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Business & Industry News, Product & Vendor Updates

The Sleep Wire 

EnsoData Raises $20M to Accelerate Commercialization of AI-powered Sleep Solutions

EnsoData, an innovator in AI healthtech solutions, announced a $20 million Series B financing led by Questa Capital. This new capital will enable EnsoData to accelerate adoption of its AI-powered sleep medicine solutions, improving the sleep care pathway for, in the US alone, an estimated 54 million patients suffering from sleep apnea.

“Traditional approaches in sleep medicine have left nearly 80% of patients undiagnosed and, of the 20% that are positively diagnosed, only 1 in 2 will be successfully treated,” stated Dr. Justin Mortara, Ph.D., President and CEO of EnsoData. “We need to expand patient access with simpler and more economic testing while embracing new approaches for sleep apnea therapies to improve this reality. EnsoData’s AI solutions are uniquely positioned to do both, and this Series B fundraise will allow us to rapidly scale our commercial team to deliver the next wave of AI-driven healthcare solutions.”

The EnsoData team is already growing, with the addition of a new Chief Commercial Officer, Bobby Cockrill, MBA, announced last month. “The appointment of Bobby is our first step toward establishing a substantial U.S. commercial team. His deep experience in diagnostics and managing strategic sales and sales operations are already having an exciting impact,” said Mortara.

“EnsoData has built a uniquely comprehensive platform that integrates disruptive, FDA-cleared clinical technologies across a complete care pathway,” stated Brian Butler, Partner at Questa Capital. “The team’s design discipline emphasizes usability and interoperability, an approach that has established EnsoData as a leader in sleep while positioning the company for future growth in adjacent specialties. We are thrilled to partner with such an experienced team at the helm of an innovative technology company.”

For more information, visit www.ensodata.com.

Source: EnsoData

Nihon Kohden Advances Remote Neurology Care with Second-Generation Live View Panel Pro

Nihon Kohden announces the launch of its second-generation Live View Panel Pro™, a specialized virtual health system designed to transform remote neurophysiological assessment and treatment. The upgraded platform combines real-time interactive viewing, integrated two-way intercom and centralized data management to address modern healthcare challenges such as staff shortages, rising patient volumes, information overload and fragmented care processes. New features help streamline decision-making, reduce costly transfers and ensure timely, effective treatment—empowering neurology teams to deliver expert care to more patients across multiple locations.

Live View Panel Pro drives measurable advantages at every level of the healthcare ecosystem, with proven results benefiting hospitals, clinicians and patients alike:

  • For clinicians, the system offers streamlined data access, improved workflows and remote interactive viewing that prioritize critical cases. These features enable more proactive and informed decisions, helping to enhance both patient care and outcomes while reducing the administrative burden on healthcare teams.
  • For patients, Live View Panel Pro helps enhance satisfaction by reducing travel requirements and accelerating access to care. As patients increasingly prefer the convenience of virtual care, the platform helps enable timely and effective treatment through telemedicine services, improving overall patient experience and care delivery.

“We work closely with clinicians every day, actively listening to their needs and challenges,” said Roy Sakai, president of Nihon Kohden America, LLC. “Incorporating their direct feedback into this latest update to Live View Panel Pro helps break down physical and logistical barriers, empowering medical professionals to deliver exceptional care with greater ease and efficiency. Its advanced features modernize neurology care, driving better outcomes for both patients and providers.”

Source: Nihon Kohden

American Sleep Apnea Association Rebrands as Wellness, Sleep & Circadian Network (WSCN)

Today marks a transformative moment in the 35-year history of the American Sleep Apnea Association (ASAA). The organization proudly rebrands as the Wellness, Sleep & Circadian Network (WSCN), a global “KNOWLEDGE HUB” empowering anyone, anywhere to own all 24 hours with practical, science-based tools that improve sleep, circadian health, and overall well-being.

WSCN, pronounced “WISSEN” (means “knowledge”), and builds upon ASAA’s legacy of advocacy, education, research and support for people with sleep apnea. It is now expanding its reach to address the growing global demand for guidance around whole-day health. The organization is redefining what it means to live well and make every moment count, acknowledging that life happens 24 hours a day 7 days a week.

“When we were building out our new direction, the concern was that no one knows what circadian means. My response? Exactly. That’s our purpose. Share the words to what we experience across all 24 hours,” said Dr. Anne Marie Morse, Chair of the Board of Directors for WSCN and a nationally recognized leader in sleep and circadian medicine.

“Our name says it all,” said Morse. “The Wellness, Sleep & Circadian Network reflects our vision to be a global masterclock, harmonizing health across all hours of the day and night.”

“This isn’t just a rebrand,” Morse added. “It’s a global movement. A bigger, bolder commitment to every person who wants to reclaim their health, one day and night at a time.”

Source: PR Newswire

ProSomnus Introduces EVO Guided  for the Treatment of Obstructive Sleep Apnea

ProSomnus Sleep Technologies announces EVO Guided. EVO Guided is a new precision, custom oral device for the treatment of Obstructive Sleep Apnea (“OSA”). FDA cleared, patented and covered by most medical insurances, EVO Guided is the first oral device bioengineered to dilate the oropharynx and the velopharynx for optimal therapeutic success.   

EVO Guided is engineered to encourage the oral mechanics linked with elevated levels of treatment success, while minimizing, if not avoiding, counterproductive mechanics such as inaccurate mandibular repositioning and stabilization, posterior tongue posture, and forcing larger than necessary separation of the upper and lower teeth. EVO Guided has a 95-degree guided prescription post-titration mechanism that guides the mouth closed and stabilizes the mandible within microns of the target therapeutic position. It features lingual-less maxillary and mandibular dental overlays that encourage a beneficial, anterior tongue posture to minimize deformation and collapse of the ventral wall of the velopharynx.

“We designed EVO Guided with enhanced efficacy in mind, prioritizing 3-dimensional precision mandibular positioning and maximizing tongue space,” commented Sung Kim, CTO. “EVO Guided is our continued commitment to advanced, patient-centric Oral Appliance Therapy for improved OSA treatment.”

“The ProSomnus EVO Guided device has a true custom, anatomical design that maximizes efficacy by guiding mandibular repositioning and guiding the tongue anteriorly while maintaining mouth closure, noted Edward T. Sall, MD, DDS, MBA. As both a physician and dentist treating patients, I believe it should be considered as the new ‘gold standard’ for Oral Appliance Therapy in the treatment of OSA.”

EVO Guided is engineered to precisely reposition and stabilize the mandible. It features a lingual-less splint design to create more room for the tongue and allow a natural contact pressure between the tongue and the lingual dental anatomy.

Source: ProSomnus Sleep Technologies

Harmony Strengthens Patent With ANDA Settlement

Harmony Biosciences Holdings, Inc., today announced a settlement agreement with Lupin Limited, resolving the patent infringement litigation related to Lupin’s Abbreviated New Drug Application (ANDA) for a generic version of WAKIX® (pitolisant hydrochloride). As part of the agreement, litigation in the United States District Court for the District of Delaware will be dismissed, and Lupin will receive a license to launch its generic product no earlier than January 2030 (or July 2030 with pediatric exclusivity), or earlier under certain circumstances.

Harmony had asserted multiple patents covering its WAKIX® (pitolisant HCl) product, the first and only non-scheduled FDA-approved treatment for excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy and for the treatment of EDS in pediatric patients 6 years of age and older with narcolepsy. This settlement reinforces the validity and strength of Harmony’s intellectual property portfolio, which continues to protect its innovations in sleep/wake therapeutics. Harmony is currently advancing next-generation formulations of pitolisant with utility patents filed with potential exclusivity to 2044, designed to address ongoing unmet medical needs in patients living with narcolepsy and other central disorders of hypersomnolence.

Further underscoring Harmony’s patent strength, on July 31, 2024, the U.S. Patent Office Patent Trial and Appeal Board declined, for the second time, to institute an Ex Parte Reexamination of Harmony’s exclusively licensed polymorph patent for pitolisant hydrochloride. The Board’s decision affirms the validity and enforceability of Harmony’s patent estate.

Harmony remains committed to vigorously defending its intellectual property and will continue litigating its consolidated patent infringement case against several other companies that have filed ANDAs seeking approval for generic versions of WAKIX® (pitolisant hydrochloride).

Source: Business Wire

Avadel’s LUMRYZ Receives FDA Orphan Drug Designation for Idiopathic Hypersomnia

Avadel Pharmaceuticals plc  announced that LUMRYZTM has been granted Orphan Drug Designation (ODD) from the U.S. Food & Drug Administration (FDA) for the treatment of Idiopathic Hypersomnia (IH). Specifically, ODD was granted based on the plausible hypothesis that LUMRYZ may be clinically superior to the same drug(s) already approved for the same indication, because LUMRYZ may provide a major contribution to patient care due to its once-nightly dosing for patients with IH, a chronic sleep disorder that requires potentially lifelong treatment.

“We are pleased that LUMRYZ has been granted Orphan Drug Designation for the treatment of IH, and this recognition reinforces our strategy to develop differentiated therapies for patients with rare sleep disorders,” said Greg Divis, Chief Executive Officer of Avadel Pharmaceuticals. “Receipt of ODD highlights the unique value of our next-generation, extended-release oxybate and its potential for IH patients, if approved. We continually hear from clinicians and patients of the substantial need for an extended-release oxybate for this patient population – a population who suffers from profound sleep inertia, making waking up in the middle of the night an even greater challenge than in narcolepsy. With continued progress in our pivotal Phase 3 REVITALYZ trial, an established commercial foundation in narcolepsy, and a relentlessly devoted team, we are well-positioned to advance LUMRYZ in IH with the goal of ultimately transforming the IH treatment landscape, if approved.”

IH is a rare and debilitating sleep disorder characterized by excessive daytime sleepiness not attributable to any other medical conditions. LUMRYZ is currently being evaluated for the treatment of IH in the REVITALYZ™ trial, which is a double-blind, placebo-controlled, randomized withdrawal, multicenter Phase 3 study designed to evaluate the efficacy and safety of LUMRYZ when given as a once-at-bedtime dose. The study will enroll approximately 150 adults who are diagnosed with IH. REVITALYZ enrollment is open for both participants switching from immediate-release oxybates as well as those not currently taking oxybates, and is on track to be completed by year-end 2025.

Source: GlobeNewswire

Nox Medical Redefines Sleep Diagnostics with AI, Cloud and Home Sleep Testing as a Service

Nox Medical is proud to unveil the expanded capabilities of Nox Connect™, a secure, cloud-based platform that now features Artificial Intelligence, web-based scoring and interpretation, and a fully integrated Home Sleep Testing Service. The new platform features were showcased at the SLEEP 2025 conference in Seattle, offering a glimpse into the future of connected, intelligent sleep diagnostics.

“Nox Connect is now the backbone of our diagnostic portfolio,” said Hulda Hallgrimsdottir, COO at Nox Medical “it unifies secure data management and AI-assisted scoring and interpretation into a unified platform—simplifying workflows across in-lab and home testing, and enabling clinicians to interpret studies with clarity and efficiency from anywhere”.

Built on the highest security standards, Nox Connect enables sleep labs and health systems to manage diagnostics, testing logistics, and scoring workflows—from anywhere. At the heart of the platform is a range of FDA-cleared AI tools that support clinical decision-making, including BodySleepTM, OSA Endotyping, Hypoxic Burden, and Ventilatory Burden as part of Noxturnal Web*.

“For nearly two decades, Nox has been at the forefront of diagnostic innovation—delivering technology recognized for its accuracy, precision, and patient-friendly design,” said Sveinbjörn Höskuldsson, Founder and CTO at Nox Medical. With the launch of Nox Connect, that legacy continues—now extended to the cloud with intelligent tools like Nox BodySleep™, which give clinicians greater clarity in interpreting home sleep tests by capturing arousals and sleep staging through respiratory signals. These insights support more conclusive interpretations often missed by proxy-based HSATs.

Source: Nox Medical

DormoVision X Launches at SLEEP 2025

Dormotech launched DormoVision X™ at SLEEP 2025. This FDA-cleared, wireless home sleep testing device delivers real-time data and diagnostic accuracy comparable to gold-standard polysomnography (PSG), with 96.6% equivalence, reshaping how sleep labs deliver care and scale their clinics.

With millions affected by sleep disorders like obstructive sleep apnea (OSA), traditional in-lab PSG can be costly, inconvenient, and resource-intensive. Meanwhile, many home testing options are limited and fall short in capturing comprehensive sleep data. DormoVision X™ addresses this gap with a patient-centric, wireless design—validated in a 2025 Sleep and Breathing study to deliver 96.6% agreement with PSG across AHI, sleep stages, EEG, EOG, EMG, and oxygen saturation (Cohen’s Kappa 0.97). Rated 4+/5 for comfort and ease, with zero reported adverse events, DormoVision X™ enables natural sleep at home while providing clinicians with real time data insights and lab-quality diagnostics.

“As a pediatric sleep specialist, I’ve always looked for more accurate readings for children. DormoVision’s home testing capability has been revolutionary—children sleep in their own beds, and I receive clinical-grade data across all 25 signals. It’s a game changer,” said Prof. Asher Tal, MD, Professor Emeritus of Pediatrics and Founder of the Pediatric Pulmonary Unit and Sleep Laboratory at Soroka Medical Center, Ben-Gurion University.

DormoVision X™ portable, multi-night testing capability reduces turnaround times and scheduling bottlenecks, allowing labs to serve more patients in a single night without the high upfront costs of in-lab equipment. This not only drives significant operational savings but also aligns with Dormotech’s mission to advance early disease detection and treatment through precise, accessible sleep data.

Source: Dormotech

Featured in SleepWorld Magazine Jul/Aug 2025 

Related Posts

ProSomnus Introduces EVO Guided for the Treatment of Obstructive Sleep Apnea

Avadel’s LUMRYZ Receives FDA Orphan Drug Designation for Idiopathic Hypersomnia

Study Identifies ‘Visual System’ Protein for Circadian Rhythm Stability

Harmony Biosciences Updates Status of Pitolisant sNDA for Idiopathic Hypersomnia

Philips Unveils Trilogy Evo Portable Vent at ERS 2018 in Paris

 

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