Abbott gets FDA nod for Infinity DBS in Parkinson’s disease, unveils positive data on Proclaim XR
Abbott Laboratories had a winning week, scoring U.S. FDA approval of its Infinity directional deep brain stimulation (DBS) system in treating symptoms of Parkinson’s disease not adequately managed by medication. The company also reported new data underscoring the benefits of its Proclaim XR neuromodulation system in people living with chronic pain at the North American Neuromodulation Society (NANS) conference.

Abbott gets FDA nod for Infinity DBS in Parkinson’s disease, unveils positive data on Proclaim XR
Abbott Laboratories had a winning week, scoring U.S. FDA approval of its Infinity directional deep brain stimulation (DBS) system in treating symptoms of Parkinson’s disease not adequately managed by medication. The company also reported new data underscoring the benefits of its Proclaim XR neuromodulation system in people living with chronic pain at the North American Neuromodulation Society (NANS) conference.
Intuitive dips as robotic surgery becomes more mainstream and competition looms
Intuitive Surgical Inc. more than gave back all its 2020 share price gains thus far, dipping almost 4% on earnings news. Over the past few years, its valuation (NASDAQ:ISRG) repeatedly has climbed, only to later retrench and then rise again to a slightly higher peak.
Amazon’s Majmudar discusses challenges of getting novel tech to market
SANTA CLARA, Calif. – Translating novel technology into the care delivery system is not easy, according to Maulik Majmudar, medical officer at Bellevue, Wash.-based Amazon.com Inc. In fact, he said at the Precision Medicine World Conference that “it’s a hot mess.” In his presentation, Majmudar spoke about the classic barriers that prevent technologies from getting adopted at scale in a timeline that's usually feasible for early- and mid-stage startups – and even for large companies – and developing strategies to overcome those challenges.
MDMA’s Leahey: ACA supporters saw device tax as ‘a spreadsheet exercise’
The 2.3% tax on medical devices is a thing of the past. Now, Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA), has revealed to BioWorld that the supporters of the Affordable Care Act (ACA) saw the tax as little more than “a spreadsheet exercise” in financing the more costly elements of the legislation.
Australia’s TGA proposes fee increases to implement recent drug, device reforms
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is seeking input from industry stakeholders on a proposal to increase its fees to cover projected deficits this year. The proposal outlines three options.
BioWorld MedTech’s Neurology Extra for Jan. 24, 2020
Keeping you up to date on recent developments in neurology, including: Axomax Technologies
Med-tech gainers and losers for Jan. 20-24, 2020
The top 10 med-tech stock gainers and losers for the week.

Digital health

Verily highlights diabetes care, Project Baseline even as related partnerships are restructured
Deals and M&A
SANTA CLARA, Calif. – Diabetes seems likely to be the first area to really show concrete products and results for the ambitious Verily Life Sciences, which is the med-tech business of Mountain View, Calif.-based Google parent Alphabet Inc. However, its two major diabetes partners both have been...
AI, data science companies strut their stuff at PMWC
Conferences
SANTA CLARA, Calif. – While many of the presentations at the Precision Medicine World Conference revolved around clinical studies and their promise for future breakthroughs in health care, a continuous stream of companies made their pitches for translating these studies into actual products that...
French university hospitals grasp AI
Artificial intelligence
PARIS – EY SAS has published the results of the first edition of a barometer dedicated to the role of artificial intelligence (AI) in French public hospitals. The health care sector, which is undergoing wholesale change in France, is suffering tight economic constraints and faces ever-increasing...
Novel imaging, AI combo enables rapid, accurate brain tumor diagnosis during surgery
Cancer
Unlike with other kinds of cancer, there’s no opportunity for a biopsy ahead of surgery for a suspected brain tumor. To help matters, researchers have developed a novel approach that combines a new, commercially available imaging technology – stimulated Raman histology (SRH) – with an artificial...

Financings

Novel Dx companies start to see a better path with payers, but continue to work all the angles
Analysis and data insight
SANTA CLARA, Calif. – It has never been easy to get payers to reimburse in a timely and adequate fashion for novel diagnostics, making it notoriously difficult to build a business from them. But a few high-flying diagnostics companies, such as Madison, Wis.-based Exact Sciences Corp. and Redwood City, Calif.-based Guardant Health Inc., have been blazing the trail recently on how to rapidly scale up to become valuable commercial entities from origins as a research-based startup.

Newco news

Company designs glove to replace echocardiography device
Cardiovascular
BOGOTA, Colombia – A startup in Mexico has developed an intelligent glove to diagnose cardiac diseases in seconds just by touching a patient’s chest. The invention could become available on the market by the end of 2020, when Soluciones Kenko, from Jalisco, Mexico, expects to hit the Mexican market...

Breaching all three meninges improves drug delivery to brain
Science
A single injection of SOD1-targeting RNA into the subpial space, which is below the innermost meningeal layer, was able to spread throughout the spinal cord and, via retrograde delivery, into brain centers that project to the spinal cord in several animal models, including primates.
New year much clearer for i/blue bladder cancer imaging system
Cancer
TORONTO – Imagin Medical Inc., which has a presence near Boston and in Vancouver, British Columbia, will have verified and built a device in early January that meets all functional, electrical safety and radiated emission requirements for a new way of visualizing bladder cancer. Jim Hutchens,...

Deals and M&A

M&As and deals up overall in 2019 for med tech, an investor haven in 2020
Analysis and data insight
Last year’s robust deal-making environment, high-value M&As, increasing financings and a supportive public market has set the stage for continued med-tech enthusiasm among investors and partners in 2020.
3D Systems and Collplant Biotechnologies construct new partnership
Collaboration
3D Systems Inc., of Rock Hill, S.C., and Rehovot, Israel-based Collplant Biotechnologies Ltd. have established a blueprint for their collaboration to develop tissue and scaffold bioprinting processes.
Masimo to buy Nanthealth’s connected care business, provides estimates for 2020 guidance
Digital health
Irvine, Calif.-based Masimo Corp. has agreed to buy the connected care assets of Nanthealth Inc., of Culver City, Calif., for a $47.25 million up-front cash payment. In addition, Masimo provided estimates for its full-year 2020 financial guidance, saying product revenue will increase to $1.035 billion, which reflects reported growth of 10.6% to 10.9%. The transaction is expected to close in the first quarter of the year, subject to customary closing conditions. In addition, Masimo expects to fund the acquisition with existing cash on hand.
Sebacia names CEO, picks up Sienna assets
Aesthetics
Duluth, Ga.-based Sebacia Inc., which is focused on dermatology and aesthetics, has introduced its new CEO and reported the acquisition of all assets related to Sienna Biopharmaceuticals Inc.'s silver photoparticle technology, which is being reviewed by the FDA for light hair removal.
Illumina, Pacific Biosciences abandon $1.2B merger over FTC opposition
Diagnostics
Two players in the gene sequencing space, Illumina and Pacific Biosciences, have scotched their planned $1.2 billion merger roughly two weeks after the U.S. Federal Trade Commission (FTC) posted a 5-0 vote to seek an injunction against the merger. While Illumina is consequently liable for nearly $100 million in termination fees, it could recoup those monies under some circumstances. The $1.2 billion merger between Illumina Inc., of San Diego, and Pacific Biosciences of California Inc., was formally announced by the two companies in November 2018, but the deal faced substantial regulatory difficulty from the outset.

Europe

Oviva raises $21M to advance diabetes treatment program in Europe
Diabetes
LONDON – Oviva AG has raised US$21 million in a series B funding to further advance commercialization of its digital diabetes treatment program across Europe.

Asia-Pacific

India extends med-tech registration deadline amidst regulations scramble
Regulatory
HONG KONG – Indian authorities have apparently given medical device manufacturers a one-year extension to register for market authorization that was originally to be done by the New Year.

Inhalation specialist CF Pharmtech closes $90M series E
Respiratory
BEIJING – CF Pharmtech Inc., of Suzhou, China, closed a ¥630 million (US$90 million) series E financing round to bring its inhaled respiratory drugs to global markets and replace imports with homegrown products faster.
Lunit secures $25.6M in series C funding for AI-based cancer diagnostics software
Cancer
HONG KONG – South Korean-based med-tech Lunit Inc., of Seoul, has secured ₩30 billion (US$25.6 million) in series C funding. Founded in 2013, the Korean company has raised $50 million so far. Lunit’s corporate value was evaluated at as much as ₩200 billion as of the fundraising.

Clinical

Study of paclitaxel devices in infrapopliteal arteries resurrects mortality controversy
Cardiovascular
The controversy over the use of paclitaxel-bearing devices in the femoropopliteal arteries is far from over. Now, a new medical journal article makes a similar claim about mortality in connection with the use of these devices in the infrapopliteal arteries, threatening once again to take a bite out of utilization. The first study to generate controversy over paclitaxel in drug-coated balloons and drug-eluting stents appeared in the medical literature toward the end of 2018, and a flurry of activity ensued.
Tennor’s prosthetic joint infections therapy, TNP-2092, set to start phase III soon
Infection
BEIJING – With promising phase II data in hand – and newly designated FDA orphan drug status – Suzhou, China-based Tennor Therapeutics Suzhou Co. Ltd. is gearing up to move into pivotal testing with TNP-2092 to treat prosthetic joint infections. TNP-2092 is a multitargeting drug conjugate designed to exert antibacterial activity by inhibiting three essential targets in bacterial biofilms, namely RNA polymerase, DNA gyrase and topoisomerase IV.
Could SBRT with Cyberknife become new standard of care for recurrent prostate cancer?
Cancer
Nearly 70% of men with locally recurrent prostate cancer who received radiation therapy initially could delay androgen deprivation therapy (ADT) for at least five years following stereotactic body radiation therapy (SBRT) with Accuray Inc.’s Cyberknife system, according to a study published in the International Journal of Radiation Oncology • Biology • Physics.
Embolization coils show well in study of LAA leaks, but questions abound
Cardiovascular
A new study of 30 patients has demonstrated that embolization coils adequately seal the left atrial appendage after implant of LAA closure devices, but the author of an accompanying editorial expressed concerns regarding the absence of understanding of both the causes and implications of these leaks.
Abbott gets FDA OK to start Mitraclip study in moderate surgical risk patients
Cardiovascular
Abbott Park, Ill.-based Abbott Laboratories has gained the U.S. FDA’s nod for a clinical trial that will compare the effectiveness of Mitraclip to open-heart mitral valve surgical repair in people with primary mitral regurgitation (MR) who are eligible for open-heart surgery. The prospective, randomized REPAIR MR clinical trial is expected to enroll 500 patients.
Saluda’s closed-loop SCS system continues to see positive results as company awaits word from FDA
Neurology/Psychiatric
Saluda Medical Pty. Ltd., of Artarmon, Australia, made waves in 2019, winning the CE mark for its Evoke closed-loop spinal cord stimulation (SCS) system. The good news kept coming following the publication of results from a pivotal study in The Lancet Neurology.

BioWorld MedTech Perspectives

The demise of the device tax and other fun med-tech stories
It’s mighty tempting to run a little play on words with regard to eyesight in this new year, but I need reading glasses, so far be it from me to pepper a...
Missed Opportunity: The epidemic of poor sleep
BioWorld MedTech
There are a lot of ways to save money without going bankrupt in the process, but health care in the U.S. certainly has not lent itself to that sort of...
Next up for TAVR; bicuspid valve
BioWorld MedTech
Now that the existing inventory of FDA-approved transcatheter aortic valve replacement (TAVR) devices has received a green light for patients at low...
Cabanas and commissioners; med tech in the news
BioWorld MedTech
We who write about medical devices rarely suffer for content, but the month of May was unusually cooperative even by our standards. Following are two...
FDA’s new man of regulatory mystery
BioWorld MedTech
Life has a lot of unknowns, and one of the big unknowns for 2019 is what the FDA will look like now that Scott Gottlieb has returned to the American...
Scott Gottlieb and the FDA’s revolving door problem
BioWorld MedTech
Now that the dust is still swirling over the news that Scott Gottlieb will leave the FDA, it’s time to conduct a hasty post-mortem on his tenure at the...
Four “Spooky” ways to fix the 510(k) dilemma
BioWorld MedTech
A now-little known band called the Classics IV made a big splash in 1968 when their Hallowe’en love song “Spooky” charted at #3 on the U.S. Billboard Hot...

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