MassDevice Archives - Page 418 of 587 - Medical Design Sourcing

Unraveling aducanumab’s impact remains a challenge

The FDA’s conditional approval of Biogen’s (NSDQ:BIIB) and Eisai’s (OTCMKTS:ESALY) Alzheimer’s drug aducanumab (Aduhelm) may have been controversial, but the decision will likely have a significant financial impact.

There are 6 million people with Alzheimer’s in the U.S. alone, according to Alzheimer’s Association estimates. Approximately half of those patients have mild symptoms, which is the group most likely to be prescribed the drug.

A significant number of physicians are considering prescribing the intravenous drug for approximately one-third of Alzheimer’s patients with mild cognitive impairment, according to an analysis from Jefferies.

The need for such PET scans could drive an uptick in PET imaging, according to an investor briefing note from UBS.

As a result, Cardinal Health (NYSE:CAH) could be among the beneficiaries of the aducanumab approval as the company’s Nuclear & Precision Health Solutions division has a significant reach acro…

Fractyl raises $100M for diabetes reversal tech, renamed as Fractyl Health

Fractyl Labs today announced the closing of a $100 million Series F financing round in addition to a name change to Fractyl Health.

Lexington, Mass.-based Fractyl Health received contributions to the round from new investors Maverick Capital, M28 Capital and Population Health Partners, while other new and existing investors participated, too.

Get the full story at our sister site, Drug Delivery Business News.

3 things medical device companies should know about the Patent Trial and Appeal Board

With nearly a decade of proceedings behind it, the Patent Trial and Appeal Board (PTAB) has established a record. Medtech companies can learn from it.

Timothy P. McAnulty and Daniel F. Klodowski, Finnegan

One of the key aspects of a strong patent is the owner’s ability to enforce it. And when a patent is asserted against an accused infringer in court, two core issues always arise: whether the patent is infringed, and whether it is valid. Because there can be no infringement if the patent is not valid, attacking a patent as invalid (or “unpatentable”) is one of the primary defenses for every alleged infringer.

Patent validity can be challenged in several forums, including in court as part of an infringement litigation. It’s also possible to challenge validity through various “post-grant” procedures at the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB). The PTAB was created in 2012 and has become a popular forum, receiving over 10…

FDA approves Stratatech’s StrataGraft skin graft

Mallinckrodt‘s (NYSE: MNK) Stratatech today received FDA approval for its StrataGraft for treating adult patients with thermal burns.

The Bedminister, N.J.-based company designed StrataGraft to treat thermal burns that have intact dermal elements, or remaining deep skin layers, for which surgical intervention is clinically indicated.

“Serious burns can be an incredibly difficult injury to treat and can adversely affect more than just the skin. The goal of burn management is to help the patient return to the highest level of functionality and independence possible while improving the overall quality of life,” Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, said in a news release. “This approval provides health care professionals a novel way to treat burn wounds.”

The gold standard treatment for many deep burns involves removing damaged, burned skin and replacing it with a skin graft. Skin grafts are often taken from the patien…

MedTech Innovator selects 50 startups for showcase and accelerator program

MedTech Innovator today revealed the 50 startups it selected to partake in its flagship showcase and accelerator program.

The four-month program offers the startups visibility and access to leading manufacturers, providers, investors and other industry stakeholders, with up to $500,000 available in cash and in-kind prizes during the final competition at The MedTech Conference, powered by AdvaMed.

Get the full story at our sister site, Medical Design & Outsourcing.

Frequency Therapeutics faces growing legal challenges

Hearing loss drug developer Frequency Therapeutics (NASDAQ: FREQ) is the subject of a growing number of security fraud accusations on behalf of investors.

Earlier this year, things were looking up for the company’s lead product candidate, FX-322. But on March 23, Frequency Therapeutics announced that interim results suggested that FX-322 was not effective at improving mild to moderately severe sensorineural hearing loss in a Phase 2a study compared to placebo. Previous results from a smaller study had been more positive.

The company’s stock fell from a high of $55.01 on Feb. 19 to $9.55 in mid-day trading on June 15.

Get the full story from our sister site, Drug Discovery & Development.

VoluMetrix’s venous waveform monitor wins FDA breakthrough designation

[Image from VoluMetrix]VoluMetrix announced today that it received FDA breakthrough device designation for its NIVA HF venous waveform monitor.

Nashville, Tenn.–based VoluMetrix designed the investigational NIVA HF device to monitor the venous waveform, a novel physiologic signal in heart failure patients, through its non-invasive venous waveform analysis (NIVA) technology.

According to a news release, a fast-track grant from the National Institutes of Health (NIH) supports the development of NIVA HF, which is currently being prepared for FDA de novo regulatory clearance.

NIVA technology represents a way to optimize hemodynamic assessment through signal capture with a non-invasive wrist sensor, signal deconstruction and signal decoding, VoluMetrix said. NIVA HF provides a proprietary NIVA score that corresponds to a pulmonary capillary wedge pressure (PCWP), a value that can only be obtained through invasive catheterization of the heart and vasculature at p…

How Abbott engineered a catheter-delivered device for premature babies

Abbott’s experience designing its Piccolo device provides essential lessons for medical device creators who want to spark a pediatric medical device renaissance.

The Amplatzer Piccolo occluder from Abbott is one of the first medical devices that health providers can implant in premature babies weighing as little as 2 lb to treat patent ductus arteriosus (PDA) in a minimally invasive way.

PDA is an opening between two blood vessels leading from the heart. It is one of the most common congenital heart defects in premature babies and accounts for up to 10% of all congenital heart diseases.

Approved by FDA in early 2019, Piccolo is a self-expanding, wire mesh, catheter-deployed device inserted through a small incision in the leg and guided through vessels to the heart, according to Abbott. The Abbott Park, Ill.–based medtech giant designed Piccolo to allow a physician to insert it through the aortic or pulmonary artery with the ability to retrieve and redepl…

Former FDA commissioner Hahn to join VC behind Moderna

Flagship Pioneering announced that former FDA commissioner Dr. Stephen Hahn will lead its Preemptive Medicine & Health Security initiative.

A “bioinnovation platform company,” Flagship Pioneering has originated and fostered more than 100 scientific ventures totaling more than $90 billion in aggregate value, according to the company.

Get the full story at our sister site, Drug Discovery & Development.

Invo Bioscience names chief financial officer

Invo Bioscience (OTCQB:IVOB) today announced that it has appointed Andrea Goren as chief financial officer.

Goren has more than 27 years of experience in finance. He has held a number of leadership roles at Phoenix Group, Shamrock Group and Madison Capital Group.

“We are pleased to appoint a financial executive the caliber of Andrea Goren as chief financial officer of INVO Bioscience. Andrea has been serving INVO over the past year in a consulting capacity and thus is familiar with the operations of the company, including many within the finance function,” CEO Steve Shum said in a news release. “As he takes over as our permanent CFO, he will continue to interface with our current outside CFO consulting firm to assure a seamless transition. His well-rounded skill set will benefit INVO as we continue to successfully execute on our strategic business plan, including the operational launch of our various company-owned INVO clinics set for the seco…

MedinCell to begin regulatory development of long-acting injectable malaria treatment

MedinCell announced that its long-acting injectable malaria treatment is ready to enter into the stages of regulatory development.

Montpellier, France-based MedinCell conducted an in vivo proof of concept on cattle that demonstrated three-month mosquitocidal effectiveness in the injectable, long-acting formulation of Ivermectin using the company’s BEPO delivery technology.

Get the full story at our sister site, Drug Delivery Business News.

Novavax’s COVID-19 vaccine demonstrates 90% efficacy

Novavax (NSDQ:NVAX) announced today that its COVID-19 vaccine demonstrated 90.4% efficacy in protecting against COVID-19.

Gaithersburg, Md.–based Novavax’s recombinant nanoparticle protein-based COVID-19 vaccine demonstrated 100% protection against moderate and severe disease, with 90.4% efficacy overall as it met the primary endpoint in the Prevent-19 pivotal Phase 3 trial.

Get the full story at our sister site, Drug Discovery & Development.