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The Memo: Marine Biomedical Turning Mother of Pearl Into the Next Generation of Bone Grafts

Under the direction of CEO Rolee Kumar, Marine Biomedical is advancing a novel approach to bone regeneration by transforming mother of pearl from Western Australia’s pearling industry into a biomaterial designed to support natural bone healing. Built on research originating at the University of Western Australia, the company has developed PearlBone™, a marine-derived bone graft substitute that combines the consistency and scalability of manufactured materials with the biological architecture found in nature. With an FDA 510(k) submission under review, a planned clinical trial on the horizon, and manufacturing operations established in Broome, Marine Biomedical is working to bring an entirely new category of regenerative biomaterials to orthopedic surgeons.

Origin Story

Marine Biomedical’s roots can be traced back to the University of Western Australia and the work of regenerative medicine pioneer Professor Ming Hao Zheng, who recently received the Member of the Order of Australia for his contributions to the field. Alongside orthopedic surgeon Dr. Rui (Chris) Ruan, Zheng began exploring a deceptively simple question: Could nature provide a better blueprint for bone repair?

The answer emerged from an unlikely source.

Located in Western Australia, the company sits within one of the world’s most renowned pearling regions. For generations, the industry has harvested some of the world’s highest-quality pearls. Yet the oyster shells that house those pearls remained an underutilized byproduct.

“They came together, and the idea was, why don’t we look at nature to solve the problem with bone grafts?” Kumar explained. “They looked at the architecture of a pearl shell, and it mimics a lot of what natural bone does.”

The founders discovered that nacre, also known as mother of pearl, shares structural characteristics with human trabecular bone. After millions of years of natural evolution, the material had developed a complex architecture that appeared uniquely suited to supporting bone regeneration.

That concept eventually led to the formation of Marine Biomedical in 2021 and the development of PearlBone, the company’s platform technology built around marine-derived regenerative biomaterials.

The Current Landscape

The global bone grafts and bone graft substitutes market is estimated at approximately US$3–4 billion today and is projected to exceed US$5.5–6.0 billion by 2032–2033, driven by increasing fracture rates, aging populations, spinal fusion procedures, and demand for advanced regenerative biomaterials.

Yet existing solutions come with significant tradeoffs.

Autografts, which use the patient’s own bone, remain the clinical gold standard. However, harvesting that material requires a second surgical site, increasing procedure complexity, recovery burden, and surgical time.

“You are actually increasing the burden of recovery for the patient because you’re creating another site of injury,” Kumar said.

Alternatives such as allografts and xenografts can avoid that additional surgery, but they introduce challenges related to supply, variability, cost, and patient acceptance.

As a result, many companies have focused on synthetic bone graft materials that offer manufacturing consistency and reliable supply chains. The challenge is that these products often struggle to match the biological performance of natural bone.

“This is the opportunity that PearlBone is trying to capture,” Kumar said. “You’re kind of marrying the worlds of being able to produce something and have the consistency of supply and manufacturing it, but also being able to marry it up with a biological performance.”

The need is only expected to grow. Aging populations, increasing rates of osteoporosis, and rising demand for orthopedic procedures continue to drive interest in new approaches to bone regeneration.

This blog is originally published here: https://www.lifesciencemarketresearch.com/insights/the-memo-marine-biomedical-turning-mother-of-pearl-into-the-next-generation-of-bone-grafts

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The Memo: Earflo Giving Families an Option Before Surgery

Under the direction of Co-Founder and CEO Intan Oldakowska, PhD, Earflo has brought to market an FDA-cleared, at-home medical device designed to treat the negative middle ear pressure that leads to fluid buildup and chronic ear infections and avoid the path toward surgery. By transforming treatment into something as familiar as drinking from a sippy cup, Earflo aims to address one of the most common pediatric conditions with a solution that is non-invasive, child-friendly, and designed for use at home. Following FDA clearance and a U.S. commercial launch, the company is now focused on expanding access for families while building evidence that earlier intervention can improve quality of life for both children and parents and help avoid ear tube surgery.

Origin Story

Earflo traces its roots to the Stanford Biodesign program, where innovators are trained to identify significant unmet clinical needs before ever thinking about solutions. For Oldakowska and her future co-founders, that process led them to a problem affecting millions of children worldwide: Eustachian tube dysfunction and the chronic ear infections that often follow.

“The project started through the Stanford Biodesign program,” Oldakowska said. “The focus of that program is giving innovators the tools to understand a clinical unmet need and then work toward a solution that can improve patient outcomes.”

During the program, the team observed clinicians in ear, nose, and throat departments and evaluated hundreds of potential needs. One stood out.

“These young children, often under the age of five, can develop ear infections that cause the Eustachian tube to become stuck closed,” Oldakowska explained. “When that happens, fluid builds up behind the eardrum, and it stops them from hearing.”

For children at such a critical stage of development, hearing loss can quickly become more than an ear health issue.

“The issue is that if they can’t hear, they can’t learn,” she said. “These children can experience speech delays, developmental delays, trouble learning at school, difficulty socializing with their peers, sleep issues, and behavioral problems due to pain.” The founding team brought together expertise from multiple disciplines. Oldakowska and Matt Oldakowski, PhD, contributed engineering and product development experience. Peter Santa Maria, MD, PhD, brought clinical expertise as an ENT surgeon. Stephen Kargotich, PhD, added finance, legal, and commercialization experience. Together, they built Earflo around a shared goal: creating a better option for families navigating a condition that frequently leaves parents with little to do except wait until surgery becomes the only option.

The Current Landscape

Negative middle ear pressure and fluid buildup behind the eardrum represent one of the most common pediatric health concerns. According to studies undertaken at daycares, approximately one in five preschool-aged children is affected at any given time, and the condition contributes to millions of pediatric visits each year.

For many families, the treatment pathway has remained largely unchanged. Children are often monitored through a period of watchful waiting in the hope that the condition resolves naturally. If it does not, ear tube surgery frequently becomes the next step.

“Parents are often told to wait a few months to see if the condition resolves on its own, while their children continue to suffer,” Oldakowska said. “If waiting does not work, the next step is often ear tube surgery.”

The scale of the issue is significant. Oldakowska noted that ear tube placement is the most common pediatric surgery in the United States, with nearly one million procedures performed annually.

For Earflo, the opportunity lies in providing an earlier intervention that can be used at home while families and clinicians determine the best path forward.

“Earflo is designed to help families manage their child’s condition in the convenience of their own home and give them an option they can use immediately,” Oldakowska said. “Right now, many families are told to wait, potentially until surgery. We want to empower parents to help their children sooner with a fun, child-friendly design.”

This blog is originally published here: https://www.lifesciencemarketresearch.com/insights/the-memo-earflo-giving-families-an-option-before-surgery

#healthtech #medtech

The Memo: Flux Robotics Brings Magnetic Precision to Vascular Navigation

Under the direction of Founder and CEO Christoff Heunis, PhD, Flux Robotics is developing a magnetic vascular navigation platform designed to give physicians more controlled steering of guidewire movement inside blood vessels. By replacing the traditional reliance on pushing and twisting wires from outside the body with magnetically guided tip steering, the company aims to make one of the most challenging steps in vascular intervention more predictable, repeatable, and accessible. As vascular disease burdens rise worldwide and specialist shortages intensify, Flux is pursuing a new approach to minimally invasive surgery that could help more physicians successfully treat more patients.

Origin Story

For Heunis, the inspiration behind Flux Robotics traces back to a deeply personal experience.

“When I was 20, studying mechatronic engineering in South Africa, my best friend Shaun called me,” he recalled. “I’ve known Shaun since I was five, and his mother was like family to me. She had suffered an MCA stroke and ended up in a wheelchair because treatment came too late.”

What shocked him most was learning how limited access to advanced vascular care could be.

“At the time, there were only around three surgeons on the entire continent who could perform the procedure she needed. That made no sense to me.”

The experience set Heunis on a path that would shape the rest of his career. He transitioned from mechatronics into biomedical engineering, pursued a PhD in surgical robotics at the University of Twente in the Netherlands, and focused his research on magnetic navigation systems for minimally invasive vascular procedures. Today, he has authored 27 peer-reviewed publications, accumulated more than 460 citations, and co-owns two patents related to magnetic vascular navigation.

More importantly, the experience crystallized the mission behind Flux.

“What excited me was realizing that many vascular procedures still depend on one very manual step: the surgeon’s ability to physically push and twist a tiny wire through fragile blood vessels,” Heunis said. “If only a few surgeons can perform a procedure well, then access is not truly solved.”

Founded in the Netherlands, with activities in Groningen and Enschede, Flux Robotics was built to make complex vascular navigation “more controlled, repeatable, and scalable, so more patients can benefit regardless of where they live or which specialist happens to be available.”

The Current Landscape

In vascular interventions, one of the most difficult and consequential tasks is often the simplest sounding: crossing a blockage.

“The problem is control inside blood vessels,” said Heunis. “In many vascular procedures, the hardest step is crossing a blocked artery.”

Today, physicians typically navigate guidewires manually under fluoroscopic imaging, pushing, twisting, and exchanging devices while interpreting two-dimensional X-ray images in real time. While effective in many cases, the approach can become increasingly challenging in tortuous anatomy and difficult blockages, where guidewire movement may become less predictable.

If the guidewire fails to cross the blockage, the consequences can be significant.

“If the surgeon cannot cross the blockage, the procedure can fail,” Heunis explained. “In severe peripheral artery disease, that can mean amputation. In other vascular territories, it can mean longer procedures, more radiation, more device exchanges, or escalation to more invasive treatment.”

The need for improved navigation tools is growing. Peripheral artery disease affects more than 200 million people globally, and incidence continues to rise alongside aging populations and increasing rates of diabetes. At the same time, physician shortages threaten access to specialized care, creating a widening gap between patient demand and available expertise.

For Heunis, those trends reinforce the same access challenge that first inspired the company years ago.

This blog is originally published here: https://www.lifesciencemarketresearch.com/insights/the-memo-flux-robotics-brings-magnetic-precision-to-vascular-navigation

#healthtech #medtech

The Memo: EndoShunt Medical Giving Surgeons the Gift of Time So They Can Give Patients the Gift of Life

Under the direction of CEO Tyler Zanon, EndoShunt Medical is developing a minimally invasive endovascular shunting device designed to give trauma surgeons temporary, targeted control over abdominal blood flow while maintaining perfusion to the rest of the body. In the most severe hemorrhage cases, where every minute can shape both survival and long-term quality of life, EndoShunt is working to replace blunt tools with a more controlled approach. As Zanon put it, “EndoShunt gives trauma surgeons the gift of time, so they can give trauma patients the gift of life.”

Origin Story

For Zanon, the mission behind EndoShunt is closely tied to the realities of trauma care. Based in Chicago, he has spent roughly 15 years in healthcare product development, first in academia and then in industry. Living in a major city with high rates of traumatic injury, he has seen how urgent the problem remains.

“We haven’t seen actual innovation since World War II,” Zanon said.

He often explains the challenge with a burst pipe analogy. When water is leaking, the options are either to apply pressure from the outside or shut off flow entirely. “While that’s great in plumbing, it’s not great in healthcare,” he said. “And that’s unfortunately exactly how surgeons are empowered to deal with abdominal bleeding today.”

That gap helped bring together a team of engineers, trauma surgeons, and medical device leaders around a shared goal: giving surgeons more time to perform definitive repairs without sacrificing downstream blood flow.

The Current Landscape

Today, trauma surgeons managing severe abdominal bleeding are often forced to choose between invasive packing, cross-clamping, or balloon occlusion. Each comes with serious tradeoffs.

Packing requires opening the patient and racing to locate the source of the bleed, often under extreme time pressure. Cross-clamping and balloon occlusion can reduce hemorrhage, but they do so by cutting off downstream blood flow, introducing a different set of risks.

“While that may mitigate bleeding, it starves our tissues of oxygen, and as little as 30 minutes can lead to irreversible damage as serious as blood poisoning, amputation, or even organ failure,” Zanon said.

That risk is not theoretical. Zanon described a case involving a 22-year-old patient with severe abdominal bleeding who underwent a blood flow restriction intervention and ultimately required a leg amputation.

“It’s a real problem for a predominantly young adult population who then has to go on with hopefully 70 years of life, but 70 years of very negatively impacted quality of life,” he said.

The burden extends beyond individual outcomes. According to EndoShunt, abdominal hemorrhage contributes to hundreds of thousands of fatalities globally each year, alongside high complication rates and billions in healthcare costs.

This blog is originally published here: https://www.lifesciencemarketresearch.com/insights/the-memo-endoshunt-medical-giving-surgeons-the-gift-of-time-so-they-can-give-patients-the-gift-of-life

#healthtech #medtech

Medtech M&A Activity Is Rising, But Is It Really a Boom?

Over the past several weeks, acquisition announcements have arrived at a rapid pace across the industry. Between transactions involving Medtronic, ResMed, Artivion, and Roche, nearly $2 billion in deal value has been announced in a short period of time.

The headlines naturally raise a question: are we witnessing a true surge in medtech M&A, or are a handful of high-profile deals creating that impression?

A review of recent transactions, combined with activity tracked in Compass AI, suggests that strategic buyers remain highly active. However, the broader data indicate a market that is accelerating within an established trend rather than entering entirely new territory.

The Same Acquisition Playbook Continues to Win

Although the companies and technologies differ, the latest transactions share several common characteristics.

Strategic acquirers continue to target businesses with commercial traction, attractive growth profiles, and technologies that strengthen existing franchises. Rather than transformational platform shifts, most acquisitions remain focused additions that expand already successful business lines.

That pattern is evident across all four recently announced deals.

ResMed Acquires Noctrix Health for $340 Million

ResMed’s planned acquisition of Noctrix Health stands out because of how closely the company fits within ResMed’s existing sleep ecosystem.

Noctrix developed Nidra, a wearable neurostimulation therapy designed for patients suffering from drug-refractory restless leg syndrome (RLS). The condition affects nearly 10% of adults worldwide and shares significant overlap with obstructive sleep apnea, ResMed’s core market. Estimates suggest that 10% to 30% of RLS patients also experience OSA.

From a strategic perspective, ResMed already understands the physician audience, patient population, and distribution channels involved. The company also noted that Noctrix is growing faster and generating stronger gross margins than ResMed itself.

The transaction additionally broadens ResMed’s sleep portfolio while providing exposure to an area that is less directly tied to ongoing discussions around GLP-1 therapies and their potential effect on OSA.

Artivion Moves Quickly on Endospan

Artivion’s $175 million acquisition of Endospan came shortly after FDA approval of the NEXUS Aortic Arch System.

The deal structure may be as noteworthy as the technology itself. According to SEC filings, Artivion previously paid $1 million for an option to acquire Endospan, with the option becoming exercisable following FDA approval of NEXUS. Approval arrived on April 2, 2026, and Artivion exercised the option just over a month later.

The acquisition gives Artivion a comprehensive portfolio of aortic arch solutions and strengthens its competitive position against companies including Cook, Gore, and Terumo.

While the U.S. patient population is relatively limited at roughly 15,000 annually, Artivion appears to be betting on both limited competition and the potential for additional regulatory approvals within Endospan’s broader pipeline.

Roche Expands Its Digital Pathology Strategy with PathAI

Roche announced plans to acquire PathAI in a transaction valued at up to $1 billion, extending a partnership that began in 2021.

PathAI's AISight is a cloud-native image management system that converts physical slide workflows into fully digital, AI-augmented processes. The company’s technology has already gained validation beyond Roche through partnerships with both Quest Diagnostics and Labcorp.

The acquisition supports Roche’s broader strategy of integrating diagnostics, software, and AI capabilities into a unified ecosystem. By combining imaging infrastructure, workflow software, and artificial intelligence under a single platform, Roche hopes to simplify adoption of digital pathology while strengthening biomarker discovery and companion diagnostics development.

Investors and analysts have largely viewed the rationale favorably. The long-term success of the deal will depend in part on how laboratories respond to a more integrated approach.

This blog is originally published here: https://www.lifesciencemarketresearch.com/insights/medtech-ma-activity-is-rising-but-is-it-really-a-boom

#healthtech #medtech

Neuroimaging and Siemens Healthineers’ Push to Build a Neuro Platform

Siemens Healthineers sits among the largest companies in medtech. With approximately $25 billion in revenue in 2025, the company operates at a scale comparable to some of the industry’s biggest names and continues to invest heavily in markets where it sees long-term growth potential.

A series of partnership announcements over the past year offers a window into where Siemens Healthineers appears to be investing for the future. Across robotics, AI, diagnostics software, and health system infrastructure, Siemens Healthineers has assembled a network of relationships that increasingly points toward one destination: neuro. Viewed individually, each agreement serves a specific purpose. Taken together, they suggest a broader strategy centered on neuroimaging, precision therapy, and integrated clinical workflows.

A Company Becoming More Focused

Siemens AG announced plans to deconsolidate its majority stake in Siemens Healthineers, a process that has been underway for some time. For Healthineers, that focus appears increasingly concentrated on businesses where it believes it holds the strongest competitive advantages.

Imaging and Precision Therapy are viewed as the highly synergistic core of the company, and both segments are also posting high single-digit growth. Diagnostics occupies a different position. By management’s own admission, the business has relatively few synergies with either segment. While no formal separation has been announced, the discussion reflects a broader trend toward portfolio simplification across medtech.

The company’s own reporting reinforces this view. Imaging and Precision Therapy remain central to the growth story, while Diagnostics continues to face challenges, particularly in China.

The Partnerships Behind the Strategy

During the last 12 months, Siemens Healthineers announced nine notable partnerships spanning multiple areas of healthcare technology.

Three stand out as especially relevant to its broader neuro ambitions.

The partnership with Stryker, announced in September 2025, focuses on neurovascular workflows. The collaboration combines Siemens Healthineers’ imaging capabilities with Stryker’s therapeutic devices to support stroke and neurovascular interventions.

In May 2026, Siemens Healthineers partnered with Cercare Medical to integrate Cercare’s Neurosuite platform into syngo DynaCT. The combination enables automated cone-beam CT perfusion imaging within the angiography suite, with the goal of reducing the time between stroke diagnosis and treatment.

Another May 2026 announcement connected LSI Alumni company AiM Medical Robotics’ MRI-compatible robotic neurosurgery platform with Siemens Healthineers’ MAGNETOM MRI scanners. The collaboration enables real-time in-bore guidance during brain biopsies and neurostimulation procedures.

Building a Neuro Ecosystem

Additional agreements further strengthen the company’s position.

Methinks AI joined the ecosystem in October 2025, bringing AI-driven acute stroke triage capabilities. In February 2026, Siemens Healthineers and Mayo Clinic announced a collaboration focused on clinical digital twins and AI-enabled MRI/PET protocols for neurodegenerative disease and oncology applications.

The company has also signed health system partnerships with Northwestern Medicine, Onvida Health, and Hawaii Pacific Health. While less visible than robotics or AI announcements, these relationships help reinforce imaging infrastructure adoption across large provider networks.

This blog is originally published here: https://www.lifesciencemarketresearch.com/insights/neuroimaging-and-siemens-healthineers-push-to-build-a-neuro-platform

#healthtech #medtech

Medtech Q1 Earnings: What the Major Strategics Are Telling Us

With Q2 already underway, the latest medtech Q1 earnings reports offer an early read on where major strategics are gaining momentum, where pressure is building, and what strategic priorities are becoming clearer.

This quarter’s results point to a consistent theme: focused portfolios are outperforming broader platforms. Companies concentrated in clearly defined growth markets, particularly cardiovascular/structural heart, are delivering stronger execution. More diversified players remain highly competitive, but they are managing a wider mix of operational, integration, and macroeconomic challenges.

A closer look at the numbers makes that trend difficult to ignore.

Focused Players Continue to Separate Themselves

Abbott delivered $5.5 billion in Q1 Medical Devices revenue, representing 8.5% organic growth and 13.2% reported growth year over year. Electrophysiology, Rhythm Management, and Heart Failure each posted double-digit gains, while the U.S. launch of Volt supported EP performance. Continuous glucose monitors contributed $2 billion of the quarterly total. Still, softer U.S. prescription demand in diabetes care, delayed international tenders, and investor concerns around slowing organic momentum weighed on sentiment. The Exact Sciences acquisition also introduces integration complexity.

Boston Scientific generated $5.2 billion in Q1 revenue, up 9.4% organically and 11.6% reported. Cardiovascular remained the growth engine, climbing 13.5%. However, management reduced guidance from 10%–11% growth to 6.5%–8%, reflecting pressure across electrophysiology, WATCHMAN, and urology.

The EP story is especially notable. After benefiting from an early pulsed-field ablation advantage, Boston Scientific is now facing intensifying competition. Meanwhile, acquisition integration remains uneven, with Axonics experiencing commercial disruption while Valencia Technologies may provide support to urology over time.

Edwards Lifesciences posted one of the strongest quarters among peers, reaching $1.7 billion in revenue with 16.7% reported growth. Performance exceeded expectations across segments, prompting management to raise full-year guidance to 9%–11%.

TAVR growth of 14.4% stands out, given the maturity of that segment. Strong clinical evidence supporting earlier intervention continues to expand the addressable market, and Edwards appears well-positioned to apply that strategy in adjacent structural heart categories.

Medtech Q1 Earnings Reveal The Value Of Portfolio Discipline

Intuitive continues to execute at an exceptionally high level. Q1 revenue climbed 23% year over year to $2.8 billion, exceeding estimates by nearly 6%. da Vinci procedure volumes reached approximately 874,000 cases, while Ion volumes climbed to roughly 43,000 procedures. da Vinci 5 placements nearly doubled, reaching 232 for the quarter.

Challenges remain in China and Japan, where domestic competition, pricing pressure, and low tender activity are weighing on performance. U.S. bariatric procedures also declined about 10%, reflecting the continued impact of GLP-1 adoption.

Even so, management raised procedure growth expectations for the year, an important signal for future recurring revenue.

Insulet reported 33.9% revenue growth, reaching $762 million. International Omnipod sales jumped nearly 60%, and guidance was raised again.

Yet despite strong operating performance, shares fell sharply following results. An unusual $87 million expense, a voluntary recall, concerns about competitive dynamics, and expectations that had climbed even higher all contributed to investor disappointment.

This blog is originally published here: https://www.lifesciencemarketresearch.com/insights/medtech-q1-earnings-what-the-major-strategics-are-telling-us

#healthtech #medtech

This week’s recap features new funding, clinical milestones, regulatory approvals, and more from medtech companies in the LSI Alumni communi

In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni receive new funding, achieve clinical milestones, receive regulatory approvals, and much more on the road to LSI Asia ‘26 in Singapore (June 30 - July 2).

#medtech #healthtech

This week’s recap features new funding, clinical milestones, awards, and more from medtech companies in the LSI Alumni community.

In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni receive new funding, achieve clinical milestones, receive awards, and much more on the road to LSI Asia ‘26 in Singapore (June 30 - July 2).

Acorai Won the CSI Congress Start-up Competition, including a $50K prize from the Jon DeHaan Foundation. The company is developing a device for heart failure management through non-invasive cardiac and pulmonary pressure sensing, to help reduce hospitalizations and readmissions.

Aevice Health

Announced a new partnership with Parkway MediCentre to roll out one of Singapore’s first home-based pediatric asthma monitoring programs. Powered by the AeviceMD Monitoring System, the program allows clinicians to monitor a child’s respiratory health during sleep, the critical window when symptoms could be missed.

Originally published at: https://www.lifesciencemarketresearch.com/insights/the-weekly-recap-61226-lsi-alumni-achievements-driving-medtech-and-healthtech-forward

#medtech

The Weekly Recap 5/1/26: LSI Alumni Achievements Driving Medtech and Healthtech Forward

In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni receive regulatory approvals, secure funding, launch partnerships, and much more on the road to LSI Asia ‘26 in Singapore (June 30 - July 2).

Avatar Medical

Received FDA 510(k) clearance for Avatar Medical Vision, its software platform for instant 3D medical image processing, review, and surgical planning, enabling commercialization in the U.S. This clearance also establishes compatibility with the Barco Eonis 3D glasses-free display, forming the foundation of Eonis Vision, a joint solution that aims to bring clinicians and patients together around a shared, real-time view of anatomy during consultations.

Axoft

Raised an oversubscribed $55M Series A led by C.P. Group Innovation, with participation from Alumni Ventures, the Stanford President’s Venture Fund, Hillhouse Investment, and Gaorong Ventures. The company will use the funds to expand global clinical trials, advance U.S. regulatory approval of its implantable brain-computer interfaces, and build a GMP facility for large-scale production.

BrightHeart

Appointed Jeff Barone as its VP of Sales, U.S., to lead U.S. commercial strategy and execution. Barone brings an extensive track record of executive leadership across imaging, medtech, minimally invasive surgical technologies, and robotic platforms.

Circular Genomics & Vitazi.AI

Announced a strategic alliance to jointly develop a next-generation multimodal workflow for the early detection and risk stratification of Alzheimer's disease. The collaboration will combine Vitazi.ai's non-invasive, AI-driven retinal imaging analytics with Circular Genomics' proprietary circRNA biomarker data, leveraging shared algorithmic and machine learning workflows to deliver intelligent, accurate early detection of Alzheimer’s and risk stratification.

CorFlow

Successfully completed Phase 1 of its MOCA II FDA Pivotal Trial and enrolled the first patients for Phase 2 of the trial while simultaneously gaining approval to enroll patients in its parallel flagship clinical trial, the novel randomized REVITALISE trial. The company also welcomed Dr. Rick Kuntz to its Board of Directors and appointed LSI Alumni Dr. Pedro Eerdmans as VP Clinical.

CorTec

Announced that the first participant in the University of Washington’s NIH-funded clinical trial of the Brain Interchange™ BCI system has successfully controlled a computer through thought alone, including a functional demonstration of the video game Pong, using the implanted device and cortical electrodes placed to support his motor recovery after stroke. This is the first reported instance worldwide in which a single fully implanted, wireless BCI system has demonstrated both brain stimulation for therapeutic stroke rehabilitation enhancement and thought-based computer control in the same patient using identical hardware.

CorVista Health

Announced a research collaboration with Mayo Clinic to evaluate how next-generation, non-invasive diagnostics may transform the identification and management of pulmonary hypertension. The collaboration will pair the FDA-cleared CorVista-PH test, part of the CorVista System, with Mayo Clinic’s expertise in cardiovascular research and pulmonary vascular disease to determine whether the CorVista-PH test can meaningfully improve how physicians identify and evaluate pulmonary hypertension earlier in the patient journey.

FluidAI Medical & Qaelon Medical

Announced a strategic collaboration to develop a continuous surgical data ecosystem spanning the operating room through recovery, with a focus on addressing anastomotic leaks in gastrointestinal surgery. The partnership combines Qaelon’s intraoperative leak detection platform with FluidAI’s established post-operative monitoring and intelligence ecosystem, and aims to create a unified framework linking intraoperative data with post-operative healing to improve patient outcomes and reduce complications.

Hypervision Surgical

Closed an oversubscribed $23M Series A financing round led by Heal Capital, with participation from Angelini Ventures, IP Group, Daycrest, and follow-on investment from Heran Partners, Redalpine, LifeX Ventures, and Zeiss Ventures. The company plans to use the funds to accelerate commercial deployment of its Hyperspectral Intelligence® platform, expand clinical adoption, and advance next-generation hyperspectral sensing technology in partnership with Imec.

This blog is originally published here: https://www.lifesciencemarketresearch.com/insights/the-weekly-recap-5126-lsi-alumni-achievements-driving-medtech-and-healthtech-forward

#healthtech #medtech

The Weekly Recap 5/8/26: LSI Alumni Achievements Driving Medtech and Healthtech Forward

In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni receive regulatory approvals, launch partnerships, achieve clinical milestones, and much more on the road to LSI Asia ‘26 in Singapore (June 30 - July 2).

APEX Biologix

Welcomed LSI Alumni Jeff Cambra to its Board of Directors. Cambra brings extensive experience across the medical device and therapeutics industry, with leadership roles spanning general management, sales, marketing, and product development, along with experience supporting commercialization strategy, portfolio management, and strategic transactions.

Aqua Medical

Announced 12-month follow-up clinical data outside the U.S. for its proprietary radiofrequency vapor ablation platform, highlighting the potential of its proximal intestinal mucosal ablation procedure as a durable treatment for type 2 diabetes. Results showed up to a 2.6% reduction in HbA1c, 100% elimination of exogenous insulin in treated patients, 80% remaining insulin-free without additional medications, and a favorable safety profile for the approximately 60-minute outpatient procedure.

Calla Lily Clinical Care

Treated the first patient in the FREEDOM trial, evaluating 400mg progesterone CallavidⓇ in women with luteal phase insufficiency, a condition associated with infertility and recurrent miscarriage. Callavid is being developed as a first-in-class women’s health innovation, with the potential to become the world’s first drug-device combination product for threatened miscarriage prevention, as well as supporting luteal phase support in IVF.

Discure Technologies

Appointed Ray Baker, M.D., to its Board of Directors. Dr. Baker brings more than 30 years of experience across interventional pain, spine care, and medtech innovation, and will support the company in a fractional Chief Medical Officer capacity to support clinical, regulatory, and market-access strategy.

E-Scopics

Received FDA clearance for new enhancements to its HepatoscopeⓇ platform, including a dedicated Spleen Exam workflow that expands the system’s utility in the non-invasive assessment of cirrhosis complications. The updated platform features optimized acquisition parameters, including adjusted vibration frequency and a spleen-specific region of interest, to improve reliability when measuring high stiffness values.

GraMedica

Announced a partnership with LovellⓇ Government Services to serve federal healthcare systems, including the Veterans Health Administration, Military Health System, and Indian Health Service. Under the partnership, Lovell will serve as GraMedica’s Service-Disabled Veteran-Owned Small Business vendor of record to help expand access to the company’s HyProCureⓇ.

Gwen Watanabe

LSI Alumni Gwen Watanabe has co-founded Blackwell Health Partners, a new healthcare-focused private equity fund. The fund aims to unite deep healthcare and buyout expertise to accelerate the transformation of promising healthcare companies.

Interventional Systems

Announced a strategic platform partnership with ProVoyance to explore and develop integrated robotic navigation capabilities. The partnership brings together two FDA-cleared platforms, Interventional Systems’ Micromate™ miniature robot and ProVoyance’s AI-enabled preoperative planning software, into a collaboration framework to deliver seamless, end-to-end solutions for OEM partners and the surgeons and patients they serve.

Microsure

Appointed LSI Alumni Alex Joseph as its CEO and received CE mark for its MUSA-3 system. The company can now deploy the MUSA-3 system for clinical use across Europe, moving from product development to a clinical medical device business, where it aims to gather evidence and support adoption among medical centers.

MMI - Medical Microinstruments

Completed the first robotic-assisted procedure in REMIND, its U.S. IDE Study evaluating the SymaniⓇ Surgical System to perform microsurgical techniques in the region of the neck for treatment of Alzheimer’s disease. The procedure, performed using Symani, explores whether restoring lymphatic drainage pathways in the deep cervical lymph nodes may support improved clearance of harmful neurotoxins that scientific researchers believe contribute to the progression of Alzheimer’s disease.

Noctrix Health

Entered into a definitive merger agreement to be acquired by Resmed for $340M. The company developed and manufactures Nidra, a novel non-invasive, wearable therapy to treat drug-refractory restless legs syndrome.

This blog is originally published here: https://www.lifesciencemarketresearch.com/insights/the-weekly-recap-5826-lsi-alumni-achievements-driving-medtech-and-healthtech-forward

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The Weekly Recap 5/15/26: LSI Alumni Achievements Driving Medtech and Healthtech Forward

In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni receive new funding, launch partnerships, receive regulatory approvals, and much more on the road to LSI Asia ‘26 in Singapore (June 30 - July 2).

Adialante

Granted its second U.S. patent covering the core technology behind its ability to image in MRIs using radio waves. The company is developing a new class of mobile MRI systems designed to deliver diagnostic-quality imaging directly to practices without the need for construction or major capital investment.

Angelini Ventures

Welcomed Samantha Wong, PhD, as Investment Analyst. Dr. Wong played a key role in the launch of EspressoLab by Angelini Ventures and the establishment of the company’s Singapore office.

Apreo Health

Announced the appointment of LSI Alumni David Amerson to its Board of Directors and a strategic investment from OSF Ventures, the corporate investment arm of OSF HealthCare. Amerson has over 30 years of leadership in the medical device industry, most recently serving as President of Interventional Urology at Teleflex following its $1.1B acquisition of NeoTract, where he was President and CEO.

BlueWind Medical

Closed $47.8M in financing in a combination of equity and debt. The company plans to use the proceeds to fund further commercialization for its Revi® System, an implantable tibial neuromodulation platform that treats urgency urinary incontinence.

Brainomix

Announced an expansion of its partnership with Boehringer Ingelheim to improve the care of patients with progressive pulmonary fibrosis. Building on results from the REVISE PPF study, the next phase, PROGRESS PPF, a prospective multicenter study, will focus on generating evidence of e-Lung’s clinical impact at scale, with deployments of e-Lung planned at numerous sites across the U.S.

Butterfly Medical

Closed a $21M upsized Series C fundraising round, including participation from the European Innovation Council (EIC), Junson Capital, MedVenture, and New Rhein Healthcare Investors. The company's flagship product, the Butterfly® Medical device, is designed to restore natural urinary flow to provide significant, long-term relief from benign prostatic hyperplasia symptoms, thereby improving patients' quality of life.

Canary Medical

Granted FDA BDD for its Canary Revision Tibial Extension. The system is designed to provide clinicians with autonomous kinematic data following TKA revision procedures, supporting earlier identification of recovery concerns and more informed postoperative management decisions.

CustomSurg

Appointed Richard Keiser as its CTO. Keiser has over a decade of experience in medtech managing and directing software platforms and infrastructure, and looks to help the company advance its OrthoPlanner™, an FDA-cleared solution for pre-operative fracture planning.

EndoShunt Medical

Welcomed LSI Alumni Catherine Kiani as a Board Observer on behalf of Elderberry Ventures. Kiani, backed by an involved advisory team with four decades of experience building, scaling, and defending medical device companies, brings a rare combination of legal, governance, and medical technology expertise.

Endospan

Acquired by Artivion for an upfront purchase price of $135M. The acquisition comes on the heels of FDA approval for its NEXUS Aortic Arch Stent Graft, which was supported by the one-year results of the prospective multicenter TRIOMPHE investigational device exemption study.

HeartBeam

Entered into an agreement with Atelier Health to expand its commercial footprint into Southern California. Combined with its recent partnership with ClearCardio, the partnership with Atelier establishes the company’s initial presence across Southern California, the New York metro, Dallas, and South Florida, creating a foundation for broader national growth.

This blog is originally published here: https://www.lifesciencemarketresearch.com/insights/the-weekly-recap-51526-lsi-alumni-achievements-driving-medtech-and-healthtech-forward

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The Weekly Recap 5/22/26: LSI Alumni Achievements Driving Medtech and Healthtech Forward

Activ Surgical

Partnered with Medical Dynamics to be the company’s exclusive distribution partner in Belgium, the Netherlands, and Luxembourg for ActivSight™. ActivSight Intelligent Light is the first and only modular form-factor with multimodal Advanced Visualization, allowing surgeons to augment their senses using augmented reality overlays.

Adagio Medical

Submitted PMA application to the FDA for its vCLAS Ventricular Ablation System for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia in patients with ischemic or non-ischemic structural heart disease. The submission is supported by the FULCRUM-VT pivotal IDE trial, which enrolled 209 patients and demonstrated 97.4% acute clinical success, 84.3% freedom from ICD shock at six months, low major adverse event rates, and a 78% reduction or elimination of anti-arrhythmic drug use.

Aevice Health

Announced a new collaboration with Cedars-Sinai Medical Center to launch a pediatric at-home asthma monitoring program powered by its smart wearable stethoscope. The AeviceMD is an at-home monitoring device designed to track early signs of asthma and provide clinicians with continuous or on-demand remote monitoring of lung sounds.

Arsenal Medical

Received FDA IDE approval to initiate RADIANT, a pivotal trial evaluating NeoCast™. NeoCast is a novel liquid embolic under development that is designed to achieve pain-free, predictable distal penetration of the middle meningeal artery.

Asabys Partners

Announced the launch of Asabys Innvierte Tech Transfer, a new fund backed by the Ministry of Science, Innovation, and Universities, through CDTI, and the EIF, with a joint commitment of €74.7M. With a target size of up to €120M, the fund will support the creation and growth of breakthrough companies in biotechnology and medical technologies, with a strong focus on technology transfer from universities, hospitals, and research centers.

Cagent Vascular

Announced the successful completion of the first human-use cases with the SerranatorⓇ SONIC Intravascular Lithotripsy System and the closing of a $41M Series D financing round. The round, co-led by U.S. Venture Partners (USVP) and Astoria Health Investors, funds the global REMODEL II pivotal trial and commercial launch of the SONIC IVL System.

Elixir Medical

Announced four-year results from the BIOADAPTOR randomized controlled trial comparing its DynamX coronary bioadaptor system to the Medtronic Resolute Onyx DES, highlighting durable clinical outcomes with DynamX. Investigators reported no new target lesion failure or cardiovascular death events between years three and four, while the system maintained a very low plateauing rate of adverse events compared to the continued annual increase seen with drug-eluting stents.

Endologix

Acquired the Pounce™ Thrombectomy System from Surmodics, closing the deal on May 18, 2026. Pounce, a clinically differentiated mechanical thrombectomy system for peripheral arterial clots, enables the company to support a broader continuum of care for patients with peripheral vascular disease and complements the company’s existing vascular intervention portfolio for the physicians who treat them.

Galvanize Therapeutics

Received FDA 510(k) clearance for the AliyaⓇ EX Generator, expanding the Aliya PEF portfolio by enabling treatment across a broader range of lesion sizes with an ablation zone up to seven times larger. Aliya EX maintains the core attributes of the platform’s pulsed electric field technology, including predictable non-thermal ablation, a favorable safety profile, compatibility with existing workflows and therapies, and potential immune activation.

This blog is originally published here: https://www.lifesciencemarketresearch.com/insights/the-weekly-recap-52226-lsi-alumni-achievements-driving-medtech-and-healthtech-forward

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The Memo: Paradromics Advancing Brain-Computer Interfaces to Restore Communication

Under the direction of Founder and CEO Matt Angle, Paradromics is advancing a high-data-rate brain-computer interface (BCI) designed to restore communication for people with severe motor impairments by translating neural signals directly into speech, text, and computer control.

Origin Story

Paradromics was founded to address a clear gap between academic promise and real-world usability in BCIs. Early systems demonstrated compelling proof of concept but lacked the performance and durability required for clinical deployment.

“We saw that while brain-computer interfaces had demonstrated incredible proof of concept in clinical research, they were limited by low data rates, poor long-term performance, and bulky through-skin connectors. They weren’t ready for deployment as robust products,” Angle explained.

With early support from DARPA, the team set out to build what Angle describes as “broadband for the brain,” focusing on high-channel-count systems capable of recording from large populations of neurons. That vision became the foundation for ConnexusⓇ BCI, now approved for a first-in-human clinical trial.

The Current Landscape

At its core, Paradromics is solving a fundamental interface problem between biology and technology.

“At the highest level, we are solving the problem that human beings don’t come with USB-C connectors, so when we need to get data in or out of the brain, we need to create a physical data interface,” Angle said.

The immediate clinical focus is restoring communication. Approximately 150,000 Americans have lost the ability to speak and have limited limb function, often due to ALS, stroke, or spinal cord injury. Many of these individuals remain cognitively intact but rely on tools such as eye-tracking systems and letter boards, which are slow and cognitively and physically demanding, limiting natural conversation.

“Communication is central to independence and everyday life. Restoring it in real time allows people to express themselves and stay connected to others,” Angle said.

Inside the Innovation

Paradromics’ Connexus BCI captures neural activity at the level of individual neurons and decodes intended communication in real time. The system translates brain signals into text, synthesized speech, or cursor control, creating a direct pathway from thought to output.

At a technical level, the platform uses platinum-iridium microwire electrodes to record action potentials, preserving the timing and structure needed for high-quality decoding. This data is then processed by downstream software that interprets patterns associated with intended communication.

“Our performance and purpose define the platform,” Angle said. “The Connexus BCI records activity from individual neurons and has demonstrated data rates above 200 bits per second, more than 20 times higher than the next highest data rate BCI.”

Equally important is durability. The system is designed as a fully implantable device with no wires or components breaking the skin’s surface, and preclinical data have shown stable recordings over multiple years. This combination of high data throughput and long-term reliability is central to enabling continuous, natural communication.

Progress and Milestones

Paradromics has entered the clinical stage, marking a major transition from development to real-world application.

“In 2025, we completed our first-in-human procedure, demonstrating safe implantation and stable neural signal recording,” Angle shared.

The company has also received FDA IDE approval for the Connect One clinical study, which is now enrolling patients and will evaluate safety, feasibility, and early communication performance.

Beyond this initial indication, Paradromics is building toward a broader platform roadmap. “Restoring communication is the first step in developing a massively scalable platform that’s designed to target a longstanding pipeline of neurological and psychiatric applications, benefiting millions of individuals who have been left with severely limited options for far too long,” Angle emphasized.

With its APEX Partnership Program connecting leading BCI researchers and clinicians, and a stated goal of doubling data rates with each generation, Paradromics is positioning its technology not as a single application, but as a foundational interface for future neurological and psychiatric therapies.

This blog is originally published here: https://www.lifesciencemarketresearch.com/insights/the-memo-paradromics-advancing-brain-computer-interfaces-to-restore-communication

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The Memo: Nami Surgical Unlocking the Future of Ultrasonic Surgery

Under the direction of CEO Nikki Palfrey and Co-Founder and COO Nico Fenu, PhD, Nami Surgical is developing a meaningful new capability in robotic-assisted surgery: integrated ultrasonic advanced energy with wristed articulation. Built on deep expertise in ultrasonics and designed specifically for robotic integration, the company is working to address a functional gap that has persisted as surgical robotics has scaled, creating a platform intended to bring the speed, precision, and safety advantages of ultrasonic energy into a new generation of procedures.

Origin Story

Nami Surgical was founded in December 2021 by Dr. Nico Fenu and Dr. Rebecca Cleary, both alumni of the University of Glasgow’s Centre for Medical and Industrial Ultrasonics, the world’s largest academic ultrasonic engineering unit. The company emerged directly from Fenu’s PhD research, as well as the founders’ work within the Ultrasurge: Surgery Enabled by Ultrasonics program, giving Nami a foundation rooted in specialized scientific research and firsthand technical expertise.

Fenu completed his PhD focused on piezoelectric materials for ultrasonic surgery, while Cleary, now the company’s CTO, researched ultrasonic needles for bone penetration and received the prestigious R.W.B. Stephens Prize at the International Congress of Ultrasonics. Together, they identified a clear technology gap in the operating room: ultrasonic surgical tools had become indispensable in minimally invasive surgery, but their architecture had not evolved to match the demands of robotic platforms.

“As founders, Rebecca and I are deeply committed to improving patient outcomes. We are excited about the opportunities ahead in a rapidly growing global market,” said Fenu.

In December 2024, the company entered a new phase when Nikki Palfrey stepped into the CEO role after joining Nami’s board the previous year. With more than 25 years of medtech leadership experience spanning growth, global expansion, and M&A, Palfrey’s appointment marked Nami’s transition from advanced development toward market entry.

“Nami is exceptionally well-positioned to become a leading force in the robotic-assisted surgery market. I am excited to lead the company as we enter a new chapter focused on innovation, scale, and long-term value creation,” said Palfrey.

The Current Landscape

Advanced energy remains one of the highest-utilization consumable categories in minimally invasive surgery, and ultrasonic devices have become indispensable in many procedures. By simultaneously cutting and coagulating tissue, reducing thermal spread, improving hemostasis, and eliminating the need for instrument exchanges, these tools can contribute to faster, safer procedures.

The ultrasonic scalpel market is valued at approximately $2.7 billion globally, growing at an 8–10% CAGR, underpinned by 15–25 million procedures annually, according to the Nami team.

At the same time, surgical robotics is expected to exceed $25 billion by 2030, with over six million procedures projected.

Yet one important limitation remains. Robotic surgery is built around wristed precision, but ultrasonic energy instruments have not evolved in parallel. While many robotic tools articulate at the tip, current robotic ultrasonic energy devices remain constrained by architectures originally designed for handheld laparoscopic use.

Conventional ultrasonic systems rely on rigid waveguides to transfer energy into the surgical site. That architecture creates meaningful limitations in robotic environments, where maneuverability and articulation are central to the value proposition.

This leaves one of robotic surgery’s clearest functional gaps still unresolved, and one with meaningful strategic implications. Advanced energy represents a major recurring consumables category, and integrated ultrasonic capability could become an important differentiator as more robotic platforms compete for adoption.

This blog is originally published here: https://www.lifesciencemarketresearch.com/insights/the-memo-nami-surgical-unlocking-the-future-of-ultrasonic-surgery

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BCI Market: Following the Capital Into Neurotechnology’s Next Frontier

It has been a quieter stretch across medtech headlines, with recent editions focused heavily on M&A and portfolio reshuffling. This week, we are shifting attention to a segment that continues to attract outsized investor interest relative to its stage of development: the BCI market.

As Q1 2026 wrapped, one signal stood out clearly in recent funding data. Capital is increasingly flowing toward companies developing brain-computer interface platforms. The scale of recent financings demonstrates that trend. Merge Labs launched out of stealth with a $252 million Seed round in January. Science Corp. followed with a $230 million Series C in March. That same month, Stairmed raised $73 million with backing from Tencent and Alibaba, while Gestala secured $21.6 million. These rounds build on earlier financings, including $200 million for Synchron and $650 million for Neuralink.

This level of investment is notable given that no BCI device has yet reached commercial approval in the United States. Understanding why requires a closer look at the underlying market dynamics.

A Grounded View of the BCI Market Opportunity

Rather than focusing on long-term projections, it is more useful to assess the near-term reality. Today, most BCI developers are targeting patients with severe motor impairment, primarily paralysis resulting from traumatic spinal cord injury and stroke.

Estimates suggest that roughly 55,000 patients in the United States fall into this initial addressable group. On a global scale, about 14 million people live with paralysis, including approximately six million in China. While these figures are significant, they represent a concentrated population. Not every patient will qualify for implantation, which limits early adoption.

A helpful comparison is the deep brain stimulation (DBS) market. Both technologies involve neurosurgical implantation of electrodes and address neurological conditions with high unmet need. After more than 25 years, the global DBS market is valued at approximately $1.1 billion to $1.5 billion. Devices are priced between $18,000 and $35,000 and have reached only about 10% of eligible patients.

Adoption has been constrained by the limited number of trained functional neurosurgeons and the complexity of patient selection. These same factors are likely to influence BCI adoption. Early estimates suggest BCI systems could cost around $50,000, adding another layer of friction.

Structural Barriers to Scale

The path to commercialization is shaped by several structural challenges. First, the neurosurgical workforce remains limited. Training neurosurgeons takes years, and the number of specialists capable of performing these procedures is relatively small.

Companies such as Synchron, Neuralink, and Precision Neuroscience are developing different approaches to mitigate these constraints. Even so, scaling procedures across healthcare systems will take time.

Reimbursement presents another unresolved issue. While discussions are underway, formal pathways have not yet been established. Additional considerations include device durability, signal quality over time, data privacy requirements, and the complexity of manufacturing at scale.

Why Capital Keeps Flowing

Despite these hurdles, funding momentum remains strong. In Q1 2026, BCI companies accounted for approximately 22% of total medtech funding raised. Part of this is driven by hype, but several underlying factors help explain sustained investor interest.

Expanding clinical indications is one key driver. Beyond paralysis, applications such as speech restoration and vision are advancing through active programs at Neuralink, Paradromics, and Science Corp. Broadening use cases early could accelerate growth compared to more narrowly defined neurotech markets.

Regulatory progress is also contributing to momentum. The FDA has shown increasing engagement with developers, and several companies are approaching pivotal trials. Internationally, China is moving even faster. Neuracle received commercial approval in March, supported by defined pricing structures, government-backed funding, and expedited regulatory pathways. This dynamic suggests China may become a distinct and potentially closed market.

Data is another critical factor. BCI systems generate large volumes of neural data, which can be used to train algorithms that decode brain activity. Over time, these datasets could create defensible advantages and support recurring revenue models beyond the initial device.

There is also a broader narrative at play. The intersection of artificial intelligence and human cognition has drawn attention from investors outside traditional medtech. High-profile figures such as Elon Musk and Sam Altman have helped bring visibility to the space, attracting capital from technology-focused funds and corporate players.

Finally, investment in this category is highly concentrated. A small number of well-capitalized companies dominate the landscape, allowing investors to focus on differentiated platforms rather than navigating a fragmented field.

This blog is originally published here: https://www.lifesciencemarketresearch.com/insights/bci-market-following-the-capital-into-neurotechnologys-next-frontier

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Inside J&J’s Atraverse Medical Acquisition

Johnson & Johnson’s agreement to acquire Atraverse Medical fits a pattern that has become increasingly familiar across medtech M&A. Strategic buyers are continuing to target commercial-stage companies operating in expanding procedural markets where workflow advantages and ecosystem positioning matter just as much as the core technology itself.

This deal also highlights something else: the founders behind FARAPULSE have once again identified a procedural bottleneck inside the same operating room and built a company around solving it. Steven Mickelsen, John Slump, Eric Sauter, and their broader team previously helped reshape pulsed-field ablation before Boston Scientific acquired FARAPULSE in 2021. Now, they have built a left-heart access platform that Johnson & Johnson believes strengthens Biosense Webster’s position in EP.

The timing is important. So is the strategic fit.

J&J’s Structural Advantage in EP

Johnson & Johnson’s electrophysiology (EP) business is not simply large. It is deeply embedded in the clinical workflow through Biosense Webster and the CARTO mapping platform.

Today, Biosense Webster controls more than 40% of the U.S. EP ablation catheter market and roughly 60% globally. Much of that position is tied directly to the widespread adoption of CARTO, which has remained the leading cardiac mapping system for decades. More than 5,000 systems are now installed worldwide.

That installed base creates a powerful commercial foundation. Every new EP technology integrated into the Biosense Webster portfolio immediately benefits from existing physician familiarity, procedural integration, and access to established hospital infrastructure.

That is where HOTWIRE enters the picture.

Why Atraverse Medical Matters

Atraverse developed HOTWIRE to simplify transseptal access, a critical step in left-heart procedures used to treat atrial fibrillation and other arrhythmias. Physicians must cross from the right atrium into the left atrium before ablation can begin, making this one of the foundational steps in nearly every left-heart ablation procedure.

It is also one of the most technically sensitive portions of the workflow.

Conventional RF guidewires continuously deliver energy during septal crossing. Once the wire enters the left atrium, there is potential for unintended tissue injury. Existing approaches can also introduce procedural inefficiencies, including sheath exchanges, inconsistent crossing forces, and risk of dilator skiving and emboli creation.

HOTWIRE was designed specifically to address those issues. Its impedance-guided RF generator automatically stops energy delivery once left atrial entry is detected. It is currently the only device with that capability.

Clinical performance data have reinforced the value proposition. A multicenter first-in-human study involving roughly 500 patients demonstrated 100% procedural success. Data presented at the 2026 European Heart Rhythm Association meeting showed a 0% incidence of unintended left atrial injury, compared to rates exceeding 50% observed with other RF guidewires in comparative studies.

The workflow benefits are equally important:

Zero-exchange functionality that acts as both the crossing tool and support rail

Increased stiffness relative to competing systems for improved large-bore sheath support

Universal sheath compatibility that avoids forcing physicians into new procedural workflows

These types of improvements matter in high-volume AFib programs where complication reduction, procedural efficiency, and downstream cost control directly affect operational performance.

Since receiving FDA 510(k) clearance in 2024, the device has already been used in approximately 3,000 procedures as part of a limited market release. The company achieved that traction with roughly $40 million in funding and in under four years of operation.

This blog is originally published here: https://www.lifesciencemarketresearch.com/insights/inside-jjs-atraverse-medical-acquisition

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