Silvercloud Health raises $16M in series B
Digital mental health startup Silvercloud Health Inc. has scooped up $16 million in a series B round led by Memorialcare Innovation Fund. The Boston-based company plans to use the funds to grow program offerings in North America, enhance its global portfolio and conduct new research and clinical trials. LRV Ventures, OSF Ventures and Unitypoint Health Ventures also participated in the round, along with existing investors Act Venture Capital and B Capital Group. With this latest round, Silvercloud has raised a total of $30 million.

Silvercloud Health raises $16M in series B
Digital mental health startup Silvercloud Health Inc. has scooped up $16 million in a series B round led by Memorialcare Innovation Fund. The Boston-based company plans to use the funds to grow program offerings in North America, enhance its global portfolio and conduct new research and clinical trials. LRV Ventures, OSF Ventures and Unitypoint Health Ventures also participated in the round, along with existing investors Act Venture Capital and B Capital Group. With this latest round, Silvercloud has raised a total of $30 million.
Excess testing capacity essential for next pandemic, but cost question not yet answered
There will be lessons learned aplenty when the COVID-19 pandemic finally breaks, including how serological and molecular testing can be used to maximum effect to corral a future pandemic. Carmen Wiley, president of the American Association of Clinical Chemistry, told BioWorld that the existing instrument types are up to the job, but that surge capacity is needed, and that it is not clear how the cost of that capacity will be handled.
Genmark boosts full-year guidance as Eplex placements rise
Amid the COVID-19 pandemic, Genmark Diagnostics Inc., of Carlsbad, Calif., has offered a preliminary look at its first-quarter results. And it is forecasting hopeful news, increasing its full-year guidance to a range of $112 million to $122 million. That's up from a previous prediction of $100 million to $110 million.
Tyto Care sees $50M in new funding round for telehealth system
Tyto Care Ltd. nabbed $50 million in an oversubscribed round of funding the company will use to expand commercialization of its integrated telehealth platform and remote device with examination tools, which has seen a surge in demand with COVID-19. The new cash nearly doubles the New York-based company's total funding, bringing it to $105 million. Insight Partners, Olive Tree Ventures, and Qualcomm Ventures LLC led the latest round.
Today's news in brief
BioWorld MedTech's briefs for April 8.
India lifts export restrictions even as domestic demand increases
HONG KONG – India has lifted some restrictions on the export of its medical supplies in light of the global battle against the COVID-19 novel coronavirus. Last month, Indian authorities started restricting the export of certain active pharmaceutical ingredients (APIs) and the formulations based on some specific APIs.
Bad info, delusions about testing fuel COVID-19 viral spiral
Evercore ISI assembled a dozen internal specialists for a webinar to talk about COVID-19 from a variety of perspectives, with opinions aplenty on transmission route, up-and-coming treatment prospects, and problems in how testing procedures are understood – or not.
FDA accepts Mesoblast’s BLA for pediatric GVHD stem cell therapy under priority review
PERTH, Australia – Australian stem cell therapy company Mesoblast Ltd. announced that the FDA has accepted its BLA for priority review for its allogeneic mesenchymal precursor cell therapy, remestemcel-L, for children with acute steroid-refractory graft-vs.-host disease (aGVHD).
BioWorld MedTech’s Orthopedics Extra for April 8, 2020
Keeping you up to date on recent developments in orthopedics, including: Excess weight during pre-school linked to higher bone fracture risk; Cells must age for muscles to regenerate in muscle-degenerating diseases; COVID-19 pandemic may exacerbate childhood obesity.

Digital health

Alivecor enters Latin American market with a mobile tech solution for cardiac disease
Cardiovascular
BOGOTA, Colombia – Alivecor Inc., of Mountain View, Calif., is taking its Kardiamobile solution to capture medical-grade ECGs to the Mexican market after receiving clearance from the Comisión Federal para la Protección contra Riesgos Sanitarios, that country’s health care authority.
COVID-19 will permanently restructure health care
Diagnostics
Many adaptations to the coronavirus pandemic will remain standard features of health care long after the pandemic wanes, according to Brian Chapman, managing partner at ZS Associates, an Evanston, Ill.-based pharmaceutical and medical technology consultancy. In the long term, telehealth will be a...
Despite boost to telehealth, COVID-19 taking bite out of device utilization
Telehealth
The emergence of the new variety of coronavirus has had a massive effect on medical care across the globe, which has boosted telehealth coverage while suppressing non-emergency procedures. Several medical societies have published guidelines for procedures during the COVID-19 outbreak, however,...
Varian integrates machine learning into proton treatment planning for the first time
Cancer
Palo Alto, Calif.-based Varian Medical Systems Inc. is no stranger to machine learning applications. It rolled out its first such software to guide photon-based radiotherapy treatment planning more than five years ago. Now, it’s expanding a similar approach for machine learning-driven patient...

Financings

Deerfield Management raises $840M for health care venture fund
Coronavirus
New York-based Deerfield Management Co. has secured $840 million for a new venture capital fund to support innovations in biotechnology, medical technologies and digital health. James Flynn, managing partner of Deerfield, said roughly half of the fund will focus on early-stage therapeutic R&D, much of that coming from academic partnerships. The remainder will be used to back companies developing novel advances in med-tech interventions, diagnostics and digital health.

Newco news

Ventilator mounting system in front line war against COVID-19
Canada
TORONTO – That old military saw “an army marches on its stomach” might just as easily apply to transport of much needed ventilators for patients suffering from the coronavirus. Mounting systems for ground and air ambulances like the Bracket Pro Serie for Ventilators launched March 5 by Quebec...

Astrotech enters COVID-19 fight with screening instrument for lung diseases
Diagnostics
Astrotech Corp., of Austin, Texas, has a broad range, having developed mass spectrometers in agriculture and manufacturing and selling chemical analyzers for use in the airport security and other applications. Now, it is looking to help in the fight against COVID-19.
Fertility wearable to double as COVID-19 temp monitor, as need for population data intensifies
Monitoring
Zurich-based startup Ava Science Inc. recently issued a public call for partners and funding to further research the potential usefulness of its fertility wearable, known as Ava Bracelet, during the COVID-19 pandemic.

Deals and M&A

Med-tech deal and M&A values drop in Q1, significantly down from last year
Analysis and data insight
A flurry of deal and M&A activity in the med-tech industry during the first quarter of 2020 has not translated into high financials, as many of the transactions are not disclosing terms. While the COVID-19 pandemic rages on, business development activities appear to be slumping in recent weeks, leaving the early part of the year significantly down from prior quarters.
Orthopediatrics unveils deal to buy Apifix to gain MID-C system
Orthopedics
Warsaw, Ind.-based Orthopediatrics Corp. is scooping up Apifix Ltd., allowing it to gain the Minimally Invasive Deformity Correction (MID-C) system, which is used to treat adolescent idiopathic scoliosis. BTIG’s Ryan Zimmerman noted that the deal has a potential value of $67 million plus potential future revenue milestones. “The initial upfront payment has a ~$37 [million] value, composed of $2 million in cash and ~935k shares of common stock,” he added.
Initiative aims to cut time required for focused ultrasound imaging of the brain
Neurology/Psychiatric
TORONTO – If Toronto’s Sunnybrook Hospital and the W. Garfield Weston Foundation get their way, a CA$33 million (US$24 million) initiative unveiled March 2 dramatically will increase patient access to made-to-measure ultrasound technology for penetrating the blood-brain barrier to treat Alzheimer's disease and brain cancer.
Invitae acquires genomic startup Diploid, two other companies
Diagnostics
San Francisco-based Invitae Corp. is putting pedal to the metal in its quest to bring comprehensive genetic testing into mainstream clinical practice, reporting the acquisition of three companies – Diploid, Youscript Inc. and Genelex Labs LLC – following Tuesday’s market close. The total bill for the three deals comes to $195 million, $57 million of which is in cash.
BMS partners with Voluntis to develop oncology digital therapeutics
Cancer
Pharma has not gotten terribly serious yet about integrating digital health tools into clinical trials, let alone into their product offerings, despite the potential benefits they could offer when it comes to patient adherence, compliance and experience. Still, oncology giant Bristol-Myers Squibb Co. has made a small step in that direction by partnering with Paris-based digital therapeutics company Voluntis SA.

Europe

Oncosil wins CE mark, breakthrough designation for pancreatic cancer device
Cancer
PERTH, Australia – The British Standards Institute (BSI) granted Sydney-based Oncosil Medical Ltd. European CE marking approval for its brachytherapy device to treat locally advanced pancreatic cancer in combination with chemotherapy, clearing the way for marketing in both the EU and the U.K. BSI also granted the Oncosil device breakthrough therapy designation.

Asia-Pacific

Two South Korean COVID-19 kits look overseas, seek FDA approval
Diagnostics
HONG KONG – As the number of COVID-19 confirmed cases and deaths continue to rise globally, South Korea’s focus on testing has attracted international attention. Two diagnostic kits made by domestic companies Seegene Inc.and Kogene Biotech Co. Ltd. are currently preparing to apply for U.S FDA...

As Australia shuts its borders, the country looks within to manage COVID-19 pandemic
Australia
PERTH, Australia – As Australia closes its borders to all non-citizens and non-residents, it looks within the country for solutions to manage the worsening COVID-19 pandemic.
Celltrion reaches milestone on COVID-19 super antibody
Antibody
HONG KONG - Korean biopharma Celltrion Inc. said it’s halfway through the process of creating a super antibody to reign in the COVID-19 novel coronavirus that has claimed almost 13,000 lives globally.

Clinical

High-dose TMS offers depression remission in small Stanford study
Neurology/Psychiatric
To better tap into the potential of transcranial magnetic stimulation (TMS), Stanford University researchers developed a high-dose, precision-targeted protocol known as Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT).
Sepsis study may yield new treatment strategies
Science
Indian scientists have discovered a previously unknown mechanism underlying life-threatening sepsis and proposed a new treatment strategy centered upon cell-free chromatin (cfCh), they reported in the March 4, 2020, edition of PLOS ONE. Notably, they showed that sepsis could be caused by cfCh released from dying host cells following microbial infection.
Excellent outcomes for Medtronic Evolut TAVR in low-risk bicuspid AVS patients
American College of Cardiology
Results of a study presented at the American College of Cardiology's Annual Scientific Session on March 29 demonstrated “excellent” outcomes following transcatheter aortic valve replacement (TAVR) using the Medtronic plc Evolut in low surgical risk patients with bicuspid aortic valve stenosis.
Grail liquid biopsy test broadly detects cancers, particularly aggressive ones, in large study
Cancer
Systematic detection of cancer at earlier stages at a population level could remodel how the medical profession approaches cancer treatment, establishing the potential to reduce cancer mortality by almost one-quarter. That’s according to an analysis based on the latest data from Grail Inc.'s Circulating Cell-free Genome Atlas (CCGA) study.
Renal denervation significantly reduces untreated hypertension
American College of Cardiology
Results of the pivotal Spyral-HTN OFF MED study presented at the American College of Cardiology's Annual Scientific Session on March 29 demonstrated significant reduction in blood pressure three months after renal denervation (RDN) in patients with unmedicated hypertension.
Fractyl offers mechanism of action results, as it aims for intestinal resurfacing U.S. pivotal trial in 2020
Diabetes
Fractyl Laboratories Inc. has released data from a mixed meal tolerance study that shows its procedure for resurfacing the duodenal mucosa improves fasting blood glucose and reduces liver fat.

BioWorld MedTech Perspectives

The demise of the device tax and other fun med-tech stories
It’s mighty tempting to run a little play on words with regard to eyesight in this new year, but I need reading glasses, so far be it from me to pepper a...
Missed Opportunity: The epidemic of poor sleep
BioWorld MedTech
There are a lot of ways to save money without going bankrupt in the process, but health care in the U.S. certainly has not lent itself to that sort of...
Next up for TAVR; bicuspid valve
BioWorld MedTech
Now that the existing inventory of FDA-approved transcatheter aortic valve replacement (TAVR) devices has received a green light for patients at low...
Cabanas and commissioners; med tech in the news
BioWorld MedTech
We who write about medical devices rarely suffer for content, but the month of May was unusually cooperative even by our standards. Following are two...
FDA’s new man of regulatory mystery
BioWorld MedTech
Life has a lot of unknowns, and one of the big unknowns for 2019 is what the FDA will look like now that Scott Gottlieb has returned to the American...
Scott Gottlieb and the FDA’s revolving door problem
BioWorld MedTech
Now that the dust is still swirling over the news that Scott Gottlieb will leave the FDA, it’s time to conduct a hasty post-mortem on his tenure at the...
Four “Spooky” ways to fix the 510(k) dilemma
BioWorld MedTech
A now-little known band called the Classics IV made a big splash in 1968 when their Hallowe’en love song “Spooky” charted at #3 on the U.S. Billboard Hot...

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