PLEASANTON, Calif.--(BUSINESS WIRE)--Aug 14, 2024--
Calyxo, Inc., a medical device company developing innovative solutions for patients with kidney stones, announces positive new study results for its CVAC System in kidney stone clearance. The new data show that healthcare consumption (HC) events including emergency department (ED) visits, hospitalization and retreatment were significantly lower after steerable ureteroscopic renal evacuation (SURE) with the CVAC System compared to ureteroscopy (URS). The new 1-year multi-center ASPIRE study results, along with other key CVAC System data, were presented at the 41st World Congress of Endourology and Uro-Technology (WCET) in Seoul, South Korea, August 12-16, 2024.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240814987943/en/
“The ASPIRE 1-year data shows significantly lower cumulative incidence of HC events after SURE compared to standard URS,” said Dr. Karen L. Stern, urologist at the Mayo Clinic Arizona and presenter of the study results. “This new data suggests that the new CVAC System may have the potential for a positive clinical and health economic impact in the treatment of urolithiasis,” she added.
The treatment of kidney stones in the United States continues to be a growing challenge with its prevalence increasing from 3.8% in the late 1970s to 11% in 2021. 1 In addition, studies have reported that an estimated 23% of patients needed retreatment during the first year following URS. 2
The SURE procedure is exclusively performed with the CVAC System and is the only complete stone clearance solution that enables effective and efficient kidney stone removal. It is an all-in-one system that integrates ureteroscopy, laser lithotripsy, irrigation, aspiration, and stone collection.
The multi-center ASPIRE study is a prospective, randomized study comparing the safety and efficacy of the SURE approach with the CVAC System vs standard URS with basketing in 123 patients.
At 12 months, the ASPIRE study showed that HC events are significantly lower after SURE compared to URS:
Additional data presented at WCET showed:
Initial Experience with the Second Generation CVAC Aspiration System; Outcomes of Multi- Center Market Research – Dr. Brian Eisner, Massachusetts General Hospital, Harvard Medical School)
In this initial case experience, 50 urologists from 23 academic and private institutions completed 174 SURE procedures with the new CVAC System. The median stone burden was 15 mm with no stone burden limit in the study. They found the new-generation CVAC System achieved high stone clearance per intraoperative visual assessment (81% of cases demonstrated > 95% stone clearance rate) with improved ease of use. Top performance attributes included passive aspiration of dust during laser lithotripsy, active aspiration of larger fragments, direct visualization, and all-in-one capability of the system.
Safety and Feasibility of the Steerable Ureteroscopic Renal Evacuation Device, A Single Center Experience – Dr. Luke Griffiths, Smith Institute for Urology, Northwell Health
Single center retrospective chart review of all patients (n=91) who underwent SURE January 2022 through August 2023. The study showed that SURE with the CVAC System is a safe and effective treatment option for patients undergoing URS with high stone free rate comparable to URS alone. In addition, SURE with the CVAC System was associated with low morbidity even with treating large volume stone disease.
Case presentation of the new CVAC System: Is it going to change the game?!
A video case with Dr. Isaac Palma-Zamora, UT Southwestern Medical Center will also be featured during WCET on Wednesday, August 14, 2024, starting at 14:00.
“These important results presented during WCET further advance and confirm earlier data showing that the SURE approach with the CVAC System is safe and provides better stone clearance compared to standard URS,” said Joe Catanese, PhD, Calyxo’s President & CEO. “We are continuing to work with urologists, endourologists and the healthcare community to raise awareness about our new FDA-cleared CVAC System and how it can help improve outcomes for patients with kidney stones,” he added.
For more information about the newly FDA-cleared CVAC System, please visit: Calyxo, Inc.
About the CVAC System
The new CVAC System was recently FDA-cleared and enables a minimally invasive approach for kidney stone clearance. It is an all-in-one solution that is designed to efficiently and effectively remove kidney stones. It uses irrigation and vacuum aspiration to continuously clear stone fragments during and after laser lithotripsy, enabling physicians to achieve a stone-free outcome.
About Calyxo, Inc.
Calyxo, Inc. is an innovation-driven medical device company focused on improving care for patients with kidney stones by delivering paradigm-shifting solutions that enable urologists to safely, effectively and efficiently achieve unrivaled clinical outcomes. Learn more at calyxoinc.com.
FOR MORE INFORMATION:
Study investigators and presenters are available to discuss further. For more information and to schedule interviews, please contact:
Alyssa Paldo
Alyssa.paldo@finnpartners.com
M: +1 847 791 8085
1 Kidney stones. National Kidney Foundation. (2024, July 22). https://www.kidney.org/atoz/content/kidneystones
2 Johnston SS, Chen BP, Rai P, Grange P, Dwarakanathan HR, Amos T, Johnson BH, Ghosh SK, Buchholz N. Incremental Healthcare Cost Implications of Retreatment Following Ureteroscopy or Percutaneous Nephrolithotomy for Upper Urinary Tract Stones: A Population-Based Study of Commercially-Insured US Adults. Med Devices (Auckl). 2022 Nov 10;15:371-384. doi: 10.2147/MDER.S384823. PMID: 36389203; PMCID: PMC9662022.
CVAC System (Photo: Business Wire)
FRANKFORT, Ky. (AP) — A body found in rural southeastern Kentucky is believed to be the man suspected of shooting and wounding five people on an interstate highway, authorities said Wednesday night. The search ended with two private sleuths joining in the dramatic discovery.
Kentucky State Police Commissioner Phillip Burnett Jr. said the body located earlier in the day was believed to be Joseph Couch, of Woodbine. Authorities hoped the discovery signaled the conclusion of an intense, nearly two-week search that had area residents on edge.
“People have been in fear,” Laurel County Sheriff John Root said. “That’s not the normal here in Laurel County. So now that this has been discovered, I hope that our county can get back to what’s normal.”
A dozen vehicles were hit and five people wounded in the Sept. 7 shooting on Interstate 75 near London, a city of about 8,000 people roughly 75 miles (120 kilometers) south of Lexington.
Burnett said Wednesday night that accessories found with the body led authorities to conclude it was Couch. He had no details on the cause of death, saying that would be determined in an autopsy, but he said a weapon was found at the site. He didn't know how long the body had been there.
“We are very confident this brings the closure to the search for Joseph Couch,” Burnett said.
Root said the discovery of the body wasn't the outcome authorities wanted.
“I don’t think nobody on this stage wished that we would have found him in the condition that we found,” Root said at a news conference in London. “I’d rather he’d been alive and he could have paid for what he’s done.”
The body was found following an exhaustive search of the rugged and hilly terrain in the area where the attack happened. Teams combed 28,000 acres (11,331 hectares) in the search.
But it is a private couple who will reap a $25,000 reward for their part in the discovery.
YouTube streamers Fred and Sheila McCoy from Kentucky said they searched the area for about six days and were looking for signs of vultures in the air. Fred McCoy said he saw some near the I-75 exit Wednesday, and they followed the rough terrain down a valley. They then picked up on a bad smell.
“Hey guys, you won’t believe it, we found him, oh my goodness gracious,” Sheila McCoy said while filming the search. “Now this little area (London) can rest.”
State police troopers had searched the area all day and also noticed vultures hovering above and then detected a strong odor, Burnett said Wednesday night. While moving through the woods to locate the odor, the troopers heard voices, identified themselves and asked the others to do so, he said.
It turned out to be the McCoys, who told the troopers they also were searching for Couch.
“Almost immediately after that interaction between troopers and the McCoys, the troopers and the McCoys stumbled upon an unidentified body,” Burnett said.
The highway shootings led some schools to shut down and shift to virtual learning for several days as authorities warned residents to be extra vigilant. Schools reopened Tuesday with bolstered police security in the county where the shooting happened.
Kentucky Gov. Andy Beshear called the shootings an “act of violence and evil.”
Authorities said the shooter fired 20 to 30 rounds, creating a chaotic scene. The five victims survived, but some suffered serious injuries.
After sending the text message vowing to “kill a lot of people” to a woman before the attack, Couch sent another saying, “I’ll kill myself afterwards,” investigators said in an affidavit. The document did not describe the relationship between Couch and the woman. However, the two have a child together but were never married, according to an attorney who handled the custody arrangement for their son, born in 2016.
Early in the search, authorities found Couch’s abandoned vehicle near the crime scene and a semi-automatic weapon that investigators believe was used in the shooting. An Army-style duffel bag that was found had “Couch” handwritten in marker, and a phone believed to be Couch’s was found without a battery.
Authorities said he purchased the AR-15 weapon and about 1,000 rounds of ammunition at a London gun store hours before the shooting.
Couch had a military background in the Army Reserve. The U.S. Army said he served from 2013 to 2019 as a combat engineer. He was a private when he left and had no deployments.
The search focused on a densely wooded area about 8 miles (13 kilometers) north of London that a state police official described as “walking in a jungle.” Aided by helicopters and drones, search teams on the ground contended with cliffs, sinkholes, caves, waterways and thick brush.
When the ground search was suspended at night, specially trained officers were deployed in strategic locations to prevent the gunman from slipping out of the area. On Tuesday, authorities said they were pulling searchers from the woods to bolster patrols in nearby communities in hopes of calming fears among residents.
As the mystery of Couch's whereabouts appeared to be solved Wednesday, the sheriff urged prayers for the shooting victims and for the suspect's family, who he said have cooperated with authorities.
“The family cannot be blamed for the misfortune that this guy’s caused,” Root said.
Associated Press writer Dylan Lovan in Louisville, Kentucky, contributed to this report.
Trees stand in wooded areas alongside Interstate 75 near Livingston, Ky., Sunday, Sept. 8, 2024, as police search for a suspect in a shooting Saturday along the Interstate. (AP Photo/Timothy D. Easley)
This image released by Kentucky’s London Police Department shows Joseph A. Couch, a person of interest in the Saturday, Sept. 7, 2024, shootings on Interstate 75 near London, Ky. (London Police Department via AP)
Search for suspect in Kentucky highway shooting ends with discovery of body believed to be his
This image released by the Mount Vernon Fire Department shows traffic stopped during an active shooting on Interstate 75 north of London, Ky., Saturday, Sept. 7, 2024. (Camden Mink/Mount Vernon Fire Department via AP)
Search for suspect in Kentucky highway shooting ends with discovery of body believed to be his
