Andrew Cothrel

News from our portfolio company NurExone Biologic (OTCQB:NRXBF) (TSXV: NRX) (FSE: J90) NurExone Planning to Establish First U.S. Commercial Manufacturing Facility in Indiana The Indianapolis facility would serve as Exo-Top’s U.S. manufacturing base, transferring NurExone’s proprietary exosome production process into the American market. The GMP compliant site would produce exosomes both for NurExone’s therapeutic pipeline and for a growing business-to-business opportunity in regenerative aesthetics. https://lnkd.in/dFfbhGR6

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🧬 This week's Austin Bio & Health Roundup brings early-stage funding, new partnerships, and action across the Texas Bio Triangle 🧬 💰 Funding & Capital Signals Lumaegis raised $200K in pre-seed funding to advance FDA De Novo certification of its faster, energy-efficient sterilization technology. 🤝 Partnerships & M&A HumanN, a cardiovascular supplement company, signed a wide-ranging sponsorship with UT, reported as one of the largest in college sports. A strong example of the Austin flywheel. Wenzel Spine sold its Vertebral Motion Technologies portfolio to Driving Force, sharpening its focus on next-generation spine solutions. 🤠 Texas Bio Triangle Houston: Coya Therapeutics received FDA acceptance of its IND application for COYA 302 for ALS. Houston: Rice Biotech Launch secured investment from Houston-based Modi Ventures, who will now get a seat on the board, to strengthen its translational biotech initiatives. What’s Next? 🤠 🚀 🦾 🧬

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I had a conversation with Karl Schmieder, MS MFA on how #radicalcollaboration is needed to bring a bio-manufacturing industry to life. We talked about: Why invention alone isn’t enough: Discovery is no longer the bottleneck—industrial scaling, regulation, and consumer adoption are. The new role of orchestrators: The most valuable companies will be those that coordinate across supply chains, regulators, and corporates, turning fragmented players into functioning ecosystems. What this means for founders and investors: The future winners in biotech may not be those with the most novel science, but those who master the art of integration. https://lnkd.in/g4bshddA Kylie Porter Michele Stansfield David Weiner David Kestenbaum Mark Warner Sam Perkins Ian O'Hara Arturo Elizondo James Petrie Jim Fader Paul Riley Ed Husic MP Robyn Denholm Guy Reypert Chris Liu Rob Brown Emerald Scofield Dirk van der Kley

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Rethinking Heart Failure Management—Why Device Innovation Matters Interesting article from the Cleveland Clinic - Device-Based Heart Failure Therapies in the Spotlight. It highlights the shift in how we address heart failure in today’s clinical landscape. The piece emphasizes that despite advances in pharmacotherapy, hospitalisation and mortality rates continue to climb—and that earlier consideration of device-based therapies is essential to alter disease trajectories effectively. This aligns with the latest consensus guidance from the HFSA, advocating a more integrated pathway that pairs guideline-directed medical therapy (GDMT) with device-based options for patients not fully responding to medications alone. From my perspective at Ceryx Medical, this trend holds deep relevance. Our device, designed to optimise cardiac function, improve energy efficiency and boost cardiac output thereby treating symptoms and inducing cardiac repair, dovetails with this evolving paradigm. Here’s why: Early intervention is key: By targeting the root of cardiac inefficiency sooner, our device aligns with the Cleveland Clinic’s call to shift device therapy “earlier” in the care continuum, particularly in NYHA II–III patients. Bridging gaps in GDMT response: For patients who remain symptomatic despite medical management our approach offers a powerful tool for eliminating the debilitating symptoms of heart failure. Enhancing personalization of care: The trend toward phenotype-driven treatment decisions, as outlined in recent reviews, mirrors our commitment to developing solutions that fit the individual patient’s physiology, symptom profile, and treatment tolerance. Complementary rather than competitive: Ceryx has demonstrated our technology significant improves the clinical condition of subjects already treated with optimal pharmacotherapy. In essence, this Cleveland Clinic article reinforces that advanced device strategies are not just “nice to have”—they’re becoming essential companions to pharmacological therapy in improving outcomes and quality of life for heart failure patients. #HeartFailure #MedicalDevices #DigitalHealth #ClinicalInnovation #Cardiology #GDMT #DeviceTherapy #PatientCentricCare

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A turning point for precision medicine: FDA just proposed moving companion diagnostics from Class III to Class II. So diagnostic tests that previously required full PMA would now clear through 510(k), provided they meet special controls. Why this matters:👇 1. Diagnostics development suffered by PMA timelines and cost. Time to market was so long that investor interest is nearly zero for this entire category. A 510(k) significantly shortens time to market and cost, removing a major structural bottleneck. 2. Oncology now depends on molecular stratification. Faster CDx clearance tightens the therapeutic diagnostic loop and reduces latency between biomarker discovery and clinical deployment. 3. Market Shifts: Lowering the regulatory barrier for diagnostics changes the economics of precision oncology. More assays get built. More subpopulations get identified. More therapeutics can be matched to a precise patient profile instead of broad labels. If finalized, this will materially change targeted drug development. We do need more diagnostics, and the barrier just got lower. It’s a great time to build. If you’re working in this space, send me a DM. Hashtags: #oncology #precisionmedicine #regulation #diagnostics #FDA Credit Image: 360Dx, article link in comments

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Dual signals in global medtech innovation: FDA clears first at‑home brain stimulation device and AI smart dialysis manufacturing wins regulatory nod — a tectonic shift in therapeutic tech This week’s Medtech headlines spotlight regulatory validation of distributed therapeutic devices and AI‑enabled hardware moving toward scale. The U.S. FDA approved Flow Neuroscience’s FL‑100 — the first at‑home neurostimulation device for adults with moderate‑to‑severe depression — based on a mid‑stage study showing ~58% remission at 10 weeks, underscoring a broader shift of regulated therapy outside clinic walls. Simultaneously, Lords Mark Industries’ Renalyx AI‑based smart haemodialysis machines secured a national licence in India and CE marking, signaling global market access for AI‑driven critical care devices.   #MedTech #RegulatoryNews #AIinHealthcare #Innovation https://lnkd.in/gimCRHFf

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Massive News in Pharma Safety Monitoring! The FDA has officially removed the REMS requirement for CAR-T cell immunotherapies, a clear sign of growing confidence in their safety and effectiveness. This is a major win for manufacturers, easing regulatory complexity and accelerating patient access to these groundbreaking therapies. By simplifying requirements, we can reduce costs and make these life-changing treatments available more quickly to healthcare providers and patients. A powerful step forward that balances innovation with what matters most: patient safety. #FDA #Pharma #SafetyFirst #RegulatoryUpdate #Innovation #PatientCare American Association for Precision Medicine (AAPM) ##aapmhealth #aapm_health

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You may have already heard that Ori’s IRO® platform is FDA Advanced Manufacturing Technology (AMT) designated... but what does this actually mean for CGT developers? 🤝 Earlier FDA engagement: AMT designation provides developers with earlier and more frequent interaction with the agency throughout IND, NDA, and BLA processes. That means faster feedback and reduced regulatory uncertainty. 📈 Confidence in scalability: FDA recognition validates IRO® as a next-generation platform capable of reducing costs, increasing throughput, and improving reliability – critical for ensuring therapies can scale beyond the lab and into commercial success. 🥇 Competitive advantage: the IRO® platform is quickly becoming the New Standard in CGT manufacturing, delivering innovation that accelerates timelines, supports quality, and improves the likelihood of regulatory success. In short, AMT designation confirms that IRO® meets the FDA standard for advanced manufacturing. This positions us, and our partners, at the forefront of delivering life-changing therapies to patients faster, more reliably, and at scale. Learn more about our IRO® platform ➡️ https://oribiotech.com/iro  

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The Accelerate Blue Foundry from Innovation Partnerships connects entrepreneurial leaders with promising University of Michigan technologies to launch new startups tackling big challenges. Participating entrepreneurs selected for the program, which runs from Dec 2025–May 2026, will work with U of M inventors and mentors from the Innovation Partnerships team to develop commercialization plans and pitch for initial funding — with the Accelerate Blue Fund committing at least $50K to each credible startup participating in the program. This is an excellent opportunity to build a venture rooted in U of M innovation. Applications are open until Nov. 5 → https://myumi.ch/R3y6z

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Genenta Science (Nasdaq: GNTA) ANNOUNCES STRATEGIC TRANSFORMATION INTO A #BIOTECH, #DEFENSE, #AEROSPACE, AND #NATIONAL #SECURITY INDUSTRIAL CONSOLIDATOR - Building on Biotech Heritage, Expanding into Defense and National Security Through Industrial Integrations of Privately Held Specialized Italian Companies - ATC - a Defense-Sector Company: First Industrial Integration - Fondazione Praexidia Joins as a Long-Term Strategic Shareholder -Corporate Name Change to Saentra Forge S.p.A. - Biotech Clinical Updates and Partnering Strategy - Cash, Cash Equivalents, and Marketable Securities of approx. $33 million https://lnkd.in/di3z9yAF

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I am pleased to announce that Gloucester Ventures has invested in NetwoRx Bio, an early stage precision diagnostics company: https://www.netwoRx.bio https://lnkd.in/gyxSfb2F   NetwoRx Bio is tackling two of immunotherapy’s biggest challenges: why most patients don’t respond, why 96% of immunotherapy trials fail. The company is breaking new ground in immuno-oncology by mapping and scoring functional interactions between tumors and immune cells, for this $50B opportunity.   NetwoRx has developed a high-resolution platform that models receptor-ligand interactions across 30+ cell types within the tumor microenvironment, integrating newly generated data from its wet lab and computational pipelines. Unlike scRNA-seq or retrospective EHR-based models, NetwoRx generates prospective clinical data and applies mechanistic modeling - enabling superior biological resolution, consistency, and predictive power.   The applications of its platform are wide-ranging: drug-indication matching, immunotherapy combination design, precision medicine, and biomarker discovery. NetwoRx is currently building a pan-cancer dataset of checkpoint inhibitor-treated and untreated patients, based on its newly generated, proprietary high-resolution data.    NetwoRx Bio is backed by VLX Ventures and other private investors. The company has initiated a fundraising round to scale its dataset, expand clinical collaborations, and commercialize its platform. Why did we invest? We were impressed by Dr. Ilan Volovitz's presentation of the unique AI-powered platform and the clinical utility of the NetwoRx Score to predict therapeutic response for each individual patient. In our conversations with Ori Choshen CEO, we could see multiple routes for scaling, with applications for clinical trial effectiveness, biomarker insights as well as integration with clinician decision platforms. We're excited to be charting NetwoRx Bio's progress on this journey! #precision oncology #predictive diagnostics #precision medicine #Gloucester Ventures #NetwoRx Bio  

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