Nanox Signs Strategic Collaboration Agreement With USARAD

February 7, 2020

NANO-X IMAGING LTD is an innovative medical imaging technology company. They have announced a partnership with Siemens Healthineers-backed USARAD, which leverages a radiology marketplace platform to offer radiology services by over 300 board-certified radiologists to over 500 medical facilities in all 50 U.S. states and 15 countries.

As part of the agreement, USARAD will utilize existing radiologists and recruit additional professionals to become service providers using the Nanox.ARC and the Nanox.CLOUD for imaging diagnostics. The companies will collaborate on the deployment of 3,000 Nanox Systems in the U.S., under Nanox’s MSaaS (Medical Screening as a Service) pay-per-scan business model, which the Company expects will make medical imaging more accessible to patients at affordable costs.

The Nanox System is composed of the Nanox.ARC, a medical imaging system incorporating a novel digital X-ray source, and the Nanox.CLOUD, a companion cloud-based software that is designed to provide an end-to-end medical imaging service expected to include image repository, radiologist matching, online and offline diagnostics review, and annotation, connectivity to diagnostic assistive artificial intelligence systems, billing and reporting.

Nanox and USARAD will target 6,000+ freestanding imaging centers, 7,600+ urgent care clinics, numerous retail locations as well as thousands of physician practices across the U.S. for the deployment of the Nanox System, subject to regulatory approval, with the aim of improving the standard of care with significantly increased availability.

According to the World Health Organization (WHO), approximately two-thirds of the world’s population does not have access to medical imaging systems, while many people with access to medical imaging face substantial wait times for scanning. Medical imaging systems are an important early-detection tool that the Company believes are key to increasing early treatment, improving health outcomes and, ultimately, saving lives.

USARAD Holdings Inc., backed by Siemens Healthineers, Omphalos Venture Partners and Excelerate Health Ventures, offers radiology services in the U.S. across 50 states, as well as more than 15 countries, via its Radiology-On-Demand platform. USARAD leverages advanced technologies including AI and blockchain to service 100s of facilities to provide accepted, cost-effective, timely, medically accurate and up-to-date advanced teleradiology services to hospitals and outpatient care centers. USARAD acknowledges and strives to meet the growing needs of the global medical community, and by integrating the Nanox.Cloud, it will expand on its mission to supply the highest quality radiology services.

“This is a strategic agreement for Nanox,” said Ran Poliakine, Founder and Chief Executive Officer of Nanox. “USARAD brings a wealth of professional radiology and market proficiency in the American healthcare arena, as well as acts as a pivotal partner to support our business model and social agenda in the U.S.”

“Nanox brings innovation in the form of a novel and revolutionary digital X-ray source, after more than 100 years of no material change in X-ray source technology,” said Dr. Michael Yuz Founder & CEO of USARAD. “Current top-range medical imaging systems are extremely expensive and there are not enough scanners to provide proper accessibility for all communities to have early-detection healthcare. We believe the Nanox. Arc is the game-changer we have all been waiting for, to solve the availability issue in our field.”

Former US FDA Commissioner Dr Scott Gottlieb Joins Illumina’s Board of Directors

February 7, 2020

Former US FDA Commissioner Dr Scott Gottlieb has joined the Illumina Board of Directors effective February 4, 2020. Dr. Scott Gottlieb is currently a special partner at the venture capital firm New Enterprise Associates (NEA) and a resident fellow at the American Enterprise Institute (AEI). From 2017 to 2019, he served as the 23^rd Commissioner of the Food and Drug Administration (FDA).

During his time at the FDA, Dr Scott Gottlieb helped make the regulatory process for the development and review of novel drug and medical devices more efficient, including the approval of the first gene-therapy-based cancer treatments. He advanced the FDA’s Oncology Center for Excellence and helped implement the 21^st Century Cures Act to accelerate medical product development. He also presided over a record number of approvals for generic and new drugs and novel medical devices, and advanced other efforts to promote food safety, vaccinations, reduce smoking rates and address opioid addiction.

Dr. Gottlieb previously served as the agency’s deputy commissioner for medical and scientific affairs, and as a senior adviser for medical technology to the FDA Commissioner. He also served as a senior policy adviser to the administrator at the Centers for Medicare & Medicaid Services. Prior to joining the FDA as commissioner, he was a clinical assistant professor at New York University School of Medicine. Earlier, he was a practicing physician and hospitalist concurrently with his AEI work.

“I am excited to welcome Scott to Illumina’s Board of Directors,” said Francis deSouza, Illumina’s Chief Executive Officer. “Illumina will benefit from Scott’s expertise in healthcare and public policy as we work to accelerate the adoption and impact of genomics into the standard of care in oncology, reproductive health, and other clinical areas.”

Dr Scott Gottlieb has a medical degree from Mount Sinai School of Medicine and completed his residency in internal medicine at the Mount Sinai Medical Center. He is an elected member of the National Academy of Medicine. He has a B.A. in economics from Wesleyan University.

Aroa Biosurgery Launches Large Format Endoform ®

February 7, 2020

Aroa Biosurgery, the Auckland-based privately held soft-tissue repair company, has now launched a large format version of its Endoform^® Natural product.

The largest of Aroa’s wound care products, the 8.5 by 6-inch device has been launched in the United States and Canadian markets, following its recent approval for reimbursement within the U.S. healthcare system.

Aroa Biosurgery Chief Executive, Brian Ward said this large-format version of Endoform® Natural addresses the growing need to treat large wounds with a single sheet of their extracellular matrix-based product and provides more options for clinicians.

“We saw a need to offer Healthcare Providers a simple option for larger and often more difficult-to-treat wounds arising from trauma and complications from surgical wounds, or other diseases where healing is impaired. This format is also suitable for wounds such as chronic wounds and venous leg ulcers.

“We are also seeing that Endoform® Natural is increasingly being used in conjunction with negative pressure wound therapy, and this large-format will be particularly useful in these treatment applications.”

Aroa Biosurgery intends to make the large format available in a range of global markets as and when regulatory approvals are granted.

“Aroa is committed to having solutions for a wide variety of wounds and wound sizes, and to partnering with clinicians to ensure there are effective solutions for patients presenting with an array of challenging wounds,” says Brian Ward.

Onkos Surgical® Launches GenVie ™

February 7, 2020

Today Onkos Surgical^® announced the launch of GenVie ™ Magnesium Bone Scaffold, a novel biologic technology that further expands Onkos’ reach in complex limb salvage procedures. GenVie™ is the first 510(k) cleared magnesium-based bone void filler in the orthopedic marketplace and is available via a private label distribution agreement with Bone Solutions Inc. (OsteoCrete^®) announced in late 2019.

GenVieis an injectable and moldable bone void filler with a unique combination of osteoconductive and high compression strength attributes designed to assist with bone repair and regeneration. The product is intended for surgically created osseous defects or osseous defects created from traumatic injury to the bone and has a reported healing rate of 80% at twenty-six weeks in a preclinical model¹.

“We are excited for the launch of GenVie as this product platform provides extraordinary strength, resorption, and handling profile that our customers are looking for. GenVie provides an elegant solution for use in certain tumor and complex revision cases and compliments our focused and innovative portfolio,” said Patrick Treacy, CEO and Co-Founder of Onkos Surgical.

Onkos continues to bring to market solutions that address the clinical challenges of complex tumor and revision surgery. The addition of GenVie complements an existing portfolio and pipeline focused on personalized surgical planning, 3D printed limb salvage offerings, and 3D patient-specific joint sparing innovation. This launch signals the first of numerous product launches planned for Onkos Surgical in 2020.

PROCEPT BioRobotics Appoints Reza Zadno, PhD, as New President and CEO

February 6, 2020

PROCEPT BioRobotics Corporation, a Silicon Valley surgical robotics company developing intelligent solutions to transform the field of urology, has announced the appointment of Reza Zadno, PhD, as its new president and chief executive officer.

With more than three decades of leadership experience in the medical device industry, Zadno brings expertise in leading and scaling commercial operations. He is also an accomplished inventor and medical device company founder with a proven track record of building significant shareholder value.

Zadno joins PROCEPT BioRobotics as it seeks to rapidly expand the global adoption of Aquablation^® therapy, performed by the AquaBeam^® Robotic System, the first FDA-granted surgical robot for the autonomous removal of prostate tissue in males suffering from benign prostatic hyperplasia (BPH). Aquablation has been awarded both the New Technology Add-on Payment and Transitional Pass-Through Payment from CMS in the United States by demonstrating a substantial clinical improvement compared to other available surgical approaches to BPH.

“We are exceptionally pleased to appoint Reza to CEO at such a pivotal growth time for PROCEPT BioRobotics. With his remarkable business and technical acumen, we believe he is uniquely qualified to lead the company through rapid expansion and build a market leader in the BPH therapy space,” said Rodney Perkins, MD, co-founder and chairman of the board. “PROCEPT’s technology of rapid, precise image-guided tissue removal represents the next generation of surgical robotics, and Reza can lead us into this new era of surgery.”

“Technology has advanced significantly since the development of the earliest robotic platforms used in medicine,” said Frederic Moll, MD, co-founder of Intuitive Surgical and Auris Health Inc. and member of PROCEPT BioRobotics’ board. “PROCEPT BioRobotics is a unique company in the robotics space that has the ability to augment surgical technique utilizing next generation robotic technology.”

Zadno came to PROCEPT BioRobotics after serving as president and CEO of Avedro Inc. (NASDAQ: AVDR), an ophthalmology company that developed a proprietary Corneal Remodeling Platform Technology. While there, he led the company through sizeable fundraising and rapid commercialization, achieving greater than 95 percent coverage from commercial payers. Zadno took the company public in February 2019 and completed an acquisition by Glaukos (NYSE: GKOS) in November 2019.

Prior to his position at Avedro, Zadno spent five years as a venture partner at firms including Interwest Partners and Novartis Fund. Additionally, he was the founder, president and CEO of Visiogen, which was acquired by Abbott Medical Optics (now Johnson & Johnson Vision). Reza earlier co-founded PercuSurge, a maker of distal protection devices used in treating occluded carotid arteries and saphenous vein grafts, which was acquired by Medtronic.

“Surgical robotics is certainly one of the most exciting fields in healthcare, and I am a true believer in PROCEPT BioRobotics’ technology and the global market opportunity that stands before us,” said Zadno. “For the first time, PROCEPT has brought a technology to the market where the robot performs the surgical removal of prostatic tissue. This foundation allows us to now advance surgery even further by incorporating artificial intelligence.”

Stephen Trowbridge Appointed Executive VP and CFO at AngioDynamics

February 6, 2020

AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, today announced that it has appointed Stephen Trowbridge to the role of Executive Vice President and Chief Financial Officer, effective February 5, 2020.

Stephen Trowbridge has served as the Company’s Interim Chief Financial Officer since October 22, 2019, in addition to his responsibilities as Senior Vice President and General Counsel. AngioDynamics will initiate a search for the role of General Counsel; to facilitate a smooth transition, Mr. Trowbridge will retain his duties as General Counsel until a replacement is named.

“We are thrilled to have Steve assume the CFO role full-time and lead our outstanding finance organization,” said Jim Clemmer, AngioDynamics President and Chief Executive Officer. “Steve and I have worked together for several years, and I have experienced first-hand his leadership, talent, and passion for our business and patients. I’m confident that the unique insights Steve has developed during his 11 years at AngioDynamics will be instrumental as we continue our transformation into a more technology-focused medical device company.”

“I am excited to assume the CFO role on a permanent basis,” said Stephen Trowbridge, AngioDynamics Executive Vice President and Chief Financial Officer. “I look forward to continuing to work closely with Jim and the rest of the team as we enter larger, faster-growing markets and bring innovative new products to healthcare professionals and patients around the globe.”

Stephen Trowbridge joined AngioDynamics as Corporate Counsel in 2008, was promoted to Vice President and General Counsel in 2010, and subsequently promoted to Senior Vice President, General Counsel in 2013. Prior to AngioDynamics, Mr. Trowbridge served as Corporate Counsel at Philips Healthcare and Intermagnetics General Corporation. Mr. Trowbridge began his career with Cadwalader, Wickersham & Taft, LLP in the firm’s Mergers and Acquisitions and Securities Group.

Stephen Trowbridge received a Bachelor of Science in Science and Technology Studies from Rensselaer Polytechnic Institute, a Juris Doctor from the University of Pennsylvania Law School, and a Master of Business Administration from Duke University’s Fuqua School of Business.

Atlantic Therapeutics Announces FDA Clearance for Over-the-Counter Use of INNOVO®

February 6, 2020

Atlantic Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted over-the-counter (OTC) clearance to INNOVO^®, a non-invasive, clinically proven and wearable device for the treatment of stress urinary incontinence (SUI) in adult females.

This approval represents a major milestone that will be a key value driver for Atlantic Therapeutics. This achievement as well as the previous funding rounds position the company to enter its next phase of growth, driven by geographic expansion within the U.S., accelerated sales in other geographies, further development of its existing product portfolio and expansion into new clinical applications.

INNOVO® is the first transcutaneous electrical stimulation continence device to be cleared by the FDA, following positive results from two clinical trials. The clinical trials demonstrated that 80%¹ of INNOVO® users experienced significant improvements after four weeks and 87%² were considered “dry” or “near dry” after three months.

“With INNOVO^® now approved for over-the-counter use in the U.S., women suffering from urinary incontinence, a common but stigmatized condition, have easy access to this convenient, effective and safe product, which is backed by science,” said Steve Atkinson, Chief Executive Officer of Atlantic Therapeutics. “No longer requiring a prescription for INNOVO^® means women can take back control of their personal health in the safest and most convenient way possible with this effective at-home treatment. They no longer need to suffer in silence and make do with temporary fixes, such as pads, to manage their condition.”

“We are encouraged by the over-the-counter clearance of INNOVO® and believe it unlocks substantial value for Atlantic Therapeutics,” said Anne Portwich, Partner at LSP and investor in Atlantic Therapeutics. “This is an exciting time to be supporting the global expansion and growth of Atlantic Therapeutics.”

An estimated one third of all U.S. females are affected by SUI³, representing a significant market opportunity for INNOVO®. INNOVO® has an excellent safety record to date, with over 3.5 million therapy sessions delivered by INNOVO® worldwide with no reported device-related complications. INNOVO ® can be purchased without a prescription at www.myinnovo.com starting February 6, 2020.

SMART Medical Systems Launches its G-EYE® 760R Colonoscope in the European Endoscopy Market Through FUJIFILM Europe

February 6, 2020

SMART Medical Systems Ltd., a developer and manufacturer of innovative endoscopy products, announced a strategic distribution partnership empowering Fujifilm to commercialize SMART’s G-EYE^® endoscope in Europe.

The G-EYE^® endoscope is a conventional colonoscope onto which SMART’s G-EYE^® balloon is integrated. Withdrawal of the G-EYE^® endoscope in the colon with the balloon moderately inflated centralizes the image in the colon lumen and flattens colonic folds. This effect is designed to provide enhanced visualization of the colon and was proven in numerous clinical studies to enable a substantial increase in the detection of cancerous polyps which are the precursors of colon cancer (e.g., GIE Vol.89, No.3, 2019, p545-553).

The flagship product to be commercialized under the new partnership is the G-EYE^® 760R colonoscope, integrating the G-EYE^®Balloon Technology with Fujifilm’s ELUXEO system, and yielding a highly optimized colonoscopy system for screening, diagnostic and therapeutic colonoscopy.

“Our new partnership with Fujifilm is a solid and strategic relation substantiating our common efforts of making the G-EYE^® balloon endoscope available to more hospitals and practitioners, starting in Europe,” said Gadi Terliuc, SMART’s CEO. “We are excited to make the product available by Fujifilm and gain market share with a clear focus on colonoscopy.”

Novaerus Expands Distribution Network in China

February 5, 2020

Novaerus is a company that manufactures and sells patented medical-grade, clean air solutions, has partnered with seven established distributors across China, in regions such as Hubei, Beijing, Shanghai, Zhejiang, Guangzhou City and the Chinese special administrative regions of Hong Kong and Macau.

The new partnerships are welcomed at a time of growing concern surrounding the recent infectious outbreak, caused by a novel coronavirus, that started in Wuhan, Hubei Province, China.

Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). A novel coronavirus (nCoV) is a new strain that has not been previously identified in humans.

Global health authorities are currently monitoring the recent outbreak, which has been spreading across China, with a growing number of additional cases identified globally.

Symptoms of infection include respiratory symptoms, fever, cough, shortness of breath and breathing difficulties. According to the World Health Organization (WHO), in more severe cases, the infection can cause pneumonia, severe acute respiratory syndrome, kidney failure and even death. There are currently over 28,000 confirmed cases of the virus, with over 500 reported deaths.

It’s not yet clear how easily 2019-nCoV spreads from person-to-person. However, previous strains of coronavirus, MERS and SARS, were thought to have been spread via respiratory droplets produced when an infected person coughs or sneezes, similar to how influenza and other respiratory pathogens spread.

“The most difficult disease transmission route to guard against is airborne because we have very little to protect us when we breathe,” says Dr Kevin Devlin, CEO at WellAir, the parent company of Novaerus. “Infection prevention specialists have pointed out that surgical masks are not designed to keep out viruses. Cleaning the air is a fundamental component of managing infectious outbreaks.”

Due to the small size of viruses, many clean air solutions, including standalone filtration, are unable to trap viral particles. Novaerus portable air dis-infection units use a non-selective, rapid killing, patented plasma technology, offering a unique and safe solution to kill airborne viruses 24/7. The technology has also been independently tested to reduce MS2 Bacteriophage, a commonly used surrogate for SARS-CoV* (Coronavirus) by 99.99%.

“Given the rapid and consistent kill rates achieved using Novaerus, it is reasonable to anticipate that our plasma technology will show similar impact and rapid kill rates across all viral particles,” says Dr Felipe Soberon, Chief Technology Officer at WellAir.

Novaerus portable air dis-infection units will be available to healthcare facilities in the regions of Hubei, Beijing, Shanghai, Zhejiang, Guangzhou City and the Chinese special administrative regions of Hong Kong and Macau.

Biocoat Launches HYDAK® UV

February 5, 2020

Biocoat reports the innovative coating is built on the proven bi-laminar platform that is used in Biocoat’s existing thermal heat cure coating technology.

“Biocoat is the only hydrophilic coating provider that can provide industry-leading performance in lubricity, durability, and particulates for both UV and thermal hydrophilic coatings,” said Dr. Bob Hergenrother, Biocoat’s Senior Director of Research & Development. “Our proprietary, internally developed UV coatings are built on the same bi-laminar coating platform currently being used on leading neurovascular, cardiovascular, and ophthalmic devices in over 160 countries around the world.”

“Biocoat is at the forefront of developing coating solutions to meet the increasing demands of our customers who are developing cutting-edge medical devices. The introduction of HYDAK® UV positions Biocoat as the premier provider of hydrophilic coatings,” said Jim Moran, Biocoat’s President, and CEO. “By working directly with our customers to understand their needs, we’ve developed a UV coating that maximizes device performance, and we’ve designed a manufacturing process that allows them to use their current in-house equipment. In addition, Biocoat will extend our in-house coating services to offer both UV and Thermal Coating Services.”

Scott Cramer, Chairman of Biocoat added, “We believe that the future growth of Biocoat will be a direct result of simplifying the development process for our customers. The introduction of HYDAK® UV and the launch of the Contract Coating Services Unit were strategic initiatives specifically designed to improve Biocoat’s complete service offering.”

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Aroa Biosurgery, the Auckland-based privately held soft-tissue repair company, has now launched a large format version of its Endoform® Natural product.

PROCEPT BioRobotics Corporation, a Silicon Valley surgical robotics company developing intelligent solutions to transform the field of urology, has announced the appointment of Reza Zadno, PhD, as its new president and chief executive officer.

Atlantic Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted over-the-counter (OTC) clearance to INNOVO®, a non-invasive, clinically proven and wearable device for the treatment of stress urinary incontinence (SUI) in adult females.

SMART Medical Systems Ltd., a developer and manufacturer of innovative endoscopy products, announced a strategic distribution partnership empowering Fujifilm to commercialize SMART’s G-EYE® endoscope in Europe.

Novaerus is a company that manufactures and sells patented medical-grade, clean air solutions, has partnered with seven established distributors across China, in regions such as Hubei, Beijing, Shanghai, Zhejiang, Guangzhou City and the Chinese special administrative regions of Hong Kong and Macau.

Biocoat reports the innovative coating is built on the proven bi-laminar platform that is used in Biocoat’s existing thermal heat cure coating technology.

Medical Device News Magazine

Aroa Biosurgery, the Auckland-based privately held soft-tissue repair company, has now launched a large format version of its Endoform^® Natural product.

Atlantic Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted over-the-counter (OTC) clearance to INNOVO^®, a non-invasive, clinically proven and wearable device for the treatment of stress urinary incontinence (SUI) in adult females.

SMART Medical Systems Ltd., a developer and manufacturer of innovative endoscopy products, announced a strategic distribution partnership empowering Fujifilm to commercialize SMART’s G-EYE^® endoscope in Europe.