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Sleep Apnea Testing at Home: Interview with Laurent Martinot, CEO of Sunrise

Obstructive sleep apnea is very common and is associated with a variety of serious health issues, such as cardiovascular disease and diabetes. Getting a proper diagnosis is hampered by the need for patients to visit a sleep clinic and undergo a polysomnog

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Obstructive sleep apnea is very common and is associated with a variety of serious health issues, such as cardiovascular disease and diabetes. Getting a proper diagnosis is hampered by the need for patients to visit a sleep clinic and undergo a polysomnography.

This gold-standard test is complicated and requires specialized staff to interpret the results. To address these issues, a company called Sunrise has developed an at-home sleep apnea test that relies on a small wearable device. The device consists of a small sensor that a user can attach to their chin when they are about to go to sleep.

The sensor records movements of the jaw, which it correlates with sleep events using artificial intelligence. Sunrise has recently launched the device in the UK, and it is relatively inexpensive, starting at £49 ($66). Medgadget had the opportunity to talk to Laurent Martinot, CEO & Co-founder of Sunrise, about the technology.        

Conn Hastings, Medgadget: Please give us an overview of the health issues associated with sleep apnea.

Laurent Martinot, Sunrise: Due to its prevalence and its link with obesity and chronic cardio-metabolic diseases, Obstructive Sleep Apnoea (OSA) is a real public health problem. OSA is primarily responsible for symptoms such as daytime sleepiness (caused by sleep fragmentation), fatigue, irritability and snoring, possibly accompanied by a feeling of suffocation or suffocation during sleep.

Non-restful sleep is accompanied by difficulty concentrating, nocturia (waking up to urinate more than once per night), libido disturbances and disturbances in vigilance. OSA can also be responsible for disrupting the quality of life of spouses/bed neighbors of the sufferer. OSA is thus at the origin of a significant deterioration in the quality of life which can also be the origin of accidents at work and on the road. OSA is also associated with long-term consequences: cardiovascular morbidity and mortality (arterial hypertension, heart failure, atrial fibrillation, etc.), and metabolic (diabetes, obesity) and cognitive effects. It is described as an independent predictor of mortality.

Aside from consequences for quality of life (related to low emotional and professional performance, lack of energy), sleep apnoea includes a large set of comorbidities, displayed in the below chart :

Besides the health issue for the individual, sufferers of OSA also bring an additional cost to the healthcare system. OSA patients are heavy consumers of healthcare services, and due to the varied symptoms this is usually before the diagnosis of OSA is made. The cost of healthcare utilization has been shown to be significantly associated with the severity of OSA.    

Medgadget: How is sleep apnea, and other sleep disorders, currently diagnosed?

Laurent Martinot: Undergoing a polysomnography in a sleep laboratory is considered the gold standard for the diagnosis of OSA. This diagnostic test is very complex to perform and requires specialized personnel to interpret the data (with potential inter-center variability in the quality of the diagnosis). In France, the estimated wait time for a polysomnography varies from a few weeks to several months, leading to a delay and unequal access to care for a pathology which also has very effective treatment for the patient. However, the HAS recommends “promptly registering patients suspected of OSA, presenting severe daytime sleepiness and / or severe cardiovascular or respiratory comorbidities and / or occupational activity at risk of accident”.

The conditions for performing a polysomnography are long and tedious as when a polysomnography is initiated, the placement of the various sensors must be performed in either a sleep laboratory or in a doctor’s office. The patient must then either be hospitalized overnight or return home equipped with the sensors. The complex and highly specialized diagnostic process is not adapted to the prevalence of the disease and its consequences. This is why there is now a strong consensus among experts on the need to develop simplified diagnostic approaches that integrate new technologies including artificial intelligence to provide robust alternatives, on an outpatient basis, for the evaluation of sleep structure, and respiratory abnormalities.

The advantages of diagnosing OSA on an outpatient basis are well established but prior to the launch of Sunrise there has been no device capable of performing the test as efficiently as the reference examination, polysomnography. Furthermore, polygraphy (a home-based lighter version of the polysomnography), which does not allow the measurement of total sleep time, can lead to an underestimation of the severity of OSA and the differentiation of respiratory events of a central or obstructive nature is limited.

The new integrated digital solution Sunrise allows the diagnosis of OSA via an original mandibular sensor integrating the analysis of mandibular movements. This approach has been scientifically validated for the identification of respiratory events during sleep (apnea, central or obstructive hypopnea). This diagnostic solution also helps identify sleep fragmentation and estimate total sleep time. The interpretation is reinforced by an AI system which homogenizes the quality of the scoring of respiratory events. In a large single-center validation in 376 patients, the diagnostic performance was equivalent to that of polysomnography. The digital solution functions alongside a partnering app to guide patients, and offers the possibility of carrying out the diagnosis on an outpatient basis and the test can very easily be repeated over several nights. Its integration into practices around the world could respond to the problems encountered and considerably modify the diagnostic approach of a patient suspected of OSA, and thus accelerate its treatment.

While offering a major upgrade in terms of ease of use and ergonomics, Sunrise is equivalent in precision to polysomnography. Such clinical precision is quite new for a device that weighs only 3 grams and is as easy to use as a pregnancy test.

Medgadget: What would lead someone to take a test for sleep apnea? Are there any warning signs that people should be aware of?

Laurent Martinot: Studies show that 936 million people1 are affected by sleep apnoea – other papers concluding to a prevalence of almost 1 in 2 men aged 40 and above! -and more than 80% go undiagnosed despite adequate access to health care2.

Being aware of this prevalence, knowing the long-term consequences on health and keeping in mind that sleep apnoea symptoms are quite common (see list below) is the key to prompt people to take the test. This is why we made the test so simple.

Here are some of the common symptoms that can be associated with Sleep Apnoea:

  • Loud snoring
  • Exhaustion/tiredness on waking up
  • Repeated awakenings and/or insomnia
  • Choking at night
  • Palpitations & high heart rate
  • Frequent toilet runs during sleep (nocturia)
  • Anxiety
  • Mood swings

Obstructive sleep apnoea is also a major risk factor for a variety of medical conditions, increasing the risk and severity of cardiometabolic diseases, including hypertension, arrhythmias, stroke, coronary heart disease, type 1 and type 2 diabetes, and metabolic dysfunction, ultimately resulting in increased overall mortality.

Medgadget: Please give us an overview of the Sunrise sensor. How does it work?

Laurent Martinot: The Sunrise sleep test is an AI-powered innovative 3 gram sensor that sits on the user’s chin and helps to diagnose sleep disorders and monitors for sleep disorders from the comfort of your own bedroom.

Science has recently identified the most reliable signal to measure sleep. This signal comes from mandibular movements, the most direct proxy to the brain’s sleep and breathing regulation action.

The real-time analysis of these mandibular movements consists of reading the activity generated by upper airway muscle contractions. This activity reflects the adjustments performed by the brain to preserve quality sleep and provides the data to allow a complete understanding of sleep events.

Since it directly comes from the brain stem, the most profound and primitive part of our brain, this signal is free from the interference of complex cortex activity. To the purpose of sleep analysis, it is therefore considered as purer.

The Sunrise sensor, which rests securely on the user’s chin, records data whilst the user is asleep to generate a thorough report shared the next day that highlights possible sleep apnoea or other sleep conditions through the partnering Sunrise app. Once the report is generated, users are then offered the choice to connect with sleep physicians, and receive treatment when needed.

Medgadget: How is the sensor used, and how soon can it provide results?

Laurent Martinot: The sensor is clinically proven and puts science at the tip of the chin, and the Sunrise sleep test can provide results after a minimum of 4 hrs of sleep. By measuring the movements in the chin, Sunrise allows everyone to perform a clinical test in a natural  sleeping environment with the non-invasive small smart device and receive a thorough breakdown of the recording in just a few hours as the report is sent back at the user at sunrise.

This method of results delivery means that there is no need for the user to send the device back to collect the results as the data are uploaded from the sensor to the patient’s smartphone and then to the cloud, making the results directly available for the physician to also review. Additionally, the user can then either dispose of the sensor or send it back to Sunrise through a prepaid envelope that comes with the sensor on delivery. Sunrise will then reuse the electronics and recycle the plastic body.

Medgadget: How does such remote testing technology aid diagnosis and assist in limiting viral spread during the current pandemic?

Laurent Martinot: Thanks to its simplicity and ergonomics, the test can be performed by the user without the need for expert support. Therefore, the user does not have to go to a sleep clinic and get in close contact with a healthcare professional to get equipped with the device. The procedure can be fully contactless and infection risk free. Coupled with the fact that the device is disposable, there is then no risk of cross contamination.

Also after the test, Sunrise gets the user connected with a pool of sleep physicians, all able to perform their consultation via video call. To this extent, Sunrise is helping to limit viral spread in the context of the current pandemic. This is especially important as studies have shown patients with suspected sleep apnoea could be at higher risk if they were to contract COVID-19.

(1) Benjafield et al. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respiratory Medicine 2019. http://dx.doi.org/10.1016/S2213-2600(19)30198-5
(2) Risk factors for obstructive sleep apnea in adults. Young T, Skatrud J, Peppard PE.JAMA. 2004 Apr 28; 291(16):2013-6.

Link: Sunrise homepage…

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Four burning questions about the future of the $16.5B Novo-Catalent deal

To build or to buy? That’s a classic question for pharma boardrooms, and Novo Nordisk is going with both.
Beyond spending billions of dollars to expand…

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To build or to buy? That’s a classic question for pharma boardrooms, and Novo Nordisk is going with both.

Beyond spending billions of dollars to expand its own production capacity for its weight loss drugs, the Danish drugmaker said Monday it will pay $11 billion to acquire three manufacturing plants from Catalent. It’s part of a broader $16.5 billion deal with Novo Holdings, the investment arm of the pharma’s parent group, which agreed to acquire the contract manufacturer and take it private.

It’s a big deal for all parties, with potential ripple effects across the biotech ecosystem. Here’s a look at some of the most pressing questions to watch after Monday’s announcement.

Why did Novo do this?

Novo Holdings isn’t the most obvious buyer for Catalent, particularly after last year’s on-and-off M&A interest from the serial acquirer Danaher. But the deal could benefit both Novo Holdings and Novo Nordisk.

Novo Nordisk’s biggest challenge has been simply making enough of the weight loss drug Wegovy and diabetes therapy Ozempic. On last week’s earnings call, Novo Nordisk CEO Lars Fruergaard Jørgensen said the company isn’t constrained by capital in its efforts to boost manufacturing. Rather, the main challenge is the limited amount of capabilities out there, he said.

“Most pharmaceutical companies in the world would be shopping among the same manufacturers,” he said. “There’s not an unlimited amount of machinery and people to build it.”

While Novo was already one of Catalent’s major customers, the manufacturer has been hamstrung by its own balance sheet. With roughly $5 billion in debt on its books, it’s had to juggle paying down debt with sufficiently investing in its facilities. That’s been particularly challenging in keeping pace with soaring demand for GLP-1 drugs.

Novo, on the other hand, has the balance sheet to funnel as much money as needed into the plants in Italy, Belgium, and Indiana. It’s also struggled to make enough of its popular GLP-1 drugs to meet their soaring demand, with documented shortages of both Ozempic and Wegovy.

The impact won’t be immediate. The parties expect the deal to close near the end of 2024. Novo Nordisk said it expects the three new sites to “gradually increase Novo Nordisk’s filling capacity from 2026 and onwards.”

As for the rest of Catalent — nearly 50 other sites employing thousands of workers — Novo Holdings will take control. The group previously acquired Altasciences in 2021 and Ritedose in 2022, so the Catalent deal builds on a core investing interest in biopharma services, Novo Holdings CEO Kasim Kutay told Endpoints News.

Kasim Kutay

When asked about possible site closures or layoffs, Kutay said the team hasn’t thought about that.

“That’s not our track record. Our track record is to invest in quality businesses and help them grow,” he said. “There’s always stuff to do with any asset you own, but we haven’t bought this company to do some of the stuff you’re talking about.”

What does it mean for Catalent’s customers? 

Until the deal closes, Catalent will operate as a standalone business. After it closes, Novo Nordisk said it will honor its customer obligations at the three sites, a spokesperson said. But they didn’t answer a question about what happens when those contracts expire.

The wrinkle is the long-term future of the three plants that Novo Nordisk is paying for. Those sites don’t exclusively pump out Wegovy, but that could be the logical long-term aim for the Danish drugmaker.

The ideal scenario is that pricing and timelines remain the same for customers, said Nicole Paulk, CEO of the gene therapy startup Siren Biotechnology.

Nicole Paulk

“The name of the group that you’re going to send your check to is now going to be Novo Holdings instead of Catalent, but otherwise everything remains the same,” Paulk told Endpoints. “That’s the best-case scenario.”

In a worst case, Paulk said she feared the new owners could wind up closing sites or laying off Catalent groups. That could create some uncertainty for customers looking for a long-term manufacturing partner.

Are shareholders and regulators happy? 

The pandemic was a wild ride for Catalent’s stock, with shares surging from about $40 to $140 and then crashing back to earth. The $63.50 share price for the takeover is a happy ending depending on the investor.

On that point, the investing giant Elliott Investment Management is satisfied. Marc Steinberg, a partner at Elliott, called the agreement “an outstanding outcome” that “clearly maximizes value for Catalent stockholders” in a statement.

Elliott helped kick off a strategic review last August that culminated in the sale agreement. Compared to Catalent’s stock price before that review started, the deal pays a nearly 40% premium.

Alessandro Maselli

But this is hardly a victory lap for CEO Alessandro Maselli, who took over in July 2022 when Catalent’s stock price was north of $100. Novo’s takeover is a tacit acknowledgment that Maselli could never fully right the ship, as operational problems plagued the company throughout 2023 while it was limited by its debt.

Additional regulatory filings in the next few weeks could give insight into just how competitive the sale process was. William Blair analysts said they don’t expect a competing bidder “given the organic investments already being pursued at other leading CDMOs and the breadth and scale of Catalent’s operations.”

The Blair analysts also noted the companies likely “expect to spend some time educating relevant government agencies” about the deal, given the lengthy closing timeline. Given Novo Nordisk’s ascent — it’s now one of Europe’s most valuable companies — paired with the limited number of large contract manufacturers, antitrust regulators could be interested in taking a close look.

Are Catalent’s problems finally a thing of the past?

Catalent ran into a mix of financial and operational problems over the past year that played no small part in attracting the interest of an activist like Elliott.

Now with a deal in place, how quickly can Novo rectify those problems? Some of the challenges were driven by the demands of being a publicly traded company, like failing to meet investors’ revenue expectations or even filing earnings reports on time.

But Catalent also struggled with its business at times, with a range of manufacturing delays, inspection reports and occasionally writing down acquisitions that didn’t pan out. Novo’s deep pockets will go a long way to a turnaround, but only the future will tell if all these issues are fixed.

Kutay said his team is excited by the opportunity and was satisfied with the due diligence it did on the company.

“We believe we’re buying a strong company with a good management team and good prospects,” Kutay said. “If that wasn’t the case, I don’t think we’d be here.”

Amber Tong and Reynald Castañeda contributed reporting.

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Petrina Kamya, Ph.D., Head of AI Platforms at Insilico Medicine, presents at BIO CEO & Investor Conference

Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb….

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Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb. 26-27 at the New York Marriott Marquis in New York City. Dr. Kamya will speak as part of the panel “AI within Biopharma: Separating Value from Hype,” on Feb. 27, 1pm ET along with Michael Nally, CEO of Generate: Biomedicines and Liz Schwarzbach, PhD, CBO of BigHat Biosciences.

Credit: Insilico Medicine

Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb. 26-27 at the New York Marriott Marquis in New York City. Dr. Kamya will speak as part of the panel “AI within Biopharma: Separating Value from Hype,” on Feb. 27, 1pm ET along with Michael Nally, CEO of Generate: Biomedicines and Liz Schwarzbach, PhD, CBO of BigHat Biosciences.

The session will look at how the latest artificial intelligence (AI) tools – including generative AI and large language models – are currently being used to advance the discovery and design of new drugs, and which technologies are still in development. 

The BIO CEO & Investor Conference brings together over 1,000 attendees and more than 700 companies across industry and institutional investment to discuss the future investment landscape of biotechnology. Sessions focus on topics such as therapeutic advancements, market outlook, and policy priorities.

Insilico Medicine is a leading, clinical stage AI-driven drug discovery company that has raised over $400m in investments since it was founded in 2014. Dr. Kamya leads the development of the Company’s end-to-end generative AI platform, Pharma.AI from Insilico’s AI R&D Center in Montreal. Using modern machine learning techniques in the context of chemistry and biology, the platform has driven the discovery and design of 30+ new therapies, with five in clinical stages – for cancer, fibrosis, inflammatory bowel disease (IBD), and COVID-19. The Company’s lead drug, for the chronic, rare lung condition idiopathic pulmonary fibrosis, is the first AI-designed drug for an AI-discovered target to reach Phase II clinical trials with patients. Nine of the top 20 pharmaceutical companies have used Insilico’s AI platform to advance their programs, and the Company has a number of major strategic licensing deals around its AI-designed therapeutic assets, including with Sanofi, Exelixis and Menarini. 

 

About Insilico Medicine

Insilico Medicine, a global clinical stage biotechnology company powered by generative AI, is connecting biology, chemistry, and clinical trials analysis using next-generation AI systems. The company has developed AI platforms that utilize deep generative models, reinforcement learning, transformers, and other modern machine learning techniques for novel target discovery and the generation of novel molecular structures with desired properties. Insilico Medicine is developing breakthrough solutions to discover and develop innovative drugs for cancer, fibrosis, immunity, central nervous system diseases, infectious diseases, autoimmune diseases, and aging-related diseases. www.insilico.com 


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Another country is getting ready to launch a visa for digital nomads

Early reports are saying Japan will soon have a digital nomad visa for high-earning foreigners.

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Over the last decade, the explosion of remote work that came as a result of improved technology and the pandemic has allowed an increasing number of people to become digital nomads. 

When looked at more broadly as anyone not required to come into a fixed office but instead moves between different locations such as the home and the coffee shop, the latest estimate shows that there were more than 35 million such workers in the world by the end of 2023 while over half of those come from the United States.

Related: There is a new list of cities that are best for digital nomads

While remote work has also allowed many to move to cheaper places and travel around the world while still bringing in income, working outside of one's home country requires either dual citizenship or work authorization — the global shift toward remote work has pushed many countries to launch specific digital nomad visas to boost their economies and bring in new residents.

Japan is a very popular destination for U.S. tourists. 

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This popular vacation destination will soon have a nomad visa

Spain, Portugal, Indonesia, Malaysia, Costa Rica, Brazil, Latvia and Malta are some of the countries currently offering specific visas for foreigners who want to live there while bringing in income from abroad.

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With the exception of a few, Asian countries generally have stricter immigration laws and were much slower to launch these types of visas that some of the countries with weaker economies had as far back as 2015. As first reported by the Japan Times, the country's Immigration Services Agency ended up making the leap toward a visa for those who can earn more than ¥10 million ($68,300 USD) with income from another country.

The Japanese government has not yet worked out the specifics of how long the visa will be valid for or how much it will cost — public comment on the proposal is being accepted throughout next week. 

That said, early reports say the visa will be shorter than the typical digital nomad option that allows foreigners to live in a country for several years. The visa will reportedly be valid for six months or slightly longer but still no more than a year — along with the ability to work, this allows some to stay beyond the 90-day tourist period typically afforded to those from countries with visa-free agreements.

'Not be given a residence card of residence certificate'

While one will be able to reapply for the visa after the time runs out, this can only be done by exiting the country and being away for six months before coming back again — becoming a permanent resident on the pathway to citizenship is an entirely different process with much more strict requirements.

"Those living in Japan with the digital nomad visa will not be given a residence card or a residence certificate, which provide access to certain government benefits," reports the news outlet. "The visa cannot be renewed and must be reapplied for, with this only possible six months after leaving the countr

The visa will reportedly start in March and also allow holders to bring their spouses and families with them. To start using the visa, holders will also need to purchase private health insurance from their home country while taxes on any money one earns will also need to be paid through one's home country.

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