Locate Bio Expands RESTORE Clinical Study to the United States Following FDA IDE Approval
8.9.2025 08:00:00 CEST | Business Wire | Press Release
Locate Bio, the UK-based regenerative medicine company reshaping rhBMP-2 perspectives, today announced that its RESTORE clinical study will expand into the United States following Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA). Already underway across multiple sites in Australia, the study is evaluating Locate Bio’s lead product LDGraft in patients requiring anterior lumber interbody spinal fusion.
LDGraft is an investigational bone graft substitute that encapsulates, rather than surface attaches, recombinant human Bone Morphogenetic Protein-2 (rhBMP-2). The design intent is to provide dose shielding of the rhBMP-2 during the early inflammatory phase of bone healing and to allow a greater proportion of the rhBMP-2 to be available during the subsequent repair phase.
“We are thrilled to bring the RESTORE study to leading clinical centers in the United States,” said John von Benecke, CEO of Locate Bio. “We are very excited by the potential that our technology has to refine the timing of rhBMP-2 presentation, in line with the body’s natural bone healing cascade.”
The RESTORE study is a prospective, multi-center clinical investigation designed to evaluate the safety and performance of LDGraft in patients undergoing single-level anterior lumbar interbody fusion. U.S. sites are expected to begin enrolment later this year.
Locate Bio is developing a pipeline of rhBMP-2 based orthobiologic products that aim to address the limitations of current technologies. With a focus on clinical relevance, the company is committed to delivering transformative solutions in spinal fusion and beyond.
About Locate Bio
Locate Bio is a regenerative medicine company headquartered in Nottingham, England, focused on orthobiologics. Through insight driven design and precision pharmaceutical engineering, Locate Bio aims to reshape rhBMP-2 perspectives and redefine what is possible in bone healing.
For more information, please visit: www.locatebio.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20250907640087/en/
Contacts
Media Contact:
FTI Consulting
Ciara Martin, Tim Stamper
+44 (0) 203 727 1000
LocateBio@fticonsulting.com
(c) 2024 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Galderma’s Relfydess™ (relabotulinumtoxinA) Receives Approval in China for Frown Lines23.10.2026 07:00:00 CEST | Press Release
Galderma (SIX: GALD) today announced that the Chinese NMPA has approved Relfydess for the temporary improvement of moderate-to-severe frown lines in adults, marking a significant expansion of the company’s Injectable Aesthetics portfolio in China – one of the world's largest and fastest-growing aesthetics markets.8,9 This approval follows successful authorizations and launches of Relfydess in more than 35 markets worldwide. Relfydess is the first and only ready-to-use liquid neuromodulator developed with PEARL Technology, designed to deliver a highly active, innovative, complex-free molecule that addresses the real needs of patients and healthcare professionals.1,2,4,5 It is optimized for simple volumetric dosing, without reconstitution, to increase ease-of-use and help ensure consistent dose/volume every time.1,10 At a time whenpatients and healthcare professionals are increasingly seeking high-performance neuromodulators that rapidly deliver long-lasting, natural-looking outcomes, Re
Mundipharma Announces Further Phase III ReSPECT Results Presented as a Late-Breaking Oral Presentation at IDWeek 202622.10.2026 19:03:00 CEST | Press Release
Today Mundipharma announced additional results from the global Phase III ReSPECT clinical trial evaluating REZZAYO®(rezafungin acetate) for prophylaxis of invasive fungal diseases (IFDs) in adult patients undergoing allogeneic haematopoietic stem cell transplantation (allo-HSCT). The Phase III findings were presented today as a late-breaking oral presentation at IDWeek 2026. The presentation provides additional detail following the top line ReSPECT results announced in April 2026, including further endpoint analyses, the components contributing to fungal-free survival (FFS), pre-specified sensitivity analyses and detailed safety outcomes. The additional analyses were consistent with the previously announced topline findings. ReSPECT was a global, multicentre, randomised, double-blind Phase III study in which 402 patients were randomised to rezafungin and 200 to the standard antimicrobial regimen. As previously announced, the study met its primary endpoint, demonstrating non-inferiority
Tigo Energy Improves Installer Choice via Fronius Compatibility with TS4 Product Line22.10.2026 18:02:00 CEST | Press Release
Tigo Energy, Inc. (NASDAQ: TYGO) (“Tigo” or “Company”), a leading provider of intelligent solar and energy software solutions, today announced a manufacturer declaration of compatibility from Fronius International GmbH, documenting compatibility between Tigo Flex MLPE products and multiple Fronius inverter families. The letter covers Tigo TS4-A-F, TS4-A-2F, TS4-A-O, and TS4-X-O products and the Fronius Primo GEN24, Primo GEN24 208-240, Symo GEN24, Verto, Tauro, and Tauro ECO inverter families, when configured according to the requirements specified by Fronius and Tigo. Building on established compatibility in Europe, the declaration extends manufacturer-confirmed compatibility to markets worldwide, including the United States and Canada, giving solar professionals greater flexibility to design high-quality systems using manufacturer-confirmed technology combinations. Fronius develops solar technologies and solutions for residential, commercial, and large-scale applications, with a port
Saudi Maritime & Logistics Congress Highlights Maritime Sector Integration and Opportunities for Trade and Investment Growth in the Kingdom22.10.2026 16:52:00 CEST | Press Release
The Saudi Maritime & Logistics Congress highlighted Saudi Arabia’s role in supporting the continuity of trade flows and strengthening supply chain resilience as it opened at Jeddah Superdome, bringing together representatives of government entities, maritime transport and logistics leaders, and the business community. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261022362613/en/ The Congress takes place as rapid changes in trade and shipping prompt companies to reassess transport routes and operational and investment choices. It provides a platform for dialogue among stakeholders to explore opportunities for cooperation and strengthen integration between ports and maritime, land transport and logistics services, supporting operational efficiency and supply chain reliability. In his opening address, His Excellency Eng. Fawaz Alsahli, President of the Transport General Authority in Saudi Arabia, emphasised that the Kingdom’s
Ministerial Roundtable Discusses Mobilising Green Investments for a Resilient and Inclusive Global Economy22.10.2026 16:49:00 CEST | Press Release
HE Saeed Mohammed Al Tayer, Chairman of the World Green Economy Organization, opened the Ministerial Roundtable titled "From Ambition to Bankable Action-Mobilising Green Investments for a Resilient and Inclusive Global Economy," during the 12th World Green Economy Summit (WGES), held on 21-22 October 2026 at the Dubai World Trade Centre under the theme "From Success to Scale: Showcasing the Green Economy." This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261022803264/en/ Ministerial Roundtable Discusses Mobilising Green Investments for a Resilient and Inclusive Global Economy (Photo: AETOSWire) The session was attended by HE Dr. Amna bint Abdullah Al Dahak, Minister of Climate Change and Environment, the United Arab Emirates; HE Aliou Gori Diouf, Minister of Environment and Ecological Transition, Senegal; HE Balarabe Abbas Lawal, Minister of Environment, Nigeria; HE Steven Victor, Minister of Agriculture, Fisheries, and the En
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom