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FDA clears TYBR Health's gel system for preserving mobility post-surgery
FDA clears TYBR Health's gel system for preserving mobility post-surgery

Yahoo

time10-06-2025

  • Health
  • Yahoo

FDA clears TYBR Health's gel system for preserving mobility post-surgery

The US Food and Drug Administration (FDA) has granted 510(k) clearance to TYBR Health's bioresorbable B3 GEL system, a barrier intended for protecting healing tissues and preserving mobility post-surgery, which involves ligaments, tendons, and skeletal muscle. This gel temporarily separates tissues during the early healing phase, without hindering the natural healing process, while maintaining surgical precision. Composed of a naturally derived extracellular matrix, B3 GEL is applied using the company's integrated mixer-applicator system. Its flowable nature allows it to conform to complex anatomical structures and is suitable for both open and minimally invasive surgeries. The blue gel ensures visibility during placement and is fully resorbable, leaving no residual material. According to the company, the gel stays in place during the first week post-surgery, safeguarding tissues through the acute inflammation and fibroblast proliferation phases. It metabolises naturally over two to three weeks, ensuring protection when necessary and full clearance once healing is done. TYBR noted that the B3 GEL System's protective capabilities extend across various tendon and ligament complexes in the body, offering consistent performance from hand to foot and ankle surgeries. It forms a protective barrier, preventing restrictive scar tissue while aiding in healing. The company anticipates commercial sales to begin by the end of this year. TYBR Health CEO and co-founder Tim Keane said: "When we started TYBR, it was with a clear purpose: to solve a real, overlooked problem in surgical recovery. "Too often, healing goes unprotected once the procedure ends. B3 GEL is designed to fill that gap—working with the body's biology to protect tissue planes and give surgeons a way to safeguard patient outcomes during the critical early phase of recovery." "FDA clears TYBR Health's gel system for preserving mobility post-surgery" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

TYBR Health Announces FDA 510(k) Clearance for B3 GEL™ System, a Flowable Bio-Gel to Protect Healing Tissue and Preserve Function
TYBR Health Announces FDA 510(k) Clearance for B3 GEL™ System, a Flowable Bio-Gel to Protect Healing Tissue and Preserve Function

Yahoo

time09-06-2025

  • Health
  • Yahoo

TYBR Health Announces FDA 510(k) Clearance for B3 GEL™ System, a Flowable Bio-Gel to Protect Healing Tissue and Preserve Function

HOUSTON, June 9, 2025 /PRNewswire/ -- TYBR Health, a medical device and regenerative medicine company, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the B3 GEL™ System. B3 GEL™ is a bioresorbable, flowable gel barrier designed to protect healing tissue planes and preserve mobility following surgeries involving tendons, ligaments, and skeletal muscle. This clearance marks a significant milestone for TYBR Health, enabling a new approach to support functional recovery in musculoskeletal surgery. B3 GEL™ helps maintain surgical precision by temporarily separating tissues during the early healing phase—without impeding the natural healing process. "When we started TYBR, it was with a clear purpose: to solve a real, overlooked problem in surgical recovery," said Tim Keane, PhD, Cofounder and CEO of TYBR Health. "Too often, healing goes unprotected once the procedure ends. B3 GEL™ is designed to fill that gap—working with the body's biology to protect tissue planes and give surgeons a way to safeguard patient outcomes during the critical early phase of recovery." B3 GEL™ is composed of a naturally derived extracellular matrix and is applied via TYBR's proprietary integrated mixer-applicator system. Its flowable format conforms to complex anatomy and can be used in both open and minimally invasive procedures. The blue-colored gel allows for visual confirmation of placement and resorbs completely over time without leaving residual bulk. Preclinical studies submitted to support clearance demonstrated that B3 GEL™ reduced tissue binding and supported improved range of motion in treated models, with enhanced flexion and extension compared to controls (data on file). TYBR Health plans to begin commercial sales of the B3 GEL™ System by the end of 2025. About TYBR HealthFounded in 2020, TYBR Health is a medical device and regenerative medicine company focused on improving surgical recovery. Headquartered in Houston, Texas, TYBR develops solutions that help surgeons protect healing tissues and preserve function after surgery. Its lead product, the B3 GEL™ System, is a bioresorbable gel barrier cleared by the FDA to aid in the protection of soft tissues during post-surgical healing. TYBR is targeting a significant unmet need in musculoskeletal surgery, where recovery complications impact function and healthcare costs. With FDA clearance secured, manufacturing in place, and a proprietary delivery system developed for precise, intraoperative use, TYBR is preparing for commercial launch in late 2025. For more information contact: info@ View original content to download multimedia: SOURCE TYBR Health

Trump administration restores 20 revoked visas to international students in St. Louis
Trump administration restores 20 revoked visas to international students in St. Louis

Yahoo

time29-04-2025

  • Politics
  • Yahoo

Trump administration restores 20 revoked visas to international students in St. Louis

ST. LOUIS — Immigration and Customs Enforcement began restoring over 1,500 visas to international students over the weekend, including 20 registrations in the St. Louis area. The Trump administration began restoring the terminated registrations after multiple recent lawsuits against the administration, including two filed recently from students across the state of Missouri. The lawsuits are one of many across the country, as over 900 students at more than 128 colleges and universities have had their visas revoked or legal status recently terminated with little to no notice, according to the Associated Press. Federal charges filed in well-known Wildwood cat-hoarding case Webster University told FOX 2 that 20 of their undergraduate students whose visas had been revoked were restored, including an additional six students at their San Antonio, Texas campus. 'We remain deeply committed to supporting our students and are continuing to monitor this evolving situation closely, working individually with students as needed,' said Tim Keane, Webster University's chancellor, in a statement to the school. Southern Illinois University Edwardsville also became aware that beginning April 4, the student visas had been revoked of three undergraduates and six former graduates enrolled in their optional practical training program. SIUE has not released an update on whether these students' visas have been restored. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

Savannah Area Chamber travels to Charleston to talk regional growth
Savannah Area Chamber travels to Charleston to talk regional growth

Yahoo

time06-03-2025

  • Business
  • Yahoo

Savannah Area Chamber travels to Charleston to talk regional growth

SAVANNAH, Ga. (WSAV) — The Savannah Area Chamber of Commerce traveled to Charleston Thursday to discuss the growing pains of tourism in the two cities. Leaders explored how communities can collaborate to address the challenges of growth when a major economic development comes to the area. The two cities are twins in many ways with their ports, airports, downtown trolleys, and tourism. Joint Development and Regional Growth Savannah area leaders, similar to Charleston, say they're taking a regional approach to growth. According to Tim Keane, Chief of Planning, Permitting, and Engineering with Charleston, planning regionally 'Many people think of us as the same place, and we're not obviously, but there are things that we do share,' Keane said. 'The ports, airports, tourism and transportation are all similarities.' Savannah Economic Development Authority (SEDA) CEO Jesse Dillon and Regional Industry Support Enterprise (RISE) President and CEO Anna Chafin both talked about the need for more industry in our area which led to the recruitment of the Hyundai Metaplant in Bryan County. Transportation Needs Congestion on the roadways is a part of growth, panelists said. Transportation was also a major discussion point, leaders taking a closer look at travel improvements, including rapid bus service designed to connect the workforce with manufacturing, and its funding sources when a sale tax referendum does not pass. Savannah Area Chamber members and guests traveled to North Charleston on the Amtrak train. Mayor Van Johnson noted improvements that could be made to the Savannah station, comparing it to the much more updated space in Charleston. Charleston created a city transportation plan in 2018, with funding from a half cent transportation sales tax. Charleston Councilman Michael Seekings applauded a joint transit project called Lowcountry Rapid Transit, 21.3 miles of infrastructure and improvements. Seekings says they anticipate 7,600 daily riders on the line, which is a 70-minute end-to-end travel time. 'Before, it was all about roads,' Reveer Group President and CEO Rhett Reidenbach said. 'Today, roads are very unpopular. With the growth, people are more worried about green space being impacted.' Savannah is working on its own transportation plan, called 'Savannah Moves', according to Chief of Planning and Economic Development Faye DiMassimo. In 2023, Chatham Area Transit (CAT) Board of Directors approved the Master Transit Plan, an investment strategy from 2024-2050. 'We've got the tools in our tool kit to do great things,' DiMassimo said. Tourism and Quality of Life Speakers also explored the intersection of tourism, booming sports interest and quality of life, discussing how to balance economic growth with community well-being and sustainability. North Charleston Mayor Reggie Burgess touched on this when welcoming the chamber members to the Amtrak station, saying leaders need to put the citizens first and work with them. Childcare, workforce, affordable housing and infrastructure funding are four main points of investment for Charleston Regional Development Alliance (CRDA), according to Board Member Jason Brown. Housing challenges Another panel takes a deep dive into developing housing in the booming economic region and the challenges such as land and construction costs, infrastructure demands and affordable options to accommodate a growing workforce. Charleston Home Builders Association Adrian Cain says homes aren't being built fast enough, leading to rent and home prices doubling and tripling. The median home price is over $500,000, according to Zillow. Cain added that the average first time home buyer isn't able to live where they work. 'I think housing is the largest existential threat to our area,' Cain said. 'What we do not do a good job of is connecting rooftops, jobs, and roads… We can and must do better.' In Savannah, the case is a little better. The median home price is over $319,000, according to Zillow. Housing Savannah Laura Lane McKinnon shared that many people find it difficult to understand housing initiatives and techniques. They've had several collaborative meeting with developers to receive feedback from community members. Cain also mentioned that there's room for housing if governments take a closer look at zoning and empty buildings that could be developed into homes. A spokesperson with the Savannah Area Chamber tells News 3, they look to continue city to city collaboration to learn from other officials in areas with booming growth. This is a developing story. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

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