Stimwave Receives CE Mark Approval for World’s First Fully Percutaneous Stimulator Anchoring System

Posted On May 31, 2017 By OrthoSpineNews In Neuro, Regulatory /

May 26, 2017

BREDA, Netherlands–(BUSINESS WIRE)–Freedom Neuro BV, a medical device distributor for Stimwave Technologies Incorporated, today announced CE Mark approval for the world’s first Percutaneous Injectable Anchor System. The injectable anchor is utilized in conjunction with the company’s wireless neurostimulator devices to provide true innovation in fixating Stimwave’s Wireless Pain Relief^®technology through a minimally-invasive outpatient procedure for those who suffer from chronic pain.

“A wireless system that enables clinicians to actually have the full programming capabilities of IPGs, all in a device that can be injected, represents a paradigm shift in the field of options to provide the best in customization for patients to manage their pain profiles,” said Bart Billet, MD, from AZ Delta hospital group in Roeselare, Belgium.

Once the stimulator is injected, the SandShark is slid down over the device, progressing the un-deployed anchor into ligaments and strong connective tissues. Once the radiopaque anchor is in the desired location, the clinician pulls back on the handle, simultaneously deploying the wings of the anchor and pushing them laterally into the tissue. This injection process secures the anchor to the stimulator and secures the stimulator to the surrounding tissue to prevent migration throughout the life of the micro-implant. The injectable anchor stays in line with the body’s nerves, allowing for a freedom of movement generally not available in other neuromodulation devices.

“The SandShark Percutaneous Injectable Anchor System is a breakthrough for spinal cord stimulators, peripheral nerve stimulators, and all neurostimulation devices,” said Laura Tyler Perryman, founder and CEO of Stimwave. “It allows clinicians to inject a stimulator and its anchor through the same needle puncture port, opening the door for more clinicians to more easily provide patients with our highly efficient stimulators.”

Aiming to provide a non-opioid alternative in the treatment of chronic pain, Stimwave has pioneered the Stimwave Freedom Spinal Cord Stimulation (SCS) System and the StimQ Peripheral Nerve Stimulator (PNS) System. Stimwave’s devices use Wireless Pain Relief^®technology, are 95 percent smaller than any other neuromodulation device on the market and are the only system to have full body 3T MRI Conditionality. Representing a life-changing technological breakthrough for the more than 400 million people who endure daily chronic pain, the Stimwave Freedom Spinal Cord Stimulation (SCS) System is the most versatile system available in the industry. The CE Marked Freedom-8A SCS System can provide European patients with up to 64 electrode contacts and offer traditional programming options, as well as other programming options, including frequencies up to 10,000 Hz or waveform customization. The Freedom-8A SCS System with eight electrodes continues to utilize the Apple iPad programmer, leveraging Bluetooth protocols for ease of use in programming the variety of options. The devices deliver small pulses of energy to specific nerves, triggering a reaction that enables the brain to remap pain pathways, thus providing pain relief.

For more information, visit www.stimwave.com.

About Stimwave

Stimwave Technologies Incorporated is a privately held medical device company engaged in the development, manufacturing, and commercialization of wirelessly powered, microtechnology neurostimulators, providing patients with a convenient, safe, minimally invasive, and highly cost-effective pain management solution that is easily incorporated into their daily lives. Stimwave’s goal is to evolve its patented, cutting-edge platform into the default for neuromodulation, increasing the accessibility for patients worldwide while lowering the economic impact of pain management. www.stimwave.com

Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes are forward-looking statements. A number of risks and uncertainties such as risks associated with product development and commercialization efforts, expected timing or results of any clinical trials, ultimate clinical outcome and perceived or actual advantages of the company’s products, market and physician acceptance of the products, intellectual property protection, and competitive offerings could cause actual events to adversely differ from the expectations indicated in these forward looking statements.

Contacts

Glodow Nead Communications
Evan Nicholson, Sonia Sparks, Kati Stadum, and Sarah Rogers, 415-394-6500
StimwavePR@GlodowNead.com

Neuromonitoring Company Founded by Former NFL Quarterback Set to Go Public

Posted On May 30, 2017 By OrthoSpineNews In Financial, Neuro, Spine /

Source: The Life Sciences Report – May 29, 2017

Assure Neuromonitoring, a wholly owned subsidiary of Assure Holdings Inc. (IOM:TSX.V), provides intraoperative neuromonitoring (IONM) services. The standard of care in the United States is to provide IONM services to monitor the nervous systems of patients undergoing invasive surgeries such as spine, ear, nose and throat, and others, to monitor the activity and warn the surgeon if he/she is getting close to a nerve, thereby preventing nerve damage.

Most IONM services are staffed by onsite technologists and offsite neurologists who are provided by third-party services, which does not provide consistency or accountability. According to the company, the Assure platform “employs its own staff of highly trained technologists and uses its own state of the art monitoring equipment, handles 100% of intraoperative neuromonitoring scheduling and setup, and bills for all technical services provided.” Assure’s technologists and neurologists are dedicated to specific surgeons and work as a team, thereby developing rapport and trust.

The company notes that “Assure has developed a comprehensive platform that engages all stakeholders including the surgeon, the technologist, the neurologist, and the patient.”

The company began operations in Colorado in 2015 and has primarily serviced spine surgeries. The company plans to expand into additional states and into additional types of surgeries.

READ THE REST HERE

Central Connecticut Neurosurgery and Spine is the First in Connecticut to Offer New Treatment Option for Chronic Pain

Posted On May 18, 2017 By OrthoSpineNews In Neuro, Spine, Top Stories /

PLANO, TEXAS (PRWEB) MAY 17, 2017

Dr. Ahmed Khan is the first physician in Connecticut to implant Nuvectra’s Algovita® Spinal Cord Stimulation System, a powerfully versatile, patient-centric spinal cord stimulation system. The Algovita SCS System has been FDA approved as a treatment option for chronic intractable pain since late last year.

Chronic pain affects over 100 million Americans, according to the Institute of Medicine, more than diabetes, cancer, and heart disease combined. Chronic pain is difficult to treat, but one potential treatment option is spinal cord stimulation, or SCS. SCS works by masking or interrupting pain signals as they travel up the spinal cord to the brain. A small, rechargeable battery is implanted under the patient’s skin and connected to thin wires, called leads, which stimulate the nerves sending pain signals. The stimulation “overrides” the pain signals, and instead of feeling pain, patients may feel a tingling sensation known as paresthesia.

The Algovita SCS System is a new offering to the SCS market, featuring 24 current sources and the broadest overall set of parametric ranges offered for tonic SCS. This combination provides flexible coverage and expanded programming options for individualized patient therapy. Algovita also offers the industry’s only stretchable leads, which are designed to reduce the risk of lead fracture and migration. In addition, the system’s percutaneous leads feature up to 12 contacts for wide coverage of potential pain areas. The Algovita system was designed to be patient-centric and easy to use. The wireless Pocket Programmer fits discreetly in a hand, purse, or pocket and allows a patient to conveniently adjust their therapy on the go.

For more information about Nuvectra and the Algovita Spinal Cord Stimulation system, visit http://www.nuvectramed.com.

About Dr. Ahmed Khan

Dr. Ahmed Khan is a neurosurgeon in New Britain, Connecticut and is affiliated with Bristol Hospital. He received his medical degree from University of Connecticut School of Medicine and has been in practice for more than 20 years. He is one of 2 doctors at Bristol Hospital who specialize in Neurological Surgery.

About Nuvectra Corporation

NuvectraTM is a neurostimulation company committed to helping physicians improve the lives of people with chronic neurological conditions. The Algovita® Spinal Cord Stimulation (SCS) System is our first commercial offering and is CE marked and FDA approved for the treatment of chronic pain of the trunk and/or limbs. Our innovative technology platform also has capabilities under development to support other neurological indications such as sacral nerve stimulation (SNS), and deep brain stimulation (DBS). In addition, our NeuroNexus subsidiary designs, manufactures and markets leading-edge neural-interface technologies for the neuroscience clinical research market. Visit the Nuvectra website at http://www.nuvectramed.com.

Stimwave Awarded U.S. Government DAPA Contract

Posted On April 24, 2017 By OrthoSpineNews In Neuro, Regulatory /

April 21, 2017

FORT LAUDERDALE, Fla.–(BUSINESS WIRE)–Stimwave LLC, a medical device manufacturer and independent research institute headquartered in South Florida, today announced it has been awarded a Distribution and Pricing Agreement (DAPA) by the Defense Logistics Agency. Stimwave, which distributes the Stimwave Freedom Spinal Cord Stimulation (SCS) System and StimQ Peripheral Nerve Stimulator (PNS) System, received a five-year contract, negotiated by TAMM Net, Inc., which is the first global agreement for spinal cord stimulators by a U.S. government agency.

“We are extremely pleased Stimwave received a DAPA. The successful product validation process now allows Stimwave products to be accessed and used by doctors at all military treatment facilities across the globe,” said Laura Perryman, CEO and president of Stimwave. “Multiple facilities have been pleased to hear they can now acquire our products through their purchasing vehicles.”

Stimwave’s devices use Wireless Pain Relief^®technology and are 95 percent smaller than any other neuromodulation device on the market. Stimwave’s wireless device delivers small pulses of energy to specific nerves, triggering a reaction that enables the brain to remap pain pathways, thus providing pain relief. The device is fixed in place by an anchor, so it stays “in line” with the body’s nerves, allowing a freedom of motion that is impossible with bulkier implanted devices.

Stimwave launched its FDA-cleared devices for the relief of chronic back and leg pain to a limited number of patients throughout 2015. In March 2016, Stimwave was granted FDA 510(k) for the relief of peripheral nervous system (PNS) pain, becoming the only neuromodulation device manufacturer cleared by the FDA to help reduce chronic neuropathic pain at most locations throughout the body, from back and leg pain addressed by spinal cord stimulation to PNS treatment for shoulder pain, wrist and elbow pain, knee pain, hip pain and more.

About Stimwave

About TAMM Net, Inc.

TAMM is a consultancy that provides services to biomedical manufacturers seeking opportunities or overcoming obstacles presented by the U.S. government. TAMM provides complete reimbursement, full federal contracting services, regulatory affairs, and facilitating sales to federal medical facilities. http://www.tammnet.com

Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes are forward-looking statements. A number of risks and uncertainties such as risks associated with product development and commercialization efforts, expected timing or results of any clinical trials, ultimate clinical outcome and perceived or actual advantages of the Company’s products, market and physician acceptance of the products, intellectual property protection, and competitive offerings could cause actual events to adversely differ from the expectations indicated in these forward looking statements.

Contacts

Glodow Nead Communications
Evan Nicholson, Sonia Sparks, Kati Stadum, and Sarah Rogers, 415-394-6500
StimwavePR@GlodowNead.com

InVivo Therapeutics Announces Oral Presentations at the 2017 American Spinal Injury Association Annual Scientific Meeting

Posted On April 20, 2017 By OrthoSpineNews In Neuro, Sports Medicine /

April 20, 2017

CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today announced that the company will be giving two oral presentations at the 2017 American Spinal Injury Association (ASIA) Annual Scientific Meeting to be held April 26-29, 2017 in Albuquerque, New Mexico. Alex Aimetti, Ph.D., Vice President, Medical Education and Scientific Support, will present a clinical trial update during the “Clinical Trials 360-degree” session sponsored by Spinal Cord Outcomes Partnership Endeavor (SCOPE) on Friday, April 28. Dr. Aimetti will also present an abstract entitled “Relationship of ASIA Impairment Scale (AIS) Grade to Post-injury Hospitalization Costs in Thoracic Spinal Cord Injury” during a general session on Saturday, April 29. The abstract is co-authored by Dr. Aimetti, Ellen Dukes, Ph.D., Steven Kirshblum, M.D., Sarah Qin, M.B.A., Rebecca Bornheimer, B.A., and Gerry Oster, Ph.D. In addition to the two oral presentations, the company will have an exhibit booth at the meeting.

Mark Perrin, Chairman and CEO, said, “The American Spinal Injury Association Annual Scientific Meeting will allow us to continue to strengthen and expand our relationships within the spinal cord injury research and care network, and we look forward to having a significant presence at this meeting. We are also pleased to be providing an update on our clinical program, especially given our significant progress throughout the start of this year.”

About the Neuro-Spinal Scaffold™ Implant

Following acute spinal cord injury, surgical implantation of the biodegradable Neuro-Spinal Scaffold within the decompressed and debrided injury epicenter is intended to support appositional healing, thereby reducing post-traumatic cavity formation, sparing white matter, and allowing neural regeneration across the healed wound epicenter. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and currently is being evaluated in The INSPIRE Study for the treatment of patients with acute, complete (AIS A), thoracic traumatic spinal cord injury and a pilot study for acute, complete (AIS A), cervical (C5-T1) traumatic spinal cord injury.

About InVivo Therapeutics

InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffoldreceived the 2015 Becker’s Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.

Safe Harbor Statement

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect,” “designed to,” “potentially,” and similar expressions, and include statements regarding the safety and effectiveness of the Neuro-Spinal Scaffold and the progress of the clinical program. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the company’s ability to successfully open additional clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; the company’s ability to commercialize its products; the company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the company’s products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Annual Report on Form 10-K for the year ended December 31, 2016, and its other filings with the SEC, including the company’s Form 10-Qs and current reports on Form 8-K. The company does not undertake to update these forward-looking statements.

Contacts

InVivo Therapeutics Holdings Corp.
Heather Hamel, 617-863-5530
Investor Relations
Investor-relations@invivotherapeutics.com

SafeOp Surgical Files for Ninth Patent

Posted On March 28, 2017 By OrthoSpineNews In Neuro, Regulatory, Top Stories /

March 27, 2017

HUNT VALLEY, Md.–(BUSINESS WIRE)–SafeOp Surgical, Inc. (“SafeOp”), a privately held medical device company, today announced that it has filed its ninth patent application for innovations surrounding the monitoring of somatosensory-evoked potentials during surgeries. SafeOp developed and markets the EPAD™ system, a revolutionary neuromonitoring system that enables the detection of nerve damage and post-operative residual paralysis during surgical procedures. This latest filing is for the capability to reduce false positive alerts to nerve damage during surgeries. The company already holds patents for detection of nerve injury in the United States, Australia, Japan and China, and has several patents pending that include signal processing and high specificity in alerting to signal change, and on neuromuscular junction testing and spinal cord stimulator paddle placement.

“Electrical noise from nearby equipment often causes false alerts that are time consuming to deal with,” said Richard O’Brien, MD, MBA, SafeOp’s vice president of development and chief medical officer. “This new patent provides a method to condition the monitored responses and calculate an alert so that the likelihood of a false positive from a noisy signal is dramatically reduced while preserving the sensitivity of the monitoring to real changes.”

SafeOp’s EPAD™ system, which allows monitoring of both the spinal cord and peripheral nerves, was developed specifically for the rapid detection of perioperative nerve injury (“PNI”). PNI is a frequent complication of some surgeries (e.g., orthopedic, general, cardiac, or urological surgery), whereby peripheral nerves may be damaged due to unrecognized extended compression or stretching, or compromise of their blood supply. The EPAD™ system also allows easy-to-use quantitative monitoring of the neuromuscular junction to help detect another frequent complication, post-operative residual paralysis. This may occur when paralyzing agents have not sufficiently worn off at the end of surgery. The EPAD™ system provides real-time feedback, allowing caregivers to adjust the patient’s position in time to avoid nerve injury, or intervene when residual paralysis is present.

“We continue to innovate our EPAD™ system technology with powerful capabilities that will make it the most cost-effective intraoperative monitoring solution available,” said Gene Cattarina, SafeOp’s president and chief executive officer. “With its unique ability to economically and efficiently acquire somatosensory-evoked potentials, the EPAD™ is appropriate for all types of surgeries and an ideal low cost alternative to expensive insourced- and outsourced-driven neuromonitoring for certain spine and other surgeries.”

About SafeOp Surgical, Inc.

SafeOp Surgical, Inc. is a Hunt Valley, MD-based medical device company that has developed the FDA-approved EPAD™ system. The EPAD™ system enables simple-to-use neurological monitoring in a wide array of surgical procedures where full monitoring – which requires the continuous presence of a technologist and neurologist – may not be indicated, cost-effective or feasible. SafeOp currently markets the EPAD™ system to medical centers throughout the United States. For more information, visit SafeOp’s website at www.safeopsurgical.com.

Contacts

SafeOp Surgical, Inc.
Chris Brown, 410-773-9601
Cell: 214-213-9379
cbrown@safeopsurgical.com

InVivo to Initiate Cervical Spinal Cord Injury Study

Posted On March 24, 2017 By OrthoSpineNews In Neuro, Top Stories /

March 23, 2017

CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today announced that Health Canada has approved the company’s Investigational Testing Authorization application to commence a clinical study of the Neuro-Spinal Scaffold™ in patients with acute, complete (AIS A) cervical (C5-T1) spinal cord injuries (SCIs). InVivo currently is in late stage conversation with several site Research Ethics Boards and expects to announce its first Canadian site in the coming weeks.

“This approval is an important step towards our goal of redefining the life of the spinal cord injury patient,” said Mark Perrin, InVivo’s CEO and Chairman. “We are dedicated to helping as many SCI patients as we can, and this approval helps us to evaluate our investigational product in the most severe spinal cord injury cases, with neurologically complete cervical injuries involving impairment of the arms, hands, trunk, and legs. As I explain further in my CEO’s Perspective, moving into the cervical spinal cord is exciting, since each level of the cervical spinal cord has a substantial functional impact. If the Neuro-Spinal Scaffold were able to preserve, remyelinate and/or regenerate just a small area of spinal cord, we believe this could have significant functional consequences. We look forward to bringing sites onboard in Canada to commence enrollment and ultimately to expanding our study of cervical patients to the United Kingdom and the United States.”

A new CEO’s Perspective discussing the differences between thoracic and cervical spinal cord injuries can be found on the InVivo Therapeutics website: http://www.invivotherapeutics.com/about-invivo/ceo-perspective/

About the Neuro-Spinal Scaffold™ Implant

Following acute spinal cord injury, surgical implantation of the biodegradable Neuro-Spinal Scaffold within the decompressed and debrided injury epicenter is intended to support appositional healing, thereby reducing post-traumatic cavity formation, sparing white matter, and allowing neural regeneration across the healed wound epicenter. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and currently is being evaluated in the INSPIRE pivotal probable benefit study for the treatment of patients with acute, complete (AIS A), thoracic traumatic spinal cord injury and a pilot study for acute, complete (AIS A), cervical (C5-T1) traumatic spinal cord injury.

About InVivo Therapeutics

Safe Harbor Statement

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect,” “designed to,” “potentially,” and similar expressions, and include statements regarding the safety and effectiveness of the Neuro-Spinal Scaffold, the ability of the company to open a site in Canada or enroll patients in Canada, and the ability to expand the trial to the United Kingdom and the United States. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the company’s ability to successfully open additional clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; the impact of achieving the OPC on the FDA approval process; the company’s ability to commercialize its products; the company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the company’s products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Annual Report on Form 10-K for the year ended December 31, 2016, and its other filings with the SEC, including the company’s Form 10-Qs and current reports on Form 8-K. The company does not undertake to update these forward-looking statements.

Contacts

InVivo Therapeutics
Heather Hamel, 617-863-5530
Investor Relations
Investor-relations@invivotherapeutics.com

InVivo Therapeutics to Present and Exhibit at Spine Summit 2017

Posted On February 28, 2017 By OrthoSpineNews In Neuro, Spine /

February 28, 2017

CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today announced that two INSPIRE study Principal Investigators, Dom Coric, M.D. and Michael Fehlings, M.D., Ph.D., will be giving oral presentations at the Spine Summit 2017 to be held March 8-11, 2017 in Las Vegas, NV. Dr. Coric will present “INSPIRE Study Update on 10 Subjects Implanted with a Bioresorbable Polymer Scaffold Following Acute Complete Thoracic Spinal Cord Injury,” and Dr. Fehlings will present “Magnetic Resonance Imaging (MRI) Does Not Distinguish between Contusion and Compound Cord Lesions Following Severe (AIS A) Traumatic Acute Thoracic Cord Injury: Intraoperative Microsurgical Observations from the INSPIRE Trial” during the Peripheral Nerve, Basic Science Breakout session on Saturday, March 11.

Dr. Fehlings will also present during a What’s New Session on Friday, March 10. The session will include discussion of the Neuro-Spinal Scaffold™technology and INSPIRE study and will continue to raise awareness amongst leading spine neurosurgeons.

Mark Perrin, Chairman and CEO, said, “The Spine Summit affords us the opportunity to build mindshare within the most pertinent group of surgeons for the Neuro-Spinal Scaffold. This meeting has proven to be one of the most fruitful in terms of bringing on board new INSPIRE sites, and we look forward to having a significant presence at this meeting.”

The company will also have an exhibit booth to further foster relationships with the neurosurgical community. The meeting is the 33rd Annual Meeting of the AANS/CNS (American Associations of Neurological Surgeons / Congress of Neurological Surgeons) Joint Section on Disorders of the Spine and Peripheral Nerves and is being held in collaboration with the Korean Spinal Neurosurgery Society.

About the Neuro-Spinal Scaffold™ Implant

Following an acute spinal cord injury, the biodegradable Neuro-Spinal Scaffold is surgically implanted at the epicenter of the wound and is designed to act as a physical substrate for nerve sprouting. Appositional healing to spare spinal cord tissue, decreased post-traumatic cyst formation, and decreased spinal cord tissue pressure have been demonstrated in preclinical models of spinal cord contusion injury. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and currently is being evaluated in the INSPIRE pivotal probable benefit study for the treatment of patients with complete (AIS A) traumatic acute spinal cord injury.

About InVivo Therapeutics

Safe Harbor Statement

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect,” “designed to,” “potentially,” and similar expressions, and include statements regarding the addition of new sites. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the company’s ability to successfully open additional clinical sites for enrollment and to enroll additional patients; the ability to complete the INSPIRE study and submit an HDE; the company’s ability to receive regulatory approval for the Neuro-Spinal Scaffold; the company’s ability to commercialize its products; the company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the company’s products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Annual Report on Form 10-K for the year ended December 31, 2015, and its other filings with the SEC, including the company’s Form 10-Qs and current reports on Form 8-K. The company does not undertake to update these forward-looking statements.

Contacts

InVivo Therapeutics
Brian Luque, 617-863-5535
Investor Relations
bluque@invivotherapeutics.com

Bioness Announces First European Implants for StimRouter Neuromodulation System

Posted On February 23, 2017 By OrthoSpineNews In Extremities, Neuro /

VALENCIA, Calif., Feb. 22, 2017 /PRNewswire/ — Bioness, Inc., the leading provider of cutting edge, clinically supported rehabilitation therapies, today announced the first series of successful StimRouter Neuromodulation System implantations in Europe at Radboud University Medical Center (Nijmegen, Netherlands), South Victoria University (Cork, Ireland), and Kliniek Park Leopold Chirec (Brussels, Belgium). With the successful launch continuing, Bioness plans to further support clinicians across the continent who are looking to support patients seeking minimally-invasive, long-term pain relief.

Erkan Kurt, MD (The Netherlands), Dominic Hegarty, MD (Ireland), and Jean Pierre van Buyten, MD (Belgium) implanted the StimRouter to manage chronic pain conditions originating from varied peripheral neuralgias. With an estimated 100 million Europeans suffering from chronic pain, there has never been a greater need for innovative pain management options.

“For many years we have had limited solutions to help our patients manage their debilitating pain,” shared Dominic Hegarty, MD, a trained Interventional Neuromodulation and Pain Management Specialist. “I’m very pleased to be able to provide the best neuromodulation options for my patients. I am confident that the StimRouter technology will be suitable for a greater range of patients in the future.”

“The StimRouter promises to be a breakthrough in neurostimulation because it is a much smaller device to implant and therefore easier to target pain at its origin,” stated Jean Pierre van Buyten, MD, an internationally renowned Pain Anesthesiologist. “Another advantage is that it minimizes cost and recovery time when compared to other more invasive treatments.”

“Peripheral neuropathy is a very common and often painful disorder. As a neurosurgeon with more than 20 years of neuromodulation experience, the StimRouter provides a unique opportunity to deliver patients relief from chronic pain, especially among those with peripheral nerve damage and scar tissue around the targeted nerve,” explained Erkan Kurt, MD. “Where percutaneous implantation might be a difficult procedure, the StimRouter is a small device that takes a minimally invasive approach that is easy to perform. Another great advantage is the transdermal electrical stimulation which makes implantation of an implantable pulse generator unnecessary.”

As a minimally invasive device designed to reduce pain by specifically targeting the affected peripheral nerve, the StimRouter is intended to be a cost-effective and long-term alternative to immobilization, injections, and prescription opioids. The implant procedure is usually completed in less than 30 minutes and uses only local anesthesia.

“As we continue to see impressive clinical results in the US and now Europe we are excited to further our mission of supporting clinicians looking to improve the lives of patients,” said Todd Cushman, President and CEO of Bioness. “Patients and their loved ones are looking for true relief from the downward spiral of chronic pain. With greater awareness of opioid addiction, alternative choices which deliver life improving results are needed. We are thrilled to be bringing expanded treatment options to those who care for patients.”

StimRouter was the first FDA cleared minimally-invasive, long-term, minimally invasive neuromodulation medical device indicated to treat chronic pain of a peripheral nerve origin. The StimRouter System then received CE mark in February of 2014 and the Company began expanding its focus into the European Union. The patient controlled medical device is an adjunct to other modes of therapy and is being well received by patients and clinicians alike.

The StimRouter is currently being implanted at prestigious clinical institutions across the United States to treat chronic peripheral nerve pain, with specific focus on the following conditions or areas:

Axillary nerve (e.g. post-stroke shoulder pain)
Ulnar nerve (e.g. cubital tunnel syndrome)
Suprascapular
Superior Cluneal nerve (e.g. lower back neuralgia)
Genicular nerve
Median nerve
Peroneal nerves

For more information on the StimRouter as well as videos of real patients sharing their StimRouter experience, please visit www.stimrouter.com.

About StimRouter^™Neuromodulation System

StimRouter is cleared by the FDA to treat chronic pain of peripheral nerve origin. StimRouter is a minimally invasive neuromodulation medical device consisting of a thin, implanted lead with conductive electrode, external pulse transmitter (EPT), and hand-held wireless patient programmer. Electrical signals are transmitted transdermally from the EPT through the electrode, down the lead to the target nerve. StimRouter is programmed at the direction of the physician to meet patient requirements but is controlled by the patient to address the patients specific, changing pain management needs.

About Bioness, Inc.

Bioness is the leading provider of innovative technologies helping people regain mobility and independence. Bioness solutions include implantable and external neuromodulation systems, robotic systems and software based therapy programs providing functional and therapeutic benefits for individuals affected by pain, central nervous system disorders and orthopedic injuries. Currently, Bioness offers six medical devices within its commercial portfolio which are distributed and sold on five continents and in over 25 countries worldwide. Bioness innovations have been implemented in the most prestigious and well-respected institutions around the globe with 17 of the top 20 rehabilitation hospitals in the United States currently using one or more Bioness solution. Bioness has a singular focus on aiding large, underserved customer groups with innovative, evidence-based solutions and we will continue to develop and make commercially available new products that address the growing and changing needs of our customers. Individual results vary. Consult with a qualified physician to determine if this product is right for you. Contraindications, adverse reactions and precautions are available online at www.bioness.com.

Media Relations Contact Information
Next Step Communications
bioness@nextstepcomms.com
781.326.1741

StimRouter™ and Bioness® are trademarks of Bioness, Inc. | www.bioness.com | Rx Only | Additional information about StimRouter can be found at www.stimrouter.com

SOURCE Bioness, Inc.

Northwell Health is First on Long Island to Acquire Synaptive Medical’s BrightMatter™ Technology for Complex Brain Tumor and Spinal Surgery

Posted On January 31, 2017 By OrthoSpineNews In Neuro, Spine /

January 31, 2017 – TORONTO–(BUSINESS WIRE)-

Synaptive Medical Inc., a medical device and technology company, is pleased to announce that North Shore University Hospital, a member of Northwell Health, is the first center on Long Island to acquire the BrightMatter technology, an innovative solution of advanced imaging, planning, navigation, and robotics for complex brain tumor and spinal surgery.

“In our efforts to provide our patients with the absolutely latest technology and expertise, Northwell Health’s Neuroscience Institute and Cancer Institute are delighted to introduce Synaptive’s BrightMatter neurosurgical system to our area,” said Raj K. Narayan, MD, Northwell Health’s senior vice president, neurosurgery service line. “Being one of the first centers in the country to adopt this technology, we will now be able to approach tumors in the brain with visualization of details that will enable us to perform safer procedures and provide better outcomes. The system allows neurosurgeons to use sophisticated magnetic resonance imaging (MRI) data to gain insight into the structure of white matter, which can help them locate neural pathways responsible for a patient’s ability to walk, speak, or see. A very kind gift from the estate of a patient, Mr. Irwin Davis, who himself had a brain tumor several years ago, made this advance possible. We are all very grateful, as will be many future patients.”

BrightMatter provides neurosurgeons with the latest advancements in visualization tools to perform minimally-invasive, patient-specific procedures. Using an imaging method called diffusion tensor imaging, or DTI, BrightMatter uses tractography to automatically enhance MRI images of the entire brain’s pathways, allowing surgeons to see structures that can’t be seen with the naked eye and consider approaches for optimal navigation. This functionality may allow access to brain locations previously deemed inoperable.

With this information, surgeons can use Synaptive’s high-powered magnification system to view patient anatomy. This optical visualization system, mounted on a robotic arm, follows the surgeon’s tools and shows patient anatomy in unprecedented detail. BrightMatter allows for better surgical ergonomics, facilitates collaboration with operating room staff, and consumes less surgical time without the need to manipulate cumbersome optics.

“With the addition of this state-of-the-art technology, we will not only offer our patients unique treatment options, but also conduct clinical oncology research for discovery of still better approaches as we go forward,” said George Raptis, MD, Northwell Health’s senior vice president, cancer service line. “This is in step with Northwell Health’s ongoing commitment to all the communities we serve.”

Synaptive is uniquely positioned to support Northwell Health’s commitment to be on the forefront of care through state-of-the-art technologies and innovative research. “Collaborating with surgeons to better understand their challenges in the operating room is deeply rooted in Synaptive’s culture,” said Cameron Piron, Synaptive’s president. “Their insights fuel our development work and help our engineering teams to design integrated solutions, both for today and for operating rooms of the future. We look forward to exploring new opportunities with Northwell Health’s neurosurgical team.”

About Northwell Health

Northwell Health is New York State’s largest health care provider and private employer, with 21 hospitals and over 550 outpatient facilities. We care for more than two million people annually in the metro New York area and beyond, thanks to philanthropic support from our communities. Our 61,000 employees – 15,000+ nurses and nearly 3,400 physicians, including nearly 2,700 members of Northwell Health Physician Partners — are working to change health care for the better. We’re making breakthroughs in medicine at the Feinstein Institute. We’re training the next generation of medical professionals at the visionary Hofstra Northwell School of Medicine and the School of Graduate Nursing and Physician Assistant Studies. And we offer health insurance through CareConnect. For information on our more than 100 medical specialties, visit Northwell.edu.

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