Boston Scientific to acquire Apama Medical in deal worth up to $300m

Boston Scientific, Apama Medical

Boston Scientific (NYSE:BSX) said today it inked a deal worth up to $300 million to acquire Apama Medical and its radiofrequency balloon catheter system designed to treat atrial fibrillation.

The deal includes an initial $175 million in cash up-front from Marlborough, Mass.-based Boston Scientific and an additional $125 million in contingent payments between 2018 and 2020 based on clinical and regulatory milestones. Boston Scientific expects the acquisition to close the 4th quarter of 2017.

Campbell, Calif.-based Apama’s novel RF balloon is a single-shot, multi-electrode device designed to combine the benefits of RF point-by-point and balloon-based ablation approaches, the company said, claiming the system delivers differentiated energy levels and shorter procedure times.

The system features an incorporated digital camera with LED lights and sensing electrodes for real-time visualization of the procedure and catheter electrode contact.

“The acquisition of Apama further advances our continued investment in the electrophysiology category, and, upon commercialization, would broaden our portfolio of differentiated arrhythmia solutions. We are also excited about the ability to integrate the Apama RF balloon system with our Rhythmia HDx mapping system to provide physicians with an unprecedented visualization of the heart during ablation procedures,” Boston Scientific rhythm management prez Joe Fitzgerald said in a prepared statement.

Results from the 1st-in-human study of the device showed the Apama RF balloon met safety and efficacy endpoints and achieved successful pulmonary vein isolation in treating paroxysmal AF patients.

“Study results reinforce the Apama RF balloon is an advancement in single-shot technology for PVI and can provide physicians with greater control and efficiency when performing AF ablations. We look forward to continuing the development and commercialization of this novel ablation solution to treat both paroxysmal and persistent AF,” Boston Scientific rhythm management and global health policy chief medical officer Dr. Kenneth Stein said in a press release.

The Apama RF balloon is currently being studied in clinical trials in Europe as the company looks to achieve CE Mark approval, which it hopes to receive in late 2018.

Boston Scientific said the acquisition is expected to be immaterial to its adjusted earnings per share for 2017 and 2018, and more dilutive on a GAAP basis due to amoritization expense, transaction and integration related costs.

Last November, Apama Medical said it raised a total of $19.7 million, with $13.2 million coming from a closed Series C round and $6.5 million from a debt facility with Silicon Valley Bank.

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Integra LifeSciences completes purchase of J&J’s Codman Neurosurgery

Integra LifeSciences, Codman NeuroIntegra LifeSciences (Nasdaq: IART) has completed its previously announced $1.045 billion purchase of Johnson & Johnson’s Codman Neurosurgery business, the companies announced today.

“The addition of Codman Neurosurgery expands our global leadership position by creating one of the broadest medical device portfolios in the neurosurgery market,” Peter Arduini, Integra’s president and CEO, said in a news release.

“Our planned investments in product innovation and global infrastructure will allow us to provide more healthcare solutions to surgeons and their patients worldwide,” Arduini said.

Integra in coming days will complete a previously announced $48 million divestiture of certain neurosurgery assets to Natus Medical (Nasdaq: BABY) that it needed to make to in order for the Codman buy to pass muster with the U.S. Federal Trade Commission and the National Markets and Competition Commission of Spain. The divestiture includes Integra’s global Camino ICP monitoring product line, U.S. rights relating to Integra’s fixed pressure shunts, and U.S. rights to Codman’s Duraform, standard EVD catheters and CSF collection systems.

“The Codman acquisition is transformational to Integra and creates significant long-term growth opportunities for our entire company,” Arduini said.

Johnson & Johnson (NYSE: JNJ) meanwhile said it remains dedicated to ischemic and hemorrhagic stroke treatment through its newly launched Cerenovus platform.

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Mellon Medical raises nearly $7 million for suturing tech

Dutch suturing tech company Mellon Medical said today that it has raised €6 million (equivalent to Mellon Medical Switchabout $6.6 million) to advance its Switch instrument.

Mellon Medical officials boast that their Switch single use precision-suturing instrument enables surgeons to suture tubular and layered structures about twice as fast as conventional methods. Reduced clamp time for many cardiovascular procedures equals reduced complications risk, better patient outcomes and reduced costs, according to the company.

“By collaborating with medical specialists, industrial designers and ergonomic experts in the development of the Switch, Mellon has been able to reinvent suturing, bringing suturing technology into the 21st century,” Dr. Mark Vrancken Peeters, a vascular surgeon and Mellon’s founder and CMO, said in a news release.

Dutch life sciences and health investor BioGeneration Partners (BGV) led the funding round. Other investors included former Allergan CEO and private investor David Pyott, as well as existing shareholders Dutch Thuja Capital, Innovatie – en Energiefonds Gelderland, managed by Oost NL, and Brabantse Ontwikkelings Maatschappij (Brabant Development Co., BOM). BGV partner Oskar Slotboom, a partner at BGV, will join Mellon’s supervisory board.

Mellon plans to introduce an 8 cm Switch model, with an initial focus on vascular indications including carotid artery surgery, kidney transplant and peripheral bypass surgery.

The initial focus is on vascular surgery, but Mellon officials think the Switch tech could have uses in general surgery, microsurgery, urology, gynecology, coronary artery bypass surgery, neurosurgery and more.

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Cardinal Health, Hamilton Medical, Zoll Medical score DoD contracts

U.S. Department of Defense DoD Cardinal Health Hamilton Medical Zoll MedicalCardinal Health (NYSE: CAH) will receive $29.2 million under a new U.S. Department of Defense contract, with Hamilton Medical and Zoll Medical also securing contracts in the tens of millions of dollars.

Cardinal Health’s contract win, announced Sept. 29, comes nearly eight months after Dublin, Ohio–based Cardinal Health secured a $2.25 billion surgical supplies contract renewal with the U.S. military, with Owens & Minor winning another $1.125 billion as part of the deal.

In April, Cardinal Health won a $46.5 million fixed-price DoD contract to supply laboratory supplies and wares.

The $29 million contract announced last week is a nine-month base contract with eight one-year and one 15-month option periods. Customers include the Army, Navy, Air Force, Marine Corps and federal civilian agencies.

Cardinal Health wasn’t the only medtech company scoring multimillion-dollar DoD contracts.

Hamilton Medical (U.S. headquarters in Reno, Nev.) and Zoll Medical (Chelmsford, Mass.) will receive $40.0 million and $30.7 million respectively under five-year contracts for medical equipment and medical equipment spare parts, DoD announced Sept. 29. The contracts have no option periods. Customers include the Army, Navy, Air Force and Marine Corps, as well as the U.S. Department of Health and Human Services.

In other news, biotechnology and regenerative medicine company Humacyte (Research Triangle Park, N.C.) today announced a $3.4 million D0D contract to help support additional clinical sites for Humacyte’s Phase II vascular trauma trial in the U.S. Humacyte has an investigational human acellular vessel called Humacyl. The company announced last week that the California Institute for Regenerative Medicine is giving it $14.1 million to support a clinical trial comparing Humacyl to arteriovenous fistulas.

 

 

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NN acquires DRT Medical

NN announced that it has acquired DRT Medical from DRT Holdings. The financial details of the deal were not disclosed.

NN is an industrial company that has advanced engineering and production capabilities to design and manufacture high-precision components and assemblies for a number of markets across the globe. The company has 36 facilities across North America, Europe, South America and China.

Get the full story on our sister site, Medical Design & Outsourcing.

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Abbott’s $5B acquisition of Alere set to close tomorrow

Abbott to acquire Alere

Abbott (NYSE:ABT) said today it is looking to close its $5 billion acquisition of Alere (NYSE:ALR) tomorrow, saying it has received all regulatory clearances necessary.

The Abbott Park, Ill.-based company said the acquisition will establish it as a “global leader in point of care testing,” which it sees as the fastest growing segment of the $50 billion in vitro diagnostics market.

Read the whole story at our sister site, Drug Delivery Business

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Tom Price is out as HHS secretary

Rep. Tom Price HHSTom Price has resigned from his post as U.S. health and human services secretary after days of fending off criticism over chartered flights he took on the public dime.

The announcement today out of the White House said Don J. Wright – presently assistant secretary for health and director of the Office of Disease Prevention and Health Promotion – will take over as acting secretary.

The announcement came soon after President Donald Trump, at his Bedminster, N.J. gold course, told reporters that he didn’t like the “optics” around the hundreds of thousands of taxpayer dollars spent on Price’s flights – and that he was “not happy,” according to media reports in the Washington Post, Associated Press and elsewhere. Trump had publicly expressed similar unhappiness earlier this week.

Price yesterday tried to defuse the scandal by offering to personally pay for the cost of his seat on the planes. The distances of some flights had been as short at Washington, D.C. to Philadelphia.

“All of my political career I’ve fought for the taxpayers,” Price said in an HHS news release. “It is clear to me that in this case, I was not sensitive enough to my concern for the taxpayer.”

Price’s statement was apparently not enough. His departure throws another wrench into Trump and congressional Republicans’ efforts to repeal and replace the Affordable Care Act.

Price – a longtime ACA critic when he was a U.S. representative from Georgia – had been a point person for rolling back executive branch efforts to promote Obamacare while his former GOP colleagues in Congress tried to kill and replace the program for good. The future of both efforts is now unclear.

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7 medtech stories we missed this week: Sept. 29, 2017

medtech missed

[Image from unsplash.com]

From EOI getting FDA clearance to Sanuwave’s new joint venture agreement, here are seven medtech stories we missed this week but thought were still worth mentioning.

1. EOI wins FDA nod for FLXfit15 expandable cage

EOI announced in a Sept. 28 press release that it has received FDA 510(k) clearance for its FLXfit 15. The clearance will help enhance the company’s FLXfir 3D expandable cage system and help expand the surgeon’s flexibility and capability by offering different length options.

2. ivWatch inks distribution deal with Terumo

ivWatch has recently signed a licensing and distribution agreement with Terumo to improve patient safety, according to a Sept. 21 press release. Terumo will become the exclusive distributor of the ivWatch Model 400 and ivWatch OEM board in Japan. ivWatch technology can be integrated with other patient monitoring systems, infusion pumps and other devices easily with the ivWatch OEM board. The agreement also allows Terumo to exclusively integrate ivWatch into existing and future Terumo products in Japan.

3. FDA clears Mortise Medical’s LigaMetrics suture anchor system

Mortise Medical announced in a Sept. 26 press release that it has received FDA 510(k) clearance for its LigaMetrics Suture Anchor System. The LigaMetrics Suture Anchor System is the first and only knotless suture anchor that allows for precise, measured tension control of the suture repair construct. The system is designed to connect to and lock suture tape that is attached to soft tissue or a conventional suture anchor.

4. Lombard Medical launches Aorfix delivery device in Japan

Lombard Medical has commercially launched its new delivery system for the Aorfix AAA system, according to a Sept. 26 press release. The new delivery system is marketed in Japan by Medico’s Hirata and is used to deliver Lombard’s Aorfix AAA stent graph.

5. FDA expands clearance for Cefaly migraine device

Cefaly announced in a Sept. 21 press release that the FDA has expanded its clearance for Cefaly Acute migraine treatment. The device is used for the acute treatment of migraines in patients 18 years or older. The Cefaly Acute allows migraine sufferers to use the device during a migraine attack which makes it more than a preventative measure.

6. Varian touts first use of Halcyon oncology system

Varian Medical System has announced that the first patient in the world has been treated using Varian’s Halcyon system, according to a Sept. 21 press release. The patient had head and neck cancer. The system is suited to offer advanced treatments for prostate, breast, head and neck and other forms of cancer.

7. Sanuwave inks JV deal with Brazil’s Mundimed

Sanuwave announced in a Sept. 28 press release that it has signed a joint venture agreement with Mundimed in Brazil. The agreement states that the companies will split profits in the wound care industry while using the dermaPACE technology. The net present value is expected to exceed $25M. Sanuwave will also receive an undisclosed amount of cash payments beginning Sept. 30 and the payments will continue through 2019.

Here’s what we missed last week.

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Robotic start-up Reactive Robotics nets 7-figure funding round

German medical robotics start-up Reactive Robotics said earlier this month it raised a 7-figure funding amount as it looks to accelerate its platform development and entry into the global market.

The company is reportedly developing a robotic, intelligent therapy device designed to replace manual Very Early Mobilization therapy for use with intensive care patients.

Reactive Robotics said it has developed a prototype, as well as established quality management systems and inked cooperative deals with business partners and suppliers.

Existing investors include MTIP MedTech Innovation Partners AG, High-Tech Gründerfonds, Bayern Kapital and TQ-Group, according to a press release.

Reactive Robotics said it expects to deliver its 1st clinical test product by the 1st quarter of 2018.

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Cheetah Medical raises $12m

Cheetah Medical said today it raised $11.8 million in an expanded Series C funding round as it looks to grow its US footprint.

Financing was provided by existing investors including MVM Life Science Partners, Springfield Investment Management, Fletcher Spaght Ventures, HighCape Partners and Robert Basch Venture Capital, the Newton, Mass.-based company said.

Cheetah Medical provides noninvasive hemodynamic monitoring devices and systems, including its Cheetah Nicom and Starlin SV technologies, which operate around a proprietary algorithm designed to allow physicians to examine a patient’s full hemodynamic profile.

“This additional funding will enable us to accelerate investment in our U.S. sales and marketing efforts which are already driving exciting revenue growth. We believe the recent publication of a key clinical study from the University of Kansas Medical Center, which demonstrated the value of a resuscitation strategy guided by the optimization of stroke volume for sepsis patients, will fuel greater demand for the Cheetah Nicom and Starling SV monitoring solutions and support an increased field presence,” prez & CEO Chris Hutchison said in a press release.

Last July, Cheetah Medical said it inked a supplier contract with non-for-profit healthcare system Allina Health.

Through the contract, Minnesota and western Wisconsin based Allina Health will gain access to Cheetah Medical’s hemodynamic monitoring solutions to help guide volume management decisions in septic patients, Cheetah Medical said.

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