CA-AXONICS
27.9.2018 12:02:03 CEST | Business Wire | Press release
Axonics Modulation Technologies, Inc., developer of the first rechargeable Sacral Neuromodulation (r-SNM™) system for the treatment of urinary and bowel dysfunction, announced today that the Axonics r-SNM System was awarded the “Best Technological Innovation, Therapeutic Device” at the 2018 Medtech Insight Awards in partnership with the MedTech Conference being held this week in Philadelphia.
The Medtech Insight Awards highlight dedication and innovation within medical device and diagnostics, and the Axonics r-SNM System was recognized by the esteemed judging panel as “a major technological improvement in a validated market.”
“Axonics is honored by this recognition for the technological innovation of the Axonics r-SNM System,” said Raymond W. Cohen, Chief Executive Officer of Axonics. “This award is a testament to the diligence and ingenuity employed by our team over the last 4 years to develop and clinically validate a miniaturized, long-lived rechargeable SNM system.”
Axonics is currently conducting a pivotal study, ARTISAN-SNM, under an Investigational Device Exemption for urinary dysfunction designed to gain Food & Drug Administration (FDA) marketing approval in the United States upon completion of the study and review by the FDA. In June 2018, Axonics announced completion of enrollment for the pivotal study and expects all subjects to reach the 6-month primary endpoint at the end of 2018.
About Axonics Modulation Technologies, Inc.
Axonics, based in Irvine, CA, is a privately-held venture backed company that has developed a novel implantable neuromodulation technology for patients with urinary and bowel dysfunction. The Axonics r-SNM system is approved in the EU, Canada and Australia for the treatment of overactive bladder (urinary incontinence, urinary frequency), non-obstructive urinary retention and fecal incontinence. The Axonics system includes a miniaturized rechargeable implantable stimulator qualified to function at least 15 years, a charging system optimized for reduced charge time with no heating, a patient-friendly remote control and an intuitive clinician programmer that facilitates the lead placement procedure and programming. For more information, visit the Company’s website at www.axonicsmodulation.com .
View source version on businesswire.com: https://www.businesswire.com/news/home/20180927005180/en/
Contact:
Company Contact Axonics Modulation Technologies, Inc. Dan Dearen, +1-949-396-6320 President & Chief Financial Officer ddearen@axonicsmodulation.com or Investor & Media Contact W2Opure Jill Bertotti, +1-714-225-6726 jbertotti@W2Ogroup.com
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
Doubtless Pet Care Launches to Provide Peace of Mind to Pet Parents and Help Their Pets Live Happier, Healthier Lives29.6.2026 10:15:00 CEST | Press release
Doubtless combines industry-leading pet insurance with innovative care solutions, protecting more than 6 million pets across 10 global markets Doubtless launches today with the goal of helping more pet parents across the world access quality care for the pets they love. The company brings together a leading global portfolio of pet insurance brands with a growing range of connected solutions designed to support pet parents at every stage of their pet’s life. With over 4,000 employees, Doubtless insures 6 million pets across 10 markets in North America, Europe and the United Kingdom. “Uncertainty about the financial commitments associated with having a pet should never keep families from experiencing the joy of a life with pets,” said Dirk Beeckman, CEO of Doubtless. “By harnessing the power of our international footprint, we are building on our leadership in pet insurance to create a global suite of solutions for pet parents, veterinarians and industry partners that makes pet care easie
Samsung Bioepis Announces Positive Preliminary Phase 1 and Phase 3 Data for SB27, a Proposed Biosimilar to Keytruda (Pembrolizumab)29.6.2026 09:19:00 CEST | Press release
Phase 1 study demonstrated pharmacokinetic (PK) equivalence between SB27 and Keytruda; Phase 3 study demonstrated equivalent objective response rate (ORR) at Week 24Phase 1 and Phase 3 studies expected to be completed within 2026 Samsung Bioepis Co., Ltd. announced today that the Phase 1 and Phase 3 studies on SB27, a proposed biosimilar to Keytruda1 (pembrolizumab), have met their primary endpoints. “We are excited to announce preliminary results from the Phase 1 and Phase 3 studies for SB27, our pembrolizumab biosimilar candidate. These topline positive results reinforce our scientific expertise and leadership in biosimilar development,” said Donghoon Shin, Executive Vice President and Head of Clinical Sciences Division at Samsung Bioepis. “We are on track to complete both Phase 1 and Phase 3 studies within this year. Leveraging our robust quality management system, we remain committed to advancing our biosimilar portfolio to broaden access to life-saving biologic medicines for patie
IQM Named a Major Player in the IDC MarketScape: Worldwide Quantum Computing 2026 Vendor Assessment29.6.2026 09:00:00 CEST | Press release
IQM today announced it has been named a Major Player in the IDC MarketScape: Worldwide Quantum Computing 2026 Vendor Assessment. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260629748732/en/ IQM named a major player in the IDC MarketScape IQM believes this recognition comes as institutions worldwide move quantum computing out of shared cloud access and into infrastructure they own and operate themselves. IQM calls this Production Quantum: full-stack, open-architecture superconducting systems deployed on premises, inside customers' own data centers and HPC environments, where organizations own the hardware, build internal expertise, and run quantum processors alongside their existing classical infrastructure. According to the IDC MarketScape, "For institutions building long-term quantum programs, this means the workflows and intellectual property developed on IQM hardware remain portable." The report further advises: "Consi
Zambon Announces Positive CHMP Opinion for Hopledo® (IPX203) for Adults with Parkinson’s Disease and Moderate to Severe Motor Fluctuations29.6.2026 09:00:00 CEST | Press release
Positive CHMP opinion is based on data from the Phase 3 RISE-PD trial, which demonstrated significantly more “Good ON” time with fewer daily doses compared with immediate-release levodopa/carbidopa More than one million people are living with Parkinson’s disease in the European Union, and over 80% experience motor fluctuations during the course of their disease, highlighting the need for additional treatment options Hopledo® contains a unique formulation combining immediate-release granules and extended-release pellets, providing both a rapid onset of action and a longer duration of effect, sustaining the levodopa therapeutic effect for a longer period of time If approved, Zambon expects to make Hopledo® progressively available to patients with Parkinson’s disease across Europe starting October 2026 Zambon today announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of a marketing authorization by the European M
Enhertu® Approved in the EU as First Tumor Agnostic HER2 Directed Therapy and Antibody Drug Conjugate for Patients with Previously Treated HER2 Positive Metastatic Solid Tumors29.6.2026 08:30:00 CEST | Press release
Approval based on three phase 2 trials of Daiichi Sankyo and AstraZeneca’s Enhertu that demonstrated clinically meaningful responses across a broad range of tumors Enhertu now approved for six indications in the EU Enhertu® (trastuzumab deruxtecan) has been approved in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+) solid tumors who have received prior treatment and who have no satisfactory treatment options. Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use of the European Medicines Agency and is based on results from subgroups of patients with HER2 positive (IHC 3+) tumors across thr
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