Email: info@bibamedical.com Lead migration leading to revision occurred in 3.0% of HF10 therapy and 5.2% of traditional SCS therapy participants. h�bbd```b``5 �kA$SX���L���i �� ,[f'�I0 _ &�A$[1����* 2f'�d�7���g`bd������d�?×K� ��I

In November 2016, the company filed a lawsuit for patent infringement against Boston Scientific Corporation and Boston Scientific Neuromodulation Corporation (collectively, “Boston Scientific”) asserting that Boston Scientific is infringing its patents covering inventions related to its HF10 therapy and the Senza system. Jan. 22, 2019.

Traditional SCS therapy generally consists of two phases, an evaluation period, also called the trial period, which typically lasts several days, followed by a permanent implant for those patients who experience a successful trial period. Technological innovation, product enhancements and speed of innovation, Product reliability, safety and durability. Safety outcomes were consistent across the treatment groups, with the exception of uncomfortable paresthesia in traditional SCS patients, which was not in HF10 therapy patients. Nevro has also developed a clinical support team in order to provide ongoing support to physicians and patients for the use of Senza. Below are three areas where preliminary results have been promising: Chronic neck pain with or without upper limb pain is prevalent in 48% of women and 38% of men in the general adult population, with persistent complaints in 22% of women and 16% of men.

The Senza system has been commercially available in certain European markets since November 2010 and in Australia since August 2011. Nevro has obtained the following international certifications: Quality Management System ISO13485, Full Quality Assurance Certification for the design and manufacture of spinal cord stimulator systems and accessories and a Design Examination certificate for Implantable Pulse Generator and Accessories.

Following the Trial Phase with external device stimulation, subjects will be assessed for their pain, and those who have a successful Trial Phase will be eligible to proceed to permanent implantation of a SCS system.

For Patients.

Paresthesia is often considered unpleasant or uncomfortable and is sometimes made worse by a shocking or jolting sensation with changes in posture.

Medicare reimbursement rates for the same or similar procedures vary due to geographic location, nature of the facility in which the procedure is performed (i.e., hospital outpatient department or outpatient surgery centers) and other factors. LEARN MORE ABOUT OMNIA.

The results of this study led to the initiation of the SENZA-NSRBP RCT which will compare HF10 therapy delivered in conjunction with conventional medical management (CMM) to CMM alone in non-surgical refractory back pain (NSRBP) patients. To complement its sales representatives, the company intend for its marketing and reimbursement teams to drive HF10 therapy adoption through creating awareness and demand among additional stakeholders involved in the SCS treatment decision, including third-party payors, hospital administrators, and patients and their families.

As such, innovation in the SCS market has historically focused on technologies that optimize traditional SCS therapy’s ability to create more precise paresthesia fields.

In September 2017, the company entered into a first amendment to the Manufacturing and Supply Agreement with Vention, which changed the unit costs of the products supplied by Vention.

The company plan to use its platform technology to generate evidence on HF10 therapy for use in other chronic pain indications, including chronic upper limb and neck pain, non-surgical back pain, and painful neuropathies.

Introducing Senza® Omnia™ The first and only system designed to deliver and pair all frequencies between 2 - 10,000 Hz so you can provide your patients the broadest range of solutions today and in the future. Further, average neck pain scores (as measured on the Visual Analog Scale (VAS)) declined from 7.6 (n=42) at baseline to 2.6 (n=42) at three months. The company's SENZA-RCT study, along with its European studies, represents what the company believe is the most robust body of clinical evidence for any SCS therapy.

As such, Nevro has initiated an initial study to determine if HF10 therapy could help this patient group. Please be aware that the website you have requested is intended for the residents of a particular country or region, as noted on that site.

Kapural L, et al. Treating pain requires flexibility and persistence.

The Senza and Senza II SCS systems are CE Marked and FDA-approved with labeling for “at least a 10 year battery life”. Importantly, neurological assessment revealed no stimulation-related neurological deficits in either treatment group.

Charger: The charger recharges the IPG from outside the body. Communicate the clinically demonstrated, superior efficacy of HF10 therapy to patients, physicians and payors globally: Given its robust clinical evidence that demonstrates the superior efficacy of its HF10 therapy, the company believe the company will be able to position its therapy with patients, providers and payors in a differentiated way. If the trial period is successful, a permanent system is implanted in the patient. Compared to traditional SCS therapy which typically operates at 50 Hz to 60 Hz, HF10 therapy delivers spinal cord stimulation at a lower amplitude and a higher frequency waveform of 10,000 Hz. Nevro is currently investigating the use of HF10 therapy to address additional indications such as chronic upper limb and neck pain, painful neuropathies and non-surgical refractory back pain.

To charge, the charging coil of the charger is placed over the location of the IPG and then initiated by pushing a button on the charger. The company believe that further product enhancements if and when completed will drive continued adoption of its technology platform and further validate the advantages and benefits of its HF10 therapy. The company's initial prospective multicenter European clinical study (the EU study) were consistent with its subsequent findings in its prospective, comparative, randomized, controlled U.S. pivotal study (SENZA-RCT study). In spite of this extent of … Because patent applications can take many years to issue, there may be applications unknown to it, which applications may later result in issued patents that its existing or future products or proprietary technologies may be alleged to infringe. In addition, the agreement may be terminated by mutual agreement of the parties, or by either party, with written notice, upon uncured material breach or insolvency of the other party.

Implantable Pulse Generator (IPG): The IPG contains a rechargeable battery and electronics that deliver electrical pulses to the lead.

The company's SENZA-RCT study, along with the previously completed European studies, represent what the company believe is the most robust body of clinical evidence for any SCS therapy.

The company believe the superiority of HF10 therapy over traditional SCS therapies will allow it to capitalize on and expand the approximately $2.0 billion existing global SCS market by treating both back and leg pain without paresthesia.1.

Following its lawsuit, in December 2016, Boston Scientific countered with a patent infringement lawsuit against it, alleging that the company infringed Boston Scientific’s patents covering SCS technology related to stimulation leads, rechargeable batteries and telemetry. Nevro is committed to developing its employees and providing them with opportunities to contribute to its growth and success. Nevro has developed and commercialized the Senza® spinal cord stimulation (SCS) system, an evidence-based neuromodulation platform for the treatment of chronic pain. HF10 therapy provided a 69.2% reduction in back pain as measured by VAS, versus 44.2% for traditional SCS therapy, at three months, results that were superior. To accomplish this objective the company intend to: Growth Opportunities in Other Chronic Pain Indications. Oral opioids, while reducing the patient’s perception of pain, lack clinical evidence to support long-term usage and can cause multiple complications and side-effects including nausea, vomiting and dizziness. A multicenter real-world review of 10 kHz SCS outcomes for treatment of chronic trunk and/or limb pain. Although private payors’ coverage policies and reimbursement rates can differ significantly from payor to payor, the Medicare program is frequently used as a model for how private payors and other governmental payors develop their coverage and reimbursement policies for healthcare items and services, including SCS procedures. The Mayo License terminates upon the expiration of (1) the last to expire of the licensed patents or (2) its obligation to pay royalties, whichever is later. Traditional SCS therapy is currently indicated as a treatment for chronic pain of the trunk and limbs in patients who failed conventional medical management.

The company compete in the SCS market for chronic pain. The superiority of HF10 therapy for reducing leg pain was maintained through the 24-month follow-up period of the study.

Neurosurgery.

The results of the SENZA-RCT, first presented at the North American Neuromodulation Society meeting in December of 2014, provided the evidentiary basis for HF10 therapy’s superiority labeling from FDA, a first in the SCS space.

Percutaneous Leads: The percutaneous leads vary in length and are thin, insulated medical wires in a cylindrical, flexible and steerable shape that conduct electrical pulses from the IPG to near the spinal cord.

For example, certain regional Blue Cross Blue Shield plans previously denied coverage for Senza on the basis that high-frequency neuromodulation is investigational and/or experimental. In October 2006, the company entered into a license agreement (the Mayo License) with the Venturi Group, LLC (VGL) and the Mayo Foundation for Medical Education and Research (the Mayo Foundation) pursuant to which the Mayo Foundation committed to confer with it exclusively to develop products for the treatment of autonomic and peripheral nervous system disorders, including pain, using devices to modulate nerve signaling, and non-exclusively to test such devices, and VGL committed to confer with it non-exclusively to develop such devices, and exclusively to test such devices.

The agreement continues for five years unless terminated earlier. The IPG should provide the patient with multiple years of use and can be either rechargeable or non-rechargeable. }3=��LB�p��b����2)����.�4�.�dh}|X�ϸ�+P�v��� �+�����Mf���x9��ݫ:5�` ��g� As of December 31, 2017, the company had 676 employees globally. Successfully recruiting and training a sufficient number of productive sales representatives is required to achieve its expected growth rate.

Furthermore, numerous U.S. and foreign issued patents and patent applications owned by third parties exist in the fields in which Nevro is developing products. The insertion of the percutaneous leads can also be minimally invasive as they can be inserted in the epidural space through a needle. For example, over the past two years, Abbott Laboratories received FDA approval for a SCS system that offers an alternate low frequency waveform called BurstDR, and in February 2016, the company gained approval for a neuromodulation system that stimulates the dorsal root ganglion for treatment of focal pain and complex regional pain syndrome, in each case, using pivotal clinical studies for each therapy to support the FDA approval process.