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Glooko Appoints Komathi Stem as COO

Komathi Stem has been appointed Chief Operating Officer of Glooko. Stem comes to Glooko having served in a wide range of leadership roles in the life science industry with a focus on the use of real-world data and digital technologies to transform and accelerate clinical trials.

In her new role as COO of Glooko, Komathi Stem will have global responsibility for Glooko product development, clinical research, and customer support.

In her previous role, Stem was founder and CEO of monARC Bionetworks, a health data collection and analytics company aimed at modernizing clinical research by empowering patients to share their real-world data generated from routine care and digital tools so it can be transformed into real-world evidence that accelerates research and improves care.

“Glooko’s mission to empower people with diabetes to use their data to improve care and contribute real-world data to advance research is completely aligned with my passion to transform research and care using the growing body of real-world data,” Stem said. “I’m pleased to be joining the Glooko team as we continue leading the way in turning integrated diabetes data into actionable insights for people with diabetes and their providers.”

Prior to monARC Bionetworks, Komathi Stem has led the transformation of clinical trials via her leadership roles at Science 37, Genentech, AstraZeneca, Amgen and Eli Lilly. She holds a Master of Science degree in biomedical engineering from the University of Virginia.

Zach Henderson Named CCO of Glooko

As part of its continued global expansion, Glooko, the leader in diabetes digital health and data management solutions, today announced the appointment of Zach Henderson as Chief Commercial Officer.

In his new role with Glooko, Zach Henderson will have global responsibility for all commercial efforts, including the company’s work with its key strategic partners and revenue generation initiatives.

“As the leader in diabetes data management, Glooko is integrated with more diabetes and health devices than any other platform in the world, creating an opportunity to provide extensive insights. We have a unique opportunity to improve the lives of those with diabetes by leveraging the global Glooko data platform to advance research and the treatment of patients,” said Zach Henderson. “I’m excited to be joining the Glooko team as it transitions to its next phase of growth.”

Henderson comes to Glooko from LexisNexis Health Care and Elsevier, where he served as vice president of strategy, alliances and data sourcing and was responsible for the creation and development of a strategic alliance program of go-to-market and enablement partners, the negotiation of strategic partnership deals, and the integration of new business acquisitions. Prior to LexisNexis, he served in a range of senior commercial leadership roles at healthcare data and analytics companies, including Health Market Science and IMS Health (now IQVIA). Henderson earned an MBA from Villanova University.

Metactive Medical Announces Name Change to Artio Medical

Metactive Medical, Inc., a medical device company developing innovative products for peripheral vascular and neurovascular diseases, announced today that it has changed its name to Artio Medical, Inc. effective immediately.

“The corporate name change marks an important milestone as we progress toward commercialization,” said F. Nicholas Franano, MD, President and CEO of Artio Medical. “Artio is a Latin word meaning to place with a tight fit, which aligns with our strategy to design medical devices for precision placement and a hand-to-glove fit.”

Artio Medical was founded in 2014 as a small R&D group focused on developing metal implants for vascular embolization. The organization has since grown to include a team of exceptionally talented medical device professionals and expanded its focus to include flexible polymer implants to address a wide range of clinical needs and market opportunities, including artery, vein, and vascular aneurysm embolization. In conjunction with the corporate name change, the company has unveiled its new logo and website.

Artio Medical also announced new names for their portfolio of peripheral vascular and neurovascular embolization products under development, including:

  • Solus Gold™ Embolization Device for peripheral vascular embolization
  • Solus Flex™ Embolization Device for peripheral vascular embolization
  • Aneura™ Embolization Coils for peripheral aneurysm embolization
  • Aneura™ Embolization Device for peripheral aneurysm embolization
  • Endura™ Embolization Coils for cerebral aneurysm embolization
  • Endura™ Embolization Device for cerebral aneurysm embolization

Breakthrough Study Published Measuring the Effect of EOTTS to Reduce Medial Knee Compartment Forces

GraMedica, and the research team of Dr. Lukas Kolodziej, Dr. Rodney K. Summers and Dr. Michael E. Graham, is pleased to announce a groundbreaking study showing how Extra-Osseous Talotarsal Stabilization (EOTTS) can substantially reduce or possibly eliminate a leading cause of knee misalignment and arthritis.

GraMedica reports, the first of its kind, the study measured the in vivo forces acting within the medial knee compartment, before and after EOTTS. Millions of people suffer from chronic knee pain and every year that number continues to grow. Typically treatments are focused on pain relief or localized surgery to the knee. Pain relief does not eliminate or reduce the cause of knee pain. The results of conservative care, and even knee surgery, provide temporary relief; and these patients continue to have pain, or eventually have a recurrence of pain. What the research team found had been often overlooked in the treatment of knee pain, was misaligned feet.

Hindfoot misalignment, or talotarsal joint (TTJ) instability, occurs when the ankle bone partially dislocates on the heel bone. The naturally occurring space between the two bones, the sinus tarsi, should always be “open” just like an artery that carries blood throughout the body. While the link behind ankle bone displacement and knee pain is already known, the issue has been how to realign the ankle bone while still allowing a normal range of motion. With the development of an EOTTS stent – a titanium spacer called HyProCure® – that is placed into the sinus tarsi, the ankle and heel bones are instantly stabilized and realigned.

“The primary goal of knee treatment has always been to provide better stability and alignment. Failure to achieve that treatment goal leads to continued tissue stress on the knee, and continued pain,” says Dr. Kolodziej, the lead researcher in the study. “Many patients have claimed significant relief with their knee pain after the insertion of a type II EOTTS stent and we are pleased that this study confirms the importance of realigning and stabilizing the hindfoot for the prevention and treatment of chronic knee pain.”

The research from this study confirmed that ankle bone displacement leads to increased forces on the inner knee, the most common area of knee joint arthritis. The insertion of the HyProCure® titanium spacer/stent reduced the pressure by nearly 33%. This is the very first treatment that has shown this kind of reduction of pressure.

Medtronic Acquires Digital Surgery

Today (February 13, 2020) Medtronic announced the acquisition of Digital Surgery, a privately-held pioneer in surgical artificial intelligence (AI), data and analytics, and digital education and training. The acquisition of Digital Surgery will strengthen the Medtronic robotic-assisted surgery platform and has applicability for the Medtronic broader portfolio. The terms of the agreement are not being disclosed.

“Capabilities and solutions in the data and analytics space play a critical role in our continued focus on advancing minimally invasive surgery – from education and training to clinical decision support, to reducing cost and unwarranted variability,” said Megan Rosengarten, vice president, and general manager of the Surgical Robotics business, which is part of the Minimally Invasive Therapies Group at Medtronic. “We are thrilled to bring the Digital Surgery team and their expertise into Medtronic, not only due to the strategic fit from a technology perspective but due to the shared belief that patients around the world deserve access to quality surgical care. By pairing digital solutions with robotic platforms and instrumentation, we can have a big impact on expanding patient access.”

Headquartered in London, England, Digital Surgery’s mission is to digitize surgical protocols using cutting-edge computing and to support the delivery of consistent, data-driven and evidence-based surgical care.

“Joining Medtronic creates an incredible opportunity to realize the promise of reducing unwarranted variability in surgery,” said Dr. Jean Nehme, surgeon, CEO and co-founder of Digital Surgery. “We have always believed in computational power and data as two central drivers of consistency and quality in surgery. Computational power has impacted our lives in so many ways, and within surgery, it is almost absent. By joining forces with Medtronic, we will finally apply computing and AI to surgery on a meaningful scale with a goal of helping more patients in more places benefit from consistently high-quality surgical care.”

Digital Surgery will remain headquartered in London where there are plans for continued investment and workforce expansion. The company’s executive team, including the two surgeon co-founders, Dr. Andre Chow and Dr. Jean Nehme, will remain in place and continue to provide leadership. Digital Surgery and Medtronic’s co-developed digital solutions are expected to be offered on future Medtronic soft tissue robotic-assisted surgery systems.

Financial Highlights: The transaction is expected to be immaterial to Medtronic’s fiscal 2020 adjusted earnings per share and is expected to meet Medtronic’s long-term financial metrics for acquisitions. Digital Surgery will join the Surgical Robotics business as part of the Minimally Invasive Therapies Group.

Radiation Doses to the Heart Can Worsen Fatigue, Shortness of Breath in Cancer Patients

Radiation doses to the heart that occur during radiation therapy treatments for lung cancer, breast cancer, and lymphoma can increase fatigue, cause difficulty breathing and lower capacity for physical activity in patients with cancer, according to research presented at the American College of Cardiology’s Advancing the Cardiovascular Care of the Oncology Patient course. The course examines new science and best practices in assessing, diagnosing and treating the unique cardiovascular concerns of patients with cancer and/or those requiring survivorship care.

Cardiovascular disease is the second leading cause of death in cancer survivors, and it is estimated that 14.5 million cancer patients and survivors have significant cardiovascular risk factors. As more cancer patients are surviving and living longer, more long-term care issues are coming to light. Thoracic radiation therapy is a type of cancer treatment directed at the chest, heart and torso region and is highly effective in treating certain types of cancers in conjunction with chemotherapy. Thoracic radiation therapy can also cause side effects that can impact the quality of life.

Researchers in this study sought to examine thoracic radiation therapy as it impacted the quality of life in breast cancer, lung cancer and lymphoma patients. The study, conducted from 2015 to 2018, examined 130 patients with either breast cancer, lung cancer or mediastinal lymphoma who were treated with radiation to the chest. The median age of participants was 54 years and 78.5% were women.

Researchers collected data before radiation therapy was administered, immediately after the patient had received therapy, then five to nine months after the completion of radiation therapy. At each of these three-time points, patients were asked to self-report physical activity, which was assessed using the Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ). Fatigue and shortness of breath were assessed using the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue and Dyspnea Scales.

Different types of cancer showed different results:

  • Lung cancer and lymphoma participants reported an increase in fatigue and dyspnea immediately post-radiation therapy, which later improved. Each 1 Gy of increase in mean heart dose of radiation was associated with decreased GSLTPAQ scores. Additionally, every 10% increase in the volume of heart receiving a radiation dose of 5 Gy was associated with a significant reduction in GSLTPAQ scores.
  • Breast cancer participants reported significant increases in physical activity and decrease in fatigue over time. In this group, there was a non-significant trend toward increased fatigue with increasing radiation dose. However, when accounting for differences in radiation and chemotherapy treatment in these patients, high baseline moderate to vigorous GSLPTAQ scores were associated with improvements in fatigue over time.

“This study suggests that when a patient is treated with thoracic radiation therapy, it can have a negative impact on their quality of life early on. However, engaging in higher levels of physical activity before treatment may help to improve some of these symptoms over time,” said lead author Sheela Krishnan, MD, a fellow in the cardiovascular division of the Hospital of the University of Pennsylvania. “This study also confirms that increasing levels of physical activity during treatment are associated with concurrent improvements in quality of life. Though we cannot establish a clear causal relationship from these findings, it does emphasize that physical activity and quality of life are closely linked.”

Differences were observed between breast cancer and lung cancer and lymphoma patients, potentially due to differences in the delivered radiation doses. However, for all participants, accounting for the differences in chemotherapy and radiation dose they received, increases in physical activity over time were significantly associated with concurrent improvements in fatigue and shortness of breath. That’s why there are some who try the lymphoma new treatment.

“While our study is a small study, it suggests that high levels of physical activity prior to initiation of radiation therapy for cancer are associated with better physical functioning and quality of life with cancer treatment,” Krishnan said. “Additional work is still needed to understand the types and timing of exercises that can bring about the greatest benefit.”

Precision OS Trains More Than 300 Medical Device Representatives in 30 Minutes Using Virtual Reality

Precision OS Technology, developers of the medical-grade learning platform that advances surgical readiness, announced today that it carried out the first-ever and largest virtual reality training event of its kind for medical device representatives.

Held Jan. 22-25, the event brought together more than 300 medical device representatives who simultaneously accessed the training module on a complex surgical procedure. Precision OS was pleased to collaborate on the event with one of its most trusted partners in the medical device industry.

“Our educational approach has always been to deliver content that includes and goes beyond the implant,” said Dr. Danny Goel, a practicing orthopedic surgeon and Chief Executive Officer, Precision OS. “When considering how best to influence care and the transfer of appropriate knowledge to care providers, we must think along different models of education. Given these representatives provide an important role in the operating room, equipping them with advanced skills, implant comprehension and support capabilities efficiently and effectively is critical during multistep implantation of devices.”

The Precision OS training uses the mobile Oculus Quest and can be completed anywhere at anytime. Participants on the Precision OS platform can complete this multistep procedure in less than 30 minutes.

The virtual reality educational modules built by Precision OS provide a much-needed alternative to the time-intensive and costly exercises associated with traditional sales training. These reps have also historically resorted to flying to cadaver labs, listening to lectures, utilizing non-interactive training sessions via tablet and learning on-the-job during actual cases.

Despite the consistent use of these methods, studies have proven them to be less effective in the area of knowledge retention and skill transfer. Further, on-the-job learning presents significant risk variables which can influence patient outcomes and delay adequate support for complex procedures.

The Precision OS technology puts patient safety and outcomes back into the center of training, which both medical device reps and surgeons desire and appreciate.

After comparing and analyzing its method of training with those that have been traditionally used, Precision OS found a 570% gain in efficiency in learning with its approach in senior orthopedic surgical residents.

This landmark study, scheduled for publication in the coveted Journal of Bone and Joint Surgery (American) in the coming weeks, met the prestigious journal’s rigorous peer-reviewed standards for research. A major strength of the study was the research collaboration with the Canadian Shoulder and Elbow Society (CSES).

Virtual reality imparts an unmatched level of contextual learning by improving understanding, technical skills and surgical readiness. The Precision OS modules supply its users with deliberate practice that is cost-effective and scalable on a global level

“Considering the high stakes, effectively educating all members of the patient care pathway ensures we have the greatest chance to positively impact outcomes,” said Dr. Goel. “Our primary tenet is to be patient-centered and provider-focused. This is part of our culture and vision to deliver advanced education around the world.”

RedHawk Holdings Partners With Sales Organization to Market SANDD™ Needle Incineration Devices

RedHawk Holdings Corp. is a diversified holding company engaged in sales and distribution of medical devices, branded generic pharmaceutical drugs, commercial real estate investment and leasing, point of entry full-body security systems, and specialized financial services.

RedHawk Holdings announced they have partnered with Louisiana-based CKRX Enterprise LLC (“CKRX”) sales organization to market the Company’s ™DDSAN needle incineration devices.

With 8 marketing representatives located in New York, New Jersey, Connecticut, Massachusetts, Florida and Utah, CKRX markets a variety of value savings programs to hospitals, physicians, pharmacies and clinics including a free point of sale discount on both brand and generic prescriptions to an estimated 75,000 pharmacies.

Commenting on the new marketing representation agreement with CKRX, G. Darcy Klug, RedHawk Chairman, and Interim Chief Executive Officer commented, “Chez Ciccone and the CKRX team have built an impressive and well-established network of customer relationships within the medical community. By utilizing the established CKRX customer base to introduce our line of SANDD™ needle incineration devices to hospitals, physicians and pharmacies, we believe this partnership with CKRX is an efficient and economical way to execute our marketing business plan into the Northeast States, Florida and Utah. Also, Chez’s industry relationships reach far beyond these six states. We hope to leverage this partnership with Chez and CKRX as a model for SANDD™ product line sales expansion into other areas of the United States.”

Chez Ciccone, CKRX Chief Executive Officer, added, “We’re excited to be a part of this revolutionary concept represented by the SANDD™ line. SANDD™ helps providers and consumers mitigate the risk of needlestick injuries while reducing the cost of sharps disposal compared to traditional sharps disposal methods. Our sales organization collaborates with a variety of community partners including Case Managers, Healthcare Systems, Pharmacists, Physicians, Chambers of Commerce, Law Enforcement agencies and others. These groups have a great deal of contact with the audience that we believe will most benefit from access to the SANDD mini™ and the SANDD Pro™. Our clients are focused on minimizing healthcare costs while maintaining a safe workplace environment. So, if we can help our clients reduce their operating costs while minimizing exposure to needlestick injuries, we’ve done our job. This partnership with RedHawk brings our business to a new level by capitalizing on the CKRX customer relationships established and introducing them to this exciting, game-changing, cutting-edge technology.”

Neurovision Medical Products Receives Second Patent for Detection of Reversible Nerve Injury

NEUROVISION MEDICAL PRODUCTS, INC. announced that it has been granted United States Patent No. 10,517,493, making it the second patent related to the company’s nerve location platform, Nerveäna.

The Nerveäna system is designed to utilize the digital logic of NPI (Nerve Power Index) and gives surgeons the ability to collect and interpret data that detects nerve weakness before the onset of palsy during surgery. The technology allows surgeons to conveniently identify and avoid traction, stretching, or other insults that could lead to nerve damage. The ability to detect reversible nerve injury with the NPI algorithm can improve surgical outcomes for patients.

The NPI algorithm is an intuitive surgical tool that provides a real-time indication of the relative health and integrity of the nerve. A critical aspect of preventing irreversible nerve damage or vocal cord paralysis is the surgeon’s ability to identify and monitor at-risk motor nerves. With the unique algorithm, NMP has pioneered the use of data to expand the clinician’s awareness of nerve functionality intraoperatively. The NPI generates values corresponding to nerve strength within the dissecting process used to complete the surgery. Dr. James Lee Rea, CEO of NMP explains the distinct utilization of NPI:

“Unlike competitive platforms, the NPI requires no additional sensors and provides information by the same surgical instruments used in surgical maneuvers. A single NPI number, along with audio alerts, indicates the power of nerve and muscle response. The quality of conduction is audibly expressed by a two-tone system, with a higher-pitched tone occurring with an NPI >100, and a lower-pitched tone occurring with an NPI <100.”

NPI offers digital logic that can assist surgeons in their efforts to protect motor nerves and improve patient outcomes.

Jim Schuermann Appointed Independent Director at CorWave

CorWave reports Jim Schuermann was instrumental in transforming HeartWare, an LVAD start-up valued around $100M when he joined, into a $1+Bn Nasdaq-listed company. As Senior VP Sales & Marketing he led a rapid commercial scale-up from $0 to about $300M in annual sales.

After HeartWare’s $1.1Bn acquisition by Medtronic in 2016, Jim Schuermann became Vice President and General Manager of Medtronic’s Mechanical Circulatory Support Division, a newly formed business unit. In 2018, he joined Avedro, an ophthalmic pharmaceutical and medical device company focused on treating corneal ectatic disorders and improving vision, as Chief Business Officer. Avedro went public on the Nasdaq in early 2019 and was acquired by Glaukos in late 2019 for about $450M. Prior to joining HeartWare, Jim spent nearly a decade at Boston Scientific, where he held several sales and marketing leadership roles, eventually reaching global Director of Marketing of the company’s $235M Endourology franchise.

“I have been fortunate to see the LVAD space grow tremendously over the last decade. Nevertheless, the high rate of severe complications linked to current LVADs is holding back the market. I am excited to join the CorWave team and look forward to contributing to the development of this disruptive LVAD technology, which is the game-changer the market is looking for,” said Schuermann.

“We are delighted to welcome Jim as member of the board. His long experience and track record as a company builder in the LVAD space are exceptional and unique,” said CorWave chairman Gérard Hascoët.

“Jim Schuermann is a highly respected and experienced manager with compelling LVAD industry success. I am thrilled to work with him, because he has a perfect understanding of the challenges of heart failure and LVAD markets,” said Louis de Lillers, CEO of CorWave. “He is a solid asset to the team, and we will benefit from his extensive experience to grow CorWave into a global leader in heart failure therapies.”

CorWave is a medtech company focused on the development of an innovative Left Ventricular Assist Device (LVAD) to treat patients suffering from severe heart failure.