Loughborough, U.K.—Kindeva Drug Delivery L.P. (Kindeva) has announced a Knowledge Transfer Partnership (KTP) with Loughborough University to develop more sustainable alternative propellants for inhaled drug products. The KTP is jointly funded by Kindeva and UKRI (United Kingdom Research and Innovation) through Innovate UK.
The KTP with Loughborough University aims to deepen Kindeva’s understanding of alternative propellants used in pressurized metered-dose inhalers (pMDIs). The engagement proactively addresses a growing desire in the inhalation drug delivery industry to develop pMDI propellants with lower Global Warming Potential (GWP) than existing currently marketed propellants such as HFA134a and HFA227ea. Kindeva, which is already leading in the study of low-GWP propellants, will leverage the KTP to understand the physics involved in pharmaceutical spray generation, using computational fluid dynamic (CFD) simulation of such propellants. The ultimate goal is to predict spray parameters and characteristics from first principles, such as regional deposition, droplet size, and velocity, which could enable Kindeva to use simulation techniques to design faster and more reliable low-GWP pharmaceutical products for its customers.
Kindeva, a leading global contract development and manufacturing organization (CDMO), has a long track record of innovation in complex drug and combination products. The company has a history of over 65 years in innovating inhaled drug products, stretching back to the development of the first-ever pMDI. A proven leader in promoting sustainability in the industry, Kindeva led the transition from CFC- to HFA-based inhalers, developing the world’s first CFC-free pMDI and the world’s first CFC-free nasal pMDI.
“The KTP with Loughborough University is exciting because it will strengthen Kindeva’s position as a leader in sustainability,” said Aaron Mann, CEO of Kindeva. “Following the Montreal Protocol of 1989, Kindeva was a pioneer in leading the transition away from CFC-based inhalers. We have every intention of leading the industry in the development of the next generation of low-GWP propellants.”
“This announcement also reinforces our immensely important relationship with Loughborough University,” added Mann. “We hope the KTP will help us build our partnership with Innovate UK, and the United Kingdom more generally, in our mission to develop and manufacture essential and sustainable medicines for patients in the UK and abroad.”
“We are delighted to have the opportunity to work with Kindeva, who are leaders in the field of inhaled drug delivery and development of pressurised metered dose inhalers in Loughborough,” said Dr. Henk Versteeg, Senior Lecturer in Fluid Dynamics and KTP Lead Academic at Loughborough University. “The need to switch to propellants with lower global warming potential creates scientific challenges, but provides opportunities for us at Loughborough University to collaborate with Kindeva by sharing the latest insights in predictive engineering and to promote the adoption of digital engineering techniques in new product development.”
Author: Julie Kaloides
Trean Insurance Group Prices Secondary Offering of Common Stock
Wayzata, MN—(GLOBE NEWSWIRE)—Trean Insurance Group, Inc. (Nasdaq:TIG) (“Trean”) today announced the pricing of a secondary offering of 5,000,000 shares of Trean common stock at a price of $14.00 per share. The offering is expected to close on May 24, 2021, subject to customary closing conditions.
The selling stockholders named in the prospectus are offering 5,000,000 shares of Trean common stock. The underwriters have a 30-day option to purchase up to an additional 750,000 shares of common stock from the selling stockholders. Trean will not receive any proceeds from the offering.
J.P. Morgan and Evercore ISI are acting as lead book-running managers, William Blair is acting as a joint book-running manager and JMP Securities is acting as a co-manager for the offering. This offering is being made only by means of a prospectus. A copy of the final prospectus, when available, may be obtained from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 1-866-803-9204 or email at prospectus-eq_fi@jpmchase.com; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, or by telephone at 1-888-474-0200 or email at ecm.prospectus@evercore.com.
The registration statement on Form S-1 relating to these securities has been declared effective by the Securities and Exchange Commission. Copies of the registration statement can be accessed through the Securities and Exchange Commission’s website at www.sec.gov. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.
Minnetronix Medical Receives Minnesota Manufacturing Award from Business Journal
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.
Minnetronix Medical Recognized for Surgical Technology Innovation in 2021 MedTech Breakthrough Awards Program
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.”
Participation in SilverSneakers Leads to a Substantial Decrease in Overall Healthcare Costs and Improved Health Outcomes for Seniors
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.
Altaris to Partner with Michelin and Acquire Majority Stake in Solesis
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.
Kindeva Appoints Greg Sargen to Board of Directors
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.
Kindeva Drug Delivery and Cambridge Healthcare Innovations Limited to Collaborate on Development of Novel Dry-Powder Inhaler Product
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.
Altaris Exits Senior Helpers
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.
Clearwater Extends Healthcare Cyber Risk Management Leadership with AI-Driven Predictive Risk Rating, Peer-to-Peer Benchmarking and ServiceNow Integration Capabilities
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.