022
* REPRO MED SYSTEMS INC (KRMD) - COMPANY HAS ENGAGED A SPECIALIZED FIRM TO CONDUCT A SEARCH OF POTENTIAL CANDIDATES TO REPLACE FISHER
* REPRO MED SYSTEMS INC (KRMD) - IN INTERIM, TOM ADAMS, WILL SERVE AS INTERIM CHIEF FINANCIAL OFFICER OF COMPANY EFFECTIVE JULY 1, 2022
blue_skies
3年前
MMMM, let me think?
Who were the presenters doing the presentation that was left on the company's website?
MMMM let me look?
Oh ya, of course, Linda Tharby was one of the presenters.
MMMM, interesting?
Who was the CEO doing the previous presentations??
MMMM, let me think???
OH it was that other guy, the one that left just about the time the lawsuits were filed. t
UNDERSTAND NOW
blue_skies
3年前
Adding Xembify®, manufactured by Grifols is huge
Grifols, S.A. is a Spanish multinational pharmaceutical and chemical manufacturer. Principally a producer of blood plasma-based products, a field in which it is the European leader and largest worldwide, the company also supplies devices, instruments, and reagents for clinical testing laboratories
blue_skies
3年前
KORU Medical Systems Receives FDA 510(k) Clearance for the Use of the FREEDOM60® with Two Additional SCIg Drugs
https://www.korumedical.com/investors/news-events/press-releases/detail/106/koru-medical-systems-receives-fda-510k-clearance-for-the
CHESTER, N.Y.--(BUSINESS WIRE)-- Repro Med Systems, Inc. dba KORU Medical Systems (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on the development of innovative and easy-to-use home infusion solutions, today announced FDA 510(k) clearance that expands on-label use of the FREEDOM60 Infusion System to two additional subcutaneous Ig (SCIg) medications, Cutaquig®, manufactured by Octapharma, and Xembify®, manufactured by Grifols.
“We are excited to announce another milestone for KORU Medical as we seek to further improve patients’ quality of life through the development and delivery of high-quality therapeutic drug delivery in the home. Having the FREEDOM60 Infusion System cleared for use with Xembify and Cutaquig allows patients and providers additional options for life enhancing subcutaneous immunoglobulin therapy treatment in the home with a system that has broad patient and healthcare worker adoption,” said Linda Tharby, President and CEO. “KORU Medical’s Freedom Infusion System is specifically cleared for use with more SCIg drugs than any other system. Adding Xembify and Cutaquig to our label, in addition to our recent FDA 510(k) clearance for use of Hizentra® prefilled syringes with the FreedomEdge®, extends KORU Medical’s leadership position in the growing SCIg market.”
hc-investor
3年前
Dug this up from the 2018 10K. Seems like the company is great when it comes to talking with investors but terrible when it comes to execution. 9 months ended September revenues at $14mm, margins at 58%, and negative growth:
OUR STRATEGY
In January 2019, the Board of Directors approved our strategic plan to become the preferred drug delivery partner for specific infusion therapies in select markets.
The financial goals for our strategic plan through 2022 are:
• $50 million net revenue run rate
• 70%+ gross margins, and
• 20%+ annual organic revenue growth
We are committed to delivering simple, effective, drug delivery systems to the home health care environment. We believe our Freedom Infusion Systems using DynEqTM technology is superbly positioned for Immunoglobulin therapy and we plan to build on that platform. We plan to drive revenue by supporting the accelerating adoption of Hizentra®, Cuvitru® and other formulations for immunoglobulin therapy and participating in the migration of other therapeutics into the home health marketplace globally. We expect to leverage our specialty pharmacy customer base by bringing additional products and services to our channel.
blue_skies
3年前
KORU Medical’s Freedom Edge becomes the only device specifically cleared for delivery of subcutaneous Ig prefilled syringe
CHESTER, N.Y.--(BUSINESS WIRE)-- Repro Med Systems, Inc. dba 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 specialty infusion solutions that improve quality of life for patients, today announced 510k clearance for use of the KORU Medical FreedomEdge® infusion pump to deliver Hizentra® [immune globulin subcutaneous (human) 20% liquid] 20 mL prefilled syringes. Hizentra® is the most prescribed subcutaneous Ig product and the first to be available in a prefilled syringe format.
“Our patients who use prefilled syringes tell us that their infusions are significantly easier. With the FreedomEdge® they simply place syringes in the pump and infuse, avoiding the drug transfer process that many patients find difficult and stressful. We’re excited to see KORU Medical’s commitment to improve patient satisfaction by getting this important FDA clearance,” said Amy Ehlers, Senior Director of Clinical Programs at NuFactor, a leading specialty infusion pharmacy.
https://www.korumedical.com/investors/news-events/press-releases/detail/103/koru-medical-announces-fda-clearance-for-delivery-of
blue_skies
3年前
KORU Medical Systems to Participate in Two Upcoming Conferences
https://www.korumedical.com/investors/news-events/press-releases/detail/102/koru-medical-systems-to-participate-in-two-upcoming
KORU Medical's management is scheduled to present at the following;
Canaccord Genuity MedTech, Diagnostics and Digital Health & Services Forum on Thursday, November 18, 2021 at 11:00 AM EST
The 33rd Annual Piper Sandler Healthcare Conference 1x1 investor meetings will take place Wednesday, December 1, 2021. Management will also participate in a pre-recorded fireside chat, which will be available beginning Monday, November 22nd at 10:00 AM EST
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. The archived webcast will be available for six months.
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Monksdream
6月前
