KORU Medical Systems Announces Phase III Clinical Trial Collaboration for a New Drug Indication in Nephrology
KORU Medical Systems (NASDAQ: KRMD) announced a collaboration with a global pharmaceutical manufacturer for a Phase III clinical trial exploring an expanded indication of a commercialized drug therapy. The trial targets a rare renal disorder affecting approximately 30,000 patients with a projected 300,000 annual infusions.
The Phase III trial will evaluate the safety, efficacy, and performance of the drug in treating patients with kidney transplant complications. The company's Freedom Infusion System currently administers over 2 million infusions annually. Upon successful trial completion, KORU Medical will gain access to a new patient base in the rare renal disorder segment.
KORU Medical Systems (NASDAQ: KRMD) ha annunciato una collaborazione con un produttore farmaceutico globale per un studio clinico di Fase III che esplora un'indicazione ampliata di una terapia medicinale commercializzata. Lo studio mira a un raro disturbo renale che colpisce circa 30.000 pazienti con una proiezione di 300.000 infusioni annuali.
La sperimentazione di Fase III valuterà la sicurezza, l'efficacia e le prestazioni del farmaco nel trattamento delle complicanze dei trapianti di rene. Il sistema Freedom Infusion dell'azienda attualmente somministra oltre 2 milioni di infusioni all'anno. Una volta completato con successo lo studio, KORU Medical avrà accesso a una nuova base di pazienti nel segmento dei rari disturbi renali.
KORU Medical Systems (NASDAQ: KRMD) anunció una colaboración con un fabricante farmacéutico global para un ensayo clínico de Fase III que explora una indicación ampliada de una terapia medicinal comercializada. El ensayo se dirige a un raro trastorno renal que afecta a aproximadamente 30,000 pacientes con una proyección de 300,000 infusiones anuales.
El ensayo de Fase III evaluará la seguridad, eficacia y rendimiento del fármaco en el tratamiento de complicaciones de trasplantes de riñón. El sistema Freedom Infusion de la compañía actualmente administra más de 2 millones de infusiones anuales. Tras la finalización exitosa del ensayo, KORU Medical accederá a una nueva base de pacientes en el segmento de trastornos renales raros.
KORU Medical Systems (NASDAQ: KRMD)는 상업화된 약물 치료의 확장된 적응증을 탐색하기 위한 3상 임상 시험에 대한 글로벌 제약 제조업체와 협력한다고 발표했습니다. 이 시험은 약 30,000명의 환자에게 영향을 미치는 희귀 신장 질환을 대상으로 하며, 연간 300,000회의 주입이 예상됩니다.
3상 시험은 신장 이식 합병증을 가진 환자 치료에서 약물의 안전성, 효능 및 성능을 평가합니다. 현재 회사의 Freedom Infusion System은 매년 200만 회 이상의 주입을 시행하고 있습니다. 시험이 성공적으로 완료되면 KORU Medical은 희귀 신장 질환 부문에서 새로운 환자 기반에 접근하게 됩니다.
KORU Medical Systems (NASDAQ: KRMD) a annoncé une collaboration avec un fabricant pharmaceutique mondial pour un essai clinique de Phase III explorant une indication élargie d'une thérapie médicamenteuse commercialisée. L'essai cible un trouble rénal rare touchant environ 30 000 patients avec une projection de 300 000 infusions annuelles.
L'essai de Phase III évaluera la sécurité, l'efficacité et la performance du médicament dans le traitement des complications liées aux greffes rénales. Le système Freedom Infusion de l'entreprise administre actuellement plus de 2 millions d'infusions par an. Suite à l'achèvement réussi de l'essai, KORU Medical aura accès à une nouvelle base de patients dans le domaine des troubles rénaux rares.
KORU Medical Systems (NASDAQ: KRMD) gab eine Zusammenarbeit mit einem globalen Pharmahersteller für eine Phase-III-Studie bekannt, die eine erweiterte Indikation einer kommerzialisierten Arzneimitteltherapie untersucht. Die Studie richtet sich an eine seltene Nierenerkrankung, die etwa 30.000 Patienten betrifft, mit einer prognostizierten 300.000 jährlichen Infusionen.
Die Phase-III-Studie wird die Sicherheit, Wirksamkeit und Leistungsfähigkeit des Medikaments bei der Behandlung von Komplikationen nach Nierentransplantationen bewerten. Das Freedom Infusion System des Unternehmens führt derzeit über 2 Millionen Infusionen pro Jahr durch. Nach erfolgreichem Abschluss der Studie wird KORU Medical Zugang zu einer neuen Patientenbasis im Segment der seltenen Nierenerkrankungen erhalten.
- Access to new market of 30,000 patients with 300,000 annual infusions potential
- Current system already delivers 2 million infusions annually
- Partnership with global pharmaceutical manufacturer for Phase III trial
- Expansion into nephrology market segment
- Trial success and regulatory approval not guaranteed
- Timeline for potential market entry not specified
Insights
This Phase III trial collaboration marks a strategic milestone for KORU Medical Systems, representing significant potential market expansion beyond their current therapeutic areas. The target population of 30,000 patients requiring 300,000 annual infusions presents a substantial revenue opportunity in the specialized nephrology market.
The collaboration demonstrates KORU's growing influence in the rare disease space, particularly noteworthy as kidney transplant complications represent a critical unmet medical need. The company's Freedom Infusion System's track record of over 2 million annual infusions positions it as a trusted partner for pharmaceutical companies developing subcutaneous formulations of complex therapies.
From a market perspective, this expansion into nephrology diversifies KORU's portfolio and reduces dependency on existing therapeutic areas. The rare disease focus is particularly attractive as these treatments typically command premium pricing and face competition. Success in this trial could establish KORU as a key player in the renal disorder space, potentially leading to additional pharmaceutical partnerships.
The Phase III stage indicates relatively advanced development, suggesting potential commercialization within 2-3 years, subject to successful trial outcomes and regulatory approval. This timeline aligns well with KORU's growth strategy and could provide a meaningful revenue stream in the medium term. The collaboration also validates KORU's technology platform and could attract additional pharmaceutical partnerships in other therapeutic areas.
This announcement highlights an additional collaboration between KORU Medical and its partners in the development of novel therapies and enhanced drug delivery experiences for patients living with rare conditions. The Phase III trial aims to assess the safety, efficacy, and performance of the drug to treat patients with complications from kidney transplants.
“We continue to see growth in the overall large volume subcutaneous market with multiple new drugs entering clinical trials and several others receiving regulatory approval. With over 2 million infusions administered on the KORU Freedom Infusion System every year, KORU continues to be a leading collaboration partner for large volume subcutaneous drug therapies in both the home and infusion clinic settings,” said Linda Tharby, President and CEO of KORU Medical. “Assuming successful completion and results from this Phase III clinical trial, this drug’s expanded indication will give us access to a new patient base and enable the delivery of a therapy to improve the lives of those with rare renal disorder.”
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™. The Freedom System, which received its first FDA clearance in 1994, is used for self-administration in the home by the patient and/or delivery in an ambulatory infusion center by a healthcare professional. Through its Novel Therapies business, KORU Medical provides products for use by biopharmaceutical companies in feasibility/clinical trials during the drug development process and, as needed, is capable of customizing the Freedom System for clinical and commercial use across multiple drug categories. 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 the success of the Phase III trial, success of the regulatory clearance, number of potential infusions available to the Freedom Infusion System. Actual results may differ materially from these statements due to potential risks and uncertainties such as 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 January 30, 2025. 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.
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Investor Contact:
Louisa Smith
investor@korumedical.com
Source: KORU Medical Systems
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