Cerus Corp. is optimistic that its Intercept blood system will become the standard of care in the U.S. when it comes to pathogen reduction in donor plasma and platelets. But it's been more than a couple of years since the Concord, Calif.-based company first won FDA approval in those indications. Now, it's working on a phase III clinical trial program aimed at expanding the technology's application into the broader market for pathogen reduction in red blood cells (RBCs) by the end of the decade. Cerus is also awaiting a final FDA guidance on bacterial safety...

Livanova plc sees transcatheter mitral valve replacement (TMVR) is coming up next as a multibillion segment following on TAVR. To secure what it expects will be market-leading technology, the London-based company has acquired Maple Grove, Minn.-based Caisson Interventional LLC. Sorin SpA and Cyberonics Inc. merged in the fall of 2015 to become Livanova; Sorin had been a Caisson investor since 2012. Livanova has acquired the remaining 51 percent of Caisson for $78 million in cash, milestones and debt forgiveness. APPROACH ADVANTAGE? Caisson's TMVR implant is the only one designed entirely for use via a transseptal...

Hedge fund giant KKR sees opportunity in a new investment approach to the medical device space. Alongside life science private equity player Aisling Capital, KKR has created Ajax Health to enable it to provide financial and operational support to medical device companies. MED-TECH OPPORTUNITY It aims to opportunistically invest in roughly seven to 10 device companies that have only one or two significant remaining risks until they reach a major inflection point. Roughly $15 million to $30 million will be invested in total for each company. The first Ajax company is Advanced Cardiac Therapeutics Inc....

True to their word, U.S. lawmakers are pushing forward with plans to give the NIH its second consecutive $2 billion funding bump. Included in an omnibus spending bill Congress is slated to vote on in a few days, the increase ignores President Donald Trump's request for a $1.2 billion cut in NIH funding for the remainder of fiscal 2017 to help pay for more spending on defense. Largely due to that bump, the Department of Health and Human Services (HHS) – which includes the FDA, NIH, CDC, as well as other agencies – is slated...

Epic Sciences Inc. raised $40 million in a series D round, proving investors still have strong interest in the 9-year-old liquid biopsy specialist. The San Diego-based company has taken in about $85 million since it spun out of the Scripps Research Institute in 2008. Its most recent round was led by Hermed Capital. Altos Capital Partners, Domain Associates, Genomic Health Inc., Pagoda Investment, Reach Tone Ltd., RMI Partners, Sabby Capital and VI Ventures also participated in the series D financing. "As Epic has continued to grow and evolve, we see this financing round as a...

ATLANTA – The digital health market is growing. Taking in about $76.7 billion in 2015, the burgeoning space is sustained through partnerships. However, some smaller med-tech companies often have difficulties partnering with larger companies to foster innovation in the digital health market. Panelists at the Southeastern Medical Device Association (SEMDA) shared some insight on how start ups can get the attention of larger firms and forge a path in digital health. Panelist Omer Inan, an assistant professor of electrical and computer engineering at the Georgia Institute of Technology, said that traditionally the model in academia...

ATLANTA – Cybersecurity threats are becoming increasingly prevalent in the med-tech industry. Large companies are not immune to these attacks and are in some cases more of a target than smaller firms. Earlier this month Abbott Laboratories Inc. received an FDA warning letter, citing vulnerabilities with its pacemakers. (See Medical Device Daily, April 17, 2017.) The Abbott Park, Ill.-based company was brought up as an example of the growing threat of cybersecurity breaches during a panel at the Southeastern Medical Device Association's (SEMDA) annual meeting, Wednesday. Panelists presented data from BBR Services that showed 56...

Memed Ltd. has received a contract from the Defense Threat Reduction Agency, a branch of the U.S. Department of Defense (DoD) totaling up to $9.2 million. The contract will help fund the Tirat Carmel, Israel-based company's second generation point-of-care platform for distinguishing bacterial from viral infections. Memed began operation in 2009 and has CE mark approval for the Immunoxpert, a first generation in vitro diagnostic blood test to determine whether a patient has either an acute bacterial or viral infection, said Eran Eden, the company's co-founder and CEO. "When we started this journey eight years...

Becton, Dickinson and Co. (BD) is set to acquire C.R. Bard Inc. for $24 billion in cash-and-stock. The acquisition values Murray Hill, N.J.-based Bard at $317 per share, a 25 percent premium over Friday's close of trading. Bard shareholders could receive $222.93 in cash and 0.5077 shares of Franklin, Lakes N.J.-based BD for each of their shares. The acquisition is expected to close in the fall of this year. Upon news of the pending acquisition, Bard (NYSE:BCR) shares rose more than 19 percent Monday closing at $302.41. BD (NYSE:BDX) shares declined 4.4 percent closing at...

PARIS – Being first to market does not mean you have won the game. With competition heating up in a new category of in vitro diagnostics (IVDs) called syndromic testing, that lesson is being refreshed as a new case study takes shape. Based on multiplex polymerase chain reaction (PCR) assays, syndromic testing for infectious diseases in just a few years has captured 45 percent of the $2 billion market segment for molecular diagnostics, according to Grand View Research based in San Francisco. With a projected annual growth rate of 13.3 percent PCR-based molecular diagnostics are...