Category: CA Collaborations & Insights

Clinical Accelerator is pleased to announce a collaboration with HEPTA Medical, a pioneering medtech company developing next-generation therapeutic solutions for early-stage cancer treatment.

HEPTA Medical is at the forefront of innovation in thermal ablation technology. The company has developed a 𝗺𝗶𝗰𝗿𝗼𝘄𝗮𝘃𝗲 𝗮𝗯𝗹𝗮𝘁𝗶𝗼𝗻 𝗽𝗹𝗮𝘁𝗳𝗼𝗿𝗺 that integrates an 𝗶𝗻-𝘀𝗶𝘁𝘂 𝗽𝗮𝘁𝗲𝗻𝘁𝗲𝗱 𝘁𝗶𝘀𝘀𝘂𝗲 𝘁𝗲𝗺𝗽𝗲𝗿𝗮𝘁𝘂𝗿𝗲 𝘀𝗲𝗻𝘀𝗼𝗿 with proprietary predictive software, enabling 𝗿𝗲𝗮𝗹-𝘁𝗶𝗺𝗲 𝗺𝗼𝗻𝗶𝘁𝗼𝗿𝗶𝗻𝗴 𝗮𝗻𝗱 𝗰𝗼𝗻𝘁𝗿𝗼𝗹 𝗼𝗳 𝗮𝗯𝗹𝗮𝘁𝗶𝗼𝗻 𝗽𝗿𝗼𝗰𝗲𝗱𝘂𝗿𝗲𝘀 during treatment. This cutting-edge approach aims to improve precision and safety in the treatment of cancerous lesions, offering clinicians enhanced feedback throughout the procedure.

Under this collaboration, Clinical Accelerator will support HEPTA Medical in the execution and operational management of early-stage clinical trials that evaluate the safety and performance of their innovative platform. Leveraging our deep expertise in early-stage clinical research and global site networks, we will help accelerate the delivery of clinical evidence required for regulatory milestones and broader clinical adoption.

For more information on HEPTA Medical’s technology and mission, visit https://www.heptamed.com/.

We’re thrilled to announce that Clinical Accelerator is partnering with Angiolutions, a groundbreaking medtech company developing the A³-Shield®, the first-of-its-kind implant designed to stop the progression of abdominal aortic aneurysms (AAA) .

AAAs affect millions worldwide, with no available therapy to halt disease progression. Angiolutions’ innovation is based on pioneering research from Stanford University and represents the first major advance in the AAA field in over 30 years . By blocking harmful aortic pulse wave propagation, A³-Shield® has the potential to protect patients at the early stages of AAA, preventing growth and rupture — and saving lives. Through this collaboration, Clinical Accelerator will support Angiolutions in accelerating their early clinical development program, paving the way toward regulatory approvals and market access in both Europe and the U.S. We look forward to working together to bring this transformative therapy to patients who urgently need new solutions.

Clinical Accelerator, a leading CRO specializing in early-stage First-in-Human (FIH) and early feasibility MedTech studies, is pleased to announce its collaboration with Relief Cardiovascular on the FIH clinical trial of the Relief System. Full study approval has now been granted in Georgia, and preparations are underway to initiate the trial.

Innovating Fluid Management in Heart Failure

The trial will evaluate the Relief System, the world’s first transcatheter smart implant, which dynamically monitors and modulates cardiac preload and congestion. Unlike legacy passive monitoring systems, the Relief System implant autonomously captures multiparametric and hemodynamic data to guide device-driven pressure relief to optimize fluid balance and diuretic efficiency in patients with chronic heart failure. With its ability to monitor and control the implant via a remote cloud interface, the Relief System represents a new paradigm in heart failure: direct, tunable decongestion driven by a data-driven therapeutic implant.

A Strategic Location for Early-Stage Trials

Georgia’s robust clinical infrastructure combined with Clinical Accelerator’s regional experience enables rapid start-up, high-quality enrollment, and reliable data management. Clinical Accelerator will act as the CRO, overseeing regulatory liaison, site coordination, and trial operations, ensuring alignment with Relief Cardiovascular’s strategic objectives.

Next Steps

With study approval now in place, Clinical Accelerator and Relief Cardiovascular will move forward with site initiation and patient enrollment. The study is expected to generate valuable insights into the system’s clinical performance and therapeutic potential.

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About Clinical Accelerator

Clinical Accelerator is an independent, academically connected, full-service CRO operating in Central and Eastern Europe and Central Asia. The company specializes in First-in-Human and early-phase studies for innovative MedTech and biotech companies, offering accelerated timelines, cost efficiency, and access to experienced clinical sites.
www.clinicalaccelerator.com

About Relief Cardiovascular

Relief Cardiovascular is a privately held company developing a novel transcatheter platform for improving fluid management in heart failure. Its transcatheter smart implant enables pressure-guided therapy, targeting patients who are resistant to conventional diuretic treatment.
www.reliefcardio.com

We’re proud to partner with Sutra Medical, a bold innovator in the structural heart space, as we support the early clinical development of their Sutra Hemi-Valve TMVR system — a unique approach that challenges conventional thinking in transcatheter mitral valve replacement.

While many TMVR systems aim to replace the entire mitral valve, Sutra takes a minimally disruptive route. Their device replaces only the posterior leaflet, allowing it to coapt naturally with the patient’s native anterior leaflet. The result?

• A design that preserves native valve anatomy,
• Has a small footprint in LV, and
• Eliminates risk of LVOT obstruction — a known complication with bulkier full-replacement systems.

This “hemi-valve” concept introduces a new category within mitral valve intervention — less invasive than full TMVR, yet potentially more durable than repair-based strategies. It’s especially promising for patients with complex anatomies or high surgical risk who might otherwise be left with limited options.

At Clinical Accelerator, we are proud to help bring such differentiated technologies into first-in-human studies and support companies that seek not just to improve, but to reimagine the way structural heart disease is treated.

We look forward to the journey ahead with Sutra Medical.

Learn more at sutramedical.com

Interventional heart failure management is emerging as a new and promising frontier in cardiovascular medicine, offering hope to patients with few effective treatment options. Among the innovators leading this transformation is Gradient Denervation Technologies, whose novel approach to pulmonary artery denervation has the potential to significantly improve outcomes for patients with pulmonary hypertension secondary to left heart disease.

Gradient Denervation Technologies, a Paris-based leader in cardiovascular innovation, has developed a minimally invasive, ultrasound-based system designed to target the nerves surrounding the pulmonary artery. By reducing sympathetic nervous system activity, this technology may help lower vascular resistance and pulmonary artery pressures—addressing a critical unmet need in this complex patient population.

We are pleased to see Gradient’s continued progress, following a strong and successful launch of their clinical program with the first-in-human (FIH) study conducted by Clinical Accelerator in Georgia. It has been an honor to support this initiative from its earliest stages, and we remain deeply committed to advancing pioneering therapies through trusted, strategic collaborations.

We also extend our sincere gratitude to Dr. Alex Rothman for his invaluable guidance and support to the Georgian clinical team throughout the execution of Gradient’s FIH study. We look forward to the continued advancement and success of this vital clinical program.

Over the past three years, Clinical Accelerator has been honored to collaborate with Polares Medical, a pioneering company in the field of mitral valve therapies. Our partnership has focused on advancing early-stage clinical investigations of Polares’s innovative PLAR (Posterior Leaflet Augmentation and Replacement) system, and supporting the generation of quality clinical evidence regarding its safety and efficacy.

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The Evolving Landscape of Mitral Valve Innovation

Mitral regurgitation (MR) remains one of the most prevalent and challenging forms of heart valve disease. While surgical mitral valve repair and transcatheter edge-to-edge repair (TEER) offer solutions for many patients, a significant proportion remain untreated due to anatomical complexity, comorbidities, or procedural risk.

In response to this unmet need, the field of mitral valve intervention is witnessing a surge in innovation. Among the emerging technologies, Polares Medical’s PLAR system has carved out a promising position.

Unlike conventional valve replacement strategies, the PLAR system provides a transcatheter therapy that selectively replaces the posterior leaflet of the mitral valve, while preserving the native anterior leaflet. This novel approach is designed to restore normal valve function with a less invasive procedure, potentially reducing procedural risk, simplifying future interventions, and offering a more physiologic solution.

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Polares Medical: A Promising Contender in Mitral Valve Therapies

Headquartered in Lausanne, Switzerland, Polares Medical has drawn considerable attention within the cardiovascular innovation community. The PLAR system has shown promising outcomes in early clinical evaluations, including data from compassionate-use cases in Europe.

With substantial funding secured to advance clinical studies, and a clear focus on patients with complex mitral valve disease who are underserved by existing therapies, Polares is well-positioned to become a key player in the evolving structural heart landscape.

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A Productive Partnership in Georgia

As part of this global effort, Clinical Accelerator has played a important role in managing early feasibility studies in Georgia, providing operational, regulatory, and logistical support. These early-stage trials have been critical in validating the clinical potential of the PLAR system and laying the foundation for future pivotal studies.

Georgia’s growing reputation as a hub for cardiovascular research and innovation has made it an ideal environment for conducting high-quality early-stage investigations. We are proud to contribute to both the local clinical research landscape and Polares’s global mission.

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Looking Ahead

As we reflect on three years of productive collaboration, Clinical Accelerator remains deeply committed to supporting Polares Medical in its mission to revolutionize mitral valve therapy. Together, we aim to bring innovative, less invasive treatment options to patients with mitral regurgitation—enhancing clinical outcomes and improving lives.

We are pleased to announce our collaboration with Proton Intelligence, a company dedicated to transforming management of potassium to prevent hyperkalemia and hypokalemia for people living with chronic kidney disease (CKD) and congestive heart failure (CHF) through innovative technology.

Hyperkalemia, characterized by elevated potassium levels, affects more than 3.7 million people in the US alone. It is common in patients with CKD and CHF and can lead to life-threatening cardiac events. Proton Intelligence is developing the world’s first real-time, on-demand potassium monitoring wearable — aiming to equip clinicians with the tools to manage potassium safely and precisely in some of the most complex and vulnerable patient populations.

Our collaboration focuses on an early human feasibility study in dialysis patients, conducted under the leadership of Dr. Marat Fudim, MD, MHS, Advanced Heart Failure Specialist and Cardiologist at Duke University.

At Clinical Accelerator, we are committed to supporting groundbreaking medical innovations through partnerships with emerging medtech companies. Our collaboration with Proton Intelligence exemplifies our dedication to advancing innovative medical technologies through effective implementation of early human feasibility studies. We look forward to the advancements this partnership will bring to hyperkalemia management and patient care.

Clinical Accelerator, a clinical trial management organization specializing in the cardiovascular field, is pleased to announce its collaboration with Nyra Medical on the clinical evaluation of the CArdiac Leaflet ENhancer (CARLEN) System, a novel transcatheter heart valve repair technology designed to address functional mitral valve regurgitation. The study is set to take place at THVC (Tbilisi Heart and Vascular Centre) and Healthycore (Israeli-Georgian Medical Center) in Tbilisi, Georgia, two renowned centers for clinical trials with innovative cardiac devices.

The CARLEN System, developed by Nyra Medical, offers a transcatheter solution for patients suffering from functional mitral regurgitation. Using a transcatheter femoral venous approach, the CARLEN System is designed to restore normal mitral valve function by augmenting the native valve’s leaflet with an implant, restoring coaptation and correcting regurgitation. As it preserves the native valve geometry, CARLEN is designed to be the first forward compatible device that allows future interventions.

Functional mitral regurgitation (FMR), often caused by ventricular or atrial dysfunction, presents a significant challenge as it increases mortality, heart failure hospitalizations and reduces patients quality of life. There is a significant unment clinical need for therapies that would effectively treat the valve lesion, without too many anatomical exclusion criteria or sacrificing the native valve geometry. The CARLEN System addresses this gap and is designed to improve outcomes and expand transcatheter FMR therapies to a broader patient population.

“This collaboration with Nyra Medical brings an exciting new solution to the forefront of mitral valve repair,” said Dr. Nik Nikitin, Managing Director at Clinical Accelerator. “The CARLEN System’s innovative approach to valve enhancement has the potential to address a long-standing unmet need in cardiology by providing an alternative to high-risk surgical procedures. We are confident that the study at THVC and Healthycore will help validate this technology and obtain valuable early clinical data which will accelerate its further development

Unlike existing transcatheter devices which rely on approximating valve leaflets to reduce regurgitation, the CARLEN System focuses on enhancing leaflet dimensions to restore the valve’s natural function. This approach minimizes the risk of complications such as elevated transvalvular gradients or restricted diastolic inflow, which can adversely impact outcomes in other systems.

“The study at two Georgian sites will evaluate the safety and feasibility of the CARLEN System in treating patients with moderate or greater functional mitral valve regurgitation. The expertise of the investigative team at THVC and Healthycore, combined with the innovative design of the CARLEN System, aims to push the boundaries of what is possible in transcatheter mitral valve repair,” said Lori Chmura, CEO of Nyra Medical

About Clinical Accelerator

Clinical Accelerator is an independent clinical trial management organization specializing in the acceleration of medical device development through early-stage and feasibility studies. The company’s expertise allows it to facilitate the rapid and effective implementation of innovative technologies across diverse therapeutic areas.

About Nyra Medical

Nyra Medical is a pioneering medtech company committed to developing minimally invasive therapies for structural heart diseases. Its flagship CARLEN System is designed to provide a novel solution for patients with functional mitral valve regurgitation, combining innovation with a patient-centric approach to improve outcomes and expand access to life-saving treatments.

Clinical Accelerator is pleased to announce its collaboration with HVR Cardio on the development and clinical evaluation of CathHELIX, an innovative catheter-based device designed for mitral valve repair in patients with mitral regurgitation (MR). Clinical Accelerator is currently managing the clinical study aimed at assessing the safety and efficacy of CathHELIX as a novel transcatheter solution for MR.

Addressing the Unmet Needs of Mitral Valve Disease

Mitral regurgitation remains a challenging condition with limited therapeutic options, especially for patients who are not suitable candidates for surgery.  The CathHELIX Transcatheter Mitral Repair Technology transforms the standard for surgical mitral valve repair into a transcatheter approach.

This device is designed to support a streamlined and safe procedural approach, making it accessible for routine use by interventional cardiologists.

The groundbreaking CathHELIX system reduces the mitral annulus and deploys a self-securing ring to the atrial and ventricular sides, reshaping the annulus and restoring native leaflet function.

As Clinical Accelerator continues to manage this study, its expertise in cardiovascular clinical trials positions it to deliver critical data, hopefully contributing to the advancement in the treatment of MR.

About Clinical Accelerator

Clinical Accelerator is an academically linked, full-service clinical trial management organization operating in Central and Eastern Europe and Central Asia. The company specializes in implementing successful and efficient early-stage First-In-Human (FIH) and Early Feasibility Studies (EFS) with a focus on rapid patient enrollment and high-quality data collection within compact timelines. Clinical Accelerator is dedicated to supporting the advancement of innovative medical treatments through rigorous and well-executed clinical trials.