Cardionovum
Pioneering a Transformative Drug Coating Technology

The world of interventional cardiology holds limitless opportunities for innovation. In this dynamic landscape, Drug-Coated Balloons (DCBs) present a promising solution for life-threatening arterial lesions, thanks to their exceptional capability for targeted drug delivery. However, leveraging the full potential of DCB remains an elusive goal due to substantial drug loss during transit.

Cardionovum is pioneering a new paradigm in this landscape with its SAFEPAX coating technology designed for DCBs.

Distinguished by its industry-leading lowest drug wash-off rate, the clinically advanced paclitaxel matrix system is meticulously developed with a 360-degree perspective on safety and efficacy for patients, physicians, and catheter lab operators.

The German medical technology company is guided by the philosophy, “Life deserves the best,” and leverages it to develop novel DCBs and Drug- Eluting Stents (DES) with a signature stamp of quality etched in its DNA.

“Our R&D team continues to push the boundaries of what is possible in bringing the best quality products to enhance patients’ quality of life,” says Miquel Craven-Bartle Capella, CEO of Cardionovum.

Reimagining Drug Safety and Efficacy

Dr. Michael Orlowski, founder of Cardionovum, pioneered the first CE mark-approved DCB as a new therapeutical option for coronary and peripheral artery diseases (PAD). His continued focus on improving existing cardiovascular devices led to the development of the proprietary SAFEPAX technology.

SAFEPAX is aptly named, emphasizing its focus on safety. It is a springboard for safer, more effective, next-generation drug coating solutions, mitigating potential risks associated with Paclitaxel drug migration to other anatomical regions. While Paclitaxel aims to prevent tissue proliferation within arterial linings, it is crucial to apply properly the drug on the surface of the balloon to minimize the side effects. SAFEPAX’s stable amorphous coating sets it apart, minimizing the wash-off and ensuring the right drug dosage gets where it’s needed.

Compared to crystalline counterparts, its amorphous coating structure has a well-balanced lipophilicity, creating an ideal chemical condition to shield the drug. It provides homogenous and maximized drug absorption into arterial tissue.

The versatility of SAFEPAX eliminates the need for a specialized introducer during its deployment. This underscores the coating solution’s consistency and integrity while making the device more accessible and user-friendly for operators.

“Our SAFEPAX technology is a step beyond the contemporary first and second-generation DCB coatings, aligning with our core values,” says Natalia Selina, business unit director, Coronary Line, Cardionovum.

The sale of over 200,000 SAFEPAX units for coronary applications worldwide in the last two years underscores its position as the market’s leading DCB provider.

A Powerhouse of Innovations

Building on its feature-packed coating innovation, Cardionovum offers a family of coronary and peripheral intervention DCBs, including RESTORE DEB, LEGFLOW RX/ OTW, and APERTO OTW.

Its ability to enhance conventional devices stems from comprehension of the distinct needs of the DCB market.

RESTORE is ideal for treating coronary in-stent restenosis, ensuring maximum protection from downstream effects and reliable drug delivery to the target lesion site.

LEGFLOW is a peripheral balloon dilatation catheter that addresses PAD in the superficial femoral artery (SFA) and below the knee (BTK), focusing on long-term vessel revascularization. Its design, complete with Paclitaxel-releasing capabilities and a 20 to 200 centimeters length range, is well-suited for treating long lesions, especially in smaller-diameter vessels.

Our R&D team continues to push the boundaries of what is possible in bringing the best quality products to enhance patients’ quality of life

Conventionally, DCBs developed for SFA and BTK applications are often used also for arteriovenous fistula (AVF) and arteriovenous graft (AVG) treatments. However, these catheters are not the best solution for physicians to use during AVF procedures.

Prioritizing this requirement, Cardionovum introduced APERTO, a peripheral DCB with diameters ranging from 4.0 to 12.0 mm and lengths from 20 to 60 mm specifically designed for AVF and AVG therapies: it features a short shaft of 40 cm facilitating effortless manipulation during procedures and, in addition, the indication for the treatment of the CVS thanks also to the availability of the 12 mm diameter.

APERTO also addresses the challenge of using conventional balloons to deliver drugs to repaired AVF tissue. AVF lesions typically have higher fibrotic content than those in the leg, which can impede drug penetration, even with standard pressure or pre-dilation. APERTO overcomes these challenges as the market’s first high-pressure DCB, offering superior drug delivery capabilities for treating highly fibrotic AVF lesions.
Apart from its DCB product portfolio, Cardionovum offers XLIMUS DES, a Sirolimus-eluting coronary stent system designed for complex coronary artery diseases. This fully biodegradable scaffold device provides clinically effective anti-proliferative drug delivery to lesions, preventing restenosis.

Charting Clinical Breakthroughs

A fundamental element of Cardionovum’s commitment is assessing and reinforcing the safety and efficacy of its products.

With APERTO, it is proud to be the first company to demonstrate the superiority of DCBs over conventional balloon angioplasty (POBA) for AVF treatments. Its groundbreaking work included an analysis of the treatment’s effectiveness with conclusive clinical data, highlighting the significant long-term benefits of using DCBs.

In parallel, Cardionovum has been conducting a randomized controlled trial focused on BTK treatments for LEGFLOW in Japan over the past decade. It is expecting convincing results by mid-next year.

Ongoing clinical trials supporting SAFEPAX’s unmatched drug wash-off rate underscores its growing necessity in various PAD treatments.

In one instance, a PAD patient exhibited an open injury with a finger and BTK artery lesion, a condition frequently encountered by vascular surgeons and interventional radiologists. An impact study by a renowned medical device supplier investigated the use of its DCB in treating BTK lesions.

However, it reported a higher amputation rate and failed to demonstrate its superiority over the standard POBA. This outcome highlighted the limitations of DCBs in conventional BTK applications. In response to this research, Cardionovum identified two key factors contributing to these unfavorable results—the anti-proliferative drug’s downstream loss within the DCB and presence of open injuries in PAD patients. Drug loss, particularly in the fingers, can have adverse effects on the healing of existing finger ulcers. This scenario illustrates the prospective benefit of adopting SAFEPAX to minimize drug loss in BTK treatments.

Unveiling Stent-Free Cardiac Care

The company is on the cusp of a major breakthrough in rapidly evolving cardiac care with its flagship offering, SAFEPAX.

In its first trial against the gold standard of DCB, B. Braun SeQuent Please, Cardionovum established non-inferiority during the clinical follow-up with patients. This landmark study was designed to pave the way for SAFEPAX’s introduction into the Chinese market. China and Japan are currently at the forefront of embracing DCBs, progressively shifting from traditional stents. Its recent product registration in China has further solidified Cardionovum’s status as the market’s second-largest player.

Complementing this, another randomized control trial was initiated. Through a late lumen loss evaluation using angiography, Cardionovum became the first company to prove the non-inferiority of DCBs against the standard DES for treating novel lesions in small blood vessels. With its five-year follow-up data presented at TCT 2022, the publication of these study results is highly anticipated.

Typically, DCBs are employed for addressing restenosis or complex bifurcation cases where stents may not fit. SAFEPAX’s solid clinical evidence emphasizes the significant advantage of a ‘nothing left behind’ approach, which will usher in an implant-free future, taking treatment beyond the traditional use of DES and permanent fixtures. Another value-add for DCB is its bailout procedure, which allows for a stent’s potential insertion as a secondary option, if the initial treatment does not succeed.

Even though its bioabsorbable DES program is ready to market, Cardionovum considers it a second option, primarily focusing on strengthening DCB technology and building robust clinical data.

Fostering Clinical Research Excellence

The enduring accomplishments at Cardionovum are made possible by an engineering-focused R&D environment, which ensures its DCB solutions deliver the promised performance standards.

Attaining a breakeven within four years, the dynamic company maintains an adaptive approach in response to market needs and implements numerous new SOPs to support its growth. It has a lean organizational structure where decisions are made collectively, and include input from younger team members. Everyone’s voice is valued and encouraged, building open communication across the team.

Expanding from a promising R&D pipeline, Cardionovum aims to introduce innovative coating solutions for other devices across diverse medical fields, including neuro-intervention and urology. These advancements will set new standards, establishing DCB as the first-line treatment.

Its protective drug coating finesse and steadfast commitment to product quality positions Cardionovum as the global partner of choice for patients and healthcare providers in a world heading toward implant-free cardiac care.