Category: news

Minneapolis, MN—Minnetronix Medical, Inc., was honored by the Minneapolis St. Paul Business Journal with a 2021 Minnesota Manufacturing Award for Product Innovation for the Minnetronix MindsEye™ Expandable Port. Minnetronix partners with medical device companies to develop products from design through commercialization. The company also offers a portfolio of whole product solutions in neurocritical care for direct sale or distribution to health care providers.
The Business Journal’s fourth annual Minnesota Manufacturing Awards recognizes some of the industry leaders that drive the economy of the region, known as Medical Alley due to its high concentration of health and care innovators, and grow their companies through innovation and strategic evolution.
The Minnetronix Medical MindsEye™ Expandable 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 next-generation deep brain access technology minimizes invasiveness to brain tissue and allows surgeons to work without unnecessary distractions and preventing secondary injury.

St. Paul, MN—Minnetronix Medical, Inc., a leading medical technology partner to global medical device companies, today announced that its MindsEye™ Expandable Port has won the “Best New Technology Solution – Surgical” award in the fifth annual MedTech Breakthrough Awards program. The program is conducted by MedTech Breakthrough, an independent market intelligence organization that recognizes the top companies, technologies and products in the global health and medical technology market.
The MindsEye™ Expandable 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 neurosurgeons to reach target areas deep within the brain. This next-generation deep brain access technology minimizes invasiveness to brain tissue and allows surgeons to work without unnecessary distractions.
“Managing risks in neurocritical care is a complex business, with secondary injury as a critical potential complication. We’re developing therapeutic solutions to keep neurosurgeons ahead of secondary injury, enabling better outcomes in neurocritical patients,” said Jeremy Maniak, Minnetronix CEO. “The MindsEye™ Port is next-generation technology. Given its unique features, the port has already attracted interest among neurosurgeons and potential distribution partners,” he added. “We are honored to receive this 2021 MedTech Breakthrough Award. This is a testament to the hard work and dedication of the entire Minnetronix Medical team.”
The mission of the MedTech Breakthrough Awards is to honor excellence and recognize the innovation, hard work and success in a range of health and medical technology categories, including Robotics, Clinical Administration, Telehealth, Patient Engagement, Electronic Health Records (EHR), mHealth, Medical Devices, Medical Data and many more. This year’s program attracted more than 3,850 nominations from over 17 different countries throughout the world.
“The complexity of neurocritical care means unforeseen challenges are inevitable, and MindsEye helps reduce procedural risk in addressing these challenges, as well as enabling earlier intervention, accelerated healing, and improving overall quality of life for patients,” said James Johnson, managing director, MedTech Breakthrough. “Congratulations to Minnetronix Medical for this incredible piece of technology that will save lives. We’re thrilled to present you with this 2021 MedTech Breakthrough Award.”

Nashville, TN—PRNewswire—Total average healthcare expenses are significantly reduced by 16% for SilverSneakers^® participants compared to non-participating Medicare Advantage members, according to a new comprehensive scientific study. The study was conducted by well-respected healthcare consulting firm Avalere Health and released today by Tivity Health^® Inc. (Nasdaq: TVTY), a leading provider of health improvement solutions, including SilverSneakers^®, the nation’s leading community fitness program for older adults.
The study’s findings showed total annual average health expenses, including medical and pharmacy, among SilverSneakers participants to be $4,463 compared to $5,303 for non-participants. Medical component of costs was decreased by 26%, driven primarily by reductions in hospitalization costs. Use of outpatient care was higher for SilverSneakers members combined with less acute care, indicating better health management among participants compared to non-participants.
The study used clinical data to establish an evidence-based narrative on the value of the SilverSneakers program related to healthcare costs, utilization, and quality measures. SilverSneakers participant data was shared with Avalere to link up with Medicare Advantage healthcare claims data and matched participants with a similar cohort of non-participating Medicare Advantage beneficiaries.
After starting the SilverSneakers program, participants experienced a significant 42% fewer hospital stays, and 18% fewer ER visits compared to Medicare Advantage non-participants. Length of stay for hospitalizations was also significantly shorter for SilverSneakers participants, 4.4 days compared to 5.8 days for non-participants. This reinforces that SilverSneakers both improves the quality of life for health plan members and reduces overall cost of care.
“We hear about the physical, emotional and social impact SilverSneakers has on our members every day, but this data validates research from the strategic advisory firm Avalere Health, that the program is proven to improve health outcomes and reduce healthcare costs for seniors,” said Richard Ashworth, president and CEO of Tivity Health. “As health plans consider the supplemental benefits they offer, the impact on outcomes and cost is a deciding factor. SilverSneakers delivers even greater value in partnership with our health plans to enhance the patient care experience, improve the health of our senior population and reduce the per capita cost of healthcare.”
SilverSneakers participants also performed significantly better on key quality measures including all-cause 30-day readmissions, adherence to hypertension and cholesterol medications, diabetes care (HbA1c testing and eye exams), and many preventive screening measures including colonoscopy, depression, cholesterol, breast cancer, and prostate cancer screening when compared to non-participants.
“Aetna shares Tivity Health’s passion for encouraging Medicare Advantage members to stay active and connected, especially during the pandemic,” said Christopher Ciano, President of Aetna Medicare. “We recognize that staying active has a significant positive impact on members’ total health and well-being. We’re pleased that many of our Medicare Advantage members are taking advantage of the SilverSneakers online workouts and videos during this time.”
To ensure the study was designed and executed appropriately, each participant was matched using a 1:5 match ratio participant versus matched controls. Once matching was complete, more than 50,000 participants and matched controls were included in the evaluation. The study compared differences in cost and overall health improvement outcomes between the SilverSneakers members and the control group of similar non-participating Medicare Advantage patients. There are also several areas of comparison demonstrating that SilverSneakers leads to improved Stars ratings, a measurement system used by Medicare to measure how Medicare Advantage and Part D plans perform.
For more information and to view the full survey findings, visit the “Insights” section of the Tivity Health website at www.TivityHealth.com.

New York, NY—Altaris Capital Partners, LLC (collectively with its affiliates, “Altaris”) announced today that it has entered into an agreement with Michelin to acquire a 51% stake of Solesis, Inc. (“Solesis”). Following closing of the transaction, Michelin will retain a 49% stake in Solesis and will work alongside Altaris to build Solesis as an independent company. As part of this transaction, Solesis and Michelin will form a research partnership to develop complex polymers for life sciences and medical technology applications. The transaction is expected to close in the second quarter, subject to customary closing conditions.

Founded in 2002, Solesis is a market leader specializing in biomaterials for the life sciences industry. Operating through three subsidiaries, The Secant Group, Charter Medical and SanaVita

Medical, Solesis develops, manufactures and sells critical components for implantable medical devices and single-use technologies for the biopharmaceutical market, including cell and gene therapies. Based in the United States, Solesis employs 360 people across four production facilities located in Pennsylvania and North Carolina.

Altaris is an investment firm focused exclusively on the healthcare industry. Altaris targets companies that deliver value to the healthcare system by improving patient outcomes, eliminating unnecessary costs, increasing efficiency and aligning stakeholder incentives. Since inception in 2003, Altaris has made more than 40 platform investments. Altaris has $5.2 billion of equity capital under active management and is headquartered in New York, NY. For more information, please visit www.altariscap.com.

St. Paul, MN—Kindeva Drug Delivery L.P. (Kindeva) announced that Greg Sargen has joined Kindeva’s Board of Directors. The appointment of Mr. Sargen is effective as of April 5, 2021. Mr. Sargen, with over 20 years of experience in the biopharmaceutical and pharmaceutical services industries, will act as a valuable advisor to Kindeva, especially on matters related to finance and business strategy.
Mr. Sargen has held senior leadership and board roles at multiple contract development and manufacturing organizations (CDMOs) and life science companies. He has deep experience in finance, strategy, M&A, and corporate carve-outs in the pharmaceutical services sector. Most recently, he was Executive Vice President of Corporate Development and Strategy and Chief Financial Officer at Cambrex Corporation, where he played a crucial leadership role in growing Cambrex’s business through aggressive internal investment and strategic acquisitions. Mr. Sargen has had senior finance roles at Expanets, Inc. and Fisher Scientific International, Inc. (now Thermo Fisher Scientific, Inc.) and has also held positions at Merck & Co. and Deloitte & Touche LLC.
“Greg’s experience in pharmaceutical services, both as a CFO and a Board Director, is highly relevant to Kindeva,” said Aaron Mann, CEO of Kindeva. “I welcome him to our Board of Directors and am excited to work closely with him as we execute our strategy.”
“I am honored to have the opportunity to serve on this Board and help Aaron and his management team any way I can at this exciting juncture in Kindeva’s history,” said Mr. Sargen. “Kindeva is well-positioned to leverage its considerable strengths in complex drug formulations and delivery methods in the years ahead.”
Mr. Sargen also serves on the Boards of Directors for Avid Bioservices, a CDMO focused on the development and manufacturing of biologics, and Protara Therapeutics, a drug development company. He is a Certified Public Accountant and holds an M.B.A. in Finance from the Wharton School of the University of Pennsylvania and a B.S. in Accounting from Pennsylvania State University.

St. Paul, MN—Kindeva Drug Delivery L.P. (Kindeva) and Cambridge Healthcare Innovations Limited (CHI) have entered into a collaboration to develop and commercialize CHI’s αeolus dry-powder inhaler (DPI) platform technology. The collaboration will leverage Kindeva’s product development, regulatory affairs, and manufacturing capabilities in tandem with CHI’s DPI technology and device development expertise. To accelerate platform and product development, Kindeva and CHI will evaluate a range of drugs for the αeolus platform. This initial work will inform development programs undertaken in partnership with biopharmaceutical companies. Additionally, the initial drugs evaluated, subject to all required regulatory approvals, could become products to treat a range of respiratory diseases. The αeolus technology platform could also be used for the systemic delivery of drugs to the lungs, addressing a broader range of conditions.
CHI is a medical device company with deep expertise in inhalation drug delivery, designing and developing devices that enhance treatment for patients suffering from asthma, COPD, and other chronic diseases. The αeolus technology platform has been designed to promote greater delivery efficiency and consistency that is independent of patient effort, potentially leading to dose sparing. As a true platform technology, αeolus-driven devices may be available in multiple variants that utilize the same core technology. These variants include single-use, reusable, and multi-dose devices, which have the potential to incorporate SMART electronics and enable connectivity.
Kindeva is a leading global contract development and manufacturing organization (CDMO) that has a legacy of solving complex drug delivery challenges across a range of delivery formats, including inhalation. The company has over 60 years of innovation experience in inhalation. Kindeva’s novel achievements include the invention of the world’s first metered-dose inhaler (MDI) and the world’s first CFC-free MDI. This collaboration with CHI represents a natural extension of Kindeva’s DPI experience, building on significant prior work and strong global capabilities.
“With their unrivaled history and expertise in inhaled drug-delivery, Kindeva is the ideal partner to bring this revolutionary technology to the market,” said David Harris, co-founder and Chief Technology Officer of CHI. “We’re excited to be working together to bring pharmaceutical customers’ products to market faster and at significantly reduced risk, and to offer the unique opportunity to deliver therapies beyond the reach of existing inhalation technology. We’re looking forward to redefining what inhalers can achieve.”
“We are excited to partner with CHI to develop and commercialize a truly novel DPI technology platform,” said Aaron Mann, CEO of Kindeva. “As leaders in inhalation product development, Kindeva understands that the industry must embrace the development of patient-centered technologies in order to meaningfully improve the way patients are treated. The αeolus technology is designed to avoid many of the drawbacks of existing inhalation technology, addressing the need for efficiency, simplicity, and consistency of delivery, which lead to a more robust patient experience.”
Under the agreement, Kindeva will lead business development and product development activities, including toxicology, process development, and clinical design, while CHI leads technology and device development. The parties expect that their collaboration will lead to the development of multiple commercial products, with confidential discussions already underway with several global biopharmaceutical companies.

New York, NY—Altaris Capital Partners, LLC (“Altaris”) is pleased to announce that it has exited its investment in Senior Helpers through a transaction with Advocate Aurora Enterprises, a subsidiary of the not-for-profit, integrated health system Advocate Aurora Health. As part of the transaction, Altaris will retain Town Square^®, which offers unique, interactive day programs for elderly individuals nationwide.
Senior Helpers is an owner and franchisor of professional home care services. Founded in 2002, the company has over 320 locations in 44 states across the U.S., Australia and Canada. Senior Helpers’ caregivers provide essential home care services, including meal preparation and nutrition, personal care and hygiene, housekeeping and transportation, designed to allow elderly individuals to stay in their homes as long as possible. Senior Helpers also offers specialized care programs in Alzheimer’s and dementia, as well as Parkinson’s disease.
Altaris is an investment firm focused exclusively on the healthcare industry with $5.2 billion of equity capital under management. Altaris targets companies that deliver value to the healthcare system by improving patient outcomes, eliminating unnecessary costs, increasing efficiency and aligning stakeholder incentives. Since inception in 2003, Altaris has made more than 40 platform investments. Altaris is headquartered in New York, NY. For more information, please visit www.altariscap.com.

Nashville, TN—Clearwater, the leading provider of Enterprise Cyber Risk Management and HIPAA Compliance solutions for the healthcare industry, announced today new innovations being introduced as part of the forthcoming 6.0 release of its flagship software product IRM|Analysis. Focused on helping customers more confidently and efficiently analyze cyber risk across their enterprise, the innovations further establish Clearwater as the go-to partner for healthcare organizations seeking to understand where their greatest risks lie and take action in addressing them.
Used by many of the nation’s largest health systems, major physician groups, leading health IT companies, and other business partners, IRM|Analysis has become the healthcare industry’s gold standard for performing a comprehensive, efficient, by-the-book risk analysis and managing risks on an ongoing basis since the first release of the product nearly ten years ago.
The new innovations, which draw upon the software’s vast pool of data, deliver even greater power and value to customers.
More Intelligent: AI-Driven and Community-Powered Predictive Risk Rating
A risk rating is a function of the likelihood of a threat exploiting an information technology (IT) asset vulnerability and the impact to the organization should the exploit be successful. Determining the likelihood and impact requires careful analysis of controls in place for that asset by an analyst, and it can be a time-consuming, subjective, and error-prone process.
IRM|Analysis employs built-in algorithms to:

• Determine potential vulnerability and threat scenarios that should be considered
• Automatically suggest which controls are recommended to mitigate threats exploiting vulnerabilities in these specific scenarios
• Provide a standard means to rate risk based on both the likelihood of an event (based on the controls in place or not in place) and the harm that would be caused (based on the importance of the information system or its data to that organization)
• Enable an organization to prioritize and report on risks across the enterprise in a consolidated or “drill down” manner through integrated reporting tools and dashboards

With the introduction of a new Predictive Risk Rating capability in IRM|Analysis, Clearwater is leveraging Artificial Intelligence (AI) and Machine Learning technology to tap into more than a million risk ratings generated by the company’s experts and its community of software users to help healthcare organizations more quickly and confidently analyze risk across the enterprise.
“In 2019, we advanced IRM|Analysis with our patented Component Expert System technology, providing customers with a more intelligent view into all of the processes, people, locations, and technology that can pose a data security risk to an information system.,” says Jon Stone, Clearwater’s Chief Product Officer and the lead architect behind IRM|Analysis. “Now we are making IRM|Analysis even more intelligent for customers by providing AI-driven predictive risk ratings that draw upon more than a million risks scenarios that have been analyzed within the software over time.
“The goal is to help healthcare organizations make better risk rating decisions and maximize limited resources by freeing up Risk Analysts and Managers to do higher order work in documenting the impacts of an analysis rather than getting bogged down in data preparation,” he added. “Risk rating recommendations can be automatically accepted or simply serve as guidance for the user.”
More Insightful: Peer-to-Peer Benchmarking
The new release of IRM|Analysis is also bringing more insight to customers in the form of new benchmarking capabilities that empower organizations to compare their performance across key risk analysis and risk management metrics to relevant peers. Peer-to-Peer Benchmarking includes comparative data such as:

• The percentage of risks greater than or equal to the defined threshold
• The top vulnerabilities associated with risks that are greater or equal to the threshold
• The percentage of controls that are missing or deficient for risks greater than or equal to the threshold

“One of the most common questions we are asked by customers is, how do our metrics compare to other organizations in the industry?” Stone says. “Delivered as part of the CyberIntelligence Dashboards in the software and available to all Platinum and Gold subscribers, customers can now get direct access to that insight.”
More Automated: Integration with ServiceNow IT Asset Management
Analyzing cyber risk begins with building a comprehensive IT asset inventory. Through integration with ServiceNow’s IT Asset Management solution, which a growing number of healthcare organizations use to maintain their asset inventory, IRM|Analysis enables users to address the first steps of the risk analysis process in a more rapid and automated manner.
“With limited resources and a rapidly evolving IT environment, developing an asset inventory to support a comprehensive risk analysis can be a challenge for organizations,” Stone says. “The integration we have developed between ServiceNow and IRM|Analysis brings automation to the process that will make it significantly easier and more efficient for our customers.”
These latest innovations build on the tradition of innovation and leadership that has helped Clearwater earn the #1 rating for Compliance and Risk Management solutions in Black Book Market Research’s annual healthcare industry survey the past four years in a row. The new capabilities will be available as part of the 6.0 release of the software, scheduled for deployment later this month.

Global contract development and manufacturing organisation (CDMO) Kindeva Drug Delivery has expanded its operations at Charnwood Campus, in a deal expected to support Kindeva’s continued growth in the UK.
The US-headquartered company will take over a state-of-the-art research and development facility at Charnwood Campus, and a further 20,000 square feet of office space at the site.
Formerly 3M Drug Delivery Systems, Kindeva specialises in solving complex drug delivery and combination product challenges for its pharmaceutical and biotechnology customers, and currently employs over 500 staff in the UK across its two sites at Charnwood Campus, its Loughborough plant, and its Clitheroe plant. The company formulates, develops, and manufactures therapies used by patients suffering from serious health conditions including respiratory illnesses, central nervous system disorders, and cancer.
Charnwood Campus is now home to four blue-chip organisations including Almac, 3M, Kindeva, and global diagnostics company PerkinElmer.
Commenting on the deal, Gosia Khrais, Charnwood Campus Commercial Director says: “Kindeva’s expansion is great news for both the Charnwood site and the local area, with the company’s ambitious growth plans set to create new office-based roles as well as safeguard hundreds of highly valuable scientific jobs in Loughborough and the East Midlands.
“The deal is another significant milestone in our long-term development plan and further reinforces the East Midlands’ and Loughborough’s reputation for outstanding pharmaceutical research and development.
“With a strong legacy of more than 60 years of pharmaceutical innovation, Kindeva is a well-established business and a significant player in the global drug development and delivery pharmaceutical industry,” she adds. “We feel honored the company has chosen to expand its operations at Charnwood as well as support us in playing our part in the UK’s economic recovery.”
“As a growing CDMO and life sciences company, Kindeva thrives on our base of well-trained, highly-qualified leaders in scientific research and development,” said Aaron Mann, CEO of Kindeva Drug Delivery. “The Charnwood campus provides a state-of-the-art laboratory design to support our industry-leading talent. Importantly, the proximity to general management offices promotes cross-functional collaboration between our R&D team and other areas of the business, enabling consistent feedback of customer needs and insights into our R&D activities.”
Councillor Jonathan Morgan, Leader of Charnwood Borough Council, said: “This is excellent new for Charnwood Campus and the borough. I am delighted that not only are a significant number of jobs being safeguarded, but more are being created, which is important as we look to the future and recovery from the pandemic. One of the Council’s top priorities is to support the growth of the local economy and sites like Charnwood Campus will play a key role in that growth.”
Charnwood Campus is the first and only Life Sciences Opportunity Zone in the UK and part of the Loughborough and Leicester Science and Innovation Enterprise Zone.

Pittsburgh, PA and St. Paul, MN—Viatris Inc. (NASDAQ: VTRS) and Kindeva Drug Delivery L.P. today announced that the U.S. Food and Drug Administration (FDA) granted tentative approval of budesonide/formoterol fumarate dihydrate products, the first generic version of Symbicort^® based on an Abbreviated New Drug Application (ANDA). Symbicort is indicated for certain patients with asthma or chronic obstructive pulmonary disease (COPD).
Viatris CEO Michael Goettler commented: “The FDA’s tentative approval of generic Symbicort represents yet another significant milestone for Viatris in advancing access to treatment for respiratory patients. It also further demonstrates our deep commitment to continuing to leverage our scientific and regulatory expertise for a wide range of noncommunicable and infectious diseases. Our success with this partnership and approval underscores how Viatris intends to execute and optimize our Global Healthcare Gateway^® as a Partner of Choice™ for companies such as Kindeva to expand access to medicines for patients worldwide.”
Viatris President Rajiv Malik added: “I am very proud of this important regulatory milestone as it once again demonstrates our strong scientific and regulatory teams’ continued success. This only further enhances our confidence that through the Global Healthcare Gateway^® and partnerships, like this one with Kindeva, we will continue to build and commercially launch robust branded and complex generic portfolios.”
The FDA provided tentative approval at this time due to ongoing patent litigation. On March 2, 2021, the U.S. District Court for the Northern District of West Virginia found that the asserted claims of AstraZeneca’s Symbicort patents, U.S. Patent Nos. 7,759,328, 8,143,239, and 8,575,137, are not invalid for obviousness. Viatris and Kindeva disagree with the district court decision. While the trial court decision prevents commercial launch at this time, the companies intend to file an appeal to continue vigorously defending their position that the patents are invalid. Viatris and Kindeva are committed to bringing a generic Symbicort to market as soon as possible.
“This FDA tentative approval reflects the strength of the partnership between Viatris and Kindeva, and further demonstrates Kindeva’s industry-leading capabilities in formulation, development, and manufacturing of complex combination products,” said Aaron Mann, CEO of Kindeva Drug Delivery. “Once final FDA approval is achieved, Kindeva looks forward to providing Viatris with reliable, quality supply from our state-of-the-art commercial filling and packaging lines in our Northridge, California facility.”
Viatris has not planned any revenue for 2021 from generic Symbicort, and the product’s potential launch revenue was not included in the company’s recently announced 2021 financial guidance.
Symbicort had U.S. branded sales of $3.5 billion for the 12 months ending January 2021, according to IQVIA.