TTA’s Summer Kickoff 4: Waystar’s $968M IPO, Teladoc’s new CEO, Steward gets last minute DIP funding, Brightside and NeuroFlow acquisitions, are these the last appeals for Theranos? And more!

 

 

A week of ‘further developments’. Teladoc replaces its CEO in two months–record time. Waystar finally IPOs after two years. Steward Health gets the DIP bucks at the last minute to continue until it’s sold off. Devices and app systems like Dexcom and Aktiia make significant improvements that improve their marketability. Category consolidations in telemental health and behavioral health risk analytics. And are these the last appeals for Theranos’ Holmes and Balwani?

Short takes: Dexcom G7 now directly connects to Apple Watch, Brightside Health acquires Lionrock, Aktiia CALFREE gains CE Mark for optical BP monitoring not requiring calibration (Further telemental consolidation and digital health device upgrades)
Oracle’s Q4/FY 23 earnings push Cerner to background, stock price soars on AI deals; 81% of VA clinicals really can’t stand Cerner (Can this EHR be saved?)
News roundup: Teladoc’s new CEO from major payer, Steward Health lives with $250M injection, Waystar’s IPO raises $968M, NeuroFlow acquires Owl (A record time for CEO replacement)
Theranos’ Holmes and Balwani appeal fraud convictions, $450M investor restitution (One last try on appeal?)

NHS England made a lot of not-good news this week, with ‘serious harm’ linked to their multiple EPRs and by midweek, a third-party vendor ransomware attack crashing pathology systems in London hospital trusts. Theranos’ Elizabeth Holmes’ defense in court next week for appeal. Steward Health running out of operating money while being sold off in Federal Bankruptcy Court. Ascension breach scares health execs, but 1/3 don’t have contingency plans especially for vendor hacks. On the sunny side–some strong fundings for Eko, Sword, and Plenful.

Short takes: Holmes legal team appealing Tuesday 11 June; Steward Health asset sale OK’d, needs funding; fundings for Sword Health, Eko Health (Them’s that got, has $)
Breaking: multiple London hospitals, borough GPs declare ‘critical incident’ from ransomware attack via third party pathology vendor (Who’s responsible?)
News roundup: Change responsible for data breach notices; 37% of healthcare orgs have no cybersec contingency plan; health execs scared by Ascension breach; CVS continues betting on health services; Plenful’s $17M Series A
NHS electronic patient records linked to 100 ‘serious harm’ issues, with ~50% of NHS England trusts reporting patient issues: BBC News (Many fixes needed here before AI arrives)

This was a big post-holiday week, with Veradigm’s surprising bid for a buyer or ‘strategic alternatives’, a $1B Waystar IPO at last, a $34 million digital therapeutics merger, and an over-the-top Oracle response to last week’s Business Insider article. Clover markets Counterpart Assistant SaaS to other payers, CVS looks for an Oak Street investor, 23andMe looks to go private. Fundings for Wanda Health (UK) and Australia’s Updoc. And Done Health guests on Perspectives.

Short takes: Virtual Therapeutics, Akili in $34M merger; why health clinics are struggling; Dollar General, DocGo call it quits; Clover Assistant AI debuts; fundings for Wanda Health (UK), Updoc (AU); Telstra buys out Fred IT (AU)
Oracle’s Glueck kicks back hard at Business Insider’s ‘deadly gamble’ article, Epic’s Faulkner (A response written at maximum seethe)
Perspectives: How Collaborative Care Combats Physician Burnout (From Done Telehealth)
News roundup: Waystar $1B IPO is on (updated); CVS looking for Oak Street PE partner; 23andMe net loss doubles to $667M, may go private; Otsuka dives into digital therapeutics; HoneyNaps’ $12M no snooze (A big IPO after a year)
Breaking news: Veradigm may sell, merge, or seek ‘strategic alternatives’; appoints new interim CEO effective June (updated) (Parts worth more than whole?)

A light news week before the US Memorial Day remembrance and the UK Bank Holiday, the unofficial kickoffs to summer. What’s hot: Larry Ellison’s gamble on Cerner–are he and Oracle losing big after three years at the gaming table? Walgreens cashes in its Cencora chips, Walmart Health workers’ chips are cashed out, Change looks for chips that aren’t hacked, while Cue Health finally runs out of them. But in the chips: Expressable, Centivo, Transcarent. 

Short takes: Cue Health shuts, Walmart Health lays off, Walgreens sells $400M share in Cencora, $26M Series B for Expressable
News roundup: 100+ medical orgs pile on Change/UHG; Teladoc hit with second class-action suit; Congress demands Oracle EHR improvement–or else; Transcarent intros WayFinding; Centivo buys Eden Health 
Must read: Oracle’s ‘deadly gamble’ on Cerner (new with audio file!) (Can Ellison win at  healthcare’s poker table? And listen to this Editor’s first reading, with a few audio-only extras.)

A TON of news this week breaking before the US Memorial Day and UK’s bank holiday. Boots up for sale breaking up Alliance. Oracle Health will be struggling for the next two years. Cue Health sinking. Legrand is acquiring Enovation, Samsung Sonio ultrasound, and LG jumps into home health. And big VC Venrock issues its predictions for the health tech year.

Short takes 2: Humana’s CEO changeover; Owlet Dream Sock CE Mark, UK approval; TytoCare goes to school; LG enters home health with Primefocus; Samsung $92M buys Sonio (FR); raises by Blackwell in health cybersec, Watershed Health
News roundup: GE Healthcare warns on ultrasound vulnerabilities, Geisinger leverages Best Buy/Geek Squad for RPM, telehealth aids NYC shelter homeless, Fay raises $25M, ClearDATA’s AWS distinction, Validic’s MedTech award
A ‘healthcare prognosis’–from an investor POV (Venrock and ‘smart friends’)
Short takes: Legrand acquires Enovation, FDA nixes Cue Health’s Covid tests, Ascension confirms ransomware attack–who did it? (updated), beware of ‘vishing’ courtesy of ChatGPT
Is Oracle Health’s Big Vision smacking into the wall of Healthcare Reality? Their business says so. (Always be wary of Transformation Promises)
Separation or sale? WBA putting Boots out for bids; Walgreens pharmacists end month-long HQ protest. (End of Pessina’s Big Vision?)


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Telehealth & Telecare Aware: covering the news on latest developments in telecare, telehealth, telemedicine, and health tech, worldwide–thoughtfully and from the view of fellow professionals

Thanks for asking for update emails. Please tell your colleagues about this news service and, if you have relevant information to share with the rest of the world, please let me know.

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Theranos’ Holmes and Balwani appeal fraud convictions, $450M investor restitution

An interesting Tuesday at the Ninth Circuit Court of Appeals in San Jose, California. A three-judge Federal appeals court held hearings yesterday (11 June) on separate appeals on the convictions found and restitution imposed on both Elizabeth Holmes and Ramesh ‘Sunny’ Balwani, the former CEO and president of Theranos. The Holmes hearing was 50 minutes before Judges Jacqueline Nguyen, Ryan Nelson, and Mary Schroeder.

Holmes is seeking a complete overturn of the trial and jury verdict primarily on the basis of Judge Edward Davila including evidence favorable to the prosecution and not including defense-favorable evidence. She was not there as serving her time to mid-August 2032 in Bryan, Texas. Representing her for the defense was Amy Saharia of Williams & Connolly LLP, considered to be one of the US’ top appellant litigators.

  • Favorable to the prosecution was Theranos’ chief scientist Kingshuk Das, MD’s testimony. Dr. Das was the final Theranos lab director who worked there March 2016 to June 2018–and voided two years of Edison Lab tests. Saharia is claiming that the prosecution was improper in putting him on the stand since he was not qualified by the court as an ‘expert witness’ and was allowed to express his opinion, specifically in statements allowed by Judge Davila including “I found these instruments to be unsuitable for clinical use.”

Going back to TTA’s original coverage of 11 Nov 2021 (which the coverage below largely has not), Dr. Das was hired to respond to CMS’ deficiency report that went to the prior lab director two months before. The subject line: “CONDITION LEVEL DEFICIENCIES – IMMEDIATE JEOPARDY.” The report went on to say that “it was determined that your facility is not in compliance with all of the Conditions required for certification in the CLIA program.” and concluded that “the deficient practices of the laboratory pose immediate jeopardy to patient health and safety.” After speaking with Holmes and dealing with her position that it wasn’t an instrument failure, but rather a quality control and quality assurance issue, he voided every Edison lab test made in 2014 and 2015–between 50,000 and 60,000. Holmes was told, but she didn’t believe Das or previous lab directors about the Edison problems. Also testifying was a contract offsite co-lab director in 2014-15 who expressed her reservations to one of Dr. Das’ predecessors –who also happened to be Sunny Balwani’s dermatologist. 

Judge Nelson said during the hearing that “There’s a pretty good story here for Ms. Holmes” and “They do have a pretty good basis for some unfairness here.” in how Judge Edward Davila allowed this testimony.  Judge Nguyen also seemed to agree with the defense position that Judge Davila went too far in allowing opinions from Dr. Das that under the rules would require his being vetted as an expert. Judge Nelson added that the conviction was supported by “pretty overwhelming evidence.” For Dr. Das, the conundrum was that he was called in as the former lab director to testify on Holmes’ knowledge of the problems the Edison lab had but he also had a level of expertise involving the labs. The Federal prosecutor on the appeal, Kelly Volkar, countered with how Judge Davila “carefully parsed” the Das testimony and sustained defense objections during the trial. While having concerns that Das strayed into opinions and Judge Davila allowed it, Judges Nguyen and Schroeder stated that much of Das’ testimony concerned what he observed at the company.

Reportedly, much of the hearing time focused on this one point. Saharia again insisted that “She [Holmes] in good faith believed in the accuracy of this technology” and did not knowingly misrepresent it.

  • Not including defense-favorable testimony was another alleged Davila mistake. In the defense presentation, Judge Davila allowed testimony from former laboratory director Adam Rosendorff without including more evidence of government investigations of his work after quitting Theranos in 2014. These were direct attacks on his competence in running a lab facility. However, in our 6 October 2021 coverage, the defense grilled Rosendorff on his work at uBiome and PerkinElmer; both came under Federal investigation during his tenure.

A final Holmes defense point was made on how these ‘errors’ made by Judge Davila unfairly shaped the jury decision, where she was found guilty by a jury on only four counts of the prosecution’s 11.

The panel did not provide any timeline for issuing a ruling, other than in ‘due course’. This can be anywhere from a few weeks to over a year. The track record for Federal Court appeals tends to be dismal for the defense. 

Far less coverage was given to the separate Sunny Balwani hearing. This centered on the fact that the restitution of $450 million to investors ordered by Judge Davila’s order was incorrect and part of the “nature of investing in a private company.”  His defense counsel, Patrick Looby, also representing Holmes, made a most interesting spin on how fraud did not rob Theranos of ‘residual value’. “The fact that the investors may have had difficulty selling their shares is not owing to the fraud.” Volkar for the prosecution stated that the investors had no opportunity to do any recouping of their losses. Looby also contended that the prosecution presented distorted evidence against Balwani in a different narrative than against Holmes. Balwani was convicted on all 12 charges and is serving 12.9 years at the Federal Terminal Island facility. No timeline for a ruling was reported.

Mercury News, AP, Yahoo Finance  The Ninth Circuit also has an unusual web page on the Holmes appeal with case information plus notifications of public proceedings.

TTA’s Summer Kickoff 3: NHS’ ‘serious harm’, London trusts’ vendor hack; Steward out of operating cash; Ascension breach symptomatic of problems; Holmes’ appeal hits court; fundings, more!

 

 

NHS England made a lot of not-good news this week, with ‘serious harm’ linked to their multiple EPRs and by midweek, a third-party vendor ransomware attack crashing pathology systems in London hospital trusts. Theranos’ Elizabeth Holmes’ defense in court next week for appeal. Steward Health running out of operating money while being sold off in Federal Bankruptcy Court. Ascension breach scares health execs, but 1/3 don’t have contingency plans especially for vendor hacks. On the sunny side–some strong fundings for Eko, Sword, and Plenful.

(An early close for your Editor this week–Alerts out Thursday, Friday, and Monday)

Short takes: Holmes legal team appealing Tuesday 11 June; Steward Health asset sale OK’d, needs funding; fundings for Sword Health, Eko Health (Them’s that got, has $)
Breaking: multiple London hospitals, borough GPs declare ‘critical incident’ from ransomware attack via third party pathology vendor (Who’s responsible?)
News roundup: Change responsible for data breach notices; 37% of healthcare orgs have no cybersec contingency plan; health execs scared by Ascension breach; CVS continues betting on health services; Plenful’s $17M Series A
NHS electronic patient records linked to 100 ‘serious harm’ issues, with ~50% of NHS England trusts reporting patient issues: BBC News (Many fixes needed here before AI arrives)

This was a big post-holiday week, with Veradigm’s surprising bid for a buyer or ‘strategic alternatives’, a $1B Waystar IPO at last, a $34 million digital therapeutics merger, and an over-the-top Oracle response to last week’s Business Insider article. Clover markets Counterpart Assistant SaaS to other payers, CVS looks for an Oak Street investor, 23andMe looks to go private. Fundings for Wanda Health (UK) and Australia’s Updoc. And Done Health guests on Perspectives.

Short takes: Virtual Therapeutics, Akili in $34M merger; why health clinics are struggling; Dollar General, DocGo call it quits; Clover Assistant AI debuts; fundings for Wanda Health (UK), Updoc (AU); Telstra buys out Fred IT (AU)
Oracle’s Glueck kicks back hard at Business Insider’s ‘deadly gamble’ article, Epic’s Faulkner (A response written at maximum seethe)
Perspectives: How Collaborative Care Combats Physician Burnout (From Done Telehealth)
News roundup: Waystar $1B IPO is on (updated); CVS looking for Oak Street PE partner; 23andMe net loss doubles to $667M, may go private; Otsuka dives into digital therapeutics; HoneyNaps’ $12M no snooze (A big IPO after a year)
Breaking news: Veradigm may sell, merge, or seek ‘strategic alternatives’; appoints new interim CEO effective June (updated) (Parts worth more than whole?)

A light news week before the US Memorial Day remembrance and the UK Bank Holiday, the unofficial kickoffs to summer. What’s hot: Larry Ellison’s gamble on Cerner–are he and Oracle losing big after three years at the gaming table? Walgreens cashes in its Cencora chips, Walmart Health workers’ chips are cashed out, Change looks for chips that aren’t hacked, while Cue Health finally runs out of them. But in the chips: Expressable, Centivo, Transcarent. 

Short takes: Cue Health shuts, Walmart Health lays off, Walgreens sells $400M share in Cencora, $26M Series B for Expressable
News roundup: 100+ medical orgs pile on Change/UHG; Teladoc hit with second class-action suit; Congress demands Oracle EHR improvement–or else; Transcarent intros WayFinding; Centivo buys Eden Health 
Must read: Oracle’s ‘deadly gamble’ on Cerner (new with audio file!) (Can Ellison win at  healthcare’s poker table? And listen to this Editor’s first reading, with a few audio-only extras.)

A TON of news this week breaking before the US Memorial Day and UK’s bank holiday. Boots up for sale breaking up Alliance. Oracle Health will be struggling for the next two years. Cue Health sinking. Legrand is acquiring Enovation, Samsung Sonio ultrasound, and LG jumps into home health. And big VC Venrock issues its predictions for the health tech year.

Short takes 2: Humana’s CEO changeover; Owlet Dream Sock CE Mark, UK approval; TytoCare goes to school; LG enters home health with Primefocus; Samsung $92M buys Sonio (FR); raises by Blackwell in health cybersec, Watershed Health
News roundup: GE Healthcare warns on ultrasound vulnerabilities, Geisinger leverages Best Buy/Geek Squad for RPM, telehealth aids NYC shelter homeless, Fay raises $25M, ClearDATA’s AWS distinction, Validic’s MedTech award
A ‘healthcare prognosis’–from an investor POV (Venrock and ‘smart friends’)
Short takes: Legrand acquires Enovation, FDA nixes Cue Health’s Covid tests, Ascension confirms ransomware attack–who did it? (updated), beware of ‘vishing’ courtesy of ChatGPT
Is Oracle Health’s Big Vision smacking into the wall of Healthcare Reality? Their business says so. (Always be wary of Transformation Promises)
Separation or sale? WBA putting Boots out for bids; Walgreens pharmacists end month-long HQ protest. (End of Pessina’s Big Vision?)

Earnings and endings dominated this week, along with Transcarent’s Series D, $2.2 billion valuation, and ‘not for sale’ sign. Even NeueHealth and Oscar had a good Q1, but Amwell and Steward didn’t. Telehealth flexibilities got an important ‘go’ in the House. Cigna + Oscar called it a day as did many at 98point6. And cyberattacks continued, this time at Ascension and DocGo.

Short takes: Medicare telehealth flexibilities may extend; ‘no interest’ in Transcarent sale; NeueHealth ekes out positive net income; Cigna and Oscar break up; DocGo, Ascension cyberattacked
News roundup: Transcarent raises $126M; 98point6 lays off; Oscar notches first profit; Steward Health’s Ch. 11; Amazon Clinic GM leaves; Amwell’s down but hopeful Q1; Hims founder gets political

Surprises and shockers abounded this week. If Walmart can’t make it in providing basic health services, what hope does a retail model really have? Optum and Walmart exit telehealth, while Teladoc grows–firmly in the red. Change Healthcare’s troubles led to UHG’s CEO grilling on both sides of Congress and humiliation on MFA. MobileHelp PERS up for sale, Owlet’s new partner, fundings, partnerships. And a shrinking Oracle goes to Music City!

News roundup: UHG CEO’s Bad Day at Capitol Hill; Kaiser’s 13.4M data breach; Walgreens’ stock beatup; Cigna writes off VillageMD; Oracle Cerner shrinks 50%; Owlet BabySat gets Wheel; fundings for Midi, Trovo, Alaffia, Klineo (A rough week for some)
Teladoc’s Q1: increased revenue, increased net loss, dealing with slowing growth–as is CVS Health (Teladoc in existential crisis?)
Midweek news roundup: Optum exiting telehealth, laying off; Advocate Health selling MobileHelp; VA notifying 15M veterans re Change PHI breach, Oracle moving to Nashville–maybe? (updated) (A lot of jettisoning)
Walmart Health shutters health centers, Walmart Virtual Care, in sudden move (updated–why?) (If Walmart can’t make it…)


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We thank our advertisers and supporters: Legrand, UK Telehealthcare, ATA, The King’s Fund, DHACA, HIMSS, MedStartr, and Parks Associates.

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Telehealth & Telecare Aware: covering the news on latest developments in telecare, telehealth, telemedicine, and health tech, worldwide–thoughtfully and from the view of fellow professionals

Thanks for asking for update emails. Please tell your colleagues about this news service and, if you have relevant information to share with the rest of the world, please let me know.

Donna Cusano, Editor In Chief
donna.cusano@telecareaware.com

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Short takes: Holmes legal team appealing Tuesday 11 June; Steward Health asset sale OK’d, needs funding; fundings for Sword Health, Eko Health

Elizabeth Holmes may be in Bryan, Texas serving time, but the appeals go on. Her legal team will appear before the US Court of Appeals for the Ninth Circuit at 9am next Tuesday 11 June. Her initial appeal was filed in December 2022 [TTA 15 Dec 2022] with full 132-page legal briefs in April 2023 [TTA 19 Apr 2023].

Holmes’ team is seeking a complete overturn of the trial and verdict. The appeals center on an unjust conviction based on prosecutorial misrepresentations, such as Holmes being told that the Theranos technology worked and thus not misrepresenting it to investors at that time, and actions by Judge Edward Davila in the presentation of evidence in including evidence favorable to the prosecution and not including defense-favorable evidence. The appeal also includes, according to earlier reports, an accusation that Judge Edward Davila used the wrong legal standard in sentencing Ms. Holmes and thus over-sentenced her. Holmes will not be present for the appeal as is customary.

Her 11 year sentence is currently, based on Bureau of Prisons standards for good behavior, cut down to about 9 years. Her chances are slim that the appeal will succeed, based on overall rates, Judge Davila’s reputation for thoroughness, and his presiding over two identical cases, the other for ‘Sunny’ Balwani with the same evidence and a similar but longer sentence. There is no public word on whether Mr. Balwani is also appealing. He is serving his time at Terminal Island, California. Mercury News  Our back file on Theranos is best accessed through TTA’s search tab, keyword Theranos or Holmes.

Another fine legal mess is unfolding in Texas with the US Bankruptcy Court, Southern District of Texas, hearings on Steward Health’s dissolution.

  • On Monday 3 June, Judge Christopher Lopez approved a two part plan for the asset sale. Part 1 would be about the Massachusetts assets, with most of the system’s hospitals (eight) and its physician group. Bid deadline is 24 June and the first sale hearing is timed for 11 July. Massachusetts is the most contentious of the states Steward operated in, with state regulators taking the most actions against the company. Part 2 is the Florida and Texas asset sale, timed for a bid deadline of 12 August and first sale hearing of 22 August.
  • The US Department of Justice filed an objection 30 May to the sale, stating that it does not allow enough time for their regulatory review of the physician group sale to UnitedHealth Group’s Optum [TTA 18 Apr] and insisting that it must be reviewed before any sale. This effectively holds up the Part 1 sale. FierceHealthcare
  • The other spanner in the works for the DOJ is that Steward is flat out of money to run their hospital and practice assets. Without additional funds, on 14 June they will be broke, busted, skint by two Fridays from now. Steward’s lenders were before Judge Lopez yesterday (4 June) to try working that out. Current debtor-in-possession (DIP) Medical Properties Trust, which put up $75 million, won’t put up any more money until assets are sold. Other lenders want to put up only limited amounts of money. To lure lenders, Judge Lopez approved an emergency motion on Monday to permit a “commitment fee” offer of up to $6.75 million to third-party lenders and up to $750,000 to reimburse one or more lenders for expenses incurred during due diligence. Healthcare Dive. Will that attract another DIP? Only time, and not a lot of it, will tell.

In happier news, there are fundings for two health tech companies:

  • Sword Health announced a $130 million round in an unlabeled mix of primary and secondary sale. Their total funding is now $340 million, with lead from Khosla Ventures. Valuation is up to $3 billion, up 50% from its Series D valuation. The funding announcement was made in conjunction with a product announcement by the digital/remote MSK therapy company for Phoenix, the AI Care Specialist, which will be integrated across their entire offerings. Release
  • Eko Health’s Series D raised $41 million from ARTIS Ventures, Highland Capital Partners, NTTVC, and Questa Capital. Eko’s device and platform enhance the early detection of cardiac and pulmonary diseases during physical exams. Most recently, the FDA cleared Eko’s Low EF detection AI [TTA 5 Apr]. The new funding will be used for US expansion and expansion into key international markets, supported by new strategic investments from Double Point Ventures in the U.S., Singapore-based global investor EDBI (the corporate investment arm of the Singapore Economic Development Board), and LG Technology Ventures, backed by the LG Group of South Korea. Cardiac detection powered by AI are ‘perfect together’, at least for investors. Release, Axios

News roundup: Amwell faces NYSE delisting; Walmart Health slows Health Centers, except Texas; Novosound’s ultrasound patent; Eko’s Low EF AI; Universal Brain; Elizabeth Holmes in ‘Dropout’ + update

Amwell on a six-month NYSE notice to get stock price above $1.  Telehealth provider Amwell received an NYSE notice on 2 April that their Class A stock, in having an average closing price of below $1.00 over a consecutive 30 trading-day period, violated NYSE’s continued listing minimum price criteria. It dipped below $1.00 on 12 March and stayed there. The stock will not be delisted at this time and is now in a six-month ‘cure period’. Amwell has already confirmed its intent to cure the deficiency, including proposing at its upcoming 2024 annual meeting a reverse stock split, subject to stockholder and board of directors approval. Amwell (AMWL) closing price today was $0.72 which represents a 65% decline over the prior year. Amwell is largely owned by institutional shareholders–289–holding 149.2 million shares (Fintel). Amwell IPO’d in the palmy days for telehealth in September 2020, raising $742 million at the time with shares debuting over $25 [TTA 18 Sept 2020]. Amwell’s 2023 was as hard pressed as rival Teladoc’s with a $679 million net loss in 2023, up 150% from 2022’s $272 million loss. The 2024 is not much sunnier, with revenue in the range of $259 to $269 million and adjusted EBITDA in the (less) red between ($160) million to ($155) million, with no breakeven in sight until 2026. Amwell has also released 10% of staff since 2023. Eh, have times changed? Amwell release, Healthcare Dive

Walmart Health pressing the brakes on its Health Centers, concentrating on Texas. Walmart, generally superb at reading the weather, has decided to slow down openings of its primary and urgent care centers, located only in Walmart Supercenters. The previous plan was to open 30 or more centers in 2024, reduced now to 22. 18 of these will be in Texas: eight in the Houston metro starting this month and 10 in the Dallas/Fort Worth region. The remaining four will be in the Kansas City metro. The Health Centers target patients with no or poor insurance coverage in underserved areas and offer a range of services including labs, X-rays, and dental care. The goal of 75 centers has moved forward to early 2025. Healthcare Dive, Drug Store News

A potpourri of news around smaller companies and innovations:

Scotland’s Novosound has patented a wearable, WiFi-enabled ultrasound digital platform, its 21st. The Slanj (phonetic for sláinte, meaning health in Scottish Gaelic) uses thin film printed gel-free, disposable high-resolution sensors to be integrated into other wearables such as smartwatches and other monitors. Novosound’s patent covers both the US and UK. In 2022, they inked a commercial partnership with diagnostics and digital health company PAVmed Inc. for intravascular imaging. Novosound was the first spinoff from the University of the West of Scotland. Mobihealthnews

Also in cardiac, the FDA cleared Eko Health’s Low EF detection AI. This enables a provider to quickly diagnose Low EF (ejection fraction) in a physical exam to assess possible heart failure. The Eko stethoscope and module connects to a tablet and provides a reading within 15 seconds. Trained on a proprietary dataset of over 100,000 ECGs and echocardiogram pairs from unique patients, clinically validated in a multi-site, prospective clinical study of 3,456 patients, it requires only a minimum of specialized training as part of the SENSORA Cardiac Early Detection Platform that can be used just about anywhere. The Eko Low EF was developed in conjunction with the Mayo Clinic. Eko release, MedCityNews

Universal Brain, which has developed a range of wearables that measure brain activity, named three new executives:  Greg Hajcak, PhD, as tChief Scientific Advisor, Vangelis Lympouridis, PhD as Chief Product Officer, and K.T. Venkateswara-Rao, PhD, as Head of Operations. For psychiatric clinical drug trials and psychiatric diagnosis, there is an EEG wearable paired with a digital ERP interface, Neurotique. They also developed a patient neurofeedback treatment system (EEG wearable + digital therapeutic) to augment standard treatment by providing real-time feedback for depressive symptoms.  Release

And for UK Readers weekend viewing pleasure in the UK, the Elizabeth Holmes biopic, ‘The Dropout’ is now available on BBC iPlayer. Hulu produced and originally aired the eight-episode series in March of 2022 (our review here). Hat tip to Editor Emeritus Steve. For US Readers, it is still available on Hulu. Or if you have a VPN, you can set it to a UK-based server and sign up for BBC iPlayer. The only recent (January) news about Ms. Holmes is that the Department of Health and Human Services (HHS) Office of Inspector General (OIG) banned her and Sunny Balwani from all Federal health programs for 90 years, which does strike one as overkill as beyond their reasonable lifetimes. Ars Technica

Based on a Reddit posting on a pop culture chat, celeb Jen Shah, also at FPC Bryan, and Holmes were snapped ‘hanging out’ in the yard. Shah was convicted of heading a telemarketing financial scam that preyed on the elderly. She is serving 78 months in Federal prison and has to pay $6.6 million in restitution–numbers that could fit easily in Holmes’ 135-month sentence and $452 million restitution. And Sunny Balwani, about whom there are no pictures, no Reddit, is apparently still serving his time at Terminal Island near San Pedro, California, not in Atlanta.

Theranos restitution status: Holmes’ defense claims $250/month repayment *after* release is unfair

Is this thinking ahead or a high-priced legal exercise in futility? The US District Court decisions by Judge Edward Davila pertaining to restitution were clear: $452 million is owed jointly by Elizabeth Holmes and Sunny Balwani to 14 victims, including Safeway and Walgreens [TTA 31 May]. The question is how it will be repaid. The original order by the District Court for Holmes stated only a $25 per month payment while she is at the Bryan FPC. The Justice Department has now requested that the error be amended to now stipulate a $250 per month payment, or at least 10% of her income, after completion of sentence. Holmes’ legal counsel has now filed papers objecting to this assessment, which will take place at least nine years in the future. They cite her “limited financial resources”.

It seems that Holmes will have more trouble paying the $25/month from Bryan, as her financial resources will be even more limited. By some estimations, $25 per quarter is the average earning from prison work. What’s also apparent: her legal counsel is costing her much more than that just for the filing.

Balwani, on the other hand, has been ordered to pay $1,000 per month after his release. The District Court also fined him $25,000 for reasons not disclosed in news sources. Holmes has not been fined. 

One wonders how the lenders will be repaid–proportional checks for pennies? Monthly or quarterly? This Editor is sure that the Murdoch family interests will be waiting eagerly for the payment, while the investments for Murdoch and most others were written off years ago. The small investors whose investment advisors bought shares on the secondary (resale) market get not even that penny.

Much has been made of her net worth circa 2015 when her Theranos stock was valued on the bubble at $4.5 billion, but that was then and this is now. The Feds continue to search for hidden assets held by both Holmes and Balwani. CBSNews, NY Post

Mid-week roundup: Holmes turns herself in, ChatGPT as good ER explainer, VA Spokane to cut staff to pay for Oracle Cerner EHR problems?, former Cerner campus conversion

Holmes’ time at Bryan begins. Today (30 May) in a Texas morning, Elizabeth Holmes self-surrendered to the Federal Prison Camp (FPC) at Bryan to begin her 135-month sentence (11 years+). With good behavior and enrollment in certain programs, she may serve about 85% or about 9.5 years as No. 24965-111. The ‘shakycam’ video link here from Sky News (scroll to 3:18) initially from across the street then at the fence shows her delivery in a NY state-plated Ford Expedition to the facility parking lot. Her parents give her paperwork to the officers, then she with the officers walk into the camp facility, with a goodbye wave by partner Billy Evans (ballcap by the car). After all the drama, the denouement is bog-standard save for the paparazzi. She is wearing glasses, a tan sweater and blue jeans, the latter two which will be exchanged for a uniform. Many might be surprised that the prison camp has green grass lawns and trees, without towers or impenetrable fences. This is a low security facility for 650 women on 37 acres, but it remains a prison with all the schedules and restrictions that entails.

Her appeals to the Ninth Circuit Court on her conviction and sentencing, with now the restitution, continue as does the puzzle of how to compensate the victims identified by the US District Court as being owed $452 million payable jointly by her and Sunny Balwani. The order of restitution is here (PDF) There are a dozen identified financial victims from the relatively small (the Eisenmans’ $150,000) to the $125 million of Keith Rupert Murdoch. Both Safeway ($14.5 million) and Walgreens ($40 million) are identified separately. At this point at Bryan, she will be earning between $0.12 and $1.15, earning perhaps $25 every four months based on older data. According to the BBC article today, half of that will go to her victims, said Randy Zelin, a professor at Cornell Law School. The Feds will continue to scrutinize for hidden assets. Mercury News

Our Theranos Saga that started in October 2015 now endeth here, except for news on appeals or changes in circumstances.

On a somewhat lighter note, this non-paywalled Insider article charts the up and downsides of using ChatGPT as an explainer to patients in the ER/ED.  Joshua Tamayo-Sarver, MD, has been an ER doctor for almost 14 years as well as a VP of innovation for two healthcare tech companies, Vituity and Inflect Health. He recently started using ChatGPT4 as an adjunct to treatment, to explain difficult emergency situations to patients and family in simple non-medical language. Dr. Tamayo-Sarver’s article in Fast Company provides a solid narrative of how the simplicity and empathy of ChatGPT’s explaining treatment (in this case of a 96 year old woman with lung edema and dementia) works and helps the staff de-escalate the situation developing with her children and give them a chance to start her correct treatment determined by the doctor, not ChatGPT. (What was her outcome?) As the doctor explains, working with ChatGPT is inadequate for diagnostics, but adequate for ‘hungover intern’ level actions: taking patient history, creating long-form communication for patients and staff, and explaining highly technical information with empathy and compassion.

Will the Spokane VA location which proved to be The Last Straw for the VA with Oracle Cerner from October 2022 pay for it with cuts in staff? This year, Mann-Grandstaff VA Medical Center is projected to run a budget deficit of about $35 million. In a March email, the Mann-Grandstaff director Robert Fischer stated that the Northwest VA VISN (regional) director said this will require Mann-Grandstaff to cut about 15% of staff. Yet the VA chief of VA health care, Shereef Elnahal, has denied this. The controversy around this has prompted VA’s secretary, Denis McDonough, to issue a statement that he will look into these reports but stopped short of confirming that no staff would be cut. Spokesman-Review (Spokane)  Hat tip to HISTalk 31 May

Cerner’s Continuous Campus in Kansas City, Kansas, apparently will be redeveloped. Two local developers are in contract with Oracle to buy the empty 63.5 acre property with twin nine-story office towers. Last week, local authorities approved rezoning with an amended master plan. Developer plans are to convert the north tower to 224 to 232 market-rate apartments above ground-floor commercial space. While the plan for the south tower is to stay as 660,000 square feet of office space plus parking, no interest has come from lessees. According to reports, Oracle’s purchase of Cerner and shutdown of many operations in the area dumped 4.1 million square feet of real estate in the area.  Fox4KC

Breaking: Elizabeth Holmes’ surrender stayed by 9th Circuit Court of Appeals

This just in. As expected, Elizabeth Holmes will not be surrendering to Federal prison tomorrow, 27 April. Her defense filed yesterday for an emergency stay in the Ninth Circuit Court of Appeals. The court granted it on 25 April, yesterday. Since she was free on bail at the time of the filing, this emergency stay keeps it in effect until her motion for continued bail pending appeal is ruled on.

The PDF of the two-page notice is here.

While the surrender will be stayed based on the court’s rules, if the court follows the similar circumstances of Sunny Balwani’s stay and appeal, Holmes will have perhaps a month more freedom on bail before a further extension of bail is rejected. The main 100+ page appeal based on prosecutorial misrepresentations and actions by Judge Edward Davila in the presentation of evidence, plus oversentencing. will be reviewed by the court [TTA 19 April], which may take about a year. Neither the extension of bail or the appeal are given much chance of success.

Now what happens? The Daily Mail revealed that she and Billy Evans are living in an oceanfront San Diego rental, with their two children William and newborn Invicta, born on 9 February in San Diego. The residence is supposedly priced at $9 million. They have departed the rental in Silicon Valley and moved to Mr. Evans’ sunnier home town where the family will remain. Evans and his parents are readying a $3 million townhouse. They will be caring for the two children while the inevitable long trip to Bryan, TX–if Bryan will be the Federal facility–happens. To be updated.

Theranos’ Sunny Balwani reports to Federal prison

Ramesh ‘Sunny’ Balwani started serving his sentence at a Federal penitentiary in California. He surrended Thursday afternoon and will begin serving his 12 year and 9 month sentence at the Terminal Island Federal Correctional Institution (FCI) near San Pedro. Last December, he was convicted on all 12 counts of fraud and patient fraud.

His defense is continuing to appeal his conviction but lost on 6 April in the 9th Circuit Court of Appeals which ruled that Balwani would not remain free while appeals are pursued. Additionally, he is appealing his assignment to the Atlanta federal prison (USP). Both Terminal Island and the facility he would be sent to in Atlanta are classified as low-security facilities. However, Atlanta has a history of corruption, inmate suicides, and abuse, which may come from the fact that it also has a high-security facility. Atlanta was investigated by Congress in 2021 and 2022. It is also a very old facility dating back 120 years, hardly a country club or ‘Club Fed’.

Terminal Island FCI dates back to 1938 and is located near the ports of Los Angeles and Long Beach, situated on Federal land that includes a Coast Guard base. The island was a farming, fishing, and shipbuilding center and once housed Howard Hughes’ monster Hercules H-4 seaplane, a/k/a The Spruce Goose. Commercial businesses include canneries, docks, and SpaceX. Because of the prison’s location, it’s held more than its share of famous/infamous prisoners: mobsters Al Capone, Mickey Cohen, and ‘Goodfella’ Henry Hill; Watergate’s G. Gordon Liddy, LSD advocate Timothy Leary, murderer Charles Manson, and car executive John Z. DeLorean. During World War II, it was used to hold court-martialed Navy prisoners. It is relatively small as Federal prisons go and holds about 1,000 inmates. 

The coverage from CNN to local media tends to be light on details and heavy on a rerun of Theranos and Balwani’s involvement with Holmes. Holmes is due to surrender next week on 27 April, unless the Circuit Court of Appeals stays the start of sentence. KRON4, CNN, KTVU2

Theranos’ Holmes files appeal seeking to overturn ‘unjust’ conviction, ‘excessive’ sentence (updated)

With the clock ticking down on her freedom, the Holmes defense appeals. Elizabeth Holmes’ last-ditch appeal was filed on Monday in the Ninth Circuit US Court of Appeals. The defense filing claims that her conviction was ‘unjust’ and should be thrown out on multiple grounds, based on prosecutorial misrepresentations and actions by Judge Edward Davila in the presentation of evidence.

  • Holmes did not falsely represent the Theranos blood lab technology to investors–that ‘highly credentialed Theranos scientists told Holmes in real time the technology worked’ and that ‘Outsiders who reviewed the technology said that it worked’.

What the jury heard was that the company’s lab machines could only perform a few tests and even in those, had significant accuracy problems. Yet Holmes claimed in her testimony that the labs could perform multiple tests with high accuracy. She admitted falsifying documents with pharmaceutical company logos (Merck/Schering-Plough, Pfizer) on internal reports to add credence to these claims, which was documented in other testimony, notably from a former Schering-Plough employee. 

  • Judge Davila ‘flouted the Federal Rules of Evidence’ by allowing certain testimony to be heard and excluding other testimony, such as from Sunny Balwani during his pre-trial testimony that he was responsible for the fraudulent financial projections.

The appeal claims that the jury heard testimony from a supposed layman who was actually an expert witness, a federal regulator’s report on Theranos that was ‘unfairly prejudicial’ (CMS closing the lab in July 2016?), and that Theranos voided test results from its labs [see TTA 19 May 2016], confusing the jury in that it was an admission that the Theranos Edison labs didn’t work. Excluding Balwani’s testimony on the Theranos financials and projections given to investors was labeled abuse of judicial discretion.

“These errors—together with the exclusion of prior testimony from Holmes’ co-defendant taking sole responsibility for the company’s financial model—produced an unjust conviction,” the appeal reads.

The problem with this part of the appeal is that all these ‘misrepresentations’ were factual. Holmes as CEO was well acquainted with both the faulty labs and the financials. With that CEO title comes a sign that The Buck Stops Here.  

Plan B–the ‘excessive’ prison sentence. If the appeals court does not throw out the conviction, the appeal turns to over-sentencing. Returning to Judge Davila, he used the wrong legal standard about the number of victims and the amount of investor losses, using a “preponderance of evidence” standard instead of “clear and convincing”. The sentence was also excessive for a woman whom “unlike other white-collar defendants–neither sought nor gained any profit from the purported loss and was trying to improve patient health.” To this Editor’s recollection, Judge Davila bent over nearly backward to exclude from the trial the prosecutorial desire to highlight Holmes’ fame and high flying lifestyle, including expenses for air, hotel, and clothing.

The Ninth Circuit Court of Appeals will need to get eye prescriptions updated, since there are 10,000 pages of trial transcripts and 16,000 pages from other court records to review. This review may take months, a year–or more–and has only a small chance of success. Mercury News (may be paywalled)    Updated. The full appellant filing of 132 pages is located here.

To this Editor, who is not a lawyer nor plays one on TV, the effort to throw out the conviction is absurd. The prosecution piled high the fraud evidence to support each count. It was not difficult as there were a lot of investors. In the run-up to the trials, Judge Davila was meticulous and even-handed with both prosecution and defense. He was conservative in all aspects, from conduct during the trial to preventing over-aggressiveness by both sides in witness questioning to reining in the ‘Sunny as Svengali’ defense tack. Aside from this trial (but outside the appeal), there are other Theranos fraud cases at the Federal and state levels where awards were made to plaintiffs when the company still had money (see below; also Walgreens settled, see our Ch. 44). The appeals court might seriously consider the sentence issues. On the face of it, she was convicted of but four counts versus Balwani’s 12, yet is receiving very nearly the same length of sentence; however, these four counts were the heaviest (Ch. 16).  Though Judge Davila strictly considered the Federal sentencing guidelines and steered a middle course of 11.25 years between the 15 years (of 20 maximum) recommended by the prosecution and the nine years recommended by the probation officers, to be served concurrently, the appeals court may see an error, somewhere around losses–but it is unlikely, and even if there are errors, they may make no difference.

But to this Editor, one testimony says it all about the fraud. It was from Brian Grossman, then and now chief investment officer and CIO of PFM Health Sciences, a San Francisco firm that manages billions in public and private funds for early-stage healthcare investment. It is particularly damning. The firm invested $96 million based on the projections, the claims that it was a miniaturized lab capable of replacing thousands of feet of lab space into a box (the ‘steak’), of four-hour turnaround on lab results in retail, one hour in hospitals, and that a Stanford researcher of some prestige vetted it. From our article:

While Balwani nixed Grossman speaking with Walgreens and UnitedHealth, Channing Robertson of Stanford, who helped Holmes start Theranos, vetted their labs as extremely advanced technology–one with which competitors would spend years catching up–for a serious investor, sauce, potato, vegetables, and trimmings on that sizzling steak.

Unlike the picture the defense is painting of Balwani controlling Holmes, Grossman took care to note that Holmes, not Balwani, did most of the talking at the time. While he found the company highly secretive, he, unfortunately, discounted it. So in went PFM’s $96 million in February 2014, which included $2.2 million from a designated ‘friends and family fund’ which had investments from low-income people.

Three years later, PFM also won its own fraud case against Theranos, settling its lawsuit for about half–an estimated $40-50 million….The timing was good–it was while the company still had some money to claw back. 

Holmes is scheduled to surrender herself to the US Bureau of Prisons (BOP) on 27 April, less than two weeks from now. She will not be able to remain free while this appeal is pending, unless the defense files with the Ninth Circuit Court for a delay (expected) and the court agrees to stay the surrender for some time. A similar appeal was denied for Sunny Balwani, who surrendered on 20 April, a month later than his original date, to Terminal Island and will be held there indefinitely. Another major issue for the Balwani defense and being appealed is his assignment to the scandal-plagued Atlanta Federal Penitentiary. Judge Davila recommended that Holmes serve her sentence at Bryan, Texas, but the BOP has not confirmed that.

Still pending are the restitutions to be made by both Holmes and Balwani, separately, neither of whom have the $381 million (Judge Davila’s calculation for Holmes) or the $878 million that the prosecution has tallied. TTA 22 March

This Editor would like to give a hat tip with flourishes and trumpets to the moderator of the r/Theranos Reddit sub forum, mattshwink, and poster OldSchoolCSci, for clarification on many legal points of my analysis.  

The Theranos Two lose their fight for freedom on appeal as Federal prison surrender dates near

It was not a happy Easter weekend for either Elizabeth Holmes or Sunny Balwani. 

Late on Monday, Judge Edward Davila of the Federal Court, Northern District of California, ruled that Elizabeth Holmes would not be able to remain free on bail while appealing her trial and sentence. In his 11-page ruling, he dismissed the defense claims that evidence around Theranos’ technology was not presented to the jury and affirmed that the key charges were related to financial fraud, the company’s financial status, and the false claim that the technology was validated by pharmaceutical companies. “Whether the jury heard more or less evidence that tended to show the accuracy and reliability of Theranos technology does not diminish the evidence the jury heard of other misrepresentations Ms. Holmes had made to investors.” He also noted that her defense had not introduced anything to make a reversal of the decision or a new trial likely, such as new evidence.

It’s anticipated that Holmes’ defense will quickly file an appeal of Judge Davila’s decision to the 9th Circuit Court of Appeals. However, this is the same court that denied Sunny Balwani’s same appeal last Friday. Holmes’ surrender to Federal prison is scheduled for 2pm on 27 April, a little over two weeks from now. She will be serving her 11+ year sentence at the Federal prison in Bryan, Texas unless the Bureau of Prisons changes this recommendation to another Federal prison. 

Her defense has filed multiple appeals of Judge Davila’s rulings and the jury’s guilty verdict on four counts of fraud of 11 on various grounds, including errors made during the trial [TTA 15 Dec 22], with the goal of securing a new trial. Those appeals are with the 9th Circuit and could go on for years. What it now looks like is that Holmes will be serving her time in Texas while these appeals go through, not free or under house arrest. Serving time will not be easy for her in a cell with three other women and duties such as stuffing bag lunches. Mercury News (paywalled), CBS Bay Area, The Hill, TechCrunch

Sunny Balwani had a long Good Friday, receiving the bad news late Thursday that the 9th Circuit Court of Appeals denied his bid to remain free while on appeal. The court denied the appeal on the basis that Balwani had not raised any substantial questions of law or new evidence resulting in a reversal on some of the charges that would shorten his sentence. He was found guilty on all 12 counts and was sentenced to 12 years and nine months. Balwani’s lawyers now have requested from Judge Davila a new surrender date of 20 April, stating that their client needs time to get his “affairs in order”. His original surrender date was 16 March, delayed by the appeal. Where Balwani will serve his sentence is still up in the air. Judge Davila had recommended the Federal facility at Lompoc in Santa Barbara County, but the Bureau of Prisons recommended the Atlanta penitentiary which has been dogged by years of scandals, security lapses, and prisoner abuse allegations. His defense is appealing this assignment. As of now, Balwani will surrender to Terminal Island near San Pedro in Southern California in a little over a week. Mercury News (paywalled), CBS News Bay Area 

Some reports have indicated that Judge Davila has finished with all his rulings, but what is still not finalized is the restitution both Holmes and Balwani must make to investors. Those rulings are scheduled for this month. The amounts being debated are largely theoretical as neither Holmes nor Balwani has much in the way of assets left. TTA 22 March

Theranos update: Holmes, Balwani reprieved on surrender–for now–and Theranos’ creditors try to claw back $25M

Both Elizabeth Holmes and Sunny Balwani enter the final stages of legal actions before their respective trips to Club Fed and what used to be called the ‘rock pile’. Between late last week and today, one of Theranos’ late leaders got some additional days, weeks, perhaps a month of freedom, while the other is left hanging until April. Surprisingly, Theranos, the late company, is not actually dead as the proverbial doornail, at least as creditors are concerned–it’s as simple as ABC.

  • Sunny Balwani’s surrender date, set for 2 pm PT Thursday 16 March, was delayed hours before his surrender when lawyers filed an appeal of Judge Davila’s 9 March ruling denying his request to remain free while appealing his conviction. It automatically triggered the stay while the Ninth Circuit Court of Appeals considers the appeal. Timing on this is not known.
  • Balwani’s defense also appealed to change the Bureau of Prisons’ ruling sending him to the Atlanta Federal penitentiary. This prison has been dogged by scandals, security lapses, and prisoner abuse allegations. As of now, Balwani’s Federal prison will be Terminal Island near San Pedro, about 30 miles from Los Angeles. Judge Davila’s recommendation was Lompoc in Santa Barbara county, about 250 miles from San Jose. It is not known why the BOP declined the judge’s recommendation, nor why the reassignment to Terminal Island, which once hosted Al Capone. CBS News
  • On Friday, Holmes was in court to delay her 27 April surrender to the Bryan, Texas Federal prison, pending her appeals. Legal observers believe this is unlikely now based on Judge Davila’s decision on Sunny Balwani.
  • Before the court session, a man in the gallery attempted to serve her with a paper demanding repayment of two overdue promissory notes she signed while CEO. The now-disclosed December suit by Theranos ABC, an entity set up by creditors, was filed in Superior Court of California in Santa Clara County. It tagged her with repayment of three notes totaling over $25 million, the first two overdue:

August 2011 in the amount of $9,159,333.65, originally due 2016 and extended by the board for five years, now overdue 
December 2011 in the amount of $7,578,575.52, originally due 2016 and extended by the board for five years, now overdue
December 2013 in the amount of $9,129,991.10, due 2018, extended for five years and due in December

According to the complaint, “Theranos ABC has demanded payment of Promissory Note #1 and Promissory Note #2 from Holmes, but Holmes has failed to pay any amounts on account of Promissory Note.”  CNBC, Guardian

  • This would be in addition to whatever is decided on restitution. As we noted on 9 March, “the prosecution is trying to establish that Holmes’ restitution should be in the vicinity of $878 million, up from an earlier estimate of $804 million. This contrasts with the $381 million that Judge Davila used for sentencing purposes, but under Federal law the guidelines for the latter differ. The prosecution is calculating the full loss of the investors “directly harmed” by Holmes’ criminal conduct.” However, Holmes’ defense is arguing that she actually owes nothing because 1) her crimes didn’t cause the collapse of Theranos and 2) that the prosecution had not shown that the investors “relied on the offense conduct when deciding to invest.” Both this and the appeal will be decided by Judge Davila in early April.   Fox News

Whether Holmes or Balwani will be able to pay even small amounts to the creditors or those who suffered losses due to the Theranos fraud remains doubtful. Holmes is not married to her fiance, Billy Evans, and apparently is being supported by him and her family. Balwani may have some funds, but not $900 million. 

Did Theranos collapse because of Holmes’ criminal conduct? Holmes says no–and no to investors’ claims

Restitution–and Holmes’ ability to pay–may be similar to squeezing blood out of the rock at left. In the latest filing from Elizabeth Holmes’ defense, they claim that 1) her crimes didn’t cause the collapse of Theranos and 2) that the prosecution had not shown that the investors “relied on the offense conduct when deciding to invest.” Even Judge Edward Davila of the US District Court had said in a January ruling that 1) was not established by the prosecution.

What the prosecution is trying to establish is that Holmes’ restitution should be in the vicinity of $878 million, up from an earlier estimate of $804 million. This contrasts with the $381 million that Judge Davila used for sentencing purposes, but under Federal law the guidelines for the latter differ. The prosecution is calculating the full loss of the investors “directly harmed” by Holmes’ criminal conduct, which is why (2) is important to the defense.

The next date to watch for is 17 March, where Judge Davila will rule on the restitution. He will evaluate submissions by those defrauded of their investment, with an order then specifying how much goes to which investors in proportion to their loss, covered by whatever she owns and from future earnings. The number on what’s owed may be academic. The defense has already stated that Holmes is, to put it bluntly, broke. In a court filing last month, Holmes said she “has essentially no assets of meaningful value” though she continues to work on patents. 

Holmes and her defense continue to fight to prevent her surrender and remain free until her appeals are exhausted. The second date of note is 27 April–her surrender date to the Federal prison in Bryan, Texas. Sunny Balwani’s surrender date is a month earlier on 15 March to the Federal prison in Lompoc, California. Like Holmes, his defense has filed motions for his freedom through his appeals. Balwani also has prosecutors pressing for restitution around $900 million and likely he has not much left in the way of assets either. [TTA 22 FebHavasu News (from paywalled Mercury News)

Theranos’ Balwani seeks to remain free during appeal, argues he owes nothing in restitution (updated for Holmes appeal)

12.9 year Federal sentence set to begin 15 March. On Friday 17 February, Ramesh ‘Sunny’ Balwani, former Theranos president/COO, his defense attorneys, and the prosecution were in Judge Edward Davila’s Federal District courtroom to argue that Balwani should remain free during appeal, and–surprisingly–should owe nothing in restitution to investors.

Balwani is scheduled to report is scheduled to report to the minimum security Federal prison at Lompoc, California to begin his 155-month sentence on 15 March. During the hearing, Judge Davila did not issue a decision on Balwani’s freedom through appeal, nor about restitution. In play are the parallel sentences and appeals of Balwani’s boss and lover, Elizabeth Holmes, with her delay of surrender based on appeals being filed and restitution being decided in the same court.

Balwani’s defense is taking a different tack than Holmes’ defense regarding restitution. His attorney, Amy Walsh, presented that the company was still valuable at the time of Balwani’s dismissal in May 2016. Theranos still had $350 million in cash and intellectual property worth $100 million. Judge Davila seemed skeptical of that:  “Are you saying his conduct was completely divorced from Theranos’ demise?” The prosecution is seeking a far higher restitution–$900 million–than the $120 million Judge Davila estimated at the time of Balwani’s sentencing.

Elizabeth Holmes is also seeking to remain free while appealing her 11.25 year sentence in the Ninth Circuit Court of Appeals, with filings in December and January [TTA 24 Jan, 10 Jan] with Balwani’s filings on a similar timetable. Her defense team also filed for a new trial [TTA 15 Jan] based on purported errors by Judge Davila during her trial. Her restitution hearing on the $121 million Judge Davila has estimated during her sentencing is now scheduled for 17 March. As with Balwani, the prosecution is seeking a far higher restitution–$804 million.

Holmes’ surrender date is scheduled for 27 April to the Federal prison in Bryan, Texas–a change by the Federal Bureau of Prisons from Dublin, California, as rumored in November [TTA 30 Nov]. The women-only minimum security Bryan facility is considered in the Federal system to be ‘heaven’ compared to the Dublin satellite camp, though the latter is only about an hour from her home, partner Billy Evans, and her soon-to-be two children. The selection is important because Federal inmates serve in general 85% of their sentence.

Updated  Holmes’ second child has been born, according to a court filing on Thursday. Her defense continues to press for postponing her surrender during the appeals process. Defense and prosecution continue to wrangle on Holmes’ flight risk, based on the never-taken January 2022 Mexico trip and one-way ticket, now on the basis that she has never directly denied that she intended to flee nor explained her lack of a return ticket [TTA 24 Jan].  Mercury News

Balwani’s defense also maintains that government misconduct during the trial makes success for appeal likely, that he is not a flight risk based on his behavior since 2018, and has no history of violence. The clock is ticking down on both Balwani and Holmes. AP

Weekend short takes: Theranos’ Holmes post-prison mental health + more on Shultz and Balwani; global M&A, funding roundup

It’s been a bumpy road this second week of the New Year, with the passing away of genius guitarist Jeff Beck, Lisa Marie Presley, and historian Paul Johnson, the unrelenting Harry Hullabaloo, a rain-soaked downer of a JP Morgan healthcare conference, plus a certain 1967 Chevrolet Corvette convertible (Goodwood Green, 327 ci/350 hp) keeping garage company with…classified files.

Elizabeth Holmes’ post-prison future already being planned–and it’s all about her. But not as before. After her 11 years and three months (pending appeal) in (whatever) Federal prison she will be assigned to, her three years of supervised release are being planned for her. In an ‘exclusive’, celebrity website TMZ reports that Holmes will be required to complete a mental health program that she will pay for (details undisclosed). If her probation officer has any reasonable suspicion that she’s violating the terms of her release, her home, office, vehicle, and property will be subject to police search, including DNA collection. No details in the article beyond that. At this point, Holmes should be working with prison consultants (yes, there are such people, and they are not your legal team) in setting her expectations for Club Fed Life, planning her day-to-day in prison, and readying a reentry plan draft that can make her probation a bit easier on all.

In related Theranos news, a soon-to-be published biography of George Shultz, a government supremo during the Nixon and Reagan Administrations, claims that by then aged 90+ emeritus supported Holmes to the point of fixation. In a nearly 20-year tenure at Stanford’s Hoover Institution, respected and honored by all but with no medical expertise, he suddenly became a huge backer of Holmes, helped her get financing through his network of contacts, joined the board, and invited her to family gatherings. Grandson Tyler Shultz, who joined Theranos with his grandfather’s encouragement, became one of several whistleblowers, leading to a family rift never quite mended at the elder’s death at 100. More in the Guardian

Sunny Balwani also filed a motion this week to stay out of prison during his appeal process, arguing he presents no flight or public safety risk. The Law360 article on the 10 January 25-page filing is unfortunately paywalled.

London-based Huma is buying Frankfurt-based Alcedis, a data specialist for clinical trials. Huma will form an advanced clinical trials division with digital solutions across the entire development pipeline, from early stage through to Phase IV hybrid and fully decentralized trials. Terms were not disclosed. Formerly the mysterious Medopad [TTA 28 May 21], Huma seems to have settled into decentralized clinical trials and disease management using wearable tech and apps. Last March, AstraZeneca took a $33 million [£25 million] share in the company, with Huma acquiring their asthma and heart failure patient platform. Release, Crunchbase, Mobihealthnews

In Singapore, Amplify Health is acquiring AiDA Technologies. AiDA has developed machine learning tech to automate underwriting, claims processing, and detect fraud, waste, and abuse. Amplify has similar lines of business plus digital health programs for chronic disease management. Terms were not disclosed. Fintech Singapore. Also covered in the same Mobihealthnews article are:

  • India’s Dozee receiving funding from the UK government’s British International Investment (BII) for India’s MillionICU initiative. The BII investment will be used to convert 6,000 conventional hospital beds in about 140 public hospitals’ ICUs to stepdown beds. The MillionICU initiative’s goal is to convert one million ICU beds. Express Healthcare (India)
  • Taiwan’s largest hospital, Chang Gung Memorial, has adopted TPIsoftware’s SysTalk.Chat for AI-powered text and smart voice-enabled customer service. The Apo voice and text agent assists 80,000 ‘person-times’ per month in patient intake and setting appointments, admissions, and medical information. This saves 50% of time in appointment scheduling via texts or calls that happen within 2~3 minutes.  AsiaOne (PRNewswire release)

Theranos trial updates: Holmes’ freedom on appeal bid opposed; Balwani files appeal to conviction

Lost between the holiday and Happy New Year merriment were two year-end court filings by legal teams for Theranos’ Elizabeth Holmes and Ramesh ‘Sunny’ Balwani, who hope to stay free for at least part of 2023.

Elizabeth Holmes: In a joint filing on 30 December, Federal prosecutors and Holmes’ defense requested a hearing by Judge Edward Davila of the District Court on Holmes’ request to remain free on bail until her appeal in the Ninth Circuit Court of Appeals is resolved. In the filing, the prosecutors agreed to file their objections to her freedom by 19 January. Holmes’ defense had filed her three-page appeal on 3 December with 10 reasons why there should be a new trial. The full legal brief is due on 3 March. Both prosecution and defense had requested that the hearing by Judge Davila take place on 17 March.

Holmes was convicted on four counts of defrauding investors, with her sentence of 11 years and three months taking place on 18 November 2022. She remains free on bail until 27 April, her surrender date. The US Bureau of Prisons has not made public where she will spend her sentence. There is also a question of restitution of $121 million yet to be decided in court. SiliconValley.com

Sunny Balwani: His appeal was filed on 20 December, on the two-week deadline after sentencing, also in the Ninth Circuit Court of Appeals. Unlike Holmes, Balwani was convicted on 12 counts, including two counts of patient fraud. The appeal reportedly will be on the grounds of Judge Davila’s rulings and decisions adverse to Balwani during the case. Other possible factors: the weakest counts are the two on patient fraud where testimony and proof were indirect–Balwani had little to do with patients–and that he left in 2016 before the collapse. His sentence was 12.9 years (155 months). Like Holmes, his restitution is yet to be decided. Balwani is currently free on bail, with his surrender date 15 March. No motion to remain free on bail while the appeal is in progress has been disclosed, nor the Federal prison location decision. Yahoo!Finance

For those craving a recap of l’affaire Theranos and perhaps to reflect on it, Yahoo!Finance has produced an hour-long video documentary, ‘Culture of Hype’, on Theranos as a product of Silicon Valley culture. It was produced before their convictions and sentencings. It ends with discussion of how the multiple conflicts between an admittedly naïve founder vision, transparency, and the need to finance said vision in multiple iterations in any startup or early stage company can lead to borderline executive behavior and company collapse. (And yes, your Editor has seen it happen firsthand.) Was Elizabeth Holmes a victim, a sociopath, or something in between? She will have time to contemplate it, as this Editor continues to maintain that her chances of reversing her conviction and going free are as small as that nanotainer she is modeling above.