In brief: Apnimed files for IPO, BMC receives warning, Quality Biomed makes buy

CAMBRIDGE, Mass. – Apnimed has filed for an initial public offering (IPO) and announced the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application filing for Oxnimbi, an oral treatment for obstructive sleep apnea (OSA). 

In its Form S-1, the company acknowledges positive airway pressure (PAP) as the current standard of care for OSA, but notes many patients refuse or discontinue the treatment due to issues such as discomfort, pressure intolerance and lifestyle disruption, resulting in persistently low compliance.

“We believe a novel, oral and convenient treatment option that targets the underlying cause of OSA is well positioned to address significant unmet need,” the company states. “A pharmacological option could unlock latent demand for treatment and expand overall awareness, screening, diagnosis and treatment of OSA. Therefore, we designed Oxnimbi as an oral, once-daily, rapid-onset therapy to improve upper airway muscle activity during sleep, a crucial underlying cause of all OSA. If approved, we believe Oxnimbi has the potential to become a standard of care for the treatment of OSA.”

Apnimed says Oxnimbi, AD109, is designed to target the neuromuscular defect of OSA by improving upper airway muscle activity to help maintain airway patency and prevent airway collapse during sleep.

Based on the results from two registrational trials, Apnimed submitted a New Drug Application (NDA) with the FDA in April 2026. The registrational trials were Phase 3, randomized, double-blind, placebo-controlled, parallel-arm trials in adults with mild to severe OSA. Together, they enrolled approximately 1,300 patients, representing one of the largest and most diverse cohorts ever studied in an OSA pharmacologic trial, the company says. LunAIRo was conducted in the United States and SynAIRgy was conducted in the United States and Canada.

The trials found apnea hypopnea index (AHI) was reduced from baseline by 55.6% in SynAIRgy and 46.8% in LunAIRp, and hypoxic burden (HB) decreased by 60.5% and 5 8.2%, respectively, at week 26.

Earlier this year, Apnimed also entered into a secured senior credit facility for up to $150 million with funds managed by HealthCare Royalty Partners (HCRx).

FDA sends warning to BMC Medical

WASHINGTON – The U.S. Food and Drug Administration (FDA) issued a warning letter to BMC Medical, citing regulatory violations involving the company’s G3X APAP devices, which are imported into the United States by React Health (formerly 3B Medical). Through an inspection, the agency determined that BMC made significant design and software changes to a previously cleared Luna APAP device without submitting a new 510(k) premarket notification for FDA review. The newly branded G3X APAP, the FDA said, includes new software algorithms that can distinguish between central and obstructive hypopnea events and modifications to its sound-abatement system, gas pathway components, printed circuit board assembly and control software. The agency said these changes could significantly affect the device’s safety and effectiveness, requiring a new regulatory submission before commercialization. As a result, the FDA deemed the devices both “adulterated” and “misbranded” under the Federal Food, Drug, and Cosmetic Act. The warning letter also alleges that BMC failed to report a device correction to the FDA. The agency said certain Luna G3 APAP devices running firmware version G3-2.00.76 could unexpectedly shut down during use, interrupting therapy for patients with obstructive sleep apnea. BMC reportedly addressed the issue by updating the firmware to version G3-2.00.77 but did not submit the required Report of Correction or Removal within the required timeframe. The FDA instructed BMC to respond within 15 business days, outlining corrective actions and plans to prevent future violations. The agency warned that failure to address the issues could lead to further regulatory action and noted that the cited violations may indicate broader quality management and compliance concern.

• When reached for comment, Bill Shoop, CEO of React Health, stated: “React Health and BMC take this matter seriously and are actively engaged with the FDA to address their observations fully and promptly. Our commitment to patient safety, quality and compliance is unwavering, and we continue to serve our customers.”

NorthShore kicks off two-day celebration

GREEN OAKS, Ill. – NorthShore Adult Diapers will kick off its “Say Yes to Summer” campaign with NorthShore’s Day Out, a two-day celebration in Chicago July 18-19 created for people living with heavy bladder leaks (HBL). On the first day of the event, attendees will take a Chicago Architecture Center river cruise, experience a Cubs game at Wrigley Field and attend a group dinner. On the second day, they will convene at NorthShore’s headquarters for a warehouse tour, Q&A with staff, hands-on product demos and more. "People living with HBL can still say yes to the experiences on their bucket list, without worry and shame, when they have protection built to stay dry no matter what," said Adam J. Greenberg, founder and CEO of NorthShore. NorthShore's Day Out doubles as a thank-you to the NorthShore Hero Club, a community of customers and caregivers who have chosen to share their stories openly. “Say Yes to Summer” runs through August, capping off with NorthShore’s sponsorship of the North Shore RunFest 5k/8k in Salem, Mass., on Aug. 30.  The sponsorship brings the same message onto the racecourse, the company says: Incontinence doesn't have to sideline anyone from the experiences worth showing up for. "Incontinence is very common, often treatable, and regardless, can be very manageable," Greenberg said.

• Related: NorthShore joins baseball broadcasts.

NH expands coverage for prosthetics devices

CONCORD, N.H. – New Hampshire Gov. Kelly Ayotte has signed Senate Bill 408 into law, expanding health insurance coverage for prosthetic devices, including activity-specific devices, to include adults starting Jan. 1, 2028. Previously, New Hampshire law only mandated coverage for children’s prosthetics. “I was proud to sign Senate Bill 408 to expand access to prosthetic devices for adults, including activity-specific prosthetics,” said Ayotte. “No one who has experienced limb loss should have to shoulder the added burden of how to pay for prosthetics, and with this new law, we’re ensuring they can live life to the fullest and enjoy activities like swimming, running, skiing, and more. I thank Sen. Bill Gannon and all of the advocates who made this possible.” Members of the legislature from both sides of the aisle and advocates who testified in support of the bill joined Ayotte at the ceremonial signing, including U.S. Paralympic Gold Medalist Jason Lalla. Lalla won the Men’s Giant Slalom at the 1998 Paralympic Winter Games in Nagano, Japan.

Quality Biomedical buys M&M Medical Equipment Repair

PINELLAS PARK, Fla. – Quality Biomedical has acquired M&M Medical Equipment Repair, a Pennsylvania-based service specialist with nearly four decades of experience. Quality Biomedical says the deal adds a complementary service center to its national network, strengthening its coverage across the Mid-Atlantic and Midwest. “The acquisition of M&M is a natural extension of our strategy and brings incremental OEM service authorizations, allowing us to offer an even more comprehensive solution to our customers managing complex, multi-OEM fleets,” said PK Bala, CEO of Quality Biomedical. Quality Biomedical, which operates six service centers across the United States, is an authorized service center for most of the HME industry’s leading respiratory OEMs, supporting more than 3,000 HME and post-acute care locations nationwide. After nearly 40 years in business, Ed Minor, CEO of M&M Medical Equipment Repair, said it was time to partner with a larger company. “Quality Biomedical understands our business and will take care of our existing customers, while bringing a wealth of technology and operational excellence that will help take our company to the next level.” Quality Biomedical says its proprietary QConnect platform provides customers with deep insights into their respiratory fleet, enabling data-driven management of warranty and out-of-warranty assets.

• Related: Quality Biomedical is expanding into larger facilities in the Dallas-Fort Worth area to meet the growing demand for its services.

HHS moves to end pandemic-era emergency use authorization

WASHINGTON – The U.S. Department of Health and Human Services has signed determinations terminating the COVID-19 Emergency Use Authorization (EUA) declarations for drugs and biological products and for medical devices. “Americans deserve a regulatory system that is transparent, accountable, and rooted in the rule of law,” said HHS Secretary Robert F. Kennedy, Jr. “By ending these COVID-19 emergency use authorization declarations, we're reinforcing public confidence that emergency authorities are temporary and targeted.” The terminations will take place following advance notice periods: The declaration for drugs and biological products will terminate 12 months after the secretary’s determination, while the declarations for medical devices will terminate 180 days after the secretary’s determination. The advance notice periods are designed to provide manufacturers, health care providers, health systems, distributors, and patients adequate time to transition away from products authorized solely under the COVID-19 EUA declarations. During this transition, HHS and the Food and Drug Administration (FDA) say they will continue working with manufacturers on appropriate regulatory pathways for products seeking traditional approval, clearance, or licensure. The COVID-19 EUA declarations were first issued in 2020 to enable rapid access to medical products during the pandemic.

• Related: FDA extends EUA for vents, other devices.

Merits announces Bret Tracy’s return

FORT MYERS, Fla. – Merits Health Products has appointed Bret Tracy as vice president of sales and marketing. Tracy, who has more than 26 years of experience in complex rehab technology (CRT), previously worked at Merits from 2017-24. “We are thrilled to welcome Bret back to the Merits family,” said Andrew Maskery, president. “His extensive knowledge and experience in the HME and CRT industries, combined with his deep familiarity with Merits and our products, make him an outstanding addition to our leadership team. Bret’s passion for helping providers serve their patients and his proven ability to build strong industry relationships will be tremendous assets as we continue to grow and deliver life-enhancing mobility solutions.” In between his roles at Merits, Tracy served as executive vice president of operations at ATLAS Technology. He also serves on the AAHomecare Complex Rehab and Mobility Council and has previously served as a board member for ALS of South Carolina, ALS of Nevada, the Neveda Association of Medical Product Suppliers (NAMPS), the California Association of Medical Product Suppliers (CAMPS) and the Arizona Medical Equipment Supplier Association (AZMESA). He is also an assistive technology professional (ATP).

GEMCO makes Top Workplaces list for 7^th consecutive year

HUDSON, Ohio – GEMCO Medical and its parent company GEMCORE have once again been recognized as one of Northeast Ohio’s Top Workplaces by The Plain Dealer and Cleveland.com. This year’s award marks the seventh consecutive year the company has received the recognition. “Our people are what GEMCO special,” said Matt Edwards, CEO of GEMCO Medical. “Earning this recognition for the seventh year in a row is a testament to the culture we’ve built together and the shared passion our employees bring to serving customers and improving lives every day.” Presented annually, the Top Workplaces award is based entirely on employee feedback collected through a confidential survey administered by Energage. The survey measures key aspects of workplace culture, including leadership, alignment, communication, engagement and employee connection. This year’s list recognizes 191 organizations across Northeast Ohio that have demonstrated a commitment to creating exceptional workplace experiences. GEMCO, which employes more than 300 at its local headquarters, was ranked 37^th in the mid-sized companies category.

• Related: GEMCO increases shipping capacity, sets stage for automation.

McKesson publishes Impact Report with key milestones

IRVING, Texas – McKesson has published its Fiscal Year 2026 Impact Report, outlining key milestones across its four impact pillars: people, partners, community and planet. “At McKesson, impact is at the heart of our strategy and embedded in how we operate every day,” said Nimesh Jhaveri, R.Ph., executive vice president and chief impact officer. “This year’s report reflects our progress in strengthening health care for the providers, patients and communities we serve today, while building the capabilities needed for tomorrow. As healthcare grows more complex, our focus remains simple: Advancing Health Outcomes for All.” Milestones include:

• Through an automated, digitally connected distribution network, McKesson distributes one-third of America’s medicines with more than 99% inventory and order accuracy.
• Supporting approximately 3,300 independent oncology providers across The US Oncology Network, McKesson enables practices to deliver innovative therapies, participate in clinical trials and navigate increasing treatment complexity – advancing care for patients.