By Omar Ford, Staff Writer
Mallinckrodt plc has closed on a $690 million deal to sell its nuclear imaging business to St. Louis-based Iba Molecular Corp. The deal was first disclosed back in August of last year. The Staines-upon-Thames, U.K.-based company's imaging business produces the radioisotope molybdenum-99, from which technetium-99m is derived and is used in about 80 percent of all nuclear medicine procedures worldwide.
"Our view of an announced sale of the Nuclear Imaging business for $690 million is positive even if the divestiture takes away [about] $415 million in sales," said David Buck, an analyst with Northland Capital Markets.
However the business has recently dealt with significant headwinds. In 3Q16 the business had recorded sales of $104 million, down 4.4 percent on a nominal basis and down 4.7 percent on a constant-currency basis from $108.8 million in 3Q15.
This isn't the first deal in which Mallinckrodt has sought to reduce its imaging offerings.
About two years ago, the company sold its contrast media division to Villepinte, France-based, Guerbet LLC, for $270 million. In the deal, Mallinckrodt divested products in X-ray and MRI.
The Iba deal closure comes at the same time Mallinckrodt has inked a deal to divest its Intrathecal Therapy business to anesthesia-specialist Piramal Critical Care Inc., of Bethlehem, Pa. The $203 million deal is expected to be completed in 1Q17. Mallinckrodt's Intrathecal Therapy business markets products for the treatment of spasticity via intrathecal (spinal column) drug delivery. Its main product is Gablofen (baclofen injection), which was approved by the FDA for use in management of severe spasticity of cerebral or spinal origin in adult and pediatric patients age four years and above.
Mallinckrodt has been reshaping its portfolio through acquisitions over the past few years – becoming more of a pure play pharma company. In August, it picked up Stratatech Corp., a privately held regenerative medicine company focused on the development of skin substitute products.
In 2015, Mallinckrodt bolstered its hospital-based drug portfolio with the acquisition of Hampton, N.J.-based Ikaria in a transaction valued at about $2.3 billion. (See Medical Device Daily, Aug. 11, 2015.) Ikaria is focused on therapies and delivery systems for critically ill infants in hospital neonatal intensive care unit settings, and brought to the table Inomax, a continuous flow version of inhaled nitric oxide. Cleared by the FDA in 1999, the vasodilator is indicated to treat term and near-term neonates with hypoxic respiratory failure associated with pulmonary hypertension.
The company also picked up West Chester, Pa.-based Therakos Inc. for about $1.3 billion.
In its most recent earnings call, Mallinckrodt's president and CEO Mark Trudeau spoke about the deals and said the company is focused on acquiring highly durable assets, typically those that are under-resourced, and those that have relatively low patient penetration where the opportunity for long-term growth is driven predominantly by volume.
"We like specifically the hospital marketplace," Trudeau said. "We like the autoimmune and rare disease space because we believe these areas of the pharmaceutical industry typically are going to offer those types of assets."
OUT OF TROUBLED WATERS
Earlier this month, the company paid out $100 million to settle a Federal Trade Commission complaint that it and its Questcor subsidiary had engaged in anti-competitive behavior by acquiring Basel, Switzerland-based Novartis AG's Synacthen Depot, the rival drug to H. P. Acthar Gel. The FTC complaint said Mallinckrodt and Questocor had kept Synacthen Depot off the market to protect Acthar Gel profits. The settlement also includes a provision where Mallinckrodt must license the rights to Synacthen Depot to a competitor. The drugs offer treatment for infantile spasms.
Michael Waterhouse, an analyst for Morningstar, said Mallinckrodt's drug could face competitive headwinds over the long term.
"Regardless, we already incorporate increased competition and pricing pressure for Acthar Gel in our model due to potential emergence of therapeutic alternatives over the long term, and this development doesn't materially alter our outlook," Waterhouse said.
By Omar Ford, Staff Writer
Avinger Inc. reported positive two-year clinical data from the pivotal VISION study of its Lumivascular technology. The VISION study was designed to evaluate the Redwood City, Calif.-based company's Pantheris system, which received FDA clearance last year. (See Medical Device Daily, March 10, 2016.) Interim results from 55 patients in the study were released at the Leipzig Interventional Course conference.
Pantheris is used for directional atherectomy while allowing physicians to use real-time intravascular imaging to aid in the removal of plaque from diseased lower extremity arteries. The study was used to further clarify the utility of the device, said John Simpson, Avinger's founder and executive chairman.
"We have argued from the very beginning of the formation of Avinger, that if we can see inside the artery in a way that would allow us to treat the artery more safely and more predictably in better outcomes, that we could avoid things like stents and drugs," Simpson, told Medical Device Daily.
Data from the study showed that survival probability measured 86 percent freedom from target lesion revascularization (TLR) at 12 months and 82 percent freedom from TLR at 24 months.
A majority of lesions were treated using standalone optical coherence tomography guided atherectomy with the Pantheris catheter, with only 9.6 percent receiving adjunctive drug coated balloon (DCB) therapy and only 5 percent (n=10/198) receiving adjunctive stent therapy.
"We think for a two-year-follow up for an event analysis this is very compelling," Simpson added. "The critics will say we need to wait until the full data set is there. I think this data set looks so good because there is a consistent trend."
Joshua Jennings, an analyst with Cowen and Co. said the results were favorable and could help drive Pantheris' adoption rates.
"The positive durable efficacy data builds a stronger case for adoption of Pantheris as the evidence is highly competitive vs. results for DCB, bare metal stents and drug eluting stents," Jennings said. "We remain optimistic in the disruptive potential of Pantheris and the Lumivascular platform."
Pantheris incorporates lumivascular technology, which enables physicians to see inside the artery using optical coherence tomography. In the past, physicians, including Simpson, have had to rely solely on X-ray as well as touch and feel to guide their tools while they try to treat complicated arterial disease.
"I always found X-rays limiting," Simpson told Medical Device Daily. "I just couldn't see enough on the X-ray images to work safely on the arteries."
He said because of this conundrum he came up with the Pantheris concept – but ultimately the engineers at Avinger brought the concept to life.
Avinger is in plans to file a 510(k) submission of the next generation of Pantheris by the end of 2Q17. The device has an improved balloon inflation system and the balloon itself has undergone a re-design with a different material that affords higher compliance and more integrity.
"With the successful track record with the initial FDA approval of the Pantheris, the [company] could see a positive decision by late 3Q17 or early 4Q17," Jennings said.
The device goes up against some established contenders in the $400 million U.S. atherectomy market. One of the top technologies in the market is the Foxhollow line of catheters, which was acquired by Dublin-based Medtronic plc after several high profile mergers and acquisitions. Foxhollow Technologies Inc. and Avinger share a common tie – the med-tech entrepreneur Simpson.
He founded both companies and was once CEO of Foxhollow before it was acquired by Plymouth, Mass.-based Ev3 for $780 million in 2007.
About three years later, Covidien Ltd. acquired Ev3 for $2.3 billion in 2010. Medtronic then made its bid to acquire Covidien for $43 billion. (See Medical Device Daily, June 17, 2014.)
By Omar Ford, Staff Writer
Alphabet Inc.'s Verily Life Sciences LLC is set to receive $800 million in funding from Temasek, a Singapore-based investment company. A majority of the investment will be funded in the coming days, and the remainder will come in the second half of this year. In exchange for the funding, Temasek will receive a minority stake in the Mountain View, Calif.-based company, which was once Google's life sciences division.
This will be the first time Verily has taken funding from an outside investor, said Carolyn Wang, a spokesperson for Verily. The company primarily derives its funding from licensing deals and its parent company Alphabet.
"We see this as less about a capital need and more about having another advisor working with us, as we start to set our sights on Asia," Wang, told Medical Device Daily.
She noted that Asia represented 50 percent of the health care market and is an excellent opportunity for Verily. China represents Temasek's largest country by underlying asset exposure after Singapore, making up 23 percent of its $180 billion portfolio. The investment firm established a San Francisco office late last year.
The path to Verily's formation began two years ago when many of Google's elements broke off into independent units. (See Medical Device Daily, Aug. 12, 2015.) Those units were set up to be run by Google's holding company Alphabet. Shortly after that, Google's life sciences unit was re-branded as Verily.
Currently, Verily is part of Alphabet's Other Bets Bucket, the businesses that are separate from Google. Verily is one of three units within Other Bets Bucket that brings in revenue. For 3Q16, Other Bets revenue was $197 million, according to Alphabet's earnings report.
PARTNERSHIPS CONTINUE TO BE VERILY'S LIFEBLOOD
Verily has been a part of a long string of partnerships in both the med-tech and pharmaceutical space. The company has projects that span from the development of a smart contact lens with Novartis AG, to forming Galvani Bioelectronics with Glaxosmithkline plc. Galvani Bioelectronics will focus on developing bioelectronic medicines.
Verily strengthened its focus on the diabetes market and entered into an agreement with Dexcom Inc. The pact would have Verily and the San Diego-based company developing smaller continuous glucose monitoring products that are more affordable to the patient.
While Verily has been involved with a lot of projects, it hasn't been shy about sharing its progress. On Thursday, Verily gave an update on its Verb Surgical collaboration with New Brunswick, N.J.-based Johnson & Johnson Corp.'s Ethicon Endo-Surgery Inc. The surgical robotics company was created in 2015. (See Medical Device Daily, Dec. 11, 2015.) Verb demonstrated its first digital surgery prototype to both J&J and Ethicon executives.
The digital surgery platform prototype included all elements of the company's five technology pillars – robotics, visualization, advanced instrumentation, data analytics and connectivity.
"Completing this prototype milestone was an achievement that we aimed for a year ago, and I'm excited to say we achieved it and are on track with our development schedule," said Verb Surgical CEO Scott Huennekens.
One of Verily's largest joint ventures to date is a $500 million collaboration with Paris-based Sanofi SA to launch Onduo, a Cambridge Mass.-based company focused on combining devices with services to tackle diabetes. (See Medical Device Daily, Sept. 13, 2016.) Sanofi has invested $248 million in Onduo, and will have a 50 percent stake in the joint venture.
"What we're doing in diabetes is a really nice illustration of where we want to go in terms of our work on Ondou with Sanofi," Wang said. "We want to look at other therapeutic areas that have a great need like [diabetes] where [Verily] can have an impact."
The company has been working on several different projects for the life sciences space, which include breeding sterile mosquitoes to combat the Zika Virus and specialized spoons for Parkinson's disease patients. Verily has even tried to develop a device that could mimic the fictional performance of the Tricorder from Star Trek – a hand-held device used for sensor scanning, data analysis and recording data.
Wang said that the company was not putting restraints on developing ideas.
"We have an internal cultural value here that questions convention," she said. "We're not afraid to go tackle some of the hairier projects and think of new ways of doing things."
By Omar Ford, Staff Writer
Heart Test Labs Inc. (HTL) has raised about $12 million in its most recent funding round. The company is developing Myovista, an electrocardiography device, that it said could potentially fill the "diagnostic gap" in heart disease. HTL is currently vying for approval of Myovista in Europe.
"We're on the cusp of going to market [in Europe]," Andrew Simpson, executive chairman of Westlake, Texas-based HTL, told Medical Device Daily. "Fingers crossed, we expect to get CE mark approval this quarter. This round is going to be used to build up the sales capacity of the company to support revenues. The funding is also going to support the ongoing clinical work as well as further product development."
Simpson said the company was also seeking FDA approval, but that could come later.
HTL was formed in 2009 and including the most recent funding round, the company has raised $33 million since inception.
"All of that money has been raised from private investors," he said. "Some of our investors invested in 2009 and 2010 and they continue to be very supportive in multiple rounds."
If approved, Myovista could help provide a non-invasive, low cost screening to identify asymptomatic patients before an adverse cardiovascular event occurs. Existing ECG technology is generally not considered effective for use on asymptomatic patients. The U.S. Preventive Services Taskforce and other health care bodies around the world recommend against screening with resting or exercise for the prediction of coronary heart disease events in asymptomatic adults at low risk for coronary heart disease events. Myovista uses standard 12-lead resting ECG protocols and provides an ECG test incorporating interpretive analysis that can assist a physician in identifying heart disease at an early stage. HTL said that electrophysiological signals at the cellular level of myocardium are related to specific patterns on the Myovista device.
"Because it's an ECG it's a low-cost technology and that means physicians can use it much more easily for screening purposes," Simpson said.
HTL is involved in several studies of the device. In Dec. of 2015, the company announced the clinical study of its Myovista device by Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center. The 200-patient study sought to compare the results of the Myovista test to an established testing method, cardiac computed tomography angiography.
The market for Myovista and cardiac monitoring devices is projected to reach $28 billion by 2021 from $22.19 billion in 2016, at a change of growth rate of 4.8 percent, according to a report from Markets and Markets.
Although HTL said it doesn't have any direct competitors, companies like Irhythm Technologies Inc. are seeking to change the cardio-diagnostics paradigm. The San Francisco-based company has developed Zio, a patch-like device worn by the patient for up to 14 days and records every single heartbeat of information that the person has. Simpson said the market is ripe for new cardiovascular diagnostic technologies.
"How do most people find out they have heart disease? They have an adverse event," Simpson said. "There are lots of screening tests in lots of areas – such as cancer – that are highly effective at catching things at an early age, but there is nothing effective in heart disease."
He added HTL is very hopeful it could catch people at an early stage before an event and that could save the health care industry billions of dollars each year.
By Omar Ford, Staff Writer
Johnson & Johnson Corp. (J&J) forecast lower-than-expected 2017 sales but managed to beat Wall Street expectations for its 4Q16 earnings. In addition, the New Brunswick, N.J.-based company said it could potentially sell off its diabetes care businesses amid disappointing sales.
Tuesday's news was mixed at best. While 4Q16 adjusted earnings per share of $1.58 exceeded analysts' consensus estimates of $1.56, J&J drew criticism for its soft 2017 guidance.
The firm forecast 2017 adjusted earnings of $6.93 to $7.08 per share – below the average analyst estimate of $7.11 per share.
Joshua Jennings, an analyst with Cowen and Co. said 2017 guidance "tells a deeper than expected deceleration story for the crown jewel Pharma franchise and has offset the strong 4Q print."
Part of the reason for the low guidance stems from headwinds J&J's pharmaceuticals division is facing.
Particularly, J&J's biologic immune disorder drug's revenue dropped 3.3 percent to $1.62 billion in 4Q16. The firm's Remicade had been a strong revenue stream for nearly 18 years but has been taking a pounding from Pfizer Inc.'s Inflectra. The New York-based company received approval for the biosimilar in April 2016 but launched the product in October. The products treat rheumatoid arthritis, psoriasis, Crohn's disease and colitis.
"Full-year operational sales growth guidance for  reflects management's expectations for a pharma slowdown as the unit's significant success has created difficult comps and the Remicade biosimilar launch will have an impact," Jennings said.
But all is not lost for J&J in the immunology drug market, said Damien Conover, an analyst with Morning Star.
He said other immunology drugs, including Stelara and pipeline drugs guselkumab and sirukumab, should help stabilize the franchise for J&J.
Conover added that "the tepid growth is probably driving J&J to make acquisitions" and mentioned J&J's potential acquisition of Allschwil, Switzerland-based Actelion Ltd. The two companies have been in discussion for a potential merger for weeks.
During the call, J&J's Alex CEO Gorsky declined to give further detail on the possible acquisition.
DIABETES NO LONGER VIABLE FOR J&J?
There can be no denying that the diabetes monitoring and treatment space is exploding. Firms such as San Diego-based Dexcom Inc. have been gaining ground in diabetes. Unlikely competitors such as Google's Verily Lifescience's have begun to populate the diabetes market and have formed high profile partnerships with existing market players to bring new products to market.
However, the space has been a sore spot for J&J throughout 2016. The company took in sales of $1.8 billion from its diabetes businesses in 2016, down about 7.2 percent from 2015. J&J's Lifescan unit was a highlight of the diabetes businesses and took in sales of $462 million, which was $41 million higher than analysts' consensus of $447 million.
Gorsky said J&J would welcome a potential sale, partnerships or other options for its diabetes businesses, which include Lifescan Inc., Animas Corp. and Calibra Medical Inc. These units sell blood glucose monitoring and insulin delivery devices.
He added that there's no guarantee this review would result in a transaction or when the review would be completed.
"This announcement is not terribly surprising given ongoing strip testing price erosion and increasingly less diabetes overlap with the existing J&J footprint," said Rick Wise, an analyst for Stifel.
DON'T CALL IT A COMEBACK
Nearly a year ago, J&J said it would lay off about 6 percent of its employees from its medical device division. (See Medical Device Daily, Jan. 20, 2016.) The company had been struggling with lagging device sales throughout 2015, prompting the firm to take such an action – which would save it about $1 billion.
Shortly after news of the layoffs, Artisian Partners began urging several activists to ask J&J to consider separating its pharmaceutical, medical device and consumer products divisions.
But J&J managed to turn its device division around.
"Our medical device business is refocused and has accelerated our pace of innovation," Gorsky said. "The [Medical devices unit] developed novel commercial models to meet the evolving needs of today's health care systems."
The company had device sales of $25.1 billion for 2016. Although sales saw a decrease of 0.1 percent vs. the prior year, domestic sales increased 1.1 percent. Medical device sales in 4Q16 of $6.44 billion beat analyst consensus of $6.4 billion.
"New product launches are helping the device segment post steady gains that should accelerate in late 2017," Conover said.
One potential boon for J&J would be the products it would gain from its $4.33 billion acquisition of Abbott Medical Optics Inc. (AMO), which is set to close before the end of 1Q17. The company first announced it would acquire AMO from Abbott Laboratories in September 2016. (See Medical Device Daily, Sept. 19, 2016.)
"Our goal is to return to above market growth [in devices] by the second half of this year," Gorsky said.
By Mark McCarty, Regulatory Editor
The FDA final guidance for combination product good manufacturing practices (GMPs) grew by 10 pages compared to the draft guidance, but the final product was hailed as "a good guidance document" by Bradley Merrill Thompson of Epstein Becker & Green, the law firm that has represented the Combination Products Coalition on combo product regulatory matters before the FDA.
The January 2015 draft guidance for combo product GMPs followed a similar document published in 2004, which the agency eventually withdrew. This was followed in 2013 by the final rule for combo product GMPs, an effort the agency undertook due to the concerns expressed regarding the 2004 draft guidance.
The 2015 draft guidance offered a more streamlined approach to compliance than was seen in the 2004 document, and it offered substantially more in the way of specifics. One consideration that emerged in connection with the 2015 draft was that design controls would take a more central place in the agency's expectations than was previously understood to be the case, and manufacturers were advised to take measures to ensure their processes and documentation were in compliance as the agency's previous forbearance on these issues was expected to end. (See Medical Device Daily, Feb. 4, 2015.)
The 2015 draft guidance, which was the subject of an extended comment period at the behest of several requestors, distinguishes the terms "constituent part" and "component" per the regulations for both drugs and devices. However, the final version explained that Part 4 of Title 21 of the Code of Federal Regulations does not stipulate that a facility that makes only device components to be used in a combination product is necessarily subject to the quality systems regulations (QSRs), and likewise that a facility making active pharmaceutical ingredients for use in a combination product is not automatically subject to compliance with Part 211 if that API is made for use in a combination product.
One of the interesting excisions of the draft was a paragraph discussing the meaning of the term "where appropriate" regarding a manufacturer's determination of the applicability of drug and device GMPs. The draft guidance pointed to the fact that the manufacturing practices seen in one regulation may be sufficiently similar "to demonstrate compliance in whole or in part" with the other. This paragraph, which made reference to 21 CFR 211.192 and 21 CFR 820.100, is entirely absent in the final guidance.
In its comments to the docket for the draft, the Advanced Medical Technology Association had requested that the FDA provide more details as to what the agency would expect regarding compliance with drug-related provisions in Part 4. The final guidance added details such as the types of containers and closures that would be subject to testing, and it noted that two ASTM standards for sampling can be used to test components, containers and closures.
The Pharmaceutical Research and Manufacturers of America had responded to the draft in part with the observation that drugmakers have experienced "varying expectations" in terms of compliance with Part 4 during inspections handled by FDA investigators from different product centers. PhRMA also said the agency should update its policies and procedures manuals so as to ensure that FDA staff are up to date on the streamlined GMP approach, but noted that some drugmakers have indicated that FDA staff from the Center for Drug Evaluation and Research will not routinely consult with their counterparts at the Center for Devices and Radiological Health when reviewing prefilled syringes and combination products for respiratory therapy.
PhRMA argued further that Part 4 is not exhaustive in its description of the features of the Quality Systems Regulations that agency staff would expect to see in a combination product GMP system. The final guidance offered additional details for Part 820's mandates for design controls, including a brief discussion of how a drugmaker might demonstrate compliance by extrapolating from a syringe maker's data to deal with most such issues, with the only exception being how the contact between the drug and the syringe might affect the combination's safety and effectiveness profiles.
Brad Thompson, who along with several other attorneys with Epstein Becker & Green had represented the Combination Products Coalition, told Medical Device Daily, "we are delighted to see this final guidance." He said the final is a solid guidance document thanks in part to the fact that the agency "has been incorporating into its guidance not only answers to questions, but case studies that illustrate how FDA approaches these issues."
Thompson said the final guidance clarified the circumstances in which the products in a kit cause that kit not to be considered a convenience kit. He explained that when a kit includes products "otherwise modified from the independently marketed product," the kit is no longer a convenience kit. "This slightly revised language seems to indicate that the act of kitting alone would not 'modify' the product," he said, adding "it appears the intention is that such modification pertains to changes to packaging or labeling of the independently marketed product."
The final guidance also clarified that manufacturers will not have to routinely submit GMP information prior to clearance of 510(k)s, Thompson said, and that the final version drops the use of the word "sponsor" so as to eliminate confusion as to the facilities that have to demonstrate compliance with GMPs.
"There are, of course, a few areas where we have lingering questions, and we look forward to exploring those issues with FDA," Thompson said, adding, "I think the agency is planning to do educational programs through some of the professional societies like RAPS, which will present an ideal opportunity for some dialogue and further understanding."
"On the whole, we are pleased" with the final guidance, Thompson said.
By Omar Ford, Staff Writer
Amedica Corp. is looking to raise $4.5 million through a public offering slated to close on Tuesday. The funding raise comes in the middle of the Salt Lake City-based company's bid to obtain clearance for its Valeo cancellous-structure ceramic cervical (C+Csc) implant. Amedica has been waiting for the FDA to green light the device for nearly two years now. (See Medical Device Daily, Feb. 13, 2015.)
Amedica said it will use proceeds from the offering to fund research and development and commercialization activities of its product candidates, including the funding of clinical trials. It will also use funding to help build its sales and market capabilities for its products.
The company said its Valeo C+Csc implant is designed to encourage the patient's own bone to grow into the porous structure.
Previously, FDA had inquiries regarding the firm's CASCADE trial, a study which compared the 24-month outcomes from the C+Csc implant. The agency had questions about the outcomes at earlier time points. In November FDA, declined to award 510(k) clearance for Valeo C+Csc.
News of the denied approval of the Valeo C+Csc implant caused shares of Amedica (NASDAQ:AMDA) to drop as much as 30 percent last November. Amedica regained some ground in December, as shares jumped up by seven percent after the company said it had encouraging data for Valeo C+Csc and refiled its application with the FDA. However on Friday, shares were down as much as 4.4 percent.
"Pending approval, we believe Amedica will then commence manufacturing, marketing and sales of the product in the U.S.," said Anita Dushyanth, an analyst with Zaks Small-Cap research. "That could be a big driver of interbody fusion device sales."
Amedica enjoyed some success in August 2016 when it received the FDA nod for additional sizes of its Valeo II lateral lumbar interbody fusion device. The company said the cleared sizes allow for greater accommodation for a wide range of patient anatomies as well as greater stability as the shape of the implant distributes weight over a larger surface area.
Amedica's most recent funding raise is one of several measures the company has used to garner additional capital.
In July 2016, the company brought in about $12.7 million in an underwritten public offering. And in October 2016, the company enacted significant cost-saving measures by reducing its workforce by 38 percent. The layoffs resulted in savings of about $2 million in annual cash operating expenses. The company said the action also incurred $465,000 in one-time severance and related costs, which would be recorded in the yet unreleased 4Q16 earnings.
During its most recent earnings call, Amedica CEO Sonny Bal said the company had "reduced its cash burn significantly" and "had reduced its debt."
Bal added, "the most important task in the forthcoming months is to validate our material science and material platform through increased spine sales."
If Amedica can gain approval for its C+Csc implant, it will still face a great deal of competition.
Zimmer Biomet Inc.'s Primagen autograft substitute is the device's most direct competitor. The Warsaw, Ind.-based firm launched the technology last month. (See Medical Device Daily, Dec. 15, 2016.) Zimmer Biomet said Primagen offers a combination of demineralized cortical bone fibers with verified osteoinductivity and cancellous bone, providing a trabecular structure for natural bony in-growth with optimal handling and delivery characteristics.
Primagen is moldable and delivered via a syringe rather than being a solid implant like Amedica's. It is indicated for use beyond the spine, and may be used in the repair, replacement, reconstruction or supplementation of tissue in other musculoskeletal defects.
By Omar Ford, Staff Writer
Banyan Biomarkers Inc. is getting $7 million in funding from in vitro diagnostics specialist Biomérieux SA to help develop a blood test for traumatic brain injury (TBI). In addition, the Marcy L'etoile-France-based company has also obtained the right to commercialize Banyan's TBI tests with its Vidas immunoassays range platform.
Banyan's test uses two brain specific protein biomarkers (Banyan UCH-L1 and Banyan GFAP) that rapidly appear in the blood after a brain injury. The San Diego-based company was founded in 2002 and is a spin off from the University of Florida.
"We are excited about the Biomérieux partnership because they have a very strong global presence with the Vidas family instrumentation," Tony Grover, vice president of business development for Banyan, told Medical Device Daily. "It will give us a chance to really get our biomarkers out there."
Grover said the company hopes to submit an FDA application for approval of its biomarkers for TBI in 2Q17.
"We are expecting this to be a clinical [in vitro diagnostic] test," Grover said. "This is not a research use only test."
To date, the company has had some success with previous studies of the UCH-L1 and GFAP biomarkers.
Results published in the November 2015 edition of Journal of Neurotrauma, show that UCH-L1 and GFAP, are detectable in blood shortly after a TBI. The prospective multi-center observational study included 251 patients with mild to moderate TBI who presented to seven emergency departments in the U.S. and Europe. All patients in the study underwent a CT scan as part of routine care and had blood drawn for biomarker analysis within six hours of injury.
According to the paper, the results demonstrate that within six hours of injury, UCH-L1 was very sensitive in identifying patients with a positive CT scan of the head. The authors also analyzed S100B, another potential blood based biomarker for TBI, and determined that S100B was not able to achieve the same performance as UCH-L1.
EXTRA FIREPOWER FOR BIOMÉRIEUX
The partnership stands to be beneficial to Biomérieux, which has had strong organic growth because of its Filmarray rapid test for infectious diseases, but now faces off against a growing number of competitors.
"If [Biomérieux's] impressive growth continues then the impact on product mix will be positive, but competitive threats may be looming," said Peter Welford an analyst with Jefferies.
The firm's margins were challenged from Basel, Switzerland-based Roche Holding AG's Smarticles Mdx technology for the rapid ID of resistant bacteria and antibiotic susceptibility. Roche acquired the technology when it picked up Geneweave Biosciences Inc. for $425 million. (See Medical Device Daily, Aug. 14, 2015.) The test cuts out the need for culturing.
Welford cited more competition for the company in the form point-of-care testing platforms, which include Genmark Diagnostics Inc.'s Eplex; Danaher Inc.'s Genexpert Omni and T2 Biosystems Inc.'s sepsis offerings.
Welford said that to ward off competitors Biomérieux's management must "execute further acquisitions to fend-off competitive threats, notably from potentially disruptive products."
NOT TIED DOWN IN TBI EFFORTS
Banyan's lifeblood comes from its partnerships with large medical device firms. In January 2016, the company was able to add Amsterdam-based Royal Philips NV to its growing list of collaborators.
The two entered into a multi-year joint development agreement to develop and commercialize a new handheld blood test to detect and evaluate mild TBI at the point of care. The new handheld test is based on Philips' Minicare I-20 system. The financial details of the agreement were not disclosed.
The company has a license agreement – dating back to 2014 – to use its assays on Abbott Laboratories Inc.'s Istat device, Grover said.
Banyan scored another high profile partnership with Lexington, Mass.-based Quanterix Corp. in August. (See Medical Device Daily, Aug. 2, 2016.) Under the agreement, the Quanterix Simoa platform would incorporate the Banyan UCH-L1 and Banyan GFAP assays to help further neurological research for improved TBI diagnosis and treatment.
"I really think companies are starting to realize this will be the future of diagnostics," Grover said in response to the Banyan's numerous partnerships. "The ability to get this information about the brain to health care providers to improve patient outcomes is extremely important to the patient, the caregiver, the family and payers as well."
By John Brosky, Contributing Writer
PARIS – A month earlier than expected, Dublin-based Medtronic plc said it has received the CE mark for the Corevalve Evolut R 34 millimeter transcatheter aortic valve implantation (TAVI).
The clearance for commercialization in the European Union follows approval by the U.S. FDA in October 2016, and rounds out the top end of the Medtronic TAVI portfolio that includes 23 millimeter, 26 millimeter and 29 millimeter valves.
"We look forward to working with physicians across Europe to offer this highly anticipated valve size to the thousands of patients who were previously unable to receive TAVI due to valve size," said Rhonda Robb, vice president and general manager of Medtronic's Heart Valve Therapies business.
Significantly, an XL version of the Evolut R surpasses the offering by the leader in the TAVI market, Irvine, Calif.-based Edwards Lifesciences, which tops out at with a 29 millimeter Sapien 3 valve.
Medtronic also may hold an edge over Edwards among physicians for the ability to reposition the valve during the implantation procedure.
"Consistent with the Evolut R platform, the 34 millimeter valve delivery system assists with accurate placement with the option to recapture and reposition if needed. This gives physicians great confidence that exceptional outcomes can be achieved for our patients" with large aortic root anatomies, said Darren Mylotte, interventional cardiologist at the University Hospitals and National University of Ireland in Galway, Ireland.
According to Robb the ability to treat patients with a larger native aortic annulus expands the eligible European TAVI patient population by 20 percent to 25 percent.
Significantly, the CE approval is for patients with an intermediate risk for undergoing traditional heart valve surgery, as well as for high and extreme risk patients. FDA approval does not include the intermediate risk patient group.
In a meeting with Medtronic management earlier in January 2017, Lawrence Biegelsen with Wells Fargo Securities LLC reported the company expected the Evolut R 34 would be available in Europe in February 2017 and that executives are confident it will drive strong growth.
According to Wells Fargo, Medtronic holds a 31.5 percent share of the European TAVI market, earning $332 million in sales revenue. That compares with a 52.3 percent market share for Edwards that is valued at $552 million in sales.
The leaders face increasing competition in Europe from new entrants such as St. Paul, Minn.-based St. Jude Medical (now part of Abbott Laboratories) with a 1.5 percent share, Natick, Mass.-based Boston Scientific Corp. capturing 7.4 percent of the European market and a cluster of other companies that have collectively claimed a further 7.3 percent market share.
In the U.S., where no valves are yet approved for new entrants, Edwards holds a 70 percent share of the TAVI market against 30 percent for the Medtronic Corevalve product line.
"It's important that patients with large aortic root anatomies can also have access to this recapturable TAVI system, which has proven to be an excellent treatment option for many patients," said Mylotte.
The Evolut R 34 millimeter valve is delivered through the Enveo R Delivery Catheter System, which features an Inline Sheath, which Medtronic states is the lowest delivery profile currently on the market at 16 French. The clinical advantage is to treat patients with smaller vessels through the transfemoral access route.
In August 2016, Medtronic issued a warning to physicians to not force the passage of the Enveo R catheter as it could puncture or damage a blood vessel. The warning was prompted by 39 cases where patients' arteries were damaged during the procedure. Nineteen of those patients died.
By Omar Ford, Staff Writer
Global Kinetics Corp. is taking a more personalized approach in monitoring Parkinson's disease symptoms. The Melbourne, Australia-based company has developed its Parkinson's Kinetigraph (PKG) system, an approved device that sits firmly in the digital health space.
Recently, the private company secured a CE mark for the second generation of the PKG. The second generation system boasts technological enhancements that could ultimately allow patients to continuously monitor their condition.
"PKG is a patient friendly algorithm based system," Timothy Still, president and CEO of Global Kinetics, told Medical Device Daily. "It has a smart watch that records the symptoms and body movements over the course of many days. It then transmits this information to the cloud, where the personalized treatment and management recommendations are offered for the clinician."
Parkinson's patients often experience fluctuations throughout the day where they may have their symptoms under control for a few hours and then suddenly they are "off." Those symptom fluctuations can be difficult to capture because patients don't always remember them during office visits or they struggle to put their symptoms into words. The technology also has the potential to help physicians and their patients make difficult decisions, such as when it might be time to consider a more aggressive therapy option like deep brain stimulation.
PKG first gained FDA clearance in 2014. (See Medical Device Daily, Sept. 15, 2014.) The company received FDA clearance for the second generation of the technology in September 2016. The company said it has an opportunity to move into the Huntington's disease space but would primarily keep its focus on Parkinson's.
The PKG device was developed by Australian neurologists at the Florey Institute of Neuroscience and Mental Health in an effort to provide an objective measurement tool for the symptoms of movement disorders.
DIGITAL HEALTH MARKET SET TO EXPLODE
Global Kinetics Corp. was founded in 2007, at a time when the digital health space was in its infancy and wasn't getting much attention.
"We were in digital health before it was cool to be in digital health, but for the reason of having better patient management and really giving them effective information," Still said.
Now the digital health space is exploding. A December report from Research and Markets shows that the digital heath market accounted for revenue of $76.7 billion in 2015, and is expected to grow at a compound annual growth rate of 21 percent by 2022. The topic of digital health even dominated the conversation during the final day of Cleveland Clinic's Medical Innovation Summit. (See Medical Device Daily, Oct. 28, 2016.)
Now high profile partnerships in the space occur such as Dublin-based Medtronic plc and IBM Watson Health collaboration to develop the Sugar.IQ with Watson, a first-of-its-kind cognitive app that helps detect important patterns and trends for people with diabetes.
Global Kinetics noted that traditional device and pharma companies would likely be drawn to more partnerships with Global Kinetics, to monitor the impact of treatment on patients.
Still said Medtronic, Abbott Laboratories and Boston Scientific Corp. could be potential partners because each company has access to deep brain stimulation technology. He noted that on the pharma side, Abbvie Inc. – with its Duopa formulation – could be a partner. Other companies developing drugs for Parkinson's include Neuroderm Ltd., Acorda Therapeutics Inc. and Cynapsus Therapeutics Inc.
There could also be partnerships from non-traditional health care companies like Google's former life sciences division, Verily Lifesciences, or Apple Inc. Still said while Verily and Apple could be potential competitors it might be more cost-effective to form collaborations. In the past, Verily has done just that, spreading across a variety of different disease states.
"If someone wants to get in on this space, then it will be a decision point – does someone want to take years of product development and gather clinical data to do it themselves, or does it make sense to partner with someone who has been the market leader since day one," Still said.
As far as direct competition, Still said he's not aware of another company in the space doing something similar to Global Kinetics.
"I'm like a lot of CEO's," he told Medical Device Daily. "I worry about the company we haven't heard about yet."