CereVasc
Overview
CereVasc, Inc. is a clinical-stage medical device company that specializes in developing minimally invasive treatments for neurological diseases. Founded in 2014 by Carl Heilman, Adel Malek, Daniel Levangie, and Patrick Sullivan, the company is headquartered in Boston, Massachusetts. CereVasc has raised a total of $114 million in funds, with a recent Series B round in May 2024 raising $70 million to advance the development of its flagship product, the eShunt System, designed for treating communicating hydrocephalus.
Recent Developments
- FDA Breakthrough Device Designation (August 2024): CereVasc received FDA breakthrough device designation for its eShunt System, aimed at treating normal pressure hydrocephalus. This designation will facilitate priority review during the clinical trial and premarket review process.
- 50th Patient Enrolled (August 2024): The company announced the enrollment of the 50th patient in its pilot studies for the eShunt System, marking significant progress towards upcoming clinical trials.
- Partnership with LianMedical (June 2023): CereVasc partnered with LianMedical to extend its technological reach to the Asian market, particularly focusing on China, Hong Kong, Taiwan, and Macau.
- FDA IDE Approval for STRIDE Study (May 2024): The FDA approved an investigational device exemption (IDE) for the STRIDE pivotal study of the eShunt System, aimed at treating normal pressure hydrocephalus. The study will compare eShunt's performance against the traditional ventriculo-peritoneal shunt.
- $70 Million Series B Financing (May 2024): CereVasc secured $70 million in Series B funding co-led by Bain Capital Life Sciences and Perceptive Xontogeny Venture Fund to support the STRIDE pivotal study and facilitate regulatory development.
- 30th Patient Treated with eShunt (October 2023): CereVasc announced that the 30th patient was treated with its eShunt System, demonstrating ongoing success in its pilot studies conducted in the U.S. and Argentina.
Company Information
| Attribute | Information |
|---|---|
| Founding Date | 2014 |
| Headquarters | Boston, Massachusetts |
| Founders | Carl Heilman, Adel Malek, Daniel Levangie, Patrick Sullivan |
| Revenue | Estimated $1M - $5M |
| Key Investors | Bain Capital Life Sciences, Perceptive Xontogeny Venture Fund |
| Industry | Medical Devices |
| Employees | Approximately 12 |
| Major Products/Services | eShunt System for treating communicating hydrocephalus |
Early History
CereVasc was founded in 2014 as a collaboration between entrepreneurs and medical professionals from Tufts Medical Center, driven by the need for innovative approaches in neurosurgical care. The company's first aim was to address the complications associated with the traditional ventriculo-peritoneal shunt systems used for treating communicating hydrocephalus, which is a common neurological disorder. In its early years, CereVasc concentrated on research and development, leading to the creation of the eShunt System. By 2019, the company had received significant regulatory approvals to initiate human clinical studies for its device in Argentina and later the United States.
Company Profile and Achievements
CereVasc operates under a comprehensive business model focusing on the development and clinical validation of its medical devices, specifically targeting neurological disorders like hydrocephalus. The eShunt System, the centerpiece of its efforts, is designed to simplify the treatment process by providing a less invasive alternative. The system's implementation involves a short outpatient procedure, reducing the risk and recovery time traditionally associated with neurosurgery.
Significant Achievements:
- FDA Approvals: Secured investigational device exemption (IDE) approval for multiple studies, allowing clinical trials in the U.S.
- International Clinical Trials: Conducted pivotal trials in Argentina, expanding its global research footprint.
- Innovative Partnerships: Collaborated with Asian companies such as LianMedical to explore new market opportunities.
- Safety Milestones: Treated over 50 patients in clinical studies with promising efficacy and safety results.
Current Operations and Market Position
Currently, CereVasc is focused on advancing their pivotal clinical trials for the eShunt System, expecting to transform standard care practices for hydrocephalus treatment. The company's strategic alliances, particularly in Asia through LianMedical, demonstrate its commitment to global market expansion. With its innovative approach and robust backing from investors, CereVasc is positioning itself as a pioneer in the medical device industry, using technology to reduce the complexities and costs associated with neurological treatments.
Is CereVasc Legit
CereVasc is a legitimate company, recognized for its medical device innovations aimed at improving neurological treatments. With multiple rounds of funding from credible investors and FDA approvals for its investigational studies, CereVasc demonstrates strong regulatory and financial grounding. The company's initiatives are further validated through partnerships and ongoing clinical trials, establishing it as a reputable entity in the medical community.
CereVasc eShunt
The eShunt System is CereVasc's flagship device, designed to treat communicating hydrocephalus by providing minimally invasive cerebral spinal fluid management. It aims to overcome challenges associated with traditional shunt systems, like infections and mechanical failures. The device's implantation process is much simpler, needing only local anesthesia and a short procedure time, significantly reducing patient recovery periods and improving overall outcomes.
Conclusion
CereVasc stands out in the field of medical device innovation through its focus on neurological diseases and the development of minimally invasive treatment methods. The company's eShunt System reflects significant technological advancement in the treatment of hydrocephalus, offering a streamlined, patient-friendly alternative to existing surgical procedures. As CereVasc continues to secure partnerships and expand its market presence, it is well-positioned to influence the future landscape of neurological treatments, providing hope and improvement in healthcare delivery for affected patients worldwide.