More device shortages pegged to sterilization plant shutdown

Cardinal Health’s Accu-Trace intrauterine pressure catheter (Image from Cardinal Health)

More medtech companies are experiencing shortages of medical devices due to the sudden closure in February of a Sterigenics sterilization plant.

Officials from Cardinal Health (NYSE:CAH), and Guerbet (EPA:GBT) have written letters to customers indicating that certain devices are already in short supply or may experience shortages, Medical Device & Outsourcing has learned.

The letter from Cardinal Health (Dublin, Ohio) said that the company expects a shortage of its Kendall Accu-Trace intrauterine pressure catheter until early August. This device is placed inside a pregnant woman’s uterus to monitor uterine contractions during labor. The letter from Guerbet (Villepinte, France) said that disposable power injectors used with its Optistar, Optivantage and Illumena contrast delivery systems may experience shortages. Officials from those companies did not immediately respond to requests for comment.

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

EO plant shutdown leads to pediatric breathing tube shortage

Smiths Medical Bivona tracheostomy tubes are in short supply, according to the FDA. (Image from Smiths Medical)

The February shutdown of an ethylene oxide (EO) sterilization plant has produced the first temporary medical device shortage, according to the FDA.

The device in short supply is the Bivona tracheostomy tube manufactured by Smiths Medical and used by many pediatric patients. The FDA anticipates the tube will be made available again the week of April 22, according to a statement from Dr. Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health (CDRH). The state of Illinois ordered the shutdown of the Sterigenics plant in Willowbrook, Ill. due to emissions of EO, a highly carcinogenic chemical compound.

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

NuVasive launches X360 lateral single-position surgery device

NuVasive Inc. (NSDQ:NUVA) said yesterday that it launched its X360 system intended for lateral single-position surgery in the U.S.

The newly launched X360 system features improvements intended to accommodate advanced techniques and technologies for enhanced operating room workflow and efficiency, the San Diego-based company said.

The system also features integration with NuVasive’s Pulse surgical automation platform to allow surgeons to perform multiple procedures from the lateral position.

“X360 has transformed my approach to treating patients, allowing me to customize my surgical workflow, reduce patient anesthesia time, and efficiently treat the patient in a single, lateral position. Integrating planning, imaging, navigation, and automation throughout this entire surgical approach has become an integral component to the clinical outcomes of my patients,” Dr. Anand Veeravagu of Stanford University Medical Center said in a prepared statement.

NuVasive touted that because the system allows surgery to be performed without repositioning, it can reduce operating times by up to 60 minutes, saving hospitals on average of approximately $5,000 per patient.

“The X360 system is the most comprehensive approach to lateral single-position surgery available on the market. NuVasive continues to extend its global leadership position in lateral surgery with the integration of X360 and Pulse, the only surgical automation platform designed for spine surgery. By incorporating Pulse and, in the future, robotic automation, with X360, we are enhancing the overall OR workflow and helping surgeons deliver greater clinical predictability and reproducible outcomes for their patients,” NuVasive prez Matt Link said in a press release.

In February, NuVasive said that it won FDA 510(k) clearance and CE Mark clearance in the European Union for its Precice bone transport system.

Stryker wins FDA PMA, launches Lifepak CR2 AED


Stryker (NYSE:SYK) said yesterday that it launched its Lifepak CR2 defibrillator featuring the LifelinkCentral AED program manager after winning FDA premarket approval for the system.

The newly launched Lifepak CR2 AED features new technology including CPRInsight, which allows users to continue chest compressions during ECG analysis and can improve survival outcomes, the Kalamazoo, Mich.-based company said.

The Lifepak CR2 AED also features a child mode button to reduce defibrillation energy for pediatric patients and an optional bilingual feature.

The system can be connected to the LifelinkCentral AED program manager to allow an organizations AED manager to remotely monitor and manage the device to improve readiness, Stryker said.

“In order to save more lives from sudden cardiac arrest, we must save time. The Lifepak CR2 is designed to help rescuers provide higher quality CPR and to provide the fastest first shock when defibrillation is needed. Everything about it is designed to increase user confidence. The Lifepak CR2 harnesses the benefits of connectivity to provide a foundation for better care throughout the entire chain of survival and to simplify AED program management for our customers,” Stryker emergency care public access GM Ryan Landon said in a press release.

The Lifepak CR2 was previously released in Europe and Canada in 2017 and in Japan in 2018, Stryker said.

In March, Stryker said that it put $220 million on the table for OrthoSpace and its InSpace rotator cuff repair device.

TissueTech raises $55m


TissueTech has raised approximately $55.3 million in a new round of equity financing, according to a recently posed SEC filing.

The Doral, Fla.-based company makes amniotic membrane- and umbilical cord-based products designed to treat ocular surface diseases (its Bio-Tissue subsidiary) and musculoskeletal conditions and wound care (its Amniox Medical business).

Money in the round came from three unnamed investors, with the first sale dated as having occurred on April 9, according to the filing.

The company is looking to raise an additional $27 million, which would bring the total raised up to approximately $82.3 million, according to the SEC filing.

TissueTech said that it plans to use a $10 million of the proceeds to repurchase from common stockholders on a pro rata basis, according to the SEC filing.

The company has not yet announced any other plans for the funds.

Philips to private-label Demant hearing aids

Demant, Philips

William Demant (CPH:WDH) said this week that it inked a deal to market its line of hearing aid devices under Royal Philips (NYSE:PHG) brand.

Denmark-based Demant said that Amsterdam-based Philips will offer a complete range of hearing aids, accessories and applications under the Philips HearLink brand

“Based on a shared vision of improving the lives of people through innovative healthcare this new cooperation will not only change the way we see hearing healthcare, but also widen the definition of hearing healthcare, supporting healthier lifestyles and active aging. Combining Demant’s world-leading hearing aid technology with Philips’ global brand presence in healthcare, the cooperation will enrich the hearing healthcare experience,” Philips brand licensing senior director Spencer Ramsey said in a prepared statement.

The companies said that the HearLink devices can be connected to other devices, including smartphones and televisions, and that the products are available now.

“The Philips hearing aids will provide users with an innovative, future-proof hearing solution. We live in an age where user engagement and digital services are shaping the future of healthcare technology. More and more people are conscious of taking control of their own personal healthcare and are using electronic devices to do so. In this light, Philips hearing solutions offers new and exciting premium solutions alongside Philips’ healthcare ecosytem, which will attract interest and generate significant benefits to users, ultimately supporting our valued customer base of hearing care professionals. With this partnership, we take connected hearing healthcare to the next level and offer new and exciting solutions within integrated healthcare services to the benefit of both professionals and people suffering from a hearing loss. Health, caring and innovation are cornerstones in the vision of both Demant and Philips, which makes the partnership a great match for the future. Furthermore, it will strengthen and add value to both companies’ ambition to improve people’s lives,” Demant prez & CEO Søren Nielsen said in a press release.

Earlier this month, Philips won a $450 million contract to supply the U.S. Department of Defense with patient monitoring systems, accessories and training.

Ajax Health raises $85m for medtech investment

Ajax Health

Ajax Health, the company formed in 2017 by a pair of private equity giants to manage their medical device investments, said today that it has raised more than $85 million to help fund operations and expansions of select medical device companies.

The round was led by HealthQuest Capital and joined by Aisling Capital and Polaris Partners, the Menlo Park, Calif.-based company said.

“Ajax Health approaches medical device innovation in a novel way, applying best-in-class strategies to pinpoint technologies with the greatest opportunity to take off, then rapidly developing them into a fully integrated business. Ajax Health’s proven executive team, led by Duke Rohlen, Doug Koo and Aftab Kherani, has shown an exceptional ability to develop medical technologies successfully and cost efficiently,” HealthQuest founder & managing partner Dr. Garheng Kong said in a prepared statement.

Ajax Health said that it will seek to invest in companies with disruptive medtech devices with its newly raised funds, focusing on businesses with a potential for high-exit demand where returns could be realized within 48 months.

“I am extremely grateful to our partners HealthQuest, Aisling and Polaris for backing Ajax II. These firms have been exceptional partners for a long time and I look forward to working with them again,” Ajax Health chair & CEO Duke Rohlen said in a press release.

In May 2017 KKR and Aisling Capital joined to launch Ajax, tapping Spirox chairman & CEO Rohlen to lead it. Rohlen is the former president of FoxHollow Technologies and the founder & former chief executive of CV Ingenuity.

Last July, Ajax said that it raised a Series B round of $120 million.

Synaptive Medical raises $5m

Synaptive Medical

Synaptive Medical has raised approximately $5 million in a new round of debt and options financing, according to a recently posted SEC filing.

The Toronto-based company has not yet stated how it plans to spend funds raised in the round.

Synaptive Medical produces medical devices intended to facilitate surgical planning, navigation, robotic automation, digital microscopy and informatics through an interconnected platform, according to its website.

Money in the round came from a single unnamed investor, according to the filing, with the first date of sale noted as having occurred on March 26.

Last month, Synaptive Medical said that it named Sandra Clarke as its new finance chief.

Ex-MiMedx CEO Petit mounts proxy war


MiMedx (NSDQ:MDXG) is facing a proxy battle being led by former CEO Parker Petit, who was ousted last July “for cause”, according to a recently posted SEC filing.

The ex chief-exec nominated himself alongside former Pulte Home Corp tax director David Furstenburger and George & Lorenson partner Shawn George as candidates for the company’s board of directors, set to be elected at an upcoming shareholder’s meeting.

Petit said that he believes that the current MiMedx board has “failed shareholders with disappointing performance, failure to ensure competent leadership and lack of engagement with MiMedx shareholders.” He added that he “felt compelled to launch a contest seeking changes on the board,” according to the filing.

“In my opinion, the current board has done a major disservice to MiMedx’s shareholders and there is no sign the board has the ability, judgment or commitment to return MiMedx to its former growth and profitability as a NASDAQ listed company. Shareholders have been left in the dark while the company’s value has significantly dropped. I could no longer sit on the sidelines. Together with Shawn and David, we, if elected, will bring a wealth of experience working on and resolving expeditiously highly contentious and complicated matters. I believe that our slate of candidates will instill the much needed accountability and reason in the boardroom that MiMedx is now lacking, while supporting its valuable employees and expanding its best in class intellectual property patents,” Petit said, according to the SEC filing.

MiMedx faced a number of troubles last year, including the ouster of Petit and president & COO William Taylor amid a board-directed independent investigation that had already prompted the departure of CFO Michael Senken and treasurer John Cranston in June.

At the time, MiMedx said it would restate all of its earnings reports going back to 2012 and was cooperating with U.S. Securities & Exchange Commission and Justice Dept. investigations into the matter.

The company later said that all four executives’ departures were for cause, triggering the forfeit of all equity and incentive awards for the executives and Petit’s resignation from the board. Petit and Taylor denied the allegations in a statement from their lawyer.

In December, the accounting firm tapped to audit MiMedx’s books resigned in the wake of the financial issues the company faced.

5 digital health startups you need to watch in 2019

(Image from Unsplash)

Funding for digital health companies continues to rise, with 2018 the biggest year so far this decade, according to healthcare investment firm StartUp Health. Investors took a greater interest in machine learning, blockchain and artificial intelligence (AI).

Digital health funding was 14 times greater than it was eight years ago, when New York-based StartUp Health began tracking these investments. From 2017 to 2018, the average deal size grew by $6 million. Machine learning companies cut 66 deals to raise $940 million, an 80% increase in funding compared to 2017. Patient empowerment received the most funding of any function in 2018, $3 billion across 193 deals.

Here are five of the up-and-coming digital health companies to watch in 2019:

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