Medtech Innovation News: LSI Alumni Milestones Announced in December

Highlighting recent medtech innovation news and celebrating the recent wins of our LSI presenting company and speaker alumni community.

Altra

Altra has engineered a novel, dual-chamber infusion pump, inspired by the human heart, to address adverse events and challenges associated with drug delivery. The Altra Infusion System incorporates numerous advancements designed to enhance patient safety and improve infusion reliability, including state-of-the-art air-in-line detection, and an occlusion detection system which provides timely alerts and reduces risks during therapy.

The Redmond, OR-based company recently announced that its Altra Infusion System has been accepted into the FDA’s Safer Technologies Program (STeP). Altra’s inclusion in this program will play a critical role as the company prepares its 510(k) submission to secure market clearance.

FDA’s collaborative STeP program, launched in 2021, is designed to streamline the regulatory review process for medical devices that significantly enhance patient safety, but that target an underlying disease or condition associated with morbidities and mortalities less serious than those eligible for the Breakthrough Devices Program. The program provides select companies with the opportunity to collaborate closely with the agency, offering real-time feedback, interactive communication, and customized regulatory guidance. 

Cala Health

San Mateo, CA-based Cala Health is a bioelectronic medicine company transforming the standard of care for chronic disease. The company's wearable neuromodulation therapies merge innovations in neuroscience and technology to deliver individualized peripheral nerve stimulation, and its direct-to-home digital durable medical equipment platform is reshaping the delivery of prescription therapies. Cala Health's products are the only FDA-cleared, clinically validated noninvasive devices for the relief of hand tremors. In December, the company completed the initial closing of an oversubscribed $50 million growth round, co-led by Vertex Growth Fund and Nexus NeuroTech Ventures. All existing Cala investors participated in the round, including Action Potential Venture Capital, Johnson & Johnson (through its corporate venture capital organization, Johnson & Johnson Innovation – JJDC, Inc.), Lightstone Ventures, Lux Capital, GV (Google Ventures), OSF Ventures, Ascension Ventures, TriVentures, Reimagined Ventures, Peak6 and Fiscus.

Cala is continuing to build strong clinical evidence to expand patient access for its neurostimulation therapy. The results of a study by CVS Health, presented at the Movement Disorders Congress this year, concluded that TAPS therapy offers substantial benefits for patients with essential tremor (ET) in reducing ET-related healthcare resource utilization, healthcare costs, and improving clinical outcomes.

The Cala kIQ System with TAPS (Transcutaneous Afferent Patterned Stimulation) Therapy is the only non-invasive, FDA-cleared, wearable device that delivers effective therapy for action hand tremor relief in people with essential tremor and Parkinson's disease. The TAPS device is clinician-prescribed and clinically proven to safely and effectively reduce action hand tremors. The Cala kIQ device treats tremor by sensing each patient's unique tremor signature and delivering individualized stimulation to the nerves on the wrist that then reach the brain to counteract tremor. 

ET impacts over 7 million people in the U.S. and is characterized by uncontrollable movement that can make critical daily activities very difficult. Drugs are most used to treat ET, but they can cause a range of unwanted side effects such as fatigue, nausea and depression and may not provide desired outcomes. Surgical options like deep brain stimulation or focused ultrasound ablation can be effective but are invasive procedures that carry the risk of potentially irreversible side effects.

Capstan Medical

California-based Capstan Medical is creating a new standard for minimally invasive heart valve intervention, with a suite of next-generation implants and a first-of-its-kind, catheter-based, robotic delivery platform. Established in 2020, Capstan Medical came out of the Santa Cruz incubator, Occam Labs. 

The company recently closed an oversubscribed $110 million Series C round led by Eclipse. Existing investors Intuitive Ventures, Yu Galaxy, and new investor Gideon Strategic Partners, participated in the round. Last year, Capstan closed an oversubscribed $31.4 million Series B funding round, which Eclipse also led. 

While many cardiovascular treatments have improved and become less invasive, traditional heart valve surgery remains highly invasive and is associated with lengthy recovery times. Given the risks associated with open-heart surgeries, many patients delay treatment, unwittingly increasing their health risks as well as the chances they may be too weak later on for open heart surgery. Capstan's minimally invasive solution seeks to overcome limitations of current treatment options by bringing together novel heart valve implants and advanced catheter technology, fully enabled through a robotic platform, to treat a broader set of patients.

Centerline Biomedical

Centerline Biomedical, a cardiovascular navigation and visualization systems innovator, has received FDA 510(k) clearance for its new IOPS Guidewire Handle. This second-generation device is the most recent addition to the company’s novel, patented IOPS (Intra-Operative Positioning System) technology portfolio. The IOPS Guidewire Handle is used with the sensorized IOPS Guidewire and new Viewpoint Catheter to support 3D navigation of a patient’s vasculature. When combined with the proprietary algorithms of the IOPS software, clinicians are able to clearly visualize these devices in real-time and with minimized dependence on fluoroscopy during procedures.

During endovascular procedures, clinicians typically rely on fluoroscopy, or live x-ray, to see medical devices inside the body. Using fluoroscopic imaging exposes the treating clinicians and staff to x-ray radiation, which aggregated over time may introduce risks for DNA damage and other medical complications. IOPS was designed without the need for prolonged fluoroscopy during endovascular procedures to promote the safety of clinicians and patients. This is achieved through advancements in both device navigation and visualization. 

IOPS advancements in visualization, including the novel Spintegration feature, enables multicolor 3D visualization of the arteries and their branches before, during, and after stent graft placement. The result is unparalleled vascular mapping with colorful, 3D images displaying the fine features of diseased arteries; including calcifications, occlusions, dissections, and other anatomical formations not as visible when using traditional 2D grayscale x-ray fluoroscopy. In addition, new software features, only available on IOPS by Centerline, add the capability to create and display 3D wireframe vessel models for procedure mapping.

Founded in 2015 and headquartered in Cleveland, OH, Centerline Biomedical’s commercially available platform, IOPS, has 510(k) clearance from the US FDA for use in the descending aorta. 

Distalmotion

Distalmotion’s mission is to empower robotic surgery excellence across all sites of care, including hospital outpatient and ambulatory surgery centers, by expanding access and improving care with robotic-assisted surgery. The Dexter Surgical Robot is designed to address the growing demand for cost-effective and efficient solutions for high-volume procedures in these settings. Its mobile design, small form factor, and open platform design make it particularly well-suited to outpatient environments, enabling hospitals and ASCs to optimize resources while still accessing the latest technologies and best-in-class surgical tools. Distalmotion recently announced that its Dexter Surgical Robot has successfully treated the first U.S. patients in an outpatient setting. Two adult inguinal hernia repairs were completed with Dexter on November 26, 2024, less than 30 days after receiving FDA de novo approval for its Dexter surgical robot for this indication. Dexter seamlessly integrates into existing operating workflows and is fully compatible with current operating room equipment, protecting hospitals’ existing investments. Additionally, its single-use instruments remove the complexities of reprocessing, further enhancing workflow efficiency. The system can work natively with third-party 3D imaging systems, energy devices, vessel sealers and other laparoscopic devices. It features a suite of fully wristed, single-use instruments. These deliver dexterity, precision of movement, reliable instrument performance and lower reprocessing requirements.

Unique to Dexter, the surgeon remains sterile at the console, enabling direct and quick access to the patient at any point during the procedure. This empowers surgeons to flexibly choose the best technique for each step of the procedure. Dexter is designed to be the “surgeon’s robot” that provides the physician complete control of the procedure to optimize patient outcomes. 

The company raised $150 million last year to progress its regulatory efforts in the U.S., and reports more than 1,400 patients successfully treated in Europe.

EndoQuest Robotics

Houston, TX-based EndoQuest Robotics designed its flexible endoluminal robotic technologies to address unmet needs in gastrointestinal and other endoluminal surgeries. The proprietary technology navigates and performs procedures within the body’s luminal spaces, via a trans-oral or trans-anal approach, allowing for minimally invasive interventions, while offering precision and flexibility to improve patient outcomes. 

The company recently announced it received FDA investigational device exemption (IDE) for its pivotal colorectal clinical study, Prospective Assessment of a Robotic-Assisted Device in Gastrointestinal Medicine (PARADIGM). The landmark multi-center, open-label study will examine the Endoluminal Surgical (ELS) System’s safety and performance in robotic endoscopic submucosal dissection (ESD) procedures for the removal of colorectal lesions. EndoQuest expects 50 subjects to participate in the study. It will take place across five leading U.S. healthcare institutions: Brigham and Women’s Hospital (Boston), Mayo Clinic (Scottsdale), Cleveland Clinic (Cleveland), AdventHealth (Orlando), and HCA Healthcare (Houston). 

The ELS System is designed to solve the technical challenges and decrease the learning curve associated with complex endoluminal procedures such as ESD. The system enables endoluminal procedures with the visualization, precision, and main tenets of conventional surgical technique, allowing for surgical tasks and maneuvers not currently possible in advanced endoscopy. A pre-clinical ESD study presented at Digestive Disease Week in 2024 demonstrated that the ELS System had superior procedural outcomes, a shorter learning curve, and reduced procedure time versus the conventional technique.

The company, which is currently led by interim CEO Eduardo Fonseca, raised $42 million to support the platform a year ago.

Fluid Biomed

Fluid Biomed is a clinical-stage medical device start-up founded by two neurosurgeons, Dr. John Wong and Dr. Alim Mitha, at the University of Calgary. The pair has developed a novel polymer-based stent, ReSolv, that can heal a blood vessel by diverting blood flow away from a weak brain aneurysm. Working together for the past two decades to help people with stroke, their drive and commitment to improve patient health sparked a vision to create a novel stent technology to cure a wide variety of aneurysms with greater efficiency and safety.

The company recently completed a $27 million oversubscribed Series A equity financing round to advance the development of its device. The round was co-led by Amplitude Ventures and an undisclosed major strategic partner. New participants in the investment syndicate include IAG Capital Partners and LifeArc Ventures, as well as returning investors, ShangBay Capital and METIS Innovative. Fluid Biomed plans to use the proceeds to further validate the ReSolv stent and its proprietary delivery system in expanded patient studies.

Fluid Biomed’s bioabsorbable, polymer-based ReSolv stent has been validated by years of scientific research with functional benefits demonstrated in a first-in-human clinical study to treat brain aneurysms. The self-expanding stent is engineered to be highly flexible to navigate into delicate blood vessels of the brain, and provides a scaffold for endothelial cells to promote blood vessel healing. After the aneurysm is cured, ReSolv is gradually integrated into the vessel wall, leaving very little footprint behind. Because the polymer is invisible to x-rays and eventually dissolves away, there is minimal interference with follow-up CT and MRI scans, so patients are not required to undergo invasive angiogram tests or take life-long blood thinners.

About 6.7 million people in the U.S. have unruptured brain aneurysms and more than 30,000 rupture and bleed each year, often leading to disability and death. 

InkSpace Imaging

InkSpace Imaging’s vision is to transform the magnetic resonance imaging (MRI) experience for healthcare professionals, radiologists, MRI technologists, and patients by providing superior comfort and performance at a lower cost. Its lightweight, ultra-flexible MRI coils are designed with groundbreaking versatility, utilizing advanced printed electronics to conform effortlessly to each patient’s unique anatomy. This innovative approach not only enhances patient comfort but also optimizes signal quality, resulting in sharper imaging and more efficient scan times, ultimately improving the diagnostic experience for both clinicians and patients. 

The company, based in Pleasanton, CA, recently announced that its Small Body Array has achieved FDA clearance for use with the Siemens HealthineersMagnetom 1.5T platform. This milestone highlights the robust capabilities of InkSpace Imaging's technology and underscores its potential to expand accessibility and efficiency in the broader 1.5T MRI market. By addressing a key gap in patient comfort and diagnostic precision, this clearance positions the company to accelerate its commercialization efforts and make a meaningful impact in clinical imaging.

Lauxera Capital Partners

Founded in 2020, Lauxera Capital Partners is an independent asset management company and healthcare specialist investor based in Paris, France and San Francisco, CA, that is working to promote the growth of European healthtech companies. 

The company announced the first close of Lauxera Growth II at €300 million ($315 million), representing 75% of the target and already exceeding the size of its first fund. In February 2022, Its first fund, Lauxera Growth I, gathered €262 million ($275 million) of capital from investors and had invested in 12 fast-growing healthtech businesses in France, the UK, Germany, Sweden, Denmark, and the U.S.

Lauxera Capital Partners also announced the acquisition of Galen Data, a leading provider of secure, cloud-based connectivity solutions for medical devices. This transaction follows Lauxera’s 2022 acquisition of Matrix Requirements, a leading application lifecycle management and electronic quality management software solution for medical device R&D and Quality teams. 

Lindera

Berlin, Germany-based Lindera, founded in 2017, has developed AI-powered mobility analysis tools utilizing smartphone cameras to perform 3D motion tracking and assess fall risk, primarily aiding elderly individuals.

The Lindera Mobility Analysis app allows individuals to determine their risk of falling, easily and precisely. For the first time, a 3D analysis of gait movement is possible using a simple smartphone camera. The precise 3D motion tracking accurately calculates step patterns as well as body inclination – even with the use of walking aids. Using a short video recording and a questionnaire, patented algorithms determine the risk of falling, and provide personalized recommendations for preventing falls and maintaining mobility in old age. System integration allows results and suggested measures to be automatically transferred to care documentation software. The repeated use of the app is associated with significant decreases in fall risk. Study results show a fall risk reduction of 18% after the second analysis and an overall improvement of the clinically relevant gait parameters.

The company has published a new groundbreaking study in the journal JMIR Aging, validating its AI-driven fall risk prediction system, based on real-world data from over 600 seniors. The retrospective cohort study evaluated the prognostic validity of the Fall Risk Score (FRS), a multifactorial fall risk scale generated by the mHealth app Lindera Mobility Analysis. The study included 617 older adults (857 observations) residing in German nursing facilities. The FRS was assessed at the initial evaluation and correlated with fall frequency during follow-up evaluation. The study concluded that FRS exhibits good prognostic validity for predicting future falls, particularly in specific subgroups. The findings support a stratified fall risk assessment approach and emphasize the significance of early and personalized intervention.

Lungpacer Medical

Lungpacer Medical is a neurostimulation company dedicated to developing innovative interventional therapies to free patients from mechanical ventilation and improve diaphragm, lung, heart, and brain health.

In early December, FDA approved Lungpacer Medical’s AeroPace System, a first-of-a-kind temporary diaphragm activation system placed with the AeroPace Catheter, indicated to improve ventilator weaning success in patients 18 years or older. The AeroPace System previously received a Breakthrough Device designation.

Muscles necessary for breathing, such as the diaphragm, may be inactive while a patient is mechanically ventilated. As a result, a type of muscle atrophy, known as ventilator-induced diaphragm dysfunction, may occur. The AeroPace System uses neurostimulation via an electrode-containing, cardiovascular-catheter and software-controlled system to contract and strengthen the diaphragm in patients on mechanical ventilation. The system’s FDA-approved indication is to improve weaning success – increase weaning, reduce ventilator days, and reduce reintubation – in patients ages 18 years or older on mechanical ventilation ≥ 96 hours and who have not weaned.  

A growing body of research including more than 100 scientific presentations, 30 peer-reviewed publications, and clinical studies in over 400 patients at 50 international centers, is building evidence and data to demonstrate the value of Lungpacer’s AeroPace System and the investigational AeroNova System, currently in clinical trials. Together, these therapies can address approximately 2.5 million mechanically ventilated critical care patients in the U.S. 

MedLumics

Founded in 2014, MedLumics is developing fiberoptically guided platform technologies, with an initial focus on the treatment of atrial fibrillation (AF). MedLumics’ product, the AblaView Optically Guided Pulsed Field Ablation (PFA) System, is a catheter-based, pulsed field ablation (PFA) technology that optically guides catheter positioning and ablation treatment strategy using optical coherence reflectometry (OCR). AblaView proprietary multibeam technology provides real-time, direct visual confirmation of catheter contact, contact stability, and predicts lesion durability during tissue ablation, with the potential to reduce recurrence rates and reduce procedure technical complexity while increasing procedural safety. Although AF patients are expected to benefit most from this innovation, AblaView is a platform technology with multiple therapeutic applications using OCR and PF ablation.

The company recently announced completion of its first-in-man study, with successful remapping at three months, demonstrating the efficacy of its AblaView system.

AF is the most common type of heart arrhythmia. An estimated 100 million people worldwide currently suffer from AF, and prevalence of the disease is expected to increase as the number of people over the age of 65 continues to expand, and the greatest risk factor is age. Although many technologies have emerged over the last several years to improve the catheter ablation treatment of AF, the ablation procedure has been elevated to first-line therapy in European and North American clinical guidelines, but outcomes remain difficult to predict. Broad registries reveal recurrence rates of up to 60% at the one-year follow-up time point.

Nervonik

Nervonik is a CA-based medical device startup focusing on peripheral nerve stimulation (PNS) for the treatment of chronic pain—a rapidly growing therapy space within the multibillion-dollar chronic pain market that involves applying highly controlled electrical currents to nerves in the body, which modulate pain signals and provide relief. 

The company announced that it has successfully completed a first-in-human clinical study, using its proprietary Nervonik PNS device. The implantable device utilizes proprietary technology, originally developed in Dr. Aydin Babakhani’s laboratory at the University of California, Los Angeles, to enhance therapy outcomes. The implants rely on next-generation, neural-sensing integrated circuits to deliver an optimized therapy with minimal therapeutic resistance. The implants’ small size and PNS targeting offer new hope for managing intractable discomfort and suffering, and represents a new, long-term, narcotic-free solution for chronic pain. 

Neurent Medical

Headquartered in Galway, Ireland, Neurent Medical develops innovative non-surgical treatments for chronic inflammatory sino-nasal diseases. By targeting and safely disrupting the hyperactive autonomic nerves that drive underlying inflammation, their revolutionary treatment provides effective relief to patients. Neurent has its U.S. office in Boston, MA.

The company recently announced that it has secured €9 million ($9.3 million) in growth capital from the Claret European Growth Capital Fund III (CEGCF III), as part of a larger fundraising to further develop its product portfolio and expand its presence in the U.S. market. 

Neurent closed the €18.2 million ($18.9 million) deal with equity investors, which included a drawdown of €3 million ($3.1 million) from the Claret Capital facility. It was one of the biggest Irish venture funding deals of 2024.

Approximately one in four Americans suffer from chronic rhinitis, a common condition that results in persistent symptoms including congestion, rhinorrhea, sneezing and nasal itching. Chronic rhinitis significantly decreases quality of life and can have an adverse effect on sleep quality, mood, and daily activities.

The traditional rhinitis patient journey is often full of frustration due to limited treatment options. The NEUROMARK System is a groundbreaking, minimally invasive treatment option designed to target the underlying drivers of chronic rhinitis. The NEUROMARK System enables the physician to simultaneously treat multiple nerve branches with a high degree of precision, safety, and patient comfort.

Neuroelectrics

Barcelona, Spain-based Neuroelectrics is a pioneer in high-definition brain stimulation and EEG technology. Its products are being used worldwide for both neuroscience and clinical research in hundreds of universities and academic medical centers. The company’s vision is to create a powerful neurotechnology platform upon which verticals can be developed to improve the lives of as many people as possible. Clinical applications are being developed to diagnose and treat brain diseases as well as improve brain health (e.g., in epilepsy, neuropathic pain or mood disorders) and cognitive function (e.g., memory in dementia or executive function in children with ADHD).

The company recently announced a partnership with Neuronostics, an innovator in advanced digital biomarkers and electroencephalography (EEG) analysis, to deliver an integrated EEG solution tailored for pharmaceutical companies, contract research organizations (CROs), and academic partners. This collaboration combines Neuroelectrics’ cutting-edge EEG hardware with Neuronostics’ proprietary analytics to accelerate clinical trials with advanced EEG solutions, providing pharmaceutical and device companies with tools to optimize participant selection, protocol design, and data analysis, and unlock new possibilities in neurological research. The collaboration addresses a critical need in clinical trials for high-quality, actionable data, by providing an integrated platform that accelerates research and improves outcomes. 

OSSIO

Woburn, MA-based OSSIO is a device company focused on evolving orthopedic surgery with bio-integrative fixation technology. Founded in 2014, the company’s vision is to provide the first credible replacement for metal implants in the multibillion-dollar global orthopedic fixation market, with its OSSIOfiber Intelligent Bone Regeneration Technology. OSSIOfiber implants provide strong fixation while leaving nothing permanent behind, which avoids the risk of common post-surgical complications and secondary procedures associated with metal and similar materials. After serving their fixation function, they fully integrate and are replaced with the patient’s natural bone.

The company recently closed on $27.6 million in equity funding to rapidly scale all aspects of its commercial efforts, including a new product pipeline, sales channel and medical education, as well as building out a flagship U.S. manufacturing site and surgeon training center in Florida. Questa Capital, which focuses on investments in expansion-stage healthcare companies, led this latest round of financing, with participation from existing investors MVM Partners, OCV, Ortho-Vision, and Courage Capital.

Since the company’s first product launch in 2019, upwards of 50,000 OSSIOfiber implants have been used across a broad spectrum of orthopedic procedures. The company presented at LSI’s USA ‘20 event.

PhotoniCare

PhotoniCare has secured $4.6 million in Series B financing for its first-in-class, FDA-cleared OtoSight Middle Ear Scope. The new funding is the first close in an expected $9 million round.

The company also formed a manufacturing partnership with Gentex Corporation for its OtoSight Middle Ear Scope, and finalized the relocation of its headquarters from Champaign, Illinois to Grand Rapids, Michigan. Founded in 2013, PhotoniCare’s mission is to improve clinical outcomes and serve unmet patient and provider needs by translating novel light-based technologies into objective medical practice, starting with the OtoSight Middle Ear Scope. The FDA-cleared device was developed for healthcare providers seeking a superior solution for pediatric middle ear issues. With remarkable 90+% reader accuracy in determining the presence or absence of fluid in the middle ear, the device eliminates subjectivity and speculation by providing patients with a non-invasive and comprehensive assessment of middle ear fluid, even in the presence of significant earwax. 

Middle ear infections are the leading cause of hearing loss, surgery and antibiotic use, especially in children. Affecting more than 80% of children, they are misdiagnosed up to 50% of the time using the current gold standard, examination via otoscope. Children can suffer from recurring ear infections for six to 12 months before they are referred to an ENT specialist, and are often prescribed increasingly potent antibiotics during this time. Often, the endpoint of the disease is insertion of tympanostomy tubes in the eardrum. More than 1 million tube surgeries are performed in the U.S. alone every year.

RevBio

Lowell, MA-based RevBio is a clinical-stage device company developing and commercializing TETRANITE, a patented, synthetic, injectable, self-setting, and osteoconductive adhesive biomaterial. This novel technology will be indicated for use in dental, cranial, and broader orthopedic applications as well as animal health. 

The company recently announced it has received FDA approval to expand its ongoing clinical trial to immediately fixate cranial flaps using TETRANITE. RevBio also received reimbursement coverage from CMS for the use of TETRANITE to replace metal plates and screws.

Previously, RevBio received FDA approval to initiate a first-in-human clinical study for an initial five patients to restore cranial flaps following craniotomy procedures and to repair extradural use cases where intentional durotomies are not required. The approval of this clinical trial expansion is a result of the successful demonstration of safety in the first five patients treated with TETRANITE. The neurosurgeon investigators involved in this study will now be able to use TETRANITE in intradural use cases, such as tumor resection surgeries and other cranial procedures, which require intentional durotomies.

Metal plates and screws can produce radiographic artifacts which make it difficult to accurately interpret patient imaging following surgery. What’s more, traditional cranial flap closure methods do not lead to the full osseous reintegration of the flap with the skull, resulting in issues with flap movement, patient pain, and the potential for post-surgical infection. Because TETRANITE eliminates radiographic artifacts and results in osseous union of bone flaps with the surrounding skull, it could become the new standard of care for cranial surgery, according to company representatives.

Roivios

Roivios and its wholly owned R&D subsidiary, 3ive Labs, are clinical-stage medical device companies striving to sustain or enhance kidney function during times of acute stress. The company is initially focused on providing a first-to-market solution to sustain or enhance kidney function for patients with impaired kidney function during a cardiac surgery with cardiopulmonary bypass (CPB). 

The company recently received FDA investigational device exemption (IDE) approval to conduct a pivotal trial for its renal assist device (RAD), the JuxtaFlow RAD, for treating cardiac surgery patients with renal insufficiency. This IDE follows FDA breakthrough device designation for JuxtaFlow in April. The GRADIENT trial aims to address the need for renal support among patients on CPB. The study will be a prospective, multicenter, randomized, controlled, open-label trial. Roivios plans to look at JuxtaFlow’s safety and effectiveness in sustaining or enhancing renal function during and following CPB surgery. The trial marks a critical step in validating the safety and effectiveness of its innovative renal therapy designed to enhance outcomes for patients with kidney disease.

Bahamas-based Roivios designed JuxtaFlow to improve treatments for patients facing kidney disease during cardiac surgery. JuxtaFlow, which combines a catheter and pump system, uses a unique, gentle negative pressure technique on the kidneys’ urine-collecting system. It enhances function and shields against hypoxia-induced damage under acute conditions. 

The company believes the technology can reduce ICU stays, minimize the need for emergency dialysis, and enable savings for healthcare providers. Roivios expects a U.S. launch in late 2025.

SamanTree Medical

Panakes Partners' portfolio company SamanTree Medical SA has announced promising results from the SHIELD study, presented by researchers on December 12 at the 2024 San Antonio Breast Cancer Symposium. The findings show that the company’s flagship product, the Histolog Scanner, a confocal laser microscope, reduced reoperation rates during breast-conserving surgery (BCS) from 30% to 10%—representing a 67% reduction. The innovative imaging device also demonstrated significant accuracy in detecting positive margins with high sensitivity and specificity.

The prospective study, conducted at St. Vincenz Hospital in Paderborn, Germany, evaluated the impact of the Histolog Scanner on reducing reoperation rates during BCS. Fifty patients with invasive breast cancer and/or ductal carcinoma in situ (DCIS) were enrolled, and reoperation rates were compared to historical data from the POLARHIS study, a retrospective observational study performed at the same breast center by the same surgical team using standard intraoperative margin assessment techniques. The Histolog Scanner outperformed standard techniques by achieving a sensitivity of 80.9% and a specificity of 99.5% for positive margin detection, compared to the combined sensitivity of 17.4% and specificity of 97.3% achieved
with standard methods, as seen in the SHIELD study.

SamanTree Medical’s Histolog Scanner features massive parallel confocal microscopy, a cutting-edge technology that expands the imaging field up to 40,000 times larger than standard confocal microscopy. The breakthrough device enables surgeons and pathologists to visualize large, fresh tissue samples in real-time with exceptional resolution and accuracy, making it uniquely suited for intraoperative environments in oncologic surgery.

Headquartered in Liège, Belgium, with U.S. regional headquarters in Boston, SamanTree Medical SA is dedicated to improving oncologic surgery through innovative imaging solutions. Founded in 2010 based on innovations from the École Polytechnique Fédérale de Lausanne (EPFL), a leading Swiss research institute renowned for engineering and technological advancements, SamanTree Medical is committed to improving surgical precision and outcomes by enabling real-time fresh tissue imaging.

Sensome

Sensome, developer of microsensing technology for instant intra-operative tissue analysis, announced that results from two studies of its FDA Breakthrough Device-designated Clotild smart guidewire system demonstrated the device’s ability to identify “fresh” clot—thrombus rich in red blood cells (RBCs)—in peripheral artery disease (PAD) and differentiate it from other tissue encountered during PAD procedures.

Results from the SEPARATE and E-SEPARATE studies were presented in a late-breaking trial session at the Paris Vascular Insights Course 2024, held December 12-14 in Paris, France.

According to the company, the prospective, single-arm SEPARATE study was composed of 17 patients who were treated at AZ Sint Blasius Hospital in Dendermonde, Belgium. In a postprocedure analysis, the study showed that there was a high level of agreement between the technology’s identification of fresh clot, the expert’s assessment of fresh clot, and the treatment decisions appropriate for fresh clot.

The E-SEPARATE study demonstrated the technology’s ability to differentiate fresh clot from other tissue collected from these PAD patients and examined ex vivo. It also demonstrated the correlation between the technology’s ability to determine the RBC content of clots collected from PAD patients with subacute and chronic lesions and a histological analysis of the same clot by an outside core lab, according to the company.

The investigational Clotild device is based on electrical impedance spectroscopy, which measures the electrophysiologic characteristics of fluid or tissue in the 360 degrees surrounding the sensor, and analyzed by Sensome’s predictive models. Sensome has miniaturized the technology to fit on the distal part of a standard 0.014-inch guidewire, directly behind a soft, atraumatic tip. The company stated that the technology can be integrated into devices commonly used during PAD procedures, such as guidewires and catheters, without changing current workflow.

SpinaFX Medical

SpinaFX Medical is a Toronto, Ontario, Canada-based device company working to bring innovative, minimally invasive, image-guided treatments to patients with back pain due to contained herniated discs.  

The company recently announced the successful completion of its Series B funding round, raising its last tranche of CAD $5.3 million ($3.7 million), led by an unnamed strategic investor. The financing will support the company’s continued efforts to secure regulatory approvals, drive commercialization, and expand innovations with its next-generation solution as the company seeks to advance spinal care. 

After failed conservative treatments for back pain, surgery is often the only treatment option. SpinaFX is addressing this therapeutic gap with a minimally invasive, image-guided therapy for contained herniated discs, called Triojection, an investigational therapy, which delivers an ozone-oxygen mixture into the disc. Preliminary data from studies indicates the potential of this outpatient procedure to address disc volume and related nerve pressure, pending further clinical validation and regulatory approval. 

SymPhysis Medical

Galway, Ireland-based medtech company SymPhysis Medical has developed releaze, a minimally invasive home-use drainage device that offers a novel, and patient-empowering approach to managing malignant pleural effusion, which occurs as fluid accumulates in the chest due to cancer. The condition can cause severe discomfort, pain, and shortness of breath, often requiring frequent hospital visits. The device is manufactured in Letterkenny, Co. Donegal, by Phillips Medisize. 

The company recently secured €2.2 million ($2.3 million) in funding from a combination of investors, including Irrus Investments, MedTech Syndicate, Boole Investments, Enterprise Ireland, and a new private investor. This funding positions the company for its next major milestone: obtaining regulatory clearance in the U.S. for its innovative releaze device. With a total fundraising goal of €6.5 million ($6.7 million), SymPhysis Medical plans to conduct preclinical studies, usability tests, and seek FDA clearance by 2026.

Following FDA approval, the company aims to be treating the first patients at leading institutions, including MD Anderson Cancer Center in Houston, TX and Mayo Clinic in Rochester, MN. These partnerships, developed over years of collaboration, will help demonstrate releaze’s effectiveness and collect clinical data for broader adoption.

Synova Life Sciences

Synova Life Sciences is a privately held biotechnology company that develops medical devices and methodologies that harness the body’s natural healing ability to address symptoms of degenerative conditions. The company helps physicians and patients harvest autologous stem cells and use their regenerative ability to enhance quality of life.

The company is currently in development with a device, the Synova WAVE, that extracts a patient's own stem cells from their fat (adipose tissue), using a novel, non-enzymatic process to provide patients, doctors and researchers with fast, safe, sterile, high-yield access to stem cells - a solution that allows personalized autologous therapies to scale. The company recently submitted a 510(k) application to the FDA for its technology. 

The Synova WAVE Adipose Processing Device is the world’s fastest fat processing system. This breakthrough product offers a 3-minute cycle yielding twice as many stem cells as the industry-standard enzyme, collagenase. From the same sample of fat, cells derived from the WAVE Device are also healthier and more uniform in size.   

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