Short takes: Synchron BCI integrates with Apple devices, Shields Health partners with Duke on specialty pharmacy, raises for Cohere Health, Olio

May 15, 2025 | by | No Comments

Another brain-computer interface (BCI) makes a major advance. Synchron, a BCI company based in Brooklyn, NYC, announced that it will be the first BCI company to achieve native integration with Apple’s new BCI Human Interface Device (BCI HID) profile. The 13 May Apple announcement of a native integration means that Synchron’s BCI can control iPhone, iPad and Apple Vision Pro directly with their thoughts without physical movement or voice commands. Synchron’s BCI device, Stentrode, is placed in a blood vessel in the brain via a minimally invasive endovascular procedure, not directly in the brain, captures the neural signals, and connects to the IRT signaling device that has a two-way interface with the Apple devices. Controlled rollouts with trial participants using BCI HID-compatible features are expected to begin later this year. Synchron release, Mobihealthnews, MassDevice

The Synchron Stentrode device is still in clinical trials and has been in development since 2012. Synchron achieved the first BCI in 2019. In March, they and NVIDIA announced Chiral, a foundation model of human cognitions, and developing a cognitive AI model—artificial intelligence trained directly on human neural activity. From their announcement release, Chiral will be trained on a roadmap via NVIDIA’s Holoscan (motor inference), NVIDIA’s Omniverse platform and Cosmos world foundation models to simulate environments, and then through deidentified data. They have also partnered with Team Gleason, a foundation dedicated to improving the lives of people living with ALS. Earlier this month, Neuralink announced its third successful human implant in an ALS patient [TTA 8 May]. 

Shields Health Solutions partnering with Duke Health in North Carolina. The partnership between Duke Specialty Pharmacy and Shields Health Solutions aims to enhance personalized patient care by expanding services, reducing costs, and improving access to treatment options and medication management. Shields Health equips health systems with integrated specialty pharmacy solutions, enabling Duke to support patients with complex chronic conditions through regular follow-ups, side effect management, financial assistance, and medication delivery, with the goals of better medication adherence and patient outcomes. Shields partners with nearly 80 health systems, providing access to over 80% of limited distribution drugs (LDDs) and with most payers. Their clinical model is designed to reduce the total cost of care by 13%. Release

Two raises of note this week (are we seeing the return of lettered rounds?):

Cohere Health lands a $90 million Series C raise. The round was led by by Temasek, with continued support from Deerfield Management, Define Ventures, Flare Capital Partners, Longitude Capital, and Polaris Partners. Their total funding now exceeds $200 million since their start in 2019. Cohere Health automates prior authorization workflows, accelerating decisioning and review for physician practices. They are planning to expand their technology with AI to improve care management and other types of administrative burden.  Release, FierceHealthcare

Olio Health raised $11 million in a Series B. The round was led by by Fulcrum Equity Partners, with participation from Mutual Capital Partners (MCP). Their Series A round of $13 million in August 2022 was led by MCP for a total since 2017 of $26.5 million. Olio’s ‘oil’ is a care management platform for value-based care primary care providers, payers, and health systems for post-acute care. The additional funding will be used for product expansion and accelerate their go-to-market initiatives. Olio is headquartered in Indianapolis.  Release, Mobihealthnews

Theranos’ revenge? Holmes’ partner Billy Evans founds a startup for diagnostic testing, denies it is ‘Theranos 2.0’; Holmes loses Federal rehearing appeal.

May 14, 2025 | by | No Comments

The technologies may differ, but the functions remain the same. Haemanthus, a biologic testing startup founded by hotel heir Billy Evans—widely recognized as Elizabeth Holmes’ partner and father of her two children—has suddenly and bumpily emerged–kind of–from stealth mode. Coverage in the New York Times and NPR has drawn unfavorable comparisons to Theranos’ failed blood-testing venture and highlighted Evans’ connection to Holmes, who is currently serving an approximately 11 year sentence at the women’s Federal Prison Camp in Bryan, Texas.

Haemanthus, named after the Latin name for the blood lily plant, has developed a prototype box-like device (right) that uses Raman spectroscopy, using lasers, photonics, and other light technologies, coupled to AI-based software that analyzes biologic samples. The initial diagnostics will focus on pet diseases and the veterinary market before entering the human market, with the machine analyzing blood, saliva, and urine for biomarkers such as glucose and hormones. Deep learning models based in the software would then have the ability to detect diseases such as cancer and infections. Raman spectroscopy is already used in human diagnostics to analyze biomolecules like proteins, DNA, and lipids, as well as studying cell structure, tissue composition, and cellular processes. The company, in its investment materials, intends to develop a stamp-size, wearable device for humans.

The company, currently backed by Evans, has raised money from friends, family and other supporters so far, according to one of the sources quoted by NPR. The NYT stated that was a $3.5 million raise. This spring, Evans has been reaching out to other investors in Austin, where he lives with the children, and the Bay Area. The goal is eventually $50 million. To expand to humans after pets, their investor materials state that it will take three years and a total raise of $70 million.

James Breyer of the eponymous Breyer Capital was approached for investment but turned it down for the same reasons as he did Theranos, twice. Michael Dell also passed, according to the NYT. A local investor the NYT identified is Matthew E. Parkhurst, an investor who is also the part owner of a Mediterranean tapas bar in downtown Austin.

The NYT article brings up regulatory oversight. The USDA, the US Department of Agriculture, regulates veterinary medicine and diagnostics. Yet Mr. Evans sent to the NYT a partially redacted document from the USDA that said, “It does not appear that the proposed product is within the regulatory jurisdiction” of the Center for Veterinary Biologics, which is a part of the USDA.” 

What has created the most news is that the NPR article explicitly stated that Elizabeth Holmes was advising Evans on the startup, without specifics on what and how. The company reportedly has about 12 employees, some of whom worked at Evans’ prior venture, Luminar Technologies, a developer of autonomous vehicle sensors, according to the company’s patent and Delaware incorporation paperwork.

The two articles generated enough stir that Haemanthus took to X on 11 May to state in several tweets (samples below):

We’re Haemanthus. Yes, our CEO, Billy Evans, is Elizabeth Holmes’ partner. Skepticism is rational. We must clear a higher bar. When @nytimes contacted us, we invited them: see our lab, tech, and team. They declined. The headline was already written. Our reality inconvenient.
2/This is not Theranos 2.0. Theranos attempted to miniaturize existing tests. Our approach is fundamentally different. We use light to read the complete molecular story in biological fluids, seeing patterns current tests can’t detect. Not an improvement. A different paradigm.
3/ Setting the record straight. Elizabeth Holmes has zero involvement in Haemanthus. We’ve learned from her company’s mistakes, but she has no role, now or future. NYT & @NPR implied otherwise. We’ve stayed quiet to build real tech, not conceal. Demonstrating, not promising.

Fast Company and the Mercury News also review Haemanthus’ sudden emergence. Hat tip to HIStalk 5/12/25

Elizabeth Holmes will likely be remaining in Bryan for the remainder of her sentence. The Ninth Circuit US Court of Appeals rejected her petition last week to have a full en banc or original panel review of her fraud conviction appeal. The District Court’s sentence of both Holmes and Sunny Balwani were upheld in February [TTA 5 Mar]. “The full court has been advised of the petition for rehearing en banc, and no judge of the court has requested a vote on whether to rehear the matter en banc,” the panel said in its short, four-sentence order. Unless the US Supreme Court issues a highly unlikely writ of certiorari based on her petition, this is the end of her long-running courtroom drama. Her 11 year sentence is at this point at about two years served with additional reductions of two years and four months, now with a release date of 18 February 2032.  There is also a small matter of Holmes and Balwani paying back $452 million in restitution for their fraud. Courthouse News Service, CNBC  

The only discussion of Balwani’s separate petition for a review (Court Listener) has been on Reddit by legal maven mattschwink. Balwani’s argument for a rehearing is based upon an assertion that a witness, investor Brian Tolbert, lied on the stand about being told by Holmes on an investor call that the Theranos machines were being used on Afghanistan medevac helicopters. The investor call was not played, nor the testimony brought up at Balwani’s trial, which based on precedent may constitute withholding of exculpatory evidence. In his view, this is likely not enough to constitute a falsehood by the prosecution.

Regardless of whether Haemanthus’ denials of Holmes’ “advisory services” are true, it’s unlikely that Holmes could provide substantial guidance to the company beyond brief, casual talks during Billy Evans’ visits—especially considering whether such activities are allowed while residing in an FPC.

News roundup: Omada Health files for IPO, UPMC-Redesign partner on chronic pain management, OK and PA AGs warn 23andMe users to delete data, Verily to build Parkinson’s dataset, what payers paid for exec security

May 13, 2025 | by | No Comments

Omada Health’s IPO filing kicked off the week’s news. The chronic condition care management company is the second with a major IPO this year, stirring a dormant healthcare market. There aren’t a lot of offering details in the 9 May SEC Form S-1 registration and preliminary prospectus, but the IPO will launch on Nasdaq Global Markets under the symbol OMDA. There is no disclosure of timing, number of shares to be offered, or pricing. Their prior funding since 2011 is over $528 million through a Series E and debt financing, with lead investors including Andreessen Horowitz, Norwest Venture Partners, Wellington Management, New Enterprise Associates, and Founder Collective (Crunchbase).

Omada’s focus on ‘bending the disease’ curve via a ‘between-visit care model’ for diabetes, obesity, hypertension, and MSK patients has met with success. With a listing of 2,000+ customers and over 679,000 total members enrolled in one or more programs, their 2024 revenue grew 38% from $122.8 million to $169.8 million in 2023, with Q1 2025 by 57% to $55.0 million from 2024’s $35.1 million. Revenue does not mean profit, with net losses of $67.5 million in 2024 and $47.1 million in 2023, with $9.4 million in losses during Q1 2025 reduced from $19 million in Q1 2024. CNBC, Mobihealthnews, FierceHealthcare

Larger and MSK-focused competitor Hinge Health announced its own IPO back in mid-March [TTA 14 Mar] via a SEC S-1 filing and preliminary prospectus, but sent out word that it was postponing by April [TTA 8 April]. With markets doing much better, it’s anticipated that their debut on the NYSE will be this summer. Their funders which have invested over $826 million since 2012 are undoubtedly eager for ROI.

The Redesign Health-UPMC Enterprises partnership launches Glimmer Health. The new company supports primary care physicians to manage their patients’ chronic pain. Chronic pain affects 25% of, or 70 million, US adults. It addresses the lack of resources that primary care practices generally lack to manage the chronic pain of their patients. The Glimmer Health platform integrates advanced medical expertise, behavioral health support, and seamless care coordination via specialized nurse-practitioners, care managers, and social workers to coordinate care plans and guide patients. The company grows out of UPMC’s pain clinics and 12 years of experience in comprehensive assessment and multimodal treatment approaches. Ajay Wasan, M.D., M.Sc., professor of anesthesiology and psychiatry at the University of Pittsburgh and vice chair for pain medicine at Pitt and UPMC, who leads the clinics, is now medical director of Glimmer Health. CEO is Alissa Meade, previously CEO of Together Senior Health, sold last year to Linus Health according to her LinkedIn profile. UPMC release

“Delete Your 23andMe Data!” say Oklahoma’s and Pennsylvania’s Attorneys General. Oklahoma’s AG Gentner Drummond finally got the news (via the wind whistling down the plains?) along with Pennsylvania’s AG Dave Sunday that 23andMe went bankrupt in March and it, or parts, are up for sale. The two AGs advise citizens of their respective states to delete their data, instruct 23andMe to destroy their test sample, and revoke research consent for their data. Well, the rush is over at least…it’s better late than never. The instructions are clear, though their efficacy with 23andMe in actually removing it, including survey data, versus following FTC policies on securing the data, is in reasonable doubt [TTA 3 April]. After all, user genetic data and information is all that 23andMe has to sell.  Oklahoma AG’s release, The Oklahoman, Levittown (PA) Now

Alphabet/Google’s Verily health data/AI unit to build a Parkinson’s molecular research dataset. With a $14.7 million grant from the Michael J. Fox Foundation (MJFF), Verily will be building what they term is a comprehensive molecular dataset to advance Parkinson’s disease research. The dataset is based on data previously collected as part of the Personalized Parkinson’s Project (PPP), a collaboration with the Radboud University Medical Center, in a two-year longitudinal study of 520 people with Parkinson’s. It included detailed clinical histories, data from the Verily Study Watch, imaging data, and matched biospecimens such as blood and cerebrospinal fluid. It will be made publicly available to researchers through Verily’s Workbench solution. According to Verily’s release, the molecular data includes:

  • A comprehensive, high-resolution immunogenomic data resource to fuel research on the immune system’s association with Parkinson’s disease pathogenesis.
  • Whole genome sequences for those that have consented to enable discovery of genetic factors associated with different aspects of Parkinson’s disease.
  • Metabolomic and alpha-Synuclein data, which have shown promise for assessing and predicting disease activity and stages.

No deadline was disclosed. Mobihealthnews

How much does it cost to protect healthcare corporate executives? Executive security is one of those hidden costs that is not always easy to determine. Some receive it, others do not, at least for public consumption or paid for by the company.

  • UnitedHealth Group in 2024 totaled $1.7 million in security costs.  The largest cost was for executive protection for Optum CEO Heather Cianfrocco, $926,989. CEO Andrew Witty’s security costs, not included in the $1.7 million, totaled $150,951. He was also required to use the company’s corporate aircraft for business travel (cost not itemized) and was encouraged to do so for personal travel, should the plane be available. Witty did not use it for the latter in 2024. Brian Thompson unfortunately received no security.
  • CVS Health did not itemize direct security costs for CEO David Joyner in 2024. His disclosed expenses from October on were $15,787 on personal use of the company plane; $7,713 for the use of a company car and driver; and $82,603 on home security. Personal travel expenses using company resources must be reimbursed over $250,000 (!). Previous CEO Karen Lynch racked up expenses of $242,051 on personal aircraft use; $95,199 on the use of a company car and driver; and $44,645 on personal protection. Security totaling $56,610 was extended to her for six months after she was replaced by David Joyner.
  • Cigna’s CEO David Cordani is required to use the company aircraft for business and personal travel. The latter totaled $231,008 in 2024. Spending for executive protection was not disclosed. Cigna does not consider security a perquisite for executive compensation purposes. There is no further information about executive security.
  • Elevance Health lists executive security as “other perquisites” and apparently it is modest. For CEO Gail Boudreaux, they spent $93,387 and for Peter Haytaian, president of Elevance’s Carelon unit, $36,213. Boudreaux also was permitted limited use of corporate aircraft for up to 50 hours of personal flight time each year not to exceed a total of $199,000 in costs. 
  • Centene Corporation discloses few costs around executive security, only providing it to CEO Sarah London until December 2024. Her 2024 security totaled $69,133. Interestingly, CFO Drew Asher received $98,358 in protection services and COO Susan Smith $33,244. London also had $143,854 in expenses for personal aircraft usage. Centene policy is that the aircraft is available for security reasons but did not disclose whether London or other executives were required to use the plane for business use.
  • Finally, Humana’s only disclosures around security was for the perquisite of personal corporate plane usage, and it’s limited. CEO Jim Rechtin incurred $36,166, with former CEO Bruce Broussard spending $37,434 .

FierceHealthcare’s Paige Minemeyer did the dig.

This just in: UnitedHealth Group CEO Andrew Witty steps down immediately, replaced by former CEO Stephen Hemsley (updated 15 May)

May 13, 2025 | by | No Comments

This was drastic. This morning (13 May), UnitedHealth Group announced that CEO Andrew Witty is stepping down immediately “for personal reasons” which are not specified. Replacing him is former (2006-2017) Stephen (Steve) Hemsley, who will remain chairman of UHG’s board of directors. Mr. Witty has been named as “senior adviser to Hemsley” which is a typical resignation/separation workout for CEO/president departures, indicating continuity to soften the immediacy of the change.

The quotes in the release are also typical of these ‘friendly’ transitions. Mr. Witty:  “Leading the people of UnitedHealth Group has been a tremendous honor as they work every day to improve the health system, and they will continue to inspire me.”  Mr. Hemsley: “We are grateful for Andrew’s stewardship of UnitedHealth Group, especially during some of the most challenging times any company has ever faced. The Board and I have greatly valued his leadership and compassion as chief executive and as a director and wish him and his family the best.

Mr. Hemsley is 72. There is no mention in the release that he is interim or of an executive search.

Sir Andrew Witty, aged 60, is British, knighted in 2012 for his leadership of GlaxoSmithKline. He became CEO of UHG in February 2021 after three years as Optum CEO starting in 2018. Previously, he was CEO of GSK from 2008 to 2017. Witty led the National Health Service’s Accelerated Access Collaborative for a year after, 2017-2018, and had been chancellor of the University of Nottingham while heading GSK 2013-2017. Certainly he experienced many challenges during his UHG/Optum tenure that accelerated in the past two years: the Covid pandemic, the assassination of Brian Thompson, Change Healthcare’s massive cyberattack that disrupted the entire provider payment structure for months and exposed patient data, and the continuing Federal opposition to the Amedisys home health buy. Notably, Witty was one of the pioneers aggressively pursuing the ‘payvider’ structure. According to STAT News, by 2024 almost 10% or 90,000 US physicians were affiliated with Optum, either via 10,000 owned practices, or 80,000 affiliated through various value-based care arrangements.

At 8am EDT, UHG held an investor call, so there will be developing news from it. At the very bottom of the release is that UHG has now suspended its revised its 2025 outlook due to high utilization costs: accelerated care activity, more benefit offerings, and higher costs associated with Medicare Advantage beneficiaries. These primarily affect the UnitedHealthcare unit but also have knock-on affects on the non-insurance business (25% of the company) that presumably Mr. Hemsley and company are calculating. Also FierceHealthPayer

An exceedingly tart take on Mr. Witty’s tenure at UHG was posted today by Sergei Polevikov today in his ‘AI Health Uncut’ Substack, ‘UnitedHealth Bleeds, CEO Witty Steps Down’. In his view, Witty left a trail of damage during his tenure that includes far more than my challenges above, that include discrimination, claims denials, class action lawsuits around earnings manipulations, and the ever-popular insider trading–but UHG always seems to get away with minimal damage. Till today. UHG stock closed down today (Tuesday 13 May) 22% from its price on Monday.

A thought among many is that UHG should be broken up as a healthcare monopoly–the end game of integration. That seems to be a lead taken by Substack commenters and on other social media. MedCityNews takes a look at the impact today. And almost as an aside–what will be the future of top management identified as part of the Witty tenure? Exits done with prejudice at the top are usually the start.

Update 15 May: This Editor underestimated Mr. Market’s continued agita. The share price of UnitedHealth Group (UNH) has gone from one month ago at $585 (16 April 4pm close) to 11:07am today (15 May) at $258 and change. That is a slide of 56%. What is worse is since that the CEO changeover was announced on Tuesday, the price has continued to slide from $311 to today, a 17% drop. The management change did not stabilize the price even in a bouncy market. For some reason unknown to the general audience and certainly to us chickens, UNH is being pummelled. Hard. We will see what happens next week.

Best wishes to Strata-gee’s Ted Green on a fast recovery!

May 13, 2025 | by | No Comments

Our expert on all things Masimo is down, but certainly not out. Last Monday (5 May) Ted Green, the founder of audio business website Strata-gee, while out power walking, was hit by something (spaceship, meteorite–your Editor will let him tell you), and wound up hospitalized for a few days with a variety of injuries. He’s now recuperating at home. Our very best wishes for his recovery from multiple bang-ups, bruises, and a nasty shoulder.

If you like audio, Ted’s website is a must-read for the business behind the brands. Even if you are old-school audio like me, you’ll find it fascinating and written from the perspective of a real Business Insider. 

He digs deep. Right before his ‘airborne’ event, Ted’s last Masimo story for Strata-gee dated 1 May investigated what was going on with their website. I had casually mentioned to Ted that the Masimo website was down after picking up his analysis of former CEO Joseph Kiani’s claim to 13.2% share ownership. Ted is the one who investigated that Masimo’s website remained down with no explanations that made sense and it had spread internally. He was the first to bring to everyone’s attention on the healthcare side that Masimo Had A Problem, and it was bigger than a temporary outage. Commenters weighed in with updates. Masimo finally admitted in their SEC Form 8-K on 6 May that they had a cyber incident that affected most of their systems, including manufacturing and customer service. The story developed last week as you’ll see here—while Ted was in the hospital–as well as the Sound United sale.

If you’ve liked our coverage on Masimo–and the ‘hits’ indicate that you, our Readers, have–you can thank Ted.

Add your good wishes to comments under his story on his ‘event’. (BTW, the care he received at JFK Hospital in Edison, New Jersey was excellent.)

Short takes: HHS forms NIH/CMS autism data project; Oscar Health beats Street w/Q1 $275M net; Centene’s $1.3B earnings; UHG has class action suit on earnings, 1K AI apps in production; Cedars-Sinai and Redesign Health partner on development; FDA, Lilly, Novo Nordisk win vs. compounders

May 8, 2025 | by | No Comments

NIH, CMS to create autism data platform to enable research. The National Institutes of Health (NIH) and the Centers for Medicare & Medicaid Services (CMS), both under Health & Human Services (HHS), are partnering to enable NIH to build a real-world data platform. The purpose is to advance research around the root causes of autism spectrum disorder (ASD) that now affects 1 in 31 US children, according to HHS. The data gathered include claims data, electronic medical records, and consumer wearables focused on Medicare and Medicaid enrollees with a diagnosis of ASD. The first step establishes a data use agreement under CMS’ Research Data Disclosure Program.

Researchers will focus on autism diagnosis trends over time, health outcomes from specific medical and behavioral interventions, access to care and disparities by demographics and geography, plus the economic burden on families and healthcare systems.

The pilot program, intended to be a model for other conditions, will create a secure tech-enabled mechanism to enhance data sharing with timely, privacy and security compliant data exchange.  HHS release, FierceHealthcare

Payers, other than UnitedHealth, had an upbeat Q1.

  • Oscar Health, the feisty provider of ACA exchange individual and small group plans, notched a Q1 net income of $275 million with adjusted EBITDA of $329 million on revenue of $3 billion, up 42% from Q1 2024. Membership exceeded 2 million, up 41% from prior year. The ever-feisty CEO Mark Bertolini (center) railed on the earnings call against a shortened Federal enrollment period cutting off at 15 December versus January, as well as other enrollment changes. Oscar release, FierceHealthcare
  • Centene Corporation, one of the main rivals to UnitedHealth Group and a significant player in Medicaid state plans, had a decent Q1 turnaround with $1.3 billion in earnings and a  17% jump in premium and service revenues to $42.5 billion from $36.3 billion in Q1 2024. Their current membership versus Q1 prior year was down about 500,000 with the losses in Medicaid and traditional Medicare. They also increased their 2025 premium and service revenues guidance range by $6.0 billion to a range of $164.0 billion to $166.0 billion due to ACA exchange plans and Medicare Advantage (MA) revenue forecast performance. However, it’s projected by analysts that Centene will exit the Medicare Advantage market after this year in Alabama, Massachusetts, New Hampshire, New Mexico, Rhode Island and Vermont–about 3% of MA membership. CEO Sarah London criticized proposed cuts to Medicaid. Centene release, HealthcareFinance
  • UnitedHealth Group, after an anemic Q1 financial report driven by increased utilization and rising costs, cut its 2025 earnings per share (EPS) guidance by 12% to between $26 and $26.50 (Healthcare Dive). This just in: a shareholder group filed in Federal Court in the Southern District of New York on violations of securities laws affecting share price. It centers on the 2025 financial guidance provided prior to Brian Thompson’s assassination and how group CEO Andrew Witty did not account for: 1) the impact of that act but doubled down on the EPS forecast, 2) the increased scrutiny around the company for denials of claims even prior to the act, and 3) the general ill will generated as more information reached the general public. The affected group are those shareholders purchasing UHG stock between 3 December 2024 and 16 April 2025. Healthcare Dive, SDNY filing
  • Meanwhile, UHG has doubled down on AI development, totaling over 1,000 apps. According to a report in the Wall Street Journal, the company has these apps in production in their health delivery and pharmacy units, transcribing conversations from clinician visits, summarizing data, helping process claims, powering customer-facing chatbots, and in engineering to write software. According to chief digital and technology officer Sandeep Dadlani, half of the apps use generative AI and the remainder a more “traditional” form, without explanation of “traditional”. According to Dadlani in the article, “AI has a role to play in the claims evaluation process, but it will never be allowed to deny a claim”. Software, not necessarily AI powered but usually rules-based or using algorithms, ‘auto adjudicate’ 90% of UHG claims. UHG was sued in Federal Court as far back as 2023 in using an AI-powered application to evaluate and deny claims.

Redesign Health gets freshened up with a Cedars-Sinai partnership. Redesign Health is a combination funder and company builder which has launched over 60 healthcare-related companies, some clear successes such as Calibrate (weight loss) and Jasper Health (cancer care navigation), with others on the development curve such as Vault Health and Uptiv Health. They announced a partnership with the Cedars-Sinai health system in Los Angeles to add their clinical expertise and innovative research. Other strategic value additions through the new partnership are tapping into funding support, access to clinical environments within Cedars-Sinai’s network, and their dataset for validation of technologies and design. Redesign release

And in the pharma compounders versus Big Pharma war, the former have lost two battles. The compounder’s trade group, the Outsourcing Facilities Association (OFA), had separate lawsuits filed in Texas to force the FDA to reclassify both tirzepatide and semaglutide as still in shortage, which would permit compounding pharmacies to produce weight loss drugs with these active ingredients. The Texas judge found yesterday (7 May) for both FDA and Eli Lilly, the producer of Zepbound, that tirzepatide was no longer in shortage, which closed the door on the OFA. At the end of April, the same Federal judge ruled against the continued compounding of semaglutide, the active drug in Novo Nordisk’s Wegovy and Ozempic [TTA 27 Feb]. 22 May is the end date for the large compounding pharmacies for semaglutide, while smaller state-based compounders must cease immediately. Biospace 8 May, 25 April  Novo Nordisk’s new partnerships for Wegovy-based weight loss prescribing: TTA 1 May, 8 May

News roundup: WeightWatchers in 45-day prepackaged Ch. 11, Neuralink BCI successful in ALS subject, telehealth VR reduced TMD pain–study, AliveCor maxes up KardiaMobile 6L, TytoCare-Allina Health partnership, UHG-Amedisys divest some more

May 8, 2025 | by | No Comments

WeightWatchers (WW) unburdens itself of debt in a prepackaged Chapter 11 bankruptcy. The reorganization under the bankruptcy filed yesterday in the US Bankruptcy Court for the District of Delaware will take $1.15 billion of a total $1.62 billion (as of March 2025) in debt off their books while providing it with enough capital to reemerge in an estimated 45 days or around 1 July, or less. The Chapter 11 plan retains $175 million from their revolving credit facility, reduces its annual interest payments by $50 million, and extends their debt maturity dates. With bankruptcy court approval, their lenders receive new secured debt and equity. In the company statement, CEO Tara Comonte expressed confidence about WW’s future:  “The decisive actions we’re taking today, with the overwhelming support of our lenders and noteholders, will give us the flexibility to accelerate innovation, reinvest in our members, and lead with authority in a rapidly evolving weight management landscape.” The first day hearing is on 8 May. WW release, Kroll case information

WW entered the GLP-1 prescription weight loss drug race relatively late, last October, with compounding semaglutide, which boosted their fortunes for a time. They acquired telehealth provider/clinical weight manager Sequence in mid-2023 [TTA 2 Mar 2023], then formed the WeightWatchers Clinic program by December [TTA 21 Dec 2024] Results this year were projected at 140-160,000 subscribers. But that was not enough to correct WW’s problems, which were a profound loss of total subscribers: in Q1 2025 3.4 million subscribers versus 4 million in Q1 2024, with 2.8 million of them. Stock had traded on Nasdaq for some months below $1, with today’s trading below $0.50. Shares had lost 71.9% over the past 12 months, making it a (money) loss for nearly all common stock holders. Morningstar

The (physical) weight loss segment now dominated by Hims & Hers, Ro, LifeMD–now with prescription deals for Novo Nordisk’s Wegovy—and other telehealth providers and teleprescribers such as Teladoc, FuturHealth, RemedyMeds, Eden, and many others, made WW a latecomer. Even CVS Caremark got into the partnering act when it switched over to Wegovy from Lilly’s Zepbound in its standard formulary. This move may lure more members to its weight management program. As with Ro and LifeMD, the lowered cash pricing is $499/month. Healthcare Dive. For WW, is this a lasting cure or just kicking the can down the floor?

Brain-computer interfaces (BCI) notch a big win. At the end of April, Neuralink confirmed its third successful implant, this one in an ALS patient, Brad Smith. The disease rendered him non-verbal, on a ventilator, and paralyzed below the shoulders. With the Neuralink brain implant, about the size of five quarters, he can now communicate verbally through his MacBook Pro and play video games only with his thoughts–essentially telepathy. He created a video using a voice cloned from previous recordings when he could speak, and using a mouse to create the narration. Previously, he used an eye gaze controller to communicate. This is truly miraculous and flying under the radar. Mobihealthnews, RedState  The previous recipients, Noland and Alex, are both paraplegics[TTA 21 Feb 2024].

Next up is Blindsight, which Elon Musk has said that will be tested in humans by the end of 2025 [TTA 10 Apr]. There is also a Canadian clinical trial, the “Canadian Precise Robotically Implanted Brain-Computer Interface” (CAN-PRIME) for subjects with tetraparesis or tetraplegia resulting from cervical spinal cord injury or the neurological disease ALS [TTA 27 Nov 2024].  A competitor of Neuralink, Precision Neuroscience, closed a Series C at $102 million last December.

A telehealth virtual reality (VR) solution effective for reducing chronic pain. A study published last month in Nature/NPI Digital Medicine demonstrated significan reductions in a 54-participant group, with some receiving telehealth-based immersive VR intervention on chronic orofacial pain (temporomandibular disorders or TMD) versus an audio-only (MP3) same-content control intervention and non-intervention on five-day ‘waves’. Pain intensity, unpleasantness, anxiety, sleep disturbance, and mood were monitored. There was significant reductions achieved with the immersive VR on pain intensity and other factors, with lesser results achieved with the MP3 intervention. The study directionally confirms results in other studies on lower back pain and other pain studies. Researchers were based in the University of Maryland School of Medicine, School of Nursing, and Towson University.

Short takes:

AliveCor is adding to its new KardiaMobile 6L Max KardiaAlert. KardiaAlert is now integrated into KardiaCare, a subscription service for the KardiaMobile 6L Max AI-assisted ECG monitor. The consumer purchase of the KardiaMobile 6L Max includes the device and a one-year subscription to KardiaCare, which now includes the KardiaAlert feature. The six-lead KardiaMobile 6L Max identifies up to 20 arrhythmias with a clinician review. Introductory price is $169. Release

Allina Health deploying TytoCare at 12 urgent care locations. The Midwest health system is adding the TytoCare Pro Smart Clinic service to a dozen of its urgent health locations in order to shorten wait times and offer additional remote treatment. For Allina, this allows their urgent cares to see more patients, offer hybrid care, and additional services such as heart and lung exams (featuring AI-driven wheeze and crackle detection), throat and ear assessments, skin exams and body temperature measurements. Allina Health, with hospitals in Minnesota and western Wisconsin, already uses TytoCare remote monitoring in hospital settings. TytoCare release

UnitedHealth Group and Amedisys persist. The long-running and DOJ-challenged acquisition by UHG of Amedisys home care is once again trying to remove the anti-competitive stumbling block by divesting more home care and hospice operations, this time to BrightSpring Health Services and Pennant Group. This was disclosed in Amedisys’s SEC Form 8-K. It is contingent of course on the closing of the UHG buy. BrightSpring is based in Kentucky and Pennant in Idaho. Pennant’s own SEC filing lists their purchase price as $102.5 million. The total number of operations to be sold is not disclosed. UHG and Amedisys extended their runway on closing to 31 December in January.  Healthcare Dive, Home Health Care News

The Department of Justice has been prominently blocking the $3.3 billion UHG acquisition, announced in what seems an eon ago in June 2023, on anti-trust grounds nearly immediately after the Hart-Scott-Rodino Act (HSR Act) premarket notification was filed, but most recently in a civil lawsuit filed last November in District Court in Maryland. The DOJ was joined by the Attorneys General of Maryland, Illinois, New Jersey, and New York. It alleges elimination of competition, harm in over 100 markets, falsely certifying compliance with HSR Act requirements, withholding documents, and much more. Additional background on that lawsuit is here. As this Editor said when UHG won in Federal court on acquiring Change Healthcare, a win they have 190 million reasons why to regret, “DOJ has a long memory, a Paul Bunyan-sized ax to grind, and doesn’t like losing.”

Breaking–Masimo Mystery SOLVED–cyberattack, website down for days, new websites up–and where’s the public explanations? Sound United sold.

May 7, 2025 | by | No Comments

The Masimo website goes offline–coinciding with their investor meeting. When this Editor posted an article on former Masimo CEO Joseph Kiani’s “beneficial ownership” SEC filing (Schedule G/A, for amended) last Tuesday late evening (29 April), as we generally do, we included a link to the main corporate website. I noted the following day that the home page was down and displayed a ‘performing some maintenance’ message. This is not especially unusual in the evening, as our Readers know, but unusual to continue beyond that.

Checking Wednesday, the website remained down. Yet their consumer-direct sales ‘Shop’ and Investor Relations pages remained up if you linked to them directly, though the medical monitoring smartwatches listed on the shop page were ‘coming soon’. Consulting with Ted Green of Strata-gee, who follows Masimo from their now-sold audio business (see update below) and an excellent source for us, he followed up as it remained offline into Thursday. Press contacts there were unresponsive. An “inside source” provided the only answer obtainable, which was ‘we’re working on it’. Ted called their main line–and received a recorded message that “All circuits are busy, please try your call later”. Calling Customer Service as a final attempt, even they did not know what was going on with the website…and, while phones were working, their internal systems had gone down. Finally, late on Thursday, Ted received an email from a PR representative who pointed him to their changed message on their website stating that the website was down and that they were working to resolve the issue. Ted relates this far more entertainingly in his Search for Information. 

Certainly an unusual and embarrassing situation for a tech-based medical device company, especially one that, at least for investors, is backing up its claims of a new transparency to the max. (See their working Investor Relations page for their postings of their Q1 financial presentation, webcast, and press release). For those of us in the business, an extended ‘offline’ means that we automatically think ‘hack’–another victim of cyberattack or ransomware.

And that is exactly what it turned out to be. Masimo’s SEC Form 8-K filed yesterday led with the following:

On April 27, 2025, Masimo Corporation (the “Company” or “we”) identified unauthorized activity on the Company’s on-premise network. Upon detection, we activated our incident response protocols and implemented containment measures, including proactively isolating impacted systems. We promptly commenced an investigation and are actively working to assess, mitigate, and remediate the incident with the assistance of third-party cybersecurity professionals. The Company has also notified and is coordinating with law enforcement.

As a result of the incident, certain of the Company’s manufacturing facilities have been operating at less than normal levels, and the Company’s ability to process, fulfill, and ship customer orders timely has been temporarily impacted. The Company has been working diligently to bring the affected portions of its network back online, restore normal business operations and mitigate the impact of the incident.

The investigation of the incident remains ongoing, and the full scope, nature, and impact of the incident are not yet known. At this time, the Company believes that the incident appears unrelated to and is not affecting the Company’s cloud-based systems.

Comments below Ted’s Strata-gee article, from an anonymous commenter, said that the FBI had visited the Masimo Irvine headquarters, which lines up with the last sentence of the first paragraph. The filing confirms that the intrusion was detected on Sunday, 27 April–which does not mean that they started then, just that it was found.

It is also evidently broad and deep, not only affecting the website and internal systems used by customer service, but also internal systems used in manufacturing and at all Masimo locations are ‘locked down’ in the words of another commenter. It’s serious when orders can’t ship and most employees are reportedly being told to stay home for the better part of the week, according to commenting insiders.

According to the report in FierceBiotech, CEO Katie Szyman stated that the cyberattack will not dent the company’s financial guidance for the year.

What’s not here: what Masimo is doing to inform customers of the outage, how long it will be, changes in delivery dates of devices, and if performance of any devices has been affected.

Back to the ‘restored’ websites:

A questionable restoration of their website(s). As of Tuesday (6 May, 9 pm EDT), the Masimo website is back live–but it depends on how you enter the URL! There are apparently two websites: a finished corporate and professional product website with a Personal Health section under construction with placeholders, but other live web pages which are accessible, apparently mainly for Canada–or for US under construction or discarded designs. 

  • Masimo.com entered as this link (https://www.masimo.com) features a home page with Masimo SET and their professional products such as SafetyNet Alert, a ‘cloud-based telehealth platform’. It is a tidy, respectable, and up-to-date corporate website featuring the full line of Masimo’s many professional monitoring products. Links in header and footer are standard, including corporate information and links to investor relations. Where it is not complete: clicking on Personal Health in the footer links will take you to a URL with a path that indicates a US ‘Shop’ page but is titled Support–Masimo Customer Service. Links for four individual product areas, including ‘Health at Home & Opioid Safety’, lead only to customer support information and a repeated, annoying cookies permission popup. This website appears finished except for Personal Health.
  • But if you enter only Masimo.com, the URL immediately redirects to a Canadian shop domain page and path that features how their pulse oximetry device and app (SafetyNet Alert) can monitor prescribed opioid usage for difficulties in breathing (respiratory depression) which can prove, from their tragic case study example, fatal. The new Halo app can be downloaded on the Apple App Store or Google Play. Want to find out more about it? It goes to a page that no longer exists. 
  • Clicking on the Personal Health tab at the top, it links to another Canadian ‘Shop’ domain page highlighting that their noninvasive monitoring used by hospitals is now available for home use, but the only item for sale is the Denon PerL Pro earbuds with a Canadian dollar price. No mention of SafetyNet Alert. 
  • To find their personal health devices, one has to go to the links on the footer under Customer Service>>Track Order’. This takes you to the US ‘Shop’ path page. There three ‘Health at Home’ devices are featured without descriptions. Clicking on the ‘Shop All’ button takes you to a US path page featuring the MightySat home pulse oximeter, the W1 smartwatch, and the RadiusT temperature tracker. Unfortunately, clicking on the ‘Find A Retailer’ button on each individual page leads you to a 404 page–‘That Page No Longer Exists’. 
  • These pages are in layout and style unlike the corporate website. Formats vary all over the lot.
  • On other pages linked in the footer, it appears there are some new pages, along with old web pages restored without updating.
  • Extremely annoyingly, on every page or return to a page, a permission popup for accepting cookies blocks the page until you accept or decline.

Where’s the project/marketing manager supervising this? Again, it’s embarrassing for a digital health technology company, even post-cyberattack, to have this level of visible website disorganization, coupled with days offline and reports of complete disruption. The best approach would be a minimal website until a finished website, working on all URLs and paths, is completed. Other than the main corporate website, the ‘Canadian’ and other pages should be offline until discarded or finalized.

As of 13 May, there are still problems and ‘holes’ in the websites, with the tracking the same.

Update–Sound United sold. Also announced yesterday (6 May) was the $350 million cash sale of Sound United to HARMAN International, a wholly-owned subsidiary of Samsung Electronics Co., Ltd. The definitive agreement release did not mention staff transitions. HARMAN’s audio products include Harman Kardon, JBL, and AKG. The sale is scheduled to close by the end of 2025. The sale was mentioned several times during the Q1 earnings call but HARMAN was not mentioned. The sale is not included in Masimo’s 2025 forward outlook, versus the considerable impact of tariffs on their imports from China and Malaysia.

Sound United’s sale for a third of its purchase price is the finale of a very big, very bad billion-dollar bet made by Joe Kiani and his management team in 2022. The ‘vision’, such that it was, was that the audio brands would leverage consumer health wearables into retailers such as Best Buy. It didn’t. The buy immediately tanked the value of the company by an estimated $5 billion in one day, and kicked off a long trail of investor unrest that resulted in a takeover by Politan Capital and the ouster of Kiani and his board members last year. The rest, as they say, is history. (And Joe Kiani is likely enjoying a good bottle of vintage Pol Roger and shivering with schadenfreude.) Wall Street Journal

This just in: Teladoc acquires UpLift for $30M, bolstering struggling BetterHelp telemental health; Q1 revenue down 3%

May 1, 2025 | by | No Comments

Teladoc closed out a down Q1 with buying UpLift. The $30 million acquisition is clearly strategic in bolstering BetterHelp, their floundering direct-to-consumer mental health provider. It closed on 30 April, the same day as Teladoc’s Q1 results call. UpLift was bought in an all-cash transaction, with up to $15 million in additional contingent earnout consideration. UpLift’s 2024 revenue was approximately $15 million. It is small compared to BetterHelp’s Q1 revenue of $239.9 million, which fell 11% versus Q1 2024 and continuing a decrease from Q4 2024, when its revenue was $250 million, after sinking through the entire fiscal year. 

What UpLift adds is insurance-reimbursable mental health coverage with all major commercial insurers, including Medicare and Medicaid, something that the cash-pay-only BetterHelp lacked. It also adds coverage of 100 million lives and a network of over 1,500 mental health providers. According to the release, BetterHelp will work with its customers to help them access insurance coverage. Their network providers will “have an opportunity to be considered for inclusion in the benefits coverage network, based on the respective requirements, needs and interests”, which is an interesting way to present it.

Teladoc said in the release  and on the earnings call that UpLift will be reported under BetterHelp’s results, although it will be run separately under its current CEO Kyle Talcott. There is no further indication as to management transitions. The impression given from the release at least in the short term is that it will be run separately for management of their provider network, quality and patient outcome oversight and the acceptance and administration of insurance coverage. 

What does this mean? How much of a lift UpLift will give this year to BetterHelp is anyone’s guess, but adding insurance coverage is a much needed move by Teladoc, given BetterHelp’s expensive DTC cash model.

  • Teladoc has known for some time that lack of insurance coverage was a key part of BetterHelp’s performance problems. UpLift will help in that regard.
  • In the past 18 months, it moved from Teladoc’s great hope, one which former CEO Jason Gorevic bet ‘large’ on only for him to depart in a haze of red ink [TTA 5 Apr 2024], to a slowly eroding asset or worse, a rolling failure. It is particularly inexplicable given the growth of virtual mental health.
  • In the past year, BetterHelp operations were responsible for a $790 million impairment that hit Teladoc’s Q2 and a nasty, embarrassing rap by short seller Blue Orca Capital on ChatGPT being used in therapeutic responses [TTA 25 Feb], vigorously denied by Teladoc [TTA 25 Feb]. 
  • BetterHelp’s revenue for the remainder of 2025 is expected to shrink by up to 9.75%.

The main Teladoc operation, segmented as Integrated Care, also performs virtual mental health care within its services. This is noted in the release: “Teladoc Health’s Integrated Care segment offers a range of digital tools, coaching, therapy, and psychiatry services for employers and health plans (Editor’s emphasis), and completed nearly a million mental health visits in 2024.” Since those virtual mental health services are within Integrated Care, its performance is not public. 

Is a real solution a rebranding of BetterHelp when it is integrated (as it eventually will be) with UpLift?

HIT Consultant, FierceHealthcare, Mobihealthnews

Teladoc Q1 financial highlights:

There wasn’t much encouragement across the board in Teladoc’s Q1 report.

  • Total Q1 revenue decreased 3% to $629.4 million from prior year’s $646.1 million in First Quarter 2024
  • The bright spot was that their main business under Integrated Care had a revenue increase of 3% to $389.5 million 
  • As mentioned, BetterHelp’s revenue decreased by 11% to $239.9 million
  • By domestic versus international, US revenue decreased 4% to $525.0 million. International revenue grew 6% to $104.4 million.
  • Net loss also increased to $93.0 million, or $0.53 per share, versus prior year’s Q1 $81.9 million, or $0.49 per share.
  • Adjusted EBITDA for Q1  decreased 8% to $58.1 million, versus $63.1 million in the prior year. \
    • Integrated Care’s adjusted EBITDA increased 6% to $50.4 million.
    • BetterHelp’s adjusted EBITDA decreased 50% to $7.7 million.

The release also confirms full year 2025 revenue projections of $2,468 – $2,576 million. BetterHelp’s revenue is projected to continue to shrink by 3.75 to 9.75%.

News roundup: Hims, Ro, LifeMD and Novo Nordisk partner on Wegovy prescribing (updated); Commure partners with HealthTap for virtual care after hours; WebMD Ignite adds texting to member health ed; hellocare.ai raises $47M for virtual nursing

May 1, 2025 | by | No Comments

Partnerships and add-ons are much in the news this week.

Hims & Hers isn’t worrying about GLP-1 drug sourcing. Neither are Ro and LifeMD. All three made a deal with Novo Nordisk on providing branded Wegovy to cash-paying members with a prescription. Wegovy is supplied through NovoCare Pharmacy through each of the telehealth suppliers.

Hims & Hers received immediate benefit–their stock jumped 23% on Tuesday above $33. Wegovy is already available to Hims & Hers members, but  those without a membership, they will bundle a membership with Wegovy and supply services including 24/7 care, nutrition guidance, and clinical support, starting at $599/month. Longer term, the two companies plan to match up Novo Nordisk’s technologies with Hims & Hers’ ability to scale access to care. Novo Nordisk’s programs with competitive telehealth prescribers Ro and LifeMD start at $499/month, but may be more based on services provided.

Updated: The smaller LifeMD, a below $10 Nasdaq stock, also jumped 40% to above $8 and settled in around $7 this morning (Friday 1 May). (Ro–Roman Health–is a private company.) FierceHealthcare LifeMD also recently acquired assets of women’s telehealth provider Optimal Human Health MD as their entrée into the women’s health market. The new service will be focused on menopause and osteoporosis, monitoring hormone health, bone density, metabolism and long-term wellness. Debut is this summer. No financials were disclosed.  Release, FierceHealthcare

This was just in time to meet the FDA deadline on GLP-1s. All three teleprescribing companies were using less expensive compounding pharmacies to supply generic versions of semaglutide up until recently. In February, the FDA reclassified the drug as no longer scarce, which ended that authorization to sell the compounded drugs as of now [TTA 25 Feb, 27 Feb]. Hims, as the largest, stood to lose the most and fought very hard to keep the compounded versions of these drugs including an aggressive ad blitz blasting the pharmas. Evidently, they’ve now reconsidered–as has Novo Nordisk in lowering prices and selling through the teleprescribers. If you can’t beat them, join them. However, based on what this Editor hears on the radio, companies like FuturHealth are selling compounded versions alongside branded GLP-1 medications. Mobihealthnews, CNBC

Software integration meets virtual healthcare for after-hours coverage. Healthcare software integrator Commure is partnering with HealthTap‘s online primary care network and telehealth services to provide what they term a ‘unified solution that bridges the gap between in-person and virtual care’. Commure’s slightly bewildering tech stack centers on EHR integrations for workflow, scribing, RPM, RCM, and AI-powered agents–along with a workplace security system, Strongline. The partnership now offers to providers turnkey implementation for services such as after-hours coverage and virtual primary care, with the big plus of not adding staff. Mobihealthnews, Release 

Commure’s interesting developments in the past year or so included a fire-sale priced buy of Memora Health for $30 million in December 2024, adding its conversational AI-powered agent to its ‘stack’, undoubtedly to the relief of in-common investors General Catalyst and Andreessen Horowitz (a16z). In October, Commure bought ambient AI medical documentation company Augmedix (one of the few SPACs that didn’t crack) in a $139 million deal [TTA 8 Jan].    Axios‘ further analysis of the Memora Health buy is worth a read.

WebMD Ignite’s Coach health education and engagement platform adds text messaging. The Coach platform, used by care managers for health plan members, has added an integrated SMS text messaging app. This provides for plan care managers:

  • Real-time reach: Push notifications ensure messages are seen promptly, keeping health education and motivation top of mind.
  • Custom branding: Text templates can be customized to reflect each health plan’s brand and messaging.
  • Member convenience: Deliver concise, actionable information directly to members’ mobile devices.
  • Seamless workflow integration: Care managers can select, send and track text-based education within Coach, including opt-in and opt-out management.

The text messaging can also be used for population-wide campaigns to engage members at scale for health initiatives. Text’s advantages over email delivery is immediacy and also more narrow targeting, as many have multiple emails but only one (or two) mobile phone numbers. Release, FierceHealthcare  (Disclaimer: this Editor previously worked as a marketing consultant to what was then Krames, now part of the services under WebMD Ignite)

Our one significant raise of the week is (again) in virtual nursing. hellocare.ai‘s $47 million raise was led by HealthQuest Capital led the round with participation from several health systems and digital health investors, including UCHealth, Bon Secours Mercy Health, LRVHealth and OSF Ventures. hellocare.ai provides an in-room AI-assisted virtual nursing platform for “smart hospital” rooms plus telehealth and hybrid care services for hospitals, home care, and primary care. The platform includes virtual sitting in up to 32 rooms 24/7 on a single remote clinician’s monitor, virtual consultation, ambient documentation, digital whiteboards, patient engagement, and hospital-at-home integrated into the hospital’s EHR. hellocare.ai claims installations in 70+ health systems that include the investors. Since 2012, the Clearwater, Florida company has raised over $88 million. Release, Mobihealthnews

Masimo updates: former CEO Kiani claims 13.2% ownership, and a review of the new management’s style (updated)

April 30, 2025 | by | No Comments

Medical device company Masimo may not be able to rid itself entirely of its meddlesome former CEO, Joe Kiani. In fact, if a court awards him the shares exercised under his various employment agreements, he could be 1) a billionaire and 2) the second largest shareholder in the company after Fidelity Investments (FMR). He currently and undisputedly holds 7.5% of Masimo’s shares (Nasdaq: MASI), trading today at over $163.00 and ironically up substantially since his departure. The latest is that Mr. Kiani cleverly filed with the SEC a mandatory “beneficial ownership” report (Schedule G/A, designating an amended form) stating that he owned 13.2% of shares.

The difference? The options, restricted stock units (RSUs), and performance stock units (PSUs) that he attempted to exercise, but have not been granted by the current management, controlled by Politan Capital Management, owner of 8.8% of common shares. Mr. Kiani maintains  that he resigned from Masimo on 19 September 2024, the day of the Annual Shareholders Meeting, “for good reason” after losing his board seat and control of the company to Politan. The new, Politan-controlled board on that day placed him on indefinite leave, named an interim CEO (Michelle Brennan), then in October expanded the board by two directors and formally terminated him on 24 October ‘for cause’, invalidating the terms of his eye-watering (and questionable) $400 million severance agreement. That difference–5.7%–is a whopping 3,226,702 shares on top of his existing 4,085,799 shares. In the Schedule 13G/A comments section, the non-granted shares are delicately termed as “subject to a dispute between the Issuer and the Reporting Person” (Mr. Kiani).

This Editor’s source is the excellent and detailed analysis done by Ted Green of Strata-gee. His reporting on Masimo is from close attention to their audio business as they attempt to shed Sound United, comprising major brands such as Polk, Marantz, Denon, and Boston Acoustics. As of this writing, that has not happened though in 2025 financial reporting, it is classified as a “discontinued operation”. His opinion on the strategy behind the unusual filing on shares claimed to be owned, but not in the possession of Mr. Kiani, is that it is a legal tactic thrown into the ongoing dispute around Mr. Kiani’s employment and severance/change of control agreements. Quentin Koffey, Masimo’s vice-chairman plus CIO of Politan, has argued that the previous board controlled by Joe Kiani signed off on compensation packages so rich that they threatened the company’s stability, among other things. 

As previously noted in our 6 March and 30 January updates, both Mr. Kiani and Masimo ever since have been going mano-a-mano in the courts–the Southern District of New York (SDNY), Delaware Chancery Court, and in California with the Private Attorneys General Act (PAGA) notice submitted to the California Labor & Workforce Development Agency (LWDA) alleging multiple Labor Code violations concerning wages, multiple stock options, and severance owed to Mr. Kiani under his employment agreements. None of these have been resolved yet to this Editor’s knowledge. 

Masimo has been going about its business, holding their annual stockholders’ meeting today. They’ve had good news since September regarding share price, with its rise largely maintained in this roller coaster market, despite a 2024 that was in the red. Strata-gee has an excellent delving into their SEC Schedule 14A filing issued in advance of the stockholders’ meeting. Mr. Green notes that it is full of disclosures and rationales on board and management duties, longer-term compensation structures, and more, written to be investor-friendly in contrast to the over-stuffed filings of the prior regime:

Written in a highly professional, precise, and clear tone, the company is changing many long-held policies – policies related to business management, board oversight, management performance, compensation, and more. And this document delves deeply into these many changes, often explaining what was done in the past, how it will be changed in the future, and why it needs to be done.

Mr. Green’s prognostication is that he expects all directors to be elected (there are no holdovers from the prior regime) and proposals to pass. Masimo’s emphasis on growth and R&D will mean developments in the medical device area. The company is now led by a 100% medical device CEO. They have a core market in hospital monitoring with some extensions into wearables. What direction they go in digital health will play out over this year and next.  

Update 30 April: The main website (masimo.com) has been ‘down’ for two days–unusual–while the ‘shop’ pages are still up but not really working. And their W1 watch is no longer for sale as ‘coming soon’. What is afoot?

Product & funding very short takes: South Australia 1st with Sunrise EMR; S. Korea pain research, new emergency services app; BCI + telehealth for stroke patients; VirtuSense monitoring launches at Emory; Series B raises for Nourish, Healthee

April 25, 2025 | by

Starting with international health tech developments…

South Australia Health has rolled out Altera Digital Health’s Sunrise Electronic Medical Record (EMR) and Patient Administration System (PAS). The EMR and PAS is being implemented across over 100 hospitals and health services, in both metropolitan and rural areas, in South Australia. South Australia is fourth-largest state in Australia, covering 983,482 square kilometres, which makes it five times larger than Texas and 10 times larger than the UK–but has only 1.7 people per square kilometer, which makes healthcare service challenging. Altera Release

In South Korea, researchers at Asan Medical Center have developed a pain assessment model which can be used during surgery, a time when the patient cannot provide feedback. The metrics include tracking a patient’s heart rate, blood pressure, and blood volume change during surgery, then using a machine learning algorithm combining them that confirms pain during and after surgery. The study tracked  242 AMC surgery patients. Mobihealthnews Also in South Korea, their Ministry of Health and Welfare’s emergency services 129 app has added new features to access health counseling via the web chat feature.  A 24/7 chatbot feature now answers inquiries about health and welfare-related policies. The Ministry has been developing health tech features to compensate for staff shortages, including a regional emergency system for patient classification and transfer, a multi-institutional real-time critical patient transfer management system, and an AI-based clinical decision support system for predicting cardiac arrest, cardiovascular diseases, and sepsis in emergency departments. Mobihealthnews

Back in the US, an intriguing combination of brain-computer interface (BCI) and telehealth for stroke. Neurolutions, a BCI company, is merging with telehealth provider Kandu Health. and have raised $30 million from Ally Bridge Group and AMED Ventures. Now known as Kandu, Inc., the combined company will provide an end-to-end solution for stroke survivors. Kandu’s app and care navigators provide support in the hospital-to-home transition for stroke patients and families. Neurolutions’ IpsiHand device is designed to improve arm and hand movement, reporting improvement in 70% of clinical trial patients. Kandu will now be able to offer telehealth rehabilitation, therapy monitoring, education, caregiver support, advocacy and navigation. Release, MedTech Dive

VirtuSense monitoring launched at Emory Healthcare for virtual nursing. The VirtuSense VSTOne monitoring and telemetry platform is being integrated into Emory’s virtual nursing initiative in Peoria-area (Illinois) hospitals, Midtown as the first and later Emory Hillandale Hospital for a total of eight inpatient units and 1,000 beds this year. VSTOne uses LIDAR (Light Detection and Ranging) technology in patient rooms to detect falls, continuous monitoring of patient data to anticipate deterioration or emergencies, and care staff to call directly into patient rooms to expedite admission, discharge, and general documentation. At Emory, it integrates with Epic MyChart Bedside TV. Release

In company fundings:

  • In the burgeoning ‘food as medicine’ segment, Nourish raised $70 million in a Series B funding round. Nourish works with national commercial, Medicare, and Medicaid plans to better manage and guide those with chronic conditions through nutrition. Users work virtually with registered dietitians along with a support app with AI meal tracking, wearable and lab integrations, recipes, and more. The funding was led by JP Morgan Private Capital’s Growth Equity Partners, with participation from Thrive Capital, Index Ventures, Y Combinator, Maverick Ventures, BoxGroup, Atomico, G Squared, and Pinegrove. The fresh funding will be used for product development, expand Nourish’s Registered Dietitian (RD) network, and strategic partnerships. Nourish is also a founding member of ATA Action’s new initiative, the Virtual Foodcare Coalition [TTA 10 Apr]. Release, Mobihealthnews
  • Healthee raised $50 million in an oversubscribed Series B round from Key1 Capital, with participation from Fin Capital, Glilot Capital Partners, and Group11. Healthee’s health benefits platform uses AI to help employees navigate healthcare and benefits and simplify a complex enterprise benefits system. Interestingly, Healthee management claims that they did not seek the funding but were sought after. They will use it for scaling their product suite, go-to-market operations, and deliver intuitive, AI-powered tools for benefits. Release, Mobihealthnews

Short takes: Veradigm’s interim CEO departing, Blue Shield CA breached 4.8M members’ PHI to Google, advice on expanded M&A premarket notification rules

April 25, 2025 | by

Veradigm’s interim CEO departing, CFO continuing. Tom Langan, who has been in place as Veradigm’s CEO for the last 11 months, will be departing after a little more than 13 months, according to Veradigm’s SEC Form 8-K securities filing dated 22 April. The former president and chief commercial officer (CCO), who replaced an earlier interim CEO, Dr. Dr. Shih-Yin (“Yin”) Ho, on 7 June 2024, has signed a separation agreement effective 31 July. According to the filing, the Veradigm board will be resuming a search for a permanent CEO. Mr. Langan declined the opportunity to participate as a candidate.

Lee Westerfield, who has been interim CFO since 7 December 2023 through three six-month agreements, has signed an extension until 31 December. 

Both Mr. Langan and Mr. Westerfield have been through considerable tumult at Veradigm: first (for Mr. Langan), the inability to file audited financial reports for 2022-24; the failed effort to sell, merge, or find a strategic partner [TTA 31 Jan]; finally, a major investor, Kent Lake, stepping in and controlling the board with the chairman stepping down as well as two other directors [TTA 22 Feb]. While the 2022 financial report was released last month along with 2025 guidance, the catchup won’t be done until sometime in 2026 [TTA 19 Mar].

One could not blame either of them, but especially CEO Langan, for tiring of the entire situation. He has been there in various positions since 2018 when it was Allscripts. His tenure will certainly be worth his while. Based on the filing, after termination he will receive $1.4 million over 12 months, which is a year of salary plus his target bonus; a lump sum cash payment for $406,000 for his pro-rated annual bonus, based on target performance; a year of health and dental coverage at active employee rates; and reimbursement of $10,000 in attorney’s fees incurred in negotiation of the separation agreement. His unvested portions of the stock options, restricted stock units or other equity awards will vest through those dated 31 July 2027. CFO Westerfield, on board as an interim for a considerably shorter time but in a mission-critical position, has a less golden package–a simple pay continuance through the end of the year plus five months if he is terminated not for cause or departs for good reason. Healthcare Dive

Blue Shield of California breached personal health information (PHI) via Google, in the second largest breach of 2025 to date. The unusual breach was not from the usual bad actor, but from Blue Shield’s use, unbelievably, of Google Analytics. According to their submission to the Department of Health and Human Services’ Office for Civil Rights’ (HHS-OCR) breach portal, their Google Analytics on how customers used their websites was configured in such a way that sent selected member PHI data over to Google Ads. Google Ads could then send these users and members targeted advertising. This went on for three years, ending only in January 2024. 

The data included:

  • Insurance plan name, type and group number
  • Patient names, city, ZIP code, gender and family size
  • Blue Shield of California identifiers for members’ online accounts, medical claim service date and service provider and patient financial responsibility.

It may have also included data around “Find a Doctor” search criteria and results, such as location, plan name and type, provider name and type. Other sensitive information, such as SSI#, credit cards, and driver license numbers, were not included. Because of its duration, it could potentially affect up to 4.8 million BSC members. BSC’s notice

The questions are–who programmed it this way? Was it Google? And if Google, who is responsible there? Is it configured that way at other health plans? And if not Google, who did it at BSC?

The analyses in both FierceHealthcare and Healthcare Dive point accusing fingers at Google, which has also been kicked very hard by the Department of Justice in their antitrust win on Google’s online advertising products or “ad tech stack” that dominates the industry–and may force the divestiture of Google Chrome as the result of another decision on web search. The Verge

M&A-ing? Premarket Notifications now in place makes it tougher. Our series of articles in 2023-24 explained the steeper requirements to our Readers for transactions that fall under the nearly 50-year-old Hart-Scott-Rodino (HSR) Act requirements. The threshold of value for 2025 is set at $126.4 million. Our 15 October 2024 overview summarizes the changes and links to other documentation on the many changes, particularly around the buyer’s investors and a five-year lookback at the under-the-HSR-wire serial acquisitions (rollups) made by both companies. The information required now is much more extensive and demanding. FTC will also have an online portal for comments on every acquisition. HIMSS has a six-minute plus interview with Michael Ramey, a managing principal of Strategic & Transaction Solutions at PYA (better known to many of us as Pershing), that touches on the highlights.

News roundup: Walgreens’ $350M opioid settlement, only 30% of healthcare AI pilots reach production, Medicare RPM usage up 10-fold despite benefit limitations

April 24, 2025 | by

Walgreens continues to clean up on Aisle 9 before it goes private. Walgreens settled the Federal allegations around illegally filling invalid prescriptions for opioids and seeking payment from Federal programs for $300 million. There’s an additional $50 million tagged onto it if the company is sold, merged, or transferred prior to fiscal year 2032. Since Walgreens has ‘done the deal’ with Sycamore Partners, the settlement amount will be the full $350 million. According to the Department of Justice’s press release, the settlement was based on Walgreens’ ability to pay. There was no statement on when the $350 million will be due.

This settles the complaint filed on 16 January (amended 18 April) in the US District Court for the Northern District of Illinois by the Department of Justice (DOJ), the Drug Enforcement Administration (DEA), and the Department of Health and Human Services Office of Inspector General (HHS-OIG). In the suit, Walgreens faced civil penalties of up to $80,850 for each unlawful prescription filled in violation of the Controlled Substances Act (CSA), plus treble damages and applicable penalties for each prescription paid by Federal programs in violation of the False Claims Act (FCA) for over 10 years–approximately August 2012 through March 1, 2023 The red flags included prescriptions for the ‘trinity’ of an opioid, a benzodiazepine and a muscle relaxant. If Walgreens had been found guilty, the penalty could have been billions. 

Given the numbers that in January presented a large impediment to a sale, settling rather than fighting makes sense. The projected Sycamore Partners closing is only two quarters away (Q4, TTA 11 Mar). The 35-day ‘go shop’ period has closed with no other offers. The DOJ has moved to dismiss its complaint in Illinois, while Walgreens will also move to dismiss a related declaratory judgment action filed in the District Court for the Eastern District of Texas. In addition to Illinois, the District of Maryland, the Eastern District of New York, the Middle District of Florida, and the Eastern District of Virginia participated in the complaint.

In addition to the settlement, Walgreens’ pharmacy operations are now under Federal scrutiny, based on multiple agreements with DEA and HHS-OIG attached to the settlement, addressing what they and the DOJ saw as compliance violations in dispensing controlled substances. From the release:

  • Walgreens and DEA entered into a memorandum of agreement that requires the company to implement and maintain certain compliance measures for the next seven years. 
  • Walgreens must maintain policies and procedures requiring pharmacists to confirm the validity of controlled substance prescriptions prior to dispensing controlled substances, provide annual training to pharmacy employees regarding their legal obligations relating to controlled substances, verify that pharmacy staffing is sufficient to enable pharmacy employees to comply with those legal obligations, and maintain a system for blocking prescriptions from prescribers whom Walgreens becomes aware are writing illegitimate controlled substance prescriptions.
  • Walgreens has also entered into a five-year Corporate Integrity Agreement with HHS-OIG, which further requires Walgreens to establish and maintain an extensive compliance and training program

Crain’s Chicago Business, Healthcare Finance, Settlement Agreement

Healthcare AI continues to be more show than go. A report by Bessemer Venture Partners surveying payers, pharma, and providers states that 95% of respondents said GenAI will be transformative, with 85% of provider and 83% of payer leaders expecting it to reshape clinical decision-making within three to five years. Yet only 30% of AI pilots — what the report calls “internally and externally developed GenAI proof of concept (POC) projects” make it to production. 

Generative AI applications are being developed by the organizations’ IT teams, building their own tools by partnering with horizontal AI labs (i.e., Anthropic), Big Tech companies, or going to current and new vendors. The impediments they face are cybersecurity, data readiness, integration costs, and limited in-house expertise. Procurement is shifting toward co-development; 64% of execs are open to co-developing with early-stage partners. A contradiction is that only 32% of executives believe GenAI solutions from startups are superior to those from large tech incumbents. yet 48% prefer working with startups over established players.

Yet with these “aspirations and expectations” in the 80-90th percentile, only half of the surveyed organizations surveyed have a clear AI strategy with 57% having an AI governance committee, with payers in the lead. Those in it are putting real money behind it and seeing some meaningful ROI (54%), however. 

Among the three surveyed segments, Bessemer identified 59 jobs-to-be-done. Yet 45% of these jobs are still in the ideation or POC phase, with far fewer actually in production. These jobs clustered as follows: 22 for payers (claims, network, member, pricing), 19 for pharma (preclinical, clinical, marketing, sales), and 18 for providers (care delivery, revenue cycle management). The survey was performed by Bessemer with Amazon Web Services and Bain & Company, across 400 leaders in the three segments. 

Remote patient monitoring (RPM) Medicare usage growing steadily, despite limitations on clinical effectiveness. This new report from the Peterson Center on Healthcare tracks how RPM usage has grown among Medicare (traditional, Medicare Advantage) and Medicaid beneficiaries since 2019, when CMS enabled Medicare codes for reimbursement. For Medicare, despite only 1% of beneficiaries using RPM, it grew exponentially–10-fold for traditional Medicare between 2019-2023 and 14-fold for MA between 2019 and 2022.

  • Top chronic conditions are hypertension (57%) with diabetes far behind at 13%. Also growing but much smaller is remote therapeutic monitoring (RTM), dominated by musculoskeletal (MSK) disorders.
  • Traditional Medicare spent $194.5 million on RPM and $10.4 million on RTM in 2023.
  • Clinical effectiveness tends to be short-term. In hypertension, RPM is most valuable within the first six months, when blood pressure medications are actively monitored. For diabetes, the prime target is likely patients with the highest starting HbA1c levels and those
    who are at critical transition points in their care plan, such as starting insulin. For RTM, the most effective gains occur in 2-4 months.
  • Yet utilization is increasing. The duration of continuous RPM in traditional Medicare in 2023 was 5.2 months, with 22% over nine months. For hypertension, the average is 6.6 months. For MSK RTM, the average was below effectiveness-only 1.7 months.

The Peterson Center’s policy conclusions advocate a reset:

  • Coverage and reimbursement need to be better aligned to actual clinical value
  • Adoption of high-impact remote monitoring services and minimizing or eliminating the use of poorly performing digital applications
  • Improved data collection for remote monitoring services for evidence-based coverage and reimbursement decisions

Evolving Remote Monitoring

The weekend read: why SPACs came, went, and failed in digital health–the Halle Tecco analysis/memorial service; why OpenAI is going to be a bad, bad business

April 10, 2025 | by

Let us now hold the formal memorial service for the SPAC–the special purpose acquisition company, at least for digital health. Halle Tecco, whom many of us know as the founder and past CEO of Rock Health, plus angel investor, plus adjunct professor in digital health at Columbia, now has an opinion blog on Substack. As our Readers know, this Editor, who is none of the above, has been shoveling dirt on SPACs here on TTA since they became an Easy Way To Avoid the cumbersome, oh-so-tiresome preparation for a public IPO during the Digital Health Boom of 2020-22 (RIP). She has been covering their Trouble Every Day and demise ever since. Having not kept quantitative track of Cracked SPACs, only the news as they floated, declined, and failed, this Editor enjoyed Ms. Tecco’s quantitative analysis of the overall picture. She puts it into a readable business context. 

Shockingly, SPACs across all IPOs are still going on. In 2023 and 2024, total SPACs as a percent of IPOs neared 40%. Their high was reached in 2022 at 73%. The attractiveness of SPACs was obvious: an investor sets up a publicly traded company and goes through the hassle of an IPO. It raises money on public markets and from investors to acquire another company. Then it hunts for a company to acquire. The target is landed, is acquired, symbols change, and the deal is done, all in three to six months. The acquired company doesn’t have to go through the investor pitches, the due diligence, the incessant filing…less fuss and muss, but missing the rigor of a traditional IPO. For the SPACs, especially those focusing on digital health, 2020-22 became FOMO Fever–the fear of missing out.

For digital health companies, the boom became a race to the bottom. 

  • 30.4% went bankrupt, some spectacularly, others with a whimper as they’ve failed, one after the other: 23andMe, Cano Health, Babylon Health, Nuvo, Pear, others
  • 26.1% were acquired well below their SPAC entry price: Sharecare, SOC Telemed, Akili and others. The only exception: Augmedix, with a $40 million SPAC valuation, was bought for $139 million by Commure. (Commure is backed by General Catalyst and Andreessen Horowitz; Commure/Athelas itself is an interesting and complex story.)
  • 39.1% are still in business but trading below their SPAC entry price. A number flirted with the Devil of Demise and are recovering: Clover Health, Owlet (baby monitors), Butterfly (ultrasound POC), Talkspace. DocGo became a Covid play and then got into political trouble and is nearing $2/share from their late 2022 high of just below $11. And others.
  • There is exactly one success story: hims & hers (4.3%)

Enjoy this read on her blog. If you prefer a podcast, here’s Ms. Tecco on her ‘Heart of Healthcare’ with Mohamad Makhzoumi (link is to Spotify), co-CEO of New Enterprise Associates (NEA), a VC in healthcare and technology (33 minutes), discussing healthcare’s evolution, so to speak, from “the trailer park of venture investing” and the hilarious ‘healthcare hokey-pokey’. And here’s a Gimlety View of SPACs from 26 June 2024.

Another Big and Disastrous Fail in the making may be OpenAI, the creator of ChatGPT. It is converting from a non-profit to a for-profit company, losing its founder group, fundraising like crazy, and generally has ditched its Mission. “OpenAI is an AI research and deployment company. Our mission is to ensure that artificial general intelligence benefits all of humanity.”  OpenAI has raised the largest venture-backed fundraise of all time, $6.6 billion, and is now valued at $157 billion. Why overvalued? A tell is that SoftBank has invested $500 million into this megillah–this Editor recalls that SoftBank invested in Theranos and WeWork. Another tell–the NY Times and The Information estimated that Open AI lost $5 billion in 2024, it loses money on every copy of ChatGPT, and its revenue projections are near-absurd at $11.6 billion in 2025 and $100 billion by 2029. It totally ignores that every major player has an AI program, from Microsoft to Google. If you’re a fan of ChatGPT or need your eyes cleared around this type of AI, grab your cuppa and a bottle of your favorite pain reliever for Ed Zitron’s article, OpenAI Is A Bad Business. (Ed is an English tech writer, podcaster, and PR specialist)

Extra, extra!: ATA Action forms Virtual Foodcare Coalition, Ophelia and Spring Health partner on opioid treatment, ISfTeH renews NSA status with WHO

April 10, 2025 | by

Extra non-merger/financing news.

A new virtual food initiative from ATA Action. In another sign that the ATA Action portfolio is enlarging, they announced the formation of a new advocacy group, the Virtual Foodcare Coalition. The new group, composed of organizations ranging from food providers to telehealth and a law firm, is promoting healthy food as an integral part of healthcare. Their five policy priorities center on Federal laws, telehealth, and cross-state practices:

  1. The Medical Nutrition Therapy (MNT) Act
  2. Funding for Medically Tailored Food and Food Benefits Management that Foster Optimal ROI and Sustained Impact
  3. Rationalize Supplemental Nutrition Assistance Program (SNAP), Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), and School Meals; Align with Clean Food Initiatives
  4. Expand Reimbursement and Incentive Models for Telenutrition, Remote Monitoring Devices, Remote Therapeutic Monitoring and Foodscripts
  5. Facilitate Cross-State Nutritional Healthcare Delivery

The founding coalition members are: Albertsons Companies, Inc., Circle Medical, Foodsmart, hims & hers, Lifepoint Health, Nixon Law Group, Nourish, and Teladoc Health. With RFK, Jr. as head of Health and Human Services, there’s no better time. Release

Ophelia and Spring Health partner for opioid treatment. In another alliance to expand telehealth treatment versus standing alone, Ophelia, an opioid use disorder (OUD) treatment provider, will be joining with Spring Health in providing medication-assisted treatment (MAT) OUD for Spring Health’s employer and health plan clients. Spring Health’s telementalhealth clients include Adobe, Bumble, General Mills, Moda Health, Wellstar, and Guardian with a total access to 20 million lives. In return, Ophelia’s clients will now be able to access Spring Health’s behavioral health services, including therapy and psychiatric support, in an expansion of Spring Health’s portfolio. Release

Internationally, it’s another three-year agreement between ISfTeH and WHO.  ISfTeH, the International Society for Telemedicine & eHealth, is formally a Non-State Actor (NSA) in official relations with the World Health Organization (WHO). That status has been renewed for another three-year period. In that regard, ISfTeH works on and provides input to Research on Quality of Care, the Global Telehealth Community of Practice (GTCoP), Digital Health Atlas, Global Digital Health Monitor, Guidelines on Cross-Border Telemedicine, the WHO Acute Care Action Network (ACAN), and more. ISfTeH members also have an opportunity to participate in some of the WHO’s annual constitutional meetings–contact here for more information. LinkedIn post. ISfTeH/WHO’s collaboration document. Hat tip to Frederic Lievens of ISfTeH.