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BrightWater™ Medical’s ConvertX® Biliary Stent System Receives FDA Clearance

March 25, 2019

TEMECULA, Calif.--(BUSINESS WIRE)--Mar 25, 2019--BrightWater Medical, Inc. announced today that the U.S. Food and Drug Administration (FDA) has cleared the company’s innovative ConvertX ® Biliary Stent System for treatment of biliary obstructions. The biliary ducts carry bile from the liver and gallbladder to the small intestine. Patients with severe duct blockages or difficult anatomies – such as gastric bypass or liver transplant patients -- face serious complications including infection, sepsis, biliary cirrhosis or injury to the liver.

Today, most of these patients will either need to undergo two separate one-hour interventional procedures for stent placement or if considered poor candidates for the staged stent procedure, undergo a drain placement instead. If the biliary blockage is managed with a drain, the drain must be exchanged for a new one every 2-3 months, for life.

The ConvertX System is the first system to provide interventional radiologists with a percutaneous plastic biliary stent option. The system is designed to eliminate the need for the second invasive procedure and the associated risk, cost, and time. Rather than a drain-to-stent exchange, the ConvertX System itself enables stent release in less than one minute during an in-office visit or at bedside without the need for sedation or repeated drain insertions.

“Before this, we have had to treat these serious cases without having the right tools,” explained Saher S. Sabri, MD, Director of Interventional Radiology at MedStar Washington Hospital Center and Professor of Radiology at MedStar Georgetown University Hospital. “The ConvertX is a significant paradigm change that enables the IR to be involved in percutaneous temporary plastic stent placement for benign and malignant biliary disease. It allows us to treat with one less invasive procedure for the patient, reducing radiation exposure for the patient and staff.”

Biliary obstructions may be caused by tumors, gallstones, enlarged lymph nodes, cysts or strictures. IRs treat biliary obstructions that are more severe or anatomically challenging, such as in patients with gastric bypass or liver transplants, through two separate one-hour interventional procedures for stent placement.

“The Biliary Stent System was designed by IRs for IRs,” explained ConvertX System developer Bob Smouse, M.D., founder and CEO of BrightWater Medical and Professor of Radiology & Surgery at the University of Illinois College of Medicine. “It is simple to use and deliver with standard interventional techniques and does not require additional physician training. Before the ConvertX, the absence of a percutaneous plastic stent was a huge product gap in the device armamentarium of the IR. According the ACR Practice Guidelines1, a temporary plastic stent is the device-of-choice in 8 out of 9 bile duct blockages and now the IR has that stent option.”

The ConvertX Biliary Stent System is part of BrightWater Medical’s ConvertX Stent Family, which includes the company’s innovative ConvertX Nephroureteral Stent System cleared by the FDA for treatment of ureteral obstructions. That system enables the IR to eliminate a second invasive interventional procedure in treating patients with severe ureteral blockages.

The ConvertX Stent Family was featured at the Advanced Interventional Management (AIM) Symposium in New York City in November 2018 as the lead presentation during the “ New and Innovative Technologies ” section. BrightWater received its medical device manufacturing license from the California Department of Public Health and manufactures the ConvertX Stent Family at its facility in Temecula, CA.

About BrightWaterMedical

BrightWater Medical is a mid-stage medical device company uniquely positioned to significantly impact treatments provided by interventional radiologists. The company was founded by Dr. Bob Smouse, Professor of Radiology & Surgery, University of Illinois College of Medicine. Dr. Smouse is a leading interventional radiologist, clinician, academic and entrepreneur, with more than 20 years of experience in interventional radiology, endovascular surgery and clinical research. The company is developing additional ConvertX-based products for other staged procedure treatments in interventional radiology. For more information, please visit www.brightwatermed.com.

1 American College of Radiology, ACR Appropriateness Criteria ®: Radiologic Management of Biliary Obstruction, https://acsearch.acr.org/docs/69344/Narrative/

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CONTACT: Ed Stevens

727-412-1541

EdStevensPR@Brighthouse.com

KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA

INDUSTRY KEYWORD: SURGERY TECHNOLOGY HARDWARE HEALTH BIOTECHNOLOGY HOSPITALS MEDICAL DEVICES ONCOLOGY RADIOLOGY FDA MANAGED CARE

SOURCE: BrightWater Medical, Inc.

Copyright Business Wire 2019.

PUB: 03/25/2019 08:00 AM/DISC: 03/25/2019 08:01 AM

http://www.businesswire.com/news/home/20190325005137/en