In brief: Drug reduces OSA severity, Drive DeVilbiss makes buy, OM replaces CFO 

INDIANAPOLIS – Eli Lilly’s tirzepatide demonstrated a mean reduction of up to 62.8% on the apnea-hypopnea index (AHI), or about 30 fewer events restricting or blocking a person's airflow per hour of sleep, compared to placebo, according to the company’s SURMOUNT-OSA phase 3 clinical trials evaluating the drug for the treatment of moderate-to-severe obstructive sleep apnea in adults with obesity, with and without CPAP therapy. 

In a key secondary endpoint, the company says the efficacy estimand showed that 43.0% (Study 1) and 51.5% (Study 2) of participants treated with tirzepatide at the highest dose met the criteria for disease resolution. In this context, it says "disease resolution" means achieving an AHI of fewer than 5 events per hour, or an AHI of 5-14 events per hour and an Epworth Sleepiness Scale (ESS) score of ≤10.  

"In the trials, patients with moderate-to-severe obstructive sleep apnea and obesity treated with tirzepatide experienced about 30 fewer disruptive events every hour of sleep and nearly half achieved disease resolution," said Atul Malhotra, MD, the Peter C. Farrell presidential chair, professor of medicine at University of California San Diego School of Medicine and director of sleep medicine at UC San Diego Health. "OSA can be very disruptive to daily life and affects a person's long-term health when left untreated because it can lead to serious cardiometabolic complications. These data support the efficacy of tirzepatide in adults living with moderate-to-severe OSA and obesity and has the potential to add to our toolbox for OSA treatment." 

Eli Lilly has submitted tirzepatide for the treatment of moderate-to-severe OSA and obesity to the U.S. Food and Drug Administration and will initiate submissions for other global regulatory agencies in the coming weeks. 

Full results from the clinical trials were published in The New England Journal of Medicine (NEJM) and presented at the American Diabetes Association 84th Scientific Sessions. 

For full results, go here. 

Drive DeVilbiss buys Mobility Designed’s portfolio 

PORT WASHINGTON, N.Y. - Drive DeVilbiss Healthcare has acquired Mobility Designed’s full portfolio of products, including the company’s flagship product, the M+D Comfort Crutch.  

As part of the acquisition, Mobility Designed’s co-founder and chief innovation officer, Max Younger, will join DDH as senior director of industrial design and innovation. 

“I am incredibly excited to join Drive DeVilbiss Healthcare,” said Younger. “This opportunity is a great example of Drive’s focus on innovation and allows us to bring our portfolio of designs to a broader audience continuing our mission of improving people's lives through thoughtful design. I look forward to working with the talented team at DDH to push the boundaries of what’s possible in medical equipment.” 

The Comfort Crutch, which was named a finalist in Fast Company’s prestigious Innovation by Design Awards and which was the subject of a viral video that reached more than 50 million viewers in 2016, shifts the user’s weight to the elbows instead of the armpits or wrists, providing more comfort to users, the companies say. 

Younger, who brings more than 15 years of industrial design experience to his role at DDH, including positions focused on product innovation at Techtronic Industries, Dimensional Innovations and Hallmark Cards, designed the Comfort Crutch after witnessing his father’s struggles with conventional crutches following an amputation. 

“We are delighted to welcome Max Younger and the Mobility Designed team to the DDH family,” said Jen Nicholson, SVP product & marketing strategy for DDH. “This acquisition elevates our portfolio with forward-thinking domestic design capabilities that set DDH apart in the industry. We are excited about the potential for enhanced innovation and improved patient outcomes that this collaboration brings.” 

Investor buys BioMatrix 

SEATTLE – Frazier Healthcare Partners, a Seattle-based, health care-focused investment firm, has closed on its acquisition of BioMatrix Holdings, a Plantation, Fla.-based national provider of home infusion services. 

Frazier is partnering with Ted and Kathee Kramm, two highly experienced industry executives in the home infusion market, to lead BioMatrix with Ted as CEO and Kathee as president. The Kramms began their careers as clinicians (pharmacist and nurse, respectively) and have scaled multiple infusion pharmacy businesses, including AxelaCare, which, over the course of a decade, grew into one of the largest providers of home infusion services in the country. 

“Backing best-in-class operators is a core tenet of our investment strategy, and we are thrilled to back Ted and Kathee,” said Frazier Partner Philip Zaorski. “As they have done previously, our shared vision for this asset is to build a nationally renowned platform that puts the patient at the center of everything we do.” 

BioMatrix serves a diversified base of patients with more than 2,500 physician-referral relationships across all 50 states. It specializes in neurological diseases, immunology deficiencies and transplants, as well as blood disorders. 

DME MACs ease wheelchair policies 

WASHINGTON – The DME MACs have announced increased flexibility for home assessments for manual wheelchairs and streamlined replacement in certain cases. 

Home assessments 

This change allows for indirect assessments, such as phone calls, easing the burden on providers and improving access for Medicare beneficiaries in remote areas, AAHomecare says. The documentation for these assessments must clearly detail the beneficiary's home layout, surfaces and any obstacles that might impact wheelchair use. 

Stakeholders were able to work with the DME MACs and CMS during the public health emergency to allow indirect assessments, but Medicare traditionally requires an in-person assessment for manual wheelchairs. 

Wheelchair replacements 

This change allows Medicare to treat wheelchairs as “lost” if replacement parts become unavailable due to a manufacturer ceasing operations and no aftermarket parts exist. Beneficiaries can use existing procedures for obtaining replacement equipment, similar to when a wheelchair is lost, stolen or damaged beyond repair, AAHomecare says. 

AAHomecare says the changes address long-standing requests from stakeholders. 

Owens & Minor asks CFO to leave, names interim replacement 

RICHMOND, Va. – Alexander Bruni, Owens & Minor’s executive vice president and CFO, has, at the request of the company, resigned effective June 21, according to a Form 8-K filed with the U.S. Securities and Exchange Commission. Bruni will remain with the company until Sept. 5, 2024, to support a transition of his leadership duties and, thereafter, will depart to pursue opportunities outside of the company. Owens & Minor has appointed Jonathan Leon, its senior vice president and corporate treasurer, as interim CFO. Leo, 58, joined the company in January of 2017 as senior vice president and corporate treasurer, responsible for global treasury, corporate development, taxation and investor relations. Prior to joining Owens & Minor, he worked at Brinks Company from 2008-17, where he served as treasurer. 

AdaptHealth announces corporate governance changes 

PLYMOUTH MEETING, Pa. – AdaptHealth’s stockholders approved, at a recent annual meeting, an amendment and restatement of the company’s stock incentive plan to increase the number of shares reserved by 8.35 million shares, according to a Form 8-K filed with the U.S. Securities and Exchange Commission. Stockholders also approved a proposal to phase out the company’s classified board structure and provide for the annual election of directors. Previously, the board was divided into three classes of about equal size, with each class serving a staggered three-year term. Under the amendment, directors elected prior to the recent annual meeting will continue to serve the remainder of their staggered three-year terms, but going forward, at each annual meeting, elections will be held to elect directors to serve one-year terms expiring at the next annual meeting. After the 2026 annual meeting, the phase out of the classified board structure will be complete and all directors will be subject to annual election for one-year terms. 

Tandem backs up efficacy of Mobi 

SAN DIEGO – Eighty-six percent of participants were satisfied or very satisfied with Tandem Diabetes Care’s Mobi regardless of prior therapy and agreed the automated insulin delivery system improves their quality of life, according to survey results the company presented at the 84th Scientific Sessions of the American Diabetes Association. “These real-world user insights provide evidence that we are furthering our mission to improve the lives of people with diabetes by demonstrating that Tandem Mobi not only meets but exceeds user expectations,” said Jordan Pinsker, MD, chief medical officer at Tandem Diabetes Care. “We are proud to share these results at ADA and will continue to innovate to provide the diabetes community with choice and improved quality of life.” In the six-week limited launch survey, early users who were previously using multiple daily injections (MDI) or other insulin pumps (tubed and tubeless) or were previous Tandem pump users also exhibited high satisfaction with the Mobi combined with the Control-IQ algorithm. The company also shared at ADA insights from an independent study involving Tandem Mobi users that showed their time in range improved with no increase in time spent below range. The company made Mobi commercially available in the United States in February. 

Gilgal Medical opens multiple locations in Florida  

ORLANDO, Fla. – Gilgal Medical Supplies has expanded to multiple cities across Florida to address the growing demand for reliable DME providers in the state, it says. The locations are in Miami, Jacksonville and Tampa. "We recognize the significant gap in the availability of durable medical equipment in Florida, and we are committed to filling that void," said Sainty Chacko, CEO of Gilgal Medical Supplies. "Our mission is to improve the quality of life for our customers by providing dependable and affordable medical supplies. Expanding into these key cities allows us to better serve the healthcare needs of Floridians." The new locations in Florida will offer medical supplies, including ostomy, wound care and urology, as well as power mobility devices, beds and mattresses, living aids, nutritionals and feeding supplies. It also offers online ordering and delivery. 

ACHC launches staffing accreditation 

CARY, N.C. – The Accreditation Commission for Health Care (ACHC) has launched Healthcare Staffing Services Certification to validate that staffing agencies meet recognized standards for quality in providing clinical professionals to health care organizations. Staffing shortages have accelerated since the onset of COVID-19, and access to readily available, highly qualified and skilled clinical professionals for immediate placement has become essential for hospitals and clinics to maintain their level of service to patients. “Health care staffing has been a hot topic since before the pandemic,” said Barb Provini, RN, BSN, senior clinical manager for ACHC. “With more organizations looking to staffing agencies to support their workforce needs, we designed Healthcare Staffing Services Certification as an independent third-party confirmation that an agency is a viable entity that meets recognized standards for credentialing professionals, tracking placements, conducting training, and evaluating competencies.” ACHC Certification verifies that processes and policies meet recognized standards for temporary staffing placements to ensure patient safety and excellence in care delivery. 

Empower Pharmacy recognized 

HOUSTON – Empower Pharmacy has been named a finalist in the Best Family-Owned Business Awards organized by the Houston Business Journal. This recognition underscores Empower Pharmacy's commitment to excellence, innovation and community investment within the Houston business landscape, the company says. "We are honored to be recognized as a finalist in the Best Family-Owned Business Awards," said Shaun Noorian, CEO of Empower Pharmacy. "This acknowledgment reflects our dedication to family values and our deep-rooted commitment to serving our community as we grow. Today, Empower has over 1,000 employees with over 90% located in Houston, and remains a family centered thanks to the hard work and dedication of our entire team." Empower Pharmacy, a compounding pharmacy, was categorized within the large company list, demonstrating its substantial presence and impact as a large employer within the Houston area, the company says. To qualify for consideration, all nominees had to meet stringent criteria set by HBJ, including being at least 51% family owned with multiple generations involved in company operations and exhibiting longevity in business.