John Dinusson

Bloomberg announced that Neuralink will be raising its next round at a valuation of $8.5B. Nice work DJ Seo and team! For those of you wondering what this means for the larger BCI industry, I have created a thoughtful infographic. https://lnkd.in/dHa4avuX

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If you’re waiting to start M&A conversations until you're ready to sell, we’ve got intel from 5 medtech CEOs with a track record of medtech exits who may tell you otherwise. They’d probably also tell you that companies that get acquired for the best valuations *start* building relationships with strategics at least 2-3 years before they even consider an exit. For an article I wrote for MassDevice, 5 CEOs who've successfully navigated M&A transactions told me this: The best exits are planned from day one. ➡️ Jennifer Fried (Flow Medical) says that before she even joined her current company, she was already calling potential acquirers. Not to pitch — to listen. "What do you really think about the pulmonary embolism space? What are the big inflection points?" Early conversations helped her understand market dynamics and have shaped the strategy at Flow. ➡️ Joe DeVivo’s (Butterfly Network, Inc.) approach is people-oriented. Joe has delivered 5 exits (!) and he knows M&A is about building relationships, not deal flow. "Simply befriend them. At trade shows, be very open. Keep the dialog going." The onus is on you to help potential buyers understand your business and why it’s worth acquiring. ➡️ James Reinstein (Conformal Medical) emphasizes market selection and timing: "Find a market that's growing fast, has few competitors, and is one that investors want to be in." The idea is to position yourself as part of a growing pie and then show acquirers you’re continually hitting key milestones. ➡️ Cary Vance (previously PhotoniCare, Inc.) says it’s important to cultivate relationships with multiple strategics, but is quick to point out that deals are never guaranteed. "Run your company as if you're going to make a go of it alone — don't count on an acquisition as your rescue plan." ➡️ Nitin Salunke (Supira Medical) says identifying an end goal as early as possible will put you at an advantage:  "Don't go fishing for deals. Make incremental progress on strategics' watch lists, rising from bottom to top." Let value guide your company’s trajectory and align your milestones with that to make the business acquisition-worthy. Simply put: You want your business to get bought, not sold. Strategics are rarely lining up to buy companies that are desperate to be acquired. But startups focused on building great businesses while cultivating the right relationships? They get bought. In short, this is what separates the successful exits from the failed attempts: - They educate potential acquirers without being pushy  - They understand that timing matters as much as value - They pick fast-growing markets with limited competition - They build companies strong enough to survive independently  - They align major conversations with their strongest milestones Check out the full article through the link in the comments. And last, big thanks to Chris Newmarker for your publishing support!

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"ECG diagnostics software platform AccurKardia and cardiac medical technology company HeartBeam Inc. (NASDAQ: BEAT) are joining forces to make AccurKardia's ECG analysis software available on HeartBeam's devices. HeartBeam's cable-free, 12-lead ECG system captures electrical signals from the heart from three directions to assess arrhythmias. The platform is designed for portable devices so physicians can identify cardiac health trends and acute conditions wherever patients are." AccurKardia is an American Heart Association & MedTech Innovator innaugural "Heart & Brain" startup accelerator alumni company! Heart Rhythm Society #HRX2025 #epeeps LSI MedTech World MedTech Strategist European Society of Cardiology EHRA President American College of Cardiology

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🚀Weekly #MedTech Industry News Update – Week 16, 2025 🧠🩺 Funding News: 💰 Phantom Neuro raised $19M Series A for its Phantom X neural interface. Connor Glass Cadwell Industries made a strategic investment in Seer Medical to create a new epilepsy diagnostic line. Patrick Jensen, Dean Freestone Egg Medical raised $14.3M to commercialize its EggNest shielding system. Robert Wilson SPRIG Equity closed its first fund with $50M AUM, already backing four medtech companies. HEARTio shared that they have secured Shepherd Ventures as lead investor as they scale post-FDA clearance! Michael Leasure RadNet agreed to acquire iCAD for $103M, expanding its AI and imaging technology footprint. #RegulatoryApprovals & Clearances: ✅ Innoblative Designs received #FDA IDE approval for its Sira RFA device for breast-conservation surgery. Richard Stark Intuitive received FDA clearance for its SP SureForm 45 stapler for the da Vinci SP system. Turbett Surgical gained FDA 510(k) clearance for its enhanced Instrument Pods. Bill Dubiel DESKi received FDA clearance for HeartFocus, its AI-powered heart exam software. Bertrand Moal Ceribell │ AI-Powered Point-of-Care EEG received FDA clearance for Ceribell Clarity, a pediatric seizure detection solution. Xingjuan (Jane) Chao EBR Systems, Inc. received FDA PMA for its WiSE CRT System, the world’s first leadless LVEP device. John McCutcheon LUMA Vision received FDA clearance for Verafeye, a 4D cardiac imaging and navigation system. Fionn Lahart Adagio Medical Inc. received FDA Breakthrough Device Designation for its vCLAS Cryoablation System for ventricular tachycardia. Alesi Surgical Ltd received CE certification under EU MDR for its Ultravision2 surgical smoke management system. Neurosom™ received FDA 510(k) clearance for its NEAT sleep-stage classification EEG software. Clinical Trials & Studies: 🧪 FIRE1 's heart failure device showed positive results in its first-in-human study. Conor Hanley Eclipse Regenesis treated the first pediatric patient in its short bowel syndrome study at Cincinnati Children’s Hospital. Hy2Care® BV received FDA IDE approval to begin U.S. clinical trials for its CartRevive® hydrogel implant for knee cartilage repair. Leo Smit Lenoss Medical completed its 175th surgery using the OsteoPearl™ implant for vertebral fractures. M&A and Strategic Partnerships: 🤝 SpineGuard transferred its U.S. operations to Omnia Medical as part of a strategic collaboration. Pierre Jerome, Troy Schifano Major Industry Milestones: 🌟 Cagent Vascular initiated a clinical study for its balloon angioplasty technology. Edwards Lifesciences received CE Mark for its SAPIEN M3 transfemoral valve. Johnson & Johnson MedTech announced completion of the first procedures using its highly anticipated Ottava robotic system. Happy Easter everyone!

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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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AtaCor Medical, Inc. is bringing meaningful innovation back to a space (Cardiac Rhythm Mgt.) that at once dominated the Med Tech headlines. The hallmarks of CRM over the last decade plus have been iterative tech advancement, while 3 major competitors traded 2-3 percent market share back and forth on a quarterly basis. Atacor plans to change that. Rick Sanghera (CEO of Atacor) and his highly accomplished team are developing two game changing technologies: 1. An extravascular, implantable pacing lead which requires no fluoroscopic imaging or cath lab time for delivery. 2. A revolutionary All-In-One EV-ICD lead system to provide reliable sensing, pacing, and shock therapies to treat life-threatening tachyarrhythmias – all without entering the heart and vascular system. In a major announcement Atacor recently revealed it initiated its ASCEND EV study. Initial cases demonstrated that the revolutionary lead was successful in the sensing and defibrillation of induced ventricular fibrillation while connected to various commercially available ICD's. "The all-in-one system facilitates both antitachycardia pacing (ATP) and shock delivery from a single lead and with one procedure – all without entering the heart or vascular system." Congrats to Rick Sanghera & the entire Atacor team on achieving this critical milestone in the company's development. Maria Berkman, MD, MBA Sean McGeehan Jonathan Freund Jan Garfinkle Benjamin Kreitman James Kim Don Scheck Darshana Zaveri Alan Marcovecchio Rahul Veetekat Jeff Terrell Sarah Hase, BS, CCRA Gary Gershony Neil Meyer Jan Bregman Libet Garber, Ph.D. Steven Girouard Sterling EricksonBrent Cadavona Matthew Rollins TJ Ho Suzan Hughes David Prim, PhD https://lnkd.in/gjuhc-rq

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We are thrilled to share some major news from our valued partner, the Midwest Pediatric Device Consortium (MPDC)! They have announced several incredible opportunities for the pediatric Medtech community. Major Funding Announcement: $400,000 Pitch Competition MPDC is collaborating with the UCSF-Stanford Pediatric Device Accelerator for the Fall 2025 PDC Pitch Competition, offering up to $100,000 per project along with advising, prototyping support, and commercialization coaching. This is a fantastic opportunity for U.S.-based academics, businesses, or startup innovators with a promising pediatric device idea. Applications Open: June 20, 2025 Total Awards: $400,000 Learn More & Apply: https://mpdc.smapply.us/ Upcoming MPDC Events: MPDC Webinar: Economics & Reimbursement Topic: Making Sense of Pediatric Medtech Health Economics Date: June 18, 2025 | 12:00 PM - 1:00 PM Register Here: https://lnkd.in/e8Sirdzb MPDC Webinar: Funding Topic: Bridging Pediatric Funding Gap Legislative Strategies Date: July 8, 2025 | 4:00 PM - 5:00 PM Register Here: https://lnkd.in/eR86gbCp MPDC 2025 Showcase in Cleveland, OH Join MPDC and their partners Project MedTech and JumpStart Inc. for insightful panels on SaMD and a live pitch competition with over $100K in awards. Date: July 9, 2025 Register Here: https://lnkd.in/eUKeB5p4 Project Medtech is proud to support MPDC's work in accelerating pediatric MedTech innovation. Don't miss out on these events and funding opportunities! #medicaldevices #startup #medtech #projectmedtech #innovation #medicaldevice #podcast #strategy

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