Rion

OU Health Stephenson Cancer Center shared a compelling expanded-access case using investigational PEP Biologic™ (Purified Exosome Product) for a severe radiation-associated wound that persisted despite months of antibiotics, debridement, and hyperbaric oxygen therapy. Despite months of antibiotics, in-office and formal surgical debridement, and 30 hyperbaric oxygen sessions, the wound failed to heal and progressively worsened. Under the care of Dr. Greg Krempl, PEP Biologic™ was applied weekly for 16 weeks—and by June 2025, the patient no longer required a bandage and new skin covered the entire wound. “Without this therapy, he would have likely lived with an open wound for the rest of his life with regular infections,” Dr. Krempl said. Read the full case here: https://lnkd.in/ed7hTZ5m PEP™ is investigational, is being evaluated in FDA-regulated clinical studies, and is not commercially available.   #WoundHealing #RegenerativeBiologics #ClinicalTrials #InnovationInCare #Exosomes #RION #INTENTBiologics

We’re excited to share a new SmartTRAK interview featuring Suneet Varma, CEO of INTENT Biologics: “Exosomes in Wound Care: The Next Big Thing?”   In the conversation, Suneet discusses INTENT Biologics’ novel exosome technology for advanced wound care, the origins of the approach, and the company’s focus in diabetic foot ulcers (DFUs). SmartTRAK also includes a video of the interview and a downloadable transcript.   Watch/read here: https://lnkd.in/eizCetPH #WoundCare #Biotech #Exosomes #Biologics #RegenerativeMedicine

INTENT Biologics is proud to announce that the FDA has agreed to our Initial Pediatric Study Plan (iPSP) for PEP Biologic™ under IND 019567, supporting our request for a full pediatric waiver for our forthcoming Biologics License Application (BLA).   FDA’s agreement reflects alignment that pediatric studies are not required for PEP Biologic’s flagship indication, diabetic foot ulcers (DFU). The agreed iPSP provides important regulatory clarity and removes the requirement to conduct clinical studies in the pediatric population as part of the DFU development program, contingent upon biologic licensure.   Read more: https://lnkd.in/eQBq4kb2 #WoundCare #Biotech #Regulatory #ClinicalDevelopment #DFU

INTENT Biologics is proud to announce that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for PEP Biologic™ for the treatment of diabetic foot ulcers (DFU) under IND 019567.   Fast Track is designed to facilitate development and expedite review for therapies addressing serious conditions and unmet medical need. Under this designation, PEP Biologic™ is now eligible for more frequent interactions with the FDA, rolling submission of portions of a BLA, and the potential for accelerated or priority review in the future.   Read the full announcement: https://lnkd.in/eMWE_JNE #WoundCare #Biotech #Regulatory #Diabetes #DFU

INTENT Biologics is in New York this week! 🗽 We’re pleased to share that Suneet Varma, CEO of INTENT Biologics, attended the AdvaMed & EY Medtech Investors & Innovators Reception on Tuesday, December 2 at The New York Lotte Palace, alongside leaders gathering for Piper Sandler’s 37th Annual Healthcare Conference in NYC.  This invite-only reception convenes top private medtech investors, CEOs, and corporate strategics to discuss where innovation, capital, and patient need intersect across the medtech ecosystem. INTENT Biologics is advancing first-in-class regenerative therapies in advanced wound care, and Suneet was able to connect with investors and partners who share our commitment to transforming outcomes for patients with chronic and hard-to-heal wounds. #INTENTBiologics #MedTech #WoundCare #RegenerativeMedicine #AdvaMed #EY #PiperSandlerHC #HealthcareInnovation

https://lnkd.in/eq7-bc84

RION Engages Lonza to Scale Manufacturing Exosome Based Therapeutics   •             Lonza to support cGMP manufacturing of RION’s Purified Exosome Product™ (PEP™), a platelet-derived exosome-based drug candidate for chronic wound care and tissue regeneration •             Collaboration leverages RION’s proprietary biomanufacturing process to propel RION’s industry-leading clinical development pipeline towards late-phase trials and commercialization for multiple regenerative medical conditions   Atta Behfar, Cofounder and CEO, RION, said: "This collaboration with Lonza ensures that our proprietary exosome manufacturing platform can be scaled to meet clinical and future commercial demand. RION’s breakthrough in exosome biomanufacturing now paired with Lonza’s global infrastructure allows us to bring this biologics-based innovation to patients rapidly and reliably, while staying true to our mission of affordable access."   If you want to learn more, please see the link below. https://lnkd.in/e_CeTjnC

RION Engages Lonza to Scale Manufacturing Exosome Based Therapeutics   •             Lonza to support cGMP manufacturing of RION’s Purified Exosome Product™ (PEP™), a platelet-derived exosome-based drug candidate for chronic wound care and tissue regeneration •             Collaboration leverages RION’s proprietary biomanufacturing process to propel RION’s industry-leading clinical development pipeline towards late-phase trials and commercialization for multiple regenerative medical conditions   Atta Behfar, Cofounder and CEO, RION, said: "This collaboration with Lonza ensures that our proprietary exosome manufacturing platform can be scaled to meet clinical and future commercial demand. RION’s breakthrough in exosome biomanufacturing now paired with Lonza’s global infrastructure allows us to bring this biologics-based innovation to patients rapidly and reliably, while staying true to our mission of affordable access."   If you want to learn more, please see the link below. https://lnkd.in/e_CeTjnC

We are excited to announce the launch of Intent Biologics, an independent biotechnology company established to develop late-stage clinical exosome-based therapies in inflammation and immunology, and congratulate biopharma veteran Suneet Varma on his appointment as CEO. INTENT Biologics will advance RION’s proprietary Purified Exosome Product™ (PEP™) biologic platform into Phase 3 clinical development. Learn more about INTENT Biologics and Suneet’s appointment by clicking the link below. https://lnkd.in/eVfj_ySP