In brief: OPGA names finalists, Insulet grows, Breas corrects 

WATERLOO, Iowa – The Orthotic and Prosthetic Group of America has announced the four finalists nominated for the 2024 O&P Woman of the Year Award. 

The finalists are: 

• Dr. Justina Appel, PhD, CO, BOCP, LPO, clinical specialist with NuTech Synergies; 
• Jenna Calomeris, vice president of sales with ThorWear, DBA Elevate Movement; 
• Dr. Sara Peterson, PhD, L/CPO, FAAOP(D), clinical research scientist/certified prosthetist orthotist (CPO) with O&P Clinical Innovations; and 
• Sheryl Sachs, MSPO, certified prosthetist orthotist (CPO) with Dankmeyer, Inc. 

“We’re excited to recognize these outstanding women who positively impact the O&P profession,” said Adam Miller, president of OPGA, a division of VGM & Associates. “Each of the finalists exemplify everything that is exceptional about the O&P community, and we look forward to recognizing the winner with a special toast at the AOPA National Assembly in September.” 

The winner of the 2024 O&P Woman of the Year award will be announced at the AOPA National Assembly on Sept. 13 at the Product Preview Theater (PPT) in the exhibit hall. 

The annual award, sponsored by Össur and presented by OPGA, is open to all women who work in the O&P profession. Nominators were encouraged to provide examples of how the nominee has made significant contributions throughout her career to serve her patients, community, business and the O&P profession. 

Finalists were selected by a committee of O&P professionals. 

FMI: www.vgm.com/oandpwomanoftheyear. 

Insulet: ‘2024 is shaping up to be another year of rapid growth’ 

ACTON, Mass. – Insulet has reported revenue of $488.5 million for the second quarter of 2024, a 23.2% increase year over year, exceeding the high end of the company’s guidance, driven by outperformance for all product lines. 

Total Omnipod revenue was $480.4 million, a 26.3% increase, including $352.3 million in the U.S., a 27.3% increase. 

“2024 is shaping up to be another year of rapid growth, fueled by strong Omnipod 5 demand and our accelerating pace of product innovation,” said Jim Hollingshead, president and CEO. “Omnipod 5 continues to disrupt the diabetes landscape in every market in which it is offered, and we are thrilled to have expanded the Omnipod 5 platform globally with multiple integrations and product launches. We remain the clear leader in our industry, and in light of our first half results and our confidence in delivering an even stronger second half, we have increased our full year guidance for revenue, gross margin and operating margin. We are poised for continued profitable growth, while successfully advancing our mission to simplify and improve the lives of people with diabetes.” 

Other results from the quarter: 

• Gross margin of 67.7%, up 90 basis points, compared to gross margin of 66.8% in the prior year. Gross margin for the current period includes a charge of $13.5 million relating to certain inventory components, which the company expects will not be utilized. This charge negatively impacted gross margin by 280 basis points. 
• Operating income of $54.6 million, or 11.2% of revenue, up 340 basis points, compared to operating income of $31.1 million, or 7.8% of revenue, in the prior year. Operating income for the current period includes the $13.5 million charge noted above, which negatively impacted operating margin by 280 basis points 
• Net income of $188.6 million, or $2.59 per diluted share, compared to net income of $27.3 million, or $0.39 per diluted share, in the prior year. Adjusted net income of $38.3 million, or $0.55 per diluted share, excludes $151.7 million of income resulting from the release of the majority of the company’s valuation allowance and a $1.4 million loss associated with an investment. 
• Adjusted EBITDA 1 of $90.8 million, or 18.6% of revenue, up 310 basis points, compared to $61.3 million, or 15.5% of revenue, in the prior year. 

For the quarter, Insulet highlighted the full market release of Omnipod 5 integrated with Dexcom’s G7 sensor and the limited market release of the Omnipod 5 App for iPhone.  

Looking ahead, the company expects revenue growth of 18% to 21% for the third quarter and 16% to 19% for the full year. 

Breas initiates correction 

NORTH BILLERICA, Mass. – Breas Medical has initiated a nationwide correction of 8,186 Vivo 45 LS ventilator devices. Internal testing of the ventilator identified the potential for short-term elevated levels of formaldehyde exposure to users under specific conditions, the company says. Short-term formaldehyde emissions may lead to adverse pulmonary or neurological effects, such as the potential for transient, reversible airway irritation or inflammation that could lead to airway hyperresponsiveness, such as asthma in small pediatric patients, resulting in additional medical intervention, it says. The devices subject to the correction were manufactured from Feb. 4, 2021, to July 1, 2024, and distributed from Feb. 12, 2021, to July 24, 2024. The correction reduces the maximum room air temperature for operation of the device from 104 degrees Fahrenheit to 86 degrees Fahrenheit, and requires new devices shipped through July 24, 2024, to be pre-run for 14 days prior to use. Breas says it has not received any reports of patient injury or adverse effects related to potential exposure to formaldehyde from the use of the Vivo 45 LS to date. The company is notifying its distributors and commercial customers in the U.S. of the correction by email or phone. Breas has notified the U.S. Food and Drug Administration of the correction. 

Senators push CMS to cover standing systems 

WASHINGTON – U.S. Sens. Bob Casey, D-Pa., Tammy Duckworth, D-Ill., and Marsha Blackburn, R-Tenn., are calling on CMS to extend Medicare coverage to standing systems embedded in power wheelchairs. The Aug. 9 bi-partisan letter comes after the senators successfully pushed the agency to extend Medicare coverage to seated elevation systems last year. “These [standing] systems enable users to achieve a standing position, which can greatly enhance their independence, improve metabolic functions, reduce the risk of secondary complications, such as pressure sores and osteoporosis, and improve their overall physical and mental well-being,” the senators wrote. “The absence of Medicare coverage for these systems leaves many beneficiaries without access to critical technology that can significantly improve their health outcomes and quality of life.” Currently, Medicare beneficiaries with disabilities are forced to pay out of pocket for standing systems. The senators are calling on CMS to open a national coverage analysis for standing systems in Group 3 power wheelchairs to align with its commitment to provide equitable access to vital rehab technology, as well as advance the development of rehab technology for Medicare beneficiaries. In a previous letter in October 2021, the senators highlighted the need for CMS to consider coverage for both seat elevation and standing systems. Read the Aug. 9 letter here. 

NHIA develops drug list 

ALEXANDRIA, Va. – The National Home Infusion Association has developed a list of medications to serve as a reference when making site of care decisions for patients requiring intravenous or subcutaneous infusions. The list reflects current U.S. prescribing practices and was compiled from medication dispensing reports from home infusion providers and reviewed by NHIA’s Quality and Standards Committee. “Home infusion providers have special expertise in the assessment, coordination and provision of professional services required to safely furnish infused medications in the home and alternate settings,” says NHIA President and CEO Connie Sullivan, BSPharm. “This list can be helpful as they work through the multitude of variables that factor into their decision making.” The list also identifies which drugs may qualify for coverage under Medicare Part B DMEPOS or Local A/B MAC policies, which have specific criteria for eligibility. Unlike commercial plans, Medicaid programs and other government payers (e.g., TRICARE), Medicare does not offer a comprehensive home infusion benefit; however, a handful of drugs are covered under Part B. The Medicare prescription drug benefit, Part D, covers additional therapies, but none of the supplies and services associated with administration. In addition to clinicians and reimbursement professionals, the list may be useful for other home infusion industry stakeholders, payers, regulators and policymakers. NHIA intends to update the list as new products are approved, as well as when new data supports moving a drug onto the list. To submit updates, send a message to info@nhia.org.        

SageHome names COO 

ATLANTA – SageHome has appointed Aaron Carmack as its new COO. He brings more than 30 years of sales and operations experience gained in the retail home improvement sector, most recently as COO of Rogers Electric, a national electrical contractor operating across 48 states, where he was responsible for driving the company’s sales and operations strategies. "On behalf of everyone at SageHome, I am delighted to welcome Aaron to the company,” said Joe Gorman, CEO. “He joins at a pivotal point in our growth trajectory and his proven track record in operational excellence complements the strengths of our executive team. His knowledge and experience will be instrumental in helping us scale the business and generate further growth, to ensure that SageHome fulfills its ambitions." Before Rogers Electric, Carmack had a 12-year career at Home Depot serving in various leadership roles. As COO of SageHome, Carmack will be instrumental in leading the company’s core operations functions, as well as the general managers of each of its trading brands. He will also drive the company’s expansion efforts and ensure the continued delivery of exceptional service to its customers. Additonally, he will collaborate closely with Gorman to scale the business through a combination of organic growth and strategic acquisitions.   

Pacific Therapy Access rebrands, adds DME division 

DALLAS – Pacific Therapy Access, a provider of reimbursement strategies, prior authorization and health insurance appeals services, has rebranded to Walnut Hill Medical and added DME, health economics and market access divisions. "We are thrilled to embark on this new chapter as Walnut Hill Medical," said Chris Hanna, CEO of Walnut Hill Medical. "This transformation represents our ongoing commitment to excellence and innovation in health care solutions. Our expanded services allow us to offer comprehensive solutions to the medical device industry. As we evolve, our focus remains on delivering superior service and value to our clients and partners in the healthcare community." Walnut Hill Medical says it excels in navigating the complex landscape of U.S. health insurance policies, offering customized solutions that enhance commercialization success. The company's deep expertise and customer-centric approach have made it a trusted partner for innovators seeking reliable support in managing commercialization challenges effectively. 

HME Home Health buys Coast Ability 

RICHMOND, B.C. – HME Home Health has acquired Coast Ability in Sechelt, B.C., its eighth location in the province. HME Home Health will re-brand Coast Ability under its own name. “The acquisition of Coast Ability is in line with HME’s strategic interest to continue our growth in B.C.,” said Robert Boscaci, CEO and co-founder. “HME will now be able to serve the over 30,000 residents of the Sunshine Coast – from Sechelt to Powell River. The Sunshine Coast offers HME a new market to expand our services and our exclusive HME Signature Series line of products.” The acquisition was made possible by the retirement of Coast Ability’s owner, Greg Patton. HME Home Health now has a total of more than 80,000 square feet of office and warehouse space in Richmond, Victoria, Surrey, Nanaimo, North Vancouver, Kelowna and Sechelt. It employs more than 120 professionals, technicians and support staff. 

Rehab Medical adds office in Houston 

INDIANAPOLIS – Rehab Medical is adding a new office in Houston to offer residents in the eastern and central regions of Texas access to the company’s specialized mobility services. Rehab Medical already has offices in Austin, Dallas and San Antonio. “The addition of our Houston location continues the strong trend of growth throughout the state of Texas,” said Kenneth Flaming, Rehab Medical’s regional vice president of sales. “We've seen tremendous success serving other markets in Texas and know this growth is largely predicated on the success of nearby markets in the state.” Reece Hall, sales manager and assistive technology professional, will lead the Houston office. Rehab Medical says Houston is home to the largest population of people living with disabilities in Texas. 

Pride Mobility launches app 

DURYEA, Pa. – Pride Mobility has introduced a convenient alternative to a hand control – the new My VivaLift app. The app is designed to make it easier than ever for a user to find the perfect resting position or adjust the chair to their liking. It’s also a convenient alternative to a hand control. All users need to do is download the app and enable Bluetooth capability on their preferred device. The app contains the same functions as a hand control, as well as heat and massage sliders on the Ultra and Radiance, and Ultra models, respectively. With the app, users can lay flat or reach a standing position with just one button and save up to five memory positions. FMI: pridemobility.com/my-vivalift-app.