In brief: Medline’s IPO, GLP-1's expansion, DME’s ‘hidden cost,’ Nymbl’s investment
By HME News Staff
Updated 10:05 AM CST, Fri January 3, 2025
NORTHFIELD, Ill. – Medline has confidentially submitted a draft registration statement on Form S-1 to the U.S. Securities and Exchange Commission for a proposed initial public offering of its common stock.
The number of shares to be offered and the price range for the proposed offering have not yet been determined. The offering is subject to market and other conditions and the completion of the SEC's review process.
In 2021, Medline announced it had received outside investment from private equity firms Blackstone, Carlyle and Hellman & Friedman in a deal reportedly worth more than $30 billion. Since then, the company has since made multiple moves to strengthen its role as a strategic partner, including joining forces with Microsoft to address supply chain complexity.
In 2023, Medline promoted Jim Boyle to serve as CEO, and Jim Pigott as president & COO, culminating a five-year succession planning process.
FDA approves GLP-1 for OSA
WASHINGTON – The U.S. Food and Drug Administration announced Dec. 20 that it has approved Zepbound (tirzepatide) for the treatment of moderate to severe sleep apnea in adults with obesity to be used in combination with a reduced-calorie diet and increased physical activity.
“Today’s approval marks the first drug treatment option for certain patients with obstructive sleep apnea,” said Sally Seymour, M.D., director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research. “This is a major step forward for patients with obstructive sleep apnea.”
Zepbound works by activating receptors of hormones secreted from the intestine (glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)) to reduce appetite and food intake. By reducing body weight, studies show that Zepbound also improves OSA, according to the FDA.
Zepbound’s approval for moderate to severe OSA in adults with obesity is based on two randomized, double-blind, placebo-controlled studies of 469 adults without Type 2 diabetes. One study enrolled participants using positive airway pressure (PAP), the standard of care for moderate to severe OSA, and one study enrolled participants unable or unwilling to use PAP. In both studies, participants randomly received either 10 or 15 milligrams of Zepbound or placebo once weekly for 52 weeks.
The results: After 52 weeks of treatment in both studies, participants who received Zepbound experienced a statistically significant and clinically meaningful reduction in events of apnea or hypopnea as measured by AHI compared with placebo, and greater proportions of participants treated with Zepbound achieved remission or mild OSA with resolution of symptoms compared to placebo. Participants treated with Zepbound had a significant decrease in body weight compared with placebo at 52 weeks. The improvement in AHI in participants with OSA is likely related to body weight reduction with Zepbound.
Zepbound received Fast Track, Priority Review and Breakthrough Therapy designations for this indication.
The FDA granted approval to Eli Lilly and Co.
AOPA names interim executive director
ALEXANDRIA, Va. – The American Orthotic and Prosthetic Association (AOPA) board of directors has announced that Teri Kuffel, JD, will serve as interim executive director effective Jan. 1.
AOPA’s current executive director, Eve Lee, is resigning effective Jan. 22 to become CEO of the Society of Interventional Radiology.
As interim executive director, a six-month term, Kuffel, who is also vice president and co-owner of Arise Orthotics & Prosthetics in Minnesota, will guide AOPA through this transition in leadership, working with the board of directors and staff to ensure continuity in the administration of AOPA’s programs and services.
“The board of directors unanimously approved the appointment of Teri Kuffel to serve a six-month term as we initiate and complete a diligent search for AOPA’s next executive director,” said Rick Riley, AOPA president. “I had the privilege to serve on the board with Teri the past eight years, and she has earned the respect and appreciation of AOPA’s board, staff, and the members. Serving as Immediate Past-President throughout 2024, Teri has been involved in our budget and planning activities that defined AOPA’s scope of work and priorities for 2025. Her proven leadership, integrity, expertise, and passion made her an ideal and obvious candidate to temporarily step into this role.”
Kuffel previously served on AOPA’s board of directors for eight years, including president from December 2022 to November 2023. Throughout her many years of volunteer service, she has demonstrated exceptional leadership, strategic insight and a passion for advocacy and advancing the goals of AOPA, the organization says.
Inogen OK’d to supply airway clearance device
GOLETA, Calif. – Inogen has received 510(k) clearance from the U.S. Food and Drug Administration for the Simeox 200 Airway Clearance Device, expanding the company’s ability to market and meet the various needs of patients with chronic respiratory diseases in the U.S.
Inogen entered into a definitive agreement to acquire Physio-Assist SAS, a privately held company based in France that makes the technology-enabled Simeox for $32 million in 2023.
“We are very excited to receive FDA clearance for the innovative SIMEOX 200 therapy for patients in the U.S.,” said Kevin Smith, president and CEO. “By tapping into our well-established network of health care providers, B2B partners and our direct-to-patient team, we aim to bring this next-generation airway clearance device to patients within the next year and significantly expand our reach over time.”
SIMEOX 200 is the next generation of the original Simeox (currently available in select international markets).
The device is intended to promote and improve bronchial drainage by enhancing mobilization of bronchial secretions via high frequency oscillatory vibrations and intermittent negative pressure to the airway during exhalation. It is predominantly aimed to help patients with chronic lung diseases associated with mucus hypersecretion and mucus retention, such as bronchiectasis, COPD, cystic fibrosis or primary ciliary dyskinesia.
New abstract highlights ‘hidden’ costs of DME
YARMOUTH, Maine – A careful cost-benefit approach to covering DME electricity costs under insurance programs should consider the potential improved health and the reduced mental strain from financial worries, as well as potential increases in Medicare spending, according to a new abstract published in Nature.
As there is an increase in the consumption of these devices, more careful consideration should be devoted to possible insurance policy coverage of these “hidden” out-of-pocket costs of DME, the abstract says.
“We find that the average cost across the most common types of high-frequency DME – including oxygen concentrators, continuous positive airway pressure machines, and peritoneal kidney dialysis machines – is between $120 and $333 per year, depending on device size and usage frequency,” it says. “Some DME can cost more than $700 per year to operate, which is an increase of over 40% above the average household bill, and well over that in in states with higher electricity prices.”
The abstract offers several policy changes to address the issue, including utility disconnection protections. While all but five states offer disconnection protections for those with medical conditions, few specify any requirements pertaining to reliance on DME, the abstract says. Moreover, many of those existing serious illness protections do not adequately protect those using DME, it says. For example, many of them can only be invoked or renewed for limited periods of time, require a doctor to certify that the underlying medical condition is life-threatening (which may not be true for many with DME), still require partial or deferred payments from the customer, or require burdensome proof of low-income status. States could more explicitly protect those with DME by removing existing barriers to asserting protection against termination.
The abstract also offers another potential policy change: Helping patients who cannot afford the additional energy burden to defray the cost of running their medical devices. Medicare and Medicaid in several states are beginning to provide more flexibility for covering a greater range of items, the abstract says. For example, some states are allowing Medicaid managed care organizations to cover air conditioners for patients with asthma, medical transport for patients, utility deposit fees, and meals; and the federal government allows Medicare Advantage to offer similar benefits to patients, the abstract says. None of these programs currently cover the electricity costs of DME or of electricity consuming benefits offered through their social determinants of health (SDOH) programs.
“It is essential to recognize and document the challenge households face in paying for the electricity needed to operate DMEs and thus access full medical care,” the abstract says. “It is also important to design public policy and program solutions that address this challenge directly.”
Nymbl Systems receives investment
COLUMBUS, Ohio – Nymbl Systems, a provider of cloud-based practice management software for orthotics and prosthetics, complex rehab technology and home medical equipment providers, has received an equity investment from Frontier Growth.
The amount of the deal was not disclosed, but Charlotte-based Frontier Growth typically makes initial equity investments of $5 million to $30 million in mission critical vertical SaaS companies with $3 million to $20 million of annual recurring revenue and +25% annual growth.
Nymbl says it plans to use the funds to accelerate its growth, drive continued product innovation and enhance its ability to support health care providers nationwide.
"This partnership with Frontier Growth is a major milestone for Nymbl Systems," said Josh Lau, CEO of Nymbl Systems. "Their deep expertise in scaling vertical SaaS businesses, combined with their 'people-first culture' aligns perfectly with our customer-centric approach, making them the ideal partner to help us achieve our growth objectives. We're excited to partner with Frontier to expand our reach, develop even more innovative solutions for our customers, and strengthen our mission to help providers deliver exceptional care while optimizing their operations."
In conjunction with the investment, Dave Pandullo will join the company’s board of directors, alongside existing investors Ben Trumbull of Tamarind Hill, Josh Lau and Chad Feinberg of Nymbl and Mike Morgan (independent director) formerly of Updox.
Nymbl says its solutions, which streamline workflows, enhance efficiency and accelerate revenue by automating processes such as clinical notes and patient intake, are used by hundreds of O&P, CRT and HME businesses.
"Nymbl Systems is transforming how healthcare providers manage critical workflows," said Dave Pandullo, partner at Frontier Growth. "We were extremely impressed by Nymbl's track record of product innovation and exceptional customer trust they've earned, as evidenced by their strong market traction with hundreds of providers across the U.S. We're excited to partner with the Nymbl team to support their vision of driving continued innovation and improving outcomes for the O&P, CRT and HME markets. We believe there's a compelling opportunity for Nymbl to continue winning its market, further amplifying value to its customers, and ultimately transform these verticals.”
Diabetes, weight loss drugs cause spike in spending, utilization
WASHINGTON – Medicaid spending on 10 selected diabetes and two selected weight loss drugs totaled more than $9 billion in 2023, a 540% increase compared to 2019, according to a new Data Brief from the Office of Inspector General.
“This substantial increase could have a financial impact on the Medicaid program,” the brief states. “Information in this data brief may be beneficial to CMS and State Medicaid agencies when developing future program guidance related to these drugs.” Other findings in the brief:
During this same time period, utilization of the 12 drugs increased by 350%, totaling 11 million claims in 2023.
We estimated that Medicaid gross spending on the 12 selected drugs accounted for approximately 9% of Medicaid spending on covered outpatient prescription drugs in 2023.
We also estimated that Medicaid gross spending on the 12 selected drugs could potentially amount to over $29 billion in 2026.
The brief did not contain recommendations. CMS did not provide written comments but it did furnish technical comments, which the OIG addressed.
- Read the brief here.
AlayaCare ‘delivers results’
NEW YORK – AlayaCare Marketplace has created more than 96,000 referrals across 43 states, with a 95% completion rate, the company says. “This integrated tool in AlayaCare Cloud allows organizations to send and receive patient referrals between providers, eliminating unnecessary back and forth when coordinating and staffing cases, saving time and improving outcomes,” the company says. AlayaCare noted that key highlights from 2024 include:
- 255-plus onboarded home infusion agencies, expanding access to skilled nursing providers.
- Median referral processing time of 2.5 minutes to send a referral, with total acceptance and nursing agency assignment averaging 51 minutes. This automates multiple manual steps traditionally done via phone, fax, and email.
- 93.3% of users report improved efficiency in their workflows and processes.
By leveraging AlayaCare’s advanced features — such as integration with pharmacy management systems, robust clinical documentation capabilities, and streamlined referral management between infusion nursing agencies — specialty pharmacies and nursing agencies are transforming their workflows and improving patient outcomes, while addressing the challenges of nursing shortages and operational inefficiencies, the company says. “AlayaCare Marketplace is delivering measurable results, helping infusion providers scale efficiently while maintaining high-quality care,” said Kaila Raimondo, director of U.S. markets at AlayaCare. “This year’s milestones highlight the platform’s ability to meet rising demands, address nursing shortages, and improve patient access to infusion services. We’re proud to support pharmacies and nursing agencies in expanding their reach and delivering care where it’s needed most.”
Abbott, DexCom settle patent disputes
SAN DIEGO and ABBOTT PARK, Ill. – DexCom and Abbott Diabetes Care have entered into a settlement and patent cross license agreement to resolve all outstanding patent litigation between the parties related to their continuous glucose monitors, according to a Form 8-K filed by Dexcom with the U.S. Securities and Exchange Commission. Both companies have accused the other of infringing certain patents and each company has filed counterclaims and actions to invalidate the other’s patents. Under the agreement, DexCom has granted Abbott and its affiliates, and Abbott and its affiliates have granted DexCom and its affiliates, a worldwide, royalty-free, non-exclusive, fully paid-up license to certain patents and patent applications relating to analyte sensing. The agreement does not obligate DexCom or Abbott to pay any royalties or any other form of financial compensation. Also as part of the agreement, both companies have agreed not to litigate patent, trade dress and design rights disputes with each other for the next 10 years. “Abbott considers this agreement a positive development as it allows the company to fully focus on supporting people with diabetes with its technologies and services,” the company stated in a press release.
SuperCare Health donates gifts
CITY OF INDUSTRY, Calif. – SuperCare Health supported its SuperKids pediatrics department this holiday season with an annual toy drive and gift-sharing event with families in need. Over the past decade, SuperKids has donated more than $8,000 in toys and charitable contributions to families whose children battle chronic health care conditions. This year, dozens of team members from across the organization brought gifts not only to SuperKids patients but also to families enrolled in programs at Children’s Hospital in Los Angeles and University of California Davis. “The holiday season is all about giving,” said Dalila Sanchez, customer care manager at SuperCare Health. “Through our annual toy drive, we are able to bring joy and comfort to children and families in need. Every gift, big or small, makes a meaningful difference. SuperKids is a program for pediatric patients who may have gone through life-sustaining treatments. We are grateful to be able to support the families of these resilient children and help make their holidays brighter. I'm incredibly thankful for our team's support in making this holiday season special for families in need.” SuperCare Health says SuperKids reduces respiratory-related hospitalizations, enhances quality of life and engages parents and caregivers in personalized health management for pediatric patients. Its patients and their families have access to a portal and an around-the-clock care team, and benefit from partnerships with pediatric respiratory therapists and assistance through a clinical outreach program.
Gilgal drops insurance to focus on retail
ORLANDO, Fla. – Gilgal Medical Supplies will no longer accept insurance for medical supplies. The decision, effective immediately, comes after years of increasing challenges associated with insurance reimbursement processes. "Providing durable medical equipment and supplies for thousands of patients has always been at the core of our mission," said Thomas Chacko, vice president. "However, the constant denials, excessive documentation requests, unnecessary audits, and recoupment efforts by Medicare and insurance companies have made the process untenable." Gilgal Medical Supplies has taken measures to ensure its current patients have ample time and support to transition to other providers. The company plans to focus on retail sales and wholesale distribution and continue providing high-quality medical supplies without the constraints and inefficiencies of the insurance reimbursement system. Gilgal, which also has locations in The Villages and Fort Myers, carries medical supplies, compression stockings, braces and scrubs, and DME like wheelchairs, hospital beds and rollators.
Direct Supply’s Nick Bush joins HIDA council
MILWAUKEE – Direct Supply has announced that Nick Bush, vice president of sales, homecare, has been appointed vice chair of the Health Industry Distributors Association's Home Care Advisory Council. The council builds the value of distribution channels to patients and providers in the home care setting and helps to develop the annual Home Care Market Report, according to HIDA’s website. “We are confident that (Nick’s) experience and vision will help drive meaningful discussions and advancements within the HIDA Home Care Council,” the company stated in an announcement on LinkedIn. Bush also serves on AAHomecare’s board of directors. He has more than 20 years of experience in the health care industry. HIDA’s distributor members offer logistics services that increase the efficiency of the nation's hospitals, nursing homes, physician practices, home health organizations, and other healthcare providers. Members range from local businesses to international Fortune 500 companies.
NHIA seeks board members
ALEXANDRIA, Va. – The National Home Infusion Association is accepting applications for members of its board of directors. Board members serve three-year terms as representatives for their NHIA member organization. Seats are open only to provider members and are assigned at the organization level. Seats are currently available for one national provider (multi-site organization with 20 or more locations), one hospital provider and two at-large providers (any type). Companies that are interested in serving on the board must submit a letter to Connie Sullivan, president and CEO of the NHIA (Connie.Sullivan@NHIA.org), no later than Jan. 24 that includes a description of the company, its history of involvement with NHIA, why it should be considered and the name of the individual that would serve as a representative. Applicants are evaluated based on the following categories of participation in NHIA/NHIF: committee participation, fellow participation, magazine contribution, journal contribution, research/data initiative contribution, resident program, advocacy, conference participation and NHIF board member/donation.
Care Synergy, RCC Medical Equipment form JV
DENVER – Care Synergy and RCC Medical Equipment Co. have agreed to form a joint-venture partnership to provide enhanced health care services throughout the Colorado Front Range region. Together, Care Synergy, a health care management service organization, and RCC Medical Equipment Co. will provide high-quality health care equipment to the patient populations of Care Synergy’s health care affiliates, including The Denver Hospice, Colorado PACE, Pathways Hospice, Pikes Peak Hospice & Palliative Care, and Colorado Visiting Nurse Association (CVNA). “The partnership between Care Synergy and RCC Medical Equipment is important to the advancement of hospice care, palliative care and home health in Colorado,” said Tim Bowen, president and CEO of Care Synergy. “By leveraging a legacy of exceptional service delivery in the medical equipment sector, we can offer even better support for our patients and our communities.” In early 2025, the partnership will initially focus on caring for the Weld County and Larimer County patient populations served by Pathways Hospice. However, the plan is to expand service to the Denver metropolitan area and Colorado Springs in late 2025 and 2026. Care Synergy provides mission-support services for not-for-profit, community-based home health care, hospice and palliative care providers serving the Front Range of Colorado, including the Colorado Visiting Nurse Association, The Denver Hospice, Pathways and Pikes Peak Hospice and Palliative Care, and in the future, Colorado PACE. Care Synergy Affiliate organizations operate as distinct organizations, while sharing best practices to help more Coloradans.
Ki Mobility names new president
STEVENS POINT, Wis. - Ki Mobility has appointed Charlie Covert as president of Mobility North America effective Jan. 6. Covert joins Ki Mobility and Etac with more than 20 years of experience in the md-tech sector, most recently as general manager for Pain Interventions at Medtronic. Doug Munsey, co-founder of Ki Mobility and current president of Mobility North America, will transition into a partial retirement and senior advisor role starting Jan. 1 to support Etac and the chairman of the board in shaping strategy. “Having been part of the selection process, I am certain that Charlie's extensive experience will support our ambition of always being your preferred partner,” he said.
- Related: Etac bought Ki Mobility in 2021.
Aeroflow's contract with Montana Medicaid reupped
ASHEVILLE, N.C. – Aeroflow Breastpumps, a subsidiary of Aeroflow Health, has been selected by Montana’s Department of Public Health and Human Services as a contractor to provide double electric breast pumps and related supplies for eligible members of Montana Medicaid and Health Montana Kids/Children’s Health Insurance Plan through Sept. 30, 2025. “We’re very grateful to continue serving the residents of Montana and look forward to expanding our services throughout the state to include breast pumps through this RFP contract award,” said Casey Hite, CEO of Aeroflow Health. “Aeroflow is dedicated to maintaining the highest standards of product and service quality, and believes the technology platform we’ve developed will allow us to improve access to necessary health supplies for mothers and their families, no matter how remote in Montana they may be.” Aeroflow Breastpumps says it was awarded the contract following a competitive selection process, signifying the company’s ability to meet the state's challenges in providing health care services and supplies to residents due to its rural setting. Utilizing its proprietary technology management system, the company says it will be able to seamlessly deliver breast pumps and other breastfeeding resources to mothers under Montana Medicaid. It says it will also continue to collaborate with the Montana state department to establish policy that is both economical to the state and supports HRSA-Supported Women’s Preventive Service Guidelines.
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