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Novocure (NASDAQ: NVCR) lifts 2026 outlook after strong Q2 revenue growth

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(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Novocure Limited reported second-quarter 2026 net revenues of $183.6 million, a 16% increase year-over-year, with gross margin rising to 78% from 74%. The quarter remained loss-making, with a net loss of $15.7 million or $0.13 per share, but Adjusted EBITDA turned positive at $10.8 million.

Total active patients on Tumor Treating Fields therapy reached 5,128 globally, including 4,636 on Optune Gio, 207 on Optune Lua and 285 on Optune Pax. Cash, cash equivalents and short-term investments totaled $440.6 million as of June 30, 2026, against total liabilities of $457.1 million.

The company received a CE Mark for Optune Pax for locally advanced pancreatic cancer, with Germany as the first launch market, and updated 2026 guidance to $710 million–$725 million in net revenue and $0–$15 million in Adjusted EBITDA. Anticipated Q4 2026 milestones include a U.S. FDA decision on a premarket approval application for brain metastases from non-small cell lung cancer and completion of enrollment in the Phase 3 KEYNOTE D58 glioblastoma trial.

Positive

  • Net revenues grew 16% year-over-year to $183.6 million, with gross margin expanding to 78% from 74%, indicating improved scale and cost efficiency.
  • Adjusted EBITDA improved to a positive $10.8 million from a loss in the prior-year quarter, and full-year 2026 Adjusted EBITDA guidance was raised to a range of $0 million–$15 million.
  • 2026 net revenue guidance increased to $710 million–$725 million, up from $690 million–$710 million, supported by contributions from Optune Lua and Optune Pax.
  • CE Mark approval for Optune Pax in locally advanced pancreatic cancer and more than 280 active patients on Optune Pax as of June 30, 2026, support ongoing international and indication expansion.

Negative

  • Novocure remains unprofitable on a GAAP basis, reporting a second-quarter 2026 net loss of $15.7 million and an accumulated deficit of $1,377.2 million as of June 30, 2026.
Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Net revenues Q2 2026 $183,584 thousand Three months ended June 30, 2026; up 16% year-over-year
Net loss Q2 2026 $15,658 thousand Three months ended June 30, 2026; loss per share $0.13
Adjusted EBITDA Q2 2026 $10,757 thousand Non-GAAP Adjusted EBITDA for three months ended June 30, 2026
2026 net revenue guidance $710 million - $725 million Updated full-year 2026 total net revenue guidance as of July 23, 2026
Cash and short-term investments $440.6 million Cash, cash equivalents and short-term investments as of June 30, 2026
Total active patients 5,128 Active TTFields therapy patients globally as of June 30, 2026
Gross margin Q2 2026 78% Quarter ended June 30, 2026; benefited from a $4.9 million tariff refund
Accumulated deficit $1,377,153 thousand Retained earnings (accumulated deficit) as of June 30, 2026
Tumor Treating Fields medical
"developing and commercializing its innovative therapy, Tumor Treating Fields (TTFields)"
Tumor treating fields are a medical therapy that uses low‑intensity, alternating electric fields applied through pads on the skin to interfere with cancer cells as they try to divide, slowing or stopping tumor growth. Investors pay attention because the therapy’s clinical results, regulatory approvals, reimbursement and device sales directly influence a company’s revenue outlook; think of it like a new tool in a toolbox whose market adoption and proof it works determine its commercial value.
Adjusted EBITDA financial
"Adjusted EBITDA* for the quarter was $10.8 million"
Adjusted EBITDA is a way companies measure how much money they make from their core operations, like running a business, by removing certain costs or income that aren’t part of regular business activities. It helps investors see how well a company is doing without distractions from unusual expenses or gains, making it easier to compare companies or track performance over time.
Conformité Européenne regulatory
"Optune Pax received CE (Conformité Européenne) Mark for the treatment"
A CE marking (Conformité Européenne) is a regulatory sign placed on many products to show they meet European Union health, safety and environmental rules and may be sold across the EU/EEA. For investors, it matters because the marking is like a passport that opens a large market and lowers the risk of forced recalls, sales bans or extra costs for redesigns—factors that can directly affect revenue, timelines and company valuation.
premarket approval application regulatory
"Decision by the U.S. Food and Drug Administration on the premarket approval application"
A premarket approval application is a formal, data-packed request submitted to regulators to get permission to sell a high-risk medical device. It is like asking for a driver’s license for a complex product: the company must show clinical trial results, safety testing and manufacturing controls to prove the device works and won’t harm people. Investors watch these filings because approval unlocks revenue and sharply reduces the regulatory risk that can halt a product’s commercial launch.
Consolidated Statements of Operations financial
"NOVOCURE LIMITED AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS"
A consolidated statement of operations is a company’s combined profit-and-loss report that adds together the revenues, costs and resulting profit or loss of a parent firm and all its controlled subsidiaries, removing internal transactions so the group is shown as one business. Investors use it like a single household budget for a family of companies: it reveals overall sales trends, profit margins and expense patterns that indicate the group’s true operating performance and helps compare results across periods or peers.
non-U.S. GAAP financial
"We measure our performance based upon a non-U.S. GAAP measurement of earnings"
Non-U.S. GAAP describes financial measures or reporting methods that differ from the accounting rules set by U.S. Generally Accepted Accounting Principles. These alternative figures are often used to highlight particular aspects of performance—like cash flow or adjusted profit—by excluding items that a company considers one-time or non-operational. Investors care because such numbers can make results easier to compare or understand, but they require scrutiny since they can omit costs that affect long-term value.
Net revenues $183.6 million increase of 16% compared to the same period in 2025
Net income (loss) ($15.7 million) improved from a net loss of $40.1 million in Q2 2025
Adjusted EBITDA $10.8 million up from an Adjusted EBITDA loss of $9.9 million in Q2 2025
Total active patients 5,128 up from 4,331 total active patients at June 30, 2025
Guidance

For full-year 2026, Novocure guides to total net revenue of $710 million - $725 million and Adjusted EBITDA of $0 million - $15 million, assuming mid-to-high single digit net revenue growth from Optune Gio and gross margin in the mid-70s percent.

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FAQ

What were Novocure (NVCR) net revenues and growth in Q2 2026?
Novocure reported Q2 2026 net revenues of $183.6 million, a 16% increase versus the same period in 2025. Growth was primarily driven by higher global active patient counts across Optune Gio, Optune Lua and Optune Pax therapies.

Did Novocure (NVCR) achieve positive Adjusted EBITDA in Q2 2026?
Yes. Novocure generated Adjusted EBITDA of $10.8 million in Q2 2026, compared with an Adjusted EBITDA loss of $9.9 million in Q2 2025. This reflects higher gross profit and lower share-based compensation.

What is Novocure (NVCR) full-year 2026 financial guidance?
Novocure forecasts 2026 net revenue of $710 million–$725 million and Adjusted EBITDA of $0 million–$15 million. Guidance assumes mid-to-high single-digit net revenue growth from Optune Gio and gross margin in the mid-70s percent range.

How many active patients were on Novocure (NVCR) TTFields therapy at June 30, 2026?
As of June 30, 2026, there were 5,128 active patients on Tumor Treating Fields therapy globally: 4,636 on Optune Gio, 207 on Optune Lua, and 285 on Optune Pax, reflecting continued adoption across indications and geographies.

What new regulatory milestone did Novocure (NVCR) achieve for Optune Pax?
Optune Pax received CE Mark in June 2026 for treating adult patients with locally advanced pancreatic cancer of exocrine origin, used with gemcitabine and nab-paclitaxel. Germany is the first market to launch under this approval.

What was Novocure (NVCR) cash and investment position at June 30, 2026?
At June 30, 2026, Novocure held $93.7 million in cash and cash equivalents and $346.9 million in short-term investments, totaling approximately $440.6 million in liquid financial resources on its balance sheet.

Is Novocure (NVCR) still reporting a net loss in Q2 2026?
Yes. Despite revenue growth and positive Adjusted EBITDA, Novocure recorded a Q2 2026 net loss of $15.7 million, or $0.13 per share, though this was an improvement from a $40.1 million loss a year earlier.
0001645113false00016451132026-07-012026-07-31


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934

July 23, 2026
Date of Report (date of earliest event reported)

NovoCure Limited
(Exact name of registrant as specified in its charter)
Jersey
001-37565
98-1057807
(State or other jurisdiction of incorporation or organization)
(Commission File Number)
(I.R.S. Employer Identification No.)
No. 4 The Forum, Grenville Street
St. Helier
Jersey
JE2 4UF
(Address of Principal Executive Offices)
(Zip Code)
+44 (0) 15 3475 6700
Registrant's telephone number, including area code

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading Symbol(s)Name of each exchange on which registered
Ordinary Shares, no par valueNVCRThe Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
o



Item 2.02     Results of Operations and Financial Condition.

On July 23, 2026, the Company issued a press release announcing certain financial results for the quarter ended
June 30, 2026. A copy of the press release is attached as Exhibit 99.1.

Item 9.01    Financial Statements and Exhibits.

(d)    Exhibits

Exhibit No.Description
99.1
Press Release of NovoCure Limited, dated July 23, 2026
104Cover Page Interactive Data File (embedded within the Inline XBRL document)





SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

NovoCure Limited
(Registrant)

Date: July 23, 2026


By: /s/ Christoph Brackmann  
Name: Christoph Brackmann
Title: Chief Financial Officer


Novocure Reports Second Quarter 2026 Financial Results

Quarterly net revenues of $184 million, an increase of 16% year-over-year, driven by 18% global active patient growth across indications

CE Mark received for Optune Pax® for the treatment of locally advanced pancreatic cancer, Germany first market to launch in EU

More than 280 active patients on Optune Pax as of June 30, 2026

BAAR, Switzerland – July 23, 2026 - Novocure (NASDAQ: NVCR) today reported financial results for the second quarter that ended June 30, 2026. Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing and commercializing its innovative therapy, Tumor Treating Fields (TTFields).

“This was our strongest quarter to date, with record net revenues and active patients on therapy,” said Frank Leonard, CEO, Novocure. “We continue to launch our therapies in multiple markets allowing us to bring TTFields therapy to many more patients who can benefit. We are well-positioned to advance our patient-forward mission while driving sustainable growth and making material progress on our path to profitability.”

Financial updates for the quarter ended June 30, 2026:
•Total net revenues for the quarter were $183.6 million, an increase of 16% compared to the same period in 2025. This increase was primarily driven by active patient growth globally.
◦The U.S., Germany, France and Japan contributed $103.0 million, $23.3 million, $21.3 million and $11.8 million, respectively, with other active markets contributing $18.2 million.
▪$2.8 million in net revenue recognized from one-time benefits in the U.S., Germany and France.
◦Net revenue from Optune Lua® and Optune Pax® in the quarter was $7.0 million.
▪Recognized revenue from Optune Lua in the quarter was $5.4 million. The U.S., Germany and Japan contributed $1.9 million, $1.7 million and $1.8 million, respectively.
▪Recognized revenue from Optune Pax in the quarter was $1.6 million.
◦Revenue in Greater China from Novocure’s partnership with Zai Lab totaled $6.0 million.
•Gross margin for the quarter was 78% compared to 74% in the prior year. Cost of revenues in the quarter benefitted from a one-time $4.9 million tariff refund.
•Research, development and clinical study expenses for the quarter were $51.4 million, a decrease of 8% from the same period in 2025. This decrease was primarily driven by lower direct clinical trial expenses from completed trials.


•Sales and marketing expenses for the quarter were $61.7 million, an increase of 8% compared to the same period in 2025. This increase was primarily driven by costs associated with the launch of Optune Pax in the U.S. and Optune Lua in Japan.
•General and administrative expenses for the quarter were $39.9 million, a decrease of 9% compared to the same period in 2025. This decrease was primarily driven by lower share-based compensation expenses.
•Net loss for the quarter was $15.7 million with loss per share of $0.13.
•Adjusted EBITDA* for the quarter was $10.8 million.
•Cash, cash equivalents and short-term investments were $440.6 million as of June 30, 2026.
Operational updates for the quarter ended June 30, 2026:
•As of June 30, 2026, there were 5,128 total active patients on TTFields therapy globally.
•Optune Gio
◦As of June 30, 2026, there were 4,636 active patients on Optune Gio, an increase of 11% from the same period in 2025.
◦The U.S., Germany, France and Japan contributed 2,341; 637; 471 and 553 active patients, respectively, with 634 active patients contributed by other active markets.
•Optune Lua
◦As of June 30, 2026, there were 207 active patients on Optune Lua, an increase of 51% from the same period in 2025.
◦The U.S., Germany, France and Japan contributed 99; 38; 1 and 64 active patients, respectively, with 5 active patients contributed by other active markets.
•Optune Pax
◦418 prescriptions for Optune Pax were received in the quarter.
◦As of June 30, 2026, there were 285 active patients on Optune Pax in the U.S.

Quarterly updates and achievements:
•June 2026
◦Optune Pax received CE (Conformité Européenne) Mark for the treatment of adult patients with locally advanced pancreatic cancer of exocrine origin, concomitant with gemcitabine and nab-paclitaxel (gem/nab-pac) in accordance with guideline recommendations.

2026 financial guidance:
Novocure’s updated guidance for the full year 2026, as of July 23, 2026, is summarized below:
•Total net revenue: $710 million - $725 million (previous: $690 million - $710 million)
◦Guidance includes collective net revenue contribution from Optune Lua and Optune Pax between $20 million - $30 million.
•Adjusted EBITDA*: $0 million - $15 million (previous: $(15) million - $0 million)



This guidance assumes full-year mid-to-high single digit net revenue growth from Optune Gio, foreign exchange rates as of June 30, 2026 and consistent quarterly gross margin in the mid-70s percent.

Anticipated clinical and regulatory milestones:
•Decision by the U.S. Food and Drug Administration on the premarket approval application for use of TTFields therapy for the treatment of brain metastases from non-small cell lung cancer (Q4 2026).
•Complete enrollment in Phase 3 KEYNOTE D58 clinical trial in newly diagnosed glioblastoma (Q4 2026).

Conference call details
Novocure will host a conference call and webcast to discuss second quarter 2026 financial results at 8:00 a.m. EDT today, Thursday, July 23, 2026. To access the conference call by phone, use the following conference call registration link and dial-in details will be provided. To access the webcast, use the following webcast registration link.

The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.investor.novocure.com, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

About Novocure
Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields. Novocure’s commercialized products are approved in certain countries for the treatment of adult patients with glioblastoma, pancreatic cancer, non-small cell lung cancer, malignant pleural mesothelioma and pleural mesothelioma. Novocure has several additional ongoing or completed clinical trials exploring the use of Tumor Treating Fields therapy in the treatment of glioblastoma, non-small cell lung cancer and pancreatic cancer.

Novocure’s global headquarters is located in Baar, Switzerland, with U.S. headquarters located in Portsmouth, New Hampshire and research and development facilities located in Haifa, Israel. For additional information about the company, please visit Novocure.com and follow @Novocure on LinkedIn and X (Twitter).

Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.





*Non-GAAP Financial Measurements
We measure our performance based upon a non-U.S. GAAP measurement of earnings before interest, taxes, depreciation, amortization and shared-based compensation ("Adjusted EBITDA"). We believe Adjusted EBITDA is useful to investors in evaluating our operating performance because it helps investors compare the results of our operations from period to period by removing the impact of earnings attributable to our capital structure, tax rate and material non-cash items, specifically share-based compensation.

Forward-Looking Statements
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, clinical study progress, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, coverage, collections from third-party payers and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, environmental, regulatory and political conditions and other more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 26, 2026, and subsequent flings with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.



NOVOCURE LIMITED AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
U.S. dollars in thousands (except share and per share data)
Three months ended June 30,Six months ended June 30,Year ended December 31,
20262025202620252025
UnauditedUnauditedAudited
Net revenues$183,584 $158,805 $357,639 $313,799 $655,353 
Cost of revenues41,106 41,472 80,035 79,993 166,879 
Gross profit142,478 117,333 277,604 233,806 488,474 
Operating costs and expenses:
Research, development and clinical studies51,448 55,833 109,784 109,610 224,544 
Sales and marketing61,684 57,066 120,041 112,858 240,064 
General and administrative39,908 43,955 125,761 88,724 177,666 
Total operating costs and expenses153,040 156,854 355,586 311,192 642,274 
Operating income (loss)(10,562)(39,521)(77,982)(77,386)(153,800)
Financial income (expenses), net(1,890)4,542 (3,728)12,112 17,550 
Income (loss) before income tax(12,452)(34,979)(81,710)(65,274)(136,250)
Income tax3,206 5,160 5,086 9,184 (23)
Net income (loss)$(15,658)$(40,139)$(86,796)$(74,458)$(136,227)
Basic and diluted net income (loss) per ordinary share$(0.13)$(0.36)$(0.75)$(0.67)$(1.22)
Weighted average number of ordinary shares used in computing basic and diluted net income (loss) per share116,012,397 111,572,191 115,106,850 110,930,576 111,471,991 




Consolidated Balance Sheets
USD in thousands (except share data)
NOVOCURE LIMITED AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands (except share data)
June 30,
2026		December 31, 2025
UnauditedAudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents$93,701 $93,548 
Short-term investments346,858 354,126 
Restricted cash9,917 9,842 
Trade receivables, net99,131 89,435 
Receivables and prepaid expenses46,690 58,669 
Inventories42,224 41,111 
Total current assets638,521 646,731 
LONG-TERM ASSETS:
Property and equipment, net75,369 77,606 
Field equipment, net26,582 22,066 
Right-of-use assets43,789 47,327 
Other long-term assets10,930 10,596 
Total long-term assets156,670 157,595 
TOTAL ASSETS$795,191 $804,326 
LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES:
Trade payables130,729 122,231 
Other payables, lease liabilities and accrued expenses89,981 100,997 
Total current liabilities220,710 223,228 
LONG-TERM LIABILITIES:
Senior secured credit facility, net
195,891 195,047 
Long-term leases37,529 41,647 
Employee benefit liabilities2,969 3,938 
Total long-term liabilities236,389 240,632 
TOTAL LIABILITIES457,099 463,860 
COMMITMENTS AND CONTINGENCIES
SHAREHOLDERS' EQUITY:
Share capital -
Ordinary shares no par value, Unlimited shares authorized; issued and outstanding:
116,442,465 shares and 112,492,667 shares at June 30, 2026 (unaudited) and December 31, 2025, respectively
— — 


Additional paid-in capital1,718,667 1,634,264 
Accumulated other comprehensive income (loss)(3,422)(3,441)
Retained earnings (accumulated deficit)(1,377,153)(1,290,357)
TOTAL SHAREHOLDERS' EQUITY338,092 340,466 
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY$795,191 $804,326 

Non-U.S. GAAP Financial Measures Reconciliation
USD in thousands

Three months ended June 30,Six months ended June 30,
20262025% Change20262025% Change
Net income (loss)$(15,658)$(40,139)(61)%$(86,796)$(74,458)17 %
Add: Income tax3,206 5,160 (38)%5,086 9,184 (45)%
Add: Financial expenses (income), net1,890 (4,542)(142)%3,728 (12,112)(131)%
Add: Depreciation and amortization4,307 3,444 25 %8,431 6,769 25 %
EBITDA$(6,255)$(36,077)(83)%$(69,551)$(70,617)(2)%
Add: Share-based compensation17,012 26,143 (35)%80,021 55,695 44 %
Adjusted EBITDA$10,757 $(9,934)(208)%$10,470 $(14,922)(170)%

Active Patients at Period End
June 30,
20262025
Optune GioOptune LuaOptune PaxTotalOptune GioOptune LuaOptune PaxTotal
Active patients at period end
United States2,341 99 285 2,725 2,177 98 — 2,275 
International markets:
Germany637 38 — 675 581 33 — 614 
France471 1 — 472 453 — — 453 
Japan553 64 — 617 451 — — 451 
Other international634 5 — 639 532 6 — 538 
International markets - Total2,295 108 — 2,403 2,017 39 — 2,056 
4,636 207 285 5,128 4,194 137 — 4,331 

Investors:
Adam Daney
investorinfo@novocure.com

Media:


Catherine Falcetti
media@novocure.com




Indication and Important Safety Information for Optune Gio®

What is Optune Gio ® approved to treat?
Optune Gio is a wearable, portable, FDA-approved device indicated to treat a type of brain cancer called glioblastoma multiforme (GBM) in adult patients 22 years of age or older.

Newly diagnosed GBM
If you have newly diagnosed GBM, Optune Gio is used together with a chemotherapy called temozolomide (TMZ) if:
•Your cancer is confirmed by your healthcare professional AND
•You have had surgery to remove as much of the tumor as possible

Recurrent GBM
If your tumor has come back, Optune Gio can be used alone as an alternative to standard medical therapy if:
•You have tried surgery and radiation and they did not work or are no longer working AND
•You have tried chemotherapy and your GBM has been confirmed by your healthcare professional

Who should not use Optune Gio?
Optune Gio is not for everyone. Talk to your doctor if you have:
•An implanted medical device (programmable shunt), skull defect (missing bone with no replacement), or bullet fragment. Optune Gio has not been tested in people with implanted electronic devices, which may cause the devices not to work properly, and Optune Gio has not been tested in people with skull defects or bullet fragments, which may cause Optune Gio not to work properly
•A known sensitivity to conductive hydrogels (the gel on the arrays placed on the scalp like the ones used on EKGs). When Optune Gio comes into contact with the skin, it may cause more redness and itching or may rarely cause a life-threatening allergic reaction

Do not use Optune Gio if you are pregnant or are planning to become pregnant. It is not known if Optune Gio is safe or effective during pregnancy.

What should I know before using Optune Gio?
Optune Gio should only be used after receiving training from qualified personnel, such as your doctor, a nurse, or other medical staff who have completed a training course given by Novocure®, the maker of Optune Gio.
•Do not use any parts that did not come with the Optune Gio Treatment Kit sent to you by Novocure or given to you by your doctor
•Do not get the device or transducer arrays wet
•If you have an underlying serious skin condition on the scalp, discuss with your doctor whether this may prevent or temporarily interfere with Optune Gio treatment



What are the possible side effects of Optune Gio?
Most common side effects of Optune Gio when used together with chemotherapy (temozolomide, or TMZ) were low blood platelet count, nausea, constipation, vomiting, tiredness, scalp irritation from the device, headache, seizure, and depression. The most common side effects when using Optune Gio alone were scalp irritation (redness and itchiness) and headache. Other side effects were malaise, muscle twitching, fall and skin ulcers. Talk to your doctor if you have any of these side effects or questions.

Please visit OptuneGio.com for Instructions For Use (IFU) for complete information regarding the device’s indications, contraindications, warnings, and precautions.


Indication and Important Safety Information for Optune Lua®

What is Optune Lua ® approved to treat?
Optune Lua is a wearable, portable, FDA-approved device used together with PD-1/PD-L1 inhibitors (immunotherapy) or docetaxel. It is indicated for adult patients with metastatic non-small cell lung cancer (mNSCLC) who have progressed on or after a platinum-based regimen.

Who should not use Optune Lua?
Optune Lua for mNSCLC is not for everyone. Talk to your doctor if you have:
•An electrical implant. Use of Optune Lua together with electrical implants has not been tested and may cause the implanted device not to work properly
•A known sensitivity to gels like the gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes. In this case, skin contact with the gel used with Optune Lua may commonly cause increased redness and itching, and rarely may even lead to severe allergies such as a fall in blood pressure and difficulty breathing
•Do not use Optune Lua if you are pregnant or are planning to become pregnant. It is not known if Optune Lua is safe or effective during pregnancy.

What should I know before using Optune Lua?

Optune Lua should only be used after receiving training from qualified personnel, such as your doctor, a nurse, or other medical staff who have completed a training course given by Novocure®, the maker of Optune Lua.
•Do not use any parts that did not come with Optune Lua Treatment Kit sent to you by Novocure or given to you by your doctor
•Do not get the device or transducer arrays wet
•Please be aware that Optune Lua has a cord that plugs into an electrical socket. Be careful of tripping when it’s connected
•If you have an underlying serious skin condition where the transducer arrays are placed, discuss with your doctor whether this may prevent or temporarily interfere with Optune Lua treatment.



What are the possible side effects of Optune Lua?

The most common side effects of Optune Lua when used together with certain immunotherapy and chemotherapy drugs were dermatitis, pain in the muscles, bones, or joints, fatigue, anemia, alopecia (hair loss), dyspnea, nausea, cough, diarrhea, anorexia, pruritus (itching), leukopenia, pneumonia, respiratory tract infection, localized edema (swelling), rash, pain, constipation, skin ulcers, hypokalemia (low potassium levels), hypoalbuminemia (low albumin levels), hyponatremia (low sodium levels), and dysphagia (difficulty swallowing).

Other potential adverse effects associated with the use of Optune Lua include treatment related skin irritation, allergic reaction to the adhesive or to the gel, overheating of the array leading to pain and/or local skin burns, infections at site where the arrays make contact with the skin, local warmth and tingling sensation beneath the arrays, medical device site reaction, muscle twitching, and skin breakdown/skin ulcer. Talk to your doctor if you have any of these side effects or questions.

Please visit OptuneLua.com for Instructions For Use (IFU) for complete information regarding the device’s indications, contraindications, warnings, and precautions.



Indication and Important Safety Information for Optune Pax®

What is Optune Pax® approved to treat?

Optune Pax is an FDA-approved wearable therapeutic device, used together with gemcitabine and nab-paclitaxel (a chemotherapy combination). It is indicated for the treatment of adult patients with locally advanced pancreatic cancer.

Who should not use Optune Pax?

Optune Pax for locally advanced pancreatic cancer is not for everyone. Talk to your doctor if you have:
•An electrical implant. Use of Optune Pax together with electrical implants has not been tested and may cause the implanted device not to work properly.
•A known sensitivity to gels like the gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes. In this case, skin contact with the gel used with Optune Pax may commonly cause increased redness and itching. In rare cases, it may lead to severe allergic reactions that can cause a drop in blood pressure and difficulty breathing
•Do not use Optune Pax if you are pregnant or are planning to become pregnant. If you are a woman who is able to get pregnant, you must use birth control when using the device. It is not known if Optune Pax is safe or effective during pregnancy.



What should I know before using Optune Pax?

Optune Pax should only be used after receiving training from qualified personnel, such as your doctor, a nurse, or other medical staff who have completed a training course given by Novocure®, the maker of Optune Pax.
•Do not use any parts that did not come with the Optune Pax Treatment Kit sent to you by Novocure or given to you by your doctor
•Do not get the device or transducer arrays wet
•Please be aware that Optune Pax has a cord that plugs into an electrical socket. Be careful of tripping when it's connected
•If you have an underlying skin condition where the transducer arrays are placed, discuss with your doctor whether this may prevent or temporarily interfere with Optune Pax treatment
•
What are the possible side effects of Optune Pax?

The most common side effects of Optune Pax used together with chemotherapy drugs were low neutrophils, low red blood cell count, low platelet count, low white blood cell count, diarrhea, nausea, vomiting, abdominal pain, constipation, fatigue, swelling, fever, pain, COVID-19, infection, respiratory tract infection, urinary tract infection, pneumonia, liver enzyme increased, weight loss, low potassium level, low albumin level, high blood sugar, muscle pain, neuropathy peripheral (damage to the nerves outside the brain and spinal cord), taste disorder, dizziness, difficulty sleeping, shortness of breath, hair loss, skin-related disorders, and low blood pressure.

Device-related skin adverse effects associated with the use of Optune Pax include skin inflammation, rash, itching, skin redness, skin irritation, skin infection, heavy sweating, and open sores. Other device-related adverse effects associated with the use of Optune Pax include overheating of the array, leading to pain and/or local skin burns, allergic reaction to the adhesive or gel from the transducer arrays, and local warmth and tingling sensation beneath the arrays. Talk to your doctor if you have any of these side effects or have any questions.

Please visit OptunePax.com for Instructions For Use (IFU) for complete information regarding the device’s indications, contraindications, warnings, and precautions.



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