Saint Paul, MN—Minnetronix Medical, the company known for 25 years of developing and manufacturing products for medical device companies throughout the world, today announced that it has received FDA clearance for its first platform product: the MindsEye™ Expandable Port for neurosurgical procedures. This clearance represents an expansion of the company’s traditional offerings to include market-ready platforms.
The MindsEye Port is the first minimally invasive, expandable port designed for use in the treatment of stroke, cancer, and other conditions. The device’s dynamic retraction creates a custom-sized channel allowing surgeons to reach target areas deep within the brain. “This is next-generation deep brain access technology,” said Dr. Mario Zuccarello, Professor of Neurosurgery, University of Cincinnati Medical Center. “Minimizing invasiveness as much as possible is important to respect the eloquence of brain tissue. The MindsEye Expandable Port allows surgeons to work without unnecessary distractions, which ultimately improves quality of life for the patient.”
“Given its unique features, the port has already attracted interest among neurosurgeons and potential distribution partners. They’re excited to get their hands on it,” says Matt Adams, vice president and general manager at Minnetronix Medical. “The MindsEye Port is an exciting example of how Minnetronix Medical is expanding its offerings by developing market-ready products.” He adds that the port represents an entire platform for the company, as it has additional applications and complimentary product opportunities in the neuro market and beyond.
Category: news
Radius Health: Enrollment Completed for Phase 3 wearABLe Trial
Waltham, MA/(GLOBE NEWSWIRE)—Radius Health, Inc. (“Radius” or the “Company”) (Nasdaq: RDUS) today announced completion of enrollment in its “wearABLe” phase 3 trial.
The study was designed to look at the effects on bone mineral density of abaloparatide delivered via a novel transdermal device (“abaloparatide-patch”) compared with the current subcutaneous formulation, marketed as TYMLOS®. The study aimed to enroll 474 postmenopausal women with osteoporosis at high risk for fracture. Actual patients enrolled, based on demand, was approximately 500. These patients will be treated for 12 months and have a further one month on study for safety assessment at the completion of 12 months of therapy.
“We are delighted to have completed enrollment of the wearABLe study,” commented Dr. Charles Morris, Radius’ Chief Medical Officer. “This brings us one step closer to potentially having the ability to deliver osteoanabolic therapy through an alternative to daily subcutaneous injection,” he continued. “I am grateful to our teams, our investigators, and their patients who have helped us reach this milestone. We will share top-line data results in the fourth quarter of 2021.”
The abaloparatide-patch leverages the technology advances of the solid microstructured transdermal system, which was developed by Kindeva Drug Delivery, a spin-out of the 3M Corporation. This technology innovation allows the successful delivery of peptides — in our case, abaloparatide — across the skin. To date, this has not been proven possible by traditional transdermal patch capabilities.
This initiative was designed as a patient-centric approach and differentiating strategy for Radius as part of a multi-year partnership with Kindeva/3M. A successful trial and subsequent regulatory approval would provide patients with a new option of abaloparatide administration. Such an option is typically not available for biological products.
“This drug delivery technology is being developed to provide a favorable experience for patients with osteoporosis treated with TYMLOS,” commented Dr. Bruce Mitlak, recently named Head of Discovery Science for the areas of musculoskeletal, endocrinology, and metabolic for Radius.
Nutrisystem Launches Innovative Partner Plan to Encourage and Help Maintain Weight Loss
Philadelphia, PA/PRNewswire—Nutrisystem®, a Tivity Health® brand, announced today the launch of its new Nutrisystem Partner Plan, a program designed to enable two people living in the same home to experience the benefits of losing weight together. Studies continue to show that dieting with a partner leads to greater success and helps people maintain their weight loss.
According to a recent JAMA study, individuals are more likely to lose five percent or more weight if their partner joins them. A five percent weight loss is considered clinically significant to reaping health benefits like reduced risks of developing diabetes, heart disease, and certain types of cancer. Evidence suggests that people tend to exhibit the health behaviors of those around them and that partners greatly influence that behavior, especially in relation to diet and exercise. For Nutrisystem customers, social support and accountability are two factors proven to facilitate weight loss. Now, the Partner Plan offers Nutrisystem customers a shared experience to leverage those factors.
“Eating is a social event and with the new Nutrisystem Partner Plan, friends and loved ones can enjoy meals together,” said Tommy Lewis, President, Nutrisystem. “We are less likely to stay on a weight loss program when we feel like we’re all alone. Having a built-in support system at home means you’ll be able to motivate and celebrate each other as you hit goals. In today’s climate, it is more important than ever for our health to connect with and lean on the strength of loved ones.”
On the Nutrisystem Partner Plan, customers will receive one shipment every two weeks that includes meals and snacks for two people at one great price. The program also provides free access to the NuMi® app, unlimited support with Nutrisystem weight loss counselors and dietitians by phone or online any day of the week, and free shipping.
Customers can lose weight while eating the foods they love, made healthier. The program meets, or in most cases exceeds, recommendations set forth in the Dietary Guidelines for Americans. The plans include the right mix of nutrients to fuel your body—plenty of healthy, lean protein; high fiber to help keep you feeling fuller, longer; low-glycemic carbohydrates to stabilize blood sugar; and never contain artificial sweeteners or flavors.
Those with specific dietary needs can customize their program to include diabetes-friendly foods, vegetarian foods, or to exclude foods that contain milk, wheat, nuts, and more. Customers can tap into the knowledgeable team of Nutrisystem weight loss counselors to help them select foods that work for both partners’ needs.
CSafe Global Expands Further into Asia Opening Hub Operations in Taipei, Taiwan
CSafe Global has contracted with C.H. Robinson in Taipei to provide containers locally.
CSafe Global, the innovation leader in temperature-controlled container solutions for the transport of life-enhancing pharmaceuticals, has once again expanded their global reach and local presence with the opening of a new hub operation in Taipei, Taiwan.
This new addition to CSafe’s worldwide container operations facilities ensures Taiwan’s thriving biotech and pharmaceutical sectors have consistent, easy access for to the cold chain industry’s top performing containers. “We’ve been supplying containers to Taipei for some time now from our Hong Kong facility,” explained Tom Weir, chief operating officer for CSafe Global. “As the demand has consistently increased over time, we felt it important to invest in a local hub where we can inspect and service incoming containers so they can be released for usage by local organizations. To do this efficiently, we’ve partnered with C.H. Robinson in Taipei to make units available at their Taiwan International Global Forwarding facility.” CSafe will have access to 2,500 square-feet of space to store CSafe RKN and RAP containers.
CSafe continues expanding its presence in Asia by investing in best-in-class facilities to provide the best service possible to customers in their local area.
SilverSneakers Calls for 2020 Swanson Inspiration Award Nominations
Chandler, AZ/PRNewswire—SilverSneakers®, the nation’s leading community fitness program for older Americans by Tivity Health® (Nasdaq: TVTY), is currently accepting nominations for the 16th annual SilverSneakers Swanson Inspiration Award. This prestigious national award honors SilverSneakers members who have improved their lives through a healthy lifestyle that incorporates fitness and social interaction, while helping others navigate their own fitness journeys.
The call for nominations is open through August 7, 2020 at SilverSneakers.com/SwansonAward and anyone can nominate an inspiring SilverSneakers member. The top 10 nominees’ stories will be shared on the SilverSneakers website where the public will select the national award recipient. Online voting will begin August 24, 2020, and the winner will be announced on September 14, 2020.
“Despite the challenges our SilverSneakers members have experienced due to the COVID-19 pandemic, there have been remarkable members who continue to inspire, support and motivate others to improve their quality of life no matter the obstacles,” said Richard Ashworth, president and CEO, Tivity Health. “That perseverance and commitment embody the spirit of the Swanson Inspiration Award and the power of the SilverSneakers community across the country. We honor our award winners who are core to our mission and who are leaders in their member communities.”
Even though COVID-19 has made staying fit and healthy more challenging, SilverSneakers members have access to multiple digital engagement options, enabling them to stay active while staying safe. Facebook Live, SilverSneakers Live and SilverSneakers Flex fitness classes are available for all members. We have had significant participation in our new virtual options. As of July 2020, there have been 10.2 million views of our Facebook Live classes alone. SilverSneakers will continue offering virtual exercise, nutrition, health and social community options for members to continue their fitness regimens while practicing safe social distancing behaviors.
Over 16 million people are eligible for the SilverSneakers benefit generally at no additional cost through their Medicare Advantage, Medicare Supplement and group retiree plans. The program is offered at more than 17,000 participating fitness locations nationwide, where members can take advantage of amenities and various class offerings including signature SilverSneakers classes and SilverSneakers BOOM™, all led by certified instructors for ongoing support. In addition, SilverSneakers FLEX® classes, also led by certified instructors, are offered in neighborhood venues outside the traditional fitness center.
Altaris Announces IPO of Trean Insurance Group, Inc.
New York, NY—Altaris Capital Partners, LLC is pleased to announce that Trean Insurance Group, Inc. (“Trean”) priced its initial public offering at a price of $15 per share, the top of the previously announced valuation range, resulting in gross offering proceeds of approximately $160 million through a combination of primary and secondary shares. The shares began trading on the Nasdaq Global Select Market on July 16, 2020 under the symbol “TIG”.
Trean is a specialty insurance company that sells products through its program partners and managing general agencies. Trean also provides a variety of services including issuing carrier services, claims administration and reinsurance brokerage. Trean is licensed to write business across 49 states and the District of Columbia.
J.P. Morgan, Evercore ISI and William Blair acted as joint book-running managers for the offering. JMP Securities acted as a co-manager.
Paramit Sponsors Life Science Angels
Morgan Hill, CA—Paramit Corporation, a leading developer and manufacturer of medical devices and life science instruments, is pleased to announce our sponsorship of Life Science Angels, a not-for-profit corporation with 130-150 accredited investor members, 12-18 highly qualified Fellows, and 12-15 Sponsor organizations.
Life Science Angels was founded in 2005 by active members Allan May and Casey McGlynn. The organization has invested over $60 million in over 100 startups exclusively in the life science industry. They are located in Silicon Valley, although their portfolio companies are widespread geographically.
Their mission is to improve healthcare worldwide by helping entrepreneurs with disruptive advances in healthcare discovery and delivery.
CSafe Global Mobile Refrigeration Units Ensure Safe Transport of COVID-19 Test Kits
CSafe Global’s AX56L active mobile refrigeration unit is allowing Genome LLC to safely transport COVID-19 test kits to their lab for analysis.
CSafe Global, the innovation leader in temperature-controlled container solutions for the transport of life-enhancing pharmaceuticals, is working with Genome LLC to ensure that their COVID-19 genetic testing kits arrive safely at Genome’s lab for analysis using CSafe’s AX56L mobile refrigeration units.
Genome is a high complexity, genetic testing lab based in South Florida that is specializing in COVID-19 testing. According to Genome, their genetic test protects against false positive and negative results because it detects the actual virus in your system using genetic analysis rather than looking for antibodies in a patient’s blood.
Because the genetic testing process is so complex, it is critical that the nasal and throat swabs collected from patients remain at sub-zero temperatures from the time of collection until they are tested. If the testing was happening at the collection site, this would be a simple process, however, Genome has two testing locations that require the samples to be transported from the collection site to the lab.
This is where CSafe’s AX56L mobile refrigeration unit comes in. Built with emergency services and field medical use in mind, the unit is small enough to fit into the back of any SUV for easy transport. The AX56L is a small active system lined with VIP insulation that requires no ice or additional coolants to maximize the 56L payload space. It offers a broad operating range (-20°C to +49°C / -4°F to +120°F) using forced air convection, a 48-hour payload temperature duration on internal batteries and a safety alarm for temperature deviations.
Using these small active systems, Genome safely transports samples every day and is able to quickly analyze them and provide highly accurate results to patients allowing them to either self-quarantine, eliminate a cause for their symptoms, or rest assured they are not spreading the virus.
CSafe Global Completes Successful Commercial Pilot of Real-Time Track and Trace Technology
Dayton, OH—CSafe Global has completed the first commercial test of their new location and temperature tracking technology with exemplary results.
CSafe Global, the innovation leader in temperature-controlled container solutions for the transport of life-enhancing pharmaceuticals, became the first cold chain packaging provider to successfully implement track and trace technology into their active air cargo containers following a flawless commercial pilot shipment.
CSafe partnered with DHL, a leading logistics company, for the pilot shipment. The RKN containers were loaded with temperature-sensitive pharmaceuticals and flown from Puerto Rico to Kentucky and then transported by truck to their destination in Chicago.
The shipment began when CSafe engineers successfully integrated state-of-the-art tracking devices into the RKN containers. These tracking devices provide real-time location, container temperature, ambient temperature, container tilt, container shock, door opening/closing events and humidity.
“This technology will bring the insight into shipment status and product condition that customers expect,” noted Tom Weir, CSafe’s Chief Operating Officer. “The tracking devices continually collect data and deliver it in real-time to a cloud-based platform. From there customers and CSafe support staff will have 24/7 access to monitor every shipment and intervene if necessary. It’s this ability to intervene that will give CSafe customers additional peace of mind that their products will arrive in perfect condition for patients. Being first to market with this type of innovation demonstrates CSafe’s commitment to best-in-class products and continuous improvement across our product portfolio.”
With this first commercial pilot now finished, CSafe will move on with additional commercial test shipments during the next few months and incorporate customer feedback into their custom visibility platform. The platform will be device agnostic and able to track additional, commercially available telemetry devices. This flexibility is essential for CSafe as they implement the technology across their entire portfolio of Air Cargo, Parcel and Cell & Gene solutions.
As a key partner focused heavily on their Strategy 2025 of digitalization, DHL has been very supportive of CSafe’s efforts on this project. Patricia Cole, global head Temperature Management Solutions and Same Day for DHL Global Forwarding, noted that, “We at DHL appreciate partners who are dedicated to innovation that not only meets the current need, but goes well beyond to anticipate the future needs of our customers. This technology will revolutionize the cold chain and we are thrilled to be involved.”
CSafe’s CEO, Patrick Schafer, was not at all surprised that the team delivered in spite of challenges 2020 has brought with it. “Tom and his entire team have been researching, planning, testing and retesting every aspect of this project for months to ensure we provide the best possible hardware, software and experience to our customers. They enlisted help and insight from our partners and customers and the result is once again something we are all very proud to offer. While others may have delayed or cancelled innovation efforts due to COVID-19, we saw it as an opportunity to truly test the equipment and software. As always, the CSafe team, our partners at DHL and our active containers performed exceptionally well.”
Tivity Health Appoints Healthcare Industry Veteran Richard Ashworth President and CEO
Healthcare leader brings wealth of operational, consumer and business development experience.
Nashville, TN—PRNewswire—Tivity Health®, Inc. (Nasdaq: TVTY), a leading provider of fitness, nutrition and social engagement solutions, announced today that its Board of Directors has appointed Richard Ashworth as President and Chief Executive Officer effective June 1. Ashworth most recently served as the president of Walgreens, where he was responsible for developing the strategies and plans for all Walgreens operations including leadership, development and management of the business. He will also serve on Tivity Health’s Board of Directors.
In his nearly 30-year career with Walgreens, Ashworth helped lead the transformation of the brand to become a global leader in pharmacy and health and wellness. Ashworth served as President of Operations from November 2017 to February 2020. Ashworth led the Company’s pharmacy segment as President of Pharmacy and Retail Operations from 2014 to 2017. In 2013, Ashworth also led the development and delivery of the healthcare strategy for the Company’s strategic partnership with U.K.-based Alliance Boots, which Walgreens later acquired.
“We are excited to bring someone with Richard’s extensive background in health and wellness to Tivity Health. Richard has significant experience navigating a rapidly changing healthcare landscape while serving a portfolio of large customers and individual consumers in the intensely competitive retail realm,” said Anthony Sanfilippo, Chairman of the Board of Directors. “We conducted a thorough search and we believe Richard is the right person to lead the Tivity Health team. Richard will leverage our core capabilities in healthcare and consumer-focused nutrition programs to deliver market-leading solutions that focus on profitable revenue growth. With a disciplined approach to managing the business, we are confident Richard will move the Company forward as a leading provider of healthy lifestyle solutions that improve health and lower healthcare costs.”
“Tivity Health is a leader in helping adults adopt healthier behavior through physical activity, nutrition and weight loss, and social engagement solutions. I am excited to partner with our Medicare Advantage clients who invest in the health and well-being of millions of beneficiaries,” said Ashworth. “I look forward to building on the Company’s 30-year history and its deep relationships with health plan clients and employers, while charting a course for growth to build Tivity Health’s trusted brands to deliver even greater value to our shareholders, consumers, clients, partners, and colleagues.”
Richard will be stepping into a role that has been filled by Bob Greczyn, Interim CEO, since February 19, 2020. Greczyn has been a member of the Tivity Health Board of Directors since 2015 and has over 30 years of leadership experience in managed care and healthcare.
“Bob has been an exceptional Interim CEO. In the months that he has led the Company, the country has been disrupted by a global pandemic which immediately changed how all businesses operate,” said Sanfilippo. “On behalf of the Board, we thank Bob for agreeing to serve as Interim CEO and for actively galvanizing and inspiring our colleagues to move the Company forward. Our Tivity Health team, through Bob’s leadership, and with prompt and innovative action, has continued to serve our members and customers, providing solutions to promote a better and healthier lifestyle. We’re fortunate that we will continue to benefit from Bob’s experience as a member of the Board.”
Ashworth has a Doctor of Pharmacy degree (PharmD), and a master’s degree in business administration. He will be based at Tivity Health’s Franklin, TN campus.