MiroMatrix raises $23m for decellularizing tech

Decellularization technology developer MiroMatrix Medical raised $23 million in a new round of equity financing, according to an SEC filing posted last week.

MiroMatrix develops and utilizes a proprietary technology to remove cells, or decellularize, organs and tissue.

Currently, MiroMatrix has 510(k) clearance for its MiroMesh biological mesh used during hernia repair procedures and as a general wound treatment, and plans to submit additional applications for other indications, according to its website.

MiroMatrix plans to pursue other applications of its proprietary technology, including creating a cortical strut, cardiac patch and other regenerative uses, according to the Eden Prairie, Minn.-based company’s site.

The round saw participation form 116 unnamed investors, according to an SEC filing. The company did not indicate if any returning investors cooperated in the round.

The post MiroMatrix raises $23m for decellularizing tech appeared first on MassDevice.

from MassDevice http://ift.tt/1N5vCPa

ConforMIS plunges on recall, guidance cut

ConforMIS (NSDQ:CFMS) shares plunged nearly 19% today after the Bedford, Mass.-based company recalled some 950 of its customized knee replacements and cut its outlook for the rest of the year.

The company received 3 complaints of moisture on the patient-specific instrumentation used with the implants, although all 3 procedures went off without a hitch, ConforMIS said. The recall affects its iUni, iDuo, iTotal CR and iTotal PS devices. Roughly 650 of the devices involved in the recall have already been implanted and the remaining 300 have shipped for scheduled procedures but not used, the company said.

“The company does not believe that the customized knee implants used in these procedures were themselves affected. While the number of complaints the company has received is small, and the company has not received any reports of adverse events related to these complaints to date, the company initiated this recall voluntarily and is working to resolve the complaints quickly,” ConforMIS said in a press release.

The instruments were made at a new plant in nearby Wilmington, Mass., between July 18 and August 28, the company said.

“Based on an initial assessment, ConforMIS believes that the recalled instrumentation held excess water before undergoing the commonly used ethylene oxide sterilization process and, as a result, may contain small amounts of ethylene glycol residue. Ethylene glycol residue may form when ethylene oxide comes into contact with water. ConforMIS has temporarily suspended its use of the ethylene oxide sterilization process and is working expeditiously to investigate the root cause of the excess moisture and evaluate potential corrective and preventative actions,” the company said. “ConforMIS is seeking the return of the approximately 300 knee replacement product systems, which include the patient-specific instrumentation sets. The company does not believe that the customized knee implants included with the sets themselves were affected.”

Production is expected to slow substantially in September and perhaps October, as it moves to an existing alternative sterilization process while it investigates and corrects the problem. That prompted ConforMIS to pare $8 million from its sales forecast for 2015, saying it now expects revenues of $64 million to $66 million, down from $72 million to $74 million.

CFMS shares closed down -18.9% at $16.05 apiece today.

 

The post ConforMIS plunges on recall, guidance cut appeared first on MassDevice.

from MassDevice http://ift.tt/1O4enuK

MassDevice.com +3 | The top 3 medtech stories for August 31, 2015

Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

 

3. How Reshape Medical built an alternative to bariatric surgery for obesity| DeviceTalks Podcast

In this episode of DeviceTalks, we speak with Richard Thompson, CEO of ReShape Medical, about the company’s bariatric surgery alternative for people suffering from obesity. Read more

---

2. Mitralign wins FDA nod for tricuspid valve feasibility trial

Mitralign said today that the FDA approved a U.S. feasibility study of its tricuspid valve repair device, under an investigational device exemption. Read more

---

1. Medtronic says a pair of studies show genetic link to sudden cardiac death

Medtronic (NYSE:MDT) today said 1st-of-a-kind results from a pair of independent clinical trials discovered a gene linked to abnormal heart rhythms that can lead to sudden cardiac death. Read more

The post MassDevice.com +3 | The top 3 medtech stories for August 31, 2015 appeared first on MassDevice.

from MassDevice http://ift.tt/1fRSLpC

Mainstay: ReActiv8 data may be enough for CE Mark, announces earnings

Mainstay Medical (EPA:MSTY) said that data from a trial of its ReActiv8 neurostim may be enough to win it CE Mark approval in the European Union and released its 6-month earnings today.

The company’s multi-center, prospective ReActiv8-A clinical trial examined patients with chronic lower back pain treated with the company’s implantable ReActiv8 neurostimulation device. Of the patients in the trial, 70% were being treated with opioid painkillers.

Preliminary data from the 1st 47 patients implanted with the device showed an average 63% improvement in back pain as defined by a minimum 2-point gain on a 0-10 numerical rating scale after 90 days, and a 54% responder rate for pain, indicating an improved average numerical pain rating over 7 days without an increase in pain medications.

The company reported results from another cohort of 33 patients who reached the 180-day mark, with 58% reporting better back pain scores and 64% reporting a greater than 50% reduction in pain.

“The results from the ReActiv8-A trial show improvements which are better than any other therapy for this group of people as reported in the literature. We are excited that our unique approach to treating this type of chronic low back pain offers the potential to change the lives of millions of people worldwide who have no effective treatment alternative,” CEO Peter Crosby said in a press release.

Data from the trial will be used to support the company’s submission for CE Mark approval.

Mainstay also reported losses of $6.4 million, or $1.48 per share for the 6 months ended June 30.

That amounts to a 91.6% reduction in losses compared to the same period last year, with losses per share down 58.2% compared with the same period last year.

Operating expenses increased for the company by $1.5 million, mainly due to the increased activity of its clinical trial of ReActiv8, the company said in its earnings release.

Shares have been less than optimistic, dropping 7.9% as of mid-day trading.

The post Mainstay: ReActiv8 data may be enough for CE Mark, announces earnings appeared first on MassDevice.

from MassDevice http://ift.tt/1fRSLpo

NovaBone wins PMA for MacroForm bone repair device

Bio-active synthetic bone graft company NovaBone said today it won FDA premarket approval for its MacroForm minimally invasive bone repair device.

The device is designed to deliver bone marrow aspirate to a graft via an minimally invasive cannula, the Jacksonville, Fl.-based company said.

“The MacroForm MIS delivery system builds off the commercial success of the intuitively-designed collagen devices we have launched over the past several months. Moreover, NovaBone’s MacroForm technology, which offers more bioactivity than any other competitive product, is now available in multiple formulations, and delivery options,” sales & marketing veep Dennis McBride said in a press release.

The company said it released 6 new collagen products over the past year and claims to have the broadest portfolio of bone graft substitutes in the world, according to a press release.

“We continue to reach milestones we have established. Our team has done an excellent job in terms of both design and manufacturing of collagen products and creating a robust pipeline of products that harness the natural healing process of the body,” products prez Art Wotiz said in prepared remarks.

The post NovaBone wins PMA for MacroForm bone repair device appeared first on MassDevice.

from MassDevice http://ift.tt/1Ui8X6s

ESC guidelines updated to include subcutaneous defibs

The European Society of Cardiology updated its treatment guidelines for ventricular arrhythmia patients to include subcutaneous implantable cardioverter defibrillators.  The announcement was made at the society’s annual meeting in London on Saturday.

The new guidelines recommend the use of the S-ICD units as a possible alternative to transvenous defibrillators in patients with an ICD indication who don’t require cardiac resynchronization or pacing therapy for bradycardia and antitachycardia.

“As the manufacturer of the world’s 1st and only subcutaneous defibrillator, we are extremely pleased that the updated ESC guidelines have now been published. The guidelines recognise the strong clinical science supporting the compelling benefits of a device that can protect a broad range of patients from sudden cardiac death while leaving the heart and vascular system untouched. This represents another important milestone after the launch of Emblem S-ICD System, the second generation S-ICD, earlier this year,” Boston Scientific (NYSE:BSX) chief medical officer Dr Kenneth Stein said in a press release.

The ESC gave the device an official class IIa recommendation with the change to its guidelines.

In June, Boston Scientific launched a global clinical trial for its Emblem S-ICD in primary prevention patients with severely reduced cardiac function. The study is slated to enroll a minimum of 2,015 patients with no documented, life-threatening arrhythmic event who are at risk of sudden cardiac death.

Earlier in April, Boston Scientific touted a study published in the Journal of the American College of Cardiology showing the long-term safety and effectiveness of its S-ICD “leadless” defibrillator.

The study pooled 6-month to 1-year data from a pair of Boston Scientific-funded clinical trials, the S-ICD investigational device exemption trial and the Effortless post-market trial.

The post ESC guidelines updated to include subcutaneous defibs appeared first on MassDevice.

from MassDevice http://ift.tt/1Q445Mp

Toshiba delays annual report by a week

Toshiba (TYO:6502) delayed reporting its annual fiscal earnings again, filing for a week extension from the previously set deadline of August 31st as it continues to wrestle with an internal accounting scandal.

The company apologized for the delay in a press release and rescheduled with a new date of September 7th.

The delay was a result of newly uncovered problems, including financial reporting issues from both Japanese and international subsidiaries that required auditing and an independent audit of a U.S. subsidiary, according to a press release.

Toshiba originally extended the deadline in late May due to an independent investigation panel that found that top executives were involved in improper practices that extended across virtually all business areas of the semiconductor-to-nuclear conglomerate.

In July, the panel found that former CEO Hisao Tanaka had known about the company inflating its profits by $1.2 billion over several years. Tanaka and other Toshiba execs resigned in response to the scandal.

Earlier this month, a Nikkei Business daily report suggested Toshiba will report earnings in the red for the last fiscal year. The company originally projected a profit of $964 million (¥120 billion) for the fiscal year, but withdrew the expectations in May and has delayed its earnings announcement.

Last month, Toshiba said it would cut its interim CEO Masahi Muromachi’s pay by 90% for 2 months following the accounting investigation.

The post Toshiba delays annual report by a week appeared first on MassDevice.

from MassDevice http://ift.tt/1NIZ65m

St. Jude Medical’s Nanostim leadless pacer meets 6-month safety, efficacy goals

The Nanostim implantable pacemaker made by St. Jude Medical (NYSE:STJ) met its 6-month safety and efficacy endpoints, according to data presented over the weekend at the annual meeting of the European Society of Cardiology in London and published in the New England Journal of Medicine.

The Leadless II study enrolled 526 patients in the primary cohort, with 300 completing the 6-month protocol in June. The entire group was followed for a mean 6.9 months, showing successful implantation of the Nanostim device in 504 (95.8%) of subjects, according to the NEJM paper. In some 29.8% of the cases, the Nanostim device needed repositioning; in 22 cases (4.4%) the device needed repositioning more than twice.

“In summary, the Nanostim leadless cardiac pacemaker met pre-specified pacing and sensing requirements in 90% of the patients in whom an implantation was attempted and in 93.4% of the patients in whom the implantation was successful,” the researchers wrote, noting that the study design was limited in not allowing a direct comparison to conventional pacers.

“Currently, the leadless cardiac pacemaker can serve as only a single-chamber ventricular pacemaker, which accounts for a minority of implanted pacemakers in the United States. The leadless cardiac pacemaker also cannot provide electrographic data. Refinements in device-to-device communication, atrial affixation, and device diagnostics would be necessary for this device to fully replace conventional dual-chamber pacemakers,” they wrote.

“Leadless pacing is a new frontier for modern medicine, and a potential solution for physicians who want to retain the reliability of conventional pacing options but offer their patients a less invasive procedure,” chief medical officer Dr. Mark Carlson said in prepared remarks. “The Nanostim leadless pacemaker allows for a procedure without the need for a surgical pocket or the leads required by traditional pacemakers. Combined with prior data from the Leadless trial, the results of Leadless II demonstrate the Nanostim leadless pacemaker should be considered as a clinical alternative by physicians who want to provide patients a leadless pacing option that offers long-term longevity and device retrievability.”

The researchers said 270 patients (90.0%; 2-sided 95% confidence interval [CI], 86.0 to 93.2) reached the primary efficacy end point in an intention-to-treat analysis. Device implantation was unsuccessful in 11 patients; among the remaining 289 patients in whom implantation was successful, 270 reached the primary efficacy end point (93.4%; two-sided 95% CI, 89.9 to 96.0; P<0.001), according to the study.

 

Nanostim met the primary safety endpoint in 280 of 300 patients (93.3%; 2-sided 95% CI, 89.9 to 95.9), with 22 device-related serious adverse events in 20 patients (6.7%) over a period of 6 months. The rate of device-related serious adverse events was 6.7%, including device dislodgement in 1.7% of patients, cardiac perforation in 1.3%, elevated pacing thresholds requiring device retrieval and reimplantation in 1.3%, and vascular complications in 1.3%.

That compares with a 3.2% complication rate with conventional ventricular pacemakers, excluding lead fracture but including pneumothorax in 1.1%, lead dislodgement in 0.8%, and infection in 0.5%, the researchers wrote.

Importantly for St. Jude, which earlier this year paused enrollment in a European Nanostim trial to evaluate a series of adverse events including cardiac perforation and dislodgement, the rate of cardiac perforation (1.5% among the 526 patients in the total cohort) was similar to the rate observed with transvenous leads, they wrote. Enrollment in the Nanostim was paused once before, in April 2014, after researchers reported 6 instances of perforation, including 2 patient deaths, out of more than 200 implantations.

For the entire 526-patient cohort the rate of device-related serious adverse events was 6.5%, according to the NEJM study, including cardiac perforation in 1.5%, device dislodgement in 1.1% and device retrieval due to elevated pacing thresholds in 0.8%. There were 28 deaths (5.3%) during follow-up of the larger group, with 19 deaths (68%) occurring within 6 months, 8 (29%) between 6 and 12 months, and 1 (4%) after 12 months.

St. Jude acquired Nanostim in 2013 for $123.5 million, 2 years after making a strategic investment in the Milpitas, Calif.-based company.

The post St. Jude Medical’s Nanostim leadless pacer meets 6-month safety, efficacy goals appeared first on MassDevice.

from MassDevice http://ift.tt/1X5TzJd

How Reshape Medical built an alternative to bariatric surgery for obesity| DeviceTalks Podcast

In this episode of DeviceTalks, we speak with Richard Thompson, CEO of ReShape Medical, about the company’s bariatric surgery alternative for people suffering from obesity.

In July, San Clemente, Calif.-based ReShape won pre-market approval from the FDA for its dual balloon system, indicated to facilitate weight loss in obese adult patients. The system is designed to be inserted endoscopically into the stomach, where it remains for 6 months to help patients feel full. The balloon is meant to be temporary and patients with the device undergo supervised diet and exercise plans to maintain weight loss following its removal, according to ReShape.

Last week, the company added another $38 million to its war chest in a Series D round led by HealthCor Partners Management. Endeavour Vision SA, SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners and Venture Investors also participated.

In this episode of DeviceTalks, MassDevice.com publisher Brian Johnson discusses ReShape’s procedure, the difficulty of combating obesity and why Thompson feels this treatment will work where so many others have failed. Thompson will be a featured speaker at our DeviceTalks live event Dec. 9 in Orange County, Calif.

The post How Reshape Medical built an alternative to bariatric surgery for obesity| DeviceTalks Podcast appeared first on MassDevice.

from MassDevice http://ift.tt/1Et4vub

Biotronik launches China arm in Orsiro stent trial

Biotronik said today it enrolled the 1st patient in its new Chinese Bioflow-VI study of its Orsiro drug-eluting stent for treating patients with coronary artery disease.

The prospective, multi-center trial is slated to enroll 440 patients at 15 sites in China to support Chinese market approval of the Orsiro drug-eluting stent.

“Based on the wealth of clinical evidence demonstrating Orsiro’s safety and efficacy, I am very excited to begin enrollment in the Bioflow-VI study. This trial represents a key step in the process of bringing this remarkable product to Chinese patients. Once approved for use here, I’m convinced Orsiro will benefit Chinese patients and physicians as it does in Europe,” coordinating clinical investigator Dr. Yuejin Yang said in a press release.

The primary endpoint for the study is in-stent late lumen loss at 9 months and the primary safety endpoint is the rate of major adverse cardiac events at 1 year, according to the company.

“Our mission is to improve and save patients’ lives all over the world with innovative devices like the Orsiro hybrid DES, which has proven itself time and again both in clinical studies and in routine clinical practice. The start of Bioflow-VI is an important milestone in our quest to bring Orsiro, one of our most successful products globally and a cornerstone of the Biotronik Masterpieces portfolio, to China,” Biotronic Asia Pacific veep Gunnar Wochnowski said in prepared remarks.

Earlier this month, Biotronik announced 2 new studies that are slated to examine the company’s CRT-D device and BioMonitor implanted cardiac monitor.

A 277-patient BioContinue clinical trial will examine the risk of ventricular arrhythmias after CRT-D replacement, enrolling patients over 2 years at 40 centers across 8 countries, the company said.

Another trial, the BioGuard MI1 study, will examine the effectiveness of Biotronik’s BioMonitor at reducing the likelihood of major adverse cardiovascular events in patients with relatively preserved ejection fraction who have experienced myocardial infarction.

The post Biotronik launches China arm in Orsiro stent trial appeared first on MassDevice.

from MassDevice http://ift.tt/1Et4vdT

Mitralign wins FDA nod for tricuspid valve feasibility trial

Mitralign said today that the FDA approved a U.S. feasibility study of its tricuspid valve repair device, under an investigational device exemption.

Tewksbury, Mass.-based Mitralign did not provide any details on the Scout study or its design for its percutaneous tricuspid valve annuloplasty device, other than that it will occur at “select” sites in the U.S.

Mitralign, which last year reported the 1st-in-human use of its replacement tricuspid valve, had raised about $50 million as of September 2014. The company is backed by a mix of venture capital and strategic medical device investors, including Forbion Capital Partners, Orchestra Medical Ventures, Oxford Bioscience Partners, Triathlon Medical Ventures, Medtronic (NYSE:MDT) and Johnson & Johnson (NYSE:JNJ).

The tricuspid valve separates the heart’s right atrium and right ventricle. The Mitralign system is designed to use wire and catheters to implant polyester anchors within the valve’s annulus; those anchors are then cinched together to reduce the circumference of the mitral valve, creating a functional bi-cuspid valve. Earlier this year, the company closed enrollment in European trials aimed at winning CE Mark approval there for a mitral regurgitation indication. Mitralign stitched up an $8 million equity round in June 2014.

“Percutaneous repair of the tricuspid valve represents one of the largest remaining unmet needs in the structural heart space,” CEO Rick Geoffrion said in prepared remarks. “We mimic a known surgical procedure but do not require open heart surgery, providing a potential treatment option for a large number of patients that are too sick for surgical intervention. This approval from the FDA demonstrates their continued commitment to encouraging medical device innovation to address clinical needs and improve patient care.”

“Even though the first group of patients treated were very sick, compassionate use candidates in Europe, the system has shown an excellent safety profile along with tremendous improvements in significant clinical measures,” added Dr. Rebecca Hahn of New York’s Columbia University Medical Center and Presbyterian Hospital, principal investigator in the Scout study. “This patient population has very limited options, and the possibility of performing a transcatheter repair is very exciting. This innovation has significant potential to be a first line therapy.”

The post Mitralign wins FDA nod for tricuspid valve feasibility trial appeared first on MassDevice.

from MassDevice http://ift.tt/1Fcfa7D

US anti-trust regulators clear St. Jude’s Thoratec buy

U.S. Anti trust regulators cleared St. Jude Medical‘s (NYSE:STJ) $3.4 billion acquisition of Thoratec (NSDQ:THOR) as the HRS Act waiting period for the purchase expired on August 28, according to an SEC filing.

The passing of the waiting period is the last antitrust hurdle for Little Canada, Minn.-based St. Jude’s purchase. The company said the acquisition is still subject to approval by Pleasanton, Calif.-based Thoratec’s shareholders and other closing conditions.

The acquisition is still expected to close in the 4th quarter of this year, according to the SEC filing from Thoratec.

Last week, St. Jude said it took out a 5-year, $2.6 billion loan from Bank of America to fund its $3.4 billion purchase ofThoratec (NSDQ:THOR). According to the loan terms, $2.1 billion of the funds will go entirely towards the cost of acquiring Thoratec, with $500 million slated to be used to refinance existing debt and for general purposes.

The news came shortly after the 30-day “go-shop” period in St. Jude’s pending acquisition of Thoratec lapsed without a 2nd suitor emerging, which sent the companies’ stock prices down slightly last Friday.

The merger, medtech’s latest multi-billion union, calls for St. Jude to pay $63.50 in cash for each share of Thoratec, funded using term loans and senior unsecured debt.

Last month St. Jude raised its 2015 outlook, saying it expects to post earnings of $3.96 to $4.00, up from prior guidance of $3.92 to $3.97, and boosted the top end of its constant-currency sales growth outlook from 4% to 5% to 4% to 6%.

The post US anti-trust regulators clear St. Jude’s Thoratec buy appeared first on MassDevice.

from MassDevice http://ift.tt/1X5vP88

Medtronic says a pair of studies show genetic link to sudden cardiac death

Medtronic (NYSE:MDT) today said 1st-of-a-kind results from a pair of independent clinical trials discovered a gene linked to abnormal heart rhythms that can lead to sudden cardiac death.

Fridley, Minn.-based Medtronic said the studies, Discovery and Oregon SUDS, found a gene associated with SCD in patients with implantable cardioverter defibrillators. Results were presented over the weekend at the annual meeting of the European Society of Cardiology in London.

The Medtronic-sponsored Discovery trial used ICDs to monitor patients and evaluate whether 7 biomarkers in 3 genes helped predict ventricular tachyarrhythmia and sudden cardiac death, identifying the gene associated with a 50% relative risk increase in  life-threatening arrhythmia, the company said.

Those results  Discovery were echoed by the 12-year Oregon SUDS trial conducted by the Arrhythmia Research Laboratory at the Cedars-Sinai Heart Institute in Los Angeles, Medtronic said.

“The results presented today are part of Medtronic’s efforts to better identify people at risk of SCD and to get them the right life-saving therapy,” tachycardia general manager Dr. Marshall Stanton said in prepared remarks. “Medtronic looks forward to partnering with the larger clinical research community to further our shared understanding of the risk for sudden cardiac death and how to prevent it.”

“This is the first time a gene has been identified using ICD monitoring and then confirmed to be associated with sudden cardiac death in the general population,” added Discovery principal investigator Dr. Heiner Wieneke of the St. Marien-Hospital in Mülheim, Germany. “These findings are a first step to learning more about how to determine better ways to prevent and treat this condition.”

“This research is vital to helping us better understand why some patients are at higher risk of sudden cardiac death, one of the leading causes of death globally,” said Dr. Sumeet Chugh, lead investigator for the Oregon SUDS project. “These findings put us one step closer to understanding the complexities of sudden cardiac death and may, someday, help us identify which patients are at risk.”

The post Medtronic says a pair of studies show genetic link to sudden cardiac death appeared first on MassDevice.

from MassDevice http://ift.tt/1FbN3Wl

CSS opens a new office in Europe and releases French and German websites

CSS is pleased to announce that they have opened a new sales and marketing office located in the Netherlands. This office will provide additional on-the-ground support for CSS customers and partners located throughout Europe. Although the company has been serving international markets and shipping products globally for decades, having a dedicated office established in the region will reinforce CSS’ commitment to growing their business worldwide.

In addition to the new office, CSS is pleased to announce the launch of its new French and German website translations at fr.ctspring.com and de.ctspring.com. This is a strategic enhancement to the extensively redesigned CSS website, which went live in July 2015. Prospects, customers and business partners in Europe can now easily access information about CSS’ advanced capabilities and products such as precision springs, CNC machined stampings, fineblanked components and complete mechanical assemblies.

“CSS is a global company serving OEMs all over the world. We already have established manufacturing capabilities in Asia, and operate sales and warehouse facilities in China and in Latin America. The new sales office in the Netherlands was a natural progression for CSS to better serve international markets. We are very excited about the growth that CSS is experiencing abroad,” said Steve Dicke, Vice President of Sales and Marketing at CSS.

Connecticut Spring & Stamping
www.ctspring.com

The post CSS opens a new office in Europe and releases French and German websites appeared first on MassDevice.

from MassDevice http://ift.tt/1JrCgsO

Becton Dickinson closes Cellular Research buy

Becton Dickinson & Co. (NYSE:BDX) said Tuesday it closed its purchase of biotech firm Cellular Research for an undisclosed price.

Cellular Research develops tools for parallel single cell genetic analysis based upon its proprietary molecular indexing technology, according to Franklin Lakes, N.J.-based Becton Dickinson.

“The acquisition of Cellular Research, combined with our existing cell sorting technology, will provide our customers with a more complete and simplified workflow solution for single cell analysis. The addition of Cellular Research builds on our GenCell acquisition and underscores BD’s commitment to a genomics strategy focused on next generation sequencing sample preparation,” BD life sciences prez Linda Tharby said in a press release.

BD has been collaborating with Cellular Research since 2014 to develop single cell analysis workflows that operated with both company’s tech platforms, BD said.

“Integrating BD’s single cell sorting capabilities and world-leading expertise with our next generation single cell genomic technologies will provide researchers with a scalable, cost-effective approach to high resolution gene expression studies. We are excited about the possibilities we can offer researchers by combining our expertise, and believe it has the potential to meet several unmet needs in single cell genomics research,” Cellular Research CEO Stephen Fodor said in prepared remarks.

The acquisition is small compared to BD’s $12.2 billion merger with CareFusion, which closed in March after European anti-trust regulators approved the deal.

Franklin Lakes, N.J.-based Becton agreed last October to pay a total of $58.00 a share – $49.00 in cash and 0.0777 of a BDX share – for each CFN share, representing a premium of 26% to the closing price on Oct. 3.

The deal unites 2 complementary product lines: BD makes products to deliver and administer drugs, such as disposable needles, syringes and intravenous catheters, while CareFusion makes products to store and deliver drugs, such as infusion pumps.

Anti-trust regulators in the U.S. approved the deal last November; the EU nod was the buyout’s final regulatory hurdle, according to a regulatory filing. In January CareFusion and BD agreed to settle a raft of lawsuits filed by shareholders seeking to block the merger. CareFusion’s shareholders OK’d the deal later that month.

The post Becton Dickinson closes Cellular Research buy appeared first on MassDevice.

from MassDevice http://ift.tt/1IqG7EO

Carefusion, Elite Biomed issue Class I Alaris pump recalls

The FDA today issued 2 recall notices related to CareFusion‘s Alaris pumps, including 1 to CareFusion over alarm issues and another to Elite Biomedical Solutions over a flaw in a replacement frame membrane for the drug pumps.

The FDA has labeled the recalls as a Class I, the most serious type of recall issued by the federal watchdog, which indicates “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”

CareFusion received 108 reports of an error in which a visual and audible alarm that causes the Alaris pump to stop supplying infusion to the patient, according to the FDA.

Even if the error is cleared, the pump does not respond to key presses until the unit is completely disconnected and reconnected to the computer unit used to program, monitor and provide power to the pump, the federal watchdog said.

Failures in the syringe pump may cause delays or interruptions of therapy and can lead to serious injury or death, the FDA said. So far, CareFusion has not received any reports of permanent injury or death.

A total of 6,458 Alaris syringe pumps, model number 8110, are affected by the recall.  The recalled pumps were manufactured between March 2014 and September 2014 and distributed between March 17, 2014 and September 30, 2014. All units recalled were distributed within the U.S.

CareFusion began notifying customers of the issue July 20, saying the company would initiate repairs on the units within 60 days and advising users to sequester the pumps and use alternate units.

A 2nd Alaris recall was issued involving Elite Biomedical Solutions’ Alaris medley large volume pump frame membrane, a replacement piece for a CareFusion Alaris pump. The frame membrane is a part of the Alaris pump that prevents fluids from leaking into internal components, according to the FDA.

Elite Biomedical Solutions said it discovered that use of the replacement frame membrane could lead to over or under infusion of fluids to the patient, with the potential to cause injury or death.

A total 1,502 units distributed within the U.S. are affected by the recall, manufactured between February 20, 2015 and April 21, 2015 and distributed between February 25, 2015 and May 8, 2015, the FDA said.

Elite Biomedical Solutions began contacting customers about the issue on May 21, urging customers to quarantine any indicated products and contact any patients the parts could have been distributed to.

The post Carefusion, Elite Biomed issue Class I Alaris pump recalls appeared first on MassDevice.

from MassDevice http://ift.tt/1hivoq5

MassDevice.com +3 | The top 3 medtech stories for August 26, 2015

Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

 

3. Abbott denies St. Jude Medical buyout report

Abbott denied reports that it’s prepping a $25 billion offer for St. Jude Medical, but the rumor nevertheless propelled STJ shares up YY% this morning.

Investors were sparked by a Financial Times report of the potential offer. Abbott is working with banks on a cash-and-stock proffer, the newspaper report, citing people familiar with the situation. A deal between Abbott and St. Jude, which already jointly sell their cardiovascular products, would give the new entity stronger ground in negotiations with hospital customers, the newspaper reported. Read more

---

2. Cardinal Health to buy NaviHealth for $410m

Cardinal Health said it paid $290 million for a majority stake in post-acute care management firm NaviHealth, in a 4-year deal worth $410 million.

The $290 million payout gives Dublin, Ohio-based Cardinal a 71% share in NaviHealth, the company said. NaviHealth’s Brentwood, Tenn.-based management team will continue to lead the business and principal investor Welsh, Carson, Anderson & Stowe will hold on to its stake, Cardinal Health said. Read more

---

1. Greatbatch to buy out Lake Region Medical for $1.7B

Greatbatch said that it agreed to acquire Lake Region Medical for $1.73 billion in cash and stock.

Terms call for Frisco, Texas-based Greatbatch to pay $478 million in cash and some 5.1 million shares of stock (which closed at $49.89 per share, making that portion of the offer worth another $254.4 million). Greatbatch said it also agreed to assume $1 billion worth of Wilmington, Mass.-based Lake Region Medical’s debt Read more

The post MassDevice.com +3 | The top 3 medtech stories for August 26, 2015 appeared first on MassDevice.

from MassDevice http://ift.tt/1IlJeh3

AxoGen deals 16% stake to Essex Woodlands for $17.1m

AxoGen Inc. (NSDQ:AXGN) said today it sold 4.8 million shares to investment firm Essex Woodlands, reeling in $17.1 million for Axogen and giving Essex Woodlands a 16% stake in the company.

The funds from the sale are slated to support market growth and accelerate the company’s entry into new nerve repair markets, including the development and commercialization of new nerve repair products.

“Our partnership with Essex Woodlands puts AxoGen in an excellent position to build on the momentum we are generating in the nerve repair market as well as capitalize on our numerous opportunities. Essex Woodlands is a premier, long-term focused healthcare investor and through their investment in AxoGen we now have the resources in place to execute our current business plan as well as fund expansion. Based on our current operations, we believe the investment provides AxoGen with the resources to achieve positive operating cash flow,” CEO Karen Zaderej said in a press release.

Peripheral nerve-repair focused Axogen said it would be taking on Essex Woodlands operating partner Guido Neels as a new member of its board along with the new financing.

“We are very glad to be a shareholder of AxoGen and we look forward to supporting Karen and the management team to continue AxoGen’s momentum as the leader of innovative surgical solutions for peripheral nerve injuries. We expect a very successful growth trajectory for the company,” Neels said in a prepared statement.

In June, Axogen said it enrolled the 1st subject in a clinical trial of its Avance nerve graft. The multicenter, prospective randomized Recon study will compare the Avance graft to nerve tubes currently used for bridging peripheral nerve tissue gaps, the Florida-based regenerative medicine company said.

The post AxoGen deals 16% stake to Essex Woodlands for $17.1m appeared first on MassDevice.

from MassDevice http://ift.tt/1fIHp7b

Boston Scientific looks to block pelvic mesh plaintiff’s bid to exclude murder conviction

Boston Scientific (NYSE:BSX) wants a federal judge to allow evidence of a pelvic mesh plaintiff’s murder conviction, arguing its relevance to her claims that its Uphold device affected her mental health.

Ramona Winebarger in 1995 pleaded guilty to murder in the death of her 1st husband and the shooting of another man. Sentenced to 35 years, she served 8, according to court documents.

After suing Boston Scientific in November 2013, Winebarger and 2nd husband Rex Winebarger asked Judge Richard Voorhees of the U.S. District Court for Western North Carolina to exclude evidence of her murder conviction, and another charge of giving a false statement. The Winebargers contended that the statute of limitations and the fact that both events stemmed from “a domestic violence situation” makes the evidence inadmissible.

Marlborough, Mass.-based Boston Scientific argued this week that Voorhees should allow the evidence, saying it goes toward her claim to have suffered mental anguish from the implantation of its Uphold vaginal support device in 2010.

“Mrs. Winebarger’s medical records, however, establish a long history of anxiety, depression, and flashbacks unrelated to her 2010 surgery. Mrs. Winebarger’s emotional history – which is necessarily intertwined with her criminal record – is directly relevant to her claimed damages,” the company argued. “Moreover, this evidence is also relevant to Mr. Winebarger’s claim for loss of consortium. Boston Scientific does not seek to impeach Mrs. Winebarger’s character for truthfulness – but rather to rebut her claim for damages.”

Boston Scientific also argued that the domestic violence claim calls her credibility into play, as it contradicts her 1995 confession in which she admitted to lying in wait at her 1st husband’s friend’s house before shooting him and wounding the friend.

“Mrs. Winebarger’s current claim that her convictions stemmed from a ‘domestic violence situation’ contradicts her earlier admission that she lied in wait for her husband and ‘had been planning [his murder] all day,'” the company contended in an August 25 court filing.

The post Boston Scientific looks to block pelvic mesh plaintiff’s bid to exclude murder conviction appeared first on MassDevice.

from MassDevice http://ift.tt/1LDW4yP

Skyline Medical gets $15m from Dawson James

Skyline Medical said yesterday it acquired $15 million from a follow-on offering from new investor Dawson James Securities, floating 1.7 million shares of stock at $9 each.

Each share sold in the offering consists of a common share of stock, 1 share of Series B convertible preferred stock and 4 Series A warrants, according to the company.

“We are pleased to provide Skyline Medical with the capital required to expand their business and deliver on their overall strategic plan. The strength of the Skyline Medical story, combined with this unique unit structure, facilitated a successful transaction in the face of a volatile market environment. The up-listing from the OTCBB to Nasdaq should help position the company going forward with increased liquidity as well as attracting new institutional investors,” Dawson James CEO Robert Keyser Jr. said in a press release.

Funds are slated to be used to build inventory, increase research & development and expand U.S. sales and marketing, according to the Minneapolis, Minn.-based company.

Skyline Medical makes the Streamway system, designed for the collection and disposal of infectious fluids that result from surgical procedures and post-operative care, according to the company.

The post Skyline Medical gets $15m from Dawson James appeared first on MassDevice.

from MassDevice http://ift.tt/1i4VYnx

J&J, PCH join forces for medtech hardware incubator

Johnson & Johnson (NYSE:JNJ) is teaming up with hardware manufacturer PCH to create a medtech hardware accelerator.

The joint operation, titled Hardware for Health, will be overseen by PCH and provide physical space, funding, and assistance designing, distributing, marketting and navigating regulatory channels for medical devices, according to the companies.

The program, based in the San Francisco, Calif. area, is accepting applications starting today, according to the Hardware for Health site.

The new accelerator is looking for applications from a wide breadth of start-ups, including early prototype companies and companies that have already produced products for the market.

“Hardware and healthcare are converging as consumers increasingly interact with health-related devices. We will help take hardware health companies to market with a one-stop program to assist with product design, manufacturing and distribution, while navigating the complex regulatory framework surrounding healthcare,” PCH Access veep David Austin said in a press release.

The program won’t be limited to only healthcare, however, with the incubator program allowing any devices related to well-being that target an area of unmet need, according to the companies.

The post J&J, PCH join forces for medtech hardware incubator appeared first on MassDevice.

from MassDevice http://ift.tt/1MXrYqw

FTC clears Pfizer’s $15B Hospira buy

Pfizer (NYSE:PFE) said Monday it won approval from the Federal Trade Commission for its $15 billion acquisition of Hospira (NYSE:HSP).

The clearance came with a caveat –Pfizer must divest itself of its Acetylcysteine, Clindamycin, Voriconazole and Melphalan sterile injectable assets, according to the company.

The news from the FTC came August 21, according to an SEC filing from Hospira, and leaves the company with only 1 post-clearance waiting period in a single foreign jurisdiction, though the region was not specified.

Pfizer also announced that Brazil has given the merger the thumbs up.

“We are pleased to have received these final regulatory approvals for our pending acquisition of Hospira. We now look forward to combining our two companies and expect the transaction to close in early September,” CEO Ian Read said in a press release.

Pfizer, maker of impotence treatment Viagra and cholesterol drug Lipitor, is making its biggest-ever acquisition aimed at expanding its portfolio of generic injectable drugs and copies of biotech medicines.

Hospira makes generic versions of injectable drugs used in hospitals, pumps to deliver such medicine and also sells biosimilars or copies of biotech drugs.

The post FTC clears Pfizer’s $15B Hospira buy appeared first on MassDevice.

from MassDevice http://ift.tt/1NJE2uC