Abbott’s Confirm Rx Implantable Cardiac Monitor Connects to Smartphones, Food and drug administration Removed


Individuals at Abbott received Food and drug administration clearance for that Confirm Rx implantable cardiac monitoring device that wirelessly connects towards the patient’s smartphone. Cardiac tracks pass in the device towards the smartphone after which to the company’s online portal where cardiologists can observe the information anytime. By having the ability to immediately share occasions using the physician, patients could be diagnosed faster whether and what sort of cardiac arrhythmias they’ve already.

The individual simply installs the myMerlin application on their own phone and uses Bluetooth to sync towards the implant. An agenda is placed to maneuver saved data in the device, towards the phone, and also to the internet portal. All of the data transfers are encrypted to make sure privacy. If your patient feels that something might be happening using their heart, they are able to make use of the application to record time from the event and signs and symptoms being experienced. That’s pretty convenient, like a separate system is not needed to assist synchronize the cardiac waveforms towards the signs and symptoms, and time they happen.

A pleasant additional feature would be that the Confirm Rx is conditionally safe, meaning that it may be implanted as the patient receives an MRI scan, as lengthy as certain safeguards are taken into consideration.

Product page: Confirm Rx ICM…

Via: Abbott…

Editors

At Medgadget, we set of the most recent medical technology news, interview leaders within the field, and file dispatches from medical occasions from around the globe.

Philips showcases expanded cardiovascular care solutions at TCT 2017

Printed 31 October 2017

Royal Philips stated that it’ll showcase its lately expanded image-led therapy portfolio in the Transcatheter Cardiovascular Therapeutics (TCT) annual event in Denver, Colorado, that is being held between 29 October 29 and a pair of November.

Having a concentrate on cardiac and endovascular care, at TCT Philips will reveal its advanced interventional imaging systems, diagnostic and therapeutic devices, planning and navigation software, and services.

Philips is going to be showcasing its latest cardiac care solutions in ultrasound and image led therapy to supply enhanced patient care over the health continuum. Philips may also display its Dynamic Coronary Roadmap 2. with FFR/iFR Roadmap feature, so it lately received 510(k) clearance in the U.S. Fda (Food and drug administration) to promote. Philips’ unique portfolio enables clinicians to determine, guide, treat and ensure the right procedure, for the exact purpose to boost patient care at lower costs.

Next-generation image-led therapy platform

Every single day, a couple of,200 Americans die of coronary disease, averaging one dying every 40 seconds [1]. Within the U . s . States alone, 92 million adults live with coronary disease. Now more than ever before, the requirement for integrated image-led therapy solutions that connect interventional staff people, technology and knowledge is crucial.

Harnessing vital procedural information from various sources, for example imaging systems, interventional devices, navigation tools and patient health records, Philips’ Azurion next-gen image-led therapy platform offers a strategy to provide interventional staff people using the control and knowledge they have to perform procedures efficiently. Complementing Philips’ interventional X-ray systems, Philips also provides next-gen 3D TEE technology, which supplies for brand new amounts of live 3D imaging.

Onpar gps incorporate a new acoustic design with greater frequencies and bandwidth to supply elevated resolution and tissue filling. Furthermore, fast, simple and easy , confident transthoracic and transesophageal echo enables clinicians to identify surgical pathology instantly.

Diagnostic devices 

Philips may also debut its Refinity ST, the following-generation rotational intravascular ultrasound (IVUS) catheter. With exceptional deliverability, 5F guide compatibility, and 45 MHz high-resolution image, Refinity ST is made to help clinicians meet the requirements of the most complex percutaneous coronary interventional cases.

The lately Food and drug administration-removed iFR Roadmap technology, only at Philips’ interventional labs, enables physicians to navigate vessels and coronary arterial blood vessels instantly, guiding decision-making in treating coronary heart.

Philips’ CoreVision iFR co-registration solution along with the main IVUS and physiology technology, may be used within the stenting process when lesions tend to be more complex. CoreVision may be used in almost any interventional lab to map pressure gradients to the angiogram for precise lesion location, severity and length measurements. 

Therapeutic devices ]

The current purchase of Spectranetics expands Philips’ selection of therapy devices for coronary and peripheral artery disease. Only at that year’s congress, Philips will feature the Stellarex drug-coated balloon. Stellarex delivers top-tier clinical recent results for present with complex patients, targeting an underserved need within the fast growing peripheral vascular market.

Because the only commercially accessible drug-coated balloon with two reported randomized controlled trials, Stellarex has shown durability with consistently high patency rates in an array of patients.

“TCT offers the chance for all of us to talk about our expanded portfolio that aims to assist individuals impacted by coronary disease to return to living their lives,” stated Bert van Meurs, Business Leader Image Led Therapy for Philips. “In the congress this season, we’ll demonstrate how we are furthering our goal to assist clinicians decide, guide, treat and ensure the best therapies for his or her patients and supply safe and personalized treatments to allow faster recoveries while reducing costs.”

In the TCT booth this season, Philips may also host a number of short, daily presentations and live situation demonstrations on optimizing patient take care of coronary disease. Furthermore, Philips and Spectranetics holds a lunch symposium every day of TCT on various topics including, “Condition-of-the-art” PCI approach (learnings from SYNTAX II), imaging technologies for brand new valve therapies, and optimizing outcomes in coronary heart.  

Source: Company Pr Release

Health2047 spins out healthcare data discussing business

Money bag icon on blackboard with hand

Health2047 has spun out a technology company to talk about health data between patients, physicians, healthcare facilities, payers, pharma along with other healthcare enterprises, based on a news release.

Health2047 closed a $ten million Series A round for Health2047 Switch, however the spinout also received another $12 million, the discharge stated.

The move follows adding Celgene like a collaboration partner recently. The pharma company was introduced aboard by Health 2047 to assist build the bandwith business. Doug Given, Health2047 Chief executive officer, described at that time there was an interest in developing a method to move data better between pharmacies, patients, and physicians.

The offer reflects the driving pressure behind Health2047. The audience is associated with the Ama. It seeks to enhance the way digital health tools are developed and commercialize them through partnerships with established companies and startups.

Inside a phone interview with Given, he stated the funding could be utilized in part to improve staff. They of 14 would expand to 60-80 quickly the following 12 to 18 several weeks. The brand new hires is going to be mostly software engineers dealing with pilot customers and driving for scale.

Given stated the motivation behind the Switch is to produce a common mechanism to talk about data between greater than 100 major healthcare systems. To that particular finish, Switch works with every of Health2047’s stakeholders. The information transmission network includes Health Information Exchanges and let personal health records to become transmitted.

Adriaan Ligtenberg, a md with Health2047, will mind up Switch because the Chief executive officer. He formerly brought cardiovascular medical device monitoring business BMEYE BV, which Edwards Lifesciences acquired this year. Charles Aunger assists as CTO. He formerly offered as senior executive director from it at Stanford Healthcare.

“We is going to be at alpha and beta stage and also have a minimally viable product throughout the the coming year. Then we are moving beta users to general availability” in 2019, Given stated.

Photo: StockFinland, Getty Images

MedCity ENGAGE, October 23-24 in North Park, concentrates on the most recent strategies and innovations to boost patient engagement, care delivery and company wellness. Use code MCNTAG in order to save $50.

Atlantis Healthcare emite united nations documento sobre las mejoras en alianza terapéutica

LONDRES, October 31, 2017 /PRNewswire/ —

Atlantis Healthcare Limited., líder mundial en programas de cambio de conducta y auto-tratamiento de pacientes, ha publicado hoy su último documento centrado dentro del apoyo al auto-tratamiento en enfermedad crónica.

Enhancing Therapeutic Alliance and Promoting Shared Making Decisions examina cómo la comunicación colaborativa entre los profesionales del cuidado en salud y sus pacientes, a large amoun que denomina ‘alianza terapéutica’, puede llevar a la mejora de los resultados de los pacientes si se consideran las necesidades y preferencias de los propios pacientes. El documento explora además el papel desempeñado por las compañías farmacéuticas en la superación de las barreras para una comunicación eficaz disadvantage los pacientes durante la consulta y el tratamiento. El documento revela además los beneficios potenciales de conseguir una buena alianza terapéutica, de cara a los HCPs, pacientes y el sistema de cuidado de salud en general.

Lo que realmente importa es una alianza fuerte 

La literatura de investigación destaca el valor de las interacciones positivas que apoyan los HCPs para superar los retos de los pacientes el conocimiento por sí mismo no es suficiente para cambiar la conducta del paciente. La toma de decisiones compartida entre el HCP y el paciente es united nations componente vital de cara a conseguir los objetivos de tratamiento. Además, esta aproximación puede ayudar a construir united nations vínculo de confianza, crédito y empatía.

Explorando los componentes principales del cuidado centrado dentro del paciente 

Este documento examina cómo se puede construir una alianza de éxito entre el paciente y HCP, utilizando una aproximación biopsicosocial que incorpore el cuidado físico, de conducta, emocional y cognitivo. Incluye además united nations ejemplo de una guía de debate desarrollada por medio de Atlantis Healthcare para facilitar y apoyar los HCPs de cara a hacer frente a las necesidades de los pacientes.

Las perspectivas reveladoras del personal clínico de Atlantis Healthcare han desvelado los principales factores para conseguir una alianza terapéutica eficaz. Estos incluyen el aprovisionamiento de herramientas que permitan a los pacientes el auto-tratamiento eficaz y el posicionamiento adecuado de materiales para el viaje de los pacientes. De forma adicional, la formación es esencial para asegurar que los HCPs se resuelven adecuadamente para apoyar a los pacientes en todos los dominios de tratamiento y para mejorar la relación disadvantage los pacientes.

Lucy Ashworth, especialista en psicología en salud y principal autora del documento, descatacó: “La alianza entre united nations paciente y united nations profesional en salud desempeña una parte integral dentro del modelado de los resultados de los pacientes.

Hay varios factores que pueden influir en la conducta de los pacientes y sobre cómo piensan acerca de su tratamiento y cuidado. Una concienciación acerca de estos factores puede ayudar a que los HCPs impacten positivamente en la capacidad de las personas para auto-tratarse a largo plazo. 

Si desea descargar el documento y conocer más sobre la aproximación de Atlantis Healthcare al despliegue de las mejores soluciones de su clase dentro del auto-tratamiento de pacientes, visite la página web https://atlantishealthcare.com/en-us/white-colored-papers.

Si desea más detalles acerca de Atlantis Healthcare Group, contacte disadvantage: Matthew Walls: consejero delegado, +44-208-747-4360

FUENTE Atlantis Healthcare

Freudenberg Medical launches new hemostasis valves for interventional and diagnostic catheters

MDBR Staff Author Printed 31 October 2017

Medical devices maker Freudenberg Medical features new hemostasis valve products for interventional and diagnostic catheters.

The brand new products for example HyperSeal and CertuSeal valves compliment the FlexSeal valve, that was launched this past year.

Hemostasis valves, which is accustomed to reduce bloodstream loss, will facilitate non-invasive and catheter-based surgical procedures.

The organization has additionally introduced HyperSeal introducer sheath with hydrophilic coating, which joins the FlexSeal introducer sheath like a white-colored label device solution for big bore procedures.

The brand new hemostasis valves could be directly built-into therapeutic catheter development projects, assisting to provide new design options, reduce development some time and costs.

Freudenberg’s medical device products likewise incorporate Composer deflectable catheter handle platform.

Freudenberg Medical portfolio management director Bernie Kaeferlein stated: “Freudenberg Medical’s hemostasis valves provide an array of innovative features made to greatly improve hemostasis and procedural performance when built-into next-gen catheters and delivery systems.

“As someone for innovation, we’re dedicated to proactively addressing unmet clinical needs and offering our medical device customers an increasing portfolio of finished device, design, and process methods to help to improve efficiency and accelerate time to promote.Inches

In Feb, Freudenberg announced that it’s developing roducts which make delivering medications for probably the most common illnesses more precise and also the recovery process faster.

The organization is presently purchasing the development of their medical technology division worldwide.

Freudenberg is involved in the designing, development and manufacturing of medical devices, components and product solutions.

The organization produces high precision silicone and thermoplastic components, in addition to tubing, drug coatings, finished devices and subassemblies for non-invasive, handheld, and catheter-based devices.


Image: Freudenberg’s medical device solutions for interventional and diagnostic catheters. Photo: thanks to Business Wire.

Butterfly iQ, an entire body Ultrasound That Matches inside a Pocket


Butterfly Network, a strong located in Guilford, Connecticut, won Food and drug administration clearance and it is presenting its Butterfly iQ portable ultrasound system. It includes a portable transducer that connects straight to an apple iphone, as well as an iOS application to show the pictures and also to control settings.

The unit really works as three different transducers because of an ultra wide band matrix array. This enables a clinician to carry out a couple of different scans but for the Butterfly iQ to become relevant in various clinical settings. The matrix variety of microelectromechanical (MEMS) sensors is directly integrated onto a built-in circuit which contains all of the necessary electronics. This tight integration supposedly produces a fast, high-resolution device that may perform tasks that just full-sized ultrasound machines were capable only a couple of short years back. The firm compares its technology to how photo camera sensors happen to be integrated within smartphones, enabling anybody to possess top quality photo imaging within their pocket.

Possibly the greatest cope with the Butterfly iQ is it costs under $2,000. Previous portable, hands-held ultrasounds have frequently been costing greater than $10,000.

This can be a promo video for that Butterfly iQ:

Listed here are a few videos taken while using new device:

Product page: Butterfly iQ…

Via: Butterfly Network…

Editors

At Medgadget, we set of the most recent medical technology news, interview leaders within the field, and file dispatches from medical occasions from around the globe.

Gene editing remains early-stage, but Big Pharma has had notice

The concept of gene editing is moving fast. At the end of October, two new papers described technologies that provide the actual editing of individual DNA bases  ? a b to some T, a C to some G ? and, individually, a mechanism for genetically editing RNA. Have been heralded as major advances.

But let’s support a little in the leading edge tools to the actual application: How’s gene editing progressing, when it comes to biotech pipelines, investment, and therapeutic approvals?

In the recent report, entitled Gene Editing: The Following Breakthrough in Regenerative Medicine, Informa Pharma Intelligence solutions individuals questions having a concentrate on three major existing technologies: CRISPR/Cas9, zinc-finger nucleases (ZFNs), and transcription activator-like effector nucleases (TALENs). The 3 tools allow scientists to permanently modify an organism’s genome, without presenting foreign DNA.

CRISPR/Cas9 has undoubtedly attracted probably the most buzz and investment dollars. Based on Informa’s research, near to three-quarters (74 percent) of gene editing programs are now using the process. This, regardless of the attracted-out patent dispute cheap it had been harnessed for human genome editing under 5 years ago. Despite this dominance, the invention might rapidly become dated, noted Amanda Micklus, principal analyst for Informa Pharma Intelligence.

“I have no idea think CRISPR/Cas9 will probably be the finish-all,” Micklus stated inside a phone interview. “I believe that once we move ahead, as increasing numbers of breakthroughs are created, there’s likely to be more tools put into the gene editing toolbox and we’ll need to observe how a few of these candidates engage in.Inches

It might be also premature to create-off ZFNs and TALENs, she stated. Both technologies have arrived at human trials, a milestone that no CRISPR/Cas9 companies have yet achieved. 

When it comes to investment, the 3 technologies received backing from Big Pharma between 2012 and 2017, the report highlights. Four of individuals deals were believed to become more vital than $1 billion (the financials behind several others were undisclosed).

Pfizer tops their email list using its 2014 Cellectis partnership, that could be worth as much as $3 billion. Servier partnered with Cellectis exactly the same year, inside a deal worth approximately $1 billion. In 2015, Vertex closed a $2.6 billion agreement with CRISPR Therapeutics and Shire (dealing with Baxalta) signed a $1.7 billion Vehicle-T cope with Precision Biosciences in 2016.

With regards to repeat business, Novartis committed to three gene editing companies in that five-year window. AstraZeneca and Shire also individually penned two separate gene editing contracts.

While all the deals might be characterised as initial phase, Sangamo Therapeutics and Cellectis have moved their particular technologies in to the clinic.

Using the ip underpinning ZFN technology, Sangamo Therapeutics has initiated a strong pipeline, targeting illnesses varying from Aids/AIDs to hemophilia A and B. Based on the report, five of those candidates resulted in Phase 2 numerous studies. The Richmond, California-based biotech has additionally joined into contracts with Biogen, Shire, and also the CHDI Foundation to co-develop or out-license we’ve got the technology.

Meanwhile, Cellectis seems is the king of TALEN editing. The decades-old French biotech first licensed we’ve got the technology this year from Iowa Condition College. It’s now among the leaders in this subject, attracting partnerships with Pfizer and Servier because of its operate in oncology. Particularly, it’s developing so-known as chimeric antigen receptor T-cell (Vehicle-T) therapies, an essential component of Vehicle-T cell immunotherapies. It’s one enter in Phase 1 numerous studies.

For CRISPR/Cas9, Intellia Therapeutics could be the first to submit an investigational new drug application within the U.S., the authors note, becoming the first one to begin human trials. Editas Prescription medication is close behind, getting bumped back its timeline for initial human testing from 2017 to 2018. In vivo work continues to be made by research institutes within the U . s . States and China, building understanding in this region whilst raising many ethical questions.

While an Food and drug administration approval is clearly still years away, the problem of prices is definitely coming. 

“It’s likely to be a very tough problem for payers so that you can handle these high priced gene therapies, especially as patients frequently change insurance providers and change from plan-to-plan. Who’s likely to be accountable for individuals costs?” Micklus declared.

Possibly the model for any gene-editing launch can come through its close relative, gene therapy. Food and drug administration is anticipated to follow along with the recommendations of their advisory committee and approve Spark Therapeutics’ Luxurna. The novel gene therapy targets an uncommon disease referred to as RPE65-mediated inherited retinal disease. Experts expect so that it is priced more than $500,000. Some analysts are predicting a $a million cost tag, using the first-ever gene therapy approved in Europe, referred to as Glybera.

“A large amount of these therapies will be one-time therapies, so you’ve to consider the way they are compensated for,” Micklus mentioned. “Are they likely to be compensated upfront? Could they be likely to be compensated with time? As well as, could they be likely to be compensated depending on how well someone reacts to individuals therapies?”   
Gene editing might be a thrilling new frontier, but it’s likely to encounter some familiar walls.

Photo: wildpixel, Getty Images 

Food and drug administration approves Butterfly Network’s ultrasound-on-a-nick based imaging system

MDBR Staff Author Printed 30 October 2017

Butterfly Network has guaranteed approval in the US Fda (Food and drug administration) because of its ultrasound-on-a-nick based imaging system.

Butterfly iQ for iPhone is alleged is the world’s first ultrasound-on-a-nick based imaging system, that has been approved to pay for 13 clinical applications.

Featuring around 10, 000 sensors, the machine could be combined with a HIPAA-compliant cloud that allows image storage and collaboration among clinicians, in addition to connectivity with traditional hospital permanent medical record systems.

The firm’s ultrasound-on-a-nick technologies are stated to aggregate the abilities of three typical probes right into a single ultra wide-band and 2D matrix array made up of a large number of microelectromechanical systems (MEMS).

The sensors are directly covered with an integrated circuit encompassing the electronics of the high end ultrasound system.

Based on the organization, the Butterfly iQ is included by 33 issued patent distinctively melding micromachines and integrated circuits.

The organization is promoting deep learning-based artificial intelligence applications, which supplies clinicians with image acquisition and interpretation.

Butterfly Network’s chief medical officer Dr John Martin stated: “Supplying a unique mixture of affordability, diagnostic versatility, and assistive intelligence, Butterfly can impact human health more profoundly than any diagnostic device because the stethoscope, invented over two centuries ago.”

Butterfly Network founder and chairman Dr Jonathan Rothberg stated: “Just like placing a camera on the semiconductor nick made photography available to anybody having a smartphone and placing a computer on the nick enabled the revolution in personal computing before that, Butterfly’s ultrasound-on-a-nick technology enables a minimal-cost window into the body, making high-quality diagnostic imaging available to anybody.”


Image: The Food and drug administration campus in Nh Ave, Silver Spring, Maryland. Photo: thanks to The U.S. Fda.

Luminex Corporation Reports Third Quarter 2017 Financial Results

AUSTIN, Texas, Oct. 30, 2017 /PRNewswire/ — Luminex Corporation (Nasdaq: LMNX) today announced financial results for the third quarter of 2017.  Financial and operating highlights for the quarter include the following:

  • Consolidated revenue of $74.1 million, an increase of 4% compared to the third quarter 2016.
  • Assay revenue was $37.9 million for the quarter ended September 30, 2017, representing a 17% increase over assay revenue for the third quarter of 2016.
  • Total sample-to-answer molecular product revenue of $11.9 million; growth of 55% compared to $7.7 million in the third quarter of 2016.
  • Placed 60 sample-to-answer molecular systems under contract, bringing the total number of active customers to over 400.
  • 266 multiplexing analyzers were shipped during the quarter; a combination of MAGPIX® systems, LX systems, and FLEXMAP 3D® systems.
  • GAAP net income of $17.6 million, or $0.40 per diluted share. Non-GAAP net income of $10.7 million, or $0.25 per diluted share (see Non-GAAP reconciliation).
  • In September, Luminex agreed to continue to provide a major customer with our Cystic Fibrosis product portfolio through the end of 2019, with an option to extend beyond this time period.

“The tremendous momentum in our sample-to-answer molecular business drove the Company’s performance this quarter. Our VERIGENE and ARIES systems are experiencing excellent traction in the market resulting from a combination of factors, including their ease of use, a rapidly expanding FDA cleared test menu, differentiated pricing strategies, and a large, fully integrated sales and support team,” said Homi Shamir, President and Chief Executive Officer of Luminex.  “We remain enthusiastic about our diversified business model, our solid balance sheet, positive cash flow profile, and the significant future growth opportunities in both our Licensed Technologies Group and our molecular diagnostics business.”

REVENUE SUMMARY

(in thousands, except percentages) 

Three Months Ended

September 30,

Variance

2017

2016

($)

(%)

(unaudited)

System sales

$           9,903

$         10,494

$       (591)

-6%

Consumable sales

10,619

12,305

(1,686)

-14%

Royalty revenue

11,001

11,068

(67)

-1%

Assay revenue

37,917

32,443

5,474

17%

Service revenue

2,894

2,934

(40)

-1%

Other revenue

1,802

1,977

(175)

-9%

$         74,136

$         71,221

$     2,915

4%

Nine Months Ended

September 30,

Variance

2017

2016

($)

(%)

(unaudited)

System sales

$         28,309

$         27,805

$        504

2%

Consumable sales

39,314

37,489

1,825

5%

Royalty revenue

33,375

33,888

(513)

-2%

Assay revenue

113,077

85,367

27,710

32%

Service revenue

8,594

7,892

702

9%

Other revenue

5,703

5,927

(224)

-4%

$       228,372

$       198,368

$    30,004

15%

FINANCIAL OUTLOOK AND GUIDANCE

The Company reaffirms its guidance for the full year and expects fourth quarter 2017 revenue to be between $76 million to $78 million.

CONFERENCE CALL

Management will host a conference call at 3:30 p.m. CDT / 4:30 p.m. EDT, Monday, October 30, 2017 to discuss the operating highlights and financial results for the third quarter 2017 ended September 30, 2017. The conference call will be webcast live and may be accessed at Luminex Corporation’s website at http://www.luminexcorp.com.  Simply log on to the web at the address above, go to the Company section and access the Investor Relations link. Please go to the website at least 15 minutes prior to the call to register, download and install any necessary audio/video software. If you are unable to participate during the live webcast, the call will be archived for six months on the website using the ‘replay’ link.

Luminex develops, manufactures and markets proprietary biological testing technologies with applications throughout the life sciences industry. The Company’s xMAP® system is an open-architecture, multi-analyte technology platform that delivers fast, accurate and cost-effective bioassay results to markets as diverse as pharmaceutical drug discovery, clinical diagnostics and biomedical research, including the genomics and proteomics research markets. The Company’s xMAP technology is sold worldwide and is in use in leading research laboratories as well as major pharmaceutical, diagnostic and biotechnology companies.  Further information on Luminex or xMAP can be obtained on the Internet at http://www.luminexcorp.com.

Statements made in this release that express Luminex’s or management’s intentions, plans, beliefs, expectations or predictions of future events are forward-looking statements. Forward-looking statements in this release include statements regarding expected revenue and cost savings, projected 2017 performance, including revenue guidance, including the revenue contribution from our recently completed acquisition of Nanosphere, Inc. The words “believe,” “expect,” “intend,” “estimate,” “anticipate,” “will,” “could,” “should” and similar expressions are intended to further identify such forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995.  It is important to note that the Company’s actual results or performance could differ materially from those anticipated or projected in such forward-looking statements.  Factors that could cause Luminex’s actual results or performance to differ materially include risks and uncertainties relating to, among others, market demand and acceptance of Luminex’s products and technology in development, including ARIES®, Verigene®and NxTAG®products; dependence on strategic partners for development, commercialization and distribution of products; concentration of Luminex’s revenue in a limited number of direct customers and strategic partners, some of which may be experiencing decreased demand for their products utilizing or incorporating Luminex’s technology; budget or finance constraints in the current economic environment, or periodic variability in their purchasing patterns or practices as a result of material resource planning challenges; the timing of and process for regulatory approvals; the impact of the ongoing uncertainty in global finance markets and changes in governmental funding, including its effects on the capital spending policies of Luminex’s partners and end users and their ability to finance purchases of Luminex’s products; fluctuations in quarterly results due to a lengthy and unpredictable sales cycle; fluctuations in bulk purchases of consumables; fluctuations in product mix, and the seasonal nature of some of Luminex’s assay products; Luminex’s ability to obtain and enforce intellectual property protections on Luminex’s products and technologies; risks and uncertainties associated with implementing Luminex’s acquisition strategy, including Luminex’s ability to obtain financing; Luminex’s ability to integrate acquired companies or selected assets into Luminex’s consolidated business operations, and the ability to recognize the benefits of Luminex’s acquisitions; reliance on third party distributors for distribution of specific Luminex-developed and manufactured assay products; Luminex’s ability to scale manufacturing operations and manage operating expenses, gross margins and inventory levels; changes in principal members of Luminex’s management staff; potential shortages, or increases in costs, of components or other disruptions to Luminex’s manufacturing operations; competition and competitive technologies utilized by Luminex’s competitors; Luminex’s ability to successfully launch new products in a timely manner; Luminex’s increasing dependency on information technology to improve the effectiveness of Luminex’s operations and to monitor financial accuracy and efficiency; the implementation, including any modification, of Luminex’s strategic operating plans; the uncertainty regarding the outcome or expense of any litigation brought against or initiated by Luminex, risks relating to Luminex’s foreign operations, including fluctuations in exchange rates, tariffs, customs and other barriers to importing/exporting materials and products in a cost effective and timely manner; difficulties in accounts receivable collections; the burden of monitoring and complying with foreign and international laws and treaties; and the burden of complying with and change in international taxation policies, as well as the risks discussed under the heading “Risk Factors” in Luminex’s Reports on Forms 10-K and 10-Q, as filed with the Securities and Exchange Commission.  The forward-looking statements, including the financial guidance and 2017 outlook, contained herein represent the judgment of Luminex as of the date of this press release, and Luminex expressly disclaims any intent, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in Luminex’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

LUMINEX CORPORATION

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

September 30,

December 31,

2017

2016

(unaudited)

ASSETS

Current assets:

Cash and cash equivalents

$        110,911

$         93,452

Accounts receivable, net

36,432

32,365

Inventories, net

46,114

40,775

Prepaids and other

9,915

7,145

Total current assets

203,372

173,737

Property and equipment, net

57,686

57,375

Intangible assets, net

78,152

84,841

Deferred income taxes

45,943

42,497

Goodwill

85,481

85,481

Other

8,094

6,785

Total assets

$        478,728

$       450,716

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities:

Accounts payable

$            7,813

$         12,276

Accrued liabilities

21,175

22,804

Deferred revenue

5,123

5,120

Total current liabilities

34,111

40,200

Deferred revenue

1,609

1,875

Other

4,828

4,962

Total liabilities

40,548

47,037

Stockholders’ equity:

Common stock

43

43

Additional paid-in capital

345,663

336,430

Accumulated other comprehensive loss

(817)

(1,692)

Retained earnings

93,291

68,898

Total stockholders’ equity

438,180

403,679

Total liabilities and stockholders’ equity

$        478,728

$       450,716

LUMINEX CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share amounts)

Three Months Ended

Nine Months Ended

September 30,

September 30,

2017

2016

2017

2016

(unaudited)

(unaudited)

Revenue

$     74,136

$     71,221

$    228,372

$    198,368

Cost of revenue

28,317

25,556

79,706

62,976

Gross profit

45,819

45,665

148,666

135,392

Operating expenses:

Research and development

10,670

12,762

35,350

35,324

Selling, general and administrative

26,454

26,393

78,604

70,942

Amortization of acquired intangible assets

2,166

2,482

6,689

5,797

Total operating expenses

39,290

41,637

120,643

112,063

Income from operations

6,529

4,028

28,023

23,329

Other income, net

(1)

30

(6)

(1,395)

Income before income taxes

6,528

4,058

28,017

21,934

Income tax benefit (expense)

11,085

(1,307)

4,371

(4,760)

Net income

$     17,613

$       2,751

$     32,388

$     17,174

Net income attributable to common stock holders

Basic

$     17,299

$       2,751

$     31,789

$     17,174

Diluted

$     17,299

$       2,751

$     31,789

$     17,174

Net income per share attributable to common stock holders

Basic

$         0.40

$         0.06

$         0.74

$         0.40

Diluted

$         0.40

$         0.06

$         0.74

$         0.40

Weighted-average shares used in computing net income per share

Basic

43,164

42,683

43,110

42,522

Diluted

43,266

43,136

43,216

42,929

Dividends declared per share

$         0.06

$         0.18

LUMINEX CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

Three Months Ended

Nine Months Ended

September 30,

September 30,

2017

2016

2017

2016

(unaudited)

(unaudited)

Cash flows from operating activities:

Net income

$     17,613

$       2,751

$     32,388

$     17,174

Adjustments to reconcile net income to net cash provided by operating activities:

Depreciation and amortization

5,609

5,913

16,879

14,401

Stock-based compensation

3,829

3,526

8,577

8,181

Deferred income tax expense

(10,379)

1,540

(3,112)

4,471

Loss (gain) on sale or disposal of assets

417

87

417

128

Other

357

(799)

1,279

(870)

Changes in operating assets and liabilities:

Accounts receivable, net

(3,295)

(3,118)

(4,053)

3,555

Inventories, net

988

(2,125)

(5,316)

(6,165)

Other assets

(1,564)

(902)

(2,761)

(230)

Accounts payable

(2,163)

(1,674)

(4,532)

1,050

Accrued liabilities

2,273

(428)

(5,138)

(6,602)

Deferred revenue

81

112

(269)

733

Net cash provided by operating activities

13,766

4,883

34,359

35,826

Cash flows from investing activities:

Sales and maturities of available-for-sale securities

19,491

Purchase of property and equipment

(3,981)

(2,675)

(10,384)

(8,394)

Proceeds from sale of assets

1

42

1

45

Business acquisition consideration, net of cash acquired

(1,196)

(68,098)

Issuance of note receivable

(700)

(700)

Purchase of cost method investment

(500)

(1,000)

(500)

Acquired technology rights

(60)

(60)

(200)

Net cash used in investing activities

(4,740)

(4,329)

(12,143)

(57,656)

Cash flows from financing activities:

Payments on debt

(25,000)

Proceeds from issuance of common stock

1,005

1,799

3,234

3,561

Shares surrendered for tax withholding

(28)

(13)

(2,124)

(1,497)

Dividends

(2,645)

(5,281)

Net cash (used in) provided by financing activities

(1,668)

1,786

(4,171)

(22,936)

Effect of foreign currency exchange rate on cash

(152)

87

(586)

365

Change in cash and cash equivalents

7,206

2,427

17,459

(44,401)

Cash and cash equivalents, beginning of period

103,705

81,718

93,452

128,546

Cash and cash equivalents, end of period

$    110,911

$     84,145

$    110,911

$     84,145

LUMINEX CORPORATION

NON-GAAP RECONCILIATION

(in thousands)

Three Months Ended

Nine Months Ended

September 30,

September 30,

2017

2016

2017

2016

(unaudited)

(unaudited)

Income from operations

$       6,529

$       4,028

$     28,023

$     23,329

Stock-based compensation

3,829

3,526

8,577

8,181

Amortization of acquired intangible assets

2,166

2,482

6,689

5,797

Acquisition costs

479

2,487

Severance costs

243

126

901

940

Adjusted income from operations

$     12,767

$     10,641

$     44,190

$     40,734

Other income, net

(1)

30

(6)

(1,395)

Acquisition costs

1,500

Income tax expense

11,085

(1,307)

4,371

(4,760)

Income tax effect of above adjusting items

(761)

(305)

(2,053)

(721)

Income tax benefit from discrete tax items

(12,400)

(12,400)

Adjusted net income

$     10,690

$       9,059

$     34,102

$     35,358

Adjusted net income per share, basic

$         0.25

$         0.21

$         0.79

$         0.83

Shares used in computing adjusted net income per share, basic

43,164

42,683

43,110

42,522

Adjusted net income per share, diluted

$         0.25

$         0.21

$         0.79

$         0.82

Shares used in computing adjusted net income per share, diluted

43,266

43,136

43,216

42,929

The Company makes reference in this release to “non-GAAP net income” which excludes stock-based compensation expense, amortization of acquired intangible assets and the impact of costs associated with legal proceedings; some of which are unpredictable and can vary significantly from period to period; and certain other recurring and non-recurring expenses. The Company believes that excluding these items and their related tax effects from its financial results reflects operating results that are more indicative of the Company’s ongoing operating performance while improving comparability to prior periods, and, as such may provide investors with an enhanced understanding of the Company’s past financial performance and prospects for the future. In addition, the Company’s management uses such non-GAAP measures internally to evaluate and assess its core operations and to make ongoing operating decisions. This information is not intended to be considered in isolation or as a substitute for income from operations, net income, net income per share or expense information prepared in accordance with GAAP.

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SOURCE Luminex Corporation

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