Kips Bay Medical pulls the plug

Kips Bay Medical (OTC:KIPS) said last week it will be liquidating the company after terminating the Emesh I clinical feasibility trial of its eSVS mesh based on poor 6-month results.

The company’s board of directors unanimously approved a plan to dissolve the company and return any remaining cash to its stockholders, Minneapolis, Minn.-based Kips Bay said.

Kips Bay said it has $2 million in cash and cash equivalents which the company estimates will be sufficient to “pay off all of its current and anticipated liabilities and to conduct an orderly wind down of its operations,” according to a press release.

The 106-patient Emesh 1 study looked at external saphenous vein graft supports, using the company’s device, and returned poor 6-month angiographic results for the first 26 patients implanted using a new surgical technique, the company said.

The eSVS mesh is designed to keep vein grafts open during in coronary artery bypass graft surgeries, and is composed of a flexible sleeve that fits around the outside of the vein to reduce vessel wall stress and mitigate the potential for vessel injury.

“We are, needless to say, extremely disappointed with the poor 6-month angiographic results from the new technique patients. We had hoped the new technique would reduce or prevent the resulting injury which can lead to SVG failure and potentially costly and complicated re-interventions for patients undergoing CABG surgery. I would like to thank the patients who participated in this study as well as our clinical trial investigators and their teams. I am also very appreciative of our employees, to many of whom we must now sadly say goodbye and for the continued support and loyalty of our stockholders,” CEO Manny Villafaña said in prepared remarks.

Last month Kips Bay said it was considering closing shop after initial results failed to meet a last-ditch bar set in March.

In March Kips Bay turned to founder, chairman & CEO Manny Villafaña and other backers for a private placement worth up to $3.25 million. The deal called for the investors to put the cash up in 4 equal tranches, but not before the Emesh I trial generates 10 angiograms from eSVS-treated patients demonstrating that it’s “advisable for the company to continue with the Emesh I clinical feasibility trial and to continue to pursue marketing approval by the FDA for the eSVS mesh,” Kips Bay said in March.

In September 2011 the FDA issued a non-approvable letter for the device, asking for more information on the eSVS mesh before granting permission for a feasibility study. That approval came in November 2012 and was later expanded. In March, Kips Bay, which let its listing on the NASDAQ exchange expire last September, said it reached the enrollment goal for the Emesh I feasibility study.

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TAVI: Medtronic wins patent spat with doc inventor

Medtronic (NYSE:MDT) last week won a patent infringement dispute over its CoreValve aortic valve replacement with inventor Dr. Troy Norred, according to legal filings.

The U.S. Patent & Trademark Office’s Patent Trial & Appeals Board found that 16 of Norred’s claims were unpatentable, upholding Medtronic’s challenge to the patent, PTO records show.

The patent board ruled that the patent was invalid as anticipated based on prior art cited in the patent application.

Norred, who plans to appeal the decisions, according to legal filings, claims that CoreValve used his patent in developing the aortic valve replacement and that Medtronic continued to infringe the patent after acquiring CoreValve for $700 million in 2009.

The physician’s 2013 patent infringement lawsuit, filed in the U.S. District Court for Kansas, was stayed until a trio of inter partes reviews by the PTAB were concluded, according to court documents.

In May 2014, Medtronic and TAVI arch-rival Edwards Lifesciences (NYSE:EW) buried the hatchet in their long-running patent war with a $750 million settlement that will see Medtronic pay royalties through April 2022 of at least $40 million annually.

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Integra LifeSciences picks up TEI Biosciences, TEI Medical for $312m

Integra LifeSciences (NSDQ:IART) said yesterday that it agreed to acquire TEI Biosciences and sister company TEI Medical for $312 million in cash in a bid to expand its footprint in reconstructive surgery and regenerative wound care.

The deal, expected to close during the 3rd quarter, brings TEI’s PriMatrix dermal repair scaffold and a 125-member sales force under the Integra umbrella, that Plainsboro, N.J.-based company said. TEI is based in Waltham, Mass.

“This acquisition broadens our presence in regenerative wound care and tissue repair and represents a significant push forward toward our growth objectives for 2015 and beyond. The addition of TEI is an important, strategic next step for both our channel and international expansion priorities. We are enthusiastic about both TEI’s product development and commercial expertise, which accelerates our ability to establish an immediate presence in the diabetic foot ulcer space,” Integra president & CEO Peter Arduini said in prepared remarks.

“It is an exciting time for TEI, and I am confident in Integra’s ability to grow our leading platform technology to drive broader expansion into regenerative medicine including wound care, plastic and reconstructive surgery and other soft tissue repair and reconstruction applications,” added TEI chairman, president & CEO Yiannis Monovoukas.

TEI put up sales of roughly $63.5 million last year, Integra said, noting that it expects TEI’s sales growth to hit the high single digits in the 1st year after the deal closes.

. Gross margin was about 80%, which is comparable to Integra’s regenerative technology product portfolio, and EBITDA margin was about 25%.

“This transaction advances our strategy in wound care, meets our financial criteria, and generates high returns on our capital,” CEO Glenn Coleman said in a statement. “Upon closing, we expect this deal to be immediately accretive to our adjusted EBITDA and operating margins, and slightly accretive to our adjusted earnings per share, including the effects of any financing transactions that may close subsequent to the closing of the TEI acquisition.”

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Ex-OtisMed CEO Chi draws 2 years

The former CEO of Stryker (NYSE:SYK) subsidiary OtisMed, Charlie Chi, drew a 2-year prison sentence last week after pleading guilty to distributing knee replacement surgery cutting guides without FDA clearance, the safety bureau and federal prosecutors said last week.

Stryker inherited the beef when it acquired OtisMed in 2009, later offering to pay $33 million to settle the federal investigation. The misconduct occurred before the acquisition and “without Stryker’s prior knowledge or acquiescence,” the prosecutors said. The company agreed to pay $80 million late last year to settle its part of the case, with Chi pleading guilty on 3 counts.

Prosecutors said OtisMed sold more than 18,000 of the devices between May 2006 and September 2009, for revenues of some $27 million. But after an application for 510(k) clearance from the FDA was rejected in 2009, OtisMed’s board unanimously voted to stop shipment. Chi disregarded that vote and ordered the shipments “after having been told by the FDA, legal counsel and his own board of directors not to do so,” according to the government.

“At Chi’s direction, OtisMed shipped approximately 218 OtisKnee guides from California to surgeons throughout the United States, including 16 to surgeons in New Jersey, a week after the FDA expressly denied OtisMed’s request for clearance,” according to the U.S. Justice Dept.

Judge Claire Cecchi of the U.S. District Court for New Jersey also sentenced Chi to a year of supervised release and fined him $75,000.

“I’d like to say I’m sorry,” Chi told the judge before his June 26 sentencing, according to NorthJersey.com. “I made a mistake, a serious mistake, and I know it. I apologize to the FDA and to Stryker.” He added, “I am embarrassed not only for myself, but for my family and my peers.”

Although Stryker was a distributor for OtisMed at the time, it was unaware of the FDA’s denial of clearance, prosecutors said last year.

“At the time the shipments were made in September 2009, Stryker executives were not aware that OtisMed and Chi had shipped cutting guides after the FDA had rejected the company’s application for marketing clearance for the device. Stryker, OtisMed’s parent corporation, cooperated with the government with regard to OtisMed’s pre-acquisition conduct throughout the investigation,” they said in the statement.

Chi pleaded guilty last December to 3 counts of introducing adulterated medical devices in interstate commerce.

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Samsung’s Bioepis considers Nasdaq IPO, seeks funding

(Reuters) – South Korean Samsung‘s (LON:BC94) Bioepis Co Ltd, a developer of generic versions of biotech drugs, said it was considering a Nasdaq IPO – a move that comes as it seeks about $1.3 billion for product development and as the Samsung Group makes a bigger push into biopharmaceuticals.

Highlighting growth opportunities for its biopharmaceuticals business may be a tactic by the Samsung Group to win support for a planned merger of two affiliates that would strengthen control for its founding Lee family, analysts said.

A proposed $8 billion takeover of construction firm Samsung C&T Corp by the conglomerate’s de facto holding company Cheil Industries Inc has drawn opposition from activist U.S. hedge fund Elliott.

If the takeover went ahead, the merged entity would have a majority stake in Samsung Biologics which owns 90 percent of Samsung Bioepis – resulting in a clearer line of control. Currently, Cheil owns 46 percent while Samsung Electronics Co Ltd also owns 46 percent and C&T owns 6 percent.

“This looks like an attempt by Samsung Group to back up its argument for the merger in regard to the growth opportunities for the biopharmaceuticals business,” said Chung Sun-sup, head of corporate analysis firm Chaebul.com.

Bioepis is looking to raise an estimated 1.5 trillion won ($1.3 billion) for future product development, and is considering fundraising options, including an IPO on Nasdaq or elsewhere, a company spokeswoman said.

U.S. listings are rare for South Korea firms. Korean-listed stocks tend to trade at discounts to global peers due to family-dominated ownership structures, opaque decision-making processes and low dividends. It would be the first on Nasdaq since 2006.

Samsung Group will soon send proposals to investment banks before choosing advisors for an IPO, which may take place in the first half of 2016, the Korea Economic Daily reported on Monday.

Bioepis is likely to have a market value of at least 8 trillion won ($7.1 billion), the newspaper said, citing an unidentified investment banking source.

Established in 2012, Bioepis booked an operating loss of 25 billion won last year. It aims to achieve revenue of 850 billion won in five years time.

The company is pursuing approvals to sell a biosimilar version of Amgen Inc’s rheumatism drug Enbrel as early as next year. It is working on copies of Johnson & Johnson ‘s Remicade, another rheumatism treatment, and Roche’s breast cancer treatment Herceptin. It has sales agreements with Merck & Co Inc and Biogen Inc.

There were 10 South Korean companies listed in the United States as of end-March, according South Korea’s Financial Supervisory Service.

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MassDevice.com +3 | The top 3 medtech stories for June 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. SentreHeart wins FDA nod for Lariat trial

SentreHeart said it won FDA investigational device exemption approval to begin enrolling subjects in a clinical trial of its Lariat device.

The Amaze trial will evaluate the use of the Lariat for the ligation of the left atrial appendage as an adjunctive treatment to ablation in patients with persistent atrial fibrillation, the company said. Read more

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2. Medtronic wins FDA nod, launches Advisa SR MRI-safe pacer

Medtronic said that it won FDA approval for its Advisa SR MRI-safe SureScan single-chamber pacemaker, and that it is launching the device in the U.S.

The device will allow MRI scans of any region of the body as long as it is used with MRI-safe SureScan leads, the Fridley, Minn.-based company said. Read more

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1. Sorin and Cyberonics rebrand as LivaNova

Sorin Group and Cyberonics said that LivaNova will be the new name for the merged companies.

The companies said the name was chosen through a combination of market research and employee participation from both Sorin and Cyberonics. Read more

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Thermoplastic injection molding: Offering from the design concept to finished molded products

Eagle has now expanded our product capabilities and product offerings to include plastic injection molding. The same level of dedication, meticulousness, and product quality that we have put into our stainless steel tubing will also be applied to the plastic molding. With this added capability, Eagle will now be able to offer from design concept to finish molded products. This new offering will be full service plastic injection molding of all thermo plastic material such as Acrylic, ABS, Nylon, Polycarbonate, Plyethylene, Polypropylene, many engineered plastics, plus others such as PEEK, PTFE, FEP, PFA, and TPE.

About Eagle

Franklin, Massachusetts based Eagle Stainless Tube & Fabrication, Inc. has been serving customers in medical, aerospace and high tech manufacturing since 1982. Eagle Stainless’ 40,000 square feet of manufacturing facilities are ISO 9001 and AS 9100 aerospace industry certified. With a record of on-time delivery, fair pricing, product quality and highly skilled employees dedicated to continuous improvement and training, Eagle has earned its reputation as a supplier of choice of off-the-shelf stainless steel products and fabricated stainless steel components for many fortune 500 companies. For more information on Eagle Stainless Tube & Fabrication, Inc., call 800.528.8650, or visit www.eagletube.com.

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