Averto Medical Secures FDA Breakthrough Designation for ColoSeal
Averto Medical Achieves FDA Breakthrough Device Designation
Averto Medical, a pioneering name in the realm of gastrointestinal medical devices, has marked an important milestone by securing Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its innovative ColoSeal™ Intraluminal Colonic Diversion (ICD) System. This groundbreaking recognition sheds light on the significant improvement potential this device offers to patients who are undergoing colorectal surgery.
Understanding the Breakthrough Device Program
The FDA's Breakthrough Device Program is designed with the intent to hasten the development and review processes for medical devices that exhibit substantial advantages over current treatment alternatives. The program aims to facilitate innovative solutions that address life-threatening or severely debilitating conditions. With this designation, Averto Medical is set to enjoy prioritized interactions with the FDA, which will likely lead to a more efficient review process, ultimately expediting access to the ColoSeal™ system for both patients and healthcare professionals.
Significance of the FDA Designation
Grace Carlson, the Vice-President of Clinical and Regulatory Affairs at Averto Medical, expressed her enthusiasm regarding the FDA's recognition. She emphasized that this designation highlights the transformative nature of ColoSeal™ in the field of colorectal surgery, as it potentially allows patients to avoid a temporary ostomy, which can greatly enhance recovery time and overall quality of life. Moreover, she reiterated the company's commitment to pushing the boundaries of technology in gastrointestinal care.
Funding and Development Progress
To further bolster its clinical performance, Averto Medical recently closed an oversubscribed Series A financing round totaling $30.5 million. This funding was led by Cormorant Asset Management, with notable participation from Venrock Healthcare Capital Partners, LifeSci Venture Partners, CVF, and various other investors. The capital is strategically allocated towards advancing the clinical testing of the ColoSeal™ system, steering it towards regulatory approvals.
Support from the National Cancer Institute
In addition to the capital raised, Averto Medical received a $1.8 million grant from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). The support aims to enhance clinical evaluation processes for the ColoSeal™ system, potentially expediting its availability to patients in need.
Innovative Approach to Colorectal Surgery
The ColoSeal™ ICD is envisioned as a minimally invasive alternative to traditional temporary ostomies. By addressing key complications associated with conventional surgical methods, this innovative device aims to improve recovery experiences and overall patient care quality. Averto Medical is dedicated to not just creating a product, but focusing on evolving colorectal surgical care standards to meet the needs of both patients and healthcare providers efficiently.
Addressing Critical Needs in Gastrointestinal Care
The mission of Averto Medical resonates strongly within the healthcare community, particularly regarding the advancements of solutions tailored to address pressing clinical issues. As the demand for effective ostomy replacement solutions grows, the company positions itself uniquely to cater to this unmet need, aiming to set new benchmarks in patient outcomes, healthcare costs, and overall quality of life.
Frequently Asked Questions
What is the significance of the FDA's Breakthrough Device Designation?
This designation helps accelerate the development and review of medical devices that provide substantial advantages over current options, facilitating timely access for patients.
How does the ColoSeal™ system work?
The ColoSeal™ Intraluminal Colonic Diversion system is designed to serve as a minimally invasive alternative to temporary ostomies, minimizing recovery time and complications.
What recent funding has Averto Medical secured?
Averto Medical successfully closed a $30.5 million Series A financing round to further advance the clinical testing of the ColoSeal™ system.
Which institutions have supported Averto Medical?
Averto Medical received a grant of $1.8 million from the National Cancer Institute as part of its efforts to support clinical evaluation of the ColoSeal™ system.
What are Averto Medical's future plans?
The company aims to continue developing and advancing its innovative solutions in gastrointestinal care, with a focus on enhancing patient outcomes and reducing healthcare costs.
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