Conformal Medical Secures $32 Million Series D Extension for Innovative LAAO Technology Advancements
In a significant step for cardiac health innovation, Conformal Medical, Inc. has successfully closed a $32 million extension to its Series D funding round. This round has strengthened their collaborations with existing investors while bringing a new partner on board, highlighting the growing confidence in the future potential of the company. The funds raised will be pivotal for the company as they work to advance their next-generation left atrial appendage occlusion (LAAO) technology, specifically the CLAAS® AcuFORM™ system.
The CLAAS AcuFORM™ device represents a breakthrough in the treatment of patients suffering from non-valvular atrial fibrillation (AFib), a condition that significantly increases the risk of stroke. The technology is designed to effectively seal the left atrial appendage, thereby reducing this risk without the need for long-term anticoagulant therapy. By focusing on safety and efficiency, the AcuFORM system promises to transform the way LAAO procedures are performed, shifting clinical practice towards a less invasive, more streamlined model.
The financing will primarily support the CONFORM Pivotal Trial, which evaluates the CLAAS system's safety and efficacy against currently available LAAO devices. This pivotal trial is a multi-center, randomized controlled study that aims to enroll around 1,600 patients globally. With over 30% of the enrollment already completed, the trial is set to yield critical data that will assist in securing pre-market approval from the U.S. Food and Drug Administration (FDA).
James Reinstein, President and CEO of Conformal Medical, expressed his satisfaction with the progress made thus far, noting that the company has treated over 100 patients with the AcuFORM™ system since its inception. He emphasized the impressive deliverability and safety performance that the device has displayed, making it a promising option for reducing stroke risk in AFib patients.
One of the standout features of the CLAAS AcuFORM system is its innovative foam-based technology, which is designed to adapt to a diverse range of left atrial appendage anatomies using just two sizes. This characteristic not only facilitates a simplified sizing process but could also expedite the transition to ICE-guided closure procedures. With the potential to eliminate the need for general anesthesia and intubation during these procedures, the device significantly enhances patient comfort and safety.
Conformal Medical is committed to completing the ongoing CONFORM and GLACE clinical trials. The results are expected to further solidify the safety profile of the AcuFORM technology and confirm its ability to meet significant clinical needs within the healthcare market. This direction indicates a clear focus on advancing solutions that address existing gaps in treatment for AFib patients, ultimately shaping the landscape of stroke prevention therapies.
As the healthcare industry increasingly recognizes the importance of innovative approaches to treatment, Conformal Medical is at the forefront, leveraging cutting-edge technology to improve patient outcomes. With substantial backing from investors, the company is well-positioned to lead advancements in left atrial appendage occlusion procedures and, ultimately, contribute to saving lives in the process.
This funding round was advised by Piper Sandler, which acted as the exclusive financial advisor, while legal counsel was provided by Gunderson Dettmer. The confidence expressed by these partners underscores the strategic importance of Conformal Medical's mission and the anticipated impact of its advancements in cardiac healthcare.
For more detailed information about the CONFORM Pivotal Trial or to learn more about Conformal Medical, interested parties can visit their website at https://conformalmedical.com/.
The CLAAS AcuFORM™ device represents a breakthrough in the treatment of patients suffering from non-valvular atrial fibrillation (AFib), a condition that significantly increases the risk of stroke. The technology is designed to effectively seal the left atrial appendage, thereby reducing this risk without the need for long-term anticoagulant therapy. By focusing on safety and efficiency, the AcuFORM system promises to transform the way LAAO procedures are performed, shifting clinical practice towards a less invasive, more streamlined model.
The financing will primarily support the CONFORM Pivotal Trial, which evaluates the CLAAS system's safety and efficacy against currently available LAAO devices. This pivotal trial is a multi-center, randomized controlled study that aims to enroll around 1,600 patients globally. With over 30% of the enrollment already completed, the trial is set to yield critical data that will assist in securing pre-market approval from the U.S. Food and Drug Administration (FDA).
James Reinstein, President and CEO of Conformal Medical, expressed his satisfaction with the progress made thus far, noting that the company has treated over 100 patients with the AcuFORM™ system since its inception. He emphasized the impressive deliverability and safety performance that the device has displayed, making it a promising option for reducing stroke risk in AFib patients.
One of the standout features of the CLAAS AcuFORM system is its innovative foam-based technology, which is designed to adapt to a diverse range of left atrial appendage anatomies using just two sizes. This characteristic not only facilitates a simplified sizing process but could also expedite the transition to ICE-guided closure procedures. With the potential to eliminate the need for general anesthesia and intubation during these procedures, the device significantly enhances patient comfort and safety.
Conformal Medical is committed to completing the ongoing CONFORM and GLACE clinical trials. The results are expected to further solidify the safety profile of the AcuFORM technology and confirm its ability to meet significant clinical needs within the healthcare market. This direction indicates a clear focus on advancing solutions that address existing gaps in treatment for AFib patients, ultimately shaping the landscape of stroke prevention therapies.
As the healthcare industry increasingly recognizes the importance of innovative approaches to treatment, Conformal Medical is at the forefront, leveraging cutting-edge technology to improve patient outcomes. With substantial backing from investors, the company is well-positioned to lead advancements in left atrial appendage occlusion procedures and, ultimately, contribute to saving lives in the process.
This funding round was advised by Piper Sandler, which acted as the exclusive financial advisor, while legal counsel was provided by Gunderson Dettmer. The confidence expressed by these partners underscores the strategic importance of Conformal Medical's mission and the anticipated impact of its advancements in cardiac healthcare.
For more detailed information about the CONFORM Pivotal Trial or to learn more about Conformal Medical, interested parties can visit their website at https://conformalmedical.com/.
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