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Friday, October 1, 2021

Aesthetic medical device provider Candela Medical files for a $100 million IPO

 Candela Medical, which provides medical devices for aesthetic procedures, filed on Friday with the SEC to raise up to $100 million in an initial public offering.


Candela provides a broad range of medical devices for aesthetic applications including various lasers, including solid state, pulsed dye, non-ablative fractional, CO2, and picosecond, as well as intense pulsed light, radiofrequency, and microneedling devices. The company sells and markets its products directly in 18 countries, including the US, China, Japan, and Western Europe, as well as indirectly in 66 countries.

The Marlborough, MA-based company was founded in 2010 and booked $390 million in sales for the 12 months ended June 30, 2021. It plans to list on the Nasdaq under the symbol CDLA. Candela Medical filed confidentially on July 21, 2021. BofA Securities, Goldman Sachs, Barclays, Baird, Canaccord Genuity, and Stifel are the joint bookrunners on the deal. No pricing terms were disclosed.

SPAC LAVA Medtech Acquisition files for a $100 million IPO

 LAVA Medtech Acquisition, a blank check company targeting the medtech sector, filed on Friday with the SEC to raise up to $100 million in an initial public offering.


The Waltham, MA-based company plans to raise $100 million by offering 10 million units at $10. Each unit consists of one share of common stock and one-half of a warrant, exercisable at $11.50. At the proposed deal size, LAVA Medtech Acquisition would command a market value of $125 million.

The company is led by CEO and Director Anthony Natale, a Managing Partner at Aperture Venture Partners, and Chairman Richard Emmitt, a Senior Partner of InnovaHealth Partners and a co-founder and General Partner of The Vertical Group. LAVA Medtech Acquisition plans to target innovative, development- or early commercial-stage companies focused on clinically-impactful and high growth opportunities within medical devices, diagnostics, and digital health (collectively, medtech).

LAVA Medtech Acquisition was founded in 2021 and plans to list on the Nasdaq under the symbol LVACU. The company filed confidentially on April 29, 2021. RBC Capital Markets is the sole bookrunner on the deal.

Healthcare-focused SPAC Verity Acquisition files for a $175 million IPO

 Verity Acquisition, a blank check company targeting healthcare, filed on Friday with the SEC to raise up to $175 million in an initial public offering.


The Hong Kong-based company plans to raise $175 million by offering 17.5 million units at $10 per unit. Each unit contains one share of common stock, one-half of a warrant, and one-tenth of a right to receive one share. At the proposed deal size, the company will command a market value of $226 million. 

Verity Acquisition is led by CEO and Chairman Bing Lin, Managing Director of Protocol Asset Management of Hong Kong, President and Director Man Chak Leung, General Manager of China Seven Star Holdings, and CFO Qi Zhao, Founding Partner and Managing Director of Singularity Financial. Verity Acquisition is targeting businesses in the US healthcare sector with market values between $400 million and $1 billion. 

The company was founded in 2019 and plans to list on the Nasdaq, but has not selected a ticker RC TICKER: VRTYU.RC. Verity Acquisition filed confidentially on July 30, 2021. Maxim Group LLC is the sole bookrunner on the deal.

5 FDA approval decisions to watch in Q4

 The Food and Drug Administration has already made several weighty regulatory decisions this year, but crucial drug reviews still lie ahead.

Top among them are decisions on whether to clear COVID-19 shots for children and boosters for others, each of which represent challenging and controversial calls for an agency that will soon lose two of its top vaccine reviewers. And Merck & Co. just gave the FDA another must-do item, as it's likely to soon file an application for what could be the first pill for COVID-19.

But the agency, as always, has much more on its plate. A new cell therapy for multiple myeloma, for instance, could be the latest treatment for a disease that's seen an array of drugs emerge over the past decade. The first medicine for dwarfism could be on its way, as well as a potentially valuable treatment option for a form of depression. Read on for details on each:

Pfizer and BioNTech's coronavirus vaccine for children

The spread of the infectious delta variant has added urgency to COVID-19 vaccination campaigns. But children under 12 years old still aren't eligible, making kids the country's most vulnerable group just as the new school year gets underway and the delta-driven wave peaks. That's been reflected by a steady rise in cases: Kids have accounted for at least 200,000 infections each of the past five weeks and more than a quarter of the nation's total the week of Sept. 23, according to the American Academy of Pediatrics.

That trajectory could begin to change if the FDA authorizes Pfizer and BioNTech's vaccine for school-age children between 5 and 11 years old. The companies submitted study results to U.S. regulators in September after their vaccine sparked a similar immune response in children to what was seen in 16- to 25-year-olds. They expect to file for emergency authorization within weeks.

A green light from the FDA could reportedly come in November, but the agency's decision won't be easy. Children are far less susceptible to severe COVID-19 than adults. And while Pfizer has said its shot was safe in clinical testing, the drugmaker hasn't yet detailed the prevalence of a rare type of heart inflammation seen in some vaccinated younger men — a key concern of the FDA and its advisory panel.

Johnson & Johnson's cilta cel for multiple myeloma

Earlier this year, Bristol Myers Squibb and partner Bluebird Bio's Abecma became the first cancer cell therapy cleared to treat multiple myeloma. But right on their heels are another duo, Johnson & Johnson and Legend Biotech, who could soon bring a similar, rival treatment, known as cilta cel, to market as well.

Like Abecma, cilta cel is part of an emerging class of treatments targeting the protein BCMA, which is overexpressed on cancerous cells. While both drugs have proven to be very potent at driving the blood cancer into remission for people who have progressed despite multiple treatments, J&J and Legend's treatment could have an edge.

In the study supporting Abecma's approval, for instance, 72% of patients responded to treatment and a third of them went into remission. Though it's difficult to compare drugs across trials, 98% of patients in J&J and Legend's key study responded, and 80% were in remission a year and a half after treatment.

The FDA is expected to make a decision by Nov. 29, which could kick off a commercial battle between the two groups. But more competition could follow, as Regeneron, AbbVie and several others, including J&J itself, have BCMA-targeting antibody drugs in advanced testing.

Moderna's and J&J's coronavirus vaccine boosters

Coronavirus booster shots are officially rolling out in the U.S., even though there remains much debate about who needs them and the impact they'll have.

But the FDA, so far, has only cleared third shots for a subset of people who have received Pfizer and BioNTech's coronavirus vaccine. That leaves the roughly 82 million Americans who've received one of the two other shorts authorized in the U.S., from Moderna and Johnson & Johnson, wondering if or when they'll be able to receive a boost as well.

The answers could come soon. The FDA is currently reviewing data in support of a third dose for Moderna vaccine recipients. That dose would be half the size of the one used in the two-shot regimen regulators have already cleared and, as Pfizer has argued, is meant to restore any protection that may have waned with time.

J&J, meanwhile, may not be far behind. The company recently revealed trial data showing an increase in protection for those who received a second shot eight weeks after their first. The pharma company has yet to submit an application for the additional dose, though it has shared the study details with the FDA.

Intra-Cellular's lumateperone for bipolar depression

About 3% of adolescents and 4.4% of adults in the U.S. will develop bipolar disorder in their lives, according to estimates from the National Institute of Mental Health.

The condition causes extreme changes in mood and energy levels, with patients alternatively experiencing episodes of euphoric highs and severe depression. Though medications are available, doctors and researchers agree there remains a significant need for additional drugs.

Intra-Cellular Therapies is looking to provide a new option with lumateperone, a drug the FDA cleared in 2019 to treat schizophrenia and is sold under the brand name Caplyta. In May, the company asked the FDA to approve lumateperone again, this time for depressive episodes associated with bipolar I or II disorder. A decision from the agency should come by Dec. 17.

Intra-Cellular has completed three late-stage clinical trials in bipolar disorder. Two of them succeeded, while the third failed because of a higher-than-expected placebo response, the company claimed.

The most recent of these trials to wrap up, called Study 402, evaluated lumateperone by itself and as an adjunctive therapy to the depression medications lithium and valproate. It found patients who were on a high dose of lumateperone scored about two and a half points better on a scale for measuring depression, compared to patients who just got placebo.

Jefferies analyst Andrew Tsai believes there is a 75% chance the FDA greenlights an expanded label, which would open the door to a much larger marketing opportunity. Tsai projects $1.5 billion to $2 billion in peak sales for Intra-Cellular's drug across schizophrenia and bipolar disorder.

BioMarin's vosoritide for achondroplasia

BioMarin Pharmaceutical sells six drugs for rare diseases. Its seventh, a rare feat of repeat success in biotech, is approved in Europe and could be cleared in the U.S. by late November, when the FDA is expected to reach a decision.

This seventh drug is a bit different than the six that came before it, all of which treat diseases caused by breakdowns in cellular metabolism. Vosoritide, as it's known scientifically, is for achondroplasia, the most common cause of dwarfism. It would be the first drug available for the condition in the states if approved, as it was in Europe when regulators cleared it there in August.

The FDA was set to decide on approval by August, too, but extended its review to go over two-year results that BioMarin submitted from a Phase 3 trial. Those results have shown that treatment with vosoritide led to greater gains in height than a placebo in year two, and position BioMarin well for a positive decision.

But the company has been surprised before, most notably with its Roctavian gene therapy for hemophilia that was unexpectedly rejected by the FDA in August 2020. The regulator is scheduled to issue its verdict by Nov. 20.

If approved, vosoritide would likely be costly. In France, where BioMarin set up an early access plan with regulators, the company is charging roughly $300,000 per patient per year.

https://www.biopharmadive.com/news/5-fda-approval-decisions-fourth-quarter-2021/607550/

Shift treatment of type 2 diabetes to focus on weight loss

 An international panel of experts from four renowned diabetes research centers, including UT Southwestern Medical Center, has reviewed current literature and is recommending a pivotal change in treatment of Type 2 diabetes to focus on obesity first and glucose control second.

"It's known that obesity contributes to the progression of diabetes. What's new is that instead of focusing exclusively on lowering blood sugar, we recommend the primary approach to the treatment of Type 2 diabetes be on the treatment of obesity," said first author Ildiko Lingvay, M.D., M.P.H., M.S.C.S., Professor of Internal Medicine and Population and Data Sciences at UT Southwestern, ranked as one of the nation's top 25 hospitals for diabetes and endocrinology care.

The researchers state that dropping 15% or more of body weight can have a disease-modifying effect in Type 2 diabetes, an outcome that is unattainable by any other glucose-lowering intervention. The new focus would require updating current treatment guidelines and providing significant provider education, they note. The panel's recommendations are published in The Lancet and were presented at the European Association for the Study of Diabetes conference.

The current approach to diabetes treatment relies on clinical studies from the 1980s, which found that lowering blood sugar results in fewer complications from the disease. These early results supported treating blood glucose as the key target, said Dr. Lingvay.

"The problem with this approach is that it doesn't address the core problem and does not offer an opportunity to reverse the disease," said Dr. Lingvay, who leads an active clinical research program in the Division of Endocrinology at UT Southwestern. "We propose using a proactive approach. Let's address the cause of the disease -- obesity."

This latest finding continues Dr. Lingvay's careerlong effort to investigate the best means to provide the most effective clinical care to patients with Type 2 diabetes. As an early-career faculty member in 2005, Dr. Lingvay participated in UT Southwestern's first class of the Clinical & Translational Research Scholars Program, a rigorous multiyear program designed for clinical research fellows and junior faculty who are on track to obtain extramural grant funding and who show great promise toward becoming independently funded investigators. She went on to receive a National Institutes of Health Career Development Award to study the role of pancreatic triglyceride accumulation in beta-cell failure and Type 2 diabetes.

According to the American Diabetes Association, Type 2 diabetes is a progressive disease caused by obesity or by abnormalities in metabolism. More than 10% of the U.S. population has been diagnosed with diabetes, and 1.5 million more are diagnosed each year.

Bariatric surgery can be effective for patients with obesity, but not all patients have access to this option. "It's hard to achieve sustained weight loss. Most lifestyle interventions result in progressive weight loss over six months, followed by a plateau and weight regain over one to three years," added Dr. Lingvay. "New weight loss medications and those in the pipeline will help patients succeed in managing their weight over the long term."

The researchers also stressed the importance of advocating for insurance coverage that supports treatment of obesity and diabetes, and working in public health to increase access to care and reduce disparities.

The authors' disclosures are listed in the manuscript.


Story Source:

Materials provided by UT Southwestern Medical CenterNote: Content may be edited for style and length.


Journal Reference:

  1. Ildiko Lingvay, Priya Sumithran, Ricardo V Cohen, Carel W le Roux. Obesity management as a primary treatment goal for type 2 diabetes: time to reframe the conversationThe Lancet, 2021; DOI: 10.1016/S0140-6736(21)01919-X

AMD: Reading ability crucial indicator of functional loss

 In geographic atrophy, a late form of age-related macular degeneration (AMD), reading ability is closely related to the altered retinal structure. This has been demonstrated by researchers from the Department of Ophthalmology at the University Hospital Bonn with colleagues at the National Eye Institute and the University of Utah. Reading speed makes everyday functional impairment measurable, which the most common functional test in ophthalmology -- the best-corrected visual acuity assessment -- cannot reflect. Retinal imaging can be used to assess loss of reading ability even when central visual acuity is still good. The study has now appeared in JAMA Ophthalmology.

As the proportion of older people grows, the number of patients with geographic atrophy (GA) also increases. This is a late form of age-related macular degeneration. The retinal disease leads to considerable limitations, among other things in reading or recognizing faces. So far it is not treatable. Everyday functional tests are important to assess the success of possible therapeutic approaches. "However, conventional functional tests such as visual acuity do not capture all the dismal functional consequences of the diesease," explains Prof. Dr. Frank G. Holz, Director of the Department of Ophthalmology at the University of Bonn. "Therefore, it is crucial to explore further functional assessments, such as reading performance."

This is where the study initiated by Prof. Monika Fleckenstein comes in, investigating the correlation of reading ability with retinal findings in 85 participants with geographic atrophy. "Especially patients in whom the site of sharpest vision is not yet affected still show good visual acuity in clinical examinations," first author Sandrine Künzel reports from clinical practice at the University Eye Hospital in Bonn. "Nevertheless, they sometimes report severe limitations in their daily life, which also encompass reduced reading ability."

This finding has now been confirmed by the study. Both reading ability and reading speed proved to be important functional tests for clinical therapy studies. In contrast, the suspected phenomenon of "binocular inhibition" -- a negative influence of the worse-seeing eye during reading -- did not show up. Thus, future therapeutic approaches should focus primarily on the better-seeing eye to achieve an overall improvement in visual ability. "We were able to contribute to the understanding of reading ability and its role as a study endpoint," said Priv.-Doz. Dr. Maximilian Pfau of the University Eye Hospital in Bonn, who is currently a fellow of the German Research Foundation (DFG) at the National Eye Institute in Bethesda (USA).

The study was supported by the German Research Foundation (DFG), the German Ophthalmological Society, and the BONFOR program of the Medical Faculty of the University of Bonn.


Story Source:

Materials provided by University of BonnNote: Content may be edited for style and length.


Journal Reference:

  1. Sandrine H. Künzel, Moritz Lindner, Josua Sassen, Philipp T. Möller, Lukas Goerdt, Matthias Schmid, Steffen Schmitz-Valckenberg, Frank G. Holz, Monika Fleckenstein, Maximilian Pfau. Association of Reading Performance in Geographic Atrophy Secondary to Age-Related Macular Degeneration With Visual Function and Structural BiomarkersJAMA Ophthalmology, 2021; DOI: 10.1001/jamaophthalmol.2021.3826

Early accumulation of tau in brain predicts memory decline in Alzheimer’s

 Researchers at Karolinska Institutet in Sweden have compared how well different Alzheimer's biomarkers predict the progression of the disease and its effect on the memory. They found that early accumulation of tau proteins in the brain as measured by PET scanner was more effective at predicting memory impairment than biomarkers in the cerebrospinal fluid or amyloid plaque in the brain. The results are published in the journal Molecular Psychiatry.

Over 50 million people around the world suffer from dementia. Alzheimer's disease is the most common form of dementia and is characterised by an accumulation of the proteins beta-amyloid (Ab) and tau in the brain, followed by a continuous progression in memory decline. The pathological progression can take different forms and it is difficult to predict how quickly the symptoms will develop in any particular individual. Moreover, the presence of Ab in a person's brain -- known as amyloid plaque -- does not necessarily mean that the he or she will develop Alzheimer's dementia.

"There's been a rapid development of different Alzheimer's biomarkers in recent years, enabling us to measure and detect early signs of the disease in patients," says the study's first author Marco Bucci, researcher at the Center for Alzheimer Research, part of the Department of Neurobiology, Care Sciences and Society, Karolinska Institutet. "But we still need to find tests that can predict the development of the disease with greater specificity, so that we can improve not only its diagnosis but also its prognosis and treatment."

Some biomarkers identify accumulations of A? or tau, while others are used to measure the loss of nerve function (neurodegeneration). Protein accumulation and neurodegeneration can be measured in the cerebrospinal fluid (CSF) and plasma, or through brain imaging using positron emission tomography (PET) and magnetic resonance imaging (MRI). Current guidelines for the early detection of Alzheimer's disease with biomarkers endorse the interchangeability of brain imaging methods and analyses of CSF biomarkers (pTau and Ab), but this has been mooted. There is also a lack of longitudinal studies showing how the biomarkers are linked to gradual cognitive impairment.

"Our study shows that the presence of amyloid plaque in the brain and changes in concentrations of Ab and pTau in the CSF can be detected early during the course of the disease, but they do not seem to have any correlation with later memory loss," says Dr Bucci. "However, our results show that the presence of tau in the brain measured by a PET scanner is linked to a rapid decline, especially of the episodic memory, which is often affected at an early stage of the disease. Our observation suggests that tau PET should be recommended for the clinical prognostic assessment of cognitive decline in Alzheimer's patients."

The results are based on brain imaging (PET and MRI) and CSF analyses in a group of 282 participants comprising people with mild cognitive impairment, people with Alzheimer's dementia and healthy controls. 213 of the participants were also monitored for three years with tests of episodic memory (i.e. short term memory related to daily events).

"Our findings show that the concentration of tau in the brain in Alzheimer's disease plays an important part in its pathological progression and may become a key target for future drug treatments," says principal investigator Agneta Nordberg, professor at the Center for Alzheimer Research, Karolinska Institutet.

The study was financed by the Swedish Foundation for Strategic Research, the Swedish Research Council, Region Stockholm, the Swedish Brain Fund, the Swedish Alzheimer's Foundation, the Centre for Innovative Medicine and the Swedish Society for Medical Research. There are no reported conflicts of interest.


Story Source:

Materials provided by Karolinska InstitutetNote: Content may be edited for style and length.


Journal Reference:

  1. Marco Bucci, Konstantinos Chiotis, Agneta Nordberg. Alzheimer’s disease profiled by fluid and imaging markers: tau PET best predicts cognitive declineMolecular Psychiatry, 2021; DOI: 10.1038/s41380-021-01263-2