BioStem Technologies (OTC: BSEM)’s Post

📍 Part 3: Who Uses NanoCool™? 💙 Because protecting life doesn’t just happen in the lab—it happens at home, too. From global clinical trials to family care at home, NanoCool™ is trusted wherever temperature protection matters. Pharmaceutical companies, clinical teams, and logistics providers rely on NanoCool™ for its precision and performance in delivering life-saving therapies. But beyond the lab, its simplicity and reliability also support families, caregivers, and mothers-to-be who need safe, controlled cooling—whether for vital medications or breast milk storage during travel or recovery. With instant activation and steady 2–8°C control, NanoCool™ makes temperature-sensitive protection accessible, efficient, and dependable for everyone who counts on it. Because at Peli BioThermal, we believe every life—every family—deserves the same protection trusted by the world’s leading healthcare innovators. 🔗 Learn how NanoCool™ is redefining confidence in cold chain delivery—from the lab to the living room: https://lnkd.in/gFsGfkb2 #NanoCool #PeliBioThermal #TemperatureControl #LifeSciences #FamilyCare #MissionDriven #ColdChainInnovation #PharmaLogistics

Validation is broken and everyone knows it. We spend millions proving systems “work as intended,” yet we can’t even agree on what intended means. We generate mountains of documents, sign them in triplicate, and call it progress, but often, it’s just paper compliance. Validation was never supposed to be a paper pushing exercise. It was meant to prove trust, consistency, and patient safety. Maybe it’s time we stop validating for checking boxes and start validating for patient safety. Read the full article on the f2i partners website under industry insights. #Validation #GMP #Quality #Pharma #Innovation #F2iPartners

Between tight production timelines, radiation exposure, and strict GMP requirements, sterility testing remains a key challenge for the entire radiopharmaceutical value chain. That’s why sharing knowledge across the community, as CUP Contract Labs does here, is essential to keep improving how we develop, manufacture, validate, and deliver safe products to patients. As Thomas Vergote, PhD , Radiopharmaceutical Solutions Product Manager at Trasis, points out: «𝑾𝒊𝒕𝒉 𝑺𝒕𝒆𝒓𝒊𝑵𝒐𝒘®, 𝒊𝒏𝒗𝒆𝒏𝒕𝒆𝒅 𝒃𝒚 𝑪𝑼𝑷 𝒂𝒏𝒅 𝒆𝒏𝒈𝒊𝒏𝒆𝒆𝒓𝒆𝒅 𝒃𝒚 𝑻𝒓𝒂𝒔𝒊𝒔, 𝒚𝒐𝒖 𝒄𝒂𝒏 𝒑𝒆𝒓𝒇𝒐𝒓𝒎 𝒚𝒐𝒖𝒓 𝒓𝒂𝒅𝒊𝒐𝒑𝒉𝒂𝒓𝒎𝒂𝒄𝒆𝒖𝒕𝒊𝒄𝒂𝒍 𝒔𝒕𝒆𝒓𝒊𝒍𝒊𝒕𝒚 𝒕𝒆𝒔𝒕 𝒓𝒊𝒈𝒉𝒕 𝒐𝒏 𝒔𝒊𝒕𝒆, 𝒇𝒖𝒍𝒍𝒚 𝒂𝒖𝒕𝒐𝒎𝒂𝒕𝒆𝒅 𝒂𝒏𝒅 𝒊𝒎𝒎𝒆𝒅𝒊𝒂𝒕𝒆𝒍𝒚 𝒂𝒇𝒕𝒆𝒓 𝒑𝒓𝒐𝒅𝒖𝒄𝒕𝒊𝒐𝒏. 𝑼𝒔𝒊𝒏𝒈 𝒕𝒉𝒆 𝒈𝒐𝒍𝒅-𝒔𝒕𝒂𝒏𝒅𝒂𝒓𝒅 𝒎𝒆𝒎𝒃𝒓𝒂𝒏𝒆 𝒇𝒊𝒍𝒕𝒓𝒂𝒕𝒊𝒐𝒏 𝒎𝒆𝒕𝒉𝒐𝒅, 𝒊𝒕’𝒔 𝒕𝒉𝒆 𝒑𝒆𝒓𝒇𝒆𝒄𝒕 𝒄𝒐𝒎𝒃𝒐 𝒕𝒐 𝒆𝒍𝒊𝒎𝒊𝒏𝒂𝒕𝒆 𝒂𝒏𝒚 𝒊𝒏𝒕𝒆𝒓𝒇𝒆𝒓𝒆𝒏𝒄𝒆 𝒇𝒓𝒐𝒎 𝒓𝒂𝒅𝒊𝒐𝒂𝒄𝒕𝒊𝒗𝒊𝒕𝒚! 𝑵𝒐 𝒇𝒂𝒍𝒔𝒆 𝒏𝒆𝒈𝒂𝒕𝒊𝒗𝒆𝒔, 𝒏𝒐 𝒆𝒙𝒑𝒐𝒔𝒖𝒓𝒆, 𝒏𝒐 𝒅𝒆𝒍𝒂𝒚: 𝒋𝒖𝒔𝒕 𝒇𝒖𝒍𝒍 𝒄𝒐𝒎𝒑𝒍𝒊𝒂𝒏𝒄𝒆, 𝒆𝒙𝒂𝒄𝒕𝒍𝒚 𝒘𝒉𝒆𝒓𝒆 𝒚𝒐𝒖 𝒏𝒆𝒆𝒅 𝒊𝒕!” 🔗 Learn more about SteriNow® : https://lnkd.in/eNN3kMCQ

Legacy diagnostics meet new regulation. One of the biggest questions at IBMS 2025 was: what happens to existing products under IVDR? The answer lies in balance — maintaining continuity while meeting every new compliance demand. At BaxMed, that means close collaboration with notified bodies, strengthened technical files, and proactive communication across our supply chain. We’re reviewing all updates against the latest IVDR “significant change” guidance and MHRA registration requirements — ensuring every refinement strengthens reliability without disrupting supply. Discussions at IBMS 2025 echoed a common concern: “How do we ensure continuity without compromising compliance?” Behind the scenes, validation reviews, documentation upgrades, and performance evaluations are already underway — all to keep essential diagnostics in clinicians’ hands without disruption. Because for us, innovation doesn’t stop at a regulation. It adapts, improves, and keeps people supported. 💡 #IVDR #MedicalDevices #Compliance #Diagnostics #BaxMed

MedTech Europe has issued an FAQ to help manufacturers of #medicaldevices and #invitrodiagnostics navigate the recertification process under #MDR and #IVDR. Given the associated costs and timelines, certificate validity should follow the lifetime of the device unless a targeted review is needed, when triggered by significant changes, new safety signals, or evidence gaps. The Association advocates that eliminating fixed certificate validity periods and replacing re-certification with a risk-based assessment approach would enhance patient access to innovative devices while ensuring continuity of supply and availability. #medtech #medtechnews #biotech #biotechnews

*** New NMPA Technical Review Guidelines Just Released! *** On 11 November 2025, CMDE (NMPA) published two critical guidance documents to streamline high-risk device evaluations: • Technical Review Points for Animal Studies of Soft Tissue Regenerative Hernia Meshes; • Technical Review Points for Nerve Repair Materials. These clarify expectations on preclinical study design, biocompatibility, functional recovery assessment, and evidence linkage to clinical benefit — addressing longstanding uncertainties for regenerative/implantable devices. For global innovators, aligning early with these review standards is key to avoiding delays in China registration. At CMS Medtech, we help MedTech companies navigate complex NMPA submissions — from preclinical strategy and gap analysis to full dossier preparation and agency liaison. Contact us today at info@cmsscidoc.cn for expert support! #MedicalDevices #MedicalDeviceRegistration #NMPA #CMDE #ChinaMarket #ChinaRegulatory #CFDA #MedTech #MedTechRegulation #RegulatoryAffairs #Marketaccess #Healthcare #GlobalRegulatory #RegenerativeMedicine #HerniaMesh #NerveRepair

💊 Pharmacists see it all — the waste, the challenges, and the missed opportunities. That’s why I loved hearing from Dr. Elena Kline PharmD, BCGP, BCACP during our webinar. She perfectly captures how I2F helps protect fragile drugs, reduce waste, and ensure every vial counts. This is what innovation looks like in practice — improving efficiency, safeguarding high-value medications, and ultimately leading to better outcomes for patients and providers alike. Sometimes the most powerful innovations are the simplest. 👉 Full webinar replay: https://lnkd.in/gMTyR2fs #I2F #Pharmacy #MedicationSafety #Innovation #DrugDelivery #Healthcare

Ziad Al-Shamsie and Peter Stebbins will be at PODD: Partnership Opportunities in Drug Delivery Community News this week to discuss our ground-breaking platform to: - Improve Injection Experience - Give Formulators and Developers more ways to succeed - Advance with society and the healthcare industry, not 20 years behind. We can see even see AI (the non-autoinjector type) being a key part of drug development and patient management thanks to the functionalities untapped for data, wearables, titration, etc of powerful, as well as not so high dose, medicines - eg for neurodegenerative disease or obesity. #2025PODD. #PODD2025

BCBN Feed: RevBio® Receives First FDA Approval for a "Bone Glue" to Treat Extremity Fractures in a Clinical Trial https://lnkd.in/g7Yftnzd LOWELL, Mass.--(BUSINESS WIRE)-- #Bioengineeringabodyofapplications--RevBio® announced today that TETRANITE, the company’s first of its kind regenerative “bone glue” has been approved for a 20-patient pilot study to measure the biomaterial’s safety and efficacy to treat complex, multi-fragmented wrist fractures including those that involve articular surfaces. The focus of this clinical trial... ... [...]

How can the UK strengthen its position as a global leader in advanced therapy manufacturing? Our Chief Operations Officer, Ed Samuel, recently joined the BioIndustry Association (BIA) to discuss the opportunities and challenges of scaling up advanced therapy manufacturing, emphasising the CGT Catapult's key role in enabling #ATMP process scale-up and delivery, and driving the necessary skills and talent growth to support the sector Read the full conversation here: https://lnkd.in/eR5BuHt4 #AdvancedTherapies #CellTherapy #GeneTherapy