Guided Solutions - Global Executive Search in Medical Devices

✔ HistoSonics Inc., who develop a histotripsy treatment for liver tumor procedures, completed an oversubscribed Series D financing round worth proceeds of $102 million to support its Edison system through clinical trials and commercialisation.

⭐ Mike Blue, president & CEO, commented: "This funding will accelerate key projects designed to enhance core technical capabilities impacting current and future platforms, and support collaboration with physicians and researchers studying innovative ways to use histotripsy’s unique mechanism of action to improve patient outcomes."

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HistoSonics closes $102M oversubscribed Series D HistoSonics closes $102M oversubscribed Series D - Uncategorized

👩‍🚀 Neptune Medical completed a Series D financing round worth proceeds of $97 million, as well as did a successful spinout of its Jupiter Endovascular subsidiary.

🚀 “Neptune Medical is thrilled to announce the successful closure of our Series D financing and the spinout of Jupiter Endovascular. These significant milestones allow us to sharpen our focus on GI robotics while empowering Jupiter to drive innovation in endovascular treatments,” said Alex Tilson, founder and CEO of Neptune Medical.

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Neptune Medical raises $97M for GI robotic tech, spins out Jupiter Endovascular Neptune Medical raises $97M for GI robotic tech, spins out Jupiter Endovascular - Funding

👏 AI-powered precision surgery platform Caresyntax raised a total commitment of $180 million through a series C extension and growth debt expansion round.

💬 Dennis Kogan, Co-Founder and CEO, shared: “Together with our partners and investors, we are working towards deploying precision surgical tools, empowered by data and AI, to improve patient outcomes. This financing is not just an investment in Caresyntax, but an investment in the future of surgery.

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Caresyntax raises $180m funding to accelerate precision surgery Caresyntax raises $180m funding to accelerate precision surgery - Funding

🦴 4D Medicine develops 4Degra - a resorbable biomaterial that is being used to develop implants such as orthopedic devices or soft tissue scaffolds to help patients recovering from surgery or injuries. The company plans to use the funding to complete pre-clinical testing of its first product range and seek FDA clearance.

⭐ "Our success in continuing to raise investment despite the difficult market conditions over the last few years is testament to their belief in the company’s commercial potential and our world-class team," shared CEO Philip Smith.

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Biomaterial maker 4D Medicine raises £3.4 million in Series A funding Biomaterial maker 4D Medicine raises £3.4 million in Series A funding - Funding

🔬 RenovoRx continues enrolment for its TIGeR-PaC study, evaluating its Trans-Arterial Micro-Perfusion therapy platform, designed to administer chemotherapy through the layer of scar tissue around the tumour via pressure-mediated delivery.

👏 Good luck to RenovoRx’s chief clinical officer Leesa Gentry and CEO Shaun R. Bagai.

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RenovoRx continues drug-device combo Phase III trial in pancreatic cancer RenovoRx continues drug-device combo Phase III trial in pancreatic cancer - Clinical Trials

🦵 Knee implant maker Moximed closed a Series D preferred stock financing worth up to $91 million. It plans to use the funds to accelerate US commercialisation for its Misha knee system. The implantable shock absorber device helps people with mild-to-moderate Osteoarthrosis preserve their knee joints while enjoying active lives.

🚀 “This financing is validation of the significant market opportunity for the MISHA Knee System,” said Chris Gleason, President and Chief Executive Officer of Moximed. “We are seeing tremendous interest from surgeons and patients, and we are excited to rapidly expand our commercial infrastructure to address evolving patient needs in this growing market.”

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Moximed closes $91M Series D preferred stock financing Moximed closes $91M Series D preferred stock financing - Funding

✔ Stereotaxis has received a CE mark in Europe for its minimally invasive endovascular robotic system, GenesisX, and aims for a US FDA approval.

🥼 GenesisX distinguished itself from other surgical robots with its ease of adoption - the device installation requires minimal structural modifications, without floor anchors and specialised power outlets.

Good luck to CEO David Leo Fischel and the rest of the team 👍

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Stereotaxis’ endovascular robotic system wins EU clearance Stereotaxis’ endovascular robotic system wins EU clearance - Regulatory Approvals

👓 Surgical Planning Associates received FDA 510(k) clearance for its HipInsight 2.0 mixed-reality guidance system, which provides surgeons “X-ray vision” to see detailed, sequential 3D information in and around the patient’s hip joint without looking away from the patient.

Congratulations to Stephen Murphy and the team. 👏

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Surgical Planning Associates wins FDA nod for mixed-reality hip arthroplasty system Surgical Planning Associates wins FDA nod for mixed-reality hip arthroplasty system - Regulatory Approvals

❗ Prana Thoracic, which created an innovative tool to transform lung cancer intervention, has closed its series A extension round.

👏 "We are grateful for the overwhelming support from our investors in this financing round. Their confidence in our mission and plan is motivating,” Joanna Nathan, CEO and co-founder of Prana Thoracic, says in a news release. “This additional funding will enable us to accelerate our efforts in bringing precision surgical solutions to lung cancer patients worldwide.”

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Prana Thoracic secures additional $3M for lung cancer diagnostic tool Prana Thoracic secures additional $3M for lung cancer diagnostic tool - Funding

✔ Pneuma systems become the latest company to be admitted onto the FDA's Safer Technologies Program (STeP) for Medical Devices with its PneumaFlow Controller system.

🚀 Pneuma founder and CEO, Jeffrey Carlisle, said: “This is a tremendous milestone, not just for Pneuma, but for the infusion pump industry and, most importantly, for patients and nurses everywhere.”

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Pneuma Systems wins FDA STeP support for infusion pump control system Pneuma Systems wins FDA STeP support for infusion pump control system - Regulatory Approvals

🧩 Neuronetics agreed to acquire all outstanding shares of Greenbrook TMS in an all-stock transaction. The acquisition creates a vertically integrated organization comprised of two companies that develop transcranial magnetic stimulation (TMS) technology.

💬 “This transaction brings together two of the leaders in the mental health space in the U.S., which will allow us to provide access to innovative care to patients suffering from mental health conditions," commented Keith Sullivan, president and CEO of Neuronetics.

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Neuronetics to acquire magnetic neurostim company Greenbrook TMS Neuronetics to acquire magnetic neurostim company Greenbrook TMS - Mergers & Acquisitions

🔍 Invenio Imaging announced it completed enrolment for a pivotal trial of its NIO Laser Imaging System - an AI-driven software which identifies lung cancer. It is designed to allow for more detailed lung imaging by speeding up the production and analysis of the digital images it produces.

👏 Good luck to president and CEO Jay Trautman in the ON-SITE clinical trial.

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Invenio completes enrolment in AI-based lung cancer imaging trial Invenio completes enrolment in AI-based lung cancer imaging trial - Clinical Trials

🤝 SandboxAQ entered a technology partnership with Mayo Clinic to investigate the application of AI-driven magnetocardiography (MCG) technology: researchers at Mayo Clinic will conduct a clinical research study using SandboxAQ’s non-invasive CardiAQ system, whose sensors detect subtle magnetic field variations around the heart while AI algorithms mitigate electromagnetic interference in hospital settings.

📣 SandboxAQ medical devices division director Kit Yee Au-Yeung said: “CardiAQ captures detailed data from the heart, which could lead to faster, more accurate diagnoses and fill in the gap between low-cost EKG or biomarker tests and high-cost CT scans or invasive angiography.”

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SandboxAQ enters collaboration with Mayo Clinic for cardiac diagnostics SandboxAQ enters collaboration with Mayo Clinic for cardiac diagnostics - Innovation

💡 PhotoPharmics' Celeste device has already won an FDA breakthrough device designation - it uses phototherapy to target photoreceptors in the eyes responsible for circadian rhythm – the day-by-day biological cycles that help many bodily functions, which can be used to treat Parkinson's disease. The company is enrolling patients for a clinical trial.

🎉 "We are thrilled to reach this important milestone," commented Kent Savage, CEO of PhotoPharmics.

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PhotoPharmics reaches a third of enrolment goal for PD light therapy trial PhotoPharmics reaches a third of enrolment goal for PD light therapy trial - Clinical Trials

😴 Huxley Medical won FDA clearance its SANSA sleep apnoea diagnostic patch - a chest-worn device, designed to simplify the diagnosis of sleep apnoea, a condition that can lead to severe health complications.

⭐ Huxley Medical co-founder and chief commercial officer Chris Hallett said: “Our SANSA technology offers healthcare providers a cutting-edge tool to enhance diagnostic accuracy and patient outcomes.”

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Huxley Medical’s sleep apnoea diagnostic patch receives FDA clearance Huxley Medical’s sleep apnoea diagnostic patch receives FDA clearance - Uncategorized

🍴 Fractyl Health has reported positive results for its hydrothermal ablation device Revita, an outpatient endoscopic procedure that resurfaces the mucosal lining of the duodenum.

👏 Best of luck to co-founder and CEO Harith Rajagopalan in the further development of the technology.

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Fractyl Health touts positive year-long weight loss results for Revita device Fractyl Health touts positive year-long weight loss results for Revita device - Clinical Trials

👂AventaMed, a KARL STORZ company, won FDA 510(k) clearance for its Solo+ ear tube placement system. The company designed the system to eliminate the need for general anesthesia for ear tube placement, offering a quicker recovery and minimising disruptions.

🗣️“The Solo+ launch underpins our ambitious approach to continue to be the innovative partner of ENT surgery for state-of-the-art endoscopic treatments and to enable the different sites of care outside the operating theater to be offered more efficient solutions,” said Antonio Licata, executive director, upper endoscopy, Karl Storz.

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Karl Storz’s AventaMed wins FDA nod for ear tube placement device Karl Storz’s AventaMed wins FDA nod for ear tube placement device - Regulatory Approvals

🤍 CroíValve closed a Series B financing round with proceeds totaling $16 million. The device showed positive results in the TANDEM I first-in-human trials and the company plans to launch an early feasibility study to suppot its FDA submission.

📣“This financing is a testament to the unmet need for treating tricuspid regurgitation and the potential of the Duo system to treat more patients with a reproducible and intuitive procedure,” CEO Lucy O’Keeffe said in a news release."

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CroíValve raises $16M to support tricuspid coaptation valve CroíValve raises $16M to support tricuspid coaptation valve - Uncategorized

🥼 Galvanize Therapeutics completed patient enrolment in the AFFINITY study assessing the Aliya pulsed electric field system in treating late-stage non-small cell lung cancer and lung metastasis. The device operates by delivering high-voltage, short-duration electrical energy directly to cells, causing a disruption in their transmembrane potential and leading to programmed cell death without damaging cellular proteins or the extracellular matrix.

👏 Founder and CEO Jonathan Waldstreicher said: “Completing enrolment in AFFINITY is a significant milestone towards our goal of providing patients with solid tumours a biology-based therapy that extends beyond focal ablation."

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Galvanize concludes enrolment in study of Aliya PEF system for NSCLC Galvanize concludes enrolment in study of Aliya PEF system for NSCLC - Clinical Trials

🤝 Skanray has partnered with Tata Elxsi to advance surgical imaging core technology and develop software platforms. It forms part of Skanray’s strategy to develop a suite of reusable modules and components for medical devices, as well as an advanced analytics cloud platform.

Skanray Technologies corporate communications vice-president Priyanka Chatterjee said: “By combining Skanray’s core technology and deep understanding of medical applications with Tata Elxsi’s capabilities in futuristic technology, we are poised to drive significant advancements in healthcare delivery."

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Skanray and Tata Elxsi collaborate for surgical imaging Skanray and Tata Elxsi collaborate for surgical imaging - Innovation

👍 Diality Inc received FDA 510(k) clearance for its Moda-flx smart, flexible hemodialysis system, which provides clinicians with the flexibility to easily customise each hemodialysis experience according to patient needs in one integrated system.

👏 “Receiving 510(k) clinical clearance for Moda-flx is an incredible milestone in our mission of developing solutions to improve lives impacted by kidney disease,” said Dr. Osman Khawar, CEO of Diality.

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Diality wins FDA clearance for hemodialysis system Diality wins FDA clearance for hemodialysis system - Regulatory Approvals

⭐ Spineology said OptiMesh represents the only in situ patient-specific, expandable implant on the market. Delivered through the smallest insertion portal in the lumbar interbody market, it dynamically conforms to a patient’s unique endplate morphology.

👍 Brian Snider, Spineology CEO noted: "It is evident that surgeons and patients desire less disruptive options to treat spinal disorders, further accelerating our opportunity."

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Spineology raises $25M for lumbar implant Spineology raises $25M for lumbar implant - Funding

🧠 MMI - Medical Microinstruments completed a preclinical study evaluating its surgical robot in neurosurgical procedures. It aimed to assess the feasibility of using the Symani system for neurological conditions and involved successfully repairing a blood vessel in the brain in an animal model.

👏 Great news from CEO Jim Triggs and the rest of the team!

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MMI successfully trials Symani surgical robot in neurosurgery MMI successfully trials Symani surgical robot in neurosurgery - Uncategorized

🦴 NanoHive Medical develops 3D-printed titanium spinal interbody fusion devices, featuring the proprietary biomimetic Soft Titanium technology for the spinal interbody fusion device market.

💬 CEO Patrick O’Donnell commented: “The entire organization is excited to further execute on the company’s invigorated strategy aimed at broadening our Hive Soft Titanium portfolio’s successful clinical experiences with more patients and surgeons into more markets.”

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NanoHive Medical raises $7M Series C NanoHive Medical raises $7M Series C - Funding

✔️ Magnus Medical reported positive results from a study investigating the durability of its neuromodulation system’s anti-depressant effect in patients with treatment-resistant depression.

〰️ Magnus’ SAINT therapy, which is FDA cleared, works by pinpointing areas in the brain that would benefit most from stimulation. Utilising MRI for personalised treatment, the system emits a pattern of repetitive magnetic pulses that modify brain networks involved in mood.

📢 CSO and co-founder Brandon Bentzley said: "[These findings] further validate the transformative potential of the SAINT therapy in providing durable relief for people with debilitating intractable depression and offering a pathway for personalised continuation treatment to maintain remission.”

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Magnus Medical tout positive long-term data for neuromodulation system Magnus Medical tout positive long-term data for neuromodulation system - Innovation

😴 RingConn introduced its Gen 2 Smart Ring, claimed to be the world’s first integrated sleep apnoea monitoring in a smart ring format. It offers continuous, at-home screening, providing daily sleep health insights for the users

🤞 Best of luck to Sales Director Benjamin Lam and the rest of the team in their quest to receive FDA clearance!

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RingConn introduces smart ring for sleep apnoea RingConn introduces smart ring for sleep apnoea - Innovation

🤖 Navigantis announced the closing of a US$12 million Series A financing, which will support the ongoing development and testing of the Vasco robot, with the hope of bringing it into first-in-human clinical trials in neurovascular procedures.

💬 “We are thrilled and fortunate to have the support of such esteemed partner investors who share our vision for revolutionising neurovascular care with robotics,” commented Mor Dayan, chief executive officer of Navigantis.

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Navigantis secures $12 million to advance development of Vasco robotic platform Navigantis secures $12 million to advance development of Vasco robotic platform - Uncategorized

Bracco Imaging and Burl have teamed up to enhance ischemic stroke detection.

The partnership will see Bracco manufacture a microbubble solution that will be used with BURL Concepts’s SONAS device, a portable system designed for non-invasive brain perfusion assessment.

BURL Concepts CEO and Chief Medical Officer Thilo Hoelscher said: “This collaboration allows us to leverage Bracco’s microbubble technology exclusively as part of the SONAS system, which will enhance our ability to provide accurate and timely assessment of cerebral perfusion.

“We believe this partnership can significantly improve patient outcomes and set a new standard in brain monitoring and specifically in stroke care.”

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Bracco Imaging and BURL team up to enhance ischemic stroke detection Bracco Imaging and BURL team up to enhance ischemic stroke detection - Innovation

Thrilled to share Wise has completed a new financing round to accelerate the development of their innovative Heron Lead.

The Heron® lead is the first unidirectional multicolumn lead for spinal cord stimulation that can be implanted percutaneously for chronic pain treatment.

“We are thrilled to have the continued support of our investors and to welcome Wallaby S.p.A. on board,” said Luca Ravagnan, CEO of WISE. “The contestual EIB decision to enter into a financing agreement with WISE, following thorough due diligence of the company’s business, further demonstrates the growing confidence in our innovative technology to revolutionize the spinal cord stimulation market.”

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WISE Completes New Financing Round to Accelerate Development of Heron® Lead WISE Completes New Financing Round to Accelerate Development of Heron® Lead - Uncategorized

🌟 Cognito's sensory stimulation device has been shown to slow the decline in cognitive function in Alzheimer's patients.

If Cognito can secure US Food and Drug Administration (FDA) approval, the device could be used as a non-pharmacological alternative, or in conjunction with currently approved Alzheimer’s medications.

Cognito’s Chief Medical Officer Ralph Kern said: “This new post-hoc analysis from our OVERTURE I study highlights Spectris’ ability to significantly slow the decline in daily function and cognition in patients with Alzheimer’s, potentially offering patients more time to maintain their independence and quality of life.

“These results reinforce our commitment to bring a novel disease-modifying therapy to patients, as we continue to enrol patients in our HOPE pivotal trial.”

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Cognito’s sensory stimulation device slows decline in Alzheimer’s Cognito’s sensory stimulation device slows decline in Alzheimer’s - Uncategorized