This test can detect when your body is fighting a virus

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A test that measures the RNA or protein molecules in human cells is also able to detect when your body is fighting a viral infection from respiratory symptoms, according to Yale researchers.

The test involves a nasal swab and could be a faster and cheaper way to diagnose respiratory viral illnesses.

“It’s a simpler test and more cost-effective for looking at viral infection,” Ellen Foxman, the study’s author and assistant professor of laboratory medicine at Yale School of Medicine, said in a press release.

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

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BD closes $24B Bard buy-out

Becton Dickinson & Co. (NYSE:BDX) said today that it completed its buy-out of C.R. Bard (NYSE:BCR).

The combined company boasts $16 million in yearly revenue. The $317-per-share deal was first announced in April and in the past few months won conditional approval in the E.U., the U.S. and China.

“Today is a historic day for BD as we welcome Bard and its 16,000 associates to BD,” chairman & CEO Vincent Forlenza said in prepared remarks.

“These companies each have a legacy of more than 100 years of advancing the world of health and supporting those on the frontlines of health care. We look forward to continuing to lead the industry through innovation and partnerships that bring more valuable solutions to our customers and their patients.”

According to the terms of the buy-out, Bard is now a wholly-owned subsidiary of BD and each outstanding share of Bard common stock has been converted to the right to receive $222.93 in cash without interest and 0.5077 of a share of BD common stock.

Now that the acquisition is complete, Bard shares will stop trading and will be delisted from the New York Stock Exchange, the company reported.

Becton Dickinson said is doesn’t expect the deal to have a material impact on its financial results in the first quarter of fiscal 2018, which ends on Dec. 31, excluding transaction-related expenses.

The company added that it expects the acquisition to bring about low-single digit accretion to adjusted EPS in fiscal 2018 and high-single digit accretion in fiscal 2019.

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DelMar Pharma wins fast track status for glioblastoma drug

DelMar Pharmaceuticals (NSDQ:DMPI) said today that the FDA granted its lead product candidate, VAL-083, fast track status for approval as a therapy for recurrent glioblastoma.

The designation applies to a Phase II trial with the University of Texas MD Anderson Cancer Center and a Phase III trial in patients whose disease has progressed after treatment with temozolomide and bevacizumab.

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

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5 medtech stories we missed this week: Dec. 29, 2017

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From NanoVibronix’s new Indian regulatory and distribution agreement to Guided Therapeutics’s Turkish distribution deal, here are five medtech stories we missed this week but thought were still worth mentioning.

1. NanoVibronix inks deal with Indian regulatory and distribution consultant

NanoVibronix announced in a Dec. 20 press release that it has signed Morulaa HealthTech as its regulatory and marketing partner in India. Morulaa HealthTech will help bring NanoVibronix’s products to India, including its UroShield, WoundShield and PainShield. Morulaa HealthTech also has an in-house regulatory team and an established third-party distribution network across India in both rural and urban areas.

2. K2M wins CE Mark for Capri cervical cage

K2M has received CE Mark for its Capri Cervical 3D Expandable Corpectomy Cage System with Lamellar 3D Titanium Technology, according to a Dec. 20 press release. The Capri Cervical 3D Expandable is the first and only 3D-printed expandable device on the market that helps with in-situ height expansion and endplate angulation in the cervical spine. K2M’s cage system also stabilizes the cervical spine in vertebral body resections that happen from trauma or tumor.

3. China clears Impulse Dynamic’s Optimizer cardiac failure device

Impulse Dynamics announced in a Dec. 18 press release that the China Food and Drug Administration has approved its Optimizer system for treatment of chronic heart failure. The device delivers non-excitatory Cardiac Contractility Modulation signals to the heart to help create multiple biochemical and neurohormonal changes to the myocardium. The myocardium contractility increase and causes no concomitant increase in oxygen consumption which allows for the heart to work more efficiently.

4. NeuX inks neuromuscular strain prevention deal with Muscle Activation Technique

NeuX Technologies and Muscle Activation Technique have forged a strategic alliance to develop solutions for treating and preventing musculoskeletal conditions, according to a Dec. 14 press release. The partnership will help with musculoskeletal conditions that result in chronic pain, limited range of motion and less than optimal performance in daily and athletic activities.

5. Guided Therapeutics inks Turkish distro deal

Guided Therapeutics announced in a Dec. 8 press release that it has signed a distribution agreement with Turkish distributor ITEM for the manufacture of its single-patient-use Cervical Guides in Turkey. ITEM will hold licensing and manufacturing rights for Guided Therapeutics’s Cervical Guides in Turkey and Guided Therapeutics will receive fees of $3M in 2018. Guided Therapeutics will also receive a royalty for each device sold in Turkey.

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Nemaura readies CE Mark submission for non-invasive glucose monitor

Nemaura Medical (OTC:NMRD) finished the European clinical trial program for its non-invasive glucose monitoring system earlier this month and reported that it’s preparing to submit the product for CE Mark clearance in the E.U.

The company’s clinical trial program in Europe included 75 patients who wore sugarBeat continuously for up to 14 hours over 7 consecutive days in both home and clinical settings.

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

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TherapeuticsMD submits NDA for hormone therapy to treat vasomotor symptoms

TherapeuticsMD (NSDQ:TXMD) has submitted its bio-identical hormone therapy to the FDA for approval as a treatment for moderate-to-severe vasomotor symptoms due to menopause.

The company’s investigational combination of estradiol and progesterone is delivered in a single, oral soft-gel capsule.

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

 

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Pavmed offers warrants at half-price to raise cash for carpal tunnel syndrome device

Pavmed (NSDQ:PAVM) said this week that it plans to temporarily cut the exercise price of its outstanding Series W warrants in half.

Each of the New York-based company’s outstanding warrants is currently exercisable at $5.00 apiece for one share of common stock. After Pavmed files tender offer materials, each warrant will have an exercise price of $2.50 per share.

The company said it expects the offer will be good for 20 business days, but it could decide to extend the deal.

“Pavmed is providing this opportunity to exercise warrants at a reduced price in order to encourage holders to exercise a meaningful portion of the outstanding warrants, providing the company with additional capital to advance its lead products, particularly its CarpX minimally invasive carpal tunnel syndrome device, through important near-term regulatory and commercialization milestones,” the company said in a statement.

The CarpX percutaneous device helps doctors relieve compression of the median nerve without the need for a surgical incision. The product, positioned using ultrasound guidance, combines a balloon catheter with bipolar radio-frequency cutting electrodes.

Pavmed filed a 510(k) application with the FDA for its CarpX device last month.

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How this biotech plans to go up against big pharma with its eye disease products

Shankar Musunuri has spent time in both the pharmaceutical world and the biotech arena – after 15 years at Pfizer (NYSE:PFE), he went on to launch several biotech start-ups. As co-founder, chairman & chief executive of Ocugen, he is looking to bring eye disease products to the patients that big pharma’s drugs have left out.

“There’s so much unmet need when you look into retinal diseases,” Musunuri said.

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

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Delon Technologies acquires CoPilot VL video laryngoscope

Dilon Technologies said today it acquired the CoPilot VL video laryngoscope, saying the acquisition will expand its footprint into the anesthesia nad airway space.

The CoPilot VL video laryngoscope is designed to provide high-quality video and uses a Bougie Port system to help navigate around corners into the airway, the company said.

“We are very pleased to add the CoPilot VL video laryngoscope to our ever-growing portfolio of Dilon products. We welcome to the Dilon team both inventors of the CoPilot VL video laryngoscope to guide the launch of the product line and ongoing innovations,” Dilon Tech chair & CEO Robert Moussa said in a prepared statement.

“Dilon’s strong sales network, solid understanding of anesthesia products and firm commitment to patient care makes them a great fit for us,” CoPilot VL co-inventor Jay Tydlaska said in a press release.

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FDA clears device that treats diabetic foot ulcers for market

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The FDA announced today that it has cleared the Dermapace System diabetic foot ulcer treatment device for market.

Dermapace System, created by Sanuwave, is the first shockwave device to treat foot ulcers caused by diabetes.

“Diabetes is the leading cause of lower limb amputations,” Binita Ashar, director of the division of surgical devices in FDA’s Center for Devices and Radiological Health, said in a press release. “The FDA is dedicated to making technologies available that can help improve the quality of life for those with chronic diseases. Additional options for successfully treating and healing ulcer wounds may help prevent lower limb amputations.”

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

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Integrity Applications inks exclusive Dutch distro deal for GlucoTrack

Integrity Applications said today it inked an exclusive distribution deal with MediReva B.V. to distribute its GlucoTrack non-invasive glucose measuring device in the Netherlands, effective December 22.

Integrity Application’s flagship GlucoTrack is a sensor that clips to the earlobe and uses a combination of metrics to determine blood glucose based on physiological changes in the body.

Read the whole story on our sister site, Drug Delivery Business

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Australian Paragon Care acquires Insight Surgical, Medtech Solutions

Australian medical equipment company Paragon Care said it acquired both Insight Surgical for $5 million and Medtech Solutions for $2.4 million, according to a report from The Advertiser.

The deal came alongside a newly signed distribution deal which will position Paragon Care as the supplier to Smiths Medical across Southern Australia, according to the report.

“Our SA strategy is to partner with global healthcare manufacturers in territories where they would prefer to enjoy a partnership rather than set up their own operations in that territory,” managing director Mark Simari said, according to The Advertiser.

Both acquisitions are expected to be accretive to the company’s earnings per share for the year, according to a Reuters brief, with guidance for the first half of fiscal year 2018 expected between $52 and $53 million.

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Spectral Medical wins FDA nod for Spectral Apheresis Machine

Spectral Medical (TSX:EDT) said this month it won FDA 510(k) clearance for its Spectral Apheresis Machine designed for use in continuous renal replacement therapy and therapeutic plasma exchange.

The SAM device was developed to support commercialization of the company’s Toraymyxin, or PMX therapy, to enable intensive care units to be able to safely and efficiently deliver PMX treatments to patients undergoing septic shock.

Read the whole story on our sister site, Drug Delivery Business

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Report: Korea to adopt ‘fast-track’ approval for next-gen med devices

South Korea’s regulatory bodies have agreed to adopt a “fast-track” approval process for next-generation medical devices, according to a new report from the Korea Herald.

The policies are being enacted to promote medical devices whose success is dependent upon entering the market ahead of their competitors, and would allow devices to be certified on a global basis, according to the report.

A new value-based evaluation system will be developed for such devices, aiming to explore their immediate value to society, the Korea Herald reports.

The discussion over next-generation medical device regulations was performed by a group of government bodies including the Ministry of Health and Welfare and the Ministry of Drug and Food Safety and was joined by flagship medtech startups Healcerion, Ybrain and Lunit, according to the report.

The “value-based evaluation track” will reportedly not only explore scientific evidence on the device but also consider the technology’s “societal and clinical benefits,” according to the Korea Herald.

The group also agreed on upping health insurance reimbursement rates for innovative medical devices, according to the report.

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Beta Bionics raises $2m

Beta Bionics has raised $2.4 million in a new round of equity and securities financing, according to an SEC filing posted this week.

A total of 11 anonymous investors have participated in the round, though the company has not yet stated who has joined or how it plans to spend funds raised.

Read the whole story on our sister site, Drug Delivery Business

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Study: Legacy pacers, ICDs found safe for 1.5T MRI scans

Pacemakers and implantable cardioverter defibrillators not marked as MRI-safe could still be mostly safe to use during imaging sessions with 1.5T MRI machines, according to a new study reported on by Healio.

Results from the study were recently published in The New England Journal of Medicine.

In the prospective, nonrandomized study, researchers aimed to explore the safety of 1.5T MRI sessions in 1,509 patients with legacy pacemakers or ICDs, undergoing a total of 2,103 MRI exams.

Pacing mode in the devices was changed to asynchronies in pacing dependent patients and demand mode for other patients, with tachyarrhythmia functions disabled, according to Healio.

No clinically significant adverse events were reported at 1 year, according to the report, and only 0.4% of the devices reset to backup mode during MRI exams. A single pacer with a month of battery life was noted as having reset to ventricular inhibited pacing, could not be reprogrammed and was replaced, according to the report.

A decrease P-wave amplitude of at least 50% from baseline also occurred in 1% of patients, according to Healio.

On a longer term follow-up, 4% of patients had reported decreases in P-wave amplitude, with 4% experiencing an increase in atrial capture threshold, 4% exhibiting an increase in right ventricular capture threshold and 3% showing an increase in left ventricular capture threshold, according to the report.

None of these results were clinically significant or required device reprogramming or revisions, according to study authors.

Study researchers said that the results support that MRI scans can be performed in patients with older pacing devices “provided that an appropriate protocol is followed,” according to Healio.

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Digirad deals medical device sales & service biz to Philips for $8m

Digirad Corp. (NSDQ:DRAD) said yesterday it inked an agreement to sell its medical device sales and service business and associated contracts to Royal Philips (NYSE:PHG) for $8 million.

The divested MDSS business provides post-warranty maintenance for large diagnostic imaging equipment, mostly in the upper mid-west region of the US, Suwanee, Ga.-based Digirad said.

“Over the last few months we have been evaluating our opportunity to run this service business outside our prior Philips relationship, and we determined that the best value for the business would be in the hands of Philips.  We are very pleased with the economics and outcome of this Agreement, and this transaction will better position Digirad to focus on its core business – providing convenient mobile diagnostic healthcare solutions,” prez & CEO Matt Molchan said in a press release.

The deal is subject to customary closing conditions and is expected to close Jan. 31, the company said. Digirad added that net proceeds from the sale will be applied to its existing line of credit from Comerica.

As part of the deal, Philips and Digirad said they agreed to extend a prior consolidated service agreement for installation and warranty services sold in the upper mid-west region through Jan. 31.

In October, Digirad said that Philips decided to terminate a remote services contract with Digirad’s DMS Health Tech subsidiary, effective December 31.

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BD wins Chinese clearance for Bard buy, expects to close tomorrow

Becton Dickinson (NYSE:BDX) said today that China’s Ministry of Commerce has cleared its acquisition of  C. R. Bard (NYSE:BCR), and that the deal is expected to close tomorrow.

The news comes only a day after the company said that the US’s Federal Trade Commission gave the go-ahead to the merger, with the caveat that it divests of its soft-tissue core needle biopsy product line and Bard’s Aspira tech.

Franklin Lakes, N.J.-based Becton Dickinson said that its proposed a divestiture of the soft tissue core needle biopsy product line to Merit Medical (NSDQ:MMSI), which it announced in mid-November, is conditioned on approval from China’s Ministry of Commerce.

“MOFCOM clearance was the final regulatory approval needed to complete the Bard acquisition. We look forward to closing the transaction and welcoming Bard’s products and associates to the BD family,” chair & CEO Vincent Forlenza said in a prepared statement.

Earlier this month, BD added another extension onto its tender offer for up to $1.1 billion in outstanding Bard notes.

BD first announced the $317-per-share deal in April and it won conditional approval in the EU in October.

In the tender offer, BD said it could buy up to roughly $500 million in 4.4% notes due 2021, $500 million in 3% notes and $149.8 million in 6.7% notes, both due 2026.

For each of the notes in the offering, BD plans to offer $970 principal amount of equal notes as well as between $2.50 and $20 cash, with an early tender premium of $30 principal amount of equal BD notes. The company is also soliciting consents to adopt certain proposed amendments to each of the indentures governing Bard notes to eliminate restrictive covenants.

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Zimmer Biomet touts pilot data for nStride knee injection

Zimmer Biomet (NYSE:ZBH) last week touted data from a pilot study of its nStride autologous protein solutions kit for treating osteoarthritis of the knee.

The nStride APS kit allows surgeons to concentrate anti-inflammatory cytokines and growth factors from a patient’s blood sample, which are then injected into the knee. The 46-patient Progress II study randomized subjects to either a single nStride APS injection or a single saline injection. The study showed a 65% improvement in the WOMAC pain score for nStride APS patients, compared with a 41% improvement for the control arm. VAS pain scores improved 49% for the treatment arm compared with 13% for the control group; there were no procedure- or device-related serious adverse events and comparable adverse events in both arms.

“As a global leader in musculoskeletal healthcare, Zimmer Biomet is committed to addressing the needs of patients along the entire continuum of care, from the management of symptoms like pain and stiffness with safe, non-invasive intra-articular injections like APS and Gel-One, to restoring joint function and mobility with our extensive portfolio of implant systems to treat advanced orthopedic disease,” group president David Nolan said in prepared remarks. “The positive results of the Progress II trial not only reinforce the safety and clinical value of the autologous anti-inflammatory protein solution prepared with the nStride APS kit, but also lay the groundwork to advance our regulatory efforts in the United States and accelerate our commercial adoption and expansion in Europe and Asia-Pacific.”

“Inflammation is a critical factor in the pain and cartilage breakdown associated with knee osteoarthritis, and research has established that APS derived from the patient’s whole blood contains a host of powerful anti-inflammatory and anabolic proteins,” added lead investigator Dr. Elizaveta Kon of Milan’s Humanitas University. “After nearly a decade of preclinical and clinical research into the use of autologous anti-inflammatory cytokines and growth factors to treat osteoarthritis pain, we were pleased to demonstrate that APS, prepared with the nStride APS kit, may be a promising, safe and viable new treatment for patients living with osteoarthritis of the knee.”

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Glaukos files PMA bid for iStent Inject glaucoma treatment

Glaukos (NYSE:GKOS) said today that it filed for pre-market approval from the FDA of its iStent Inject trabecular micro-bypass stent for treating glaucoma.

San Clemente, Calif.-based Glaukos said the device is designed to treat mild-to-moderate open-angle glaucoma in patients undergoing cataract surgery. It used a pair of heparin-coated titanium stents in a pre-loaded auto-injection system that allows them to be injected into multiple trabecular meshwork locations via a single corneal entry point.

“This PMA submission marks a significant milestone for Glaukos as we continue to deliver our deep pipeline of novel glaucoma surgical devices and sustained pharmaceuticals,” president & CEO Thomas Burns said in prepared remarks. “The iStent Inject represents the first in a series of five new products we are expecting to introduce over the next five years, culminating in what we believe will be the industry’s broadest portfolio of technologies designed to address the full range of glaucoma disease states and progression.”

The PMA bid is backed by data from a 505-patient trial randomized to either treatment with iStent Inject plus cataract surgery, or cataract surgery alone. Data from the study is slated to be released next year, Glaukos said.

Last week Glaukos won an investigational device exemption from the FDA for a pivotal study of its iStent SA device.

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How smartphones can remotely monitor chemotherapy patients

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University of Pittsburgh research has recently shown that smartphone sensors coupled with a specifically-developed algorithm could detect worsening symptoms in chemotherapy patients.

The sensors offer a way for cancer patients to be remotely monitored. The sensors and algorithm can detect objective changes in patient behavior to determine if symptoms are getting worse. Indications of worsening symptoms and side effects could help doctors intervene before the next scheduled clinic visit.

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

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Anika Therapeutics wins FDA nod for bone void filler

Anika Therapeutics (NSDQ:ANIK) said today that it won 510(k) clearance from the FDA for its hyaluronic acid-based bone void filler

The indication covers filling bone voids or defects that aren’t intrinsic to the stability of the bone, created during surgery or the result of traumatic injury. Made of a synthetic, biocompatible bone graft substitute material, the filler is injected into a void and hardens at body temperature. It’s then resorbed and replaced by new bone growth.

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

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Endonovo Therapeutics finally buys Rio Grande Neuroscience assets for nearly $5m

Nearly a year-and-a-half after their planned $22 million merger fell through,Endonovo Therapeutics (OTC:ENDV) said last week that it acquired intellectual property and assets from Rio Grande Neurosciences for $4.5 million.

Rio Grande in August 2016 backed out of deal with Endonovo after seeking to renegotiate its terms when Steven Gluckstern, chairman & CEO of Santa Fe-based Rio Grande, dissolved a binding letter of intent. Los Angeles-based Endonovo, which had raised $10 million to fund the $21.5 million buyout, was to have put up $1.5 million in cash, another $15 million in ENDV shares and $5 million worth of warrants for Rio Grande.

Rio Grande has an FDA-cleared and CE-mMarked device for treating pain and edema using pulsed electromagnetic fields and a multi-coil repetitive transcranial magnetic stimulation device with a pending 510(k) application.

The new deal, executed Dec. 22, saw Endonovo put up $3 million in cash plus a $1.5 million promissory note due Nov. 30, 2018. It came after Rio Grande and Endonovo settled their dispute over the previous deal, with Rio Grande ponying up $150,000 to put the matter to rest, Endonovo said. The company said it raised the $3 million payment by issuing $700,000 worth of new preferred stock, a $1.8 million convertible note to Eagle Equities and “the application of available company funds.”

“We intend to initiate and fund both currently planned and all future clinical trials to evaluate the use of PEMF in the treatment of central nervous system disorders, including traumatic brain injury, post-concussion syndrome, stroke and multiple sclerosis,” Endonovo said in a regulatory filing. “Endonovo Therapeutics will begin the commercialization of the PEMF assets through licensing and joint venture agreements and the creation of various sales channels and distribution agreements.”

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Centinel Spine closes buyout of DePuy Synthes Prodisc assets

Centinel Spine said last week that it closed its acquisition of Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Synthes’ Prodisc assets for an undisclosed amount.

The deal covers DePuy’s Prodisc-C, Prodisc-L, Prodisc-C Vivo, Prodisc-C Nova, Prodisc-O and Discover cervical and lumbar artificial disc systems. The Prodisc-C and Prodisc-L are the only two products which have approval in the U.S. Centinel plans to launch clinical studies as it pursues FDA approval of the other devices it acquired. The buyout leaves DePuy Synthes with only the Inmotion lumbar disc.

“This transaction is the next step in the evolution of Centinel Spine executing on its mission to become the worldwide leading company addressing spinal disease through anterior access to the spine with the widest breadth and depth of technology platforms,” Centinel chairman & CEO John Viscogliosi said in prepared remarks.

The deal was funded with debt and equity; Piper Jaffray was Centinel’s placement agent, the company said.

Last June, Centinel Spine said it won Australian Therapeutic Goods Administration clearance for its Stalif L no-profile lateral lumbar integrated interbody system.

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Nanobiotix’s nanoparticle-immunotherapy trial wins FDA approval

Nanobiotix (EMA:NANO) said today that the FDA has approved its IND application for a cancer trial combining its radiotherapy-activated nanoparticle tech with an anti-PD1 antibody.

The Phase I/II trial is slated to evaluate the safety and efficacy of Nanobiotix’s NBTXR3 product administered with checkpoint inhibitors in three groups of patients with recurrent or metastatic head and neck squamous cell carcinoma or with metastatic non-small cell lung cancer.

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

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SEC subpoenas Ocular Therapeutix over pain relief implant

Ocular Therapeutix (NSDQ:OCUL) revealed last week that it received a subpoena from the Securities and Exchange Commission dated Dec. 15, requesting information about the company’s post-surgical pain relief implant, Dextenza, which was rejected by the FDA earlier this year.

The Bedford, Mass.-based company did not specify what the SEC was asking for, but noted that the request covers communications between Ocular Therapeutix and the FDA, as well as investors.

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

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FTC clears BD’s Bard acquisition

The U.S.’s Federal Trade Commission has given Becton Dickinson (NYSE:BDX) the green light to go through with its C. R. Bard (NYSE:BCR) acquisition, as long as it divests of its soft-tissue core needle biopsy product line and Bard’s Aspira tech.

“FTC approval brings us one step closer to full regulatory clearance of the Bard acquisition,” BD chairman & CEO Vincent Forlenza said in prepared remarks. “We currently expect that the Bard acquisition will close in December, pending approval by the Ministry of Commerce of the People’s Republic of China (MOFCOM) and the satisfaction of customary closing conditions.”

Earlier this month, BD added another extension onto its tender offer for up to $1.1 billion in outstanding Bard notes.

BD first announced the $317-per-share deal in April and it won conditional approval in the EU in October.

In the tender offer, BD said it could buy up to roughly $500 million in 4.4% notes due 2021, $500 million in 3% notes and $149.8 million in 6.7% notes, both due 2026.

For each of the notes in the offering, BD plans to offer $970 principal amount of equal notes as well as between $2.50 and $20 cash, with an early tender premium of $30 principal amount of equal BD notes. The company is also soliciting consents to adopt certain proposed amendments to each of the indentures governing Bard notes to eliminate restrictive covenants.

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Report: Indian legislator seeks price caps for 20 medical devices

A member of India’s parliament asked Prime Minister Narendra Modi yesterday to cap the prices on 20 medical devices, in addition to the orthopedic and cardiac products that are already cost-limited there.

The caps enacted by India’s National Pharmaceutical Pricing Authority on knee implants and cardiac stents have caused other major medtech players to seek to withdraw their devices from India. In April, the NPPA rejected applications from Medtronic (NYSE:MDT) and Abbott (NYSE:ABT) to pull their respective Resolute Onyx and Absorb stents (Abbott has since taken Absorb off the global market, citing lackluster sales). The NPPA is already considering further caps for other medical devices.

Dharam Vira Gandhi, a doctor and parliamentarian from Punjab state wrote a letter to Modi asking that additional products be capped, according to Reuters.

“Currently, there are no restrictions on the healthcare charges in the country,”Gandhi wrote, calling for further controls “at the earliest.

“This would save millions of families in the country from financial hardship and debt trap emanating from the huge healthcare costs,” he wrote.

NPPA chairman Bhupendra Singh declined to comment about the letter to the wire service.

In the U.S., the national medical device lobby and the government are pressing India to do away with the caps. AdvaMed in October filed a petition with the U.S. Trade Representative, looking to suspend Generalized System of Preferences benefits to India.

Earlier in September, the NPPA said it won’t be revising its cap on coronary stents, applied earlier this year, until Feb. 2018.

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FDA clears Xcision Medical’s GammaPod breast cancer device

The FDA said today that it granted 510(k) clearance to the GammaPod stereotactic radiotherapy device made by Xcision Medical Systems to treat breast cancer.

The federal safety watchdog said the GammaPod is designed to treat a portion of the breast in conjunction with breast-conserving surgery. It uses an array of 36 Cobalt-60 sources to beam radiation from within a two-layer vacuum cup that immobilizes the breast to minimize damage to adjacent healthy tissue.

GammaPod is not intended to replace whole-breast radiation therapy and has not been shown to be as effective as that technique, the FDA said. The clearance was based on a 17-patient study testing its ability to accurately deliver radiation while minimizing side effects in healthy tissue, such as skin redness or erythema.

“With today’s clearance, patients will have access to a treatment option that provides greater accuracy in delivering radiation therapy to breast tumors while saving surrounding breast tissue,” radiological health acting deputy director Robert Ochs, of the Office of In Vitro Diagnostics & Radiological Health, said in prepared remarks.

Xcision was founded in 2006 by CEO Cedric Yu of the University of Maryland School of Medicine in Baltimore, who in 1993 invented intensity-modulated arc therapy, now known as VMAT, according to the company’s website.

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Upcoming changes to FDA electronic medical device reporting in 2018

Registrar Corp.

Medical device manufacturers and importers are required to report “adverse events” to FDA when their device has caused or contributed to death or serious injury.  An adverse event is when a device has a malfunction that could cause death or serious injury.  Importers report this information to the manufacturer.  The FDA has announced that it will update certain codes used for Adverse Event Reporting through the Electronic Medical Device Reporting (eMDR) system on April 6, 2018.

The Agency will replace the codes for FDA Device Problem, Manufacturer Evaluation Method, Manufacturer Evaluation Result, and Manufacturer Evaluation Conclusion with similar codes established by the International Medical Device Regulators Forum (IMDRF).

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

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FDA proposes easing of medical device malfunctioning reporting

Today’s Federal Register includes a new FDA proposal that is meant to streamline voluntary malfunction summary reporting for medical device companies.

The proposal – which is now under a comment period until Feb. 26, 2018 – would allow a medtech company to provide certain malfunction medical device reports (MDRs) in a summary format on a quarterly basis – instead of filing each individual MDR within 30 days.

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

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5 medtech stories we missed this week: Dec. 22, 2017

[Image from unsplash.com]

From Hepa Wash’s new collaboration to Stimwave’s FDA clearance, here are five medtech stories we missed this week but thought were still worth mentioning.

1. Hepa Wash collaborates with GALS program

Hepa Wash announced in a Dec. 7 press release that it has collaborated with the German Accelerator Life Sciences (GALS) program to expand its company into the U.S. Hepa Wash recently introduced an Advanced Organ Support (ADVOS) procedure that offers multi-organ support for liver, lungs and kidneys while correcting acid-base balance disorders.

2. FDA clears Camber Spine interbody device

Camber Spine has received FDA 510(k) clearance for its Spira-C Open Matrix Cervical Interbody device, according to a Dec. 7 press release. The Spira-C Open Matrix Cervical Interbody is an interbody fusion implant that enhances fusion. It is the second implant clearance of the company and is a 3D printed titanium implant. It supplies the optimal environment for cell proliferation and bone growth.

3. NanoVibronix inks U.K. distribution deal

NanoVibronix announced in a Dec. 5 press release that it has entered a distribution agreement with BHR Pharmaceuticals to distribute its PainShield in the U.K. PainShield is an alternative to opioids for pain relief following surgery. It is an ultrasound-based product that is designed to treat pain in nerves, muscles, joins and soft tissue using localized ultrasound that heals soft tissue.

4. FDA clears CoLink ‘see-through’ plating system from In2Bones

In2Bones has received FDA clearance for an addition to its CoLink Forefoot Bone Plating System, according to a Dec. 5 press release. The bone plating system is used to stabilize bones during the post-surgical healing process. It features titanium metal and PEEK with an X-ray transparent PEEK hub that lets the surgeon watch a patient’s bone heal.

5. Stimwave receives 510(k) clearance

Stimwave announced in a Nov. 28 press release that it has received 510(k) clearance for its SandShark Injectable Anchor System. The clearance allows for clinicians to insert Stimwave’s Wireless Pain Relief technology in minimally-invasive outpatient procedures to treat chronic pain. The SandShark enables clinicians to anchor electrodes while causing the least amount of tissue damage to treat patients with stimulation and no opioids.

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Windtree Therapeutics implements 1-for-20 reverse split

Windtree Therapeutics (NSDQ:WINT) said today that it implemented a 1-for-20 reverse stock split of its issued and outstanding common stock.

The reverse split was approved in November by the holder of the majority of the company’s shares without a meeting of shareholders, according to the Warrington, Penn.-based company.

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

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Histogenics inks deal to develop Neocart for the Japanese market

Histogenics (NSDQ:HSGX) has inked a deal with Medinet to develop and commercialize its Neocart implant for the Japanese market.

The Waltham, Mass.-based company’s Neocart implant is designed to repair knee cartilage damage. The product is made using a patient’s own cells, harvested from the surface of the patient’s femur.

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

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Carefusion wins $50m Pentagon contract

Becton Dickinson & Co. (NYSE:BDX) subsidiary CareFusion won a U.S. Defense Dept. contract worth nearly $50 million, the Pentagon said yesterday.

San Diego-based Carefusion Solutions won the five-year, $49.5 million contract for medical equipment. The firm-fixed-price with economic-price-adjustment deal was awarded after the military reviewed bids from 31 suitors and is good to Dec. 20, 2022.

The Pentagon also said it granted a $200 million contract to American Medical Depot of Miramar, Fla., for medical surgical items, exercising the third one-year option on the contract. That deal, good to Dec. 31 next year, is a fixed-price with economic-price-adjustment, indefinite-delivery/indefinite-quantity contract, the Defense Dept. said.

Both companies will supply the U.S. Army, Navy, Air Force and the Marine Corps, plus federal civilian agencies, according to the Pentagon.

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Appeals court denies stent pioneer Jang another run at Boston Scientific

A federal appeals court yesterday denied coronary stent pioneer Dr. David Jang a re-hearing after it upheld a Boston Scientific (NYSE:BSX) win in a long-running patent infringement spat.

The case dates back to 1999, when Jang won approval from the U.S. Patent & Trademark Office for a stent design featuring lateral struts. In 2002, Jang inked a deal worth up to $160 million to license the patents to Marlborough, Mass.-based Boston Scientific; Jang received $50 million up front, according to court documents, but only $10 million of the remaining $110 million in milestone payments.

Jang sued in 2005, alleging breach of contract and other claims. Boston Scientific filed a counterclaim in 2006 “denying any obligation to make additional contingent payments to Jang on the ground that that the accused stents did not infringe,” and thus were not covered under the deal with Jang, according to the documents.

Judge Virginia Phillips of the U.S. District Court for Central California initially ruled that the Boston Scientific stents did not infringe the Jang patents, shot down the breach of contract claim and decided the other claims in Boston’s favor. After Jang appealed, the Federal Circuit in 2012 vacated the ruling and remanded it to Phillips.

A Patent Office re-examination in 2013 found the Jang patents invalid, prompting Boston Scientific to argue that it shouldn’t be required to pay royalties on invalid patents. Phillips denied that bid for summary judgment, ruling that Jang has the right to demand royalties covering the time up until Boston Scientific asked for the re-examination, according to the documents. Boston appealed, asking the Federal Circuit to review the Phillips decision; the appeals court in September 2014 declined to hear the petition. At trial the jury sent up a split verdict, finding that Boston Scientific did not literally infringe the Jang patents but did infringe under the doctrine of equivalents. Phillips found in 2015 that Jang’s claims covered previous patents, triggering an ensnarement defense barring a patentee from asserting a scope of equivalency that would encompass, or ensnare, the prior art.

Jang moved for judgment as a matter of law on the jury’s finding of no literal infringement, but Phillips found enough evidence to support the verdict and rejected Jang’s bid for a new trial. Jang appealed that decision, arguing that a reasonable jury couldn’t have found no literal infringement because the undisputed facts showed otherwise and Boston Scientific’s non-infringement arguments were legally erroneous. In September the U.S. Court of Appeals for the Federal Circuit upheld Phillips’ ruling, according to the documents.

In an Oct. 30 motion for a re-hearing, Jang argued that the appeals court was wrong in its decision regarding the ensnarement defense, because it overlooked legal questions in a pretrial order and made its last ruling at the end of the trial.

Yesterday the appeals court denied Jang’s motion for a rehearing and his move for an en banc review, saying the court is slated to issue its mandate Dec. 28.

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NovaBay shareholders clear $10m stock deal

NovaBay Pharmaceuticals (NYSE:NBY) said today that its shareholders have approved a deal to issue 2.4 million shares of common stock as part of a $10.3 million deal with Beijing-based Ch-gemstone Capital.

The private placement is slated to close in January next year, contingent upon approval by regulatory authorities in China.

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

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TearLab cuts headcount in restructuring effort

TearLab Corp. (OTC:TEAR) is looking to keep its customer base and reduce the company’s cash burn rate with a new business model that will result in people losing their jobs, according to regulatory filings.

The company said that it wants to focus resources on the development of its next-gen TearLab Discovery platform.

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

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Report: Apple is working on an in-house Apple Watch ECG to compete with AliveCor’s Kardiaband

Apple (NSDQ:AAPL) is reportedly developing an in-house ECG for its Apple Watch that would compete with the recently approved KardiaBand made by AliveCor.

The Apple ECG, which is still being testing, involves smartwatch users squeezing the frame of the device with the opposite hand, allowing Apple Watch to pass an imperceptible current across the chest to assess heart rhythm, according to Bloomberg, which cited “people familiar with the plan.”

Last month the FDA cleared AliveCor’s KardiaBand ECG device for the Apple Watch, designed to monitor for early signs of atrial fibrillation. First introduced in March 2016, KardiaBand is the first medical device accessory to be cleared by the federal safety watchdog for the Apple Watch, Mountain View, Calif.-based AliveCor said at the time. It’s designed to display and record clinical-grade cardiac rhythm readings in real time in about 30 seconds, the company said.

Apple may still decide not to include the technology in future products, according to the news site’s sources, who asked not to be identified talking about private plans; Apple spokeswoman Amy Bessette declined to comment.

Over- and mis-diagnosis a concern

Physicians expressed concern that smartwatch ECG technology, potentially useful as a long-term monitoring tool in already-diagnosed patients, could lead to over- and mis-diagnosis.

“The key is the rhythm alert which triggers the user to grab an ECG. It is interesting and I could see it used as a long-term monitor in lieu of, say, an implantable loop recorder. There is space for this. If the technology works, it could be great,” Dr. Ethan Weiss of the University of California-San Francisco told CardioBrief. “But in people with cryptogenic stroke or post-[transient ischemic attack] or even [at] very high risk (say mitral stenosis or extremely high CHA2DS2-VASc scores), this could be a very useful tool. Of course, I expect it will be used by many people in whom there is no indication, and that will lead to a lot of cardiologists trying to sort through a LOT of data they don’t understand.”

“Measuring things is not therapy,” added Mayo Clinic’s Dr. Michael Joyner. “So in terms of patient care applications, if this is not linked to a coherent way to deal with and act on the data, then any assumptions about better outcomes are premature. The well-done [randomized controlled trials] on things like [congestive heart failure] and home monitoring have not been especially impressive.

“It is easy to envision a cascade of over-diagnosis stemming from more monitoring,” Joyner told the website. “The evidence that wearables consistently motivate positive and durable behavior change over time is pretty thin. … Better technology per se is not going to solve complex systems and behavioral challenges.”

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No repeal for medical device tax this year

The U.S. Congress entered its end-of-year recess yesterday without acting to further delay or outright repeal the medical device tax, a 2.3% levy on medtech sales that’s set to resume next week after a two-year hiatus.

House Ways & Means Committee Chairman Kevin Brady (R-Texas) said repealing the medical device tax and others contained in Obamacare will have to wait until early 2018.

“We’ll have to move forward next year on those health-care taxes,” Brady said, according to The Hill. “With the end of the year and tax reform done, that clears the deck to move those things forward.”

Last week Brady and Reps. Erik Paulsen (R-Minn.) and Jackie Walorski (R-Ind.) introduced a bill that would suspend the tax for five years. This week the so-called “Problem Solvers Caucus” in the House filed a bill to amend Obamacare that would also do away with the tax, which was in effect for 2014 and 2015 before being put on a two-year moratorium for 2016-2017. It’s slated to resume Jan. 1.

AdvaMed president & CEO Scott Whitaker this week asked the president directly to kill the tax.

The national medical device lobby has long argued that the medical device tax has caused the industry to lose jobs or put off creating jobs, as well as stifle innovation by cutting R&D and slowing capital expansion.

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7 top stories that mattered for medtech in 2017

The medtech industry saw its transformation accelerate in 2017: Whether it’s the roster of largest companies, business models or the regulatory environment, times are a-changing.

Competition is also heating up in areas including diabetes care and robotic surgery.

Here are seven stories that mattered for the medical device industry this year.

Next>>

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What is the future of medtech in 2018?

[Photo by Jordan McQueen on Unsplash]

Some of the largest medtech companies showed in 2017 that they are ready to grow through embrace the new healthcare ecosystem.

Medical device companies are putting greater emphasis on value-based. They’re putting more attention to clinical and economic research and adopting digital products that incorporate machine learning and data integration.

Questions, though, still remain as we enter 2018. The editors at MDO asked several experts – many at the recent DeviceTalks West in Orange County, Calif. – to weigh in on what they believe will happen in the coming year. Some offered insight into FDA’s future, as well as the future of global regulatory bodies. Others focused on how healthcare policies and patent law trends will impact medical device businesses. And some looked at technology, most importantly, the convergence of digital technology and device technology – and shared the trends they expect to see in the coming year.

Read on to discover the experts’ thoughts about important trends facing the industry.

Next>>

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House ‘Problem Solvers’ caucus bill includes medical device tax repeal

The so-called “Problem Solvers Caucus” in the U.S. House of Representatives yesterday filed a bill to amend Obamacare that would also do away with the medical device tax that’s slated to go back into effect next year.

The tax, a 2.3% levy on all U.S. sales of prescribed medical devices, was in effect for 2014 and 2015 before being put on a two-year moratorium for 2016-2017. It’s slated to resume Jan. 1.

The bi-partisan bill, H.R. 4695, “To amend the Patient Protection and Affordable Care Act to provide for stabilization in the individual health insurance market, and for other purposes,” was co-sponsored by Reps. Tom Reed (R-N.Y.), Josh Gottheimer (D-N.J.) and Kurt Schrader (D-Ore.).

“This is a tax on innovation, a tax on jobs, and a tax on the health and well-being of millions of American patients. It makes no sense from either a health care or a tax policy perspective, which is why bipartisan majorities for years in both the House and Senate have called for this tax to be repealed,” AdvaMed president & CEO Scott Whitaker said in prepared remarks. “We only have a few days before this tax goes back into effect, so we urge the Congress and the Administration to follow the Caucus’ lead and repeal this onerous tax once and for all.”

Earlier this week Whitaker asked the Trump administration directly to repeal the tax.

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Advanced Bionics to connect cochlear implants to cell phones, TVs using Sonova’s chip tech

Advanced Bionics said today that it plans to integrate Sonova‘s Sword chip and wireless radio tech into its sound processors.

Sonova’s technology can connect hearing devices to almost any kind of cell phone, the company explained, without the need for an extra streaming device.

“By offering a solution to the entire market – including the more than 80% of the world’s smartphone owners who purchased Android devices – Sonova becomes the first and only major hearing solutions company to unlock the enormous potential of universal direct connectivity,” Sonova CEO Lukas Braunschweiler said in prepared remarks. “Our chip will be the foundation for a wide variety of unique and innovative solutions in the coming years.”

Sonova’s chip has the lowest power consumption of any hearing aid using Bluetooth, the company touted.

By integrating its hearing-loss devices with Sonova’s Sword tech, Advanced Bionic users can answer or deny a phone call by pushing a button on their hearing device. The user will hear the phone ringing through the device, according to Advanced Bionics, and the conversation begins streaming as soon as the call is accepted.

Sonova’s technology also gives users the opportunity to turn their devices into wireless TV headphones.

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Accuray to use $40m term loan to retire senior debt

Accuray (NSDQ:ARAY) said today that it plans to use the $40 million term loan it just took out from MidCap Financial Trust to buy back some of its senior debt notes and lower the amount of its credit revolver with MidCap.

Sunnyvale, Calif.-based Accuray, which makes radiosurgery devices, said it plans to use the term loan and cash on hand to buy back the same amount in its 3.5% convertible senior notes and 3.5% Series A convertible senior notes due Feb. 1, 2018. The company also plans to cut $20 million from the MidCap revolver, it said.

The interest rate on the term loan is the 90-day London Interbank Offered Rate with a 1.0% floor, plus 675 basis points; it has a final maturity date of December 2022.

“This transaction raises an additional $20 million in available funds that we intend to use in conjunction with $20 million on our balance sheet to retire the aggregate principal amount of our February 2018 convertible notes while reducing potential underlying shareholder dilution,” CFO Kevin Waters said in prepared remarks. “We will have lowered our overall convertible note exposure from $215 million two years ago to $85 million after retiring the remaining February 2018 convertible notes. This new agreement with MidCap Financial Trust, along with projected operating income, gives us the flexibility to achieve our strategic objectives.”

Accuray said it had roughly $94 million in cash & equivalents, restricted cash and investments as of Sept. 30.

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Procept BioRobotics wins de novo nod from FDA for Aquabeam prostate treatment

Procept BioRobotics said today that it won de novo clearance from the FDA for its Aquabeam device for treating benign prostate hyperplasia, saying it plans to have the device on the U.S. market early next year.

Redwood Shores, Calif.-based Procept said the federal safety watchdog used the 181-patient Water study to inform its decision. The trial, comparing Aquablation with transurethral resection of the prostate, showed equivalent efficacy and a better safety profile, including a reduction in sexual side effects by a ratio of four to one.

Get the full story at our sister site, The Robot Report.

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Taris Biomedical lands $25m Series B following Bristol-Myers deal

One day after announcing a research collab with Bristol-Myers Squibb (NYSE:BMY), Taris Biomedical revealed that it has raised $25 million in a Series B round.

Bristol-Myers also contributed to the round, which was led by Yonghua Capital.

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

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That time Roald Dahl invented a medical device

Roald Dahl is best remembered as an author of children’s books, particularly for works like Charlie and the Chocolate Factory and Matilda. His stories have sold more than 250 million copies around the globe.

But Dahl was much more than a storyteller – he also helped invent a medical device that has been used on nearly 3,000 children worldwide, according to an interview with his daughter, Ophelia, published this month in The New Yorker.

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

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British health agency backs endobronchial valves from Pulmonx, OIympus

Pulmonx and Olympus (TYO:7733) won a nod from a British health agency for the endobrachial valves they sell to treat severe emphysema.

The U.K.’s National Institute for Health & Care Excellence updated its guidance for the valves, saying it considers the clinical evidence behind them sufficient to support routine use. The one-way valves, Pulmonx’s Zephyr and the Spiration device made by Olympus, are designed to partition diseased lung tissue from healthy tissue to improve respiratory efficiency.

Redwood City, Calif.-based Pulmonx said the decision was based on data from a quartet of studies of its Zephyr EBV, which is approved in Europe and Australia. Pulmonx said it’s won support from the relevant agencies in Germany, Switzerland and Holland.

“These decisions will increase patient access to our proven and minimally-invasive Zephyr technology, which has the potential to significantly improve the quality of life for patients,” CEO Glen French said in prepared remarks.

“In light of the high burden of symptoms, progressive nature of emphysema and poor prognosis for patients, the NICE decision means that patients with severe emphysema should be referred to specialists to determine if they are good candidates for endobronchial valves or other interventions,” added Dr. Pallav Shah of London’s Royal Brompton and Chelsea & Westminster Hospitals.

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AstraZeneca wins FDA nod to remove boxed warning from asthma drug label

After reviewing results from trials involving more than 41,000 asthma patients, the FDA has agreed to remove the boxed warning of serious asthma-related outcomes for AstraZeneca‘s (NYSE:AZN) Symbicort product.

Patients using Symbicort, which combines an inhaled corticosteroid and a long-acting beta2-adrenergic agonist in a single inhaler, did not experience a significant increase in the risk of a serious asthma-related event, according to data from four clinical trials.

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

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