NY-AGNOVOS-HEALTHCARE
AgNovos Healthcare, a developer of new therapies that leverage proprietary, bone-building technology and regenerative medicine to address unmet needs in the treatment of bone disease, announced today the completion of enrollment for its CONFIRM study. CONFIRM is designed to generate additional data supporting the safety and efficacy of the Company’s AGN1 Local Osteo-Enhancement Procedure (LOEP) product when used in post-menopausal women with osteoporosis. With 60 subjects, CONFIRM is the fourth and largest study of LOEP to complete enrollment. This study includes women receiving unilateral or bilateral treatment with the CE-marked AGN1 LOEP kit.
“The completion of patient enrollment in CONFIRM is an important development for the Company.” said Adam Lowe, Senior Vice President of Clinical Research and Quality at AgNovos Healthcare. He continued, “we look forward to completing the collection, analysis and publication of this data.”
Dr. Jo De Schepper is an orthopedic surgeon and principal investigator at the highest enrolling site, AZ Nikolaas in Sint Niklaas, Belgium. He commented, “the response to the study and technology has been very positive. I know my colleagues in orthopedics and metabolic bone health are interested to see this data. We know the impact that fragility fractures associated with osteoporotic bone loss have on our local communities and are encouraged by the promise of this therapeutic approach.”
CONFIRM patients are being enrolled in an extension study to evaluate LOEP’s impact during the five years following treatment.
About AGN1 LOEP Hip Kit
The AGN1 LOEP Hip Kit contains the instruments and materials to perform a minimally invasive procedure to implant AGN1, a proprietary, calcium-based, osteoconductive, and tri-phasic implant material. AGN1 is uniquely formulated with a cell-friendly surface architecture and a resorption profile that enables the rapid formation of new bone. Preclinical and clinical research has shown that AGN1 LOEP treatment delivers immediate, substantial and durable increase in the strength of osteoporotic femurs. The kit is available in select markets under the brand name OSSURE® LOEP kit.
About AgNovos Healthcare
AgNovos Healthcare is a developer of new therapies that leverage proprietary, bone-building technology and regenerative medicine to address unmet needs in the treatment of bone disease. AgNovos Healthcare is privately held and has its corporate headquarters in New York City with manufacturing, research & development, and corporate support services located in Rockville, MD. www.agnovos.com
CAUTION this press release refers to a CE-marked device. The OSSURE Local Osteo-enhancement (LOEP) Kit is not cleared in the United States.
View source version on businesswire.com: https://www.businesswire.com/news/home/20211213006012/en/
Link:
About Business Wire
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
IMEC Achieves a World-record GaN Breakdown Voltage Exceeding 650 V on Shin-Etsu Chemical’s 300-mm QST™ Substrate13.11.2025 05:00:00 CET | Press release
The QSTTM substrate*1, a 300-mm GaN growth substrate that Shin-Etsu Chemical Co., Ltd. (Head Office: Tokyo; President: Yasuhiko Saitoh; hereinafter, “Shin-Etsu Chemical”) developed, has been adopted for the 300-mm GaN power device development program at IMEC*2, where sample evaluation is in progress. In the evaluation, the 5 µm-thick HEMT*3 device using a QSTTM substrate achieved a record-breaking voltage resistance exceeding 650 V for a 300mm substrate. Shin-Etsu Chemical, licensed by QROMIS, Inc. (Head office: CA, U.S.A, CEO: Cem Basceri, hereafter "QROMIS"), manufactures 150-mm and 200-mm QST™ substrates, as well as GaN-on-QST™ epitaxial substrates of various diameters. In September 2024, we started providing 300-mm QST™ samples in a joint initiative with QROMIS. Furthermore, Shin-Etsu Chemical and QROMIS have established a close partnership to provide 300-mm QST™ substrates for the state-of-the-art 300-mm CMOS fab of IMEC, which is based in Leuven, Belgium. IMEC is a 300-mm GaN pow
DBS and Ant International Enhance Strategic Partnership to Scale Innovative Cross-Border Payment and Fintech Solutions to Drive Inclusive Growth13.11.2025 04:00:00 CET | Press release
MoU signed at the Singapore Fintech Festival 2025 covers several areas of strategic cooperation to scale digital payments, strengthen connectivity and advance fintech innovationPartnership enables DBS PayLah! users to scan Alipay+ QR codes to pay at more than 150 million merchants across over 100 markets DBS and Ant International have agreed to deepen their existing strategic collaboration to jointly explore innovative payments, digitisation and fintech solutions aimed at providing more inclusive services for regional businesses of all sizes and individual consumers. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251112714266/en/ From left to right: Tan Su Shan, CEO of DBS, Loy Hwee Chuan, Segment Head of Telecommunications, Media & Tech, Hong Kong and GBA, DBS, Edward Yue, Alipay+ General Manager for SEA, ANZ and South Asia at Ant International, Peng Yang, CEO of Ant International The collaboration will leverage DBS’ digita
LabGenius Therapeutics Announces Poster Presentation at the ESMO Immuno-Oncology Congress 202513.11.2025 01:00:00 CET | Press release
LabGenius Therapeutics (“LabGenius”), a drug discovery company combining artificial intelligence (AI) and high-throughput experimentation to advance next-generation multispecific antibodies for solid tumours, today announced a scientific poster will be presented at the ESMO Immuno-Oncology Congress 2025, being held December 10 - 12, 2025, at the Queen Elizabeth II Centre in London, United Kingdom. LabGenius’ presentation will debut the pre-clinical in vivo efficacy (>90% tumour growth inhibition) and tolerability data for their lead asset, a highly tumour selective bispecific T-cell engager (TCE). Poster Presentation Details Title Novel Selectivity-Enhanced Bispecific T-cell Engager Utilises Avidity to Overcome On-target, Off-tumour Toxicity Date and time Wednesday, December 10, 2025, 08:00 (GMT) Poster number 309P Location The Churchill Room, Queen Elizabeth II Centre, London Bispecific TCE Overview For the selected target, LabGenius has developed a selectivity-enhanced TCE. The compa
VeriSilicon and Google Jointly Launch Open-Source Coral NPU IP13.11.2025 01:00:00 CET | Press release
Targeting edge LLM applications, accelerating edge AI ecosystem development VeriSilicon (688521.SH) recently announced the joint launch of the Coral NPU IP with Google, targeting always-on, ultra-low-energy edge Large Language Model (LLM) applications. The IP is based on Google’s foundational research in open machine learning compilers and enhanced with AI security features, providing developers with a unified open-source platform to build a robust edge AI ecosystem. The Coral NPU is built on the open RISC-V instruction set architecture, featuring native tensor processing capabilities, supporting mainstream machine learning frameworks such as JAX, PyTorch, and TensorFlow Lite (TFLite), and utilizing open-standard tools like Multi-Level Intermediate Representation (MLIR) from the Low Level Virtual Machine (LLVM) project for compiler infrastructure. It is designed for always-on, ultra-low-energy edge AI applications, particularly for wearable devices and ambient sensing systems. The Cora
Indero Announces Breakthrough Method for Early-Phase Evaluation of Topical Drugs Using Quantitative Gene Expression13.11.2025 00:00:00 CET | Press release
Indero is proud to announce the successful completion of an internally funded study that introduces a novel approach to evaluating topical new chemical entities (NCE) in early-phase clinical research. This innovative method leverages quantitative gene expression analysis to assess drug efficacy rapidly and cost effectively. Dr. Robert Bissonnette, Executive Chairman and Founder of Indero, who initiated and led the study, shared his excitement about the results: “Our goal was to rethink how to study topical drugs in early phase studies. The results of this study demonstrate that microdosing for only 3 days can provide meaningful efficacy signals. Within just 24 hours, we observed alterations in gene expression after applying a microdose of mid-potency corticosteroid on the skin of patients. By 72 hours, Th2, Th22 and Th17-specific biomarkers were significantly reduced. This outcome is exactly what we hoped for and opens the door to faster, smarter drug development strategies, demonstrat
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