In brief: Philips sues SoClean – again, AAH re-engages lawmakers, Enos re-enters sleep market

PITTSBURGH – Philips has sued SoClean in a bid to get the company, whose ozone cleaners it says “attacks” the foam in its CPAP devices, to pay part of its recently announced $1.1 billion settlement. 

Philips announced the settlement in April to resolve the personal injury litigation and the medical monitoring class action related to a recall of certain sleep and respiratory devices in the U.S.   

“(SoClean’s) negligent and intentionally misleading conduct has contributed to the negligence claims for which Philips are bearing or may in the future bear financial responsibility, making (SoClean) liable in contribution and indemnity for their relative culpability,” the lawsuit states. “Philips therefore brings this third-party complaint to ensure that, for any payment to a device user who used a SoClean device, (SoClean) is held accountable for their contributory liability to device user negligence claims.” 

Philips filed the lawsuit on May 10 in the U.S. District Court for the Western District of Pennsylvania. 

At least 15% of device users are confirmed SoClean users, according to the lawsuit. 

This is only the most recent lawsuit between the two parties. Earlier this year, Philips filed a counter lawsuit against SoClean and its private equity owner, DWHP, arguing they "recklessly and unlawfully” marketed their ozone cleaning devices as compatible with its CPAP and BiPAP devices.   

SoClean originally sued Philips for $200 million in damages in 2021 for blaming its cleaners for problems related to the recall of certain Philips respiratory devices due to degradation issues with sound abatement foam.  

Philips has since conducted expansive testing that the company says has shown that ozone dramatically increases the risk that the foam will degrade in recalled devices. 

AAH: Keep the message alive 

WASHINGTON – AAHomecare is calling for stakeholders to be a “force multiplier” to the more than 140 meetings that were held on Wednesday with lawmakers and their staff on the need to extend 75/25 blended Medicare reimbursement rates in non-rural areas. 

The meetings took place as part of a fly-in organized by AAHomecare and attended by nearly 60 industry leaders. 

“The message is simple: Ask your senators and representatives to reach out to leadership in their respective chambers in support of extending the 75/25 Medicare blended rates for DME in non-rural areas through 2024 as soon as possible,” the association stated. “You should emphasize that cuts have already taken effect and share how they are impacting your ability to support your patients.” 

The 75/25 blended rates expired on Jan. 1, 2024. 

On Wednesday, AAHomecare once again put a priority on engaging with legislators on Committees of Jurisdiction for health care finance issues, resulting in 35 meetings with members of the House Energy & Commerce and Ways & Means Committees, as well as 15 meetings with legislators on the Senate Finance Committee. 

To reach out to a member of the House go here; to reach out to a member of the Senate, go here. 

ProSomnus seeks ‘renewed foundation’ 

PLEASANTON, Calif. – ProSomnus, which makes a CPAP alternative for the treatment of obstructive sleep apnea, has filed for Chapter 11 bankruptcy in the U.S. Bankruptcy Court for the District of Delaware, listing more than $26.3 million in assets and $52.89 million in debts. 

In connection with this process, ProSomnus has secured the support of multiple key investors and lenders under a plan that is designed to deliver an aggregate of approximately $20 million of new capital into the company to support ongoing operations and the development of strategic initiatives, including the company’s next generation sensor device. 

“The voluntary restructuring announced today will enable us to move ahead as a stronger company,” said Len Liptak, CEO for ProSomnus Sleep Technologies. “This very difficult decision was reached after conducting several extensive processes to identify alternatives. Reestablishing a healthy financial foundation for our company, with the support of our lenders, we expect to leave the process with more cash, less debt, less expense, and more time to focus on devices, customers and patients. This renewed foundation will place ProSomnus in a position to realize our mission and develop our next generation sensor device technology. I am grateful for the support of our customers, suppliers, and employees as we work through this process.” 

The restructuring plan is being led by SMC Holdings II, LP, CETUS Capital VI, LP, Destinations Global Fixed Income Opportunities Fund, Cedarview Opportunities Masters Fund, LP and Riverpark Strategic Income Fund, each existing lenders to and investors in the company. 

The completion of the plan will result in ProSomnus becoming a private company, thereby eliminating $4 million to $6 million of annual recurring public company costs. 

In September 2023, Prosomnus announced it had secured $10 million in funding. 

Enos Home Medical launches new sleep division 

NEW BEDFORD, Mass. – Enos Home Medical is launching Enos Sleep Solutions, five years after it sold its sleep therapy business. “After our exit, it has become clear that physicians, patients and caregivers have been searching for personalized high quality home care that national corporations are not capable or unwilling to offer,” the company stated. “We will measure our success in patient outcomes and not the bottom line.” The family-owned Enos Home Medical, which was founded as a part-time oxygen business in 1950, serves Massachusetts, Connecticut, Rhode Island and southern New Hampshire. Over the years, the company has entered and exited several markets to pare down its offerings to focus on hospice. In 2016, it acquired Cape Medical Supply’s hospice business to gain a foothold on Cape Cod, and in 2019, it sold its sleep therapy business to Cape Medical. Cape Medical was eventually acquired in 2021 by AdaptHealth. 

FDA to launch Home as a Health Care Hub  

WASHINGTON – The U.S. Food and Drug Administration is launching Home as a Health Care Hub, an initiative to help reimagine the home environment as an integral part of the health care system, with the goal of advancing health equity for all people in the U.S. The initiative will serve as an idea lab, not only to connect with populations most affected by health inequity, but also for medical device developers, policy makers and providers to begin developing home-based solutions that advance health equity. The FDA notes that existing models that have examined care delivery at home have found great patient satisfaction, good adherence, and potential cost savings to health care systems. As part of the initiative, the FDA's Center for Devices and Radiological Health (CDRH) has contracted with an architectural firm that intentionally designs innovative buildings with health and equity in mind, to consider the needs of variable models of a home and tailor solutions with opportunities to adapt and evolve in complexity and scale. The Home as a Health Care Hub will be designed as an Augmented Reality/Virtual Reality (AR/VR)-enabled home prototype and is expected to be completed later this year. 

ADS adds to leadership team 

CARLSBAD, Calif. – Advanced Diabetes Supply has named Mike Diamond vice president of enterprise architecture, and Larry Witte III as vice president of IT operations. “We are pleased to welcome these experienced health care professionals to the team,” said Bill Mixon, CEO. “Their combined expertise, commitment to excellence and innovative thinking will be invaluable to our company’s continued growth and success.” Diamond has more than 15 years of health care experience, including roles in publicly traded and private equity companies spanning multiple vertical marketplaces. He most recently served as principle and vice president of technology services and principle consultant for MGSD Services. Witte has extensive technology and health care expertise, specializing in IT operations and leveraging ITIL best practices in parallel with IT modernization and digital transformation initiatives. He previously served in leadership roles in both publicly traded and private equity companies, including as vice president of technology support services for Modivcare. 

United Spinal, Airbnb look to increase travel accessibility 

NEW YORK – United Spinal Association is partnering with Airbnb to create an Airbnb Entrepreneurship Academy for people with mobility disabilities to increase hosting opportunities and grow the number of listings with accessibility features. "Airbnb shares our commitment to making worldwide travel accessible for wheelchair users, including identifying lodgings with accessibility features at their destinations," says Vincenzo Piscopo, United Spinal CEO and president. "We are excited to co-host the Airbnb Entrepreneurship Academy, as it will provide interested wheelchair users with the tools and knowledge that they need to become hosts. This will create economic opportunities for our community, while also providing many more wheelchair-accessible properties at popular tourist destinations worldwide." Hosted via webinar, the academy will provide participants with practical guidance on getting started on and navigating the Airbnb platform. It will highlight accessibility features on listings and lessons from successful hosts. United Spinal is actively working with Airbnb to shape the academy’s curriculum to ensure it meets the unique needs of wheelchair users. The first webinars will take place in the summer of 2024, and the series will continue throughout the year. Interested United Spinal members can visit this website to learn more about the upcoming academy program. 
 
Angel Care Medical integrates with PointClickCare 

BOARDMAN, Ohio – DME provider Angel Care Medical has integrated with PointClickCare, a health care technology platform enabling meaningful care collaboration and real-time patient insights. The integration will make Angel Care Medical’s rental solutions and process more efficient and user-friendly for health care facilities and, ultimately, enhance patient care. "Joining PointClickCare's Marketplace program marks a significant milestone for us,” said Dan Halas, president. “By combining our expertise in DME with PointClickCare's innovative health care technology, we are set to redefine the standards of care in the DME rental industry. Our efforts will ensure health care facilities have access to the most efficient, reliable and cost-effective DME rental solutions, enhancing patient care quality across the board." The integration aims to address the common challenges faced by health care facilities in managing DME rentals, such as inventory management, billing complexities and regulatory compliance.  

Insulet reports earnings increase, gains market share 

ACTON, Mass. – Insulet reported revenue of $441.7 million for the first quarter 2024, an increase of 23.3% compared to the prior year. Total Omnipod revenue was $433.0 million, an increase of 21.1%, with U.S. Omnipod revenue $317.7 million. “We are pleased with our strong first quarter results, which underscore the strength of our advanced technology platform and deep competitive advantages,” said Jim Hollingshead, president and CEO. “During the quarter, we achieved strong new customer starts and gained market share globally, and expanded access to Omnipod 5 through our commercial launches with Dexcom’s G7 in the U.S. and with sensor of choice - Abbott’s Freestyle Libre 2 Plus and G6 - in two European countries. As a result of our momentum, upcoming catalysts and operational execution, we have increased both our revenue and operating margin outlook for the year. Insulet is well positioned to drive continued profitable growth while delivering on our mission to improve the lives of people with diabetes.” Insulet is raising its expected revenue growth for 2024 to a range of 14% to 18%, up from 12% to 17%. It expects revenue growth for total Omnipod to be 15% to 19%, up from 13% to 18%, with U.S. Omnipod to be 17% to 21%, up from 16% to 21%.