Our Pipeline

Our Pipeline

The Future of Medicine is Here:

Revolutionizing Exosome Science to Heal from Within!  

At RION, we’re harnessing the power of platelet-derived exosomes, nature’s own delivery vehicles, to create the most advanced exosome clinical pipeline with PEP™

The Future of Medicine is Here:

Revolutionizing Exosome Science to Heal from Within!  

At RION, we’re harnessing the power of platelet-derived exosomes, nature’s own delivery vehicles, to create the most advanced exosome clinical pipeline with PEP™

Indication Preclinical Phase 1 Phase 2 Phase 3 Commercial
Advanced Wound Care
Phase 3
Unmet Need: Diabetic foot ulcers are chronic, non-healing wounds associated with high rates of infection, amputation, and recurrence despite available therapies.
Product: PEP + Fibrin Gel
Regulatory Designations:
• Breakthrough Therapy Designation | Granted June 2026 | A process designed to expedite the development and review of drugs which may demonstrate substantial improvement over available therapy.
• Fast Track Designation | Granted December 2025 | A process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
Partner: INTENT Biologics
Phase 3
Unmet Need: Chronic refractory wounds often remain unhealed despite standard of care, resulting in prolonged morbidity and increased healthcare burden.
Product: PEP + Fibrin Gel
Partner: INTENT Biologics
Phase 2
Unmet Need: Severe thermal burns can cause extensive tissue destruction, delayed healing, infection, and long-term functional impairment.
Product: PEP + Fibrin Gel
Partner: INTENT Biologics / DOD
Phase 2
Unmet Need: Chronic radiation ulcers result from radiation-induced tissue damage and have limited treatment options, often leading to persistent wounds and impaired healing.
Product: PEP + Fibrin Gel
Partner: INTENT Biologics / DOD
Musculoskeletal
Phase 1
Unmet Need: Current treatment options for knee osteoarthritis are largely limited to symptomatic relief and fail to modify progressive joint degeneration.
Product: PEP + saline
Partner: Nexos
Phase 1
Unmet Need: Achilles tendinopathy is a chronic degenerative tendon disorder with limited therapies that promote true tissue regeneration.
Product: PEP + saline
Partner: Nexos / DOD
Cardiovascular
Preclinical
Unmet Need: Ischemic heart disease can result in permanent cardiac tissue damage and progressive loss of heart function, highlighting the need for novel therapies that address the underlying consequences of ischemic injury.
Product: PEP + HEP-NS
Preclinical
Unmet Need: Peripheral vascular disease results in impaired blood flow, tissue ischemia, and progressive tissue damage, with limited treatment options that restore vascular function and promote tissue repair.
Product: PEP + HEP-NS
Phase 2
Unmet Need: Despite successful stent implantation, many patients remain at risk for ongoing vascular injury and adverse cardiovascular events, highlighting the need for therapies that promote durable repair and recovery.
Product: PEP + HEP-NS
Medical Aesthetics
Phase 2
Unmet Need: Current aesthetic treatments improve the appearance of photodamaged skin but do not address the underlying inflammation, oxidative stress, and impaired tissue repair that contribute to skin aging.
Product: PEP + saline
Partner: Rion Medical Aesthetics
Phase 2
Unmet Need: Existing therapies for non-scarring alopecia often require chronic use and provide modest efficacy, leaving a need for regenerative approaches that restore healthy follicular function and support durable hair growth.
Product: PEP + saline
Partner: Rion Medical Aesthetics
Veterinary
RBR
Unmet Need: Tendon, ligament, and joint injuries are a leading cause of lameness in horses, and current therapies manage symptoms but rarely restore normal tissue.
Product: ePEP
Partner: Rion Vet
RBR
Unmet Need: Osteoarthritis and soft-tissue injuries are a common cause of chronic pain and lameness in dogs, yet current therapies reduce pain without repairing tissue or slowing disease progression.
• VIP / Low Risk Approval Pathway
Product: cPEP
Partner: Rion Vet
Dermatology
Phase 2
Unmet Need: Despite topical and systemic treatment options, many patients with atopic dermatitis continue to experience inadequate symptom control, persistent itch, and recurrent flares.
Product: PEP serum
Partner: RioDerm
Pulmonary
Preclinical
Unmet Need: Patients with COPD and acute lung injury have limited treatment options that directly repair damaged lung tissue or restore pulmonary function.
Product: PEP + NEB NS
Partner: DOD
Drug Delivery
Preclinical
Unmet Need: Conventional systemic antibiotics often fail to achieve adequate concentrations at the site of infection, contributing to poor clinical response, prolonged treatment courses, and the development of antimicrobial resistance.
Product: PEP + Cargo
Preclinical
Unmet Need: Systemic chemotherapy is often limited by off-target toxicity and insufficient tumor-specific delivery, resulting in a narrow therapeutic window and treatment-limiting side effects.
Product: PEP + Cargo
Preclinical
Unmet Need: The clinical utility of nucleic acid therapeutics is often limited by delivery challenges and inadequate cellular uptake.
Product: Engineered PEP
Advanced Wound Care
Phase 3
Unmet Need: Diabetic foot ulcers are chronic, non-healing wounds associated with high rates of infection, amputation, and recurrence despite available therapies.
Product: PEP + Fibrin Gel
Regulatory Designations:
• Breakthrough Therapy Designation | Granted June 2026 | A process designed to expedite the development and review of drugs which may demonstrate substantial improvement over available therapy.
• Fast Track Designation | Granted December 2025 | A process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
Partner: INTENT Biologics
Phase 3
Unmet Need: Chronic refractory wounds often remain unhealed despite standard of care, resulting in prolonged morbidity and increased healthcare burden.
Product: PEP + Fibrin Gel
Partner: INTENT Biologics
Phase 2
Unmet Need: Severe thermal burns can cause extensive tissue destruction, delayed healing, infection, and long-term functional impairment.
Product: PEP + Fibrin Gel
Partner: INTENT Biologics / DOD
Phase 2
Unmet Need: Chronic radiation ulcers result from radiation-induced tissue damage and have limited treatment options, often leading to persistent wounds and impaired healing.
Product: PEP + Fibrin Gel
Partner: INTENT Biologics / DOD
Musculoskeletal
Phase 1
Unmet Need: Current treatment options for knee osteoarthritis are largely limited to symptomatic relief and fail to modify progressive joint degeneration.
Product: PEP + saline
Partner: Nexos
Phase 1
Unmet Need: Achilles tendinopathy is a chronic degenerative tendon disorder with limited therapies that promote true tissue regeneration.
Product: PEP + saline
Partner: Nexos / DOD
Cardiovascular
Preclinical
Unmet Need: Ischemic heart disease can result in permanent cardiac tissue damage and progressive loss of heart function, highlighting the need for novel therapies that address the underlying consequences of ischemic injury.
Product: PEP + HEP-NS
Preclinical
Unmet Need: Peripheral vascular disease results in impaired blood flow, tissue ischemia, and progressive tissue damage, with limited treatment options that restore vascular function and promote tissue repair.
Product: PEP + HEP-NS
Phase 2
Unmet Need: Despite successful stent implantation, many patients remain at risk for ongoing vascular injury and adverse cardiovascular events, highlighting the need for therapies that promote durable repair and recovery.
Product: PEP + HEP-NS
Medical Aesthetics
Phase 2
Unmet Need: Current aesthetic treatments improve the appearance of photodamaged skin but do not address the underlying inflammation, oxidative stress, and impaired tissue repair that contribute to skin aging.
Product: PEP + saline
Partner: Rion Medical Aesthetics
Phase 2
Unmet Need: Existing therapies for non-scarring alopecia often require chronic use and provide modest efficacy, leaving a need for regenerative approaches that restore healthy follicular function and support durable hair growth.
Product: PEP + saline
Partner: Rion Medical Aesthetics
Veterinary
RBR
Unmet Need: Tendon, ligament, and joint injuries are a leading cause of lameness in horses, and current therapies manage symptoms but rarely restore normal tissue.
Product: ePEP
Partner: Rion Vet
RBR
Unmet Need: Osteoarthritis and soft-tissue injuries are a common cause of chronic pain and lameness in dogs, yet current therapies reduce pain without repairing tissue or slowing disease progression.
• VIP / Low Risk Approval Pathway
Product: cPEP
Partner: Rion Vet
Dermatology
Phase 2
Unmet Need: Despite topical and systemic treatment options, many patients with atopic dermatitis continue to experience inadequate symptom control, persistent itch, and recurrent flares.
Product: PEP serum
Partner: RioDerm
Pulmonary
Preclinical
Unmet Need: Patients with COPD and acute lung injury have limited treatment options that directly repair damaged lung tissue or restore pulmonary function.
Product: PEP + NEB NS
Partner: DOD
Drug Delivery
Preclinical
Unmet Need: Conventional systemic antibiotics often fail to achieve adequate concentrations at the site of infection, contributing to poor clinical response, prolonged treatment courses, and the development of antimicrobial resistance.
Product: PEP + Cargo
Preclinical
Unmet Need: Systemic chemotherapy is often limited by off-target toxicity and insufficient tumor-specific delivery, resulting in a narrow therapeutic window and treatment-limiting side effects.
Product: PEP + Cargo
Preclinical
Unmet Need: The clinical utility of nucleic acid therapeutics is often limited by delivery challenges and inadequate cellular uptake.
Product: Engineered PEP

Expanded Access

Rion Inc. Policy on Expanded Access Program for IND 019567 for Wounds

Rion Inc. is dedicated to developing innovative treatments for serious and life-threatening conditions. Understanding that certain patients with serious or life-threatening diseases may have exhausted all available treatment options, meet the unique needs of expanded access requirements and are interested in receiving Rion’s drug candidate through an expanded access policy, Rion Inc. is willing to provide our investigational drug product PEP to patients for the treatment in compliance with FDA Expanded Access (Compassionate Use) Policies.

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