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Friday, August 3, 2018

Industry balks at FDA’s cybersecurity plans


As cyberattacks on healthcare organizations ramp up, the FDA is boosting efforts to protect the security of connected medical devices with an ambitious plan to reduce vulnerabilities throughout a product’s lifecycle.
The Medical Device Safety Action Plan calls for new authorities to require manufacturers to build security updates and patch capabilities into products beginning at the design stage and to have formal policies and procedures for swift coordinated disclosure of vulnerabilities discovered after products hit the market.
The plan also calls for creation of a CyberMed Safety (Expert) Analysis Board, or CYMSAB, a public-private partnership to assess vulnerabilities, patient risks and advise on mitigation.
Industry, which has largely supported the agency’s cybersecurity efforts, including guidance on premarket and postmarket cybersecurity considerations, fears this latest salvo of preemptive controls could strap manufacturers with burdensome obligations that cannot be sustained in the long run and will do little to improve the safety of connected technologies.
“Addressing the cybersecurity of medical devices is nowhere found in the [FD&C] statute,” says Bradley Merrill Thompson, a device attorney with Epstein Becker & Green. “Any intrusion into cybersecurity has to be predicated on actual evidence of safety issues, not science fiction fears.”
The FDA already requires companies to include capabilities for updating and patching software at the product design stage through its premarket guidance, and companies say they are widely following that.
“We already know that FDA will reject premarket submissions if they do not follow the cybersecurity guidance,” says Zach Rothstein, associate vice president for technology and regulatory affairs at AdvaMed. “So from our perspective, it didn’t seem like an issue that needed to be taken on at this stage.”
If the agency wants to boost premarket cybersecurity requirements, it should flush out the current guidance to reflect lessons learned since the original was issued, he says, noting revised guidance is expected by the end of the year.
FDA spokeswoman Stephanie Caccomo acknowledged the agency considers the adequacy of cybersecurity controls in approving new devices, but said additional authorities are needed to security by “directly addressing challenges healthcare delivery organizations and providers have encountered as a result of cyber campaigns and attacks such as WannaCry.”
That May 2017 ransomware attack forced many hospitals in the United Kingdom to suspend normal services and accept only emergency patients, and struck computers in 104 countries worldwide.

SBOMs open to potential misuse

Of particular concern for industry is the so-called Software Bill of Materials manufacturers would have to include in premarket submissions and make available to customers and users.
“As an industry, we have coalesced around the idea that is part of our shared responsibility in this healthcare ecosystem to provide Software Bill of Materials to customers that indicate it would be helpful for them to manage their networks,” Rothstein tells Healthcare Dive. He says a number of large hospital systems already require SBOMs, adding he is not aware of any holding up purchasing deals.
But industry is worried about lack of proper controls around sharing and maintenance of SBOMs. If the documents are stored in a publicly available central database, that could allow cybercriminals to learn which software is operating within a device, exposing patients to potential harm, AdvaMed warned in comments on the safety action plan. The agency needs to have protections around the issuance and maintenance of SBOMs to ensure only authorized users are able to access it and control who else can receive it.
The group also wants to see SBOMs standardized and established by regulation. “What we fear could happen without standards development or some type of consensus agreement is that each customer in the system would require a different version of the Software Bill of Materials, a different level of detail, a different type of update schedule, that would literally be unworkable for the thousands of customers a device company has,” Rothstein says.
FDA’s Caccomo said exactly what information will be subject to transparency and the mechanism providing it to customers — e.g., product labeling — will be hammered out in FDA-led stakeholder discussions.

Providers push back

Meanwhile, hospitals are putting pressure on manufacturers to bear more responsibility for the cybersecurity of their legacy medical devices.
In response to a House Energy & Commerce Committee request for information, the American Hospital Association said many legacy devices were built before the current cyber threat landscape existed and may use outdated or nonsecure software and hardware, leaving them vulnerable to attack.
The group ticked off a wide range of supports manufacturers should be required to provide to ensure a safe patient environment, including wrapping security precautions around legacy devices, adding security tools and auditing capabilities where possible, conducting regular updates and patching all software, and communicating security vulnerabilities quickly through consistent channels, the AHA said.
“Security is a shared responsibility, but really so far providers have borne the heavier load on securing medical devices,” Chantal Worzala, vice president of health IT and policy at the AHA, tells Healthcare Dive.
The group reiterated its concerns in comments on the FDA action plan. Manufacturers “share responsibility for safeguarding the confidentiality of patient data, maintaining data integrity and ensuring the continued availability and functionality of the device itself,” it wrote.
But manufacturers say expecting them to support a product’s cybersecurity into perpetuity is unreasonable.
“If Microsoft shuts down support of a particular operating system, you cannot expect the medical device manufacturer to then take the lead on keeping, for example, Windows XP secure,” Rothstein argues. “That’s just not a viable solution, and it’s not something that a medical device manufacturer has the expertise to handle.”
If a hospital intends to use a large piece of capital equipment for 15 years, that needs to be something both parties understand and agree to up front so the manufacturer knows whether it can support the product for that long and the hospital can make a rational purchase decision based on the company’s capabilities, he adds.
Both sides are seeking more information about the proposed CYMSAB, which could be deployed to investigate potential or real security threats in the field. Providers want to ensure they have a seat at the table. Industry is concerned about CYMSAB’s composition, too, but from a confidentiality standpoint.
“You could imagine a situation where there’s a potential breach or situation with a medical device … and if this board is made up of this company’s competitors or some of their customers, the type of information that would need to be shared could make it a difficult situation for the company to be in,” Rothstein says.
Moreover, if the board is established as a federal advisory committee, its discussions would be available via FOIA requests.
Ultimately, it makes sense for FDA to have a set of experts who can assist with questions that have detailed technical aspects to them, but more discussion is needed on exactly what role the board will play and how its intervention in a cyber crisis would potentially work, he argues.
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Healthcare M&A remains hot, but value fell in Q2


  • The second quarter of this year was the 15th quarter in a row with more than 200 M&A healthcare deals, according to a new PricewaterhouseCoopers report.
  • The deal volume of 255 matches the average from the previous seven quarters. The amount declined by 7.3% compared with last quarter, but increased 9.4% year-over-year.
  • Despite the active quarter, the value of healthcare deals was down. At $24.6 billion, the total was a decline of 66.1% compared to the previous quarter and 50.7% down from a year ago.

Factors that contributed to deal activity included private equity fundraising and investment and corporate strategic initiatives, Thad Kresho, U.S. health services deals leader at PwC, wrote in the report. “We don’t anticipate these trends to slow during the remainder of 2018,” he said.
​The value decline in the second quarter is attributed to more megadeal activity in previous quarters.
The second quarter’s lone megadeal, defined as worth more than $5 billion, was KKR’s acquisition of Envision Healthcare Corporation for $9.9 billion. That accounted for 40% of the quarter’s total deal value and is the third largest transaction since 2016.
The first quarter also only saw one megadeal, but it made up 92% of that quarter’s value. There were four megadeals in Q2 2017 that accounted for 56% of the value.
The other top deals for the second quarter were:
  • Long-term care: Welltower’s purchase of Quality Care Properties for $4 billion.
  • Managed care: WellCare buying Meridian for $2.5 billion.
  • Physician group practices: Summit Partners acquiring Sound Inpatient Physician Holdings for $2.2 billion.
  • Home health and hospice: Humana, TPG Capital and Welsh, Carson, Anderson & Stowe acquiring Curo Health Services LLC for $1.4 billion.
Long-term care continues to see the most deal volume with 104 in the quarter, sustaining a multi-year trend. However, physician medical group deals saw a 1,502.4% growth in value, mostly because of the KKR-Envision deal. Medical groups accounted for 49.4% of the quarter’s total deal value with $12.2 billion. A recent analysis from The Commonwealth Fund found providers are consolidating faster than payers, leading to more concentrated markets.
Managed care was the most rapidly growing subsector for volume with a 100% increase.
Healthcare M&A activity will remain hot in the coming quarters with vertical deals and megadeals expected. Two large deals to watch are Amazon’s announced acquisition of PillPack and the proposed AT&T-Time Warner merger. If AT&T-Time Warner happens, other megadeals could follow in healthcare, according to PwC.
Factors for more M&A this year include regulation and policy uncertainty, vertical integration (like Cigna-Express Scripts and CVS-Aetna), new technologies and new entrants in healthcare, sagging inpatient volume and higher costs and the move to value-based care and population health management, PwC said.
A recent New York Times article, citing data compiled by Thomson Reuters, said that the healthcare sector ranks third behind energy and media entertainment regarding total deal volume in 2018.
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Proton-Beam Therapy: Snags in US but Expanding Globally


Proton-beam therapy centers are proliferating around the world, despite remaining questions over what advantages it offers over conventional radiotherapy.
While it provides a high degree of precision, allowing an escalated radiation dose to be targeted directly on a tumor while sparing the adjacent healthy tissue, it remains controversial because of its high cost and limited evidence on how it compares with other forms of radiotherapy, as previously reported by Medscape Medical News.
The United States has the most proton-beam therapy centers, with 28 in operation, a jump from just 11 in 2013. In addition, 23 more are under construction or in development.
However, proton-beam therapy centers may be experiencing “growing pains,” according to a feature article published July 12 in the Lancet Oncology. Patient demand for the technology has been much lower than anticipated in some centers, and several centers have been grappling with financial losses or have missed financial targets, the authors report. For example, the Scripps Proton Treatment Center in San Diego, California, declared bankruptcy, is no longer affiliated with Scripps, and is now under new management.
A recent article from Kaiser Health News reported other centers with financial struggles, including one  at Indiana University that closed in 2014, and several that have been losing money and restructuring their debt. The Hampton University Proton Therapy Institute in Virginia has lost money for at least 5 years in a row, recording an operating loss of $3 million in its most recent fiscal year, the article noted.

Growing Globally

Despite the struggles in the US marketplace, proton-beam therapy centers are proliferating worldwide.
There are 63 facilities in operation, with 32 facilities under construction, and 16 more are in the planning stages of development, according to the Particle Therapy Co-operative Group, a nonprofit organization. With Argentina and Australia soon to be added to the roster, there will eventually be proton centers on every continent other than Antarctica.
About 165,000 patients with a variety of cancer types have been treated with proton-beam therapy, and in their latest global forecast, Research & Marketspredicts that it is on track to become a multibillion-dollar industry by 2024. The group estimates sales to reach between $2.3 to $4.3 billion by 2030, with 900 to 1300 particle therapy treatment rooms open to patients worldwide. The number of centers is anticipated to continue increasing each year.
In Europe, the market more than tripled between 2010 and 2017, and proton-beam therapy is being used for solid tumors, including those of the brain, spine, prostate, and stomach. Germany, Italy, Sweden, France, Denmark, the Netherlands, Switzerland, Russia, Spain, the United Kingdom, Norway, and Belgium are all setting up new centers or are in the planning stages. The European proton-beam therapy market is likely to continue growing from now until 2024, the Research & Markets group predicts.
About 60% of the global population resides in Asia, and it accounts for about half of the global cancer burden. The market in Asia for proton-beam therapy is also anticipated to increase at a double-digit growth rate from 2018 to 2024. While Japan currently has the largest number of centers in Asia, new facilities are under construction or in the development stages in China, Singapore, Thailand, and South Korea.
The first proton-beam therapy center in the Middle East/North Africa region has opened in Saudi Arabia, and another one is under construction in the United Arab Emirates. Egypt is planning a center at the Children’s Cancer Hospital Foundation in Cairo, and Israel has just announced that it will be finalizing plans to build a center. The Israeli Health Ministry estimated that approximately 250 patients will be treated annually in Israel, including 150 children. Building the facility will cost about $60 million, and another $6 million will be needed to operate it.

Arriving Down Under

A newcomer to the proton-beam therapy market is Australia, which has its first center in development in the city of Adelaide.
“The federal government has committed funding to the center in Adelaide,” said Scott Penfold, PhD, a medical physicist at the Royal Adelaide Hospital and University of Adelaide. “This is the only project that has received federal funding at this stage,” he  told Medscape Medical News.
He noted that the center is still in development and will not be in operation until 2021 at the earliest. As far as additional centers in the future, that will depend somewhat on the success of the one in Adelaide.
“We currently send patients, and their carers if required, overseas to receive proton therapy if it is deemed advantageous,” Penfold explained. “This is very costly considering the distances to be traveled. Opening of the other centers will certainly depend on demand for the service.”
An important consideration is whether the Australian healthcare system here, known as Medicare, will pay for proton-beam therapy. “We recently had a consultation report written to examine the evidence for proton therapy,” he said. “The report is currently receiving consumer responses and a final recommendation to the Health Minister is expected at the end of this year.”
Penfold added that they are hoping that at a minimum, patients who are funded to travel overseas will be covered by Medicare when a center opens in Australia. “We also hope for future consideration of wider indications,” he added.

Limited Access Up North

Despite some of the financial woes, the United States is forecast to maintain its dominant position in the proton-beam therapy market. But its neighbor to the North has not shown much interest in expanding its proton-beam therapy capacity.
Canada has one only facility, located in Vancouver, British Columbia (BC), which is primarily a research center. TRIUMF is Canada’s national particle accelerator center and a leading subatomic physics facility on an international level. Patients are treated there, but in a very limited capacity.
Cornelia Hoehr, PhD, Proton Therapy Manager at TRIUMF, told Medscape Medical News that they treat patients with choroidal melanomas, which are located at the back of the eye, and have done so since 1995.
“Our center is a collaboration between TRIUMF, the Eye Care Centre at the University of British Columbia and BC Cancer,” she said. “We are an older proton therapy center, and we only treat about 10 patients a year.”
Hoehr noted that they do not have any imminent plans to expand to treat other indications. “The BC health care system coves the cost for BC patient, and many other provinces do have agreements with BC to cover as well,” she said.
Hoehr also explained that they do have the capacity to treat more than 10 patients a year, and in fact, their ophthalmologist sees about 40 patients or so a year. “But she chooses to treat three quarters with brachytherapy, and only one fourth with the biggest tumors or tumors close to sensitive organs like the optic nerve are referred to TRIUMF,” she explained.
She added that there is “talk” about opening proton-beam therapy centers in Toronto or Montreal, given the very long distances patients living in the eastern provinces must travel to be treated in Vancouver. “For certain indications, Canadian cancer patients are referred to US centers,” she said.

Still a Niche Market

Despite the growing global number of proton-beam therapy centers, however, it is still very much a  niche market and represents only about 1% of all the external radiotherapy systems installed worldwide.
In 2017, just over 0.1% of all patients with cancer were treated with this modality, and by 2022, it is estimated that there will still be only 0.5 proton therapy treatment rooms per 10 million people worldwide, vs about 20 radiotherapy systems per 10 million patients.
By 2030, even if the projected 900 to 1300 treatment rooms will be available, that will still allow only 6% to 7% of patients with cancer to receive proton therapy treatment.
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Smarter cancer treatment: AI tool automates radiation therapy planning


Beating cancer is a race against time. Developing radiation therapy plans — individualized maps that help doctors determine where to blast tumours — can take days. Now, engineering researcher Aaron Babier has developed automation software that aims to cut the time down to mere hours.
He and his team at the University of Toronto’s Department of Mechanical & Industrial Engineering, including Justin Boutilier, supervisor Professor Timothy Chan and Professor Andrea McNiven of U of T’s Faculty of Medicine, are looking at radiation therapy design as an intricate — but solvable — optimization problem.
Their software uses artificial intelligence (AI) to mine historical radiation therapy data. This information is then applied to an optimization engine to develop treatment plans. The researchers applied this software tool in their study of 217 patients with throat cancer, who also received treatments developed using conventional methods.
The therapies generated by Babier’s AI achieved comparable results to patients’ conventionally planned treatments. — and it did so within 20 minutes. The researchers recently published their findings in Medical Physics.
“There have been other AI optimization engines that have been developed. The idea behind ours is that it more closely mimics the current clinical best practice,” says Babier.
If AI can relieve clinicians of the optimization challenge of developing treatments, more resources are available to improve patient care and outcomes in other ways. Health-care professionals can divert their energy to increasing patient comfort and easing distress.
“Right now treatment planners have this big time sink. If we can intelligently burn this time sink, they’ll be able to focus on other aspects of treatment. The idea of having automation and streamlining jobs will help make health-care costs more efficient. I think it’ll really help to ensure high-quality care,” says Babier.
Babier and his team believe that with further development and validation, health-care professionals can someday use the tool in the clinic. They maintain, however, that while the AI may give treatment planners a brilliant head start in helping patients, it doesn’t make the trained human mind obsolete. Once the software has created a treatment plan, it would still be reviewed and further customized by a radiation physicist, which could take up to a few hours.
“It is very much like automating the design process of a custom-made suit,” explains Chan. “The tailor must first construct the suit based on the customer’s measurements, then alter the suit here and there to achieve the best fit. Our tool goes through a similar process to construct the most effective radiation plan for each patient.”
Trained doctors, and often specialists, are still necessary to fine-tune treatments at a more granular level and to perform quality checks. These roles still lie firmly outside the domain of machines.
For Babier, his research on cancer treatment isn’t just an optimization challenge.
“When I was 12 years old, my stepmom passed away from a brain tumour,” Babier shares.
“I think it’s something that’s always been at the back of my head. I know what I want to do, and that’s to improve cancer treatment. I have a family connection to it. It adds a human element to the research,” says Babier.
Story Source:
Materials provided by University of Toronto Faculty of Applied Science & Engineering. Note: Content may be edited for style and length.
Journal Reference:
  1. Aaron Babier, Justin J. Boutilier, Andrea L. McNiven, Timothy C.Y. Chan. Knowledge-based automated planning for oropharyngeal cancer. Medical Physics, 2018; 45 (7): 2875 DOI: 10.1002/mp.12930
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U.S. tax cuts prompt rethink by some ‘inverted’ companies


A few U.S. companies that moved offshore in a wave of inversion deals are considering returning to the United States now that domestic tax rates are lower and tax policing is tougher abroad, attorneys and consultants said.

A handful of clients have asked about redomestication, which could involve buying a U.S.-headquartered company, the tax advisers said. No specific companies or deals were identified.
Uncertainties about U.S. Republican President Donald Trump’s trade policies have also prompted the conversations, the advisers said.
“Inverted companies have reason to look at whether or not it still makes sense for them to be offshore, particularly those that manufacture product outside the U.S. and sell it back into the U.S.,” said Pam Olson, a Washington-based tax expert at accounting and consulting group PwC.
A surge of homecomings would reverse an on-again, off-again trend since the 1980s of U.S. companies reincorporating overseas to cut tax costs.
In an inversion, a U.S. company typically buys a smaller foreign firm in a lower-tax country and adopts the acquired firm’s headquarters.
That maneuver means the company does not have to pay U.S. taxes on foreign income, even if its management and operations remain in the United States.
Trump’s public shaming of companies that move plants and jobs overseas has also made some consumer-focused firms rethink inversions, advisers said.
Executives at inverted companies see less tax “friction” under the new tax regime that would discourage redomiciling, advisers said, and have also mentioned the appeal of corporate-friendly, low-tax states and improved access to U.S. government contracts in the discussions.
More than 60 U.S. companies have inverted, including medical device maker Medtronic Plc. There was a wave of deals in 2011-2014, but inversions largely ended in 2015 after a regulatory crackdown by Democratic President Barack Obama.
Pfizer Inc walked away from a $160 billion merger with Ireland-based Allergan Plc in 2016 because of new U.S. Treasury rules.
The Trump administration last month finalized and left in place the Obama-era rules.
The Republican tax overhaul signed into law in December eliminated a key inversion incentive by slashing the U.S. corporate rate to 21 percent from 35 percent and altering how foreign profits are taxed.
A push to prevent profit-shifting strategies and corporate tax base erosion across the 36-nation Organisation for Economic Co-operation and Development is also making foreign tax domiciles marginally less attractive, especially in Europe.
Tax advisers said it is still possible to structure lower tax rates in countries such as Ireland and the Netherlands.
How the U.S. Treasury implements parts of the new tax law will help determine whether companies return to the United States.
A new tax on Global Intangible Low Taxed Income, or GILTI, on its face imposes a 10.5 percent tax rate. But because the bill is poorly worded, it can result in rates of 15 percent or more due to unfavorable effects on foreign tax credits.
GILTI’s implementation could influence tax-base decisions among companies redomiciled in Britain, which may consider whether to relocate to the United States or other countries to avoid the effects of Brexit.
Redomiciling to the United States is a case-by-case decision, said Joe Calianno, tax partner at financial advisory firm BDO.
“It really is a modeling exercise to determine whether it’s more beneficial being a U.S.-based company versus a foreign-based company,” he said.
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CNS Disease Tied to Contaminated Raw Veggies


Angiostrongyliasis was linked with the consumption of raw vegetables containing larvae of the parasite Angiostrongylus cantonensis (often called “rat lungworm”) in the continental U.S., researchers found.
The CDC identified 12 confirmed angiostrongyliasis cases in the U.S. from 2011 to 2017, and six of 11 patients reported eating raw vegetables, reported Eugene W. Liu, MD, of the CDC, and colleagues, writing in the Morbidity and Mortality Weekly Report.
Rat lungworm infection typically occurs in Asia and the Pacific Islands. The A. cantonensis parasite lives in rats, which pass feces that are then ingested by snails and slugs (gastropods) that crawl on garden vegetables. The parasite is spread to humans when gastropods containing mature larvae of the parasite are “inadvertently ingested by humans,” the authors said.
While infection with A. cantonensis often involves transient mild symptoms, larval migration to the brain can lead to eosinophilic meningitis, focal neurologic deficits, coma, and death, the researchers noted.
Cases of angiostrongyliasis were identified through A. cantonensis polymerase chain reaction testing of cerebrospinal fluid (CSF) submitted to the CDC. All 12 patients had CSF pleocytosis and eosinophilia, consistent with eosinophilic meningitis. Most reported subjective fever, generalized weakness, headache, and numbness or tingling.
Although no specific treatment for A. cantonensis infection currently exists, 11 patients received systemic steroids and 7 were treated with the anti-parasitic drug albendazole (Albenza).
Two months after their initial evaluation, all 12 patients were alive and 11 had improved symptoms. Four people had ongoing focal neurologic symptoms such as cranial nerve palsies or lower extremity weakness; one patient developed seizures 5 months after initial diagnosis and was treated with anti-epileptic drugs.
Six cases were likely a result of local transmission in the southern U.S., the CDC researchers said: “Healthcare providers, especially those in the southern United States, need to consider angiostrongyliasis in patients with eosinophilic meningitis, particularly those with a history of ingestion of gastropods or raw vegetables contaminated with larvae.”
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Fluidigm Q2 Revenues Jump 11 Percent


Fluidigm reported after the close of the market on Thursday that its second quarter revenues grew 11 percent year over year, driven in part by strong sales of its mass cytometry instruments.
For the three months ended June 30, the South San Francisco, California-based life science research tools firm reported total revenues of $26.4 million compared to $23.9 million in the same quarter a year ago, in line with analysts’ consensus estimate of $26.3 million.
Product revenues increased 12 percent to $21.8 million from $19.5 million year over year, while service revenues rose 9 percent to $4.7 million from $4.3 million.
By product category, instrument revenues grew 5 percent to $10.4 million from $9.9 million year over year as higher revenues from mass cytometry instruments were partially offset by declining genomics instrument sales. Consumables revenues increased 19 percent to $11.4 million from $9.6 million with growth in both mass cytometry and high-throughput genomics consumables, partially offset by decreased sales of single-cell genomics products.
By end market, mass cytometry revenues (instruments, consumables, and service) jumped 32 percent to $13.7 million from $10.4 million a year ago. Genomics revenues, however, fell 5 percent year over year to $12.8 million from $13.5 million.
In a conference call following the release of Fluidigm’s earnings, CEO Chris Linthwaite noted that in Q2 “robust instrument placements across pharma, translational research, and cancer centers were highlighted by our conversion of mass cytometry opportunities into orders at leading institutions around the world. Furthermore, mass cytometry consumables growth was strong, partially driven by remarkable adoption of our MaxPar Human Immune Monitoring Panel that was launched early in the second quarter.”
Linthwaite also noted that Fluidigm is primed to take advantage of the “explosive investment in the clinical, pharma, and research communities to answer questions about immune function. Most of these questions require an intersection of genomic and proteomic analysis, leading to an environment that is increasingly multi-omic. Fluidigm is a leading provider of tools to meet this need as researchers require a broad array of solutions and workflows across tissues, cells, and circulating biomarkers.”:
As an example, he noted that during the quarter an unnamed Japanese medical hospital adopted Fluidigm’s mass cytometry technology for a cancer biomarker project that is being funded by the Japan Agency for Medical Research and Development.
In addition, Linthwaite noted, Fluidigm had a “very exciting mass cytometry placement with a leader in the CAR-T cell therapy space” during the quarter. “As biotech and pharma companies investigate methods to use a patient’s own T cells to fight cancer, mass cytometry is an important tool to uncover new insights in cellular phenotypes, function, and signaling status that can further the development of cancer treatments,” he added.
Fluidigm’s Q2 net loss narrowed slightly to $16.2 million, or $.42 per share, from $16.9 million, or $.58 per share in the year-ago quarter. On an adjusted basis, loss per share was $.17, ahead of the Wall Street estimate of a loss per share of $.40.
The firm’s Q2 R&D expenses fell 1 percent year over year to $7.4 million from $7.5 million, while its SG&A spending dropped 10 percent to $19.0 million from $21.0 million.
Fluidigm finished the quarter with $39.4 million in cash and cash equivalents and $996,000 in short-term investments.
For the third quarter, the company said that it expects revenues of $26 million to $29 million. Analysts are expecting Q3 revenues of $27.9 million.
Separately on Thursday, Fluidigm disclosed in a filing with the US Securities and Exchange Commission that it has entered into a loan and security agreement with Silicon Valley Bank that provides the company with a secured revolving credit facility of up to $15 million. The company said it would use the loan for working capital and to fund general business requirements.
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