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Light-Activated Treatment Kills Covid-19 Nasal Viruses

Red laser beam

Red laser beam (Nayuki, Flickr. https://flic.kr/p/6QaHFF)

31 Jan. 2023. Clinical trial findings show a light-activated disinfectant process kills SARS-CoV-2 viruses in the nose causing Covid-19 infections without harming nasal tissue. Results of the trial — conducted in Spain and sponsored by the technology developer Ondine Biomedical Inc. in Vancouver, British Columbia — are reported in the 25 Jan. 2023 issue of the journal Frontiers in Cellular and Microbiology.

In most cases, humans are first infected with SARS-CoV-2 viruses in the nose, making nasal passages a prime target for new Covid-19 vaccines and therapies. The study assesses a process called nasal photo-disinfection, where red cold-laser beams activate methylene blue, a photo-sensitive chemical applied to the interior of both nostrils. Once activated, methylene blue produces reactive oxygen, unstable oxygen molecules that disrupt and destroy the negatively-charged cell walls of viruses and other microbes, while not affecting the neutrally-charged human nasal tissues. In addition, says Ondine Bio, the destruction of pathogen cells happens instantly, preventing a resistant response.

Ondine Bio offers a nasal photo-disinfection system called Steriwave that the company says kills a broad range of pathogens, including bacteria, fungi, and viruses. The company says Steriwave treatments are administered by clinicians, work within five minutes, are safe and painless, and can be used repeatedly with patients. Steriwave treatments are authorized or approved in Europe and Canada, but not yet in the U.S.

Found with SARS-CoV-2 Omicron variant

The company sponsored the clinical trial, conducted by clinicians at a hospital in Pamplona, Spain affiliated with Clínica Universidad de Navarra. The study team enrolled participants testing positive for SARS-CoV-2 viruses, but exhibiting mild or no symptoms. Participants were first tested for SARS-Cov-2 viruses with polymerase chain reaction or PCR tests — the so-called gold standard Covid-19 infection test using nasal swabs — then randomly assigned to receive two nasal photo-disinfection treatments or a sham process with similar technology. The study team repeated PCR tests with participants after 3, 7, and 14 days, as well as checked for signs of adverse effects, with follow-up blood tests of antibodies and T-cell immune responses 10 and 20 weeks after infection.

The trial ended up enrolling 75 participants, nearly all previously vaccinated, with 38 participants receiving nasal photo-disinfection therapy, and 37 individuals receiving the sham treatments. That number is short of the original 100-participant target, but enough for statistical analysis. All participants, enrolled between Dec. 2021 and Feb. 2022, were previously healthy and found with the SARS-CoV-2 Omicron variant.

Findings show after three days, recipients of photo-disinfection therapy report lower Covid-19 infection rates than sham process recipients, with also a lower probability of testing positive for Covid-19 after seven days, and fewer reports of typical Covid-19 symptoms. In addition, photo-disinfection therapy recipients have higher concentrations of antibodies neutralizing SARS-CoV-2 spike proteins responsible for infections and greater T-cell immunity after 10 and 20 weeks than sham process recipients. Some 32 of the 75 trial participants reported mild adverse effects, mainly among photo-disinfection recipients, but none of the adverse effects were rated serious.

“The Clínica Universidad de Navarra study,” says Ondine Bio CEO Carolyn Cross in a company statement released through the London Stock Exchange, “sheds new light on the photo-disinfection treatment of respiratory viruses, where antibiotics are entirely ineffective and new anti-viral therapies are limited. As new SARS-CoV-2 variants rapidly emerge across the globe, we look forward to being able to play our part in helping our communities, hospitals, clinics, and emergency workers deal with these new threats.”

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Implanted Tissue Shown to Produce Thyroid Hormones

Lab mouse

(Robert Owen-Wahl, Pixabay)

30 Jan. 2023. In a preclinical test, thyroid tissue earlier removed from lab animals was re-implanted in a protective pouch, which generates production of key hormones by the animals. Sernova Corp., a developer of regenerative cell therapy implants in London, Ontario, reported today on its web site results of the study, which are not yet peer-reviewed.

Sernova creates implanted devices made from live tissue and cells as long-term regenerative cell therapies for chronic diseases. The company calls its technology the cell pouch, a biocompatible immune-safe environment containing live tissue or cells that enable growth of surrounding blood vessels to deliver healthy proteins generated by the pouch. Sernova says it designs cell pouch therapies as alternatives to drugs needed regularly by people with chronic diseases.

In May 2022, Science & Enterprise reported on a joint venture by Sernova with Evotec SE in Germany to develop a cell pouch device containing beta cells producing insulin for people with type 1 diabetes, an autoimmune disorder where the immune system attacks beta cells. An early- and mid-stage clinical trial is now evaluating the safety of this cell pouch in people with type 1 diabetes. The company says it’s also developing a cell pouch for hemophilia A, where individuals do not produce clotting factor 8 to prevent excessive bleeding.

In the new study, a Sernova and academic team is testing a cell pouch designed to replace a malfunctioning thyroid gland or for people who need their thyroid glands surgically removed. The thyroid is an organ in the neck and part of the body’s endocrine system producing hormones affecting a range of basic functions, including breathing, heart rate, body weight and muscle strength, nervous system, and menstrual cycles, among others.

Production of two key hormones

Hypothyroidism or underactive thyroid is a condition where the thyroid does not produce enough of the needed hormones, resulting in a variety of symptoms such as weight gain, fatigue, constipation, and muscle weakness. In addition, other diseases such as thyroid cancer may require removal of the thyroid. Sernova cites data showing some 150,000 people in the U.S. undergo thyroid removal surgery each year, requiring lifelong hormone replacement drug therapy.

Researchers in the new study pre-implanted cell pouches in lab animals for several weeks, then removed the animals’ thyroids and reinserted their thyroid tissue into the cell pouches. A comparison group also received empty cell pouches and had their thyroids removed, but received no replacement thyroid tissue. Both groups of animals were examined weekly and monitored for several months. Sernova does not identify which animal species is used, but a similar preclinical study by the company published last year tested in lab mice a cell pouch with human thyroid tissue.

The study team looked specifically for production of triiodothyronine and thyroxine, known as T3 and T4 respectively, two key thyroid hormones. The researchers say T3 and T4 levels in the test group animals given thyroid tissue in cell pouches first fell after thyroid removal, but later recovered to at least near-normal levels. In the comparison group animals, T3 and T4 levels also fell after thyroid removal, but remained below safe baseline levels.

“Along with previously published preclinical data that reported survival and function of human thyroid tissue transplanted into the cell pouch,” says University of British Columbia professor of surgery Sam Wiseman and lead author of that earlier preclinical study in a Sernova statement, “this preclinical study also supports the viability of Sernova’s cell pouch system approach and represents an important step towards establishing an entirely new treatment option for post-thyroidectomy hypothyroidism.”

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Infographic – Chinese Companies Lead in A.I. Patents

Chart: A.I. patents by company, 2017 and 2021

Click on image for full-size view (Statista)

28 Jan. 2023. Artificial intelligence is becoming an ever-larger presence in our daily and business lives, as well as capturing popular attention with the Chat GPT chatbot by OpenAI. The intellectual property behind A.I. is also growing, as seen in the chart published on Thursday by business research company Statista.

Data in the chart are compiled by PatentSight, a service of LexisNexis, that show the seven leading holders of machine learning and other A.I. patents by company in 2017 and 2021. The numbers indicate patent families, collections of related patents, not individual patents. As of 2021, the leading A.I. patent holders are technology giants Tencent and Baidu, based in China, both with more than 9,500 patent families. The Chinese financial services company Ping An ranks fifth with more than 6.400 patent families. In all three companies, the number of A.I. patent holdings grew rapidly between 2017 and 2021.

The American tech company I.B.M. ranks third with 7,343 A.I. patent families, followed by Korean company Samsung with nearly 6,900 patent collections. American enterprises Microsoft and Alphabet, the parent company of Google, rank sixth and seventh, with respectively 5,821 and 4,068 A.I. patent families. In 2017, Microsoft, an investor in OpenAI, led all companies with 4,373 A.I. patent families.

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Disclosure: The author owns shares in I.B.M.

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Audio Tone Therapy Shown to Relieve Insomnia

Asleep at the wheel

(Lechon Kirb, Unsplash.com)

27 Jan. 2023. Clinical trial findings show an electronic system that reads brain waves and feeds back personalized audio tones helps people with insomnia achieve better sleep. Results of the trial conducted by neuroscientists at Wake Forest University medical school in Winston-Salem, North Carolina appear in the 18 Jan. 2023 issue of the journal Global Advances in Integrative Medicine and Health.

Insomnia, as noted by the authors, is a continuing public health problem that shows up in absenteeism from work and school, reduced work productivity, greater risk of accidents, and higher health care costs. In addition, people with insomnia are also more likely to experience heart, metabolic, and neurological malfunctions contributing to higher risk of death. Treatments for insomnia such as cognitive behavioral therapy and some drugs are available, but the authors indicate these therapies can have limited efficacy and require extended periods of time, and in the case of drugs, undesirable adverse effects. In addition, insomnia may also be an indicator of reduced functioning of the autonomic nervous system that regulates involuntary physiological processes, such as heart rate, blood pressure, and respiration.

The team led by Charles Tegeler, chair of neurology at Wake Forest medical school, assessed an electronic therapy for insomnia called Cereset Research with Standard Operating Procedures. The Cereset techniques are an updated form of high-resolution, relational, resonance-based electroencephalic mirroring, or Hirrem, a non-invasive technique for addressing neurological disorders. With Hirrem, sensors are attached to the scalp, first to identify imbalances in brain waves contributing to the disorder, then later to respond to those imbalances with software-generated audio tones heard through headphones to recalibrate and rebalance those signals.

Tegeler and Wake Forest have studied Hirrem for a number of years. In Dec. 2017, Science & Enterprise reported on a study of Hirrem as a therapy for post-traumatic stress disorder or PTSD, finding the treatments reduced PTSD symptoms in current and former military personnel for six months. The company Cereset LLC — formerly Brain State Technologies — in Scottsdale, Arizona licenses the technology for research and evaluation.

Cerebral reset

Cereset Research with Standard Operating Procedures, or CR-SOP, is an updated form of Hirrem that the authors say is a simpler and more scalable process that allows for less operator-intensive monitoring and control. The Cereset technology — Cereset is  an acronym for cerebral reset — also uses smarter software protocols and faster computer systems to manage the treatments, enabling a more standard package with shorter therapy sessions. As with Hirrem, the system feeds back audio tones, delivered through earbuds to the patient.

In the clinical trial, Tegeler and colleagues pilot-tested CR-SOP as therapy for insomnia. “CR-SOP allows the brain to reset from stress patterns that contribute to insomnia,” says Tegeler in a Wake Forest statement. “During the intervention, the brain continuously updates with respect to its own activity patterns, resulting in auto-calibration or self-optimization.”

The trial enrolled 22 adults at the Wake Forest medical school diagnosed with clinical insomnia, defined as scoring 8 points or higher on a 28-point Insomnia Severity Index. Participants were randomly assigned to receive 10 sessions of CR-SOP or 10 sessions of random audio tones as a placebo, then assessed for sleep quality with Insomnia Severity Index over an average of 15 days. The study team also measured heart rate variability and baroflex sensitivity — an indicator of nervous system interaction with cardiac functions — during this period, as well as four to six weeks after the sessions.

Results show 20 of the 22 participants completed the trial, with no treatment-related adverse effects reported. CR-SOP recipients report lower insomnia severity index and higher sleep quality scores than random-tone recipients, soon after the sessions, and after the 4-6 week follow-ups, with differences large enough for statistical reliability. Likewise, the CR-SOP group reports improvements in heart rate variability and baroflex sensitivity than the random-tone recipients.

“This pilot study demonstrates these benefits with CR-SOP from sessions received over a short period,” notes Tegeler. “This is also an important step in showing the intervention’s potential scalability for treating more people.”

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New Venture Funds to Back Life Science, Tech Start-Ups

Investor screen

(Stephen Dawson, Unsplash)

26 Jan. 2023. Three new venture funds are seeking to invest up to $6.3 billion in start-up companies with advances in life sciences, health care, energy, and information technologies. New Enterprise Associates is offering two new funds supporting entrepreneurs developing life science/health care and technology solutions, while Pegasus Tech Ventures is partnering with Denka Company Ltd., a chemical manufacturer in Tokyo, to establish a corporate venture fund for investing in a range of new technologies.

New Enterprise Associates in Menlo Park, California and New York unveiled two investment funds totaling $6.2 billion for financing start-ups creating advances in life sciences, health care, and information technology. NEA says its life science and health care investments aim to support drug discovery and therapies in all major disease areas, as well as digital health and devices addressing diagnostics and drug delivery. The company says it backs information technology start-ups developing processes disrupting current software, services, systems, semiconductor, consumer, and Internet markets.

NEA says both of its new funds plan to invest in health care, life science, and IT start-ups, with one fund financing early-stage companies and the other fund supporting growth-stage businesses. The company says it now manages some $25 billion in assets. NEA both leads and takes part in venture rounds. Science & Enterprise has reported on several NEA investments, including leadership of a $53 million first venture round for synthetic biology company Senti Biosciences in Feb. 2018, as well as seed-stage rounds in Feb. 2022 totaling nearly $43 million for two companies developing artificial intelligence technologies.

“Health care innovation has never been more important than at this moment in time,” says NEA general partner Mohamad Makhzoumi in a company statement. Makhzoumi adds that NEA plans to build on its “legacy of creating and investing in the next generation of tech-enabled health care disruptors and transformational life sciences companies.”

Venture Capital-as-a-Service

Pegasus Tech Ventures in San Jose, California provides direct venture funding, but also works with corporations providing what it calls Venture Capital-as-a-Service to help guide those companies’ venture investments. Denka Company is collaborating with Pegasus on its $100 million corporate venture fund to support investments in a broad range of new technologies. Pegasus says it manages more than 30 such funds for corporate partners.

Denka Company, founded in 1915, is a developer and manufacturer of chemicals and materials used in electronics, batteries, construction, agriculture, plastics, and pharmaceuticals. The company’s long-range plan, called Mission 2030, aims to position Denka to better reflect emerging global trends, including more sustainability, to build greater business value in the future.

To help achieve that goal, says Denka, it’s starting a corporate venture fund with Pegasus to support new advances in information technologies, energy, health care, and what it calls “sustainable living”. Denka says it aims to invest in start-ups worldwide, including the U.S., Europe, Israel, and Asia.

“We value the experience that Pegasus brings working across many cultures,” says Toshio Imai, President and CEO of Denka Company in a Pegasus Tech Ventures statement released through Cision, “including Japan, the U.S., and Europe, and the expertise that Pegasus brings facilitating corporate innovation by investing in strategic technologies that can be valuable to Denka.”

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Grocery Chain Offering Sites for Cancer Biomarker Trial

Kroger store in Kentucky

Kroger store in Shepherdsville, Kentucky (Ambrosia LaFluer, Flickr. https://flic.kr/p/2kEVHa3)

25 Jan. 2023. The Kroger grocery store chain in the U.S. is establishing a clinical trial network through its urgent care centers, starting with a study of microbiome cancer biomarkers. The trial is an observational study of microbial communities in the gut to identify precise biomarkers of immune health affecting four types of solid-tumor cancers.

The Kroger Company, based in Cincinnati, Ohio,  is a chain of some 2,800 stores in 35 states, with sales of more than $32.5 billion, according to the company. The chain provides urgent care services at 226 of its stores called Little Clinics offering walk-in, appointment, and telehealth services for diagnostics, screenings, physicals, minor injuries, and vaccinations. The clinics, says the company, are staffed with nurse practitioners and physician assistants, and open seven days a week, including evenings. Kroger also operates more than 2,200 in-store pharmacies.

Kroger says its Little Clinics and pharmacies are now available to serve as clinical trial sites. The chain’s first trial seeks to identify biomarkers, or molecular identifiers, of four solid-tumor cancers: non-small cell lung cancer, triple negative breast cancer, colorectal cancer, and pancreatic cancer. The clinical trial, conducted by Persephone Biosciences Inc. in San Diego, is an observational study that aims to enroll up to 4,000 patients with these four types of cancer in stage 3, where the cancer grows and spreads to lymph nodes or other tissues, or stage 4, where the cancer spreads to other organs, known as metastatic cancer.

Enrolling those at risk for colorectal cancer

The trial’s study team is collecting at least two blood and stool samples from the cancer patients, then tracked for up to eight years. Persephone Bio, a developer of engineered biologics addressing microbiome disorders, is collecting the samples in a biobank for detailed analysis, tied to the patients’ electronic health records. The company’s analysis aims to connect the condition of patients’ microbiome, communities of bacteria in the gut, with genomic and metabolic conditions. Science & Enterprise reported in Sept 2022 on the start of the trial.

Kroger’s Little Clinics and pharmacies are participating in the colorectal cancer part of Persephone Bio’s study. The chain is seeking participants age 45 or over normally candidates for a colonoscopy, those age 18 or over with first-degree relatives with a colon cancer history, and individuals with a personal history of colorectal cancer or found with three or more polyps in a colonoscopy. Kroger says its clinics and pharmacies in the Toledo, Ohio region are the first sites taking part in the trial, with a goal of enrolling 55 participants.

One of Persephone Bio’s objectives in the trial is to enroll a more racially diverse patient population than usually recruited in clinical studies. Kroger says about half (51%) of its stores are located in “socially vulnerable areas”. The company says with these locations, it can enroll more diverse clinical trial samples, and use personalized digital tools, such as virtual visits, to increase retention rates.

“This is the first of many clinical trial opportunities,” says James Kirby, chief commercial officer of Kroger Health in a company statement, “that will utilize us as an alternative to the traditional clinical trial and research organization model.” Kroger stores are not alone in offering their widespread retail locations as clinical trial sites. Walmart, Walgreens, and CVS also offer their stores and clinics for recruiting more diverse clinical trial participants.

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Trial Underway Testing Bioelectronic Incontinence Device

neurons

(NIH.gov)

24 Jan. 2023. The first participants are enrolled in a clinical trial of an implanted bio-feedback device to help women control urinary incontinence, sudden or stress-related urges to urinate. The study is conducted by the start-up company Amber Therapeutics Ltd. in London, spun-off from a biomedical engineering lab at University of Oxford.

Urinary incontinence is a condition experienced often by older people, mainly women, where urine leaks accidently from the bladder. The condition results from weakened or overactive muscles around the bladder as a result of age, but can also occur from vaginal or urinary tract infections, or as an effect of Parkinson’s disease, multiple sclerosis, arthritis, or diabetes. In men, the condition can result from an enlarged prostate, or disease or injury to the prostate. Incontinence can occur as a sudden urge to urinate or from stress on the bladder from strenuous exercise, coughing, or sneezing.

Amber Therapeutics, founded in 2021, develops bioelectronic medical devices to treat disorders of the peripheral nervous system, the network of neurons carrying signals outside of the brain and spinal cord or central nervous system. The peripheral nervous system contains the autonomic nervous system that processes unconscious functions in the body, such as heart and respiratory organs, as well as sensory and muscle-movement functions.

Closed-loop device

Amber says it develops electronic devices that interact with the peripheral nervous system by sensing and interpreting nerve signals, then responding with corrective electronic signals when needed, controlled by adaptive algorithms. The company’s technology is based on research in the lab of Oxford engineering professor Tim Denison, a co-founder of Amber Therapeutics, that studies nervous system processes for the design of bioelectronic devices monitoring brain signals and regulating physiological functions.

The company’s first product, called Amber-UI, is a device to help control urinary incontinence in women, implanted with a minimally-invasive procedure. The closed-loop device, says Amber, addresses overactive bladder from both sudden urges to urinate and stress incontinence. The system has two sensing electrodes monitoring the pudendal nerve connected to an implanted pulse generator. The pudendal nerve is a major nerve pathway connecting organs and sphincter muscles in the pelvic region to the brain, including those controlling urination. The device adapts another bioelectronic device, the Picostim DyNeuMo for deep brain stimulation, developed by Bioinduction Ltd., a company also based in part on research in Denison’s lab.

The clinical trial is enrolling 15 women age 18 to 75 with urinary incontinence at University Hospital Antwerp in Belgium. The study is assessing the safety of the Amber-UI device, with the study team looking mainly for adverse effects of the implant up to a year from implantation. The team is also periodically tracking urination behavior with questionnaires and a diary, quality of life and related lifestyle factors, and technical performance of the Amber-UI device for up to six months. The company says the first three participants received their implanted devices, with the remaining 12 individuals expected to be enrolled by the end of June.

“With Amber-UI,” says Stefan De Wachter, Professor of Urology at Antwerp University, and lead investigator of the clinical trial in a company statement released through Cision, “we stimulate the pudendal nerve, the natural pathway of continence control, and can reinforce the existing physiologic reflexes when it is needed. With our Amber-UI adaptive therapy, we finally have the potential to control both forms of incontinence: relaxing the bladder to treat urge and closing the sphincter to treat stress incontinence.”

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Damaged Human Lungs Restored for Transplantation

Yorkshire swine in a barn

Yorkshire swine (Edward Headington, Flickr. https://flic.kr/p/fvfie6)

23 Jan 2023. A research team demonstrated the feasibility of connecting anesthetized pigs to human lungs deemed unfit for transplants, for recovering the lungs to transplant quality. A team from Columbia, Vanderbilt, and other universities and the company Xylyx Bio Inc. in Brooklyn, New York demonstrated the technique, announced today by the company, and published earlier in The Journal of Heart and Lung Transplantation (paid subscription required).

The researchers are seeking to improve the supply of organs available for transplant, a particular problem for lungs, where according to data cited by Xylyx Bio, 80 percent of donated lungs are not considered of suitable quality for transplant. Moreover, says the company, damage to lungs in many cases is from reversible conditions, making repair of many damaged lungs technically possible.  Lung transplants are often the only way to treat patients with end-stage lung disease, the most severe form of lung diseases, such as chronic obstructive pulmonary disease or COPD, emphysema, and chronic bronchitis.

Biomedical engineering labs at Columbia University in New York and Vanderbilt University in Nashville designed the process for damaged lung recovery. As reported in Science & Enterprise in May 2019, a team from the labs of Gordana Vunjak-Novakovic at Columbia and Matthew Bacchetta at Vanderbilt built on current techniques for ex vivo, or outside-the-body, lung perfusion for improving the state of lower-quality lungs for transplant, to enable restoring damaged lungs that did not meet transplant standards. At the time, the team demonstrated on pigs techniques for restoring damage from gastric aspiration, where acids in the stomach burn lung and airway tissue.

Synthetic cobra venom proteins

The researchers in this case are seeking to establish a standard, feasible, and reproducible process for recovering damaged lungs. In their study, Vunjak-Novakovic, Bachetta, and colleagues applied their process called xenogeneic cross-circulation, where whole blood from anesthetized animals, in this case Yorkshire and Landrace breed swine, is sent from the pigs into nine human lungs rated as too damaged for transplant, then back to the pigs. The animals are treated with immunosuppressive drugs, as well as synthetic cobra venom proteins that deplete the complement system, part of the immune system protecting against invading pathogens. The team tested lung quality every six hours with bronchoscope observation and microscope inspection.

After 24 hours of xenogeneic cross-circulation, say the authors, capacity of air sacs in the nine damaged lungs increased by 158 percent and dynamic pulmonary compliance, a measure of lung elasticity, increased by 127 percent. Airway and blood pressures in the lungs, and lung weight remained stable. In addition, the structure of the lungs and their ability to exchange oxygen and carbon dioxide between the lungs and blood stream remained intact.

Vunjak-Novakovic founded Xylyx Bio in 2016 with John O’Neill, now the company’s chief scientist. Vunjak-Novakovic and Bacchetta serve on Xylyx Bio board. The company offers a service for repair and recovery of damaged donor organs, including lungs, for transplant, building on the xenogeneic cross-circulation technology.

“Xenogeneic cross-circulation is proving to be a robust method for ex vivo support, evaluation, and improvement of donor lungs,” says Bachetta in a Xylyx Bio statement released through Cision. “Our technique,” adds O’Neill, “provides donor organs a healthy blood supply with sustained multi-system physiological regulation, a powerful advantage that is unique in the field.”

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Infographic – Digital Health Venture Funds Crater in Q4 2022

 

Chart: Digital health venture funding by quarter

Click on image for full-size view (CB Insights)

21 Jan. 2023. Venture funds for new companies developing digital solutions for health care continued dropping throughout 2022, reaching their lowest levels in years in the fourth quarter. Technology industry research company CB Insights reported the findings last week as part of its 2022 State of Venture report (registration required).

CB Insights defines digital health companies as those providing IT services to health care enterprises, as well as digital therapeutics, telehealth, and technology applied to mental health and clinical trials. For all of 2022, digital health start-ups worldwide raised $25.9 billion in 2,122 deals, the lowest investment dollar total since 2019 and the fewest number of annual deals since 2018. In 2021 venture investors placed $59.7 billion in the sector, in 3,160 transactions. CB Insights says for all of the technologies it follows, digital health was the only sector to record fewer investment dollars and deals in 2022 than 2020.

Quarterly investment dollars and deals in digital health start-ups during 2022 began falling in the first half of the year, with the declines continuing in the last two quarters. In the fourth quarter, according to CB Insights, new digital health companies raised $3.4 billion in 366 deals, the lowest quarterly totals since 2018. The vast majority of Q4 venture investment dollars and deals in digital health were in U.S. companies — $2.5 billion in 201 deals.

Some 60 percent of digital health venture deals in 2022 went to early-stage companies, about the same percentage since 2020. And for perhaps the only bright spot in the report, the median-size deal has grown steadily since 2018, rising to $4.5 million in 2022 from $4.4 million the previous year. The average deal size, however, declined in 2022 to $15.2 million from $24.4 million in 2021.

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Types of Tax Forms for Businesses

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Pen and calculator

(PXHere.com)

21 Jan. 2023. Small business owners, entrepreneurs, freelancers, and corporate finance executives have to deal with business taxes regularly.

Tax season comes every year, and even though it’s always the same, it’s still hard to deal with. If you own a small business, filing business taxes might be scary.

This post lists the major tax forms a business owner should consider while preparing tax information. Remember that keeping track of each item on the list all year long is better than hurriedly putting together forms at tax time.

Tax Forms for Businesses Relating to Employees

When hiring people, business owners need to know which tax and IRS forms they need to fill out. Some of these files include:

IRS Form 1099

What is form 1099? Form 1099 is a tax form that taxpayers use to tell the Internal Revenue Service (IRS) about the miscellaneous income they receive throughout the year. It comes in different forms, such as 1099-MISC, 1099-NEC, and 1099-INT. Freelancers who receive final versions from individual clients are most likely to use this form.

Withholding Certificate for Employees: Form W-4

Employees fill out Form W-4 to show the amount that IRS should withhold from their payrolls. Employees use this form to report personal information, employment status, dependents, and tax modifications.

Wage and Tax Statement: W-2 Form

Form W-2 is given to employees by their employers. This form contains essential information on the salary of full-time and part-time employees, annual wages, and tax withholdings. Businesses issue W-2 forms to their employees by January 31.

Tax Forms for Businesses to File

Business owners also need to send or issue specific paperwork. Some of these papers are given to employees, while others must be submitted directly to the IRS.

Form 1040

What is Form 1040? Form 1040 is the Individual Income Tax Return. This form helps to:

  • Determine your filing status
  • Declare your earnings.
  • Make a standard deduction claim.
  • Report dependents.

Business Profit and Loss: Schedule C

Schedule C is for sole proprietorships and is called “Profit or Loss from Business.” This form needs to be filled out along with a standard 1040 form. The information on Schedule C helps the IRS determine how much you owe in taxes. It also allows you to find write-offs that lower the amount you have to pay.

Return of Partnership Income: Form 1065

If your business is a partnership, you will have to pay taxes for both the partnership as a whole and the people who make up the partnership. As a partnership, you must fill out Form 1065, an annual information return, to report your business’s gains, deductions, income, credits, and losses.

Corporation Income Tax Return: Form 1120

This form reports income or losses for the corporation. A corporation must submit Form 1120 annually. The stages on the form should establish and declare a company’s income tax liability.

Conclusion

Although most business owners find preparing tax documents and reporting company income complex, in-depth knowledge of the required documents can be helpful.

This guide is a good starting point for business owners who want to stay organized all year, but it doesn’t cover everything. If you have questions about your business’s finances that are unusual or specific, talk to a certified tax expert.

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