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With the FTC’s conditional approval, Medtronic completes its $1.1B acquisition of Intersect ENT
To get approval for the deal, Medtronic agreed to sell an Intersect subsidiary to soothe the FTC's concerns. Shares0
It has in some ways been a long time coming, but Medtronic ‘s $1.1 billion acquisition of medtech company Intersect ENT is now complete, the Dublin-based device maker announced Friday . Earlier this week, the FTC announced that Medtronic would have to divest an Intersect subsidiary —selling surgical navigation company Fiagon to the biotech firm Homeostatis—to get approval for the acquisition. Intersect, which is based in Menlo Park, California, is focused on advancing ear, nose and throat treatment. But the FTC expressed concerns that Medtronic’s acquisition of the company could lead to higher prices and reduced innovation; and it required Medtronic to offload Fiagon no later than 10 days after it acquired Intersect. “Additionally, Medtronic and Intersect must obtain prior approval from the FTC for 10 years before buying ENT navigation systems and balloon sinus dilation assets to address any future attempts to consolidate these important markets,” the FTC ordered. After agreeing to the agency’s terms, Medtronic got the OK to move ahead, following more than a decade of buildup to the deal. Medtronic first invested in Intersect in 2010. It has had a close relationship with Intersect since, and investors had long speculated Medtronic might buy the company. Finally, last August, Medtronic announced it was moving forward with the acquisition, which it completed Friday. One thing that made Intersect a particularly attractive target to the device maker is its steroid-coated stents, according to Medtronic. The sinus implants are used to treat chronic rhinosinusitis, a common chronic condition where spaces inside the nose and sinuses become inflamed, causing symptoms ranging from a lingering cold to headache. Intersect’s Propel sinus implants are used in conjunction with sinus surgery, while its Sinuva implants are a nonsurgical treatment for nasal polyps, noncancerous growths lining the nose and sinuses. Intersect was the first company to get FDA clearance for these types of devices. Medtronic said the acquisition will broaden its device offerings and improve care for patients with conditions like chronic sinusitis, or CRS. “By combining Intersect ENT’s groundbreaking localized drug delivery products with the leading navigation and powered instruments of Medtronic, we can now equip physicians with the right tools for many unique patient needs,” said Vince Racano, president of Medtronic’s ENT business, in a statement. “This acquisition expands our portfolio, and we can now provide a more comprehensive continuum of care for CRS patients while supporting the bold ambition of Medtronic to be the global healthcare technology leader.”
After the completion of the acquisition was announced, the device maker saw its stock price rise by more than $1.60 to over $102 per share in trading Friday morning on the New York Stock Exchange. Photo: maxsattana, Getty Images
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With the FTC’s conditional approval, Medtronic completes its $1.1B acquisition of Intersect ENT

Medtronic (NYSE: MDT) must divest part of a California-based medical device company it plans to acquire if it wants approval of the deal, the Federal Trade Commission says. 

The FTC, in an order published this week, indicated that it will approve Medtronic's $1.1 billion acquisition of Menlo Park, California-based Intersect ENT (NASDAQ: XENT) — but only if Medtronic sells off an Intersect subsidiary as part of the deal.

Fiagon, which makes which makes ear, nose, and throat navigation systems…

Medtronic will sell Intersect ENT subsidiary Fiagon to Hemostasis to win FTC approval of acquisition

FTC says Medtronic must divest subsidiary of device maker it wants to acquire
Medical device manufacturer is trying to buy Intersect NET Inc., a maker of sinus implants, in a $936.2 million deal. May 12, 2022 — 12:30pm
The Federal Trade Commission says Medtronic can move forward with a proposed acquisition so long as the company promptly divests a subsidiary that makes certain medical devices used in sinus procedures. In a proposed order this week, FTC imposed the condition on Medtronic's planned $936.2 million acquisition of Intersect ENT Inc., a California-based maker of sinus implants. The deal was first announced last year. FTC says that Medtronic, which is based in Dublin but has operational headquarters in Fridley, would need to promptly sell a subsidiary of Intersect ENT called Fiagon, which makes ear, nose and throat navigation systems and balloon sinus dilation products. The FTC said the Fiagon business would be sold to Hemostasis LLC, which is based in White Bear Lake, according to a news release announcing the proposed order. "Medtronic is the top provider of ear, nose and throat navigation systems," said Holly Vedova, director of the FTC's bureau of competition, said in a statement. "We are requiring Medtronic to divest Fiagon because we are concerned that the deal would otherwise lead to higher prices and reduced innovation in this important medical care market." The commission voted 4-0 to issue an administrative complaint in the case and accept the proposed consent order for public comment. The FTC soon will publish the consent agreement in the Federal Register and take comments over a 30-day period. Medtronic did not immediately respond to a request for comment. Medtronic is the dominant provider of ear, nose and throat (ENT) navigation systems, which the FTC says allow physicians to view and track medical instruments as they're being used in sinus procedures. The company also sells balloon sinus dilation products used to clear blocked sinuses. FTC's proposed order says Fiagon must be sold no later than 10 days after Medtronic acquires Intersect. In addition, to prevent future consolidation, Medtronic and Intersect over the next decade must obtain prior approval from FTC to acquire additional technology for ENT navigation and balloon sinus dilation. "Divestiture buyer Hemostatis must obtain prior approval for three years before transferring any of the divested assets to any buyer, and for seven additional years before transferring any divested assets to a buyer that manufactures and sells ENT navigation systems or balloon sinus dilation products," FTC said in a statement. A independent monitor will report on the companies' compliance with the order, FTC says. Christopher Snowbeck covers health insurers, including Minnetonka-based UnitedHealth Group, and the business of running hospitals and clinics.

FTC says Medtronic must divest subsidiary of device maker it wants to acquire

May 12, 2022
The Federal Trade Commission has issued a proposed order to require Medtronic (NYSE:MDT) to sell a subsidiary of Intersect ENT within 10 days of completing its $1.1 billion acquisition of Intersect ENT . The commission announced May 10 that it voted 4-0 to issue its complaint and accept the proposed consent order for public comment. Under the consent order, Hemostasis (White Bear Lake, Minnesota) would acquire Intersect ENT’s Fiagon business from Medtronic. Fiagon makes balloon sinus dilation products and ear, nose and throat navigation systems. Intersect ENT said in March that it planned to sell Fiagon to Hemostasis as part of the FTC review process and agreed on terms. “Today’s action by the FTC is part of our efforts to combat the problem of rising healthcare costs,” Holly Vedova, director of the FTC’s Bureau of Competition, said in a news release. “These are already concentrated markets for critical medical instruments,” she said. “Medtronic is the top provider of ear, nose, and throat navigation systems. We are requiring Medtronic to divest Fiagon because we are concerned that the deal would otherwise lead to higher prices and reduced innovation in this important medical care market.”
The FTC’s order is but the latest example of more aggressive antitrust law enforcement under the Biden administration. The proposed order appears to have provided a path for Medtronic and Intersect ENT to clear FTC concerns over the deal. Intersect ENT said in an SEC filing on May 9 that the FTC had granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 with respect to the merger. “With early termination granted under the HSR Act, the transaction has now received all applicable antitrust regulatory approvals.”
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Medtronic must sell Intersect ENT subsidiary to satisfy FTC concerns

Published May 11, 2022
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The Federal Trade Commission told  Medtronic to divest Fiagon to clear a barrier to its $1.1 billion takeover of Intersect ENT. The regulator called for the divestiture to stop consolidation of the markets for ear, nose and throat navigation systems and balloon sinus dilation products. Intersect outlined plans to sell Fiagon, which it bought in a 60 million euros ($63.3 million at Wednesday's rate) deal in 2020, to Hemostasis in March in connection with the FTC review process. The agency has confirmed Medtronic must offload Fiagon within 10 days of acquiring Intersect. The agreement also requires Medtronic and Intersect to obtain prior approval from the FTC for 10 years before buying ENT navigation systems and balloon sinus dilation assets. The agency inserted the clause to prevent consolidation that could drive up the cost of healthcare in the U.S. Dive Insight:
Fiagon became the fourth company on the U.S. balloon sinus dilation market last year, establishing itself alongside Johnson & Johnson’s Acclarent and Stryker’s Entellus Medical in the small band of businesses seeking to challenge Medtronic’s position in the sector. Medtronic’s $1.1 billion takeover of Intersect would neutralize that emerging threat while simultaneously thinning the ENT navigation field, where the medtech company competes against Acclarent, Stryker, Brainlab, Karl Storz and Fiagon. Intersect, foreseeing how the reduction in competition would play with the FTC, found a buyer for Fiagon earlier this year. The FTC accepted the proposal, positioning Hemostasis to challenge Medtronic for the markets. “Hemostasis is an established participant in the ENT medical device segment and has the expertise, sales infrastructure and resources to restore the competition that otherwise would have been lost pursuant to the Acquisition,” the FTC wrote in its analysis . “Hemostasis will be able to begin manufacturing its own supply of ENT navigation systems and balloon sinus dilation products from day one.”
The deal enables Hemostasis to enter the market immediately because it will acquire all assets related to the Fiagon business and obtain all third-party consents before the takeover closes. Hemostasis plans to retain Fiagon employees. The FTC framed the divestiture as a way to stop Medtronic’s Intersect takeover from leading to higher prices and reduced innovation. The regulator has appointed Jeryl Hilleman to monitor the compliance of the companies with the order. Medtronic commented on the order in an emailed statement. “In August 2021, we announced our plans to acquire Intersect ENT, expanding Medtronic’s ear, nose, and throat portfolio," the company said. "The acquisition is expected to close in the first quarter of our fiscal year 2023 ending July 29, 2022, subject to the satisfaction of customary closing conditions. We will announce further details following a successful close.” 
The company declined to provide further comment specific to the divestiture. Recommended Reading

FTC tells Medtronic to divest Fiagon to clear barrier to $1.1B Intersect ENT takeover

Xoran Technologies is a company focused on the development and commercialization of compact, specialized medical CT scanners in the healthcare industry. The company's main offerings include low-dose radiation, cone beam CT scanner systems designed for point-of-care use, providing high-resolution imaging for various medical applications such as sinuses, temporal bones, skull base, and full-body animal imaging. These products primarily cater to the healthcare and veterinary sectors. It was founded in 2001 and is based in Ann Arbor, Michigan.

Xoran Technologies

ANN ARBOR , Mich. , May 31 , 2018 / CNW / -- Xoran Technologies LLC and Fiagon have agreed to expand their existing relationship and to collaborate in the Neuro and Spine markets .

Xoran and Fiagon Collaborate in the Neuro and Spine Markets

Entellus Medical (NASDAQ:ENTL) is a medical technology company focused on delivering superior patient and physician experiences through products designed for the minimally invasive treatment of patients.  Entellus products are used for the treatment of adult and pediatric patients with chronic and recurrent sinusitis, as well as adult patients with persistent Eustachian tube dysfunction.

Entellus Medical

and Fiagon announced today that they have expanded their agreement allowing Entellus Medical , Inc. to exclusively distribute Fiagon branded Navigation Systems and accessories in the United States and Canada .

Fiagon Corporation and Entellus Medical Announce Expanded Agreement to Include Hospital-Based Customers.

Precision Robotics

Charite - University Clinic

METRONOM

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The digital health collection includes vendors developing software, platforms, sensor & robotic hardware, health data infrastructure, and tech-enabled services in healthcare. The list excludes pureplay pharma/biopharma, sequencing instruments, gene editing, and assistive tech.

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Fiagon operates as an electromagnetic-based surgical navigation company. The company develops navigation of instruments for spine, neuro, and ear-nose-throat (ENT) surgery. It specializes in navigation for surgery, medical technology, spine navigation, brain navigation, and ENT navigation. It was founded in 2007 and is based in Brandenburg, Germany. In September 2020, Fiagon was acquired by Intersect ENT.

Name	Timo Krüger
Work History	Precision Robotics, Charite - University Clinic, and METRONOM
Title	Founder
Status	Current

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