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

Rhea-AI Summary

KORU Medical Systems (NASDAQ: KRMD) has signed a Phase III clinical supply agreement for a new enzyme replacement therapy targeting a rare endocrinological disease. This follows the successful validation of the KORU Medical Freedom System for subcutaneous infusion. The trial will evaluate bi-weekly infusions, with potential treatment impact for 10,000 patients globally. The experimental drug has been granted Breakthrough Therapy, Rare Pediatric Disease, Fast Track, and Orphan Drug designations by the FDA and in Europe.

KORU Medical President and CEO, Linda Tharby, expressed pride in their device development for large volume subcutaneous delivery and emphasized the company's expanding role in administering rare disease drugs.

Positive

• Signing of Phase III clinical supply agreement.
• Successful validation of the KORU Medical Freedom System for subcutaneous infusion.
• Potential first disease-modifying treatment for rare endocrinological disease affecting 10,000 patients.
• FDA and European Orphan Drug designations increase chances of market exclusivity and reduced competition.
• Breakthrough Therapy, Rare Pediatric Disease, and Fast Track designations may accelerate development and approval.

Negative

• High dependency on the success of a single Phase III clinical trial.
• Competitive pressure from other companies in the biopharmaceutical sector.
• Potential financial risks if the trial results are unfavorable or delayed.

Insights

Financial Analyst

The signing of a Phase III clinical supply agreement is a significant development for KORU Medical Systems. Phase III trials are typically the final step before a drug can be submitted for FDA approval, meaning there is substantial potential for future revenue should the trial succeed. The market for rare disease treatments often involves high costs but also high-profit margins due to limited competition and strong demand for effective therapies. If successful, this collaboration could position KORU Medical uniquely within the niche market of large volume subcutaneous infusion systems for rare enzyme replacement therapies. The various designations from the FDA and European health authorities indicate a favorable regulatory outlook, potentially accelerating time-to-market.

Medical Research Analyst

From a medical standpoint, the initiation of a Phase III trial for a novel enzyme replacement therapy is promising, particularly given the multiple FDA designations. Breakthrough Therapy, Rare Pediatric Disease and Fast Track designations highlight the drug's potential to fulfill unmet medical needs quickly. Orphan Drug designation also often includes financial incentives such as tax credits, reduced regulatory fees and market exclusivity upon approval. This could significantly improve the drug's profitability and attract further investment into KORU Medical's technology.

It's critical to understand that while Phase III trials have a high success rate relative to earlier phases, they are still not guaranteed. Investors should watch for interim results and any updates on patient safety or efficacy as these could influence the company's financial outlook and stock price.

Market Research Analyst

The collaboration with a pharmaceutical company to support a Phase III trial for a rare endocrinological disease positions KORU Medical Systems advantageously in a niche but potentially lucrative market. Rare diseases affect fewer than 200,000 people in the U.S. but due to the high treatment costs, the global orphan drug market is expected to be worth billions. The Freedom System by KORU Medical will have limited competition as a novel administration method, which can create a significant market entry barrier for other companies.

Additionally, the growing trend towards personalized medicine and targeted therapies could bode well for KORU Medical, making their technology increasingly relevant. The successful validation testing also enhances the credibility of their product, potentially attracting more pharmaceutical collaborations in the future.

MAHWAH, N.J.--(BUSINESS WIRE)-- 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.

This significant milestone marks the progression of this collaboration, previously announced in July 2023. 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. The drug has been granted Breakthrough Therapy, Rare Pediatric Disease, and Fast Track designations by the FDA, as well as Orphan Drug designation in the US and Europe.

“We are proud of our role in developing devices that meet large volume subcutaneous delivery needs in collaboration with our valued pharmaceutical partners,” said Linda Tharby, President and CEO of KORU Medical Systems. “With the start of this Phase III clinical trial, we look forward to continuing to demonstrate our capability to successfully administer rare disease drugs across a growing range of indications.”

About KORU Medical Systems

KORU Medical Systems develops, manufactures, and commercializes innovative and patient-centric large volume subcutaneous infusion solutions that improve quality of life for patients around the world. The FREEDOM Syringe Infusion System (the “Freedom System”) currently includes the FREEDOM60^® and FreedomEdge^® Syringe Infusion Drivers, Precision Flow Rate Tubing^™ and HIgH-Flo Subcutaneous Safety Needle Sets^™. These devices are used for infusions administered in the home and alternate care settings. For more information, please visit www.korumedical.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties, including but not limited to those relating to the start of the Phase III clinical trial and the use of the Freedom System in the clinical trial. Actual results may differ materially from these statements due to potential risks and uncertainties such as, among others, success of the clinical trial, and by those risks and uncertainties included under the captions "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2023, which is on file with the SEC and available on our website at www.korumedical.com/investors and on the SEC website at www.sec.gov. All information provided in this release and in the attachments is as of May 14, 2024. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. We undertake no duty to update this information unless required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240514305737/en/

Investor Contact:

Louisa Smith

investor@korumedical.com

Source: KORU Medical Systems, Inc.

FAQ

What is KORU Medical Systems' stock symbol?

KORU Medical Systems is listed on NASDAQ under the stock symbol KRMD.

What recent agreement did KORU Medical Systems sign?

KORU Medical Systems signed a Phase III clinical supply agreement for a novel enzyme replacement therapy.

What is the goal of KORU Medical's Phase III trial?

The Phase III trial aims to evaluate bi-weekly subcutaneous infusions of a novel enzyme replacement therapy for a rare endocrinological disease.

What designations has the new drug received?

The drug has received Breakthrough Therapy, Rare Pediatric Disease, Fast Track, and Orphan Drug designations by the FDA, and Orphan Drug designation in Europe.

Who is the CEO of KORU Medical Systems?

Linda Tharby is the President and CEO of KORU Medical Systems.

How does the new agreement impact KORU Medical Systems?

The agreement potentially expands KORU Medical's role in administering rare disease drugs and showcases their capability in large volume subcutaneous delivery.