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Home of the Cephus Catheter

Company Overview

SealCath, LLC is a minority and veteran owned medical device company

SealCath, established in 2013 and headquartered in Mount Pleasant, South Carolina, is a Service-Disabled Veteran-Owned Small Business (SDVOSB) specializing in innovative medical devices. Our flagship product, the Cephus Catheter, is the only FDA-cleared double balloon colorectal catheter available for clinical use. Designed to create a leak-proof rectal seal, the Cephus Catheter enhances the efficiency and efficacy of various medical procedures.

CAPABILITIES STATEMENT

Procurement Eligibility Status

Core Compentencies

• Innovative Medical Device Development: Expertise in designing and manufacturing advanced medical devices that address critical healthcare challenges.

• Colorectal Procedure Enhancement: Specialization in improving the safety and effectiveness of colorectal procedures, including barium enema, rectal contrast CT scans, and CT colonography (virtual colonoscopy).

• Pediatric Care Solutions: Development of technologies that prevent unnecessary surgeries in pediatric patients, ensuring safer and more efficient care.

• Operational Efficiency Improvement: Creation of products that reduce procedure times, minimize linen usage, and enhance overall workflow in medical settings.

• Regulatory Compliance: Commitment to meeting stringent FDA standards, ensuring all products are safe, effective, and ready for clinical application.

• Veteran-Focused Initiatives: As a certified SDVOSB, SealCath is dedicated to supporting VA hospitals and military establishments, providing high-quality medical products to improve healthcare for veterans and service members.

Past Performance

The Cephus Catheter was introduced to medical professionals in June of 2019. Sales were paused during the pandemic, but not the behind-the-scenes work. We spent 2020 and 2021 redeveloping the Cephus Catheter and between January 2024 and April 2024, securing a manufacturer that was able to align with our growth and the increase in client demand.

• Post pandemic 2022, SealCath sold 194 units to Maine Medical Center and Medical University of South Carolina, a total of $58,200 in sales.

• Post pandemic 2023, SealCath sold 375 units to Banner Thunderbird Medical Center, Omaha Children’s Hospital, Kings Daughter Medical Center, Maine Medical Center, Medical University of South Carolina, and Phoenix Children’s Hospital, a total of $197,175 in sales.

• Post pandemic 2024, SealCath sold 473 units to Banner Thunderbird Medical Center, Children’s Hospital of Colorado, Kings Daughter Medical Center, Pheonix Children’s Hospital, Maine Medical Center, and Medical University of South Carolina, a total of $184,025 BUT in only 8 months. Projected minimum sales for all of 2024 would have been $245,367.

Year over year sales on average grew on average by 131.61%.

Company Codes

• EIN: 46-3956076

• UEID: UC9HNBDDBL68

• DUNS Number: 079172500

• CAGE Code: 70AJ9

• DAPA Number: SP0200-00-H-0046

State and Federal Codes

• NAICS Codes:

1. 339112 – Surgical and Medical Instrument Manufacturing

2. 339113 – Surgical Appliance and Supplies Manufacturing

3. 334510 – Diagnostic equipment, electromedical, manufacturing Surgical and Medical Instrument Manufacturing

• NIGP Codes:

1. 475, 204, 207, 610

Differentiators

• Over 60 years of technology and medical device application development experience.

• Developed the only FDA-cleared double balloon colorectal catheter available for clinical use.

• State of the Art and first ever double balloon colorectal catheter

• Made-in-America at the US by Velentium, LLC.

• Available in silicone material, which is much more durable and flexible for its use case.

Contact Information

Contact Person: Dr. Cephus E. Simmons, Sr.
Mailing Address:
3022 S. Morgan Point Rd. #263
Mount Pleasant, SC 29466
P: 843-732-9701
F: 843-732-9717
E: si*****@se******.com
W: www.sealcath.com