Showing all posts written by David Dremann

David Dremann

Covidien to Acquire Maker of PillCam

According to the Deal Book, the Jewish Voice, and a Covidien press release, Covidien will acquire all outstanding shares of Given Imaging Ltd. in a transaction valued at $860 million. Covidien has agreed to a purchase price of $30.00 per share, which is 127% of Given’s December 6, 2013 closing price.

According to its website, Given is a Yoqneam, Israel-based company that develops technologies, such as the PillCam 3, for visualizing, detecting and monitoring gastrointestinal disorders. The PillCam 3 is described as a capsule used to “visualize and monitor small bowel abnormalities associated with Crohn’s disease, iron deficiency anemia (IDA) and obscure GI bleeding (OGIB).”

According to Covidien’s Group President, Medical Devices & U.S., Bryan Hanson:

We believe GI is one of the most attractive specialty procedure areas. Acquiring Given will enable Covidien to significantly expand its presence in a $3 billion GI market. . . . Adding Given’s portfolio of diagnostics to our portfolio accelerates Covidien’s strategy of providing physicians with products that support the patient along the care continuum from diagnosis to treatment. It also confirms our leadership in developing less-invasive screening, diagnosis and treatment solutions that can improve patient outcomes and lower healthcare costs.

The Jewish Voice reports that Given made the decision to seek a sale or merger after independent investor Discovery Group recommended that the company auction itself off due to the fact that the company “was chronically undervalued” as a result of “mismanagement.”

Given’s CEO, Nachum Shamir, is reported as providing the following comment on the transaction:

After thoroughly evaluating our strategic options we determined that this transaction is in the best interests of Given Imaging, its shareholders and employees. . . .

The deal is expected to close by March 31, 2014.

 

 

Shifts in the Regulatory Landscape

Regulatory approval of medical devices is a significant consideration for any innovator or manufacturer of medical technologies.  The U.S. FDA’s regulatory approval processes, including, for example, 510(k) clearances and PMA approvals, are notoriously stringent.  So stringent is the U.S. regulatory procedure that many medical device companies opt to enter the regulatory process elsewhere before entering the U.S.  Europe, with its CE mark, which is commonly felt to be a simpler and more straightforward regulatory process, is a common choice.  PR-BG.com reports that, due to several factors, of which regulatory complexity is one of the most significant, only 4% of manufacturers approach the U.S. first for regulatory submission.  Conversely, due to the perceived regulatory simplicity in Europe, a staggering 80% of manufacturers approach the European Union first for regulatory submission.  Because of barriers to entry in the U.S., such as high regulatory uncertainty, high cost of required clinical trials, long time-to-market, and complexity of the FDA’s approval process, many manufacturers never ultimately approach the U.S. for regulatory approval.

According to PR-BG, the FDA is trying to simplify the U.S. regulatory procedure and improve the perception thereof.  As a positive result of the FDA’s efforts, backlogs and decision times have been reduced and approval rates have increased.

While the FDA attempts to make its regulatory process easier to navigate, the Irish Times reports that the EU is now attempting to tighten its medical device regulations.  Proposed changes to the regulation of medical devices in the EU are currently being considered and have just come through the European Parliament.  Such beefed-up regulations could very well increase the difficulty and cost of getting products from bench to the European bedside.  Bill Doherty, Vice President of Cook Medical’s Europe, Middle East and Africa divisions states that Europe is an attractive development center for medical device companies, such as Cook, because in Europe companies can get their products to market about three years sooner than in the U.S. and Japan.  Were the proposed regulations to become law, the European regulatory timeline and costs would likely both increase, thereby giving medical device companies serious cause to consider pulling development and manufacturing out of Europe.  According to Doherty, the proposed laws would ultimately stifle Cook’s and other manufacturers’ innovation plans.

As the EU considers making its regulatory process more stringent and the FDA looks to make its regulatory process more accessible, we may begin to see initial filings occurring with increasing frequency in the U.S. and a corresponding decreasing frequency in Europe.  However, as the U.S. is likely to remain relatively strict in its procedures (despite its efforts to ease the approval procedure), we may ultimately see medical device manufacturers moving to other, potentially more favorable, jurisdictions such as parts of Asia and South America.  Only time will tell.

 

Hacking the Human Body – Medical Device Security

Medical device development, as always, is shooting upwards – and it has just reached the clouds.

According to News Medical, Verizon just announced that it received 510(k) clearance for its Converged Health Management medical device (the first time Verizon has applied for and received FDA clearance). Converged is a remote patient-monitoring medical device based in the cloud and according to the press release should be available in late 2013.

Verizon claims that the new healthcare solution resides in its allegedly “HIPAA-ready cloud” and will provide easy access to nearly real-time patient data from connected medical devices.  Theoretically, this will allow nearly constant medical monitoring – for example, you’re driving your car and you begin to display pre-stroke symptoms (which you can’t notice), if you’re hooked up to Verizon’s “HIPAA-ready cloud,” your primary care physician can call you to tell you to make your way to the nearest hospital.

The potential benefits of this technology could be very interesting (it doesn’t take much imagination to think of some). However, there are also potentially significant consequences. Clearance to fully wireless based devices was first granted in 2006.  The FDA has recognized that, while it grants clearance to wireless and cloud-based medical devices, such wireless devices may present a significant security risk. On August 13, 2013 (a surprising 7 years after the first wireless based device clearance) the FDA issued “Radio Frequency Wireless Technology in Medical Devices – Guidance for Industry and Food and Drug Administration Staff,” a guide that attempts to offer “reasonable assurance of safety.” In recognition of the potential for cyber-attacks on wirelessly connected and internet-enabled medical devices (and the patients connected to them), the Center for Internet Security has publicized a new initiative attempting to better secure such systems from cyber-attacks.

All security systems have vulnerabilities which can be exploited – the question is how small they are and how smart a potential attacker must be to find them. Will Pelgrin, the president and CEO of the Center for Internet Security stated that:

[W]e wanted to be ahead of the curve. Instead of waiting for a major incident to happen, we wanted to provide guidance across the board. . . . As these devices become connected to the internet and networks, they become more than just clinical devices, they become IT systems. As we all know, the weakest node on a network can be your entry point for negative consequences that can affect those devices.

The EE Times points out that many medical devices (which can be connected to networks), such as sport watches, monitoring bracelets, heart rate monitors and pedometers, offer valuable information but would not harm the wearer upon malfunction.  However, there are many medical devices which are life-sustaining, such as pacemakers, insulin pumps, defibrillators, and neural implants.  If these medical devices were “hacked” through inherent weaknesses or through weaknesses in a node of the network to which they are connected, the consequences could obviously be fatal.  According to the article, an insulin pump has already been hacked (by a diabetic white hat hacker demonstrating weaknesses in the system).

Engine Grease and X-rays

Engine Grease and X-rays

As a self-diagnosed autophile (defined by wikitionary as “an automobile enthusiast”) and amateur grease monkey living in So Cal, I am a firm believer in the therapeutic powers of an internal combustion engine. 

Feeling blue?  Take the motorcycle to Ortega highway.  Job got you stressed?  Palomar.  Solved.

It seems that science is backing up my faith in the internal combustion engine.  Mohammed R. Esmaeili-Rad and Sayeef Salahuddin, two UC Berkeley engineers, published in Scientific Reports a method of biomedical imaging which, according to LaserFocusWorld, speeds up the imaging process.  Current photodetectors in many biomedical imaging devices use amorphous silicon in photodetectors.  R&D reports that while absorbing light well and being relatively inexpensive, amorphous silicon is (by today’s standards) slow.  According to the publication, the Berkeley engineers found that pairing a thin film of MoS2 (molybdenum disulfide) with amorphous silicon increases performance–by 10 times.  The publication note that amorphous silicon photodetectors have a transient response time of about 3-5 ms whereas the MoS2 layered photodetectors can achieve transient response times of about 0.3 ms.

The question remanise, what is MoS2?  By itself, it is nothing more than a common and cheap internal combustion engine lubricant (available at many auto parts stores).  The publication notes that this happy marriage of automobile and biomedical technologies has the potential to dramatically increase x-ray detector frame rates from about 10-100 Hz to several kHz, and also notes that this could drastically shorten the necessary radiation exposure to obtain an x-ray thereby decreasing the potential health hazards of that radiation.

While great strides have been made towards supporting my faith in internal combustion engines, I’m still waiting for the day that there is a prescription Rx pad for a rear-wheel drive sports car.

Mindray Acquires ZONARE Medical System for $101.7 Million in Cash

News Medical reports that on July 17, 2013, China-based medical device developer and manufacturer Mindray Medical International Limited completed the acquisition of Mountain View, California-based ZONARE Medical Systems, Inc. Under the terms of a June 12, 2013 agreement, Mindray paid $101.7 million dollars in cash for the acquisition.

According to its North American and International websites, Mindray is a Chinese medical device company which develops, manufactures, and markets an array of medical devices. Mindray focuses on patient monitoring and life support products; in-vitro diagnostic products; and medical imaging systems. According to ZONARE’s website, ZONARE develops advanced ultrasound imaging systems for diverse applications, particularly for high-end radiology.

Mindray’s co-chief executive officer, Minghe Cheng, states:

We are pleased to complete this acquisition, furthering Mindray’s goal of becoming a leading provider of high-quality imaging products worldwide. This transaction brings us superior technology that will ultimately accelerate the launch of our next-generation high-end ultrasound product. It also gives us immediate access to the high-end ultrasound market in the countries like U.S., Canada, Scandinavia and Germany. We are optimistic about the transaction and believe we will be better positioned to serve the healthcare market on a worldwide basis for the long run.

Thoratec to Acquire DuraHeart II Technology from Terumo

4-traders reports that Pleasanton, California-based Thoratec Corporation has acquired the DuraHeart II ventricular assist system from Tokyo-based Terumo Corporation for up to $43.5M.  The deal has been structured such that Thoratec will pay $13M in cash, upfront, which will be followed by milestone payments contingent upon regulatory approvals and product sales.

According to its website, Thoratec Corporation is the world leader in mechanical circulatory support with the broadest product portfolio to treat the full range of clinical needs for patients suffering from advanced heart failure.  Thoratec’s products include the HeartMate LVAS and Thoratec VAD.  According to Terumo’s website, Terumo Corporation is a leading medical device manufacturer which develops, manufactures, and distributes world-class medical devices including products for use in cardiothoracic surgery, interventional procedures, and transfusion medicine.

In Terumo’s press release, Yutaro Shintaku, President and Representative Director of Terumo Corporation stated:

Terumo believes that the transfer of the development of DuraHeart II to Thoratec is the best and fastest way to commercialize the technology and to ensure access for patients in Japan, the U.S., and the rest of the world.  We are pleased that Thoratec recognizes the value of the DuraHeart II platform and will be applying its expertise and resources to develop and bring this exciting product to market.

Techne to Acquire Bionostics Holdings for $104 million

According to Daily Finance’s Investor Center and a press release from Techne Corporation, medical device manufacturer Techne Corporation is set to acquire a 100% ownership stake in Devens, Massachusetts-based Bionostics Holdings Limited and its operating subsidiary Bionostics, Inc. for $104M in cash.  Closing of the transaction is anticipated to occur in the first quarter of fiscal 2014.

According to Techne’s website, Techne develops, manufactures, and sells biotechnology products and hematology calibrators and controls.  According to Bionostics’ website, Bionostics develops, manufactures, and distributes control solutions that verify the proper operation of in vitro diagnostic devices, applied primarily to point of care blood glucose and blood gas testing.  According to the press release, after the close of the transaction, Bionostics and Techne’s Hematology Division will collectively operate under a new Clinical Controls Division of Techne’s R&D Systems.

Regarding the acquisition, Techne President and CEO Charles Kummeth said:

“We are delighted to add the Bionostics team to our Hematology division. This business is how Techne R&D Systems was founded some 30 years ago and remains thriving today. The addition of Bionostics adds capabilities in exciting new areas like coagulation and expands our controls portfolio, giving us the critical mass we need to remain competitive and offer our customers continued value and options to serve their needs.”

AGA Medical Wins Septal Closure Appeal at the Federal Circuit

On Monday, June 3, 2013, the Federal Circuit affirmed the judgments of non-infringement and invalidity in a lawsuit filed by the University of Minnesota against AGA Medical. The opinion was authored by Judge Dyk.

The University of Minnesota alleged that AGA infringed two patents, U.S. Pat. Nos. 6,077,291 and 6,077,281, directed to  “devices and methods for occluding septal defects or shunts in the heart or the vascular system.” Following claim construction, the District Court of Minnesota granted summary judgment that the ‘291 patent was not infringed, and the ‘281 patent was anticipated. On appeal to the Federal Circuit, the University of Minnesota argued that the district court had incorrectly construed the claims of the ‘291 patent, and incorrectly found the ‘281 patent invalid.

The Federal Circuit affirmed, holding that the District Court properly construed the ‘291 patent’s claim language, correctly held that AGA’s device did not infringe the asserted claims of the ‘291 patent, and correctly held that the ‘281 patent was invalid in view of the prior art.

Implantable Device Successfully Predicts Epilepsy Seizures

News Medical reports that Seattle, Washington-based NeuroVista and professors at the University of Melbourne, led by Professor Mark Cook have collaborated to successfully develop and test in humans a device potentially capable of predicting epilepsy seizures.

Professor Cook, Chair of Medicine at the University of Melbourne and Director of Neurology at St. Vincent’s Hospital in Melbourne, Australia, states that:

Knowing when a seizure might happen could dramatically improve the quality of life and independence of people with epilepsy.  The problem is that people with epilepsy are, for the most part, otherwise extremely well.  So their activities are limited entirely by this condition, which might affect only a few minutes of every year of their life, and yet have catastrophic consequences like falls, burns and drowning.

According to News Medical, the device itself combines a first device (developed by NeuroVista) implanted between the skull and brain surface and a second device (developed as part of the collaboration) implanted under the chest.  The second device transmits a signal recorded by the first device to a hand-held monitor which, in real-time, provides the likelihood of a seizure in the hours ahead.

The press release states that the study was conducted over two years and included 15 people having epilepsy aged between 20 and 62 years.  The system correctly predicted high warning seizures 65% of the time.  Eight patients had their seizures predicted successfully between 56 and 100% of the time.

FDA Clearance for Monteris Medical Ablation System

Today’s Medical Developments reports that Monteris Medical‘s second generation MRI-guided ablation device, the “NeuroBlate System,” has just received FDA 510(k) clearance.

According to the press release, the NeuroBlate System combines updated, active MRI visualization and a surgical laser to selectively ablate diseased brain tissue.  Monteris Medical’s first generation system has been available in U.S. hospitals since 2010.  Regarding its new system, John Schellhorn, President and CEO of Monteris Medical, states that:

Monteris invested significant resources to develop a laser ablation system that is faster and adapts to contemporary clinical workflow.  The NeuroBlate System provides neurosurgeons controlled, three-dimensional ablation via a powerful software platform.  It supports surgical decision making during brain operations as well as providing post-procedure confirmation of the effects of the thermal therapy.

The press release also indicates that the Cleveland Clinic will soon be adopting Monteris Medical’s second generation NeuroBlate System to treat patients who seek minimally invasive options or are not candidates for traditional surgery.

 

Angiotech Announces Sale of Interventional Products Division to Argon Medical Devices, Inc.

Angiotech announced this morning that it has entered into an agreement to sell its Interventional Products business line for $362.5 million in cash to Argon Medical Devices, Inc.  According to the press release, the sale is expected to close before the end of April.

Angiotech describes itself as being a global specialty pharmaceutical and medical device company that discovers, develops, and markets innovative technologies and medical products primarily for local diseases or for complications associated with medical device implants, surgical interventions and acute injury.  The company focuses on the areas of interventional oncology, wound closure and ophthalmology.

Argon Medical describes itself as being a global manufacturer of specialty medical products offering a broad line of medical devices for interventional radiology, vascular surgery, interventional cardiology, and critical care procedures.

According to the press release, the businesses being acquired by Argon include:

Angiotech’s BioPince™ full core biopsy devices, Tru-Core™ II (fully automatic) and SuperCore™ (semi-automatic) disposable biopsy instruments, T-Lok™ bone marrow biopsy devices, and Skater™ drainage catheters, among other products.

Angiotech will retain both its Surgical Products Business and its Royalty Business, which it describes in the press release as including intellectual property relating to the drug paclitaxel for application in drug-eluting stents that is licensed to Boston Scientific and Cook Medical.

HD Medical Announces Visual Stethoscope

HD Medical, Inc. announced today the launch of its business operations in the United States and its flagship product, the “ViScope Visual Stethoscope.”  According to the press release, the stethoscope features:

a high-resolution visual display plus high-fidelity sound amplification of body sounds by a factor of 30 . . . . [M]edical professionals are able to perform “dynamic auscultation(TM)” and see the heart beats they hear in real-time waveforms on an integrated visual display.

The press release states that HD Medical, Inc. will unveil the stethoscope at the American College of Cardiology’s 62nd Annual Scientific Session & Expo in San Francisco on March 9-11, 2013.

FDA Approves Second Sight’s Argus II Retinal Prothesis System

NewsMedical reports that the FDA has approved Second Sight Medical Products’ Argus II Retinal Prosthesis System, an implanted device to treat patients with advanced retinitis pigmentosa.  According to the story:

a small video camera, transmitter mounted on a pair of eyeglasses, video processing unit (VPU) and an implanted retinal prosthesis (artificial retina), replaces the function of degenerated cells in the retina (a membrane inside the eye) and may improve a patient’s ability to perceive images and movement

The FDA approved the Argus II as a humanitarian device limited to fewer than 4,000 individuals in the United States annually.