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SeaSpine warns of COVID-19 hit to surgical revenue

SeaSpine Holdings (NSDQ:SPNE) is the latest medical device maker warning that the SARS-CoV-2 Delta variant wave is hurting its business.

Carlsbad, California–based SeaSpine filed an update for investors with the Securities and Exchange Commission on Friday, citing “ongoing uncertainty regarding the duration and severity of COVID-19 and/or staffing shortages on spine surgery procedure volumes throughout the United States.”

“Throughout the third quarter of 2021, and most acutely starting in August, spine surgery procedure volumes were negatively impacted in many areas of the United States, including in Florida and Texas, where SeaSpine derives a meaningful portion of its revenue, due to cancellations and/or postponements of procedures as a result of the increased cases and transmissibility of COVID-19 and because hospitals and other surgical centers were experiencing staffing shortages,” the company said in the SEC disclosure.

SeaSp…

Medical Alley appoints new CEO

The Medical Alley Association announced today that it appointed Roberta Dressen as its new president & CEO.

Dressen takes over the position previously held by Shaye Mandle since 2014 before he announced his departure for the Biotechnology Innovation Organization (BIO) in February. Steffen Hovard served as interim CEO in the time since then.

Hovard will stay on board over the next several weeks to assist with the transition as Dressen will officially begin her new role next week, according to a news release.

“The Medical Alley Association has a strong reputation of leadership and innovation,” Dressen said in the release. “I look forward to joining MAA and partnering with other global healthcare leaders to find ways to better serve our members and stimulate collaboration around how we can bridge current gaps in the healthcare industry.”

Dressen holds nearly two decades of leadership experience with some of Medical Alley’s notable healthcar…

MedAlliance completes trial enrollment for sirolimus-eluting balloon for treating PAD

MedAlliance announced today that it completed patient enrollment for a trial of its Selution SLR sirolimus drug-eluting balloon.

Geneva, Switzerland-based MedAlliance, along with Japanese partner MDK Medical, completed the enrollment following the acceptance of a Clinical Trial Notification (CTN) by the Pharmaceutical Products and Medical Devices Agency (PMDA) of Japan in June 2020.

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

Fujifilm picks up 10-year contract from U.S. Navy for digital radiography systems

Fujifilm Medical Systems has been awarded a long-term sole-source contract from the U.S. government for its digital radiography (DR) systems.

Lexington, Massachusetts-based Fujifilm confirmed last month that the U.S. Navy and Defense Logistics Agency (DLA) awarded it the 10-year contract to outfit Naval Fleet vessels with its DR x-ray room systems.

Fujifilm’s DR x-ray room systems include next-generation detector technology and a high-quality, compact, floor-mounted room with all of the latest features. The company anticipates the initial DR system delivery and installation will occur for a new U.S. navy ship later this year.

The Navy selected Fujifilm’s DR system on the back of a two-year evaluation and comparison with competitive technologies. The company was selected as the singular vendor that best met or exceeded the Navy’s standards and criteria, it said.

“Fujifilm is honored to be awarded this significant contract from the…

The MedTech Conference by AdvaMed to be a mixture of in-person and virtual

To hold an event or not to hold a live event. Medtech trade association AdvaMed chose both for The Medtech Conference, which takes place next week.

The September 27–30 conference includes a mixture of virtual presentations and in-person events in Washington, D.C., and Minneapolis. AdvaMed CEO Scott Whitaker mentioned several conference agenda highlights during a news conference today:

Former U.S. Secretary of Defense Chuck Hagel will deliver an afternoon keynote on Monday, September 27, in Washington, D.C. CMS’s chief medical officer Dr. Lee Fleisher will discuss his work during a late morning talk on September 27. FDA’s Virtual CDRH Town Hall — a perennial favorite at the conference — will take place virtually on the evening of September 27. The in-person Minneapolis events September 29–30 include a who’s who of medtech CEOs, including Abiomed’s Michael R. Minogue (also the present AdvaMed board chair), Edwards Lifesciences’ Michael…

Pavmed subsidiary Lucid Diagnostics files registration statement for IPO

Pavmed (NSDQ:PAVM) subsidiary Lucid Diagnostics announced that Lucid publicly filed a registration statement related to a proposed initial public offering (IPO).

The number of shares of common stock and the price range for the offering have not yet been determined, according to a news release. Lucid Diagnostics intends to list its common stock on the Nasdaq market under the “LUCD” ticker.

Cantor Fitzgerald & Co. and Canaccord Genuity LLC will act as joint book-running managers for the proposed offering. BTIG, LLC and Needham & Co., LLC will act as co-lead managers for the proposed offering.

In February of this year, PavMed announced that Lucid would spin off into a separate public company “if favorable market conditions continue to hold, whether it be through an initial public offering (IPO) or a business combination with a healthcare special purpose acquisition corporation.”

At the time of announcing the planned sp…

GE Healthcare to acquire BK Medical and its ultrasound portfolio for $1.45B

GE Healthcare (NYSE:GE) announced today that it entered into an agreement to acquire BK Medical for $1.45 billion.

BK Medical develops intraoperative imaging and surgical navigation technology for guiding clinicians during minimally invasive and robotic surgeries, for visualizing deep tissue during procedures in neuro and abdominal surgery and in ultrasound urology, according to a news release.

The company has headquarters in Boston and Copenhagen with more than 650 employees. GE Healthcare said it acquired BK Medical from Altaris Capital Partners and that the company is delivering double-digit revenue growth. The companies expect the transaction to close in 2022.

By acquiring BK Medical, GE Healthcare expects to create value by strengthening the company through what it calls significant synergies with the benefit of GE’s technology and commercial scale.

“Ultrasound today forms an integral part of many care pathways, and BK Medical is a stra…

Former defense chief James Mattis testifies in Elizabeth Holmes federal fraud trial

Former Theranos CEO Elizabeth Holmes leaves after a hearing at a federal court in San Jose, Calif., on July 17, 2019. [Image courtesy of Reuters/Stephen Lam]Former U.S. Secretary of Defense James Mattis testified on Wednesday in Elizabeth Holmes’ federal fraud trial that she misled him into believing the Theranos technology could save the lives of troops in battle.

Four-star Gen. Mattis testified that he first met Holmes in 2011 while still serving in the Marine Corps. where he oversaw troops and the wars in Iraq and Afghanistan. After his retirement from the U.S. in 2013, Mattis joined Theranos’ board of directors and invested $85,000 of his own money into the Silicon Valley startup, according to multiple media reports. He later became the secretary of defense under former President Donald Trump in 2017.

Mattis said that Holmes appeared to be in control of the company and allegedly told board members what to discuss with the press during her time at t…

FDA approves Baxter’s norepinephrine injection for treating low blood pressure

Baxter (NYSE:BAX) announced today that it received FDA approval for its premix norepinephrine bitartrate in 5% dextrose injection.

Deerfield, Illinois-based Baxter launched the norepinephrine injection following the approval for raising blood pressure in adult patients with severe, acute hypotension (low blood pressure).

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

Medtronic’s IP dispute against Axonics could resume in court after PTAB decisions

Medtronic (NYSE:MDT) and Axonics (NSDQ:AXNX) could see their patent dispute over neurostimulation technology resume in court.

Yesterday, the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office affirmed an additional three patents in a long-term dispute between the companies over intellectual property for Medtronic’s Interstim sacral neuromodulation (SNM) system, completing the review process initiated by Axonics to challenge the validity of the seven total patents in the case brought by Medtronic, according to a news release.

“Medtronic appreciates the Patent Trial and Appeal Board’s efforts in this matter,” Medtronic EVP & president of the neuroscience portfolio Brett Wall said in the release. “We are pleased with the outcome of the review process and look forward to our day in court to protect the proprietary technology that brings SNM therapy to patients around the world.”

Following the …

Medtronic enrolls first patient in trial of growth modulation system for treating scoliosis

Medtronic (NYSE:MDT) announced today that it enrolled the first patient in a study for its Braive growth modulation system.

Fridley, Minn.-based Medtronic also completed the first surgical procedure in the BRAIVE investigational device exemption (IDE) study evaluating the safety and effectiveness of the Braive growth modulation system for treating progressive adolescent idiopathic scoliosis.

The first patient was recruited by The Newcastle Upon Tyne Hospitals NHS Foundation Trust, United Kingdom, according to a news release.

Braive uses a braid secured to the spine with screws to slow growth on the curved side of the spine while allowing growth to continue on the other side. The IDE study will evaluate the system’s safety and efficacy in correcting the spine curve in patients with juvenile or adolescent idiopathic scoliosis in the U.S., Canada and UK.

“Launching the BRAIVE IDE study is our latest step in bringing life-changing technolo…

BD says glass prefillable syringes still perform well after deep cold storage

BD (NYSE:BDX) today shared the results from a preliminary study investigating the impact of deep cold storage on glass prefillable syringes.

Franklin Lakes, N.J.-based BD’s study evaluated deep cold storage (-20°C and -40°C) as traditional vaccine formulations are commonly stored up to about 2°C to 8°C, while mRNA vaccine formulations (the type of COVID-19 vaccine made by both Pfizer and Moderna), among other new ones, require much colder storage for over a long period of time to ensure drug-product shelf-life and potency.

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