NuVasive posts mixed-bag Q2

Shares in NuVasive (NSDQ:NUVA) have stayed stable in after-hours trading after the medical device maker beat earnings per share expectations but missed sales consensus on Wall Street with its second quarter earnings.

The San Diego-based company posted profits of $11.5 million, or 22¢ per share, on sales of $252.7 million for the three months ended June 30, seeing the bottom-line shrink 5.2% while sales grew 6.2% compared with the same period during the previous year.

Adjusted to exclude one-time items, earnings per share were 58¢ per share, just in line with the consensus on Wall Street where analysts expected too see sales of $276.3 million, which the company missed.

“We are pleased with our second quarter total revenue growth of 8.5% year-over-year driven by momentum in our U.S. spinal hardware business where we saw spine case volumes up nearly 7% versus prior year. We continue to see strong demand for new product introductions from late last year and positive surgeon conversion efforts as our new lateral single-position surgery procedure gains traction in the market. Our International business also delivered a solid performance with 21% year-over-year growth,” chair & CEO Gregory Lucier said in a prepared statement.

NuVasive updated its guidance for its fiscal year 2018, dropping its non-GAAP EPS expectations from between $2.44 and $2.47 to between $2.37 and $2.40. The company also dropped its non-GAAP EBITDA expectations for the year from 26.9% to 25.9%.

Shares in NuVasive have risen ever so slightly in after-hours trading, up 0.01% at $58.06 as of 4:55 p.m. EDT.

Earlier this month, NuVasive said that it won FDA 510(k) clearance for its Pulse spinal surgical automation platform.

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Hologic posts beat-and-raise Q3

Shares in Hologic (NSDQ:HOLX) have stayed steady in after-hours trading after the medical device maker beat expectations on Wall Street with its third quarter fiscal year 2018 earnings.

The Marlborough, Mass.-based company posted profits of $112.9 million, or 41¢ per share, on sales of $824 million for the three months ended June 30, seeing 89.7% growth on the bottom-line while sales grew 2.2% when compared to the same period during the previous year.

Adjusted to exclude one-time items, earnings per share were 58¢, just ahead of the 56¢ consensus on Wall Street where analysts expected too see sales of $800.4 million, which the company handily topped.

“We posted good financial results in the third quarter, with both revenue and EPS exceeding our guidance. Our breast health and international businesses continued their strong recent performance.  And surgical and Cynosure both showed sequential improvement, in line with our expectations,” prez & CEO Steve MacMillan said in a press release.

The company lifted its full-year 2018 revenue guidance to between $3.205 billion and $3.22 billion from previous guidance of between $3.18 billion and $3.21 billion. Non-GAAP EPS estimates also got a slight shift, moving from between $2.22 and $2.27 to between $2.24 and $2.26.

For the fourth quarter, Hologic said it expects to post sales of between $800 million and $815 million with non-GAAP EPS of between 58¢ and 60¢.

Shares in Hologic haven’t moved in after-hours trading as of 5:00 p.m. after closing at $42.91.

Yesterday, Hologic said that a US International Trade Commission Administrative Law Judge ruled in their favor in an investigation into a patent infringement complaint filed against Fujifilm Holdings (TSE:4901).

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EU Medtech voices concerns over timing, transition to new MDR, IVDR regulations

Industry group MedTech Europe is voicing concerns over the implementation of the EU’s new Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulations, which are set to go into effect in May 2020 and May 2022.

The industry group was specifically concerned about the industry’s ability to keep products on shelves after the deadlines for implementation are passed.

MedTech Europe called on the European Commission, European Parliament and all EU member states to “provide solutions that will rapidly install the functionality of the new regulatory systems and thereby safeguard the continued availability of life-saving and life-transforming medical technology products,” according to the letter.

The group warned that their ability to stock items “could be seriously jeopardized by the slow progress in putting into place the critical infrastructure that will enable the new regulatory systems to work.”

Products that weren’t re-certified would be made unavailable after the deadline, the group warned, limiting access to patients and healthcare providers.

MedTech Europe said that implementation of the new regulatory framework was lagging, and said that after 14 months only two of 18 “system-critical implementing acts” had been published. In addition, notified bodies still need to be designated before they can assess and certify medical devices under the new regulations, the group warned.

“A fully-functioning Notified Body system is needed early on, with sufficient capacity to manage the workload under the current and future regulatory framework in a timely manner. As of today, our assessment is that Notified Body availability with needed expertise and sufficient capacity cannot be ensured early enough and hence an urgent solution is needed.

The group also voiced concerns about complications brought about by the Brexit, estimating that currently between 30% and 40% of medical tech in EU are certified with UK notified bodies. MedTech Europe said that it is uncertain whether those bodies would continue to operate in the EU, or if their capacity will need to be transferred to other EU notified bodies.

“MedTech Europe is ready to cooperate with the EU institutions and all affected stakeholders to identify and deliver an optimal way forward. We urge all concerned parties in the strongest possible terms to act now, in the interest of patients and industry alike,” MedTech Europe wrote in its letter.

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Elekta picks up radiology QA software dev Acumyn

Elekta (STO:EKTA B) said late last week it acquired Canadian quality assurance company Acumyn for an undisclosed amount.

Acumyn, which spun-out of Toronto’s University Hospital Network, was started to commercialize the Aqua software platform. Aqua is intended to coordinate, centralize and automate all QA tests that need to be performed in radiotherapy clinics, Elekta said.

“This acquisition is an important step in our Elekta digital strategy. With Aqua as the backbone for all quality assurance measurements in the clinic, we can now integrate machine data acquisition and analysis across the whole department,” Elekta prez & CEO Richard Hausmann said in a prepared statement.

Elekta said it plans to fully integrate the Aqua software across its portfolio and continue to develop QA offerings through the Acumyn team.

“Aqua fills a big gap that radiotherapy departments have today. A linear accelerator and associated devices need to be calibrated and maintained on a regular basis. Aqua provides a software link between all the disparate systems and manages the workload, scheduling and reporting of routine QA tasks,” Elekta portfolio & biz dev senior VP Dee Mathieson said in prepared remarks.

Acumyn’s Aqua supports internationally recognized QA tests and standards, Elekta said, and is intended to supply clinics with limited physics resources to enable the adoption and implementation of advanced treatment techniques.

“The team and I are excited to become part of Elekta and look forward to realizing our development plans for Aqua. We plan to further integrate and automate the incongruous elements of the end-to-end QA process and leverage the wider potential of Aqua across Elekta’s treatment solutions,” Acumyn CEO Ferhan Bulca said in a press release.

Earlier this month, Croton Healthcare subsidiary York Instruments announced plans to buy Elekta’s magnetoencephalography business for an undisclosed amount.

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Cardiovascular Systems, Aerolase ink joint laser atherectomy dev deal

Cardiovascular Systems (NSDQ:CSII) said today that it inked an agreement with Aerolase to develop a laser atherectomy system designed for treating multiple arterial diseases.

As part of the agreement, St. Paul, Minn.-based Cardiovascular Systems said it made an undisclosed equity investment in Aerolase, and agreed to make more milestone-dependent investments in the company.

“We are excited to pursue the development of an atherectomy laser device with an industry-leading company like CSI. Our dermatology and aesthetic medicine customers appreciate the portability, reliability, ease-of-use and minimal set up time that our lasers offer in addition to high clinical efficacies. We look forward to demonstrating that our solid-state, patented, air-cooled laser technology can transfer to atherectomy and provide similar benefits to interventional cardiologists,”Aerolase chair & CEO Pavel Efremkin said in a press release.

“We believe there is an opportunity to leverage Aerolase’s innovative proprietary laser technology, which is FDA-cleared for dermatology and medical aesthetic uses, and supported by leading physicians in those fields. The collaboration project aims to create a significant improvement in the quality of care for patients suffering from peripheral arterial disease and in-stent restenosis. The successful development and commercialization of this laser atherectomy technology will expand the number of patients CSI serves. We are committed to transforming CSI into an innovative and global leader in the treatment of peripheral and coronary artery disease,” Cardiovascular Systems CEO Scott Ward said in a prepared statement.

Yesterday, Cardiovascular Systems saw its shares stay steady in after-hours trading after the medical device maker posted full year and fourth quarter fiscal year 2018 earnings that beat expectations on Wall Street.

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Rapid Medical wins CE Mark for Tigertriever 13 stent retriever

Neurovascular device maker Rapid Medical said it won CE Mark approval in the European Union for its Tigertriever 13 stent retriever intended for treating ischemic stroke, and added that the first patient in the region has been treated with the device.

The Israel-based company touted the Tigertriever 13 as the first-ever fully-visible stent retriever that can be adjusted by the physician to fit in the dimensions of the blocked blood vessel.

Rapid Medical said that the device’s profile is 83% smaller than any other devices on the market, and that it is designed to recanalyze intracranial vessels of between 1mm and 2.5mm.

“We know that endovascular therapy is the best option for large vessel occlusions. The Tigertrriever 13 will further extend this powerful treatment for acute ischemic stroke to patients with medium vessel occlusions,” Dr. Jeffrey Saver of UCLA’s David Geffen School of Medicine said in a prepared statement.

The company said it plans to launch the Tigertriever 13 in the EU during the third quarter of this year.

Last September, Rapid Medical said it launched a registry study of its Tigertreiver controllable stent retriever.

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Thermedical wins FDA nod for Durablate catheter trial

Thermedical said today that it won an investigational device exemption from the FDA for a clinical trial of its Durablate catheter for treating ventricular tachycardia.

The Durablate catheter is designed to simultaneously inject hot saline and use radiofrequency energy to effect the ablation; the Thermedical claims that the method is 20 times more effective than conventional RF ablation.

The Waltham, Mass.-based company said the 30-patient early feasibility study is designed for patients already implanted with an implantable cardioverter defibrillator who’ve also had a conventional VT ablation procedure that failed. The trial’s primary completion date is January 2019, with a final completion date in July 2019, according to ClinicalTrials.gov.

The primary safety outcomes are device-related adverse events at 30 days, major adverse cardiac events after two days and non-inducibility of clinical VT and/or elimination of clinically relevant scar or channels. The efficacy outcomes are intraprocedural non-inducibility and/or scar homogenization of target VT and elimination of the target VT and/or reduction in number of VT episodes at six months.

“Receiving IDE approval to begin clinical testing of our innovative ablation therapy in patients is an important next step to advance treatment to reduce or potentially eliminate VT episodes,” co-founder & CEO Michael Curley said in prepared remarks. “There is significant need for an effective ablation therapy that can serve as an adjunct to, or as a possible replacement for ICDs. We believe our solution may be a low-cost alternative for treating VT and it might save the US healthcare system significant costs associated with VT treatment today.”

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CT imaging, robotics dev Epica Int’l raises $12m

Privately held CT imaging and robotics company Epica International said yesterday it raised $12.2 million.

The San Clemente, Calif.-based company said the funding came from healthcare investment group SWK Holdings, and includes a second, milestone-dependent $1.8 million traunch, which the company said it hopes to receive in early 2019.

“We are pleased to partner with Epica International with this nondilutive financing. We are impressed with the depth of the management team, sales execution in existing product verticals, and product roadmap that may lead to entering the human imaging and robotic market in coming years,” SWK Holdings CEO Winston Black said in a press release.

Epica said it also reported sales of $24.1 million for its 2017 fiscal year, with an EBITDA of $2.2 million.

Epica is developing CT systems it says will show never seen before soft-tissue and hard-tissue imagery and robotic systems intended for use in imaging and creating prosthetics.

“Our R&D activities, coupled with the use of the SWK proceeds, are both focused on the launch of our unique CT imaging platform into the human market and the further development of our robotic surgery platform, which represents a fusion of CT imaging + robot guidance,” CEO Frank D’Amelio said in a prepared statement.

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Tamarack’s GlideWear helps kids with painful skin condition

Photo by Alison Bents Photography for Tamarack Habilitation Technologies, Inc.

A company that makes ultra-low-friction fabric for people with burn injuries, amputations and pressure sores has launched a clothing line for children with a painful skin condition.

Known as “butterfly children,” these patients have epidermolysis bullosa (EB), a rare genetic disorder in which their bodies do not produce a protein that would enable the skin to adhere to itself. Their extremely fragile skin blisters and tears from minor friction or trauma, making it seem as fragile as the wings of a butterfly.

When officials with low-friction fabric maker Tamarack Habilitation Technologies, Inc. (Blaine, Minn.) learned of a local child who had EB in 2015, they began working with the little girl and her family to develop clothing that would protect her knees, elbows and armpits, all high-friction areas.

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

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FDA warns on ‘vaginal rejuvenation’ procedures

FDA head Scott Gottlieb today released a statement warning about “vaginal rejuvenation” procedures intended to treat conditions related to menopause, urinary incontinence or sexual function, saying that the products used in the procedures “don’t have adequate evidence to support their use for this purpose.”

Gottliebb said that the procedures use lasers or energy-based devices to destroy or reshape vaginal tissue, and while the FDA has approved such devices for treating serious conditions such as the destruction of abnormal or precancerous cervical or vaginal tissues, the devices and procedures have not been evaluated for “vaginal rejuvenation.”

“In addition to the deceptive health claims being made with respect to these uses, the “vaginal rejuvenation” procedures have serious risks. In some cases, these devices are being marketed for this use to women who have completed treatment for breast cancer and are experiencing symptoms caused by early menopause. The deceptive marketing of a dangerous procedure with no proven benefit, including to women who’ve been treated for cancer, is egregious,” Gottlieb said in a press release.

Upon reviewing adverse event reports and published studies, Gottlieb said the FDA found numerous cases of vaginal burns, scarring, pain during sexual intercourse and recurring or chronic pain, according to the release. He added that as the devices haven’t been reviewed for ‘vaginal rejuvenation’ purposes, the true extent of the risk is unknown, but that reports seem to indicate that the procedures can cause serious harm.

The FDA warned women and healthcare providers of the serious risks associated with the devices, and said it has notified seven device makers about their concerns. The makers include Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen, according to the release.

“We requested that the manufacturers address our concerns within 30 days. If our concerns are not addressed, then the FDA will consider what next actions, including potential enforcement actions, are appropriate. This matter has the full attention of our professional staff,” Gottlieb said in his release.

Gottlieb said that the “deceptive marketing” may not only cause injuries, but also keeps individuals from accessing appropriate care for their conditions. He suggested that women seeking non-hormonal options for issues such as vaginal dryness speak to their doctor about risks and benefits of suggested treatment options.

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GE Healthcare, Lantheus launch 2nd Phase 3 trial of PET imaging agent

GE Healthcare (NYSE: GE) and Lantheus Holdings, Inc. (NASDAQ: LNTH), parent company of Lantheus Medical Imaging, Inc. have started a second Phase 3 clinical trial of flurpiridaz ¹⁸F, an investigational agent being evaluated for the detection of coronary artery disease.

Flurpiridaz¹⁸F is designed as a positron emission tomography (PET) myocardial perfusion imaging (MPI) agent. The companies agreed in April 2017 to work together on Phase 3 development and commercialization of flurpiridaz F 18.

In the prospective, open-label AURORA study, patients with suspected coronary artery disease and for whom an intracoronary angiography has been indicated will undergo a single-photon emission computed tomography (SPECT) MPI and a flurpiridaz ¹⁸F injection PET MPI before having coronary angiography. Investigators in the international, multicenter study will seek to determine the diagnostic efficacy (sensitivity and specificity) of the flurpiridaz ¹⁸F injection PET MPI in detecting significant coronary artery disease.

The first patient was enrolled in the study in June 2018. A total of 650 patients will be enrolled, with the last patient follow-up projected to occur in August 2020.

Coronary artery disease affects an estimated 15.5 million Americans 20 years of age or older, according to the American Heart Association and is the leading cause of death in the United States, notes the National Heart, Lung, and Blood Institute. In Europe, coronary artery disease is responsible for 20% of deaths among women and 19% of all deaths among men each year, according to the European Heart Network.

“The second Phase 3 study of Flurpiridaz ¹⁸F represents a significant milestone in the development of this promising investigational agent,” said Mary Anne Heino, president and CEO of Lantheus in a prepared statement. “Importantly, it illustrates our strong collaboration with GE Healthcare, and we look forward to the continued progress of the clinical program.”

Kevin O’Neill, General Manager of Core Imaging for GE Healthcare, said, “We are thrilled to see this critical stage of the study move forward. We are committed to the development of a potential new diagnostic option for clinicians and their CAD patients in the future.”

Under the 2017 agreement, GE Healthcare will lead and fund the development of flurpiridaz ¹⁸F, including the second Phase 3 clinical study. GE Healthcare will also have exclusive worldwide rights for the commercialization of Flurpiridaz¹⁸F. Lantheus was to receive $5 million up front as part of the deal, with an opportunity for up to $60 million in regulatory and milestone payments, as well as royalties inside and outside the US. Lantheus also agreed to collaborate in both the development and commercialization process and maintains the option to co-promote the agent in the United States.

 

 

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ITC backs Hologic in mammography patent spat with FujiFilm

Hologic (NSDQ:HOLX) said yesterday that a US International Trade Commission Administrative Law Judge ruled in their favor in an investigation into a patent infringement complaint filed against Fujifilm Holdings (TSE:4901).

Marlborough, Mass.-based Hologic said the complaint was related to x-ray mammography with tomosynthesis and other related mammography tech found in its Selenia Dimensions and 3Dimensions systems.

The judge ruled that Fujifilm infringed on all of the patents brought to trial and rejected Fujifilm’s defense against the patents, according to a Hologic press release. The judge also recommended an exclusion order to prevent further importation into the US and a cease-and-desist order to prevent sale and marketing in the US.

Hologic said that a final ruling from the ITC is scheduled to be issued by November 26.

“We are pleased that the Administrative Law Judge has upheld the integrity of our intellectual property against Fujifilm. We are confident that the Commission will uphold the decision to issue both an exclusion order and a cease-and-desist order covering Fujifilm’s infringing products.  As the world leader and innovator in mammography, we will continue to vigorously protect our intellectual property, which drives innovation for our customers and patients,” breast and skeletal health prez Pete Valenti said in a press release.

Last week, a federal court jury awarded nearly $5 million in damages in a patent infringement lawsuit brought over their respective endometriosis devices.

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Merit Medical closes $217m offering

Merit Medical (NSDQ:MMSI) said yesterday that it closed a stock offering worth more than $217 million after the underwriters picked up their option.

South Jordan, Utah-based Merit floated 3.5 million shares at $54 apiece and sold another 525,000 shares in the underwriter’s allotment, for gross proceeds of $217.4 million.

The net proceeds of roughly $204.9 million are slated to repay debt under an existing credit facility, Merit said.

Wells Fargo Securities and Piper Jaffray were joint bookrunners and represented the underwriters in the offering, with Canaccord Genuity, Raymond James, SunTrust Robinson Humphrey, Barrington Research and Sidoti & Co. as  co-managers, the company said.

Last week Merit posted second-quarter earnings and sales that came in ahead of expectations and raised its outlook on the rest of the year.

MMSI shares were up 0.1% at $53.05 apiece today in early trading.

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Fresenius extends deadline for $2B NxStage buyout, tops Q2 earnings forecast

Fresenius (NYSE:FMS) said today that it’s extending the deadline to close the $2 billion buyout of NxStage Medical (NSDQ:NXTM) by 90 days and posted second-quarter earnings that beat the consensus forecast.

The German dialysis giant said it moved the merger deadline from August 7 to Nov. 5, but still expects to close the deal this year.

For the three months ended June 30, Fresenius reported profits of €994 million, or €3.24 per share, on sales of €4.21 billion. The whopping 268.5% bottom-line gain came despite a -5.7% sales slide compared with Q2 2017.

Adjusted to exclude one-time items, earnings per share were €0.89, ahead of the €0.85 consensus.

“In the second quarter, we have seen solid growth resulting in a strong net income increase of 22% at constant currency – excluding the positive impact of the successful and efficient closing of the Sound Inpatient Physicians divestment. On the back of the strong development of our products business and continued growth of our services business, we expect growth to further accelerate in the second half of 2018,” CEO Rice Powell said in prepared remarks.

Fresenius said it expects adjusted profits to grow between 7% and 9% on a constant-currency basis this year, on sales growth of 5% to 7%, excluding the impacts of the NxStage buyout and the SIP sale.

In New York, the news sent FMS shares down -2.2% to $48.76 apiece today in early trading. In Frankfurt, FRE shares were down -3.9% to €66.08.

($1 = €0.853715)

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How to implement electronic Regulatory Binders in your study

Melissa Wollerman, Clinical Research Associate, IMARC Research

In a previous blog published towards the end of 2013 titled “Essential Documents – What Will Regulatory Binder Look Like in 5 Years?”, the blog encompasses the potential of Regulatory Binders becoming electronic. Now, almost five years later, many sites and sponsors have explored and implemented the electronic filing capability.

According to the applicable Federal Regulations, the following is noted on maintaining records:

‘A participating investigator must maintain the following accurate, complete and current records relating to the investigator’s participation in an investigation: (1) all correspondence with another investigator, an IRB, the sponsor, a monitor, or FDA, including required reports’. (CFR Title 21, Part 812.140 (a) Investigator records)

In ICH GCP, the following guidance is provided:

‘The investigator/institution should maintain the trial documents as specified in Essential Documents for the Conduct of a Clinical Trial and as required by the applicable regulatory requirement(s). Filing essential documents at the investigator/institution and sponsor sites in a timely manner can greatly assist in the successful management of a trial by the investigator, sponsor, and monitor.’ (ICH GCP 4.9.4 and 8.1)

As you may have noticed, the regulation and guidance do not mention how sites and Sponsors need to maintain the Regulatory Binder, only that they must be maintained.

Implementing an electronic Regulatory Binder may seem a bit out of your comfort zone; however, with the costs of office supplies, decreasing office space and a potential for misfiling, the benefits of electronic filing can be immense.

Technology is ever developing

An electronic trial master file, or eTMF, is an essential tool kept and maintained by the site and Sponsor to house all necessary regulatory documents throughout a study. Electronic filing can be utilized with the latest and greatest computer software, spreadsheets and charts; whatever it may be that keeps a site or Sponsor well organized.  

Increased productivity

The goal of electronic filing is aimed to be fast and efficient, eliminating tedious tasks such as printing, scanning and filing. Tracking down an Investigator for a signature on a regulatory document can be challenging at some sites. These valuable signatures can easily be captured in an electronic file, where the Investigator can complete at their leisure.

Fewer binders means more space

Many monitors, site or Sponsor personnel can attest to the fact that study binders take up a lot of space. These binders grow throughout a study and can crowd an area very rapidly. Rather than shuffling through these binders to find that one document you’ve been searching for, try creating a cloud-based filing system that allows you to store and access all study documents on any laptop or tablet.

Cost Effective

The cost of paper, ink and other typical office supplies can add up over the duration of a study. Looking into a cost effective electronic filing system can help save the site and Sponsor both time and money.

Enhanced Security

Have you ever experienced a site that does not maintain the Regulatory Binder in a locked, secure location? As mentioned in Daily Documentation Essentials: A Tour of the Regulatory Binder, “All Essential Documents should be stored in a locked cabinet or office. Only the study team, monitor and regulatory authorities should have access to study-related documentation.” What happens when a site does not maintain secured study-related documents? A safe option that many sites and Sponsors are leaning towards is role-based access software to implement safeguards throughout a study.

Have you changed your filing system in an effort to “go green” or to take advantage of the latest technological advances? If yes, how is this benefiting you?

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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Medtronic wins FDA nod to deliver PAH therapy with implantable pump

Medtronic (NYSE:MDT) said today that it won FDA approval for its implantable drug-delivery system designed to administer United Therapeutics‘ (NSDQ:UTHR) pulmonary arterial hypertension drug, Remodulin.

United Therapeutics is slated to take the lead on commercial promotion of the drug-device system, with support from Medtronic.

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

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Tandem posts mixed Q2 results

Shares in Tandem Diabetes Care (NSDQ:TNDM) fell this week after the insulin pump maker topped sales expectations but missed earnings estimates on Wall Street with its second-quarter financial results.

The San Diego, Calif.-based company posted a net loss of -$59.4 million on sales of $34.1 million for the 3 months ended June 30, for sales growth of 60% compared with the same period last year.

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

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SeaSpine posts mixed bag Q2

Shares in SeaSpine Holdings (NSDQ:SPNE) have stayed steady after the medical device maker posted second quarter earnings that topped Wall Street’s sales consensus but missed losses-per-share expectations.

The Carlsbad, Calif.-based company posted losses of $7.4 million or 50¢ per share, on sales of $36.4 million for the three months ended June 30, seeing losses shrink 8% while sales grew 6.5% compared with the same period during the previous year.

Losses per share were just behind the 48¢ consensus on Wall Street, where analysts expected to see sales of $34.7 million, which the company topped.

“We are pleased to report strong operating performance, which reflects solid revenue growth and gross margin expansion. We continue to advance our strategic objectives driven by our innovative product pipeline, strengthening distribution footprint and expanded and more effective medical education and training programs,” prez & CEO Keith Valentine said in a press release.

The company released updated full-year 2018 sales guidance, expecting to post revenue of between $136 million and $139 million for growth of between 3.2% and 5.5%.

Shares in SeaSpine didn’t move today, closing at $12.25.

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Cardiovascular Systems shares steady on Q4, FY2018 earnings beat

Shares in Cardiovascular Systems (NSDQ:CSII) have stayed steady in after-hours trading after the medical device maker posted full year and fourth quarter fiscal year 2018 earnings that beat expectations on Wall Street.

The St. Paul, Minn.-based company posted profits of $3.7 million, or 11¢ per share, on sales of $59.2 million for the three months June 30, seeing massive 384.1% growth on the bottom-line while sales grew 11.8% compared with the same period during the previous year.

Earnings per share beat the 6¢ expectations on Wall Street, where analysts expected too see sales of $58.2 million, which the company also topped.

For the full year, Cardiovascular Systems posted profits of $1.7 million, or 5¢ per share, on sales of $217 million, seeing a nearly 200% turn from red on the bottom-line while sales grew 5.9% compared with the previous fiscal year.

Earnings per share beat the null consensus on Wall Street, where analysts expected to see sales of $216 million, which the company topped.

“We are driving strong growth and market-leading performance in our coronary and peripheral atherectomy businesses through strong sales execution in the United States, new product introductions and the launch of our business in Japan. We successfully delivered annual revenue growth and our first annual net profit despite experiencing temporary business disruptions early in fiscal 2018. Throughout the year, we remained focused on fulfilling our mission to serve patients suffering from coronary and peripheral artery disease. In total, our orbital atherectomy systems were used in the treatment of over 67,000 patients. Fiscal 2018 included important milestones for CSI as we introduced important innovations on our existing peripheral and coronary orbital atherectomy systems. We also began expanding our product portfolio with procedure support products and launched orbital atherectomy in Japan, our first international market. We anticipate that growth in orbital atherectomy, a broader product portfolio and international expansion will remain important growth drivers in future periods,” prez & CEO Scott Ward said in a press release.

Cardiovascular systems posted outlook for the coming 2019 fiscal year, expecting to post sales of between $240 million and $250 million, with gross profit as a percentage of revenue of about 80%.

Shares in Cardiovascular Systems have stayed steady in after-hours trading after dropping approximately 1.2% today, closing at $33.51.

In May, Cardiovascular Systems posted black ink for its fiscal third quarter as it bested the consensus earnings estimate on Wall Street despite just missing the sales forecast.

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Report: Cook Medical warns of Brexit-imposed UK importation issues

Cook Medical is concerned that the Brexit may affect its ability to export products from Ireland to the UK after 2020, according to a new Irish Times report.

The Bloomington, Ind.-based company, which employs 850 people in Limerick, Ireland, is looking to extend a transition agreement originally slated to end in 2020 until 2025 to allow it and other medtech companies to meet regulatory requirements in the UK and avoid product delays.

Cook Medical didn’t state any concerns related to its employee base in Ireland or revenues, but did say that patients in the UK would likely be hurt if the deal wasn’t extended, the Irish Times reports.

With the Brexit, companies that previously traded without restrictions in the UK will have to deal with a different set of rules for importing and exporting products and components, according to the report.

Devices such as drug-eluting stents may face serious issues with importation, according to Cook European government and regulatory affairs director Emmet Devereux, as they would require separate approvals for two critical components, the Irish Times reports.

“Considering the importance of medtech to the Irish economy, we believe it is not only in the industry’s best interests, but ultimately in the interests of patients that the transition agreement is extended to avoid disruption to an integral part of the national economy,” Devereux said, according to the report.

Earlier this month, Cook Medical announced the launch and first use of its Advance CS coronary sinus infusion catheter and Compass CT disposable pressure transducer designed for treating heart failure patients.

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Zoll claims $5m win in AutoMedx dispute

Zoll Medical said today that it won more than $5 million with an arbitrator’s decision in its spat with former partner AutoMedx.

Coppell, Texas-based AutoMedx sued the Asahi Kasei (TYO:3407) subsidiary in 2015, alleging breach of contract after Zoll’s Advanced Circulatory Control Systems business spiked a product development deal “due to AutoMedx’s failure to perform,” Zoll said.

The case went to arbitration, which resulted in a $1.8 million damages award and another $3.6 million award to cover legal fees, according to Chelmsford, Mass.-based Zoll.

“We are pleased that the arbitrator found ACSI’s termination of the AutoMedx contract to have been proper and that ACSI was entitled to a refund from AutoMedx of its development costs, as well as an award of a substantial amount of the attorneys’ fees and costs that Zoll incurred in the arbitration,” Zoll CEO Jonathan Rennert said in prepared remarks. “It is unfortunate that AutoMedx chose to pursue litigation, as the arbitrator completely exonerated Zoll and ACSI from any liability to AutoMedx whatsoever.”

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SFC Fluidics lands JDRF support for interoperable insulin patch pump

SFC Fluidics said today that it inked a deal with JDRF to support the development of an insulin patch pump with open-protocol communication features.

SFC Fluidics plans to use the two-year funding deal from JDRF to speed up the development of a patch pump that securely connects with other devices, like a continuous glucose monitor and third-party algorithms, to automate insulin delivery.

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

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Cerapedics launches P-15L peptide-enhanced bone graft IDE trial

Cerapedics said today it launched a new investigational device exemption trial looking to explore the safety and efficacy of its next-gen P-15L peptide enhanced bone graft in transforaminal interbody fusion surgeries.

The Westminster, Colo.-based company said it has enrolled the first patients in the study, which aims to enroll a total of 364 patients with degenerative disk disease at 30 sites across the US.

“We are pleased to announce enrollment of the first patients in our IDE study in TLIF procedures. More than 300,000 people in the U.S. suffer from degenerative disk disease that leads to pain and nerve irritation and often requires surgery. Our first-generation bone graft is already approved for anterior cervical discectomy and fusion procedures, and this pivotal study in TLIF procedures will be instrumental in a second premarket approval application for our next-generation P-15 technology in the years ahead,” CEO Glen Kashuba said in a press release.

The trial will compare the company’s P-15L enhanced bone graft against an autologous bone graft during TLIF surgery, Cerapedics said. The P-15L bone graft is based on biomimetic small peptide tech intended to support bone growth through cell attraction, attachment and activation.

“This important first patient enrolled signifies the culmination of substantial efforts on the part of many external and internal collaborators. We are grateful for all of the efforts that have gotten us to this point and are excited about the future of this study and the P-15L Bone Graft technology. We would like to give special thanks to Dr. Small and his clinical research team for enrolling the first patient,” prez & COO Jeffrey Marx said in a prepared statement.

Earlier this month, Cerapedics said that it closed a $22 million round of financing and added three new members to its board of directors

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Spine Wave raises $5m

Spine Wave has raised $5.3 million in a new round of debt financing, according to a recently posted SEC filing.

Money in the round came from 29 unnamed investors, with the first sale noted as having occurred on July 17 of this year, according to the filing.

The Shelton, Conn.-based company is looking for an additional $199,502 in the round before it closes, according to the filing.

Spine Wave has not yet stated how it plans to spend funds raised in the round.

Last July, Spine Wave said that it completed an initial limited market release of its Leva AF interbody device for anterior lumbar interbody fusion procedures.

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The future of Abbott’s electrophysiology business

At DeviceTalks Minnesota 2018, medtech veteran Michael Pederson provided an inside look at the Abbott-St. Jude Medical merger and what’s ahead for Abbott’s cardiovascular technologies

Pederson tracked his career from a formative stint at HP to his current role as SVP of cardiac arrhythmias and heart failure at Abbott (NYSE:ABT).

To learn more from the brightest minds in medtech, don’t miss DeviceTalks Boston on Oct. 8-10

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Boston Scientific-backed gBeta accelerator picks 6 new startups

Minneapolis-based, Boston Scientific (NYSE:BSX) backed medtech accelerator Gener8tor announced six new entrants into its summer gBeta Medtech program last Wednesday, according to a MinneInno report.

The gBeta accelerator, which is also supported by the Medical Alley Association, the University of Minnesota and the Mayo Clinic, will host the six companies in a free, seven-week long session.

The program is designed to aid the startups in gaining insight on product development and customer traction and establishing metrics to seek selection into full-time accelerators or for finding seed investors, according to the report.

Included in the accelerator are St. Louis-based Intershunt, San Francisco-based Lucia Health Guidelines, Minneapolis-based Morari Medical and SuraMedical, Houston-based Noleus Tech and Boston-based Sunrise Healthy according to MinneInno.

Intershunt is designing and developing a catheter-based minimally-invasive procedure for individuals with heart failure and Lucia Health Guidelines is looking to use artificial intelligence and machine learning to improve adherence to American Heart Association guidelines, according to the report.

Morari Medical is looking to aid in the confidence of male individuals with sexual dysfunction while SuraMedical looks to increase chronic leg wound treatment consistency through remote monitoring, according to the report.

Noleus Medical is developing a disposable device that aims to mitigate postoperative bowel swelling after abdominal surgery while Sunrise Health looks to provide patients with mental health or substance-abuse issues with anonymous, text-based group support, according to MinneInno.

In March, Boston Scientific joined the Mayo Clinic and the University of Minnesota in backing Gener8tor as it launched the gBeta medtech focused incubator in Minneapolis.

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Nevro, Boston Scientific bury the hatchet

Nevro (NYSE:NVRO) said today that it agreed to bury the hatchet with Boston Scientific (NYSE:BSX) in their patent infringement spat over high-frequency spinal cord stimulation technology, sending its share prices up in mid-day trading.

Last week a federal judge in California issued a mixed ruling in the case, finding that six claims in three of the Nevro patents are eligible but also that Boston’s SCS devices don’t infringe those claims (Boston doesn’t have a competing high-frequency SCS device on the U.S. market).

Judge Vince Chhabria of the U.S. District Court for Northern California, who ruled earlier this month that any claims in the patents describing a non-paresthesia-producing therapy effect are indefinite, also found that Boston’s use of the Spectra WaveWriter device in its Accelerate study doesn’t infringe because it falls under the clinical trial safe harbor even after the patients have completed the study.

The judge also found that Spectra WaveWriter in commercial use doesn’t infringe because it does not operated at high frequencies; that claims Nevro asserted in four of the patents are invalid as indefinite; and that practicing those claims in Europe does not infringe according to U.S. patent laws.

Today Nevro said the companies filed a joint statement proposing the dismissal of the case without prejudice, “on the basis of Boston Scientific’s representations to the court that it has no plans to launch a high frequency product in the U.S.”

Nevro had assumed that Boston would seek FDA approval immediately following the planned release of Accelerate high-frequency data in early 2017, but the release was delayed and last week Boston extended the timeline by another nine months.

“In the parties’ joint statement, Boston Scientific represented to the court that, as of now, it has not decided whether to launch a high frequency product and has not established a timeline for when such a decision might be made, if ever,” Nevro said today. “On the basis of Boston Scientific’s representations, Nevro and Boston Scientific agreed to dismissal of Nevro’s declaratory judgment claims without prejudice on the grounds that the dispute between the parties is not ripe.”

Nevros said it still thinks that Chhabria’s decision precludes its rival from launching a high-frequency system in the U.S. and still plans to appeal the portions of his ruling that went against it.

NVRO shares ticked up 0.2% to $55.98 apiece today in the face of wide declines across the market. BSX shares were off -2.2% to $33.03 each, likely reflecting those declines.

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LVAD Efficiency and the Criticality of Accurate Blood Pressure Measurement

Machine-to-machine communication (M2M) refers to the sharing of information between two devices. It is a key component in the rapidly growing “Internet of Things” (IoT), the increasing connectivity of devices in the home, workspaces, industry, and beyond. M2M communication can be as simple as the unidirectional transfer of data or as complex as multiplexed signals that allow devices to share a decision-making process. Within medical device manufacturing, M2M communication is one of the fastest growing sectors. According to projections by Global Info Research, the market for connected medical devices will expand from $939 million in 2018 to $2.7 billion by 2023, with the largest growth projected for the United States.

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CarboFix wins FDA nod for its carbon/PEEK pedicle screws

CarboFix Orthopedics Ltd. has won FDA approval for a spinal screw system for use in people with advanced spinal cancer.

The CarboClear carbon fiber pedicle screw system was designed to restore the integrity of the spinal column, even in the absence of fusion, for a limited time period in patients with advanced-stage thoracic and lumbar spine tumors. The screw system will hold the spine securely until patients are able to undergo spinal fusion, according to the Herzeliya, Israel-based company. The FDA gave the system 510(k) clearance.

CarboClear pedicle screws are made of continuous carbon fibers reinforced polymer (PEEK). The PEEK adheres the fibers together, and the continuous carbon fibers are layered in a unidirectional, longitudinal orientation, as well as in helical/diagonal orientation, according to the company’s website. The material makes the CarboFix implants radiolucent, which is beneficial during surgery and follow-up.

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

 

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FDA user fees set to rise 4% in fiscal 2019

The FDA last week set the user fee rates for fiscal 2019, which is slated to begin in October, raising the fees across the board by nearly 4%.

Medical device makers pay user fees to have the FDA review their products. The rates jumped by more than 33%, with the fee for one popular protocol jumping more than 125%, for fiscal 2018.

The fees for small businesses making less that $100 million annually, and for their larger brethren, are paid to the FDA’s Center for Devices & Radiological Health.

The agency cut the fees by -2.9% for fiscal 2015, having raised them by 4.2% for FY2014.

Here’s how this year’s changes break down:

Application type	Fee for FY19	Fee for FY18	% change	Small business fee FY19	Small business fee FY18	% change
510(k) premarket notification submission	$10,953	$10,566	3.7%	$2,738	$2,642	3.6%
513(g) request for classification information	$4,349	$3,166	3.7%	$2,175	$2,098	3.7%
PMA, PDP, PMR, BLA	$322,147	$310,764	3.7%	$80,537	$77,691	3.7%
Panel-track supplement	$241,610	$233,073	3.7%	$60,403	$58,268	3.7%
180-day supplement	$48,322	$46,615	3.7%	$12,081	$11,654	3.7%
Real-time supplement	$22,550	$21,753	3.7%	$5,638	$5,438	3.7%
Annual fee for periodic Class III reporting	$11,275	$10,877	3.7%	$2,819	$2,719	3.7%
30-day notice	$5,154	$4,972	3.7%	$2,577	$2,486	3.7%

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Bayer fires back against Essure safety claims

Bayer (ETR:BAYN) last week fired back against claims that its Essure permanent birth control device is less than safe and effective after having announced plans to pull the device from the shelves in the US a week earlier.

Last Thursday, the pharmaceutical giant published a press release lauding the device as the only FDA-approved non-incisional form of permanent birth control and reiterating the its safety profile “remains positive and unchanged.”

Bayer suggested that there is “no reliable scientific evidence” suggesting its Essure isn’t safe, and said that recent concerns were merely “based on anecdotal reports, rather than science.”

“While Bayer takes any adverse event report seriously, the FDA has repeatedly cautioned that adverse event reports can be ‘incomplete, inaccurate, untimely, unverified or biased’ and duplicative, and that adverse event reports alone cannot be used to determine rates of events or causation. Indeed, in 2015 FDA reviewed the safety data for Essure and did not identify new safety or efficacy concerns,” Bayer wrote in a press release.

The company also expressed concerns about “the ongoing public promotion of Essure removal” as well as “inaccurate or misleading information spread by third parties” that would suggest the use of hysterectomies as a solution to issues with the Essure implant. Bayer said that its instructions for use state that “hysterectomy generally is not required to remove the Essure inserts,” according to the press release.

The release pre-empted the posting of a CNN report claiming that the company made $2.5 million in legal, but controversial, payments to doctors between 2013 and 2017 related to Essure consulting fees and other services, as well as the posting of a Netflix documentary critical of the medical device industry with a specific focus on Essure patients.

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J&J seeks retraction of paper critical of Pinnacle hip study

Johnson & Johnson (NYSE:JNJ) are looking to get a scholarly paper challenging the validity an internal study of its DePuy subsidiary’s Pinnacle metal-on-metal hip systems retracted, according to a Stat News report.

The study and journal paper were published by Brown University’s Dr. David Egilman and accused the J&J study of “grave fraudulence,” according to the report.

The paper, which was based on an analysis of internal documents, claims that J&J’s trial was a “seeding study” intended to market the device and not test safety and efficacy. The paper also includes claims that J&J didn’t appropriately protect it subjects or obtain appropriate Institutional Review Board approval at all of its study sites.

Authors of the critical paper said that the initial Pinnacle study served as the basis for a number of other studies and indicated the metal-on-metal hip system experienced a low rate of serious complications and a 99.9% survivorship at five years, according to Stat. The survivorship rate was used in marketing materials for the company, despite the company’s worldwide clinical research VP claiming that the data did “not accurately reflect the data” coming from investigator sites.

Johnson & Johnson recently submitted a six-page letter to the publishers of the journal where the study critical of the Pinnacle trial was published, claiming it “contains numerous factual errors that undermine its conclusions,” and claimed conflicts of interest baed on the fact that Dr. Egilman and other authors served as expert witnesses in cases involving Pinnacle hip implants.

The request, submitted by J&J medical devices biostatistics director Jim Lesko, initially demanded either a retraction of the paper or the publication of the letter critical of Dr. Egilman’s paper, though J&J later dropped interest in publishing the letter, according to Stat.

Dr. Egilman and his colleagues responded with their own 32-page letter rebutting the rebuttal, according to the report, and said they would be fine with Lesko’s letter being published.

“Needless to say this is a baseless request and merely an effort to bully the medical and scientific community to acquiesce to corporate crime never mind irresponsible and unethical conduct,” Dr. Egilman wrote in a letter to the journal publisher, according to Stat.

Last November, a Dallas federal jury ruled that J&J and DePuy Orthopaedics must pay $247 million to six patients claiming to be injured by its Pinnacle metal-on-metal hip implants.

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Hologic wins $5m from Minerva Surgical in patent infringement spat

A federal court jury last week awarded Hologic (NSDQ:HOLX) nearly $5 million in damages in a patent infringement lawsuit brought over their respective endometriosis devices.

Hologic’s NovaSure ablation device, acquired with the 2007 buyout of Cytyc (which acquired NovaSure developer Novacept in 2004), competes with Minerva’s Aurora device. Hologic sued Minerva in November 2015 in the U.S. District Court for Delaware, alleging infringement of a pair of patents after Novacept CEO Csaba Truckai founded Minerva in 2008. (Minerva sued Hologic for patent infringement in April 2017 in a California federal court; that case is still under way after being transferred to the Delaware court in February, according to court documents.)

The jury in Delaware returned a verdict July 27 in favor of Hologic, according to the documents, awarding $$4.2 million in damages for lost profits and $587,000 for lost sales royalties of 8%.

“We are extremely pleased with the court’s ruling and the jury’s verdict, which together validate Hologic’s assertions of patent infringement by Minerva Surgical and recognize the value of our intellectual property,” GYN surgical solutions president Sean Daugherty said in prepared remarks. “As the maker of the NovaSure system, we are committed to delivering best-in-class products backed by strong clinical data for our customers and their patients.”

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Nanobiotix inks $47m financing to support nanomedicine development

Nanobiotix (PAR:NANO.PA) inked a non-dilutive financial deal with the European Investment Bank last week to support the development of its nanoparticle-based cancer therapies.

The Paris, France-based company said it landed a five-year loan to borrow up to €40 million ($46.7 million) contingent upon a set of performance milestones.

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

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