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VIDEO OF THE WEEK
What Abbott’s Big FDA Approval Means for the Tricuspid Device Market
U.S. patients suffering from a leaky tricuspid valve now have a new treatment option.
U.S. patients suffering from a leaky tricuspid valve, or tricuspid regurgitation (TR), have more treatment options than ever before, thanks to two significant FDA approvals.
FDA has approved Abbott’s TriClip transcatheter edge-to-edge repair (TEER) system for the treatment of TR.
TriClip leverages the same clip-based technology as Abbott's MitraClip device , which is designed to treat leaky mitral valves (mitral regurgitation), but the company specifically designed TriClip to treat the tricuspid valve's complex anatomy. This approval comes just two months after FDA approved Edwards Lifesciences’ Evoque transcatheter tricuspid valve replacement (TTVR) for the treatment of eligible patients with TR.
The TriClip approval was not a surprise, given that an advisory committee panel in February determined that the device is safe by a vote of 14-0, effective by a vote of 12-2, and that the benefits of TriClip outweigh the risks by a vote of 13 to 1.
Delivered through a vein in the leg, TriClip's?TEER technology is designed to clip together a portion of the leaflets (flaps of tissue) to repair the tricuspid valve and help blood flow in the right direction without the need for open-heart surgery. On average, the procedure requires just one day in the hospital, Abbott noted.
Findings from the TRILUMINATE pivotal trial supported FDA approval of the TriClip. The randomized, controlled clinical study was designed to evaluate the safety and effectiveness of the device compared to medical therapy in people with severe TR who are at intermediate or greater risk for open-heart surgery. In the trial, 90% of patients who received the TriClip experienced a marked improvement in their TR grade, reducing from severe or higher to moderate or less at 30 days – a reduction that was sustained at one year. The trial also demonstrated a highly favorable safety profile, with 98% of patients being free of major adverse events through 30 days, and a significant improvement in quality of life.
“The U.S. approval of TriClip is a significant advancement for people suffering from tricuspid regurgitation, a heart condition that negatively impacts their quality of life and puts them at grave risk of serious health issues," said?Paul Sorajja, MD, co-principal investigator of the TRILUMINATE trial.
Sorajja is the Roger L. and Lynn C. Headrick Family Chair of the valve science center for the Minneapolis Heart Institute Foundation and director of the center for valve and structural heart disease for the Minneapolis Heart Institute at Abbott Northwestern Hospital.
“With TriClip, physicians can offer patients a therapy option backed by excellent safety and effectiveness to help restore tricuspid native valve performance without subjecting them to high-risk open-heart surgery that may not be feasible for individuals with TR who are generally older and sicker,” Sorajja said.
For people who continue to have symptoms or persistent TR despite treatment with medical therapy and are not considered good candidates for surgery, TriClip represents an option that can improve their quality of life, according to Abbott.
“This approval helps address a treatment gap for people with tricuspid regurgitation who previously had few options to treat a disease that adversely impacted their daily lives and could lead to other deadly conditions,"?said Sandra Lesenfants, senior vice president of Abbott's structural heart business. "With the addition of TriClip to our broad structural heart therapy offerings in the U.S., we are continuing to bring meaningful, life-enhancing benefits to patients with cardiovascular conditions."
TriClip has been approved for use in more than 50 countries, including in?Europe and?Canada, since its initial CE mark approval in 2020.
Marie Thibault, a medtech analyst at BTIG, noted that Abbott had applied for a new technology add-on payment (NTAP) under the acute inpatient prospective payment system for fiscal year 2025.
“Because the FDA approved the device before May 1, we think this means it will be eligible for the NTAP to go into effect on October 1,” Thibault wrote in a report this week. “This is a positive update, and we expect TriClip to be gradually adopted over time given the favorable pivotal data, unmet patient need, and [Abbott’s] commercial footprint in structural heart solutions.”
The analyst estimates that TriClip sales from outside the United States contributed about $100 million in revenue in fiscal year 2023.
Is quality-of-life benefit enough to make TriClip successful?
Analyst questions during previous Edwards’ earnings calls suggest that physicians may lean in on TTVR as opposed to TEER.
“This is a market we hear [about] from doctors a lot,” Robbie Marcus, a J.P. Morgan medtech analyst, said during Edwards’ third-quarter earnings call last October. “They may not be terribly excited about repair, but replacement could be a really exciting option.”
A question from Larry Biegelsen, a senior medtech analyst at Wells Fargo, during an Edwards earnings call last July raised further questions about replacement versus repair in the tricuspid valve.
“What would success look like to you, given the TRILUMINATE results showed only a quality-of-life benefit, but no positive trends on hard outcomes?” Biegelsen asked Edwards Lifesciences CEO Bernard Zovighian.
Zovighian struggled with Biegelsen's question, noting that TRILUMINATE evaluated a different technology, given that it's a TEER device rather than a transcatheter tricuspid valve replacement device. "So,?it's very tough to comment on that, but I have to say that quality-of-life is super important for patients."
Daveen Chopra, Edwards’ corporate vice president of transcatheter mitral and tricuspid therapies made an interesting point, however.
"For us, I'm actually pretty excited by what we've seen actually previously with TRILUMINATE. It helps?confirm outcomes that have come from other studies with TEER technologies that we have on PASCAL device, that?TEER in tricuspid delivers great [TR] reduction with meaningful quality-of-life improvements and, we are excited to see randomized data," Chopra said. "So, to me, these are all great positive tailwinds in tricuspid ...”
J&J Puts the Rumors to Bed & Moves to Acquire Shockwave
The New Brunswick, NJ-based company could strengthen its position in the cardiovascular intervention market with this $13.1 billion acquisition.
By Omar Ford
Johnson & Johnson is acquiring Shockwave Medical for $13.1 billion after rumors of the potential deal surfaced late last month .
The deal extends J&J MedTech’s position in the cardiovascular intervention market and follows the company’s acquisitions of Abiomed, a specialist in heart recovery, and Laminar an innovator in left atrial appendage elimination for patients with non-valvular atrial fibrillation (AFib).
Plans call for J&J to acquire Shockwave for $335 per share and the companies are aiming for the deal to close by mid-2024.
Shockwave, which has long been among the 25 Most Attractive Medtech M&A Targets , has developed an intravascular lithotripsy (IVL) technology that uses shockwaves to crack calcium within the vessel wall, thus enabling arteries to expand under low pressure and become more compliant. ???
Joaquin Duato, chairman and CEO of J&J said the company was ‘energized’ by the proposed acquisition during a call discussing the transaction details. Duato spoke about how Shockwave could potentially boost previous acquisitions.
“The proposed acquisition extends the breadth of our capabilities and the depth of our cardiovascular portfolio,” Duato said during the call.? “In fact, Shockwave’s IVL technology is complimentary to Abiomed’s heart recovery platform. The acquisition of Shockwave together with Abiomed and Laminar compliments J&J’s established global leadership position in electrophysiology through Biosense Webster, building a highly differentiated cardiovascular portfolio.”
Related:Top Medical Device M&A
Following the completion of the transaction, Shockwave will operate as a business unit within Johnson & Johnson MedTech, and financials will be reported within Johnson & Johnson MedTech’s Cardiovascular portfolio, which was previously referred to as Interventional Solutions.
In addition to his current responsibilities for Abiomed as the Global Head of Heart Recovery, Michael Bodner will assume responsibility for the business upon close. Isaac Zacharias, who has six years with Shockwave, most recently serving as President and Chief Commercial Officer, will transition to become Worldwide President of Shockwave, reporting to Michael Bodner.?Doug Godshall, Shockwave’s president and CEO,?will advise through the transition.
“As part of a larger, more diverse organization, with broad expertise and a core focus on improving patient outcomes, we are confident we will be able to further solidify IVL as the global standard of care for patients,” Godshall, said in a release. “I am deeply grateful to our team members and colleagues whose efforts have made today’s milestone possible; their accomplishments and passion have been extraordinary. I could not think of a better partner and home than J&J as the Shockwave team prepares to write its next exciting chapter.”?
领英推荐
Is M&A on the Rebound in the Medical Device Industry?
The deal marks one of the largest medtech acquisitions in 2024. It also reinvigorates the medtech sector which had sluggish M&A activity in 2023 .
The only other transaction that is close to the Shockwave deal is Boston Scientific’s proposed acquisition of Axonics – valued at $3.7 billion.
As for J&J, there could be more M&A on the horizon. During the call, questions came on whether or not the company would be involved in more M&A to boost its medtech offerings.
Company executives noted that a strong cash flow and a strong balance sheet give it flexibility in considering M&A.
“We have the financial flexibility to do all types of transactions and we are agnostic to sectors,” Duato said. “When it comes to the type of transactions as we have done in the last couple of years, sometimes we go to established platforms like in this case and sometimes we go to earlier technologies like we did with Lamina.”
Hologic to Shutter Undisclosed Number of International Facilities
The announcement comes after company CFO recently told the Wall Street Journal that Hologic operates under a “philosophy that mass layoffs are a failure of leadership.”
By Katie Hobbins , Managing Editor
Hologic recently outlined changes in its quarterly Form 10-Q filed with the SEC, writing that it plans to close an unspecified number of international facilities within its diagnostic division amid product discontinuations and restructuring. In the regulatory filing, the company did not disclose how many employees will be affected by the shutdowns, but said it expects to incur about $4 million to $8 million in severance costs related to the actions. Additionally, the medtech company said it is in discussions with works councils — bodies that represent employees in many European countries — connected to its restructuring efforts.
Hologic also “recorded accelerated depreciation of $7.2 million and a lease asset impairment charge of $12.5 million” in its fiscal first quarter as a result of its strategy changes, according to the filing.
Like many companies who offer diagnostic products, Hologic has seen noted decreases in revenue since the COVID-19 pandemic waned. In the first quarter, the company reported its total diagnostic revenue was down 20%. However, company spokesperson Bridget Perry told Medtech Dive, who originally reported the story, that “The international activity is not connected to COVID revenue.”
Hologic wrote in the SEC filing that “This action is expected to be completed by the end of calendar 2024.”
The news of the international closures and possible layoffs come not long after Hologic CFO Karleen Oberton recently scolded executives enacting layoffs in the medtech industry, telling The Wall Street Journal that the company has avoided these actions by carefully managing its hiring. Additionally, Oberton told the journal that, even before the COVID-19 pandemic, Hologic operated under a “philosophy that mass layoffs are a failure of leadership.”
Hologic did not respond to MD+DI’s request for comment.
Beyond Science: Convincing Your Way to Commercialization
In the world of medtech, the journey from a groundbreaking idea to a marketable product is not always straightforward.
By Scott Nelson , Co-founder and CEO
As the co-founder and CEO of FastWave Medical and the founder of Medsider, I've had the privilege of engaging with some of the most impressive entrepreneurs in the space . Through these conversations, one clear trend has emerged: successfully convincing a variety of stakeholders in a complex and competitive market is absolutely critical.
In this article, I bring together the wisdom and strategies of five medtech trailblazers, each of whom has successfully navigated the intricate path of turning their visions into viable, market-ready products, and have, along the way, converted regulators, capital partners, and end-users to support their ventures.
Talk to more people than you think
Armed with a PhD in Biomedical Engineering from UCLA, Shyam Natarajan started his career as an academic and worked as a post-doctoral scholar in UCLA's Department of Surgery, focusing on minimally-invasive surgical interventions.
While working on prostate cancer research, Natarajan saw a possibility to enhance disease diagnostics by combining advanced artificial intelligence (AI) with imaging technologies. He soon decided to move beyond academia to pursue this opportunity and founded Avenda Health . Today, Avenda is developing Unfold AI, a platform technology that offers a personalized, color-guided 3D map that shows how far cancer has extended within the prostate, enabling the physician to see the full picture and make better decisions.
Natarajan’s journey wasn’t a leap of faith. Even though he’s an expert with a PhD related to prostate cancer, he conducted around 20 interviews per week during the early days of Avenda to widen his perspective.
“Just because you've spotted a problem, you don't necessarily know at first blush if it's a widespread problem or if it's tangled in technology, clinical workflow, or reimbursement,” he said.
That’s why Natarajan prefers showing rather than telling. “It's all about proving out the concept, and then getting to the next stage,” he said.
His team developed a basic prototype that served as tangible proof of his concept’s viability and potential impact, as well as the foundation for gathering evidence and making informed decisions on whether to proceed further with the project.
Nail your narrative
Cecile Brosset Dubois transitioned from strategic roles at esteemed firms like Bain & Company to the cutting-edge world of medtech startups by co-founding Sonio . Her company is developing AI software that empowers ultrasound specialists to conduct more effective prenatal screenings and aids experts in fetal diagnosis.
“I had an ambitious vision building this full platform, but I think people didn't always understand that or didn't always think we could do that,” Brosset Dubois said.
Her ability to articulate her vision in a compelling and engaging way has been as crucial to her success as the innovative idea behind Sonio itself.
Under her leadership, Sonio has achieved significant funding milestones, raising €5 million in pre-seed, €10 million with the EIC Accelerator, and then €13 million in their Series A round. These challenges taught Brosset Dubois that it’s not just what you communicate, but how you communicate.
In other words, how you tell your story really matters. Different investors have different interests and concerns, so she tailors her pitches to resonate specifically with each group. "It wasn't about changing the reality but about framing our story to align with their priorities so that they feel comfortable investing,” she said.
Lastly, but maybe most importantly, rehearse your pitch as many times as possible. Seek input from mentors, people who can help you view your project through the lens of potential investors. “You have to talk to a lot of people to really nail your narrative before you actually start pitching the fancy VCs,” Brosset Dubois advised.
Find creative ways to validate your tech
Kelly Roman , a Harvard graduate with a major in English, has charted an unconventional course. When he co-authored a graphic novel adaptation of Sun Tzu's "The Art of War" the lens through which he saw the world shifted to a warrior’s — or an entrepreneur’s — mindset. He then went on to co-found Fisher Wallace Labs with a tech-savvy friend. That’s where Kelly is now, at the forefront of wearable brain stimulation technology, working to alleviate the hardships and stigma around mental health treatments through neuromodulation.
Under Roman’s leadership, Fisher Wallace has successfully navigated FDA and fundraising, mainly thanks to adaptive thinking and resourcefulness. Their latest product, Oak, is as an investigational device, which allows them to use it for clinical studies or pilot research programs prior to final FDA approval — as long as there's informed consent and monitoring. “We were able to collect data and demonstrate that a partner like the Seattle Police Department can adopt it if they think it's valuable,” he said. “It's real-world evidence, outside of the lab.”
Traditional funding methods are not the only way to raise capital. Thanks to its user base, Fisher Wallace was able to take a different approach to capital raising — crowdfunding — and close the round successfully.
To take a leaf from Roman’s book, look beyond standard clinical trials to gather valuable data. By engaging with real-world users in pilot programs, you can collect practical feedback and enhance product validation. If you have an existing customer base, like Fisher Wallace did, use it to your advantage. Engaging with these users for feedback, validation, and even crowdfunding, can provide a solid foundation for further expansion.
Don’t forget the human element
Patricia Zilliox , a veteran in the field of ophthalmology with over 30 years at Alcon, now spearheads Eyevensys , a startup developing an innovative device designed to inject DNA plasmids into the ciliary muscle.
Zilliox's experience has taught her the importance of empathy and the human element in medical innovation, especially when it comes to sensitive areas like the eye. She reminds us that effective treatment goes beyond scientific innovation; you have to consider the patient's comfort and willingness to undergo the procedure.
For instance, she said, “If you have a treatment that you know is going to work, but [the patient would] have to have an injection in the eye every day, forget about [it], it’s not going to work.”
Successful medical treatments must be as user-friendly as much as they are scientifically sound, to ensure that patients are willing and able to benefit from them.
Keep your investors close and end-users closer
Eugene Malinskiy , a serial entrepreneur, made a shift from IT to the world of medtech startups by founding Lazurite . When he saw a physician's assistant tripping over surgical camera wires, he knew this field was in dire need of innovation. Recognizing the cumbersome nature of wired camera systems in surgeries, lazurite developed its flagship product, ArthroFree, the first wireless camera system for minimally invasive surgery to ever receive FDA clearance.
Central to Malinskiy's strategy was his early and consistent engagement with surgeons. For example, during the early development phases of ArthroFree, he actively sought their input, taking care to understand their specific needs and preferences. His collaboration with surgeons was obviously pivotal in fine-tuning the device's design. But something less obvious also happened: the surgeons were so on board with the idea they turned into investors.
Keeping in touch with your investors and end users is critical, and Malinskiy was able to do both in one stroke. “As I developed the product over the years, I kept going back and talking to those surgeons: ‘What’s your market? How much would you pay for it? Who’s on your team? How are the decisions being made? For you as a surgeon, if I got rid of these cables, would this matter?’ And they provided me with a lot of input, which I then incorporated,” he said. “I was able to use those surgeon-investors to help build and create a very nice product.”
This strategy proved to be a masterstroke: it provided both capital and continuous feedback, thereby shaping ArthroFree into a product that’s completely aligned with user needs. The surgeons on the board also helped attract more sophisticated investors during Lazurite's Series B financing stage.
Destination: market adoption
Advancing your startup to its next inflection point requires a solid understanding of the domain and the creativity to validate and fund your product, mastering the art of pitching to different stakeholders, and most importantly, never losing sight of the human element.
Here are some closing nuggets of wisdom from these inspiring medtech entrepreneurs:
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